CSL ZOSTER IMMUNOGLOBULIN VF (human) 200IU injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

human immunoglobulin G, Quantity: 160 mg/mL; zoster immunoglobulin, Quantity: 200 IU

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

human immunoglobulin G,zoster immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular

Units in package:

200IU x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 8 AUGUST 2002 : Zoster Immunoglobulin is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. One of the following underlying illnesses or conditions: a. Neoplastic disease (leukaemia or lymphoma); b. Congenital or acquired immunodeficiency; c. Immunosuppressive therapy with steroids or antimetabolites. 2. One of the following types of exposure to chickenpox or shingles patients: a. Household contact; b. Playmate contact (>1 hour play indoors); c. Hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward); d. Newborn contact (newborn of mother who had onset of chickenpox <5 days before delivery or within 48 hours after delivery); e. Premature infant (>= 28 weeks gestation) whose mother lacks a prior history of chickenpox; f. Premature infant (< 28 weeks gestation or <= 1000g) regardless of maternal history. 3. Negative or unknown history of chickenpox. 4. If Zoster Immunoglobulin can be administered within 96 hours after exposure. Zoster Immunoglobulin, Normal Immunoglobulin (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. High levels of circulating antibody do not prevent dissemination of infection. Zoster Immunoglobulin is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

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

Zoster Immunoglobulin-VF AU CMI 10.00
Page 1 of 3
ZOSTER IMMUNOGLOBULIN-VF
Human Zoster Immunoglobulin, solution for intramuscular injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Zoster
Immunoglobulin-VF. It does not
contain complete information
about Zoster
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 ZOSTER
IMMUNOGLOBULIN-VF
IS USED FOR
Zoster Immunoglobulin-VF is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood. Zoster
Immunoglobulin-VF contains
protein substances called
antibodies which can provide
protection against the virus
causing chickenpox and
shingles. It is used for the
prevention of chickenpox and
shingles in people who are
susceptible to virus infection and
who come into contact with an
infected person. It is particularly
given to those whose ability to
fight infection is weakened.
Ask your doctor if you have any
questions about why Zoster
Immunoglobulin-VF has been
prescribed for you. Your doctor
will have assessed the risks and
benefits associated with the use
of this product for you.
BEFORE YOU ARE GIVEN
ZOSTER
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
product s (allergic reactions
may include skin rash, face
swelling, wheezing or
breathing difficulties) or
previously been told you
react to any of the
ingredients in Zoster
Immunoglobulin-VF
(human immunoglobulins or

Summary of Product characteristics

Zoster Immunoglobulin-VF AU PI 12.00
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
ZOSTER IMMUNOGLOBULIN-VF
(HUMAN ZOSTER IMMUNOGLOBULIN) – SOLUTION FOR INTRAMUSCULAR INJECTION
1
NAME OF THE MEDICINE
Human Zoster Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zoster Immunoglobulin-VF is a sterile, preservative-free solution
containing 160 mg/mL
human plasma protein of which at least 98% is immunoglobulin G (IgG)
with antibodies to
varicella zoster virus of at least 200 IU/vial.
Zoster Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
The pH value of the ready-to-use solution is 6.6.
Zoster Immunoglobulin-VF is manufactured from human plasma collected
by Australian Red
Cross Lifeblood.
Zoster Immunoglobulin-VF contains 22.5 mg/mL glycine.
3
PHARMACEUTICAL FORM
Solution for intramuscular injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Zoster Immunoglobulin-VF is indicated for prophylaxis against
varicella in patients who
meet all four of the criteria listed below:
1.
One of the following underlying illnesses or conditions:
a.
Neoplastic disease (leukaemia or lymphoma).
b.
Congenital or acquired immunodeficiency.
c.
Immunosuppressive therapy with steroids or antimetabolites.
2.
One of the following types of exposure to chickenpox or shingles
patients:
a.
Household contact.
b.
Playmate contact (>1 hour play indoors).
c.
Hospital contact (in same 2 to 4 bedroom or adjacent beds in a large
ward).
d.
Newborn contact (newborn of mother who had onset of chickenpox <5 days
before
delivery or within 48 hours after delivery).
Zoster Immunoglobulin-VF AU PI 12.00
Page 2 of 9
e.
Premature infant (≥28 weeks gestation) whose mother lacks a prior
history of
chickenpox.
f.
Premature infant (<28 weeks gestation or ≤1000 g) regardless of
maternal history.
3.
Negative or unknown prior history of chickenpox.
4.
If Zoster Immunoglobulin-VF can be administered within 96 hours after
exposure.
Zoster Immunoglobulin-VF, Normal Immunoglobulin-VF (immunoglobulin for
intramuscular use) or plas