Verorab

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Rabies vaccine, Wistar PM/WI 38-1503-3M 3.25 [iU] (target quantity per dose)

Tilgængelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

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

Dosering:

3.25 IU

Lægemiddelform:

Powder for injection with diluent

Sammensætning:

Active: Rabies vaccine, Wistar PM/WI 38-1503-3M 3.25 [iU] (target quantity per dose) Excipient: Albumin Hydrochloric acid BME medium - mineral salts, vitamins, amino acids including L-phenylalanine Maltose Sodium hydroxide Sodium chloride Water for injection

Enheder i pakken:

Combination pack, 1 x vial + syringe, 1 dose unit

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Sanofi Pasteur SA

Terapeutiske indikationer:

Verorab is indicated for pre-exposure prophylaxis against rabies. Verorab is indicated for post-exposure prophylaxis against rabies. Verorab should be used in accordance with official local recommendations.

Produkt oversigt:

Package - Contents - Shelf Life: Combination pack, 1 x vial + 1 x syringe - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x vial + 10 x syringe - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Type I (containing diluent), with or without fitted needle - 0.5 mL - 60 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, 3 mL Type I with chlorobutyl stopper and flip-off Al cap - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorisation dato:

2007-12-17

Indlægsseddel

Verorab®
1
VERORAB®
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 VERORAB?
Verorab contains the active ingredient rabies virus (inactivated).
Verorab 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
Verorab? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I OR MY CHILD RECEIVES VERORAB?
Do not use if you or your child has ever had an allergic reaction to
Verorab 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 I or my
child receives Verorab? in the full CMI.
3.
WHAT IF I OR MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with Verorab and affect how it works.
A list of these medicines is in Section 3. What if I or my child is
taking other medicines? in the full CMI.
4.
HOW DO I OR MY CHILD RECEIVE VERORAB?
Verorab is given as an injection, usually into muscle in the upper arm
or in the skin, by a doctor or nurse. Your doctor will
decide 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 Verorab? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER I OR MY CHILD RECEIVES VERORAB?
THINGS YOU
SHOULD DO
•
Keep an updated record of you or your child’s vaccinations.
•
Keep follow-up appointments with your doctor or clinic. It is
important to have follow-up doses of
Verorab,

Produktets egenskaber

verorab-ccdsv11-dsv1-14mar24
Page 1 of 16
NEW ZEALAND DATA SHEET
1
VERORAB 3.25 IU POWDER AND DILUENT FOR SUSPENSION
FOR INJECTION
Inactivated Rabies Virus Vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verorab is a Purified Vero Rabies Vaccine referred as PVRV.
Verorab is a sterile stable freeze-dried solution of purified and
inactivated rabies virus from
Wistar strain PM/WI38 1503-3M. It is cultured on Vero cell,
inactivated with Beta-propiolactone
and purified by ultracentrifugation.
One dose of vaccine contains 3.25 international units (IU) of rabies
antigen (in vitro potency
measured using G protein content by ELISA method) (corresponds to ≥
2.5 IU by NIH test).
_Excipient with known effect: _
Phenylalanine
...........................................................................................................4.1
micrograms
No adjuvant or preservative are added.
Verorab meets the World Health Organization (WHO) requirements for
manufacture of biological
substances.
For the full list of excipients, see Section 6.1.
The antibiotics neomycin, streptomycin and polymyxin are used in the
manufacturing process of
this vaccine and may be present in trace amounts._ _
3
PHARMACEUTICAL FORM
Powder and diluent for suspension for injection.
The powder is a white homogeneous pellet.
The diluent for suspension for injection is 0.4% sodium chloride
solution, which is a clear and
colourless solution.
After reconstitution, Verorab is limpid and homogeneous.
verorab-ccdsv11-dsv1-14mar24
Page 2 of 16
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Verorab is indicated for pre-exposure prophylaxis against rabies.
Verorab is indicated for post-exposure prophylaxis against rabies.
Verorab should be used in accordance with official local
recommendations._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
4.2.1
GENERAL
The dose and dosing schedule is identical for adults and paediatric
population. The vaccine is
administered by intramuscular (IM) injection, in the deltoid area for
adults and children or the
anterolateral area of t