Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Erysipelothrix rhusiopathiae, Porcine parvovirus
Zoetis UK Limited
QI09AL01
Erysipelothrix rhusiopathiae, Porcine parvovirus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Viral and Bacterial Vaccine
Expired
2002-04-23
Revised: November 2019 AN: 01134/2019 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SUVAXYN ® Parvo/E 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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) Montanide 888 (Emulsifier) Simulsol 5100 (Emulsifier) EXCIPIENTS: Thiomersal Formaldehyde 730.14 mg 74.32 mg 69.95 mg 0.2 mg 0.05% For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection Appearance: Ivory white oil emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (gilts and sows). Revised: November 2019 AN: 01134/2019 Page 2 of 5 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. 4.3 CONTRAINDICATIONS Do not use less than 3 weeks before mating. 4.4 SPECIAL WARNINGSNone. 4.5 SPECIAL PRECAUTIONS FOR USE (i) Special precautions for use in animals - Avoid stress in the animals around the time of vaccination. - Administer only to animals in good health condition (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user: This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss o Read the complete document