ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentofel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1ml: Active components Inactivated Feline Panleukopenia Virus (CU4 strain) Inactivated Feline Calicivirus (255 strain) Inactivated Feline Rhinotracheitis Virus (605 strain) Inactivated Feline Chlamydia psittaci (Cello strain) Inactivated Feline Leukemia Virus (61E strain) Adjuvants Ethylene/Maleic Anhydride (EMA) Neocryl XK-62 Emulsigen SA Antibody titre 1:8 in 80% of vaccinates. GMT 1:32 Antibody titre 1:2 in 80% of vaccinates. GMT 1:4 Antibody titre 1:8 in 80% of vaccinates. GMT 1:16 Antibody titre 1:40 in 80% of vaccinates. GMT 1:44 Protection from challenge in 75% of vaccinates 10mg 30mg 50mg 3. PHARMACEUTICAL FORM Solution for injection. 4. PHARMACOLOGICAL PROPERTIES Pentofel stimulates the development of active immunity against Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Chlamydia psittaci and Feline Leukaemia Virus. 5. CLINICAL PARTICULARS 5.0 Target Species Cats 5.1 Indications for Use, Specifying the Target Species For the active immunisation of healthy cats 12 weeks or older against Feline Panleukopenia Virus and Feline Leukaemia virus and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci. 5.2 Contra-indications None known. 5
5.3 Undesirable Effects (frequency and seriousness) A small percentage of vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/or depression which usually disappear within 24 hours. 5.4 Special Precautions for Use In case of anaphylactoid reaction, adrenaline should be administered intramuscularly. 5.5 Use During Pregnancy and Lactation The safety of the vaccine in pregnant queens has not been investigated. Vaccination of pregnant queens is not recommended. 5.6 Interaction with other Medicaments and Forms of Interaction Do not administer in conjunction with other products. 5.7 Posology and Method of Administration The contents of the prefilled syringe should be shaken well and administered aseptically by subcutaneous injection. When administering the product, care must be taken to attach the enclosed sterile needle aseptically to the syringe before use. Primary vaccination of cats 12 weeks and older: two doses at an interval of 3 to 4 weeks. Revaccination: one vaccination annually. 5.8 Overdose (symptoms, emergency procedures, antidotes) Administration of an overdose of the product has shown no adverse reaction. 5.9 Special Warnings for each Target Species Vaccination does not affect the course of 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 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 likelihood, they have overcome the FeLV infection. 5.10 Withdrawal Period Not applicable. 5.11 Special Precautions to be Taken by the Person Administering the Product to Animals Should the vaccinator accidentally inject himself or a bystander, he should seek the advice of a doctor immediately. 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities 6
Do not mix with other products. 6.2 Shelf-life 12 months. 6.3 Special Precautions for Storage The product should be stored at +2 C to +8 C. 6.4 Nature and Contents of the Container 3ml disposable polypropylene syringe containing one 1ml of vaccine. The syringes are sealed with rubber tips. 6.5 Special Precautions for the Disposal of Unused Product or Waste Materials, if any Any unused product or waste material should be disposed of by burning or other suitable method of disposal. 7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland 8. NUMBER IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS [...] 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [...] 10. DATE OF REVISION OF THE TEXT [...] 7
ANNEX II HOLDER(S) OF THE MANUFACTURING AUTHORISATION(S) RESPONSIBLE FOR BATCH RELEASE AND CONDITIONS OF THE MARKETING AUTHORISATION 8
A. HOLDER(S) OF THE MANUFACTURING AUTHORISATION(S) Manufacturer(s) of the active substances Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland Manufacturing Authorisation issued on 9 August 1995 by the Irish Department of Health. Manufacturer(s) responsible for batch release Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland Manufacturing Authorisation issued on 9 August 1995 by the Irish Department of Health. B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Product subject to prescription. 9
ANNEX III LABELLING AND PACKAGE INSERT 10
A. LABELLING 11
A.1 OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentofel 2. STATEMENT OF ACTIVE SUBSTANCE(S) Active Ingredients Inactivated Feline Panleukopenia Virus (CU4 strain) Inactivated Feline Calicivirus (255 strain) Inactivated Feline Rhinotracheitis Virus (605 strain) Inactivated Feline Chlamydia psittaci bacterin (Cello strain) Inactivated Feline Leukemia Virus (61E strain) Antibody titre 1:8 in 80% of vaccinates. GMT 1:32 Antibody titre 1:2 in 80% of vaccinates. GMT 1:4 Antibody titre 1:8 in 80% of vaccinates. GMT 1:16 Antibody titre 1:40 in 80% of vaccinates. GMT 1:44 Protection from challenge in 75% of vaccinates 3. PHARMACEUTICAL FORM Solution for injection. 4. TARGET SPECIES, METHOD AND ROUTE OF ADMINISTRATION For the active immunisation of healthy cats aged 12 weeks of age or older by subcutaneous injection. 5. INDICATION(S) For the active immunization of healthy cats 12 weeks and older against Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Chlamydia psittaci and Feline Leukaemia Virus. 6. WITHDRAWAL PERIOD Not applicable. 7. SPECIAL WARNING(S), IF NECESSARY Not relevant. 8. EXPIRY DATE Expiry Date: {month/year} 9. SPECIAL STORAGE CONDITIONS Store between +2 C and +8 C. 12
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS, IF ANY Any unused product or waste material should be disposed of by burning, or other suitable methods of disposal. 11. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 12. THE WORDS KEEP OUT OF REACH OF CHILDREN Keep out of the reach of children. 13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland 14. NUMBER IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS Marketing Authorisation No. [...] 15. MANUFACTURER S BATCH NUMBER Batch Number [...] 16. GENERAL CLASSIFICATION FOR SUPPLY Product subject to prescription. 13
A.2 SINGLE DOSE SYRINGE Pentofel Inactivated vaccine 1ml (1 dose) for cats. Inject S.C. see package insert for details Store at +2 C to +8 C. Batch Number: Expiry Date: For animal treatment only Keep out of the reach of children Manufactured by Fort Dodge Laboratories Ireland Product subject to prescription MA Nr.: 14
B. PACKAGE INSERT 15
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentofel 2. STATEMENT OF THE ACTIVE SUBSTANCE(S) Per dose of 1ml: Active components Inactivated Feline Panleukopenia Virus (CU4 strain) Inactivated Feline Calicivirus (255 strain) Inactivated Feline Rhinotracheitis Virus (605 strain) Inactivated Feline Chlamydia psittaci (Cello strain) Inactivated Feline Leukemia Virus (61E strain) Adjuvants Ethylene/Maleic Anhydride (EMA) Neocryl XK-62 Emulsigen SA Antibody titre 1:8 in 80% of vaccinates. GMT 1:32 Antibody titre 1:2 in 80% of vaccinates. GMT 1:4 Antibody titre 1:8 in 80% of vaccinates. GMT 1:16 Antibody titre 1:40 in 80% of vaccinates. GMT 1:44 Protection from challenge in 75% of vaccinates 10mg 30mg 50mg 3. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, Ireland 4. TARGET SPECIES, DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION, ADVICE ON CORRECT ADMINISTRATION The contents of the prefilled syringe should be shaken well and administered aseptically by subcutaneous injection. Primary vaccination of cats 12 weeks and older: two doses at an interval of 3 to 4 weeks. Revaccination: one vaccination annually. 5. INDICATION(S), CONTRA-INDICATIONS, UNDESIRABLE EFFECTS For the active immunization of healthy cats 12 weeks and older against Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Chlamydia psittaci and Feline Leukaemia Virus. Only healthy cats should be vaccinated. Should an allergic reaction occur for any reason, adrenaline should be administered intramuscularly. 16
A small percentage of vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/or depression which usually disappear within 24 hours. Vaccination of pregnant queens is not recommended. Vaccination does not affect the course of 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 testpositive cats should be isolated from other 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 likelihood, they have overcome the FeLV infection. 6. WITHDRAWAL PERIOD Not applicable. 7. SPECIAL STORAGE CONDITIONS, IF ANY Store between +2 C and +8 C. 8. SPECIAL WARNING(S), IF NECESSARY Not relevant. 9. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY Any unused product or waste material should be disposed of by burning, or by another suitable method of disposal. 10. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED [...] 11. OTHER INFORMATION None. 17