CSL TETANUS IMMUNOGLOBULIN-VF (human) for intravenous use 4000IU injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tetanus immunoglobulin, Quantity: 4000 IU; human immunoglobulin G, Quantity: 50 mg/mL

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

human immunoglobulin G,tetanus immunoglobulin

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous

Units in package:

4000IU X 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tetanus Immunoglobulin-VF (For Intravenous Use) is used in the management of clinical tetanus.

Product summary:

Visual Identification: Slightly viscous solution - clear and colourless; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-11-04

Patient Information leaflet

Tetanus Immunoglobulin-VF (For Intravenous Use) AU CMI 15.00
Page 1 of 4
TETANUS IMMUNOGLOBULIN-VF_ _(FOR INTRAVENOUS USE)
Human Tetanus Immunoglobulin, solution for intravenous infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tetanus Immunoglobulin-VF
(For Intravenous Use). It does
not contain complete
information about Tetanus
Immunoglobulin-VF (For
Intravenous Use). 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 TETANUS
IMMUNOGLOBULIN-VF
(FOR INTRAVENOUS
USE) IS USED FOR
Tetanus Immunoglobulin-VF
(For Intravenous Use) is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood. Donations
are selected on the basis that
they contain high levels of
antibodies against the poison
produced by bacteria which
cause tetanus. This medicine is
used for the treatment of tetanus
infection.
Ask your doctor if you have any
questions about why
Tetanus Immunoglobulin-VF
(For Intravenous Use) has been
prescribed for you. Your doctor
will have assessed the risks and
benefits for you associated with
the use of this product.
BEFORE YOU ARE GIVEN
TETANUS
IMMUNOGLOBULIN-VF
(FOR INTRAVENOUS
USE)
TELL YOUR DOCTOR IF YOU HAVE,
OR HAVE HAD, AN ALLERGY TO
HUMAN IMMUNOGLOBULIN
PRODUCTS OR TO MALTOSE. SOME
OF THE SYMPTOMS OF AN ALLERGIC
REACTION MAY INCLUDE RASH,
ITCHINESS, SWELLING OF THE LIPS
AND TONGUE, SHORTNESS OF
BREATH.
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER
MEDICINES OR IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO AN
INJECTION.
TELL YOUR DOCTOR ALSO IF YOU:
•
have previously been
advised t

Summary of Product characteristics

Tetanus Immunoglobulin-VF (IV) AU PI 16.00
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
TETANUS IMMUNOGLOBULIN-VF (FOR INTRAVENOUS USE)
(HUMAN TETANUS IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Human Tetanus Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetanus Immunoglobulin-VF (For Intravenous Use) is a sterile,
preservative free solution
containing 50–70 mg/mL human plasma protein of which at least 98% is
immunoglobulin
(mainly IgG), with a tetanus antitoxin activity of 4000 IU per vial.
The distribution of the IgG subclasses closely resembles that found in
normal human plasma
(approximate mean ranges: 52.5–64.9% IgG
1
, 29.0–42.2% IgG
2
, 3.1–6.8% IgG
3
, 0.4–1.2%
IgG
4
).
Tetanus Immunoglobulin-VF (For Intravenous Use) contains less than 0.5
mg/mL
immunoglobulin A (IgA).
The pH value of the ready-to-use solution is 4.25.
Tetanus Immunoglobulin-VF (For Intravenous Use) is manufactured from
human plasma
collected by Australian Red Cross Lifeblood.
Isotonicity is achieved by the addition of 292 mmol/L maltose.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tetanus Immunoglobulin-VF (For Intravenous Use) is used in the
management of clinical
tetanus.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose of Tetanus Immunoglobulin-VF (For Intravenous
Use) for the
treatment of tetanus is 4000 IU. After administration of this dose
(4000 IU), it has been
Tetanus Immunoglobulin-VF (IV) AU PI 16.00
Page 2 of 10
shown that circulating antibody levels are maintained above the
minimum protective titre for
at least 6 weeks. The dose, therefore, need not be repeated.
ADMINISTRATION
If the product appears to be turbid by transmitted light or contains
any sediment it must not
be used, and the vial should be returned to Australian Red Cross
Lifeblood.
THE PRODUCT
DOES NOT CONTAIN AN ANTIMICROBIAL PRESERVATIVE. IT MUST, THEREFORE, BE
USED IMMEDIATELY
AFTER OPENING THE VIAL. ANY UNUSED PORTION MUST BE