Merieux Inactivated Rabies Vaccine (MIRV)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5 [iU]

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5 IU

Dosage:

2.5 IU

Pharmaceutical form:

Suspension for injection

Composition:

Active: Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5 [iU] Excipient: Albumin Neomycin sulfate Water for injection

Units in package:

Combination pack, 1 x (powder + syringe), 2.5 IU

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Pasteur SA

Therapeutic indications:

Post exposure immunisation against rabies. Pre-exposure immunisation in persons at special risk of contracting rabies.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 x (vaccine powder + diluent syringe) - 2.5 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 1 x 1 mL diluent (Rovi) - 1 mL - 48 months from date of manufacture stored at or below 30°C - Syringe, 1 x 1 mL diluent (Marcy L'Etoile) - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 1 x monodose vaccine - 2.5 IU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1982-04-07

Patient Information leaflet

Merieux Inactivated Rabies Vaccine (MIRV)
1
MERIEUX INACTIVATED RABIES VACCINE (MIRV)
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 vaccinations.
•
Keep follow-up appointm

Summary of Product characteristics

mirv-ccdsv4-5.1-6-dsv4-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
MERIEUX INACTIVATED RABIES VACCINE (MIRV) 2.5 IU
SUSPENSION FOR INJECTION
Merieux Inactivated Rabies Vaccine (MIRV)
Suspension for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains inactivated Wistar rabies virus strain
PM/W1381503-3M Rabies vaccine.
The potency of the reconstituted vaccine is not less than 2.5 IU, the
WHO International Standard
per dose (1 mL). Each vial contains, in addition, between 100 and 150
microgram of neomycin
and up to 70 mg of albumin.
MIRV is lyophilised, stabilised suspension of inactivated Wistar
rabies virus strain
PM/W1381503-3M. It is cultured on human diploid cells and inactivated
by β-propiolactone.
These human diploid cells are a cell line derived from human embryonic
lung tissue in the 1960s.
The manufacture of this product includes exposure to bovine materials.
No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has
resulted from the administration of any vaccine product.
This medicine may contain undetectable traces of neomycin. See Section
4.4 Special warnings
and precautions for use.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Vial (powder for reconstitution).
1 mL diluent (water for injections).
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.
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Page 2
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
DOSE
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 indi