CSL TETANUS IMMUNOGLOBULIN VF (human) 250IU injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

tetanus immunoglobulin, Quantity: 250 IU; human immunoglobulin G, Quantity: 160 mg/mL

Commercializzato da:

CSL Behring Australia Pty Ltd

INN (Nome Internazionale):

human immunoglobulin G,tetanus immunoglobulin

Forma farmaceutica:

Injection, solution

Composizione:

Excipient Ingredients: glycine; human immunoglobulin A

Via di somministrazione:

Intramuscular

Confezione:

250IU X 1

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Tetanus Immunoglobulin is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last dose of toxoid. In all the above instances, active immunisation with Tetanus Toxoid, Adsorbed or ADT vaccine should be commenced at the same time [in accordance with details specified in table 1 (Guide to tetanus prophylaxis in wound management) in Indication section of the approved product information provided as Attachment 1]. Although Tetanus Immunoglobulin and vaccine should be given at the same time, they should be administered in opposite limbs, using separate syringes.

Dettagli prodotto:

Visual Identification: Colourless, clear to opalescent solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

1998-10-21

Foglio illustrativo

Tetanus Immunoglobulin-VF for Intramuscular Use AU CMI 10.00
Page 1 of 3
TETANUS IMMUNOGLOBULIN-VF
Human Tetanus Immunoglobulin, solution for intramuscular injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tetanus Immunoglobulin-VF. It
does not contain complete
information about Tetanus
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 TETANUS
IMMUNOGLOBULIN-VF
IS USED FOR
Tetanus Immunoglobulin-VF is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood. Tetanus
Immunoglobulin-VF contains
protein substances called
antibodies which can provide
protection against tetanus
infection. It is used for the
prevention of tetanus in a person
who has not recently been
immunised against tetanus and
who has suffered an injury
which could expose them to the
tetanus bacteria.
Ask your doctor if you have any
questions about why Tetanus
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
TETANUS
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
swelling, wheezing or
breathing difficulties) or
previously been told you
react to any of the
ingredients in Tetanus
Immunoglobulin-VF
(human immunoglobulins
or glycine)
•
been told you have
antibodies t

Scheda tecnica

Tetanus Immunoglobulin-VF AU PI 12.00
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
TETANUS IMMUNOGLOBULIN-VF (FOR INTRAMUSCULAR USE)
(HUMAN TETANUS IMMUNOGLOBULIN) – SOLUTION FOR INTRAMUSCULAR
INJECTION
1
NAME OF THE MEDICINE
Human Tetanus Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetanus Immunoglobulin-VF (for Intramuscular Use) is a sterile,
preservative-free solution
containing 160 mg/mL human plasma protein of which at least 98% is
immunoglobulin G
(IgG), with a tetanus antitoxin activity of not less than 100 IU/mL.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains less than
0.5 mg/mL
immunoglobulin A (IgA).
The pH value of the ready-to-use solution is 6.6.
Tetanus Immunoglobulin-VF (for Intramuscular Use) is manufactured from
human plasma
collected by Australian Red Cross Lifeblood.
Tetanus Immunoglobulin-VF (for Intramuscular Use) contains 22.5 mg/mL
of glycine.
3
PHARMACEUTICAL FORM
Solution for intramuscular injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tetanus Immunoglobulin-VF (for Intramuscular Use) is indicated for the
passive protection
of individuals who have sustained a tetanus-prone wound and who have
either not been
actively immunised against tetanus or whose immunisation history is
doubtful. It should also
be given to the fully immunised patient with a tetanus-prone wound if
more than 10 years
have elapsed since the last vaccine dose. In all the above instances,
active immunisation with
a tetanus vaccine should be commenced at the same time (refer to
TABLE 1
) according to
current recommendations. Although Tetanus Immunoglobulin-VF (for
Intramuscular Use)
and vaccine can be given at the same time, they should be administered
in opposite limbs,
using separate syringes.
Tetanus Immunoglobulin-VF AU PI 12.00
Page 2 of 9
TABLE 1: GUIDE TO TETANUS PROPHYLAXIS IN WOUND MANAGEMENT (REFER TO
THERAPEUTIC
INDICATIONS)
HISTORY OF ACTIVE
IMMUNISATION
TYPE OF WOUND
CLEAN, MINOR WOUND
ALL OTHER WOUNDS
TETANUS
VACCINE*
TETANUS
IMMUNOGLOBULIN- VF
(FOR INTRAMUSCULAR USE)