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Date: Wednesday, May 8, 2024 16:51

Description: MSD-AH
Release 2.125
Nobivac® FeLV, suspension for injection for cats
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Nobivac® FeLV, suspension for injection for cats
Product index: Nobivac® FeLV
Incorporating:
Qualitative and quantitative composition
Per dose of 1 ml:
Active substance
Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
Adjuvants: 3% aluminium hydroxide gel expressed as mg Al3+: 1 mg
Purified extract of Quillaja saponaria: 10 µg.
Excipient
Buffered isotonic solution to 1 ml.
For a full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Suspension for injection. Opalescent liquid.
Clinical particulars
Target species
Cats.
Indications for use
− For active immunisation of healthy cats to prevent persistent feline leukaemia-virus viraemia and any associated clinical signs of the feline leucosis.
− The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the primo-vaccination.
− Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
It is recommended that animals be treated for intestinal parasites at least 10 days prior to vaccination.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Transient and small thickening or nodule, approximately 5-10 mm in size, may be observed at the injection site and disappear within 2 to 6 weeks without treatment. Occasionally, systemic reactions (hyperthermia, anorexia, lethargy) may occur within one or two days after vaccine administration.
Where Nobivac FeLV has been used to reconstitute cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) prior to inoculation, a small nodule at the site of vaccination is frequently observed. It can persist for up to 18 days post-inoculation. Occasionally, the nodule may be painful for up to 6 days after injection. A transient rise in body temperature or lameness may occur and last up to 3 days post vaccination. In some cases, a slight dullness or reduced appetite may be observed for up to 1 day post vaccination.
In the rare event of hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline without delay and by the most-immediate route.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- 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 or lactation
Do not use in pregnant cats.
The use is not recommended during lactation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).
Do not mix with other medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).
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 another veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Shake the vial gently before use. Administer via the subcutaneous route 1 dose (1ml) of Nobivac FeLV according to the following regimen of vaccination.
Basic vaccination scheme
A first injection in cats from minimum 8 weeks of age.
A second injection of cats 3 to 4 weeks later.
Re-vaccination scheme
Following a first booster vaccination one year the primary vaccination course, subsequent vaccinations can be performed at intervals of three years.
Nobivac FeLV can be used to reconstitute 1 dose (1 vial) of cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) immediately prior to use by the addition of the contents of one vial (1 ml) of Nobivac FeLV.
Overdose
No undesirable effects have been seen after the administration of an overdose of Nobivac FeLV except those indicated in the Adverse Reactions section.
Withdrawal period
Not applicable.
Pharmacological particulars
ATCVet code: QI06AA01. Vaccine against feline leukaemia.
Pharmacotherapeutic group
Immunologicals for Felidae, inactivated viral vaccine.
The vaccine contains the purified p45 FeLV- envelope antigen, obtained by genetic recombination of the E. coli strain. The antigen suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
Protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Pharmaceutical particulars
Excipients
Sodium chloride
Disodium phosphate anhydrous
Potassium dihydrogen phosphate
Aluminium hydroxide gel
Quillaja saponaria
Water for injections
Major incompatibilities
Do not mix with other veterinary medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Do not freeze. Protect from light.
Immediate packaging
Type I glass vial containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Cardboard or plastic box with 10 vials.
Cardboard or plastic box with 50 vials.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Virbac
1ère avenue - 2065m – L.I.D.
06516 Carros Cedex
France
Marketing Authorisation Number
UK: Vm 05653/4059
Significant changes
Date of the first authorisation or date of renewal
28 October 2005
Date of revision of the text
January 2020.
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 Felv 10x1ds:
GTIN:08713184030245,
GTIN description:Nobivac Felv 50x1ds:
GTIN:08713184030252