Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
Zoetis Belgium S.A.
QI07AI05
Live canine parvovirus strain NL-35-D; Inactivated leptospira canicola; Inactivated leptospira icterohaemorrhagiae
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Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
live canine parvovirus + inactivated leptospira
Immunological - Mixed Vaccine (L & A)
Authorised
2014-09-12
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vanguard CPV-L solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains: ACTIVE SUBSTANCES: Live attenuated canine Parvovirus, strain NL-35-D, low passage, minimum: 10 7.0 CCID 50 * Inactivated _Leptospira canicola_ , between 420 and 740 RU**/dose Inactivated _ Leptospira icterohaemorrhagiae_ ,between 463 to 915 RU**/dose . *Cell culture infectious dose- 50 **Relative units EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Modified Eagles medium A clear to slightly turbid liquid. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs from 6 weeks of age. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Active immunisation of dogs to prevent mortality and clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus (types 2a, 2b and 2c) and to reduce infection caused by _Leptospira canicola _ and _Leptospira icterohaemorrhagiae_ . Onset of immunity: 2 weeks after the last dose of the Basic Vaccination Scheme. 7 days after a single dose when animals are vaccinated from 9 weeks of age for the canine parvovirus component (type 2b ) Duration of immunity: 12 months, after the last dose of the Basic Vaccination Scheme based on serology/challenge data. 3.3 CONTRAINDICATIONS Do not use in unhealthy animals. 3.4 SPECIAL WARNINGS Vaccinate healthy animals only. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: The canine parvovirus vaccinal strain may be shed from vaccinated animals for a number of days following vaccination. However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated animals separated from non-vaccinated animals. Due to the presence of maternally derived antibodies, a small percentage of pups may fail to mount an adequate immune response to vaccination and may be at risk from disease when the local disease challenge is sufficiently high. The percentage of puppies that fail t Les hele dokumentet