HEPATECT CP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HUMAN HEPATITIS B IMMUNOGLOBULIN

Available from:

KAMADA LTD, ISRAEL

ATC code:

J06BA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

HUMAN HEPATITIS B IMMUNOGLOBULIN 50 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIOTEST PHARMA GMBH, GERMANY

Therapeutic group:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic area:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic indications:

Prophylaxis against hepatitis B in adults and children over 2 years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with Hepatitis B virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. When the administration of an intramuscular hepatitis B immunoglobulin is not possible. The immunoglobulin should be administered in association with hepatitis B vaccine. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier mother.

Authorization date:

2022-11-30

Patient Information leaflet

HEAD OFFICE 2 Holzman St., Science Park, P.O. Box 4081, Rehovot,
7670402, Israel | Tel. [phone] | Fax. [phone] PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel.
[phone] | Fax. [phone]
ץרמ
9
201
,ה/דבכנ ת/חקור ,ה/אפור ןוכדיע לע עידוהל תשקבמ עדהמק תרבח ןולע
אפורל
:רישכתה רובע
HEPATECT
® CP ; CP טקטפה
SOLUTION FOR INFUSION
ןוישירל םאתהב םיליעפ םיביכרמ
:
Protein Immunoglobulin 50mg/ml
:היוותה
A. Prophylaxis against hepatitis B in adults and children over two
years of age who have not been
vaccinated against hepatitis B (including persons whose vaccination is
incomplete or missing) who
are at risk of infection with hepatitis B by accidental contact with
hepatitis B virus containing
material following
– percutaneous exposure (e.g., accidental needle stick)
– direct mucous membrane contact
When the administration of an intramuscular hepatitis B immunoglobulin
is not possible.
The immunoglobulin should be administered in association with
hepatitis B vaccine.
B. Prophylaxis against re-infection of a transplanted liver in
patients who carry the surface antigen
of the hepatitis B virus
C. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B
virus carrier-mother.
יונישה תוהמ
םי
:
.אפורל ןולע ןוכדיע
הרמחה םיווהמה םייונישה םיניוצמ וז
העדוהב
בוהצב ושגדוה(
;
הצוח וק י"ע ןמוס קחמנש טסקט
)
םייוניש ןולעב .
.הרמחה םניאש םיפסונ
4.8
UNDESIRABLE EFFECTS
There are no robust data on the frequency of undesirable effects from
clinical trials.
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 reactions:
The table presented below is according to the MedDRA system organ
classification (SOC and
Preferred Term Level). Frequ

Summary of Product characteristics

Page 1 of 11
HEPATECT
® CP
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 2000 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
A. Prophylaxis against hepatitis B in adults and children over two
years of age who
have not been vaccinated against hepatitis B (including persons whose
vaccination is
incomplete or missing) who are at risk of infection with hepatitis B
by accidental
contact with hepatitis B virus containing material following
– percutaneous exposure (e.g., accidental needle stick)
– direct mucous membrane contact
When the administration of an intramuscular hepatitis B immunoglobulin
is not
possible.
Page 2 of 11
The immunoglobulin should be administered in association with
hepatitis B vaccine.
B. Prophylaxis against re-infection of a transplanted liver in
patients who carry the surface
antigen of the hepatitis B virus
C. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B
virus carrier-mother.
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 p