SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac KC nasal drops, lyophilisate and solvent for suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (0.4 ml) of reconstituted vaccine contains: Active substances:

Live Bordetella bronchiseptica bacteria strain B-C2:	≥ 108.0 and ≤ 109.7 cfu1
Live canine parainfluenza virus strain Cornell: ≤ 105.8 TCID502	≥ 103.0 and

¹colony forming units

²Tissue Culture Infective Dose 50%

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Nasal drops, lyophilisate and solvent for suspension

Lyophilisate: Off-white or cream-coloured pellet. Solvent: Clear colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

Active immunisation of dogs against Bordetella bronchiseptica and canine parainfluenza virus for periods of increased risk to reduce clinical signs induced by B.

bronchiseptica and canine parainfluenza virus and to reduce shedding of canine parainfluenza virus.

Onset of immunity: vaccination.	for Bordetella bronchiseptica: 72 hours after vaccination; for canine parainfluenza virus: 3 weeks after
Duration of immunity:	1 year

4.3 Contraindications

None.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks and the canine parainfluenza vaccine strain for a few days after vaccination. Immunosuppressive medication may impair the development of active immunity and may increase the chance of adverse effects caused by the live vaccine strains. Cats, pigs and unvaccinated dogs may react to the vaccine strains with mild and transient respiratory signs. Other animals, like rabbits and small rodents have not been tested.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Immunocompromised individuals should avoid any contact with the vaccine and vaccinated dogs up to six weeks after vaccination. Disinfect hands and equipment after use.

4.6 Adverse reactions (frequency and seriousness)

In laboratory studies and field trials:

Mild discharges from the eyes and nose have been observed very commonly from the day after vaccination, sometimes accompanied by wheezing, sneezing and/or coughing, particularly in very young susceptible puppies. Signs are generally transient, but in occasional cases may persist for up to four weeks. In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.

In post marketing experience:

Lethargy and vomiting may occur after vaccination in very rare cases.

Hypersensitivity reactions may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. If such reactions occur appropriate treatment is recommended.

Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia or immune-mediated polyarthritis have been reported 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 treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer in conjunction with other intranasal treatments or during antibiotic treatment.

Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but not mixed, with the live vaccines of the Nobivac series against canine distemper, canine contagious hepatitis caused by canine adenovirus type 1, canine parvovirus disease (based on strain 154) and respiratory disease caused by canine adenovirus type 2, where authorised, and inactivated vaccines of the Nobivac series against canine leptospirosis caused by all or some of the following serovars: L. interrogans serogroup Canicola serovar Canicola,

L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang.

Safety data are available which demonstrate that Nobivac KC can be administered on the same day but not mixed with the bivalent puppy vaccine of the Nobivac series that contains canine parvovirus strain 630a. Efficacy of Nobivac KC 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 products at the same time.

In very rare cases a transient acute hypersensitivity reaction may occur when this product is used with other vaccines.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

In case antibiotics are administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment is finished.

4.9 Amounts to be administered and administration route

Nasal use.

Allow the sterile solvent provided to reach room temperature (15 °C – 25 °C). Aseptically reconstitute the lyophilisate with the solvent. Shake the vial well after addition of the solvent. Withdraw the vaccine into the syringe, remove the needle and administer 0.4 ml directly from the tip of the syringe into one nostril.

The reconstituted vaccine is an off-white or yellowish coloured suspension.

Vaccination scheme:

Dogs should be at least 3 weeks of age. When Nobivac KC is concurrently administered (i.e. not mixed) with another vaccine of the Nobivac series as indicated in section 4.8, dogs should not be younger than the minimum age recommended for the other Nobivac vaccine.

Unvaccinated dogs should receive one dose at least 3 weeks prior to the period of anticipated risk, e.g. temporary kennelling, in order to get protection for both vaccine agents. In order to get protection for Bordetella bronchiseptica unvaccinated dogs should receive one dose at least 72 hours prior to the period of anticipated risk (see also section 4.5 ‘Special precautions for use’).

Revaccinate annually.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Particularly in very young puppies, signs of upper respiratory tract disease may occur after an overdose, including ocular and nasal discharges, pharyngitis, sneezing and coughing. The signs may start the day after vaccination and have been seen for up to 4 weeks after vaccination.

4.11 Withdrawal period(s) Not applicable.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Canidae, live bacterial and viral vaccine.

ATCvet code: QI07AF

The product contains live Bordetella bronchiseptica strain B-C2 and live canine parainfluenza virus strain Cornell. After intranasal vaccination, the product stimulates the development of active immunity against Bordetella bronchiseptica and canine parainfluenza virus.

No data on the influence of maternal antibodies on the effect of vaccination with Nobivac KC are available. From literature, it is considered that this type of intranasal vaccine is able to induce an immune response without interference with maternally derived antibodies.

Data are available to show a reduction in shedding of Bordetella bronchiseptica from 3 months to 1 year after vaccination.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lyophilisate:

Hydrolysed gelatin

Pancreatic digest of casein

Sorbitol

Sodium chloride

Disodium phosphate dihydrate Potassium dihydrogen phosphate

Solvent:

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product, except the solvent recommended for use with the veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 27 months. Shelf-life after reconstitution according to directions: 1 hour.

6.4 Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

Lyophilisate:

Type I glass vial of 3 ml closed with a halogenobutyl rubber stopper and aluminium cap.

Solvent:

The solvent supplied for reconstitution is filled in the same type of container as the lyophilisate (type I glass vial with rubber stopper and aluminium cap). The filling volume is 0.6 ml.

Pack sizes:

Cardboard or plastic boxes with

- 5 x 1 dose of vaccine and solvent - 25 x 1 dose of vaccine and solvent

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

MSD Animal Health UK Limited

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4631

9. DATE OF FIRST AUTHORISATION

15 November 1999

10. DATE OF REVISION OF THE TEXT

December 2021

Approved: 23/12/21