Hepatitis B Immunoglobulin-VF 400IU

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hepatitis B immunoglobulin, human 160 mg/mL (( >= 98%) as Human Plasma Proteins (ex NZ))

Available from:

CSL Behring (NZ) Ltd

INN (International Name):

Hepatitis B immunoglobulin, human 160 mg/mL (( >= 98%) as Human Plasma Proteins (ex NZ))

Dosage:

400 IU

Pharmaceutical form:

Solution for injection

Composition:

Active: Hepatitis B immunoglobulin, human 160 mg/mL (( >= 98%) as Human Plasma Proteins (ex NZ)) Excipient: Glycine Water for injection

Units in package:

Vial, glass, single dose, 400 IU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

CSL Behring (Australia) Pty Ltd

Therapeutic indications:

Hepatitis B Immunoglobulin-VF is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate (< 10 IU/L). Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg-positive or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure. Hepatitis B Immunoglobulin-VF is also indicated for prophylaxis in infants born to HBsAg-positive mothers.

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, - 400 IU - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1992-07-09

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Hepatitis B Immunoglobulin-VF NZ DS 13.00
Page
1
of
9
1 PRODUCT NAME
Hepatitis B Immunoglobulin-VF 100 IU, solution for intramuscular
injection
Hepatitis B Immunoglobulin-VF 400 IU, solution for intramuscular
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Hepatitis B Immunoglobulin
Hepatitis B Immunoglobulin-VF is a sterile solution containing 160
mg/mL human plasma protein of
which at least 98% is immunoglobulin (mainly IgG), with a hepatitis B
antibody titre of not less than
100 IU/mL.
Hepatitis B Immunoglobulin-VF contains less than 0.5 mg/mL
immunoglobulin A (IgA).
Hepatitis B Immunoglobulin-VF is manufactured from human plasma
donated by New Zealand’s
voluntary and non-remunerated donors.
Hepatitis B Immunoglobulin-VF contains 22.5 mg/mL glycine.
Hepatitis B Immunoglobulin-VF contains no preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for intramuscular injection.
The pH value of the ready-to-use solution is 6.6.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatitis B Immunoglobulin-VF is indicated for post-exposure
prophylaxis in persons who did not
receive prior vaccination, or whose prior vaccination regimen is
incomplete, or when the hepatitis B
antibody level is inadequate (<10 IU/L).
Post-exposure prophylaxis should be considered following percutaneous
or permucosal exposure to
the hepatitis B virus surface antigen (HBsAg)-positive or suspected
HBsAg-positive material, for
example, by needle stick, oral ingestion or sexual exposure.
Hepatitis B Immunoglobulin-VF is also indicated for prophylaxis in
infants born to HBsAg-positive
mothers.
NEW ZEALAND DATA SHEET
Hepatitis B Immunoglobulin-VF NZ DS 13.00
Page
2
of
9
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
PROPHYLAXIS WITH HEPATITIS B IMMUNOGLOBULIN-VF IN ADULTS FOLLOWING
PERCUTANEOUS OR
PERMUCOSAL EXPOSURE TO HBSAG-POSITIVE OR SUSPECTED HBSAG-POSITIVE
MATERIAL:
Refer to TABLE 1.
TABLE 1: PROPHYLAXIS WITH HEPATITIS B IMMUNOGLOBULIN-VF IN ADULTS
FOLLOWING
PERCUTANE