Verorab, powder and solvent for suspension for injection. Rabies vaccine, inactivated.

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Rabies virus (inactivated) strain wistar (PM/WI 38-1503-3M)

から入手可能:

Sanofi Pasteur

ATCコード:

J07BG01

INN（国際名）:

Rabies virus (inactivated) strain wistar (PM/WI 38-1503-3M)

医薬品形態:

Powder and solvent for suspension for injection in pre-filled syringe

治療領域:

rabies, inactivated, whole virus

認証ステータス:

Not marketed

承認日:

2023-06-30

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERORAB, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
RABIES VACCINE, INACTIVATED
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicinal product has been prescribed for you only or has been
prescribed to your child. Do
not pass it on to others.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Verorab is and what it is used for
2. What you need to know before you use Verorab
3. How to use Verorab
4. Possible side effects
5. How to store Verorab
6. Contents of the pack and other information
1.
WHAT VERORAB IS AND WHAT IT IS USED FOR
Verorab is a rabies vaccine indicated for pre-exposure and
post-exposure rabies prophylaxis in all age
groups.
Verorab should be used in accordance with official recommendations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VERORAB
DO NOT USE VERORAB
PRE-EXPOSURE PROPHYLAXIS:
-
If you or your child are allergic to the active substance or any of
the other ingredients of this
medicine, listed in section 6.
-
If you or your child developed an allergic reaction during a previous
injection of this medicine
or of any vaccine with the same composition.
-
If you or your child are feverish or if you have an acute disease (in
this case, it is preferable to
postpone vaccination).
POST-EXPOSURE PROPHYLAXIS:
-
Given the fatal outcome of the declared rabies infection, there are no
contraindications to post-
exposure vaccination.
WARNINGS AND PRECAUTIONS
-
As with all vaccines, Verorab may not protect 100% of people
vaccinated.
-
Verorab must not be administered via the intravascular route; make
sure the needle does not
penetrate a blood vessel.
-
Use with caution if you or your child are allergic t

製品の特徴

Health Products Regulatory Authority
30 June 2023
CRN00D9HC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Verorab, powder and solvent for suspension for injection.
Rabies vaccine, inactivated.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution with 0.5 mL solvent, 1 vial contains:
Rabies virus
a
, WISTAR Rabies PM/WI38 1503-3M strain
(inactivated)................................... 3.25 IU
b
a
Produced in VERO cells
b
Quantity measured according to the ELISA test against the
international standard
Excipient with known effect:
Phenylalanine
...................................................................
4.1 micrograms
For the full list of excipients, see section 6.1.
Verorab may contain traces of polymyxin B, streptomycin and neomycin,
used in the manufacturing process (see section 4.3).
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Before reconstitution, the powder is uniform white in colour.
The solvent is a clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Verorab is indicated for pre-exposure and post-exposure prophylaxis of
rabies in all age groups (see sections 4.2 and 5.1).
Verorab should be used according to official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 0.5 mL of reconstituted vaccine
intramuscularly (IM) (pre-exposure or post-exposure) or 0.1 mL of
reconstituted vaccine intradermally (ID) (post-exposure only).
_Pre-exposure prophylaxis_
The primary pre-exposure immunisation course consists of three doses
of 0.5 mL of Verorab administered by intramuscular
route at days (D) D0, D7 and D28. The dose scheduled at D28 can be
administered at D21, if necessary.
Booster doses are determined based on the risk of exposure and on
serological tests to detect the presence of rabies
virus-neutralising antibodies (≥ 0.5 IU/ml). A booster dose consists
of one dose of 0.5 mL given by intramuscular route.
Verorab can be administered as a booster injection after pri