Atenelen may be available in the countries listed below.
Ingredient matches for Atenelen
Sodium Gualenate
Sodium Gualenate is reported as an ingredient of Atenelen in the following countries:
- Japan
International Drug Name Search
Thursday, 29 September 2016
Naklofen SR
Naklofen SR may be available in the countries listed below.
Ingredient matches for Naklofen SR
Diclofenac
Diclofenac is reported as an ingredient of Naklofen SR in the following countries:
- Slovenia
International Drug Name Search
Edifenac
Edifenac may be available in the countries listed below.
Ingredient matches for Edifenac
Diclofenac
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Edifenac in the following countries:
- Bangladesh
International Drug Name Search
Wednesday, 28 September 2016
Asmaflu
Asmaflu may be available in the countries listed below.
Ingredient matches for Asmaflu
Flunisolide
Flunisolide is reported as an ingredient of Asmaflu in the following countries:
- Italy
International Drug Name Search
Nafamostat Mesylate
Nafamostat Mesylate may be available in the countries listed below.
Ingredient matches for Nafamostat Mesylate
Nafamostat
Nafamostat Mesylate (USAN) is also known as Nafamostat (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Human Hepatitis B Immunoglobulin
1. Name Of The Medicinal Product
Human Hepatitis B Immunoglobulin, 100 IU/mL sterile solution
2. Qualitative And Quantitative Composition
Human Hepatitis B Immunoglobulin contains human protein, 10-100 g/L, of which at least 95% is IgG. The concentration of specific IgG to hepatitis B virus is 100 IU/mL in nominal 200 IU and 500 IU vials. The correct volume to give the stated potency is overprinted on the label.
This product is prepared from plasma from screened donors. Donors are selected from the USA.
For excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
Immunoprophylaxis of hepatitis B
- In case of accidental exposure e.g. skin pricks, contamination of abrasions, spillage into eye or mouth, bites or scratches, in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).
- In haemodialysed patients, until vaccination has become effective.
- In the newborn of a hepatitis B virus carrier-mother (if birthweight <1,500g irrespective of e-antigen status of mother; if >1,500g irrespective of mother's HBeAg status but not necessary if she is known to be anti-HBe positive).
- In subjects who did not show an immune response (<10 IU/L of hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
- Sexual contacts of patients with acute hepatitis B within one week of last contact.
- Sexual contacts of newly diagnosed chronic hepatitis B if unprotected contact within the last week.
4.2 Posology And Method Of Administration
Posology
- Prevention of hepatitis B in case of accidental exposure in non-immunised subjects or in subjects who have had no more than a single dose of vaccine:
At least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 – 72 hours, although it should still be considered up to a week after exposure. If it is uncertain whether the source of the exposure is HBsAg positive the prophylactic use of Human Hepatitis B Immunoglobulin is regarded as unnecessary.
- Prevention of hepatitis B in case of accidental exposure in subjects or in subjects who have had not responded to a prior, full course of vaccination:
At least 500 IU (age 10 years or older), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 – 72 hours, although it should still be considered up to a week after exposure. The dose for children is as follows:
300 IU aged 5 – 9 years (inclusive);
200 IU aged 0-4 years (inclusive).
Irrespective of whether the source of the exposure is known or unknown to be HBsAg positive, a second injection of Human Hepatitis B Immunoglobulin should be given one month later.
- Immunoprophylaxis of hepatitis B in haemodialysed patients:
8 – 12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion following vaccination.
- Prevention of hepatitis B in the newborn, of a hepatitis B carrier-mother, at birth or as soon as possible after birth, preferably within 24 hours of birth:
30 – 100 IU/kg. The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/mL
Method of administration
Human Hepatitis B Immunoglobulin should be administered via the intramuscular route. The usual recommended site for adults is the deltoid; for infants the lateral aspect of the thigh is preferable. If a large volume >2 mL for children or >5 mL for adults) is required, it is recommended to administer this in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously if no intravenous product is available. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
4.3 Contraindications
Hypersensitivity to any of the components.
Hypersensitivity to human immunoglobulins.
4.4 Special Warnings And Precautions For Use
Ensure that Human Hepatitis B Immunoglobulin is not administered into a blood vessel, because of the risk of shock.
If the recipient is a carrier of HBsAg, there is no benefit in administering this product.
True allergic reactions to Human Hepatitis B Immunoglobulin are rare.
Human Hepatitis B Immunoglobulin contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Human Hepatitis B Immunoglobulin against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Human Hepatitis B Immunoglobulin is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines, such as rubella, mumps, measles and varicella, for a period of 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Human Hepatitis B Immunoglobulin should be administered three to four weeks after vaccination with such a live attenuated virus vaccine; in case administration of hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three to four months after the administration of Human Hepatitis B Immunoglobulin.
Interference with serological testing
After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test).
4.6 Pregnancy And Lactation
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
4.7 Effects On Ability To Drive And Use Machines
No effects on ability to drive and use machines have been observed.
4.8 Undesirable Effects
There are no robust data on the frequency of undesirable effects from clinical trials. The following undesirable effects have been reported with intramuscular immunoglobulins: chest pain, dyspnoea, tremor, dizziness, facial oedema, glossitis, buccal ulceration and arthralgia. Anaphylactic reactions occur rarely and are more likely in patients who have antibodies to IgA, or who have had an allergic reaction after blood transfusion or treatment with plasma derivatives.
As with all intramuscular injections, some short term discomfort can be expected at the injection site and in rare instances local induration, which can be minimised by deep intramuscular injection
For risk of transmission of virus infections, see Section 4.4.
4.9 Overdose
Consequences of an overdose are not known.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: immune sera and immunoglobulins:
Hepatitis B Immunoglobulin ATC code: J06B B04.
Human Hepatitis B Immunoglobulin contains mainly immunoglobulin G (IgG) with a high content of antibodies against hepatitis B virus surface antigen (HBs).
5.2 Pharmacokinetic Properties
Human Hepatitis B Immunoglobulin for intramuscular use is bioavailable in the recipient's circulation within 2-3 days. Peak serum levels occur by about 5 days.
Human Hepatitis B Immunoglobulin has a half-life of about 3 – 4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
5.3 Preclinical Safety Data
Human Hepatitis B Immunoglobulin is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions which bore no relevance to administration in humans. Repeated dose toxicity testing and embryofoetal toxicity studies are impracticable due to induction of, and interference with antibodies to human protein. Clinical experience provides no evidence of tumorigenic and mutagenic effects of immunoglobulins.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride, glycine, sodium acetate and a small quantity of sodium hydroxide
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Human Hepatitis B Immunoglobulin should be stored between 2°C and 8°C. Storage for up to one week at ambient temperatures (25°C) is not detrimental. DO NOT FREEZE.
Store in the original vial. Keep vial in the outer carton in order to protect from light.
6.5 Nature And Contents Of Container
Neutral borosilicate glass vial (type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.
6.6 Special Precautions For Disposal And Other Handling
The product should be brought to room or body temperature before use.
The colour can vary from colourless to pale-yellow and is either clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Any used product or waste material should be disposed of in accordance with local requirements.
The condition of date expired, or incorrectly stored product cannot be guaranteed. Such product may be unsafe, and should not be used.
7. Marketing Authorisation Holder
Bio Products Laboratory
Dagger Lane
Elstree
Hertfordshire
WD6 3BX
United Kingdom.
Tel: +44 (0)20 8258 2200
Fax: +44 (0)20 8258 2608
Email: info@bpl.co.uk
8. Marketing Authorisation Number(S)
PL 08801/0012
9. Date Of First Authorisation/Renewal Of The Authorisation
February 1992
10. Date Of Revision Of The Text
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Elmex Fluid
Elmex Fluid may be available in the countries listed below.
Ingredient matches for Elmex Fluid
Dectaflur
Dectaflur is reported as an ingredient of Elmex Fluid in the following countries:
- Czech Republic
- Finland
- Switzerland
Olaflur
Olaflur is reported as an ingredient of Elmex Fluid in the following countries:
- Czech Republic
- Finland
- Switzerland
International Drug Name Search
Folacite
Folacite may be available in the countries listed below.
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Folic Acid
Folic Acid is reported as an ingredient of Folacite in the following countries:
- Indonesia
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Fluvastatine EG
Fluvastatine EG may be available in the countries listed below.
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Fluvastatin
Fluvastatin sodium salt (a derivative of Fluvastatin) is reported as an ingredient of Fluvastatine EG in the following countries:
- France
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Nadona
Nadona may be available in the countries listed below.
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Hydroquinone
Hydroquinone is reported as an ingredient of Nadona in the following countries:
- Spain
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Nadiflo
Nadiflo may be available in the countries listed below.
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Nadifloxacin
Nadifloxacin is reported as an ingredient of Nadiflo in the following countries:
- Japan
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Eparina
Eparina may be available in the countries listed below.
Ingredient matches for Eparina
Heparin
Eparina (DCIT) is known as Heparin in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Click for further information on drug naming conventions and International Nonproprietary Names.
Shincef
Shincef may be available in the countries listed below.
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Cefuroxime
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Shincef in the following countries:
- Singapore
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Hylnate
Hylnate may be available in the countries listed below.
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Hyaluronic Acid
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Hylnate in the following countries:
- Japan
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Burns, External Medications
Definition of Burns, External: The treatment of burns depends on the depth, area and location of the burn. Burn depth is generally categorised as first, second or third degree. A first degree burn is superficial and has similar characteristics to a typical sun burn. The skin is red in colour and sensation is intact. In fact, it is usually somewhat painful. Second degree burns look similar to the first degree burns; however, the damage is now severe enough to cause blistering of the skin and the pain is usually somewhat more intense. In third degree burns the damage has progressed to the point of skin death. The skin is white and without sensation.
Drugs associated with Burns, External
The following drugs and medications are in some way related to, or used in the treatment of Burns, External. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
See sub-topics
Topics under Burns, External
- Burns, Nitrogen Retention (3 drugs)
Learn more about Burns, External
Micromedex Care Notes:
- Electrical Burn In Children
- Electrical Burns In Adults
- Full Thickness Burn
- Lightning Injuries
- Partial Thickness Burn
- Superficial Burn
Medical Encyclopedia:
- Burns
Drug List:
Creon 40000
Creon
40000 Capsules
Pancreatin
Important things you SHOULD know about Creon 40000
- Creon 40000 is a pancreatic enzyme supplement for people whose bodies do not make enough enzymes to digest their food.
Take the amount of capsules as prescribed by your doctor or dietician.
Take Creon 40000 with a meal or a snack and drink plenty of water.
Do not take Creon 40000 if you are allergic to pork or any pig product.- If you experience severe abdominal pain while taking Creon 40000, contact your doctor immediately.
- Most people do not have problems taking Creon 40000 but side effects can occur. (see section 4)
Please read the rest of this leaflet carefully before you start taking these capsules.
It includes other important information on the safe and effective use of this medicine that might be especially important for you.
This leaflet was last approved in September 2009.
How to find the information you need
1. About Creon 40000
What Creon 40000 is and how it works.
2. Before you take Creon 40000
Who can take Creon 40000?
Can you take Creon 40000 if you are pregnant or breast feeding?
Driving or operating machinery.
3. How to take Creon 40000
How much Creon 40000 you should take.
When you should take Creon 40000.
How you should take Creon 40000.
What to do if you take too much Creon 40000.
What to do if you forget a dose.
4. Possible side effects
Abdominal symptoms (such as abdominal pain).
Side effects and what to do if you get them.
5. How to store Creon 40000
How and where to keep your capsules.
6. Further Information
The ingredients in Creon 40000.
More information about cystic fibrosis and pancreatitis.
This medicine has been prescribed for you personally. Don’t offer it to other people, even if their symptoms seem to be the same as yours.
About Creon 40000
What is Creon 40000
- Creon 40000 is a high strength pancreatic enzyme supplement.
- Pancreatic enzyme supplements are used by people whose bodies do not make enough of their own enzymes to digest their food.
- Creon 40000 granules contain a mixture of the natural enzymes which are used to digest food.
- The enzymes are taken from pig pancreas glands.
How does Creon 40000 work?
The enzymes in Creon 40000 work by digesting food as it passes through the gut. So, you must take Creon 40000 at the same time as eating a meal or a snack. This will allow the enzymes to mix thoroughly with the food.
Before you take Creon 40000
Do not take Creon 40000 if:
- Your doctor has told you that you are in the early stages of inflammation of the pancreas (acute pancreatitis)
- You are allergic to pork or any pig product, or to any of the other ingredients (see section 6).
If any of the above applies to you do not take Creon 40000. Talk to your doctor or dietician again.
Talk to your doctor if:
- you are pregnant or trying to get pregnant (Creon 40000 can be used while breast feeding)
Please tell your doctor, dietician, or pharmacist if you think that you should not take Creon 40000 for any other reason.
If you drive or use machines
It is unlikely that Creon 40000 will affect your ability to drive or operate tools or machines.
How to take Creon 40000
How much Creon 40000 to take
Always follow your doctor or dietician’s advice on how many capsules to take.
- If your doctor advises you to increase the number of capsules you take, you should do so slowly. If you still have fatty stools or abdominal pain, talk to your doctor or dietician.
When to take Creon 40000
- Always take Creon 40000 at the same time as eating a meal or a snack and drink plenty of water (see section 1).
How to take Creon 40000
- Swallow the capsules whole.
- Drink plenty of liquid every day.
How long to take Creon 40000 for
You should take your medicine until your doctor tells you to stop. Many patients will need to take pancreatic enzymes supplements for the rest of their lives.
If you take too much Creon 40000
If you take too much Creon 40000, you should drink plenty of water and see your doctor immediately.
If you forget a dose
If you forget to take your medicine, wait until your next meal and take your usual number of capsules.
Do not try to make up for the number of capsules that you have missed. Just take your next dose at the usual time.
Creon 40000 Side Effects
Like all medicines, Creon 40000 can cause side effects (unwanted effects or reactions), but not everyone gets them.
If you have severe or long-lasting abdominal pain, contact your doctor immediately.
If you notice any unusual abdominal symptoms while taking Creon 40000 – contact your doctor.
Very common side effects (affect more than 1 in 10 patients):
- stomach pains
Common side effects (affect 1–10 patients out of 100):
Inform your doctor if you have:
- diarrhoea
- constipation
- feeling or being sick
Uncommon side effects (affect 1–10 patients out of 1000):
- skin reactions, such as a rash or itching
At extremely high doses, some patients have had high levels of uric acid in their blood and urine.
If you notice any unwanted effect (even one not mentioned in this leaflet), or if you feel unwell while taking Creon 40000: Tell your doctor.
How to store Creon 40000
How and where to keep your capsules
Keep all medicines out of the reach and sight of children – preferably locked in a cupboard or medicine cabinet.
Do not store above 25 °C and keep in the original container. The enzymes in Creon 40000 are natural products and their ability to digest food decreases over time. If the container is left in warm conditions (e. g. the glove compartment of a car), the digestive activity decreases faster.
Do not take Creon 40000 capsules after the expiry date on the bottle.
Return all unused medicine to your pharmacist.
Further information
The ingredients in Creon 40000
The active ingredient in Creon 40000 is pancreatin.
Each capsule contains enteric coated brownish-coloured granules (minimicrospheres) containing pancreatin 400 mg, equivalent to:
List of Enzymes: (PhEur units per capsule)
Lipase 40,000
Amylase 25,000
Protease 1,600
The granules are coated with a mixture of the following ingredients: macrogol 4000, hypromellose phthalate, dimeticone, triethyl citrate and cetyl alcohol.
The capsules contain: gelatin, iron oxides (E172), titanium dioxide (E171) and lauryl sulphate.
Creon 40000 is available in 100 capsule packs.
The Marketing Authorisation Holder is:
Solvay Healthcare Ltd
Southampton
SO18 3JD
UK
The Manufacturer is:
Solvay Pharmaceuticals GmbH
31535 Neustadt a. Rbge
Germany
More information about cystic fibrosis and pancreatitis
You can find out more about Cystic Fibrosis from the following organisation:
The CF Trust
11 London Road
Bromley
BR1 1BY
You can find out more about Pancreatitis from the following organisation:
Pancreatitis Supporters Network
PO Box 8938
Birmingham
B13 9FW
Registered trademark
1069334
Naftilan
Naftilan may be available in the countries listed below.
Ingredient matches for Naftilan
Fenofibrate
Fenofibrate is reported as an ingredient of Naftilan in the following countries:
- China
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Naftidrofuryl Nor
Naftidrofuryl Nor may be available in the countries listed below.
Ingredient matches for Naftidrofuryl Nor
Naftidrofuryl
Naftidrofuryl oxalate (a derivative of Naftidrofuryl) is reported as an ingredient of Naftidrofuryl Nor in the following countries:
- France
International Drug Name Search
Aureo S 700
Dosage Form: FOR ANIMAL USE
Aureo S 700®
Granular
Chlortetracycline, sulfamethazine
35 G Type A Medicated Article
Active drug ingredients
Chlortetracycline calcium complex
equivalent to chlortetracycline HCl ................................................................. 35 g/lb
Sulfamethazine .................................................................................... 7.7% (35 g/lb)
Ingredients
Calcium sulfate and dried Streptomyces aureofaciens fermentation product.
For use in the manufacture of beef cattle feeds
Indications
As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.
Mixing directions
Mix sufficient Aureo S 700 in the feed to supply 350 mg of Aureomycin chlortetracycline and 350 mg of sulfamethazine per head per day. The following table shows the amounts of Aureo S 700 needed for the various quantities of supplement.
| Aureo S 700 (lb/ton of Supplement) | Supplement Will Contain (g/ton) | Feed Supplement at (lb/head/day) | |
|---|---|---|---|
| Chlortetracycline | Sulfamethazine | ||
| 40 | 1400 | 1400 | 0.5 |
| 20 | 700 | 700 | 1 |
| 10 | 350 | 350 | 2 |
| 5 | 175 | 175 | 4 |
| 4 | 140 | 140 | 5 |
| 2 | 70 | 70 | 10 |
| 1 | 35 | 35 | 20 |
Feeding instructions
Feed for 28 days.
Warning
Withdraw 7 days prior to slaughter.
A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal.
Restricted Drug (California) - use only as directed. Not for human use.
NADA #35-805, Approved by FDA
Marketed by
Alpharma Inc.
Bridgewater, New Jersey 08807
Net wt 50 LB (22.68 kg)
Trademarks
registered by
Alpharma Inc.
Made in USA
700338 0901
PRINCIPAL DISPLAY PANEL - 50 LB Bag
Aureo S 700®
Granular
ALPHARMA
Chlortetracycline,
sulfamethazine
35 G Type A Medicated Article
For indications, mixing directions
and ingredients see back
Net wt 50 LB (22.68 kg)
ALPHARMA®
Aureo S 700®
Granular
| AUREO S 700 chlortetracycline hydrochloride and sulfamethazine granule | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA035805 | 01/01/2009 | |
| Labeler - Alpharma Inc. Animal Health (070954094) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alpharma Inc. Animal Health | 005300025 | MANUFACTURE, ANALYSIS, RELABEL, REPACK | |
Mezec
Mezec may be available in the countries listed below.
Ingredient matches for Mezec
Cresol
Cresol is reported as an ingredient of Mezec in the following countries:
- Japan
Dextromethorphan
Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Mezec in the following countries:
- Japan
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Protozol
Protozol may be available in the countries listed below.
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Metronidazole
Metronidazole is reported as an ingredient of Protozol in the following countries:
- Bahrain
- Iraq
- Jordan
- Kuwait
- Lebanon
- Libya
- Nigeria
- Oman
- Qatar
- Saudi Arabia
- Sudan
- Syria
- United Arab Emirates
- Yemen
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Moducrin
Moducrin may be available in the countries listed below.
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Amiloride
Amiloride hydrochloride dihydrate (a derivative of Amiloride) is reported as an ingredient of Moducrin in the following countries:
- Germany
Hydrochlorothiazide
Hydrochlorothiazide is reported as an ingredient of Moducrin in the following countries:
- Germany
Timolol
Timolol maleate (a derivative of Timolol) is reported as an ingredient of Moducrin in the following countries:
- Germany
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Norepinefrina Northia
Norepinefrina Northia may be available in the countries listed below.
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Norepinephrine
Norepinephrine is reported as an ingredient of Norepinefrina Northia in the following countries:
- Argentina
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Norbit
Norbit may be available in the countries listed below.
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Disopyramide
Disopyramide phosphate (a derivative of Disopyramide) is reported as an ingredient of Norbit in the following countries:
- Bangladesh
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Itraconazole Solution
Pronunciation: IT-ra-KON-a-zole
Generic Name: Itraconazole
Brand Name: Sporanox
Itraconazole Solution has been shown to cause decreased heart function. Contact your doctor immediately if you experience symptoms of congestive heart failure such as swelling of the hands, ankles, feet, or abdomen; bloating; shortness of breath; fast or irregular heartbeat; severe or persistent nausea; or confusion.
Use of Itraconazole Solution along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Itraconazole Solution if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).
Itraconazole Solution is used for:
Treating fungal infections. It may also be used for other conditions as determined by your doctor.
Itraconazole Solution is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.
Do NOT use Itraconazole Solution if:
- you are allergic to any ingredient in Itraconazole Solution
- you are taking an aldosterone blocker (eg, eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), oral midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (eg, alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 5-HT receptor agonists (eg, eletriptan)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Itraconazole Solution:
Some medical conditions may interact with Itraconazole Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to other azole antifungals (eg, ketoconazole)
- if you have HIV infection, a weakened immune system, low white blood cell levels, cystic fibrosis, kidney or liver problems, abnormal liver function tests, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, or problems with swelling or retaining fluid
- if you have an irregular heartbeat or other heart problems (eg, congestive heart failure, coronary artery disease, heart valve problems)
- if you have had serious liver problems caused by Itraconazole Solution or other medicines
Some MEDICINES MAY INTERACT with Itraconazole Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or birth control [eg, birth control pills]), multivitamin products, and herbal or dietary supplements may interact with Itraconazole Solution, increasing the risk of serious side effects
- Nevirapine, rifabutin, or rifampin because they may decrease Itraconazole Solution's effectiveness
- Astemizole, cisapride, dofetilide, levacetylmethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased
- Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Itraconazole Solution, resulting in increased risk of sedation and breathing difficulties
- Aldosterone blockers (eg, eplerenone), calcium channel blockers (eg, verapamil), conivaptan, ergot alkaloids (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), 5-HT receptor agonists (eg, eletriptan), or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Itraconazole Solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Itraconazole Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Itraconazole Solution:
Use Itraconazole Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Itraconazole Solution on an empty stomach at least 1 hour before or 2 hours after eating.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you are using Itraconazole Solution to treat a mouth or throat infection, swish Itraconazole Solution in your mouth for several seconds before swallowing, unless directed otherwise by your doctor.
- Do not take antacids within 1 hour before or 2 hours after taking Itraconazole Solution.
- Take Itraconazole Solution at least 2 hours before proton pump inhibitors (eg, omeprazole).
- To clear up your infection completely, take Itraconazole Solution for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.
- Itraconazole Solution works best if it is taken at the same time each day.
- If you miss a dose of Itraconazole Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Itraconazole Solution.
Important safety information:
- Itraconazole Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Itraconazole Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Rarely, Itraconazole Solution has been associated with serious, sometimes fatal liver damage. Contact your doctor right away if you notice dark urine, pale stools, a swollen or tender stomach, or yellowing of the skin or eyes.
- Itraconazole Solution only works against fungi; it does not treat viral infections (eg, the common cold).
- Be sure to use Itraconazole Solution for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Do not switch between the capsule and oral solution forms of Itraconazole Solution without checking with your doctor. Effectiveness and side effects of these forms of Itraconazole Solution may be different even at the same dose.
- Diabetes patients - Itraconazole Solution may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Itraconazole Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- If you are using Itraconazole Solution to treat a certain type of fungal infection (onychomycosis), you should use an effective form of birth control while you are taking Itraconazole Solution and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of birth control.
- Tell your doctor or dentist that you take Itraconazole Solution before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including liver function, may be performed while you use Itraconazole Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Itraconazole Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.
- Itraconazole Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Itraconazole Solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Itraconazole Solution while you are pregnant. Itraconazole Solution is found in breast milk. If you are or will be breast-feeding while you use Itraconazole Solution, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Itraconazole Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; gas; headache; nausea; runny nose; stomach pain or upset; unpleasant taste; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; coughing up white or pink mucus; dark urine; decreased sexual ability; depression; fast or irregular heartbeat; fever, chills, or sore throat; hair loss; increased or uncontrolled urination; joint pain; loss of appetite; loss of hearing; muscle pain, weakness, or cramping; numbness, burning, or tingling of the hands, arms, legs, or feet; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; sensitivity to sunlight; severe or persistent nausea; severe or persistent vomiting; severe stomach or back pain; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach abdomen; trouble sleeping; unusual tiredness or fatigue; vision problems (eg, blurred vision, double vision); yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Itraconazole side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Itraconazole Solution:
Store Itraconazole Solution below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Itraconazole Solution out of the reach of children and away from pets.
General information:
- If you have any questions about Itraconazole Solution, please talk with your doctor, pharmacist, or other health care provider.
- Itraconazole Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Itraconazole Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Itraconazole resources
- Itraconazole Side Effects (in more detail)
- Itraconazole Use in Pregnancy & Breastfeeding
- Drug Images
- Itraconazole Drug Interactions
- Itraconazole Support Group
- 11 Reviews for Itraconazole - Add your own review/rating
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Norbal
Norbal may be available in the countries listed below.
Ingredient matches for Norbal
Buspirone
Buspirone hydrochloride (a derivative of Buspirone) is reported as an ingredient of Norbal in the following countries:
- Greece
International Drug Name Search
Prezal
Prezal may be available in the countries listed below.
Ingredient matches for Prezal
Lansoprazole
Lansoprazole is reported as an ingredient of Prezal in the following countries:
- Netherlands
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Norethin
Ingredient matches for Norethin
Ethinylestradiol
Ethinylestradiol is reported as an ingredient of Norethin in the following countries:
- United States
Norethisterone
Norethisterone is reported as an ingredient of Norethin in the following countries:
- United States
International Drug Name Search
Fortum 2g and 3g Injection
1. Name Of The Medicinal Product
Fortum® for Injection
Ceftazidime (as pentahydrate) (INN) Injection
2. Qualitative And Quantitative Composition
Fortum for Injection: Vials contain 2g or 3g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime).
Fortum Monovial in a vial containing 2g ceftazidime pentahydrate.
3. Pharmaceutical Form
Sterile Powder for constitution for Injection
4. Clinical Particulars
4.1 Therapeutic Indications
Single infections
Mixed infections caused by two or more susceptible organisms
Severe infections in general
Respiratory tract infections
Ear, nose and throat infections
Urinary tract infections
Skin and soft tissue infections
Gastrointestinal, biliary and abdominal infections
Bone and joint infections
Dialysis: infections associated with haemo - and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)
In meningitis it is recommended that the results of a sensitivity test are known before treatment with ceftazidime as a single agent. It may be used for infections caused by organisms resistant to other antibiotics including aminoglycosides and many cephalosporins. When appropriate, however, it may be used in combination with an aminoglycoside or other beta-lactam antibiotic for example, in the presence of severe neutropenia, or with an antibiotic active against anaerobes when the presence of bacteroides fragilis is suspected. In addition, ceftazidime is indicated in the perioperative prophylaxis of transurethral prostatectomy.
In vitro the activities of ceftazidime and aminoglycoside antibiotics in combination have been shown to be at least additive; there is evidence of synergy in some strains tested. This property may be important in the treatment of febrile neutropenic patients.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology And Method Of Administration
Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity and type of infection and the age, weight and renal function of the patient.
Adults: The adult dosage range for ceftazidime is 1 to 6g per day 8 or 12 hourly (im or iv). In the majority of infections, 1g 8-hourly or 2g 12-hourly should be given. In urinary tract infections and in many less serious infections, 500mg or 1g 12-hourly is usually adequate. In very severe infections, especially immunocompromised patients, including those with neutropenia, 2g 8 or 12-hourly or 3g 12-hourly should be administered.
When used as a prophylactic agent in prostatic surgery 1g (from the 1g vial) should be given at the induction of anaesthesia. A second dose should be considered at the time of catheter removal.
Elderly: In view of the reduced clearance of ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3g, especially in those over 80 years of age.
Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150mg/kg/day as three divided doses should be used. In adults with normal renal function 9g/day has been used.
Infants and children: The usual dosage range for children aged over two months is 30 to 100mg/kg/day, given as two or three divided doses.
Doses up to 150mg/kg/day (maximum 6g daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.
Neonates and children up to 2 months of age: Whilst clinical experience is limited, a dose of 25 to 60mg/kg/day given as two divided doses has proved to be effective. In the neonate the serum half-life of ceftazidime can be three to four times that in adults.
Dosage in impaired renal function: Ceftazidime is excreted by the kidneys almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function it is recommended that the dosage of ceftazidime should be reduced to compensate for its slower excretion, except in mild impairment, i.e. glomerular filtration rate (GFR) greater than 50ml/min. In patients with suspected renal insufficiency, an initial loading dose of 1g of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dose.
Renal impairment: For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units, it is recommended that the dosage should be 1g daily in divided doses. For low-flux haemofiltration it is recommended that the dosage should be that suggested under impaired renal function.
Recommended maintenance doses are shown below:
RECOMMENDED MAINTENANCE DOSES OF CEFTAZIDIME IN RENAL INSUFFICIENCY
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* These values are guidelines and may not accurately predict renal function in all patients especially in the elderly in whom the serum creatinine concentration may overestimate renal function.
In patients with severe infections, especially in neutropenics, who would normally receive 6g of ceftazidime daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency increased appropriately. In such patients it is recommended that ceftazidime serum levels should be monitored and trough levels should not exceed 40mg/litre.
When only serum creatinine is available, the following formula (Cockcroft's equation) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
Males:
Creatinine clearance = | Weight (kg) x (140 - age in years) |
(ml/min) | 72 x serum creatinine (mg/dl) |
Females:
0.85 x above value.
To convert serum creatinine in µmol/litre into mg/dl divide by 88.4.
In children the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced in cases of renal insufficiency as for adults.
The serum half-life of ceftazidime during haemodialysis ranges from 3 to 5 hours. The appropriate maintenance dose of ceftazidime should be repeated following each haemodialysis period.
Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250mg for 2L of dialysis fluid).
Administration: Ceftazidime may be given intravenously or by deep intramuscular injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.
4.3 Contraindications
Ceftazidime is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.
4.4 Special Warnings And Precautions For Use
Hypersensitivity reactions:
As with other beta-lactam antibiotics, before therapy with ceftazidime is instituted, careful inquiry should be made for a history of hypersensitivity reactions to ceftazidime, cephalosporins, penicillins or other drugs. Special care is indicated in patients who have experienced an allergic reaction to penicillins or beta-lactams. Ceftazidime should be given only with special caution to patients with type I or immediate hypersensitivity reactions to penicillin. If an allergic reaction to ceftazidime occurs, discontinue the drug. Serious hypersensitivity reactions may require adrenaline (epinephrine), hydrocortisone, antihistamine or other emergency measures.
Renal function:
Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with nephrotoxic drugs, e.g. aminoglycoside antibiotics, or potent diuretics such as furosemide, as these combinations are suspected of affecting renal function adversely. Clinical experience with ceftazidime has shown that this is not likely to be a problem at the recommended dose levels. There is no evidence that ceftazidime adversely affects renal function at normal therapeutic doses: however, as for all antibiotics eliminated via the kidneys, it is necessary to reduce the dosage according to the degree of reduction in renal function to avoid the clinical consequences of elevated antibiotic levels, e.g. neurological sequelae, which have occasionally been reported when the dose has not been reduced appropriately (see 4.2 Dosage in Impaired Renal Function and 4.8 Undesirable Effects).
Overgrowth of non-susceptible organisms:
As with other broad spectrum antibiotics, prolonged use of ceftazidime may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci and Serratia spp) which may require interruption of treatment or adoption of appropriate measures. Repeated evaluation of the patient's condition is essential.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Ceftazidime does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed. Ceftazidime does not interfere in the alkaline picrate assay for creatinine. The development of a positive Coombs' test associated with the use of ceftazidime in about 5% of patients may interfere with the cross-matching of blood.
Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime with chloramphenicol is proposed, the possibility of antagonism should be considered.
In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Therefore, alternative non-hormonal methods of contraception are recommended.
4.6 Pregnancy And Lactation
There is no experimental evidence of embryopathic or teratogenic effects attributable to ceftazidime but, as with all drugs, it should be administered with caution during the early months of pregnancy and in early infancy. Use in pregnancy requires that the anticipated benefit be weighed against the possible risks.
Ceftazidime is excreted in human milk in low concentrations and consequently caution should be exercised when ceftazidime is administered to a nursing mother.
4.7 Effects On Ability To Drive And Use Machines
None reported.
4.8 Undesirable Effects
Data from large clinical trials (internal and published) were used to determine the frequency of very common to uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency:
very common
common
uncommon
rare
very rare <1/10,000.
Infections and infestations
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Blood and lymphatic system disorders
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Immune system disorders
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Nervous system disorders
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There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy, and coma in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.
Vascular disorders
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Gastrointestinal disorders
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As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
Renal and urinary disorders
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Hepatobiliary disorders
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Skin and subcutaneous tissue disorders
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General disorders and administration site conditions
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Investigations
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4.9 Overdose
Overdosage can lead to neurological sequelae including encephalopathy, convulsions and coma.
Serum levels of ceftazidime can be reduced by dialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC classification
Pharmacotherapeutic group: cephalosporins ATC code: J01DD02
Mode of action
Ceftazidime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.
Mechanism of Resistance
Ceftazidime is effectively stable to hydrolysis by most classes of beta-lactamases, including penicillinases and cephalosporinases but not extended spectrum beta-lactamases.
Bacterial resistance to ceftazidime may be due to one or more of the following mechanisms:
- hydrolysis by beta-lactamases. Ceftazidime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) including the SHV plasmid mediated ESBLs and by the chromosomally-encoded (AmpC) enzyme that may be induced or stably derepressed in certain aerobic gram-negative bacterial species
- reduced affinity of penicillin-binding proteins for ceftazidime
- outer membrane impermeability, which restricts access of ceftazidime to penicillin binding proteins in gram-negative organisms
- drug efflux pumps.
Breakpoints
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
- Enterobacteriaceae: S =< 1 mg/l and R > 8 mg/l
- Pseudomonas aeruginosa: S =< 8 mg/l and R > 8 mg/l
Microbiological Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftazidime in at least some types of infections is questionable.
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5.2 Pharmacokinetic Properties
Ceftazidime administered by the parenteral route reaches high and prolonged serum levels in man. After intramuscular administration of 500mg and 1g serum mean peak levels of 18 and 37mg/litre respectively are rapidly achieved. Five minutes after an intravenous bolus injection of 500mg, 1g or 2g, serum mean levels are respectively 46, 87 and 170mg/litre.
Therapeutically effective concentrations are still found in the serum 8 to 12 hours after both intravenous and intramuscular administration. The serum half-life is about 1.8 hours in normal volunteers and about 2.2 hours in patients with apparently normal renal function. The serum protein binding of ceftazidime is low at about 10%.
Ceftazidime is not metabolised in the body and is excreted unchanged in the active form into the urine by glomerular filtration. Approximately 80 to 90% of the dose is recovered in the urine within 24 hours. Less than 1% is excreted via the bile, significantly limiting the amount entering the bowel.
Concentrations of ceftazidime in excess of the minimum inhibitory levels for common pathogens can be achieved in tissues such as bone, heart, bile, sputum, aqueous humour, synovial and pleural and peritoneal fluids. Transplacental transfer of the antibiotic readily occurs. Ceftazidime penetrates the intact blood brain barrier poorly and low levels are achieved in the csf in the absence of inflammation. Therapeutic levels of 4 to 20mg/litre or more are achieved in the csf when the meninges are inflamed.
5.3 Preclinical Safety Data
No additional data of relevance.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium carbonate (anhydrous sterile)
6.2 Incompatibilities
Ceftazidime is less stable in Sodium Bicarbonate Injection than other intravenous fluids. It is not recommended as a diluent.
Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.
Precipitation has been reported when vancomycin has been added to ceftazidime in solution. It is recommended that giving sets and intravenous lines are flushed between administration of these two agents.
6.3 Shelf Life
Fortum Monovial - Two years for the unconstituted product and 24 hours for the constituted product when stored below 30°C and protected from light.
Three years when stored below 25°C and protected from light.
6.4 Special Precautions For Storage
The unconstituted product should be stored below 30°C and protected from light. Constituted solutions may be stored in the refrigerator (2 - 8°C) for up to 24 hours.
6.5 Nature And Contents Of Container
Individually cartoned vials containing 2g ceftazidime (as pentahydrate) for intravenous use in packs of 1 or 5.
Individually cartoned Monovials containing 2g (as pentahydrate) for intravenous infusion.
Individually cartoned vials containing 2g ceftazidime (as pentahydrate) for intravenous infusion in packs of 1 or 5.
Individually cartoned vials containing 3g ceftazidime (as pentahydrate) for intravenous and intravenous infusion use.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Instructions for constitution: See table for addition volumes and solution concentrations, which may be useful when fractional doses are required.
PREPARATION OF SOLUTION
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*Note: Addition should be in two stages.
‡Note: Use Sodium Chloride Injection 0.9%, Dextrose Injection 5% or other approved diluent (see pharmaceutical precautions) as Water for Injections produces hypotonic solutions at this concentration.
All sizes of vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted.
250mg i.m./i.v., 500mg i.m./i.v., 1g i.m./i.v., and 2g and 3g i.v. bolus vials:
1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in about 1 to 2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). Ensure that the needle remains within the solution and does not enter the head space. The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.
2g and 3g i.v. infusion vials:
This vial may be constituted for short intravenous infusion (e.g. up to 30 minutes) as follows (mini-bag or burette-type set):
Prepare using a total of 50ml (for 2g vials) and 75ml (for 3g vials) of compatible diluent, added in TWO stages as below:-
1. Insert the syringe needle through the vial closure and inject 10ml of diluent for 2g vial and 15ml for 3g vial. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution obtained in about 1 to 2 minutes.
3. Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the vial closure to relieve the internal pressure.
4. Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag or burette-type set) making up a total volume of a least 50ml (75ml for the 3g vial), and administer by intravenous infusion over 15-30 minutes.
NOTE: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before the product has dissolved.
Fortum Monovial:
The contents of the Monovial are added to small volume infusion bags containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection, or another compatible fluid.
The 2g presentation must be constituted in not less than 100mL infusion bag.
1) Peel off the removable top part of the label and remove the cap.
2) Insert the needle of the Monovial into the additive port of the infusion bag.
3) To activate, push the plastic needle holder of the Monovial down onto the vial shoulder until a "click" is heard.
4) Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
5) Shake the vial to reconstitute the Fortum.
6) On constitution, the Fortum will effervesce slightly.
7) With the vial uppermost, transfer the reconstituted Fortum into the infusion bag by squeezing and releasing the bag.
8) Repeat the steps 4 to 7 to rinse the inside of the vial. Dispose of the empty Monovial safely. Check that the powder is completely dissolved and that the bag has no leaks.
Fortum Monovial is for i.v. infusion only.
These solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids. Ceftazidime is compatible with the most commonly used intravenous fluids.
Vials of Fortum for Injection and Fortum Monovials as supplied are under reduced pressure; a positive pressure is produced on constitution due to the release of carbon dioxide.
Vials of Fortum for Injection should be stored at a temperature below 25°C.
Vials of Fortum for Injection do not contain any preservatives and should be used as single-dose preparations.
In keeping with good pharmaceutical practice, it is preferable to use freshly constituted solutions of Fortum for Injection. If this is not practicable, satisfactory potency is retained for 24 hours in the refrigerator (2 - 8°C) when prepared in Water for Injection BP or any of the injections listed below.
At ceftazidime concentrations between 1mg/ml and 40mg/ml in:
0.9% Sodium Chloride Injection BP
M/6 Sodium Lactate Injection BP
Compound Sodium Lactate Injection BP (Hartmann's Solution)
5% Dextrose Injection BP
0.225% Sodium Chloride and 5% Dextrose Injection BP
0.45% Sodium Chloride and 5% Dextrose Injection BP
0.9% Sodium Chloride and 5% Dextrose Injection BP
0.18% Sodium Chloride and 4% Dextrose Injection BP
10% Dextrose Injection BP
Dextran 40 Injection BP 10% in 0.9% Sodium Chloride Injection BP
Dextran 40 Injection BP 10% in 5% Dextrose Injection BP
Dextran 70 Injection BP 6% in 0.9% Sodium Chloride Injection BP
Dextran 70 Injection BP 6% in 5% Dextrose Injection BP
(Ceftazidime is less stable in Sodium Bicarbonate Injection than in other intravenous fluids. It is not recommended as a diluent)
At concentrations of between 0.05mg/ml and 0.25mg/ml in Intraperitoneal Dialysis Fluid (Lactate) BPC 1973.
When reconstituted for intramuscular use with: 0.5% or 1% Lidocaine Hydrochloride Injection BP
When admixed at 4mg/ml with (both components retain satisfactory potency):
Hydrocortisone (hydrocortisone sodium phosphate) 1mg/ml in 0.9% Sodium Chloride Injection BP or 5% Dextrose Injection BP
Cefuroxime (cefuroxime sodium) 3mg/ml in 0.9% Sodium Chloride Injection BP
Cloxacillin (cloxacillin sodium) 4mg/ml in 0.9% Sodium Chloride Injection BP
Heparin 10u/ml or 50u/ml in 0.9% Sodium Chloride Injection BP
Potassium Chloride 10mEq/L or 40 mEq/L in 0.9% Sodium Chloride Injection BP
Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used. Within the stated recommendations, product potency is not adversely affected by such colour variations.
Administrative Data
7. Marketing Authorisation Holder
Glaxo Operations UK Ltd
Greenford
Middlesex
UB6 OHE
Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
8. Marketing Authorisation Number(S)
PL 00004/0294
9. Date Of First Authorisation/Renewal Of The Authorisation
18 May 2001
10. Date Of Revision Of The Text
31st July 2009
11. Legal Status
POM
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