CSL HEPATITIS B IMMUNOGLOBULIN VF (human) 400IU injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hepatitis B immunoglobulin, Quantity: 400 IU; human immunoglobulin G, Quantity: 160 mg/mL

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

hepatitis B immunoglobulin,human immunoglobulin G

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glycine; water for injections; human immunoglobulin A

Administration route:

Intramuscular

Units in package:

400IU X 1

Prescription type:

(S4) Prescription Only Medicine

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 (<10IU/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:

Visual Identification: Clear to opalescent, colourless, solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-10-21

Patient Information leaflet

Hepatitis B Immunoglobulin-VF AU CMI 10.00
Page 1 of 3
HEPATITIS B IMMUNOGLOBULIN-VF
Human Hepatitis B Immunoglobulin, solution for intramuscular
injection.
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Hepatitis B
Immunoglobulin-VF. It does not
contain complete information
about Hepatitis B
Immunoglobulin-VF. It does not
take the place of talking to your
doctor.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR. FOLLOW YOUR
DOCTOR’S ADVICE EVEN IF IT IS
DIFFERENT FROM WHAT THIS LEAFLET
SAYS.
PLEASE READ THIS LEAFLET
CAREFULLY AND KEEP IT FOR
FUTURE REFERENCE.
The information in this leaflet is
subject to change. Please check
with your doctor whether there
is any new information about
this medicine that you should
know since you were last
treated.
WHAT HEPATITIS B
IMMUNOGLOBULIN-VF
IS USED FOR
Hepatitis B Immunoglobulin-VF
is manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood.
Hepatitis B Immunoglobulin-VF
contains protein substances
called antibodies which can
prevent infection from
developing in a person who has
been exposed to the hepatitis B
virus. Hepatitis B
Immunoglobulin-VF is used to
prevent hepatitis B infection in a
person who comes into contact
with blood or other material
suspected of being infected with
hepatitis B, for example, by
accidental needle stick injury or
sexual exposure. It is also given
to babies born to mothers with
hepatitis B infection.
Ask your doctor if you have any
questions about why Hepatitis B
Immunoglobulin-VF has been
prescribed for you. Your doctor
will have assessed the risks and
benefits associated with the use
of this medicine for you.
BEFORE YOU ARE GIVEN
HEPATITIS B
IMMUNOGLOBULIN-VF
MAKE SURE YOU TELL YOUR
DOCTOR OF ANY REASONS YOU
KNOW OF WHY YOU SHOULD NOT
BE GIVEN THIS MEDICINE.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE:
•
a history of allergy to
human immunoglobulin
products (allergic reactions
may include skin rash, face
sw

Summary of Product characteristics

Hepatitis B Immunoglobulin-VF AU PI 11.00
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
HEPATITIS B IMMUNOGLOBULIN-VF
(HUMAN HEPATITIS B IMMUNOGLOBULIN) – SOLUTION FOR INTRAMUSCULAR
INJECTION
1
NAME OF THE MEDICINE
Human Hepatitis B Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hepatitis B Immunoglobulin-VF is a sterile, preservative-free 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).
The pH value of the ready-to-use solution is 6.6.
Hepatitis B Immunoglobulin-VF is manufactured from human plasma
collected by Australian
Red Cross Lifeblood.
Hepatitis B Immunoglobulin-VF contains 22.5 mg/mL glycine.
3
PHARMACEUTICAL FORM
Solution for intramuscular injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
Hepatitis B Immunoglobulin-VF AU PI 11.00
Page 2 of 9
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_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
PERCUTANEOUS OR PERMUCOSAL EXPOSURE TO HBSAG-POSITIVE OR SUSPECTED
HBSAG-POSITIVE
MATERIAL
SOURCE MATERIAL
VACCINATION HISTORY
NO PRIOR VACCINATION OR
INCOMPLETE VACCINATION REGIMEN
COMPLETED VACCI