Nobivac Ducat vet.
Active substance
ATC code
Species
Cats.
Indications
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.
Dose to be administered and administration route
Allow the sterile solvent provided to reach room temperature. Aseptically reconstitute the lyophilised vaccine with one ml of the solvent. Shake well after addition of the solvent. 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:
Primary 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).
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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Ducat lyophilisate and solvent for suspension for injection, for cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) of reconstituted vaccine contains:
Active substances:
Live attenuated feline calicivirus, strain F9: ≥ 104.6 PFU2.
Live attenuated feline rhinotracheitis virus, strain G2620A: ≥ 104.8 TCID501;
1TCID50: Tissue Culture Infectious Dose 50% 2PFU: Plaque-Forming Units
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white pellet.
Solvent: clear colourless solution.
4. CLINICAL PARTICULARS
4.1 Target species
Cats.
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
See section 4.7.
4.4 Special warnings for each target species
Vaccination at six weeks of age has been proven to be safe.
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment: Not applicable.
4.6 Adverse reactions (frequency and seriousness) 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.[3] |
|
Very rare (< 1 animal /10,000 animals treated, including isolated reports): |
Injection site pain.1 Febrile limping syndrome reactions in kittens.[4] |
4.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use during pregnancy and lactation as the product has not been tested in pregnant and lactating queens.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other, except the vaccine in the Nobivac range containing rabies antigen, strain Pasteur RIV, where this product and the combined use is authorised. 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.
4.9 Amount(s) to be administered and administration route
Allow the sterile solvent provided to reach room temperature. Aseptically reconstitute the lyophilised vaccine with one ml of the solvent. Shake well after addition of the solvent. 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:
Primary 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).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period(s) Not applicable.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Live viral vaccines ATCvet code: QI06AD03
To stimulate active immunity against feline rhinotracheitis virus and feline calicivirus.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilisate:
Disodium phosphate dihydrate
Hydrolysed gelatin Sucrose
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate Water for injections
6.2 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). 6.3 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
6.4 Special precautions for storage
Lyophilisate: Store in a refrigerator (2 °C – 8 °C). Protect from light.
Solvent: Can be stored below 25 °C if stored separately from the lyophilisate. Do not freeze.
6.5 Nature and composition of 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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirement.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5071
9. DATE OF FIRST AUTHORISATION
18 October 2004
10. DATE OF REVISION OF THE TEXT
March 2023
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Approved: 23 March 2023
[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.
[3] Lethargy may be observed during the first day after vaccination.
[4] 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.
| Art. Nr. | 01708/5071 |
|---|---|
| EAN | 8713184141385 |
