Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
live Bordetella bronchiseptica bacteria strain B-C2
Intervet International BV
QI06AE02
live vaccine against Bordetella bronchiseptica in cats
Cats
Immunologicals for felidae,
For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.Duration of immunity: The duration of immunity is up to 1 year.No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available. From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Revision: 9
Authorised
2002-09-10
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS_ _ _ _ _LABEL FOR THE SOLVENT VIAL: _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Nobivac Bb 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 dose 3. CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 0.5 ml 4. ROUTE OF ADMINISTRATION See package leaflet. 5. WITHDRAWAL PERIOD Not applicable 6. BATCH NUMBER Lot {number} 7. EXPIRY DATE EXP {month/year} 8. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET FOR NOBIVAC BB LYOPHILISATE AND SOLVENT FOR SUSPENSION 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: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each dose (0.2 ml) of reconstituted suspension contains: Lyohpilisate: 10 6.3 -10 8.3 colony forming units (CFU) of live _Bordetella bronchiseptica_ strain B-C2 Solvent: Water for injections Lyophilisate: Off-white or cream-coloured pellet Solvent: clear colourless solution 4. INDICATION(S) For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of _Bordetella _ _bronchiseptica_ associated upper respiratory tract disease. The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination. The duration of immunity is up to 1 year. 5. CONTRAINDICATIONS Do not use in pregnant or lactating queens. 6. ADVERSE REACTIONS After administration, occasionally sneezing, coughing, mild and transient discharge from the eyes or nose may occur. After overdose, identical signs appear particularly in very young susceptible kittens. In cats that show more severe signs, appropriate antibiotic treatment may be indicated. 17 If you notice any serio Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted suspension contains: Lyophilisate: ACTIVE SUBSTANCE: 10 6.3- 10 8.3 colony forming units (CFU) of live _Bordetella bronchiseptica_ bacteria strain B-C2 Solvent: Water for injection EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension. Lyophilisate: Off-white or cream-coloured pellet Solvent: clear colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cats, of 1 month of age or older to reduce clinical signs of _Bordetella _ _bronchiseptica_ associated upper respiratory tract disease. Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination. Duration of immunity: The duration of immunity is up to 1 year. No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available. From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies. 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed. 3 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only healthy cats should be vaccinated. Sneezing by cats after administration does not adversely affect the efficacy of the veterinary medicinal product. Do not administer during antibiotic treatment or in conjunction with any other intranasal veterinary medicinal products. Vaccinated animals can spread the vaccine strain of _Bordetella bronchiseptica_ for six weeks, and there may be intermittent shedding for at least Izlasiet visu dokumentu