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Date: Wednesday, April 30, 2025 8:13

Release 2.156
Purevax RCP lyophilisate and solvent for suspension for injection
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax RCP
Product index: Purevax RCP
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 16.5 μg
Solvent: Water for injections q.s. 1 ml or 0.5 ml
1: cell culture infective dose 50%
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: friable pellet, homogenous from beige to white.
Solvent: clear colourless liquid.
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.
Onsets of immunity: 1 week after primary vaccination course.
Duration of immunity: 1 year after the primary vaccination course and 3 years after the last revaccination.
Contra-indications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use in animals
None.
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
Cats:
Common
(1 to 10 animals / 100 animals treated):
Apathy, anorexia, and hyperthermia.1
Injection site reactions (pain, itching, oedema).2
Uncommon
(1 to 10 animals / 1 000 animals treated):
Hypersensitivity reaction.3
Very rare
(<1 animal / 10 000 animals treated,
including isolated reports):
Emesis.4
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 also section “Contact details” of the package leaflet details.
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 and administered with Boehringer Ingelheim non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Boehringer Ingelheim adjuvanted vaccine against rabies.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Boehringer Ingelheim non-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 formation.
Visual appearance after reconstitution: clear slightly yellow suspension.
After reconstitutionof the lyophilisate wit 0.5 ml or 1 ml of the solvent (depending on the presentation chosen), inject one dose of vaccine according to the following vaccination schedule:
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 to 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 one year after the primary vaccination course,
- Subsequent revaccinations: at intervals of up to 3 years.
Overdose
No adverse event other than those already mentioned in section “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, water for injections.
Major incompatibilities
Do not mix with Boehringer Ingelheim adjuvanted vaccine against rabies.
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 1 ml or 0.5 ml of solvent, both closed with a butyl elastomer close and sealed with an aluminium or plastic cap.
10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
50 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 of solvent.
50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml of solvent.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authority.
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 04491/5053
UK(NI): EU/2/04/052/001-004
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax RCP 1 ml
GTIN:3661103006916
GTIN description:Purevax RCP 0.5 ml
GTIN:04028691578123