Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
porcine parvovirus inactivated 2 ml
Pfizer GmbH
QI09AA02
Solution for injection
Porcine parvovirus vaccine
Pigs Females
2011-08-16
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Parvo ST suspension for intramuscular injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Quantitative composition (2 ml dose) ACTIVE SUBSTANCES: Inactivated porcine parvovirus, strain NADL-2 Antibody titre by Haemagglutination Inhibition (HI) in vaccinated rabbits ≥ 368 GMT * ADJUVANT: Carbopol #941 2.0 mg EXCIPIENTS: Thiomersal 0.17 mg * Geometric Mean Titre For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear pink suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs of a minimum age of 6 months (gilts and sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of sows and gilts to reduce transplacental infection of progeny with porcine parvovirus. Onset of immunity: 8 weeks after primary vaccination. Duration of immunity: 4 months after primary vaccination. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of a return to service, a booster vaccination should be considered. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only clinically healthy animals. Avoid stress in the animal around the time of injection. Special precautions to be taken by the person administering the veterinary medicinal product to ani- mals In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Mild, transient local reactions, including slight visible redness, and Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Parvo ST suspension for intramuscular injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Quantitative composition (2 ml dose) ACTIVE SUBSTANCES: Inactivated porcine parvovirus, strain NADL-2 Antibody titre by Haemagglutination Inhibition (HI) in vaccinated rabbits ≥ 368 GMT * ADJUVANT: Carbopol #941 2.0 mg EXCIPIENTS: Thiomersal 0.17 mg * Geometric Mean Titre For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear pink suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs of a minimum age of 6 months (gilts and sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of sows and gilts to reduce transplacental infection of progeny with porcine parvovirus. Onset of immunity: 8 weeks after primary vaccination. Duration of immunity: 4 months after primary vaccination. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of a return to service, a booster vaccination should be considered. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only clinically healthy animals. Avoid stress in the animal around the time of injection. Special precautions to be taken by the person administering the veterinary medicinal product to ani- mals In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Mild, transient local reactions, including slight visible redness, and Read the complete document