Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Porcine parvovirus
Ceva Animal Health Ltd
QI09AA02
Porcine parvovirus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Viral Vaccine
Authorized
2005-10-17
Revised: October 2022 AN: 01675/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISITICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PARVOVAX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2-ml dose of vaccine contains: Inactivated porcine parvovirus, minimum …………… 2.0 HAI.U Thiomersal,maximum…………………………………… 0.2 mg Oily adjuvant which includes light paraffin oil… 449.6 to 488.2 mg Benzyl alcohol……………………………………… 10.56mg 1 HAI.U: q.s. to obtain HAI antibody titres of 1 log10 in guinea-pigs after administration of the vaccine. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Breeder pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of breeder pigs (gilts, sows, boars) against porcine parvovirus, to reduce the number of stillbirths and mummified foetuses in vaccinates. The onset of immunity is obtained from 2 to 3 weeks after the primary vaccination. This immunity persists for up to one year. Revised: October 2022 AN: 01675/2022 Page 2 of 6 4.3 CONTRA-INDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate only healthy animals. Vaccinate sows during lactation. 4.5 SPECIAL PRECAUTIONS FOR USE (I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. (II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO THE ANIMALS Apply usual aseptic procedures. 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 of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. To the Read the complete document