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Date: Sunday, May 18, 2025 11:46

Release 2.45
Purevax RCPCh lyophilisate and solvent for suspension for injection (NI)
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax RCPCh
Product index: Purevax RCPCh
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.
Attenuated Chlamydophila felis (905 strain) ≥ 103.0 EID502
Attenuated feline panleucopenia virus (PLI IV) ≥ 103.5 CCID501
1: cell culture infective dose 50%
2: egg infective dose 50%
Excipients:
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: homogenous beige pellet
Solvent: clear colourless liquid
Clinical particulars
Target species:
Cats.
Indications for use for each target species
Active immunisation of cats aged 8 weeks and older:
- against feline viral rhinotracheitis to reduce clinical signs,
- against calicivirus infection to reduce clinical signs,
- against Chlamydophila felis infection to reduce clinical signs,
- against feline panleucopenia to prevent mortality and clinical signs.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Duration of immunity:
- Rhinotracheitis, calicivirosis and panleucopenia components: 1 year after primary vaccination course and 3 years after the last re-vaccination
Chlamydophila felis component: 1 year after the last re-vaccination.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for safe use
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 medicinal advice immediately and show the package leaflet or label to the physician.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products. If accidental self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats:
Common
(1 to 10 animals / 100 animals treated):
Transient apathy, anorexia, and hyperthermia1 (observed during safety and field studies).
Injection site reactions (slight pain at palpation, itching or limited oedema)2 (observed during safety and field studies)
Uncommon
(1 to 10 animals /1,000 animals treated):
Hypersensitivity reaction3 (observed in field studies)
Very rare
(<1 animal / 10,000 animals treated):
Emesis4; transient hyperthermia and lethargy, sometimes associate with lameness5 (based on post-marketing safety experience)
1 lasting usually for 1 or 2 days
2 disappearing within 1 or 2 weeks at most
3 may require appropriate symptomatic treatment
4 mostly within 24 to 48 hours
5 observed 1 to 3 weeks following booster vaccination in adult cats
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 the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Do not use during the whole pregnancy and lactation.
Interactions 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 luekaemia 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 routes and dosage
Subcutaneous use.
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, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9 to 12 weeks of age born 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 must be carried out:
- Chlamydiosis component: every year.
- Rhinotracheitis calicivirosis and panleucopenia components: at intervals of up to three years.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No effect other than those already mentioned in section "Adverse events" have been observed, except hyperthermia that may exceptionally last 5 days.
Special restrictions for use and special conditions for use
For administration only by a veterinarian.
Withdrawal periods
Not applicable.
Pharmacological particulars
Pharmaceutical particulars
Major incompatibilities
Do not mix with Boehringer Ingelheim adjuvanted vaccine against rabies.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months
Shelf life after reconstitution according to directions: use immediately.
Special precautions for storage
Store and transport refrigerated (2oC-8oC)
Protect from light.
Do not freeze.
Nature and composition of 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.
Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 0.5 ml of solvent.
Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml of 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
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with 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
EU/2/04/050/001-004
Significant changes
Date of the first authorisation or date of renewal
Date of revision of the text
Any other information
Legal category
Legal category: POM-V
GTIN
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