Purevax RCPCh
Active substance
ATC code
Species
Cats.
Indications
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.
Dose 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 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.
Adverse reactions
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, including isolated reports): |
Emesis4; transient hyperthermia and lethargy, sometimes associated with lameness5 (based on post-marketing 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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh lyophilisate and solvent for suspension for injection
2. 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 (FCV 431 and G1 strains) antigens.. ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ................................... ≥ 103.0 EID502
Attenuated feline panleucopenia virus (PLI IV) ............................ ≥ 103.5 CCID501
Solvent:
Water for injections...................................................................q.s. 1 ml or 0.5 ml.
1 cell culture infective dose 50% 2 egg infective dose 50%
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogeneous beige pellet. Solvent: clear colourless liquid.
4. CLINICAL PARTICULARS
4.1 Target species
Cats.
4.2 Indications for use, specifying the 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.
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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.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals 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.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products. If self-injection occurs, immediate medical advice should be sought and the doctor informed that selfinjection with a living chlamydial vaccine has occurred.
4.6 Adverse reactions (frequency and seriousness)
Cats
|
Common (1 to 10 animals / 100 animals treated): |
Transient apathy, anorexia, and hyperthermia[1] (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 reaction[3] (observed in field studies) |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Emesis[4]; transient hyperthermia and lethargy, sometimes associated with lameness5 (based on post-marketing experience) |
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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay
Do not use during the whole pregnancy and lactation.
4.8 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.
4.9 Amount(s) 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 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
4.11 Withdrawal period(s)
Not applicable.
5. IMMUNOLOGICAL PROPERTIES
ATC Vet Code: QI06AJ03. live feline rhinotracheitis virus + inactivated feline calicivirus antigen + live feline panleucopenia virus / parvovirus + live chlamydia.
Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis and feline panleucopenia.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Sorbitol
Dextran 40
Casein hydrolysate
Collagen hydrolysate
Dipotassium phosphate
Potassium dihydrogen phosphate
Potassium hydroxide
Sodium chloride
Disodium hydrogen orthophosphate
Monopotassium phosphate anhydrous
6.2 Major Incompatibilities
Do not mix with Boehringer Ingelheim adjuvanted vaccine against rabies.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after reconstitution according to directions: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 oC – 8 oC).
Protect from light. Do not freeze.
6.5 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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein Germany
8. MARKETING AUTHORISATION NUMBER
Vm 04491/5055
9. DATE OF FIRST AUTHORISATION
22 February 2005
10. DATE OF REVISION OF THE TEXT
March 2023
Approved: 30 March 2023
| Art. Nr. | 04491/5055 |
|---|---|
| EAN | 4028691578185 |
