Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
inactivated feline rhinotracheitis virus, inactivated feline calicivirus, inactivated feline Chlamydophila felis, inactivated feline leukaemia virus, inactivated feline panleukopenia virus
Zoetis Belgium SA
QI06AL01
inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis
Cats
Immunologicals
For the active immunisation of healthy cats nine weeks or older against feline panleukopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and Chlamydophila felis.
Revision: 20
Authorised
1997-02-05
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: FEVAXYN PENTOFEL, SUSPENSION FOR INJECTION FOR CATS 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: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Fevaxyn Pentofel, suspension for injection for cats 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml (single dose syringe): ACTIVE COMPONENTS RELATIVE POTENCY (R.P.) Inactivated feline panleucopenia virus, strain CU4 Inactivated feline calicivirus, strain 255 Inactivated feline rhinotracheitis virus, strain 605 Inactivated _Chlamydophila felis_ , _ _ strain Cello Inactivated feline leukaemia virus, strain 61E ≥ 8.50 ≥ 1.26 ≥ 1.39 ≥ 1.69 ≥ 1.45 ADJUVANTS Ethylene/maleic anhydride (EMA-31) Neocryl Emulsigen SA 1% (v/v) 3% (v/v) 5% (v/v) 4. INDICATION(S) For the active immunisation of healthy cats 9 weeks or older against feline panleucopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and _Chlamydophila felis._ 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/or depression which usually disappear within 24 hours. 16 A local reaction with swelling, pain, pruritus or hair loss at the injection site may be observed. Anaphylactic reactions with oedema, pruritus, respiratory and cardiac distress, severe gastrointestinal signs (including haematemesis and haemorrhagic diarrhoea) or shock have been seen during the first hours after vaccination in very rare cases. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals tre Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fevaxyn Pentofel, suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml (single dose syringe): ACTIVE COMPONENTS RELATIVE POTENCY (R.P.) Inactivated feline panleucopenia virus, strain CU4 Inactivated feline calicivirus, strain 255 Inactivated feline rhinotracheitis virus, strain 605 Inactivated _Chlamydophila felis_ , _ _ strain _ _ Cello Inactivated feline leukaemia virus, strain 61E ≥ 8.50 ≥ 1.26 ≥ 1.39 ≥ 1.69 ≥ 1.45 ADJUVANTS Ethylene/maleic anhydride (EMA-31) Neocryl Emulsigen SA 1% (v/v) 3% (v/v) 5% (v/v) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Vaccine appearance is a pale milky pink liquid which should be free from solid particles. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of healthy cats 9 weeks or older against feline panleucopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and _Chlamydophila felis._ 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccination does not affect the course of feline leukaemia virus (FeLV) infection in cats already infected with FeLV at the time of vaccination, implying that such cats will excrete FeLV irrespective of vaccination; consequently, these animals will constitute a hazard to susceptible cats in their environment. It is therefore recommended that cats with a significant risk of having been exposed to FeLV be tested for FeLV antigen prior to vaccination. Test negative animals can be vaccinated, while test-positive cats should be isolated from other 3 cats and retested within 1–2 months. Cats positive at the second testing should be considered as being permanently infected with FeLV and should be handled accordingly. Cats negative at second testing can be vaccinated since, in all Preberite celoten dokument