Nobivac Ducat Suspension for Injection for cats

Nobivac Ducat Suspension for Injection for cats.

Qualitative and quantitative composition

* tissue culture infectious dose

** plaque forming units

Excipient(s): For a full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Lyophilisate and solvent for suspension for injection.

Clinical particulars

Target species

Cats.

Indications for use

Active immunisation of cats against feline viral rhinotracheitis (feline herpes virus type I) and feline calicivirus infections. Vaccination reduces clinical signs caused by these viral infections.

Onset of immunity: 4 weeks.

Duration of immunity: 1 year.

Contra-indications

See section "Use during pregnancy or lactation".

Special warnings for each target species

Vaccination at six weeks of age has been proven to be safe.

Special precautions for use

Vaccinate only healthy animals. Care should be taken that aerosol is not formed when vaccinating the cat as nasal or oral exposure could result in clinical respiratory signs including lethargy and malaise. For the same reason, the cat should be prevented from licking the injection site.

Operator warnings:

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions

A slight transient, sometimes painful, swelling (= 5mm) may be observed at the site of injection for one day. A slight temporary rise in rectal temperature may occur, while occasionally transient lethargy may be observed during the first day after vaccination. In rare cases the vaccine may cause hypersensitivity reactions (pruritus, dyspnoea, vomiting, diarrhoea and collapse).

Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation as the product has not been tested in pregnant and lactating queens.

Interactions

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other, except Intervet's vaccine containing rabies antigen, strain Pasteur RIV, where this product and the combined use is authorised. A decision to use Nobivac Ducat before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Amounts to be administered and administration route

Allow the sterile diluent provided to reach room temperature. Aseptically reconstitute the lyophilised vaccine with one ml of the diluent. Shake well after addition of the diluent. One ml of the reconstituted vaccine should be given by subcutaneous injection.

Basic vaccination:

Cats from 8 weeks of age onwards should receive two vaccinations with an interval of 3-4 weeks.

Revaccination: Annual booster.

In the initial vaccination course, Intervet's vaccine containing rabies antigen, strain Pasteur RIV, may be used to reconstitute Nobivac Ducat at the vaccination at 12 weeks of age (where this product and the combined use is authorised).

Overdose

A transient swelling (= 5mm) at the injection site may occur for four to ten days. A transient increase in temperature (<40.8°C) may occur while occasionally lethargy for one day after vaccination may be observed.

Withdrawal periods

Not applicable.

Pharmacological particulars

Immunological properties

ATC vet code: QI06AD03, Live viral vaccines.

To stimulate active immunity against feline rhinotracheitis virus and feline calici virus.

Pharmaceutical particulars

Excipients

Gelatin-based stabiliser, Phosphate buffer, Sucrose and Water for injections.

Major incompatibilities

Do not mix with any other vaccine or immunological product except the diluent supplied with the product or with Intervet's vaccine containing rabies antigen, strain Pasteur RIV (where this product and the combined use is authorised).

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after reconstitution according to directions: 30 minutes.

Special precautions for storage

Vaccine: Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.

Solvent: Store below 25°C if stored independently from the vaccine.

Immediate packaging

Vaccine: Vial of hydrolytical class type I (Ph. Eur.) glass. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.

Solvent: Vial of hydrolytical class type I (Ph. Eur.) glass. The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.

Pack sizes: Carton-boxes with 5, 10, 25 or 50 doses of vaccine and solvent. Not all pack-sizes may be marketed.