País: Àustria
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
canine adenovirus 10 IU, canine distemper virus 10 IU, canine parvovirus 10 IU, Leptosira Canicola, Leptosira Icterohaemorrhagiae 1 IU, leptospira interrogans serogroup canicola 1 IU
Fort Dodge Animal Health
QI07AI03
Suspension for injection
live Canine distemper virus vaccine + live Canine adenovirus vaccine + live Canine parvovirus vaccine + inactivated Leptospira v
Dogs
2011-09-29
Revised: November 2012 AN: 00961/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT Duramune DAP + L 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION Combined canine distemper virus vaccine (live), lyophilisate; canine adenovirus vaccine (live), lyophilisate; canine parvovirosis vaccine (live), lyophilisate and canine leptospirosis vaccine (inactivated). QUANTITATIVE COMPOSITION 1. LYOPHILISATE FRACTION: Active Substances Per 1 ml dose Canine Distemper virus, strain Onderstepoort 10 2.5 to 10 4.8 TCID 50 * Canine Adenovirus type 2, strain V197 10 4.8 to 10 7.0 TCID 50 * Canine Parvovirus, strain SAH 10 4.7 to 10 6.5 TCID 50 * *TCID50 = tissue culture 50% infective dose Excipients None giving rise to safety concerns. 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.* Adjuvants Ethylene/Maleic anhydride (EMA) 0.01 ml Neocryl A640 0.03 ml Excipients For a full list of excipients, see section 6.1. *hamster 80% protective dose according to Ph.Eur. Revised: November 2012 AN: 00961/2011 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 yel Llegiu el document complet