SUVAXYN PARVO/E

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PORCINE PARVOVIRUS, STRAIN S-80 INACTIVATED, ERYSIPELOTHRIX RHUSIOPATHIAE SUIS, STRAIN B-7 (SEROTYPE2) INACTIVATED

Available from:

Zoetis Ireland Limited

ATC code:

QI09AL01

INN (International Name):

PORCINE PARVOVIRUS, STRAIN S-80 INACTIVATED, ERYSIPELOTHRIX RHUSIOPATHIAE SUIS, STRAIN B-7 (SEROTYPE2) INACTIVATED

Dosage:

Unknown

Pharmaceutical form:

Emulsion for Injection

Prescription type:

POM

Therapeutic group:

Porcine

Therapeutic area:

Inactivated Porcine parvovirus vaccine + inactivated Erysipelothrix vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Parvo/E.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
Appearance: Ivory white oil emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (gilts and sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs (gilts and sows) to:
Prevent reproductive disorders caused by porcine parvovirus.
Reduce clinical signs caused by _Erysipelothrix rhusiopathiae _infections, serotype 2 and serotype 1.
The onset of immunity starts 3 weeks after vaccination and duration of the protection is 6 months.
Per dose of 2 ml
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus, strain S-80:
Inducing an HIA* titre of at least 160 (in
rabbits).
Inactivated _Erysipelothrix rhusiopathiae,_
strain B-7 (serotype 2):
RP** >1.8 in accordance with the EP
Monograph
*HIA: haemagglutination inhibiting antibody
**Relative Potency compared to a reference serum obtained from a vaccine
that has given
satisfactory protection in vaccinated pigs.
ADJUVANTS:
Marcol 52 (Mineral oil)
730.14 mg
Montanide 888 (Emulsifier)
74.32 mg
Simulsol 5100 (Emulsifier)
69.95 mg
EXCIPIENTS:
Thiomersal
0.2 mg
Formaldehyde
0.05 %
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/12/2013_
_CRN 7016114_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use less than 3 weeks before mating.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
-
Avoid stress in the animals around the time of vaccination.
-
Administer only to animals in good health condition
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADM