RABIES VACCINE PASTEUR MERIEUX 2.5 IU/ML Suspension for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-03-2015
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Active ingredient:
RABIES VACCINE
Available from:
Sanofi Pasteur MSD Ltd
ATC code:
J07BG01
INN (International Name):
RABIES VACCINE
Dosage:
2.5 IU/ML
Pharmaceutical form:
Suspension for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Rabies vaccines
Authorization status:
Transfer Pending
Authorization date:
1994-12-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabies Vaccine BP > 2.5 IU/ml, Powder and solvent for suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1ml) contains :
Rabies virus* (inactivated, strain PM/WI 38 1503-3M)………… 2.5 IU
*produced in human diploid MRC-5 cells.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
The powder is pinkish beige to orangey yellow.
The solvent is a clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prophylactic immunisation against rabies.
Treatment of patients following suspected rabies contact.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Administer by intramuscular injection. The vaccine should be administered into the deltoid region. For instructions on
the reconstitution of the vaccine before administration, see section 6.6.
_Pre-exposure prophylaxis_
One injection of 1 millilitre given each day on days 0, 7 and 28.
The earliest day that the 3
rd
dose can be given to achieve effective immune status is day 21.
For those at regular and continuing risk, a single reinforcing dose of vaccine should be given at 1 year after the primary
course has been completed. Further doses should be given at three- to five-year intervals thereafter.
For travellers at intermittent risk of exposure, booster doses may be given in line with official recommendations.
The need for serology testing to detect the presence of rabies virus-neutralising antibodies ( 0.5 IU/ml) should be
assessed and conducted, if appropriate, in accordance with official recommendations.
_Post-exposure prophylaxis_
Post-exposure treatment should begin as soon as possible after the suspected contact. Immediate wound toi
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