Hepatect CP 50 IU/ml; solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-01-2020
Summary of Product characteristics
(SPC)
29-01-2020
Active ingredient:
Human plasma protein; Hbs antibodies
Available from:
Biotest Pharma GmbH
ATC code:
J06BB; J06BB04
INN (International Name):
Human plasma protein; Hbs antibodies
Dosage:
50 international unit(s)/millilitre
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Specific immunoglobulins; hepatitis B immunoglobulin
Authorization status:
Marketed
Authorization date:
2008-08-22
Patient Information leaflet
Hepatect CP 50 IU/ml solution for infusion
Package leaflet
1/7
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPATECT CP 50 IU/ML SOLUTION FOR INFUSION
Human hepatitis B immunoglobulin for intravenous administration
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or
nurse.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Hepatect CP is and what it is used for
2.
What you need to know before you use Hepatect CP
3.
How to use Hepatect CP
4.
Possible side effects
5.
How to store Hepatect CP
6.
Contents of the pack and other information
1. WHAT HEPATECT CP IS AND WHAT IT IS USED FOR
Hepatect CP contains the active ingredient human hepatitis B
immunoglobulin, which can protect you
from hepatitis B. Hepatitis B is an inflammation of the liver caused
by the hepatitis B virus. Hepatect
CP is a solution for infusion (into a vein) and comes in vials
containing 2 ml (100 International Units
[IU]), 10 ml (500 IU), 40 ml (2000 IU) and 100 ml (5000 IU).
Hepatect CP is used to give immediate and long-term immunity
(protection) to:
prevent hepatitis B infection in patients who have not been vaccinated
or fully vaccinated against
hepatitis B and who are at risk of infection with hepatitis B.
prevent infection of a transplanted liver in patients who test
positive for hepatitis B.
newborn babies whose mothers are infected with the hepatitis B virus.
protect patients for whom hepatitis B vaccination has not provided
adequate protection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HEPATECT CP
DO NOT USE HEPATECT CP:
if you are allergic to h
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
28 January 2020
CRN009L3F
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hepatect CP 50 IU/ml; solution for infusion
2 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 IU
Each vial of 10 ml contains: 500 IU
Each vial of 40 ml contains: 2000 IU
Each vial of 100 ml contains: 5000 IU
Distribution of IgG subclasses (approx. values):
IgG1: 59%
IgG2: 35 %
IgG3: 3 %
IgG4: 3 %
The maximum IgA content is 2,000 micrograms/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless to pale
yellow.
4 CLINICAL PARTICULARS
4.1 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 (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.
In subjects who did not show an immune response (no measurable
hepatitis B antibodies) after vaccination and for
whom a continuous prevention is necessary due to the continuous risk
of being infected with hepatitis B.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of hepatitis B re-infection after liver transplantation
for hepatitis B induced liver_
_failure:_
Health Products Regulatory Authority
28 January 2020
CRN009L3F
Page 2 of 9
In adults:
10 000 IU on the day of transplantation, peri-operatively
then 2000-10 000 IU (40-200 ml)/day for 7 days,
and as necessary to maintain antibody levels above 100-150 IU/l in
HBV-DNA negative patients and above 500 IU/l in
HBV-DNA positive patients.
In children:
Posology
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