Country: Միացյալ Թագավորություն
language: անգլերեն
source: VMD (Veterinary Medicines Directorate)
Canine parainfluenza virus
Zoetis UK Limited
QI07AD08
Canine parainfluenza virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Live Viral Vaccine
Expired
2007-02-19
Revised: 01 December 2014 AN: 00723/2014 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT Duramune Pi 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION Combined canine parainfluenza virus vaccine (live), freeze dried. QUANTITATIVE COMPOSITION 1. FREEZE-DRIED FRACTION: Active Substances Per 1 ml dose Canine Parainfluenza virus, Strain FDL 10 4.5 to 10 6.8 TCID 50 * *TCID 50 = tissue culture 50% infective dose Excipients For a full list of excipients, see section 6.1. 2. LIQUID DILUENT FRACTION: Water for injection 1 ml 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 the active immunisation of dogs to reduce clinical signs due to infection with canine parainfluenza virus and reduce shedding of canine parainfluenza virus. The onset of immunity is from two weeks after the second vaccination. The duration of immunity is one year. Revised: 01 December 2014 AN: 00723/2014 Page 2 of 5 4.3 CONTRAINDICATIONS See section 4.7. 4.4 SPECIAL WARNINGS The live vaccine strain may spread to unvaccinated animals, but does not cause disease. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Following the first vaccination, it is very common for puppies to develop a small visible swelling (<2 cm) lasting for generally only two days. Following the second vaccination, it is common for a small visible swelling (up to 5 cm) to be seen at the injection site, which may last for up to five days. The swelling may be painful for 1 to 2 days. In most cases, these small and transient injection site reactions resolve with no nee read_full_document