Rabies vaccine powder and solvent for suspension for injection 1ml vials

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Rabies virus inactivated

Mevcut itibaren:

Sanofi Pasteur

ATC kodu:

J07BG01

INN (International Adı):

Rabies virus inactivated

Farmasötik formu:

Powder and solvent for suspension for injection

Uygulama yolu:

Intramuscular

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 14040000; GTIN: 5015973061014

Bilgilendirme broşürü

Page 1 of 6
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 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.
•
Vaccinating you after you have come into contact with rabies virus.
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
ingredients (see section 6).
•
allergic (hypersensitive) to neomycin or betapropiolactone because
these are used during vaccine
production and may be present in the vaccine in small a

Ürün özellikleri

OBJECT 1
RABIES VACCINE BP
Summary of Product Characteristics Updated 28-Mar-2018 | Sanofi
Pasteur
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
For prophylactic immunisation against rabies. Treatment of patients
following suspected rabies contact.
4.2 Posology and method of administration
Administer by intramuscular injection. The vaccine should be
administered into the deltoid region. For
instructions on the reconstitution of the vaccine before
administration, see section 6.6.
_Pre-exposure prophylaxis_
One injection of 1 millilitre given each day on days 0, 7 and 28.
The earliest day that the 3
rd
dose can be given to achieve effective immune status is day 21.
For those at regular and continuing risk, a single reinforcing dose of
vaccine should be given at 1 year
after the primary course has been completed. Further doses should be
given at three- to five-year intervals
thereafter.
For travellers at intermittent risk of exposure, booster doses may 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 treatment should begin as soon as possible after the
suspected contact. Immediate wound
toilet is important to reduce the risk of infection, followed by the
administration of the vaccine and
passive immunisation if indicated; this should be carried out in
accorda