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Date: Thursday, May 19, 2022 2:00

Release 2.110
Purevax FeLV suspension for injection
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax FeLV
Product index: Purevax FeLV
Qualitative and quantitative composition
Each dose of 1 ml contains:
Active substance: FeLV recombinant Canarypox virus (vCP97) ≥107.2 CCID50 (cell culture infective dose 50%)
Excipients:
Potassium chloride
Sodium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Water for injections
Pharmaceutical form
Suspension for injection.
Clear colourless liquid with presence of cell debris in suspension.
Clinical particulars
Target species
Cats.
Indications for use
Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Onset of immunity: 2 weeks after primary vaccination course.
Duration of immunity: 1 year after the last vaccination.
Contra-indications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use in animals
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination. Vaccination of FeLV positive cats is of no benefit.
Special precautions to be taken by the person administering the product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
A temporary small (<2 cm) nodule, which regresses within 1 to 4 weeks, was very commonly observed at the site of injection during safety and filed studies. Transient lethargy and hyperthermia were very commonly observed during safety and field studies, and lasted usually for 1 day, exceptionally for 2 days.
Anorexia and emesis have been reported very rarely based on post marketing safety experience.
A hypersensitivity reaction may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis). If such reactions occur, appropriate treatment is recommended.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- Common (more than 1 but less than 10 animals treated in 100 animals)
- Uncommon (more than 1 but less than 10 animals treated in 1,000 animals)
- Rare (more than 1 but less than 10 animals in 10,000 animals treated)
- Very rate (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
Do not use during the whole pregnancy and lactation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Boehringer Ingelheim adjuvanted vaccine against rabies.
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 any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Subcutaneous use. Administer one dose of 1 ml or 0.5 ml (depending on the presentation chosen) according to the following schedule:
Basic vaccination: First injection from 8 weeks of age. Second injection 3 to 5 weeks later.
Revaccination: Annual
Overdose
No other effect has been observed except those mentioned in the Adverse reactions section.
Pharmaceutical particulars
Major incompatibilities
Do not mix with any other vaccine or immunological product except Boehringer Ingelheim non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calcivirosis, panleukopenia and chlamydiosis components).
Shelf life
Shelf life of the product as packaged for sale: 2 years.
Shelf life after broaching: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C). Protect from light. Do not freeze.
Nature and composition of immediate packaging
Type I glass bottle containing 1 ml or 0.5 ml of vaccine, closed with a butyl elastomer closure and sealed with an aluminium cap.
10, 20 or 50 bottles of 1 ml of vaccine.
10, 20 or 50 bottles of 0.5 ml of vaccine.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
UK(GB): Vm 04491/5050
UK(NI): EU/2/00/019/005-010
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax FeLV suspension for injection
GTIN:3661103006879