Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Leishmania infantum excreted secreted proteins
Virbac S.A.
QI07AO
Leishmania infantum excreted secreted proteins
Dogs
Immunologicals
For the active immunisation of Leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.Onset of immunity: 4 weeks after the primary vaccination course.Duration of immunity: 1 year after the last re-vaccination.
Revision: 2
Withdrawn
2011-03-14
17 B. PACKAGE LEAFLET Medicinal product no longer authorised 18 PACKAGE LEAFLET CANILEISH LYOPHILISATE AND SOLVENT FOR SUSPENSION 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: VIRBAC 1ère avenue – 2065 m – L.I.D. 06516 Carros France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT CaniLeish lyophilisate and solvent for suspension for injection for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Each dose of 1 ml vaccine contains: Lyophilisate: ACTIVE SUBSTANCE: _Leishmania infantum_ Excreted Secreted Proteins (ESP) at least 100 µg ADJUVANT: Purified extract of _Quillaja saponaria_ (QA-21) 60 µg Solvent: Sodium chloride solution 9 mg/ml (0.9%) 1 ml 4. INDICATIONS For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with _Leishmania infantum_. The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure. Onset of immunity: 4 weeks after the primary vaccination course. Duration of immunity: 1 year after the last (re-)vaccination. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. Medicinal product no longer authorised 19 6. ADVERSE REACTIONS After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days. In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported. Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common. In rare cases anorexia and emesis have been reported. Allergic-type reactions are rare. Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CaniLeish lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml vaccine contains: Lyophilisate: ACTIVE SUBSTANCES: _Leishmania infantum_ Excreted Secreted Proteins (ESP) at least 100 µg ADJUVANT: Purified extract of _Quillaja saponaria_ (QA-21): 60 µg Solvent: Sodium chloride solution 9 mg/ml (0.9%) 1 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with _Leishmania infantum_. The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure. Onset of immunity: 4 weeks after the primary vaccination course. Duration of immunity: 1 year after the last (re-)vaccination. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination. Antibodies due to vaccination can be differentiated from antibodies due to natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis. Medicinal product no longer authorised 3 In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian before deciding to use the vaccine in dogs_. _ The impact of the vaccine in terms of public health and control of the human infection cannot be esti Read the complete document