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Date: Saturday, May 18, 2024 15:55

Release 2.142
Nobivac® Ducat lyophilisate and solvent for suspension for injection, for cats
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Nobivac® Ducat lyophilisate and solvent for suspension for injection, for cats
Product index: Nobivac® Ducat
Incorporating:
Qualitative and quantitative composition
Each dose (1 ml) of reconstituted vaccine contains:
Active substances:
Live attenuated feline calicivirus, strain F9
≥104.6 PFU*
Live attenuated feline rhinotracheitis virus, strain G2620A
≥104.8TCID50**
*PFU: Plaque-Forming Units
*TCID50: Tissue Culture Infectious Dose 50%
Excipient(s): For a full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white pellet.
Solvent: clear colourless solution.
Clinical particulars
Target species
Cats.
Indications for use
Active immunisation of cats to reduce the clinical signs caused by infection with feline rhinotracheitis virus (FVR) and feline calicivirus (FCV) infections.
Onset of immunity: 4 weeks.
Duration of immunity: 1 year.
Contraindications
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.
Vaccinate healthy animals only.
Special precautions for use
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
Cats:
Very common
(> 1 animal / 10 animals treated):
Injection site swelling.1
Common
(1 to 10 animals / 100 animals treated):
Elevated temperature.2
Rare
(1 to 10 animals / 10,000 animals treated):
Hypersensitivity reactions (e.g. pruritus, dyspnoea, vomiting, diarrhoea and collapse including anaphylaxis).3
Lethargy.4
Very rare
(< 1 animal /10,000 animals treated, including isolated reports):
Injection site pain.1
Febrile limping syndrome reactions in kittens.5
1 A local swelling (≤ 5 mm), sometimes painful, may be observed at the injection site for one day post-vaccination.
2 Elevated body temperature (up to 40 °C) may occur for 1 – 2 days post vaccination.
3 Sometimes fatal. If such a reaction occurs, appropriate treatment should be administered without delay.
4 Lethargy may be observed during the first day after vaccination.
5 As reported in the literature, febrile limping syndrome reactions in kittens may occur after the use of any vaccine containing a feline calicivirus component.
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 its local representative or the national competent authority via the national reporting system. See section ‘Contact details’ of the package leaflet.
Use during pregnancy or lactation
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.
Visual appearance of the reconstituted product: off-pink or pink coloured suspension.
Vaccination schedule:
Basic vaccination:
Cats from 8 weeks of age onwards should receive two vaccinations with an interval of 3-4 weeks.
Revaccination: Annual booster.
During the initial vaccination course, the vaccine in the Nobivac range containing rabies antigen, strain Pasteur RIV, may be used to reconstitute the vaccine at the vaccination at 12 weeks of age (where this product and the combined use is authorised).
Overdose
A transient swelling (≤ 5 mm) 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
Lyophilisate: Disodium phosphate dihydrate, hydrolysed gelatin, sucrose
Solvent: Disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections
Major incompatibilities
Do not mix with any other vaccine or immunological product except the solvent supplied with the product or with the vaccine in the Nobivac range 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:
Lyophilisate: 2 years
Solvent: 5 years.
Shelf life after reconstitution according to directions: 30 minutes.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.
Solvent: Can be stored below 25 °C if stored separately from the lyophilisate. Do not freeze.
Immediate packaging
Lyophilisate:
1 dose vial of glass type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Solvent:
1 dose vial of glass type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes:
Cardboard or plastic boxes with 5 x 1 dose, 10 x 1 dose, 25 x 1 dose or 50 x 1 dose of lyophilisate and solvent. Not all pack-sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirement.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5071
UK(NI): Vm 01708/3005
Significant changes
Date of the first authorisation or date of renewal
19 October 2009.
Date of revision of the text
23 March 2023.
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 Ducat 10x1ds:
GTIN:08713184141385,
GTIN description:Nobivac Ducat 50x1ds:
GTIN:08713184041838