ZUTECTRA Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Zutectra 500 IU solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU. Human protein 150 mg/ml of which at least 96% is IgG, with a content of antibodies to hepatitis B virus surface antigen ...
3. Pharmaceutical form
Solution for injection. The solution is clear and pale yellow or light brown.
4.1. Therapeutic indications
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status ...
4.2. Posology and method of administration
Posology In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels. Prior to the initiation ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins. Zutectra must not be administered intravascularly.
4.4. Special warnings and precautions for use
Ensure that Zutectra 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 medicinal product. There is ...
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 ...
4.6. Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women. Clinical ...
4.7. Effects on ability to drive and use machines
Hepatitis B immunoglobulin has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Most adverse drug reactions (ADRs) were mild to moderate in nature. In isolated cases human normal immunoglobulins may cause an anaphylactic shock. Tabulated list of adverse ...
4.9. Overdose
Consequences of an overdose are not known.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Immune sera and immunoglobulins, Specific immunoglobulins, Hepatitis B immunoglobulin <b>ATC code:</b> J06BB04 Hepatitis B immunoglobulin contains mainly immunoglobulin ...
5.2. Pharmacokinetic properties
Distribution Zutectra is slowly absorbed into the recipients circulation and reaches a maximum after a delay of 2-7 days. Biotransformation IgG and IgG-complexes are broken down in the reticuloendothelial ...
5.3. Preclinical safety data
Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance. In a local tolerance trial in rabbits, there was no evidence of irritation ...
6.1. List of excipients
Glycine Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. No other preparations may be added to the Zutectra solution as any change in the electrolyte ...
6.3. Shelf life
2 years. The solution should be administered immediately after opening the syringe.
6.4. Special precautions for storage
Store and transport refrigerated (2°C-8°C). Do not freeze. Keep the container in the outer carton in order to protect from light.
6.5. Nature and contents of container
One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber). Pack size of five syringes in a blistered pack.
6.6. Special precautions for disposal and other handling
This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use. The solution can vary from colourless to pale yellow up to light brown. Solutions that are cloudy or have deposits ...
7. Marketing authorization holder
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
8. Marketing authorization number(s)
EU/1/09/600/001
9. Date of first authorization / renewal of the authorization
30/11/2009 / 16/09/2014
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