Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Canine parvovirus attenuated strain 154
Intervet Ireland Limited
QI07AD01
Canine parvovirus attenuated strain 154
.
Lyophilisate and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
canine parvovirus
Immunological - Live Vaccine
Authorised
2004-03-05
Health Products Regulatory Authority 14 October 2021 CRN00CCQ2 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Parvo-C 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose of the vaccine vial contains: _Active Ingredients:_ Canine parvovirus (strain 154) not less than 10 7.0 TCID 50 * *Tissue culture infective dose 50% _Excipients: _ For a full list of excipients see 6.1 _Solvent (1ml per vial):_ Phosphate buffered saline. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs to prevent clinical signs of disease and excretion of virulent canine parvovirus caused by canine parvovirus infection. Onset of immunity has been shown to occur from 1 week after dosing and last for up to 3 years. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The efficacy of the vaccine may be reduced due to maternal antibody interference. However, the vaccine has been proven to be of benefit against virulent challenge in the presence of maternal antibody levels that are likely to be encountered under field conditions. 4.5 SPECIAL PRECAUTIONS FOR USE _Special precautions for use in animals_ Only healthy dogs should be vaccinated. Dogs should not be exposed to unnecessary risk of infection within the first week after vaccination. While the canine parvovirus vaccine strain may be shed at very low levels for up to 8 days after inoculation, there is no evidence that this results in clinical symptoms if non-vaccinated animals are infected. _Special precautions to be taken by the person administering the veterinary medicinal product to animals_ In the case of accidental self-injection, wash the area immediately with water. If symptoms develop, seek medical advice immediately and show the package leaflet or the label to the physician. Health Products Regulatory Authority 14 October 2021 CRN00CCQ2 Page 2 of 4 4 Read the complete document