POLIOMYELITIS VACCINE %v/v Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

POLIO VIRUS TYPE 1 INACTIVATED, POLIO VIRUS TYPE 2 INACTIVATED, POLIO VIRUS TYPE 3 INACTIVATED

Available from:

Sanofi Pasteur

ATC code:

J07BF03

INN (International Name):

POLIO VIRUS TYPE 1 INACTIVATED, POLIO VIRUS TYPE 2 INACTIVATED, POLIO VIRUS TYPE 3 INACTIVATED

Dosage:

%v/v

Pharmaceutical form:

Suspension for Injection

Prescription type:

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

Therapeutic area:

Poliomyelitis vaccines

Authorization status:

Authorised

Authorization date:

2016-11-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER POLIOMYELITIS VACCINE (INACTIVATED) SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
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 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 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 Poliomyelitis Vaccine (Inactivated) is and what it is used for
2. What you need to know before you use Poliomyelitis Vaccine
(Inactivated)
3. How to use Poliomyelitis Vaccine (Inactivated)
4. Possible side effects
5. How to store Poliomyelitis Vaccine (Inactivated)
6. Contents of the pack and other information
1. WHAT POLIOMYELITIS VACCINE (INACTIVATED) IS AND WHAT IT IS USED FOR
Poliomyelitis Vaccine (Inactivated) is a vaccine. Vaccines are used to
protect you against
infectious diseases. This vaccine helps to protect against polio. When
an injection of
Poliomyelitis Vaccine (Inactivated) is given, the body's natural
defences will produce protection
against polio infection. Poliomyelitis Vaccine (Inactivated) can be
given to infants from 2 months
of age, children and adults.
Polio is an infectious disease that is usually caught by swallowing
polio viruses in food or drink.
It can also be caught by eating with unwashed hands if there is virus
on them. The viruses spread
to the nervous system and can cause permanent paralysis. The viruses
in the vaccine have been
killed so that they cannot cause polio but they can cause your body to
make antibodies to protect
against future infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE POLIOMYELITIS VACCINE
(INACTIVATED)
DO NOT RECEIVE POLIOMYELITIS VACCINE (INACTIVATED):
-
if you or your child are allergic (hypersensitive) to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Poliomyelitis Vaccine (Inactivated), suspension for injection in a
pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) contains:
Inactivated type 1 polio virus (Mahoney)
1
40
D-antigen
2
units
3
Inactivated type 2 polio virus (MEF-1)
1
8
D-antigen
2
units
3
Inactivated type 3 polio virus (Saukett)
1
32
D-antigen
2
units
3
1
Cultivated on Vero cells
2
Quantity of antigen in the Final Bulk Product, according to WHO (TRS
673, 1982)
3
Or equivalent nominal amount of poliovirus of each type expressed in
European Pharmacopoeia Units of D-antigen
(parallel line method)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
The vaccine is a clear and colourless suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Poliomyelitis Vaccine (Inactivated)
is indicated for active immunisation against poliomyelitis as follows:
Primary immunization is indicated in infants from 2 months of age
onwards (see section 5.1)
Revaccination (boosting) in children, adolescents and adults in
accordance with official recommendations (see section
4.2) and taking into account the pharmacodynamic properties of the
vaccine (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccination_:
The primary immunisation schedule consists of three doses of 0.5 ml of
Poliomyelitis Vaccine (Inactivated)
administered from two months of age according to official
recommendations.
There should be an interval of at least 1 month between doses.
_Revaccination (boosting):_
After completion of a primary immunisation series, booster doses
should be given to maintain immunity. The need for
and the timing of booster doses should be assessed in accordance with
official recommendations.
Poliomyelitis Vaccine (Inactivated) may be used as a booster in
individuals who have received one or more doses of an
oral poliomyelitis vaccine previously.
Method of administration
H
E
A
L