HEPATECT CP SOLUTION FOR INFUSION 50 IUML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Human Hepatitis B Immunoglobulin in 50mg/ml human plasma protein (IgG ≥ 96%)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

J06BB04

Dosage:

50 iu/ml

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

Human Hepatitis B Immunoglobulin in 50mg/ml human plasma protein (IgG ≥ 96%) 50 iu/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Biotest AG

Authorization status:

ACTIVE

Authorization date:

2014-10-24

Patient Information leaflet

184678
001
PACKAGE LEAFLET
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 anti-
bodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml
One vial of      2 ml contains:   100 IU
One vial of   10 ml contains:   500 IU
One vial of   40 ml contains: 2000 IU
One vial of 100 ml contains: 5000 IU
Distribution of IgG subclasses:
IgG1:   59%
IgG2:   35 %
IgG3:    3 %
IgG4:    3 %
IgA max 2 mg/ml.
For excipients, see section 6.1.
3.  PHARMACEUTICAL FORM 
Solution for infusion
The solution is clear or slightly opalescent.
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 per-
sons whose vaccination is incomplete or status unknown).
184.678.001.indd   1
17.05.13   08:19
- 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 IN-
DUCED LIVER FAILURE:
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

Summary of Product characteristics

Hepatect CP
1/7
12 / 2019
PACKAGE INSERT
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
One vial of 2 ml contains: 100 IU
One vial of 10 ml contains: 500 IU
One vial of 40 ml contains: 2000 IU
One 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.
Hepatect CP
2/7
12 / 2019
4.2
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 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 should be adjusted according to body surface area, on the
basis of 10 000 IU/1.73 m
2
.
IMMUNOPROPHYLAXIS OF HEPATITIS B:
- Preve