SUMMARY OF PRODUCT CHARACTERISTICS

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1 SUMMARY OF PRODUCT CHARACTERISTICS

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Ducat (DE: Nobivac RC, SE : Nobivac Ducat vet.) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Per dose of 1 ml reconstituted vaccine: Live attenuated feline viral rhinotracheitis virus, strain G2620A at least 4.8 log 10 TCID 50 *, Live attenuated feline calicivirus, strain F9 at least 4.6 log 10 PFU **. * tissue culture infectious dose ** plaque forming units Excipient(s): For a full list of excipients, see section PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 Target species Cats. 4.2 Indications for use, specifying the target species Active immunisation of cats against feline viral rhinotracheitis (feline herpes virus type I) and feline calicivirus infections. Vaccination reduces clinical signs caused by these viral infections. Onset of immunity: 4 weeks. Duration of immunity: 1 year. 4.3 Contraindications See section Special warnings Vaccination at six weeks of age has been proven to be safe. 4.5 Special precautions for use Special precautions for use in animals Vaccinate only healthy animals. Care should be taken that aerosol is not formed when vaccinating the cat as nasal or oral exposure could result in clinical respiratory signs including lethargy and malaise. For the same reason, the cat should be prevented from licking the injection site. 2

3 Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) A slight transient, sometimes painful, swelling ( 5mm) may be observed at the site of injection for one day. A slight temporary rise in rectal temperature may occur, while occasionally transient lethargy may be observed during the first day after vaccination. In rare cases the vaccine may cause hypersensitivity reactions (pruritus, dyspnoea, vomiting, diarrhoea and collapse). 4.7 Use during pregnancy or lactation Do not use during pregnancy and lactation as the product has not been tested in pregnant and lactating queens. 4.8 Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy from the concurrent use of this vaccine with any other, except Intervets vaccine containing rabies antigen, strain Pasteur RIV, where this product and the combined use is authorised. A decision to use Nobivac Ducat before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route Allow the sterile diluent provided to reach room temperature. Aseptically reconstitute the lyophilised vaccine with one ml of the diluent. Shake well after addition of the diluent. One ml of the reconstituted vaccine should be given by subcutaneous injection. - Basic vaccination: cats from 8 weeks of age onwards should receive two vaccinations with an interval of 3-4 weeks. - Revaccination: annual booster In the initial vaccination course, Intervets vaccine containing rabies antigen, strain Pasteur RIV, may be used to reconstitute Nobivac Ducat at the vaccination at 12 weeks of age (where this product and the combined use is authorised) Overdose (symptoms, emergency procedures, antidotes), if necessary A transient swelling ( 5mm) at the injection site may occur for four to ten days. A transient increase in temperature (<40.8 C) may occur while occasionally lethargy for one day after vaccination may be observed Withdrawal period(s) Not applicable. 5. IMMUNOLOGICAL PROPERTIES 3

4 Live viral vaccines ATC vet code: QI06AD03 To stimulate active immunity against feline rhinotracheitis virus and feline calici virus. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Gelatin-based stabiliser Phosphate buffer Sucrose Water for injections 6.2 Incompatibilities Do not mix with any other vaccine or immunological product except the diluent supplied with the product or with Intervets vaccine containing rabies antigen, strain Pasteur RIV (where this product and the combined use is authorised). 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after reconstitution according to directions: 30 minutes 6.4. Special precautions for storage Vaccine: Store in a refrigerator (2 C - 8 C). Do not freeze. Protect from light. Solvent: Store below 25 C if stored independently from the vaccine. 6.5 Nature and composition of immediate packaging Vaccine: Vial of hydrolytical class type I (Ph. Eur.) glass. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap. Solvent: Vial of hydrolytical class type I (Ph. Eur.) glass. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap. Pack sizes: Carton or plastic boxes with 5, 10, 25 or 50 doses of vaccine and solvent. Not all pack-sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements. 7. MARKETING AUTHORISATION HOLDER Intervet International BV 4

5 Wim de Körverstraat AN Boxmeer The Netherlands represented by the national companies in the CMS. 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT August 2014 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 5

6 LABELLING AND PACKAGE LEAFLET 6

7 A. LABELLING 7

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Ducat (DE: Nobivac RC, SE : Nobivac Ducat vet.) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES per dose: Live att. feline viral rhinotracheitis virus 4.8 log 10 TCID 50, Live att. feline calicivirus 4.6 log 10 PFU 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4. PACKAGE SIZE 5x, 10x, 25x, 50x 1 dose 5. TARGET SPECIES Cats. 6. INDICATION(S) Live vaccine against feline rhinotracheitis virus and feline calici virus. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use. 8. WITHDRAWAL PERIOD Not applicable. [Comment: will not be mentioned on the packaging item] 9. SPECIAL WARNING(S), IF NECESSARY Read package leaflet before use. [Comment: mentioned on the packaging item only once] 8

9 10. EXPIRY DATE EXP {month/year} Once reconstituted use within 30 min. 11. SPECIAL STORAGE CONDITIONS Store in a refrigerator. Do not freeze. Protect from light 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Read package leaflet before use. [Comment: mentioned on the packaging item only once] 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription. 14. THE WORDS KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. represented by the national companies in the concerned Member States 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Lot {number} 9

10 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Ducat (DE: Nobivac RC, SE: Nobivac Ducat vet.), live vaccine, for cats 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 4.8 log 10 TCID 50 FVR 4.6 log 10 PFU FCV 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose. 4. ROUTE(S) OF ADMINISTRATION s.c. 5. WITHDRAWAL PERIOD Not applicable. [Comment: will not be mentioned on the packaging item] 6. BATCH NUMBER Lot {number} 7. EXPIRY DATE EXP {month/year} Once reconstituted use within 30 min. 8. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. Company logo 10

11 B. PACKAGE LEAFLET 11

12 PACKAGE LEAFLET Nobivac Ducat (DE: Nobivac RC, SE: Nobivac Ducat vet.) 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorisation Holder: Intervet International B.V. Wim de Körverstraat 35 NL AN Boxmeer represented by the national companies in the concerned Member States Manufacturer for batch release: Intervet International B.V. Wim de Körverstraat 35 NL AN Boxmeer 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Ducat (DE: Nobivac RC, SE: Nobivac Ducat vet.) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Per dose of 1 ml reconstituted vaccine: Live attenuated feline viral rhinotracheitis virus, strain G2620A at least 4.8 log 10 TCID 50 *, Live attenuated feline calicivirus, strain F9 at least 4.6 log 10 PFU **. * tissue culture infectious dose ** plaque forming units 4. INDICATION(S) Active immunisation of cats against feline viral rhinotracheitis (feline herpes virus type I) and feline calicivirus infections. Vaccination reduces clinical signs caused by these viral infections. Onset of immunity: 4 weeks Duration of immunity: 1 year. 5. CONTRAINDICATIONS Do not use during pregnancy and lactation as the product has not been tested in pregnant and lactating queens. 6. ADVERSE REACTIONS 12

13 A slight transient, sometimes painful, swelling ( 5mm) may be observed at the site of injection for one day. A slight temporary rise in rectal temperature may occur, while occasionally transient lethargy may be observed during the first day after vaccination. In rare cases the vaccine may cause hypersensitivity reactions (pruritus, dyspnoea, vomiting, diarrhoea and collapse). If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Cats. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Allow the sterile diluent provided to reach room temperature. Aseptically reconstitute the lyophilised vaccine with one ml of the diluent. Shake well after addition of the diluent. One ml of the reconstituted vaccine should be given by subcutaneous injection. - Basic vaccination: cats from 8 weeks of age onwards should receive two vaccinations with an interval of 3-4 weeks. - Revaccination: annual booster In the initial vaccination course, Intervets vaccine containing rabies antigen, strain Pasteur RIV, may be used to reconstitute Nobivac Ducat at the vaccination at 12 weeks of age (where this product and the combined use is authorised). 9. ADVICE ON CORRECT ADMINISTRATION The contents of the vial should be used within 30 minutes after reconstitution of the product. 10. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. Vaccine: Store in a refrigerator (2 C 8 C). Do not freeze. Protect from light. Solvent: Store below 25 C if stored independently from the vaccine. 11. SPECIAL WARNING(S) Vaccination at six weeks of age has been proven to be safe. Vaccinate only healthy animals. Care should be taken that aerosol is not formed when vaccinating the cat as nasal or oral exposure could result in clinical respiratory signs including lethargy and malaise. For the same reason, the cat should be prevented from licking the injection site. No information is available on the safety and efficacy from the concurrent use of this vaccine with any other, except Intervets vaccine containing rabies antigen, strain Pasteur RIV, where this product and 13

14 the combined use is authorised. A decision to use Nobivac Ducat before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. In the case of an overdose, a transient swelling ( 5mm) at the injection site may occur for four to ten days. A transient increase in temperature (< 40.8 C) may occur while occasionally lethargy for one day after vaccination may be observed. Do not mix with any other vaccine or immunological product except the diluent supplied with the product or with Intervets vaccine containing rabies antigen, strain Pasteur RIV (where this product and the combined use is authorised). In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements. 13. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED June OTHER INFORMATION Pack sizes: 5x, 10x, 25x, 50x 1 dose of vaccine and solvent Not all pack sizes may be marketed. 14

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