Repevax vaccine suspension for injection 0.5ml pre-filled syringes

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid

Tilgjengelig fra:

Sanofi

ATC-kode:

J07CA02

INN (International Name):

Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Diphtheria toxoid

Legemiddelform:

Suspension for injection

Administreringsrute:

Subcutaneous; Intramuscular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 14040000; GTIN: 5015973651017

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPEVAX
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, Tetanus, Pertussis (acellular, component) and
Poliomyelitis (inactivated) Vaccine
(adsorbed, reduced antigen(s) content)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
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 vaccine has been prescribed for you or for your child only. 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 REPEVAX is and what it is used for
2.
What you need to know before REPEVAX is given to you or your child
3.
How and when REPEVAX is given
4.
Possible side effects
5.
How to store REPEVAX
6.
Contents of the pack and other information
1.
WHAT REPEVAX IS AND WHAT IT IS USED FOR
REPEVAX is a vaccine. Vaccines are used to protect against infectious
diseases. They work by causing the
body to produce its own protection against the bacteria and viruses
that cause the targeted diseases.
This vaccine is used to boost protection against diphtheria, tetanus,
pertussis (whooping cough) and
poliomyelitis (polio) in children from the age of three years,
adolescents and adults following a complete
primary course of vaccination.
LIMITATIONS IN THE PROTECTION PROVIDED
REPEVAX will only prevent these diseases if they are caused by the
bacteria or viruses targeted by the
vaccine. You or your child could still get similar diseases if they
are caused by other bacteria or viruses.
REPEVAX does not contain any live bacteria or viruses and it cannot
cause any of the infectious diseases
against which it protects.
Remember that no vaccine can provide complete, life long protection in
all people who are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE REPEVAX IS GIVEN TO YOU OR

Preparatomtale

OBJECT 1
REPEVAX
Summary of Product Characteristics Updated 09-Jan-2018 | Sanofi
Pasteur
1. Name of the medicinal product
REPEVAX, suspension for injection, in pre-filled syringe
Diphtheria, Tetanus, Pertussis (acellular, component) and
Poliomyelitis (inactivated) Vaccine (adsorbed,
reduced antigen(s) content)
2. Qualitative and quantitative composition
1 dose (0.5 mL) contains:
Diphtheria Toxoid
...........................................................Not less
than 2 IU* (2 Lf)
Tetanus Toxoid
...............................................................Not
less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid
............................................................2.5
micrograms
Filamentous Haemagglutinin .........................................5
micrograms
Pertactin
........................................................................3
micrograms
Fimbriae Types 2 and 3
.................................................5 micrograms
Poliovirus (Inactivated)**
Type 1
............................................................................40
D antigen units
Type 2
............................................................................8
D antigen units
Type 3
............................................................................32
D antigen units
Adsorbed on aluminium phosphate ................................1.5 mg
(0.33 mg aluminium)
* As lower confidence limit (p = 0.95) of activity measured according
to the assay described in the
European Pharmacopoeia.
** Produced in Vero cells.
REPEVAX may contain traces of formaldehyde, glutaraldehyde,
streptomycin, neomycin, polymyxin B
and bovine serum albumin, which are used during the manufacturing
process (see sections 4.3 and 4.4).
For the full list of excipients, see section 0.
3. Pharmaceutical form
Suspension for injection in pre-filled syringe
REPEVAX appears as a uniform, cloudy, white suspension.
4. Clinical particulars
4.1 Therapeutic indications
REPEVAX is indicated for active immunization against diphtheria,
tetanus, pertussis an