1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus BbPi IN nasal drops, lyophilisate and solvent for suspension for dogs (for AT, BE, DE, ES, FR, IE, IT, LU, NL, UK(NI) only) Biocan Novel Respi nasal drops, lyophilisate and solvent for suspension for dogs (for CZ, SK, EL, CY, EE, LV, LT, PL, RO, HR, HU, SI only) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains: Active substances: Live attenuated Bordetella bronchiseptica strain MSLB 3096 10 8.0 – 10 9.8 CFU* Live attenuated Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.5 – 10 5.8 CCID50** *CFU: Colony forming unit. **CCID50: Cell culture infectious dose 50%. Excipients: Qualitative composition of excipients and other constituents Lyophilisate: Glucose Sucrose Dextran 40 Sodium chloride Potassium chloride Disodium hydrogen phosphate dodecahydrate Potassium dihydrogen phosphate Solvent: Water for injections (Aqua ad iniectabilia) The visual appearance is as follows: Lyophilisate: spongy matter of whitish to yellowish colour. Solvent: clear colourless liquid. 3. CLINICAL INFORMATION 3.1 Target species Dogs. 3.2 Indications for use for each target species Active immunisation of dogs from 3 weeks of age: − to reduce clinical signs and bacterial excretion after infection with Bordetella bronchiseptica and 3 − to reduce clinical signs and viral excretion after infection with canine parainfluenza virus. Onset of immunity: 3 days after primary vaccination for Bordetella bronchiseptica. 7 days after primary vaccination for canine parainfluenza virus. Duration of immunity: 1 year. 3.3 Contraindications None. 3.4 Special warnings Vaccinate healthy animals only. This veterinary medicinal product contains a live attenuated bacterial strain and antibiotics may interfere with the veterinary medicinal product's efficacy. Therefore, vaccinated dogs should not receive antibiotic treatment. If antibiotics are used within one week after vaccination, vaccination against Bordetella bronchiseptica should be repeated e.g. with a Bb monovalent vaccine (if available) after completion of the antibiotic treatment. 3.5 Special precautions for use Special precautions for safe use in the target species: After vaccination dogs may excrete the vaccine strain Bordetella bronchiseptica for up to 11 weeks and the vaccine strain canine parainfluenza virus for 8 days. Unvaccinated dogs can manifest mild clinical signs such as sneezing and nasal and ocular discharge after contact with vaccinated dogs. The transmission of vaccine strains to cats, pigs and rodents could not be demonstrated. However, as the possibility of transmission to non-target species cannot be rejected, it is recommended to keep non- vaccinated animals out of close contact with vaccinated dogs for at least 4 weeks. Safe handling and proper administration of the veterinary medicinal product and disposal of used material contribute to eliminating the risk of spreading the vaccine antigens in the veterinary workplace. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Hands and tools should be disinfected after use. In case of accidental self-administration during dilution of the veterinary medicinal product or inhalation of the veterinary medicinal product in the form of aerosol during administration into the nostril of a dog, seek medical advice immediately and show the package leaflet or the label to the physician. Although the risk that immunocompromised people are infected with Bordetella bronchiseptica is extremely low, it should be borne in mind that dogs can excrete the bacteria for up to several weeks after vaccination. Immunocompromised persons are advised to avoid contact with the veterinary medicinal product and vaccinated dogs during excretion. Special precautions for the protection of the environment: Not applicable. 4 3.6 Adverse events Dogs: Very common (>1 animal / 10 animals treated): Nasal discharge 1 Common (1 to 10 animals / 100 animals treated): Ocular discharge 1 Cough2 Depression1 Uncommon (1 to 10 animals / 1,000 animals treated): Sneezing1 1Mild and generally subside without treatment within 1 to 3 days. 2Mild to moderate and observed in vaccinated dogs within 48 hours to one week after vaccination. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details. 3.7 Use during pregnancy, lactation or lay Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, the use is not recommended during pregnancy and lactation. 3.8 Interaction with other medicinal products and other forms of interaction This veterinary medicinal product has been shown safe in dogs from 8 weeks of age when given at the same time as vaccines of the Versican Plus/Biocan Novel and Vanguard ranges containing live canine parvovirus, adenovirus, distemper virus, parainfluenza virus as well as inactivated Leptospira and rabies virus. Mild (< 1 ºC), transient increases in temperature were very commonly observed following co-administration of these vaccines. Efficacy after concurrent use has not been tested. Therefore, while safety of concurrent use has been demonstrated, the veterinarian should take this into account when deciding to administer the veterinary medicinal products at the same time. Although proven safe it should not be necessary to give a parainfluenza vaccine twice by two different routes, therefore the veterinarian should consider vaccination options based on local availability of core vaccines without parainfluenza and monovalent Bordetella vaccines. No information is available on the safety and efficacy of this veterinary medicinal product when used with any other veterinary medicinal product except the products mentioned above. A decision to use this veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 3.9 Administration routes and dosage Nasal use. Dosage and route of administration: Aseptically reconstitute the lyophilisate with the solvent. Shake well after reconstitution. Withdraw the liquid with the syringe, remove the needle and administer directly from the tip of the syringe into one nostril. Alternatively, an intranasal applicator (available separately) can be attached to the syringe and 5 the dose then administered into one nostril. The veterinary medicinal product should then be used immediately. The head of the dog should be held with the nose pointing upwards. Administer one dose (0.5 ml) of the reconstituted veterinary medicinal product into one nostril. Appearance of the reconstituted vaccine: whitish to yellowish colour with light opalescence. Primary vaccination scheme: A single dose from 3 weeks of age. Re-vaccination scheme: A single dose to be given annually. 3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes) No adverse events other than those mentioned in section 3.6 were observed after administration of a 10-fold overdose of the veterinary medicinal product. 3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance Not applicable. 3.12 Withdrawal periods Not applicable. 4. IMMUNOLOGICAL INFORMATION 4.1 ATCvet code: QI07AF01 Live vaccine stimulating active immunity against Bordetella bronchiseptica and canine parainfluenza virus in dogs. 5. PHARMACEUTICAL PARTICULARS 5.1 Major incompatibilities Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product. 5.2 Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after reconstitution according to directions: use immediately. 5.3 Special precautions for storage Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light. 6 5.4 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap. Type I glass vial containing 0.5 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap. Pack sizes: Transparent plastic box containing 5 vials of lyophilisate (1 dose) and 5 vials of solvent (0.5ml). Transparent plastic box containing 10 vials of lyophilisate (1 dose) and 10 vials of solvent (0.5ml). Not all pack sizes may be marketed. Applicators are packed separately and can be distributed together with the veterinary medicinal product on request. 5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Medicines should not be disposed of via wastewater . Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned. 6. NAME OF THE MARKETING AUTHORISATION HOLDER TBC Nationally. 7. MARKETING AUTHORISATION NUMBER(S) TBC Nationally. 8. DATE OF FIRST AUTHORISATION Date of first authorisation: <{DD/MM/YYYY}> <{DD month YYYY}>TBC Nationally. 9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> TBC Nationally. 10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS Veterinary medicinal product subject to prescription. Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary). 7 LABELLING AND PACKAGE LEAFLET 8 A. LABELLING 9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE TRANSPARENT PLASTIC BOX CONTAINING 5 OR 10 X 1 DOSE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus BbPi IN nasal drops, lyophilisate and solvent for suspension. 2. STATEMENT OF ACTIVE SUBSTANCES Each dose of 0.5 ml contains: Active substances: Bordetella bronchiseptica 10 8.0 – 10 9.8 CFU Canine parainfluenza Type 2 virus 10 3.5 – 10 5.8 CCID50 3. PACKAGE SIZE 5 x 1 dose 10 x 1 dose 4. TARGET SPECIES Dogs. 5. INDICATIONS 6. ROUTES OF ADMINISTRATION Nasal use. 7. WITHDRAWAL PERIODS 8. EXPIRY DATE Exp. {mm/yyyy} Once reconstituted use immediately. 9. SPECIAL STORAGE PRECAUTIONS Store and transport refrigerated. Do not freeze. Protect from light. 10 10. THE WORDS “READ THE PACKAGE LEAFLET BEFORE USE” Read the package leaflet before use. 11. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 12. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 13. NAME OF THE MARKETING AUTHORISATION HOLDER TBC Nationally. 14. MARKETING AUTHORISATION NUMBERS TBC Nationally. 15. BATCH NUMBER Lot {number} 11 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL (1 DOSE LYOPHILISATE) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus BbPi IN 2. QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES BbPi 1 dose 3. BATCH NUMBER Lot {number} 4. EXPIRY DATE Exp. {mm/yyyy} Once reconstituted use immediately. 12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL (0.5 ML SOLVENT) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus BbPi IN 2. QUANTITATIVE PARTICULARS OF THE ACTIVE SUBSTANCES Aqua ad iniectabilia 0.5 ml 3. BATCH NUMBER Lot {number} 4. EXPIRY DATE Exp. {mm/yyyy} 13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET 1. Name of the veterinary medicinal product Versican Plus BbPi IN nasal drops, lyophilisate and solvent for suspension for dogs 2. Composition Each dose of 0.5 ml contains: Active substances: Live attenuated Bordetella bronchiseptica strain MSLB 3096 10 8.0 – 10 9.8 CFU* Live attenuated Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.5 – 10 5.8 CCID50** *CFU: Colony forming unit. **CCID50: Cell culture infectious dose 50%. Solvent: Water for injections (Aqua iniectabilia) 0.5 ml. The visual appearance is as follows: Lyophilisate: spongy matter of whitish to yellowish colour. Solvent: clear colourless liquid. 3. Target species Dogs. 4. Indications for use Active immunisation of dogs from 3 weeks of age: − to reduce clinical signs and bacterial excretion after infection with Bordetella bronchiseptica and − to reduce clinical signs and viral excretion after infection with canine parainfluenza virus. Onset of immunity: 3 days after primary vaccination for Bordetella bronchiseptica. 7 days after primary vaccination for canine parainfluenza virus. Duration of immunity: 1 year. 5. Contraindications None. 6. Special warnings Special warnings: Vaccinate healthy animals only. This veterinary medicinal product contains a live attenuated bacterial strain and antibiotics may interfere with the veterinary medicinal product's efficacy. Therefore, vaccinated dogs should not 15 receive antibiotic treatment. If antibiotics are used within one week after vaccination, vaccination against Bordetella bronchiseptica should be repeated e.g. with a Bb monovalent vaccine (if available) after completion of the antibiotic treatment. Special precautions for safe use in the target species: After vaccination dogs may excrete the vaccine strain Bordetella bronchiseptica for up to 11 weeks after vaccination and the vaccine strain canine parainfluenza virus for 8 days. Unvaccinated dogs can manifest mild clinical signs such as sneezing and nasal and ocular discharge after contact with vaccinated dogs. The transmission of vaccine strains to cats, pigs and rodents could not be demonstrated. However, as the possibility of transmission to non-target species cannot be rejected, it is recommended to keep non- vaccinated animals out of close contact with vaccinated dogs for at least 4 weeks. Safe handling and proper administration of the veterinary medicinal product and disposal of used material contribute to eliminating the risk of spreading the vaccine antigens in the veterinary workplace. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Hands and tools should be disinfected after use. In case of accidental self-administration during dilution of the veterinary medicinal product or inhalation of the veterinary medicinal product in the form of aerosol during administration into the nostril of a dog, seek medical advice immediately and show the package leaflet or the label to the physician. Although the risk that immunocompromised people are infected with Bordetella bronchiseptica is extremely low, it should be borne in mind that dogs can excrete the bacteria for up to several weeks after vaccination. Immunocompromised persons are advised to avoid contact with the veterinary medicinal product and vaccinated dogs during excretion. Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, the use is not recommended during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction: This veterinary medicinal product has been shown safe in dogs from 8 weeks of age when given at the same time as vaccines of the Versican Plus/Biocan Novel and Vanguard ranges containing live canine parvovirus, adenovirus, distemper virus, parainfluenza virus as well as inactivated Leptospira and rabies virus. Mild (< 1 ºC), transient increases in temperature were very commonly observed following co-administration of these vaccines. Efficacy after concurrent use has not been tested. Therefore, while safety of concurrent use has been demonstrated, the veterinarian should take this into account when deciding to administer the veterinary medicinal products at the same time. Although proven safe it should not be necessary to give a parainfluenza vaccine twice by two different routes, therefore the veterinarian should consider vaccination options based on local availability of core vaccines without parainfluenza and monovalent Bordetella vaccines. No information is available on the safety and efficacy of this veterinary medicinal product when used with any other veterinary medicinal product except the products mentioned above. A decision to use this veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. Overdose: No adverse events other than those mentioned in section “Adverse events” were observed after administration of a 10-fold overdose of the veterinary medicinal product. 16 Major incompatibilities: Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product. 7. Adverse events Dogs: Very common (>1 animal / 10 animals treated): Nasal discharge 1 Common (1 to 10 animals / 100 animals treated): Ocular discharge 1 Cough2 Depression1 Uncommon (1 to 10 animals / 1,000 animals treated): Sneezing1 1Mild and generally subside without treatment within 1 to 3 days. 2Mild to moderate and observed in vaccinated dogs within 48 hours to one week after vaccination. Reporting adverse events is important. It allows continuous safety monitoring of a product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorisation holder using the contact details at the end of this leaflet, or via your national reporting system: {national system details}. 8. Dosage for each species, routes and method of administration Nasal use. Primary vaccination scheme: A single dose from 3 weeks of age. Re-vaccination scheme: A single dose to be given annually. 9. Advice on correct administration Aseptically reconstitute the lyophilisate with the solvent. Shake well after reconstitution. Withdraw the liquid with the syringe, remove the needle and administer directly from the tip of the syringe into one nostril. Alternatively, an intranasal applicator (available separately) can be attached to the syringe and the dose then administered into one nostril. The veterinary medicinal product should then be used immediately. The head of the dog should be held with the nose pointing upwards. Administer one dose (0.5 ml) of the reconstituted veterinary medicinal product into one nostril. Appearance of the reconstituted vaccine: whitish to yellowish colour with light opalescence. 17 10. Withdrawal periods Not applicable. 11. Special storage precautions Keep out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light. Do not use this veterinary medicinal product after the expiry date which is stated on the label after Exp. The expiry date refers to the last day of that month. Shelf life after reconstitution according to directions: use immediately. 12. Special precautions for disposal Medicines should not be disposed of via wastewater . Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment. Ask your veterinary surgeon how to dispose of medicines no longer required. 13. Classification of veterinary medicinal products Veterinary medicinal product subject to prescription. 14. Marketing authorisation numbers and pack sizes To be completed nationally. Transparent plastic box containing 5 vials of lyophilisate (1 dose) and 5 vials of solvent (0.5 ml). Transparent plastic box containing 10 vials of lyophilisate (1 dose) and 10 vials of solvent (0.5 ml). Not all pack sizes may be marketed. Applicators are packed separately and can be distributed together with the veterinary medicinal product on request. 15. Date on which the package leaflet was last revised TBC Nationally. Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary). 18 16. Contact details Marketing authorisation holder : TBC Nationally. Manufacturer responsible for batch release: Bioveta a.s. Komenskeho 212/12 683 23 Ivanovice Na Hane Czechia :> To be completed nationally (if applicable ) 17. Other information Live vaccine stimulating active immunity against Bordetella bronchiseptica and canine parainfluenza virus in dogs.

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