Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae
Zoetis UK Limited
QI07AJ10
Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae
Lyophilisate for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Live Viral and Inactivated Viral and Bacterial Vaccine
Expired
2002-07-11
Revised: October 2015 AN: 00643/2015 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT Duramune DAPPi+LC Lyophilisate and Solvent for Suspension for Injection for Dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1. LYOPHILISATE FRACTION: Active Substances Per 1 ml dose Canine distemper virus, strain Onderstepoort 10 1.1 to 10 3.4 TCID 50 * Canine adenovirus type 2, strain V197 10 4.0 to 10 6.2 TCID 50 * Canine parvovirus, strain SAH 10 4.7 to 10 6.5 TCID 50 * 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: 00643/2015 Page 2 of 7 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: Cream-yellow colour powder Solvent: opaque liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs to prevent mortality and disease caused by canine distemper virus; to prevent mortality and disease and reduce virus shedding caused by canine parvovirus infection; to prevent mortality and reduce clinical signs caused by infectious canine hepatitis and _Leptospira _ _interrogans _ serogroups _canicola_ and _icterohaemorrhagiae_; and to reduce clinical signs and infection caused by canine adenovirus 2; to reduce clinical signs and shedding caused by infection with canin Read the complete document