REVAXIS 0.5 Millilitre Suspension for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-12-2014
Summary of Product characteristics
(SPC)
07-02-2015
Active ingredient:
DIPHTHERIA TOXOID, TETANUS TOXOID, POLIOVIRUS, TYPE 1, POLIOVIRUS, TYPE 2, POLIOVIRUS, TYPE 3
Available from:
Sanofi Pasteur MSD Ltd
ATC code:
J07CA01
INN (International Name):
DIPHTHERIA TOXOID, TETANUS TOXOID, POLIOVIRUS, TYPE 1, POLIOVIRUS, TYPE 2, POLIOVIRUS, TYPE 3
Dosage:
0.5 Millilitre
Pharmaceutical form:
Suspension for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Bacterial and viral vaccines, combined
Authorization status:
Authorised
Authorization date:
2000-02-18
Summary of Product characteristics
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* (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 pr
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