Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Porcine respiratory and reproductive syndrome virus
Boehringer Ingelheim Limited
QI09AD03
Porcine respiratory and reproductive syndrome virus
Lyophilisate for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Live Viral Vaccine
Authorized
2015-03-26
Revised: September 2015 AN: 00499/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ingelvac PRRSFLEX EU lyophilisate and Ingelvac PRRSFLEX EU solvent for suspension for injection for pigs (BE, CY, DE, EL, FR, IT, LI, LU) Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs (AT, BG, CZ, EE, ES, HR, HU, IE, LT, LV, NL, PL, PT, RO, SI, SK, UK) The name [the product] will be used in the Product Information 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (1 ml) contains: Lyophilisate: ACTIVE SUBSTANCE Live attenuated Porcine Respiratory and Reproductive Syndrome Virus (PRRSV), strain 94881 (genotype 1) At least: 10 4.4 TCID 50 -10 6.6 TCID 50* *Tissue Culture Infectious Dose 50 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off-white to milky-grey Solvent: clear, colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (from 17 days of age until the end of fattening) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of clinically healthy pigs at 17 days of age and older from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce virus load in blood in seropositive animals under field conditions. Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces lung lesions, virus load in blood and lung tissues as well as negative effects of infection on daily weight gain. A significant reduction of the respiratory clinical signs could additionaly be demonstrated at the onset of immunity. Page 1 of 5 Onset of immunity:3 weeks Duration of immunity: 26 weeks 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in breeding animals. Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using Read the complete document