REVAXIS Suspension for injection in pre-filled syringe Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Diphtheria toxoid; Tetanus toxoid; POLIOVIRUS, TYPE 1; Poliovirus, type 2; Poliovirus, type 3

Mevcut itibaren:

Sanofi Pasteur

ATC kodu:

J07CA; J07CA01

INN (International Adı):

Diphtheria toxoid; Tetanus toxoid; POLIOVIRUS, TYPE 1; Poliovirus, type 2; Poliovirus, type 3

Doz:

0.5 millilitre(s)

Farmasötik formu:

Suspension for injection in pre-filled syringe

Reçete türü:

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

Terapötik alanı:

Bacterial and viral vaccines, combined; diphtheria-poliomyelitis-tetanus

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2000-02-18

Bilgilendirme broşürü

1
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 defenses 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 active

Ürün özellikleri

Health Products Regulatory Authority
13 April 2023
CRN00D626
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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
1
(5 Lf)
Purified tetanus toxoid
.....................................................................
not less than 20 IU
1
(10 Lf)
Inactivated poliomyelitis virus type 1
2
............................................... 29 D antigen units
3
Inactivated poliomyelitis virus type 2
2
………………..…………….......7 D antigen units
3
Inactivated poliomyelitis virus type 3
2
…………………………….……26 D antigen units
3
aluminium hydroxide as
adsorbant…………………………………… 0.35 mg (as
aluminium)
1
As lower confidence limit (p = 0.95) of activity measured according to
the assay described in the European Pharmacopoeia.
2
Cultivated on Vero cells.
3
These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen units, for virus type 1, 2
and 3 respectively, when measured by another suitable immunochemical
method.
Excipient with known effect:
Each dose (0.5 ml) contains approximately 10 μg of phenylalanine.
For the full list of excipients, see section 6.1
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