Rabies Vaccine BP > 2.5 IU/ml, Powder and solvent for suspension for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Inactivated Rabies Virus Strain PM/WI 38 1503 3M

Tilgjengelig fra:

Sanofi Pasteur

ATC-kode:

J07BG; J07BG01

INN (International Name):

Inactivated Rabies Virus Strain PM/WI 38 1503 3M

Dosering :

2.5 international unit(s)/millilitre

Legemiddelform:

Powder and solvent for suspension for injection

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Rabies vaccines; rabies, inactivated, whole virus

Autorisasjon status:

Not marketed

Autorisasjon dato:

1994-12-12

Informasjon til brukeren

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
RABIES VACCINE BP ≥ 2.5 IU/ML
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This vaccine has been prescribed for you. Do not pass it on to others.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.
IN THIS LEAFLET
:
1.
What Rabies Vaccine BP is and what it is used for
2.
Before you are given Rabies Vaccine BP
3.
How Rabies Vaccine BP is given
4.
Possible side effects
5.
How to store Rabies Vaccine BP
6.
Further information
1.
WHAT RABIES VACCINE BP IS AND WHAT IT IS USED FOR
Rabies Vaccine BP is indicated for pre-exposure prophylaxis and for
post-exposure prophylaxis against
rabies in all age groups.
Rabies Vaccine BP is one of a general group of medicines called
vaccines. Vaccines are used to protect
against infectious diseases. This vaccine helps to protect adults and
children against rabies. Rabies Vaccine
BP can be used in two ways:
•
Vaccinating you before you come into contact with rabies virus
(pre-exposure prophylaxis).
•
Vaccinating you after you have come into contact with rabies virus
(post-exposure prophylaxis).
Rabies Vaccine BP is a preparation containing very small amounts of a
modified form of the virus that
causes rabies. When an injection of Rabies Vaccine BP is given, the
body's natural defences will produce
protection against
R
abies.
2.
BEFORE YOU ARE GIVEN RABIES VACCINE BP
To make sure that this vaccine is suitable for you or your child, it
is important to tell the doctor, nurse or
pharmacist if any points below apply. If there is anything you do not
understand, ask your doctor, nurse or
pharmacist to explain.
DO NOT HAVE RABIES VACCINE BP IF YOU OR YOUR CHILD IS:
•
allergic (hypersensitive) to Rabies Vaccine BP or any of its
in

Preparatomtale

Health Products Regulatory Authority
05 October 2022
CRN00CJMV
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabies Vaccine BP > 2.5 IU/ml, Powder and solvent for suspension for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1ml) contains :
Rabies virus* (inactivated, strain PM/WI 38 1503-3M)…………≥2.5
IU
*produced in human diploid MRC-5 cells.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
The powder is pinkish beige to orangey yellow.
The solvent is a clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabies Vaccine BP is indicated for pre- exposure prophylaxis and for
post-exposure prophylaxis against rabies in all age groups
(see Sections 4.2 and 5.1).
The use of Rabies Vaccine BP should be based on official
recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1mL of reconstituted vaccine.
_Pre-exposure prophylaxis_
The primary pre-exposure immunisation course consists of 3 doses: one
at D0, D7 and either D21 or D28.
Alternatively, in immunocompetent individuals, the one-week regimen
with 2 doses can be used: at D0 and at D7.
Individuals should be vaccinated according to local official
recommendations when available.
For individuals at continued risk, booster doses should be given in
line with official recommendations.
The need for serology testing to detect the presence of rabies
virus-neutralising antibodies (≥0.5 IU/ml) should be assessed
and conducted, if appropriate, in accordance with official
recommendations.
_Post-exposure prophylaxis_
Post-exposure prophylaxis should be initiated as soon as possible
after suspected rabies exposure and should comprise proper
wound care, vaccination, and if necessary, RIG treatment.
In all cases, proper wound care (thorough flushing and washing of all
bite wounds and scratches with soap or detergent and
copious amounts of water and/or virucidal agents) mu