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Date: Thursday, April 18, 2024 11:09

Release 2.100
Nobivac® KC Nasal drops, lyophilisate and solvent for suspension for dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Nobivac® KC Nasal drops, lyophilisate and solvent for suspension for dogs
Product index: Nobivac® KC
Incorporating:
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 ≤ 109.7cfu1
Live canine parainfluenza virus strain Cornell: ≥ 103.0 and ≤ 105.8 TCID502
1colony forming units
2Tissue Culture Infective Dose 50%
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Nasal drops, lyophilisate and solvent for suspension
Lyophilisate: Off-white or cream-coloured pellet.
Solvent: Clear colourless solution.
Clinical particulars
Target species
Dogs.
Indications for use
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:
for Bordetella bronchiseptica: 72 hours after vaccination;
for canine parainfluenza virus: 3 weeks after vaccination.
Duration of immunity:
1 year.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Vaccinated animals can spread the B. 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.
Operator warnings
Immunocompromised individuals should avoid any contact with the vaccine and vaccinated dogs up to six weeks after vaccination.
Disinfect hands and equipment after use.
Adverse reactions
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)
Use during pregnancy, lactation or lay
Can be used during pregnancy.
Interactions
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.
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 "Interactions", 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 "Special precautions for use").
Revaccinate annually.
Overdose
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.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATCvet code: QI07AF
Pharmacotherapeutic group
Immunologicals for Canidae, live bacterial and viral vaccine.
The product contains live B. bronchiseptica strain B-C2 and live canine parainfluenza virus strain Cornell. After intranasal vaccination, the product stimulates the development of active immunity against B. 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 B. bronchiseptica from 3 months to 1 year after vaccination.
Pharmaceutical particulars
Excipients
Lyophilisate:
Hydrolysed gelatin
pancreatic digest of casein
sorbitol
sodium chloride
disodium phosphate dihydrate
potassium dihydrogen phosphate
Solvent:
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except diluent recommended for use with the product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 27 months.
Shelf-life after reconstitution according to directions: 1 hour.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light.
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 or 25 x 1 dose of vaccine and solvent.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4631
Significant changes
Date of the first authorisation or date of renewal
25 July 2012.
Date of revision of the text
23 December 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobivac KC 5x1ds+5x1ds dil:
GTIN:08713184145123,
GTIN description:Nobivac KC 25x1ds+25x1ds dil:
GTIN:08713184145130