البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
Recombinant protein Q from Leishmania infantum MON-1
LETI Pharma, S.L.U.
QI07A
Canine leishmaniasis vaccine (recombinant protein)
Dogs
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
For active immunisation of dogs from 6 months of age to reduce the risk of developing a clinical case of leishmaniasis.
Revision: 11
Authorised
2016-04-20
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: LETIFEND LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: LETI Pharma, S.L.U. C/ Del Sol 5, Polígono Industrial Norte Tres Cantos 28760 Madrid SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate and solvent for solution for injection for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 0.5 ml contains: LYOPHILISATE (white lyophilisate) Active substance: Recombinant Protein Q from _Leishmania infantum_ MON-1: ≥ 36.7 ELISA units (EU) * * Antigen content determined in an ELISA against an internal standard. Excipients: Sodium chloride Arginine hydrochloride Boric acid. SOLVENT Water for injections: q.s. 0.5 ml. 4. INDICATION(S) For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to _Leishmania infantum. _ The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to _Leishmania infantum_ in zones with high infection pressure over a two years period. In laboratory studies including experimental challenge with _Leishmania infantum_, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes. Onset of immunity: 4 weeks after vaccination. Duration of immunity: 1 year after vaccination. 17 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS After vaccination, scratching at the injection site has been observed very commonly in dogs. Spontaneous resolution of such reaction was observed within 4 hours. Hypersensitivity reactions (e.g. anaphylaxis, skin manifestations such as oedema, urticaria, pruritus) have been اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate and solvent for solution for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains: LYOPHILISATE Active substance: Recombinant Protein Q from _Leishmania infantum_ MON-1 ≥ 36.7 ELISA Units (EU) * * Antigen content determined in an ELISA against an internal standard. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection. White lyophilisate. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to _Leishmania infantum. _ The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to _Leishmania infantum_ in zones with high infection pressure over a two years period. In laboratory studies including experimental challenge with _Leishmania infantum_, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes. Onset of immunity: 4 weeks after vaccination. Duration of immunity: 1 year after vaccination. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy and non-infected animals only. The vaccine is safe in infected dogs. Re-vaccination of infected dogs did not worsen the course of the disease (during the 2-month observation period). No efficacy has been demonstrated in these animals. 3 A test for the detection of Leishmania infection is recommended prior to vaccination. The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals De-worming اقرأ الوثيقة كاملة