Land: Storbritannien
Språk: engelska
Källa: VMD (Veterinary Medicines Directorate)
Canine coronovirus, Canine parainfluenza virus, Leptospira canicola, Leptospira icterohaemorrhagiae
Zoetis UK Limited
QI07AJ12
Canine coronovirus, Canine parainfluenza virus, Leptospira canicola, Leptospira icterohaemorrhagiae
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Live Viral and Inactivated Viral and Bacterial Vaccine
Expired
2007-04-02
Revised: October 2015 AN. 00644/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT Duramune Pi + LC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION Combined canine parainfluenza virus vaccine (live), lyophilisate, canine leptospirosis vaccine (inactivated) and canine coronavirus vaccine (inactivated). QUANTITATIVE COMPOSITION 1. LYOPHILISATE 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 SOLVENT FRACTION: Active Substances Per 1 ml dose Inactivated Leptospira interrogans bacteria (outer membrane coat) Serogroup _canicola_, Serovar _canicola_ Potency according to Ph.Eur.* Serogroup _icterohaemorrhagiae_, serovar _icterohaemorrhagiae_ Potency according to Ph.Eur.* Canine coronavirus, strain TN449 (inactivated) RP** 1.0-2.0 Adjuvants Ethylene/Maleic anhydride (EMA-31) 0.1 mg Neocryl 0.015 ml Excipients For a full list of excipients, see section 6.1. * hamster 80% protective dose according to Ph.Eur. ** RP = Relative Potency Revised: October 2015 AN. 00644/2015 Page 2 of 6 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: Cream-yellow colour powder Solvent: Opaque White liquid Reconstituted vaccine: orange or yellowish colour with light opalescence 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; to prevent mortality and reduce clinical signs due to _Leptospira interrogans_, serovars _canicola_ and _icterohaemorrhagiae_; and to reduce infection at the intestinal level caused by canine coronavirus. The onset of immunity is from two weeks after the second vaccination. The duration of immunity is one year; after one ye Läs hela dokumentet