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Date: Tuesday, June 17, 2025 16:19

Release 2.135
Purevax RC lyophilisate and solvent for suspension for injection (NI)
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax RC
Product index: Purevax RC
Incorporating:
Qualitative and quantitative composition
Per dose of 1 ml or 0.5 ml:
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.
1 cell culture infective dose 50%
Qualitative composition of excipients and other constituents
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Lyophilisate:
Sucrose
Sorbitol
Dextran 40
Casein hydrolysate
Collagen hydrolysate
Dipotassium phosphate
Potassium dihydrogen phosphate
Potassium hydroxide
Sodium chloride
Disodium hydrogen orthophosphate
Monopotassium phosphate anhydrous
Water for injections
Solvent:
Water for injections
q.s.1 ml or 0.5 ml
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogenous beige pellet.
Solvent: clear colourless liquid.
Clinical particulars
Target species
Cats.
Indications for use
Active immunisation of cats aged 8 weeks and older.
- against feline viral rhinotracheitis to reduce clinical signs,
- against calicivirus infection to reduce clinical signs.
Onsets of immunity: 1 week after primary vaccination course.
Duration of immunity: 1 year after primary vaccination course and 3 years after the last re-vaccination.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for safe use in the target species
None.
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.
Adverse events
Cats:
Common
(1 to 10 animals / 100 animals treated):
Apathy, anorexia, and hyperthermia1.
Injection site reactions (pain, itching, oedema)2.
Uncommon
(1 to 10 animals / 1000 animals treated):
Hypersensitivity reaction3
Very rare
(<1 animal / 10000 animals treated, including isolated reports):
Emesis4
Do not use during the whole pregnancy and lactation.
1 lasting usually for 1 or 2 days
2 slight pain at palpation, itching or limited oedema disappearing within 1 to 2 weeks at most.
3 may require appropriate asymptomatic treatment
4 mostly within 24 to 48 hours.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should b 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.
Use during pregnancy, lactation or lay
Do not use during the whole pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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.
Administration route and dosage
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 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 or calicivirosis 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 one year after the primary vaccination course,
- subsequent revaccinations at intervals of up to three years.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No effect other than those already mentioned under "Adverse events" have been observed, except hyperthermia that may exceptionally last 5 days.
Pharmaceutical particulars
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product and except those mentioned in section "Interaction with other medicinal products and other forms of interaction" above.
Shelf life
Shelf life of the product as packaged for sale: 18 months.
Shelf life after reconstitution: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C). Protect from light. Do not freeze.
Nature and composition of the 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 closure 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 solvent
50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml solvent.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products.
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
UK(NI): EU/2/04/051/001-004
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax RC 1 ml
GTIN:3661103006909
GTIN description:Purevax RC 0.5 ml
GTIN:04028691579359