Revaxis vaccine suspension for injection 0.5ml pre-filled syringes

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

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

Prieinama:

Sanofi

ATC kodas:

J07CA01

INN (Tarptautinis Pavadinimas):

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

Vaisto forma:

Suspension for injection

Vartojimo būdas:

Intramuscular

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 14040000; GTIN: 5015973561019

Pakuotės lapelis

1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
REVAXIS
®
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, Tetanus 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 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 REVAXIS is and what it is used for
2. What you need to know before you use REVAXIS
3. How to use REVAXIS
4. Possible side effects
5. How to store REVAXIS
6. Contents of the pack and otherinformation
1. WHAT REVAXIS IS AND WHAT IT IS USED FOR
REVAXIS is a vaccine. Vaccines are used to protect against infectious
diseases. This vaccine helps
boost protection against diphtheria, tetanus and poliomyelitis
(polio). When an injection of REVAXIS
is given, the body’s natural defences will produce protection
against these different diseases.
This booster vaccination is for children from the age of 6 years,
teenagers and adults who have
received this vaccine or a similar vaccine in the past. REVAXIS should
not be given as the first
vaccination (primary course) against diphtheria, tetanus and
poliomyelitis (polio).
REVAXIS will be given according to national recommendations and/or
local practice.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REVAXIS
To make sure that REVAXIS is suitable for you or your child, it is
important that you tell your doctor,
nurse or pharmacist if any points below apply to you or your child. If
there is anything you do not
understand, ask your doctor, nurse or pharmacist to explain.
DO NOT USE REVAXIS

IF YOU OR YOUR CHILD are allergic (hypersensitive)

to the activ

Prekės savybės

OBJECT 1
REVAXIS
Summary of Product Characteristics Updated 04-Jan-2018 | Sanofi
Pasteur
1. Name of the medicinal product
REVAXIS
Suspension for injection in pre-filled syringe
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed,
reduced antigen(s) content)
2. Qualitative and quantitative composition
Each dose (0.5 ml) contains:
Active ingredients:
Purified diphtheria toxoid
……………………………………………… not less than 2
IU* (5 Lf)
Purified tetanus toxoid
………………………………………………… not less
than 20 IU* (10 Lf)
Inactivated poliomyelitis virus type
1**………………..……………... 40 D antigen units***
Inactivated poliomyelitis virus type
2**………………..……………... 8 D antigen units***
Inactivated poliomyelitis virus type
3**…………………………….…32 D antigen units***
aluminium hydroxide as
adsorbant…………………………………… 0.35 mg (as
aluminium)
For the full list of excipients, see section 6.1
* As lower confidence limit (p = 0.95) of activity measured according
to the assay described in the
European Pharmacopoeia.
** Produced in Vero cells.
*** Or equivalent antigenic quantity determined by a suitable
immunochemical method
3. Pharmaceutical form
Suspension for injection in pre-filled syringe.
The vaccine has a cloudy white appearance.
4. Clinical particulars
4.1 Therapeutic indications
REVAXIS is indicated for active immunisation against diphtheria,
tetanus and poliomyelitis in children
from six years of age, adolescents and adults as a booster following
primary vaccination.
REVAXIS is not intended for primary immunisation.
4.2 Posology and method of administration
_Posology _
The dose for children from the age of six years, adolescents and
adults is 0.5 ml.
REVAXIS should be administered in accordance with official
recommendations and/or local practice
regarding the use of vaccines that provide reduced dose diphtheria
toxoid plus tetanus toxoid in
combination with inactivated poliomye