Nobivac® KC

FOR ANIMAL USE ONLY

NOBIVAC® KC is for the active immunisation of dogs against Bordetella bronchiseptica and canine parainfluenza virus.

NOBIVAC^® KC
Reg. No. G2604 (Act 36/1947)
Namibia Reg. No. V03/24.1/928 NS2

This vaccine may only be used by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS
NOBIVAC^® KC is a live freeze-dried vaccine for the active immunisation of 2-week-old puppies and mature dogs against Bordetella bronchiseptica and canine parainfluenza virus, resulting in the prevention of kennel cough. Immunity is complete against B. bronchiseptica after 72 hours, and against canine parainfluenza virus 3 weeks after vaccination.

Nobivac^® KC induces at least 1 year (56 weeks) protection against clinical signs, as well as infection against Bordetella bronchiseptica and canine parainfluenza virus.

COMPOSITION
Each dose of Nobivac^® KC contains ≥ 10^8,3 cfu of Bordetella bronchiseptica strain B-C2 and ≥ 10^3,8 TCID₅₀ of canine parainfluenza virus strain Cornell. The freeze-dried vaccine is reconstituted with the sterile diluent provided.

STORAGE

• Store in the dark between 2 °C and 8 °C.
• Do not freeze.
• Avoid prolonged or repetitive exposure to high ambient temperatures (20 ^oC to 25 ^oC) following withdrawal from the refrigerator prior to use.
• Protect from direct sunlight.
• Diluent: Store at room temperature below 25 °C.

WARNINGS

• Dispose of any unused, reconstituted vaccine, empty vaccine containers, needles, etc., by for instance burning, after the completion of the vaccination.
• Do not open and reconstitute the vaccine until ready to start the vaccination.
• Use the vaccine immediately after reconstitution.
• Do not store partially used vaccine containers for future use.
• Do not mix Nobivac^® KC with other vaccines or other products.
• Do not administer in conjunction with other intranasal treatments or during antibiotic treatment.
• Use according to the number of doses as indicated on the label.
• Keep out of reach of children and uninformed persons and animals
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

Precautions

• Vaccinate healthy puppies and dogs only.
• Ensure that the vaccination equipment (needles, syringes, etc) are clean and sterile prior to use.
• Ensure that all the vaccination equipment remain clean and sterile during the vaccination.
• The reconstituted vaccine should be used within 1 hour.
• Administer into only one nostril of the puppy or dog.
• As with all vaccines hypersensitivity or anaphylactic reactions may occur.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well after the addition of the diluent.

Dosage and Administration

• Allow the diluent to reach room temperature, below 25 °C.
• Aseptically reconstitute the freeze-dried pellet with the diluent provided.
• The contents of the vial must be used within 1 hour after reconstitution of the vaccine.
• Fill a 1 mℓ syringe with 1 dose (0,4 mℓ) of vaccine. Remove the needle and connect the supplied applicator tip.
• Fix the head of the puppy or dog in a normal upright position, place the applicator tip in front of 1 of the nostrils and carefully administer the entire contents of the syringe into this nostril.
• Unvaccinated dogs should receive 1 dose at least 3 weeks prior to the period of anticipated risk, e.g. temporary kennelling, in order to get protection from canine parainfluenza virus.
• In order to get protection for Bordetella bronchiseptica, unvaccinated dogs should receive 1 dose at least 72 hours prior to the period of anticipated risk.
• It is recommended that dogs be vaccinated against Bordetella bronchiseptica and canine parainfluenza virus annually.
• Nobivac® KC may be administered to pregnant bitches in all trimesters.

SIDE EFFECTS

• Mild discharges from the eyes and nose can occur 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 4 weeks.
• In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.

OVERDOSE

• In very young puppies, signs of upper respiratory tract disease may occur after vaccination, including ocular and nasal discharges, pharyngitis, sneezing and coughing.
• In animals that show more severe signs, appropriate antibiotic treatment may be indicated.

PRESENTATION
Polyethylene terephthalate (PET) tray containing 5 single dose vials of freeze-dried vaccine with 5 vials of sterile diluent and applicators or 3 mℓ (single dose) or 10 mℓ (5 and 10 dose) with a vial of sterile diluent and applicator.

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA 
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International B.V.
35 Wim de Körverstraat
Boxmeer, The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT
22 January 2016