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Date: Saturday, May 4, 2024 7:28

Release 2.122
Purevax RCP FeLV lyophilisate and solvent for suspension for injection
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax RCP FeLV
Product index: Purevax RCP FeLV
Incorporating:
Qualitative and quantitative composition
Per dose of 1 ml or 0.5 ml:
Lyophilisate:
Active substances: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ≥ 104.9 CCID501
Inactivated feline calicivirus antigens (FCV 431 and G1 strains) ≥ 2.0 ELISA U.
Attenuated feline panleucopenia virus (PLI IV) ≥ 103.5 CCID501
Excipient: Gentamicin, at most 23 μg
Solvent:
Active substance: FeLV recombinant canarypox virus (vCP97) ≥ 107.2 CCID501
1: cell culture infective dose 50%
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogenous beige pellet
Solvent: clear colourless liquid with presence of cell debris in suspension.
Clinical particulars
Target species
Cats.
Indications for use, specifying the target species:
Active immunisation of cats aged 8 weeks and older against:
- Feline viral rhinotracheitis to reduce clinical signs.
- Calicivirus infection to reduce clinical signs.
- Feline panleucopenia to prevent mortality and clinical signs.
- Leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Onsets of immunity:
Rhinotracheitis, calicivirus and panleucopenia components: one week after primary vaccination course.
Feline leukaemia component: 2 weeks after primary vaccination course.
Duration of immunity:
Rhinotracheitis, calicivirosis and panleucopenia components: 1 year after primary vaccination course and 3 years after the last re-vaccination.
Feline leukaemia component: 1 year after the last re-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
Transient apathy and anorexia as well as hyperthermia (lasting usually for 1 or 2 days) were commonly observed during safety and field studies. A local reaction (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most, was commonly observed during safety and field studies.
Emesis (mostly within 24 to 48 hours) has been observed in very rare cases based on post-marketing safety experience.
A hypersensitivity reaction has been observed uncommonly in field studies, which may require appropriate symptomatic treatment.
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 rare (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 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 route.
Reconstitute gently the vaccine in order to obtain a uniform suspension with limited foam formatino. Visual appearance after reconstitution: slightly yellow suspension with presence of cell debris in suspension.
After reconstitution of the lyophilisate with 0.5 ml or 1 ml of the solvent (depending on the presentation chosen), inject one dose of vaccine according to the following vaccination scheme:
Primary vaccination course:
- First injection from 8 weeks of age
- Second injection 3 to 4 weeks later
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Revaccination:
- The first revaccination must be carried out for all components one year after the primary vaccination course,
- Subsequent revaccinations: Feline leukaemia component: every year. Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.
Overdose
No effect other than those already mentioned under Adverse reactions have been observed, except hyperthermia that may exceptionally last 5 days.
Pharmaceutical particulars
Excipients
Sucrose, Sorbitol, Dextran 40, Casein hydrolysate, Collagen hydrolysate, Dipotassium phosphate, Potassium dihydrogen phosphate, Potassium hydroxide, Sodium chloride, Potassium chloride, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Water for injections.
Major incompatibilities
Do not mix with any other product, except the solvent supplied for use with the product.
Shelf life
Shelf life of the product as packaged for sale: 18 months.
Shelf life after reconstitution according to directions: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C). Protect from light. Do not freeze.
Immediate packaging
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 0.5 ml or 1 ml solvent, both closed with a butyl elastomer stopper and sealed with an aluminium cap.
10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
10 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
10 bottles of 1 dose of lyophilisate and 10 bottles of 0.5 ml solvent.
50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml solvent.
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 04491/5054
UK(NI): EU/2/04/048/001-004
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax RCP FeLV 1 ml
GTIN:3661103006862
GTIN description:Purevax RCP FeLV 0.5 ml
GTIN:04028691577942