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SPC, UK: HEPATECT CP Solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Hepatect CP 50 IU/ml solution for infusion.

Qualitative and quantitative composition

Human hepatitis B immunoglobulin. Human protein 50 g/l of which at least 96% is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml. Each vial of 2 ml contains: 100 ...

Pharmaceutical form

Solution for infusion. The solution is clear or slightly opalescent and colourless to pale yellow.

Therapeutic indications

Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure. Immunoprophylaxis of hepatitis B: In case of accidental exposure in non-immunised subjects ...

Posology and method of administration

Posology Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure: In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulin. Patients with selective IgA deficiency who developed antibodies to IgA, as administering ...

Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Precautions for use Monitoring ...

Interaction with other medicinal products and other forms of interaction

Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as rubella, mumps, measles ...

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 and breast-feeding ...

Effects on ability to drive and use machines

Hepatect CP has minor influence on the ability to drive and use machines. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines. ...

Undesirable effects

Summary of the safety profile Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4): chills, headache, dizziness, fever, vomiting, allergic ...

Overdose

Overdose of immunoglobulins may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4). ...

Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins / specific immunoglobulins / Hepatitis B immunoglobulin ATC code: J06BB04 Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) ...

Pharmacokinetic properties

The bioavailability of human hepatitis B immunoglobulin for intravenous use is complete and immediate. IgG is quickly distributed between plasma and extravascular fluid. Hepatect CP has a half-life of ...

Preclinical safety data

Immunoglobulins are normal constituents of the human body. Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies. Effects ...

List of excipients

Glycine Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products, nor with any other IVIg products. No other preparations may be added to the Hepatect CP solution as any change in the electrolyte ...

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

Nature and contents of container

Hepatect CP is a ready-for-use solution for infusion provided in vials (Type II glass) with a stopper (bromobutyl) and a cap (aluminium): Pack size of 1 vial with 2 ml, 10 ml, 40 ml or 100 ml solution. ...

Special precautions for disposal and other handling

The product must be brought to room or body temperature before use. The solution should be administered immediately after opening the receptacle. The solution should be clear or slightly opalescent and ...

Marketing authorization holder

Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Tel.: (49) 6103 801-0, fax: (49) 6103 801 150, Email: mail@biotest.com

Marketing authorization number(s)

PL 04500/0006

Date of first authorization / renewal of the authorization

12/04/2015

Date of revision of the text

22/11/2019

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