MERIEUX INACTIVATED RABIES VACCINE 2.5IU Powder for Injection with Diluent

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Rabies virus, Quantity: 2.5 IU

Saadav alates:

Sanofi-Aventis Australia Pty Ltd

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: Albumin; neomycin

Manustamisviis:

Intramuscular

Ühikuid pakis:

1 vial of powder - 2.5IU, 1 syringe of diluent - 1mL

Retsepti tüüp:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Näidustused:

IDICATIONS AS AT 12 JULY 2004: Post exposure immunisation against rabies. Pre-exposure immunisation in persons at special risk of contracting rabies.

Toote kokkuvõte:

Visual Identification: Slightly pink pellet of powder; 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

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-10-21

Infovoldik

MERIEUX INACTIVATED RABIES VACCINE (MIRV)
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about you or child receiving this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I OR MY CHILD RECEIVING MIRV?
MIRV contains the active ingredient rabies virus (inactivated). MIRV
is a vaccine used to help prevent rabies infection in people who
have been, or are likely to be, bitten, licked or scratched by an
animal that has rabies.
For more information, see Section 1. Why am I or my child receiving
MIRV? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE ME OR MY CHILD RECEIVES MIRV?
•
Do not use if you or your child has ever had an allergic reaction to
MIRV or any of the ingredients listed at the end of the CMI.
•
Do not use if you or your child has a high temperature or serious
illness.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAS ANY OTHER MEDICAL
CONDITIONS OR IS TAKING ANY OTHER MEDICINES. TELL YOUR DOCTOR
IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before me or
my child receives MIRV? in the full CMI.
3.
WHAT IF ME OR MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with MIRV and affect how it works.
A list of these medicines is in Section 3. What if me or my child is
taking other medicines? in the full CMI.
4.
HOW DO I OR MY CHILD RECEIVE MIRV?
•
MIRV is given as an injection, usually into muscle in the upper arm,
by a doctor or nurse. Your doctor will decide how much
MIRV is needed.
•
Your doctor will tell you how many injections you or your child should
have and when they should have them. Carefully follow all
of your doctor's directions.
More instructions can be found in Section 4. How do I or my child
receive MIRV? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER ME OR MY CHILD RECEIVES MIRV?
THINGS YOU
SHOULD DO
•
Keep an updated record of you or your child’s vaccination

Toote omadused

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Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – MERIEUX INACTIVATED
RABIES VACCINE, RABIES VIRUS (INACTIVATED)
1
NAME OF THE MEDICINE
Rabies Virus (Inactivated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MERIEUX INACTIVATED RABIES VACCINE (MIRV) is lyophilised, stabilised
suspension of inactivated Wistar rabies virus strain PM/W1381503-3M.
It is cultured on
human diploid cells and inactivated by ß-propiolactone. These human
diploid cells are a cell
line derived from human embryonic lung tissue in the 1960s.
The potency of the reconstituted vaccine is not less than 2.5 IU, the
WHO International
Standard per dose (1 mL).
Excipient with known effect: Neomycin
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The powder is pinkish beige to orangey yellow. After reconstitution
with the diluent supplied,
MIRV is a clear or slightly opalescent red to purplish red suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pre-exposure immunisation in persons at special risk of contracting
rabies. Post exposure
immunisation against rabies.
4.2
DOSE AND METHOD OF ADMINISTRATION
One dose consists of 1 mL of vaccine administered by the intramuscular
route, in the deltoid
area for adults and children or the anterolateral area of the thigh
muscle in infants and
toddlers.
The vaccination schedule should be adapted in accordance with the
circumstances of the
exposure and the individual’s rabies immune status. For further
information, refer to the
current Immunisation Handbook.
Product is for single use in one patient on one occasion only. Discard
any residue.
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Page 2 of 12
PRE-EXPOSURE PROPHYLAXIS
•
Primary vaccination: 3 injections at day 0, day 7, and day 21 or day
28
For further information about pre-exposure prophylaxis refer to the
current Australian
Immunisation Handbook.
Regular serology testing of neutralising antibodies is recommended to
assess seroconversion
of individuals at increased risk of exposure to rabi