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Date: Wednesday, May 8, 2024 1:51

Release 2.128
Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection (GB)
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax RCPCh FeLV
Product index: Purevax RCPCh 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 Chlamydophila felis (905 strain) ≥ 103.0 EID502
Attenuated feline panleucopenia virus (PLI IV) ≥ 103.5 CCID501
Solvent:
Active substance: FeLV recombinant canarypox virus (vCP97) ≥ 107.2 CCID501
1: cell culture infective dose 50%
2: egg infective dose 50%
For the full list of excipients, see pharmaceutical particulars section.
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
Active immunisation of cats aged 8 weeks and older against:
- Feline viral rhinotracheitis to reduce clinical signs.
- Calicivirus infection to reduce clinical signs.
- Chlamydophila felis 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, Chlamydophila felis and panleucopenia components: 1 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 revaccination
- Chlamydophila felis and feline leukaemia components: 1 year after the last revaccination.
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 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 self-injection with a living chlamydial vaccine has occurred.
Adverse reactions (frequency and seriousness)
Common
(1 to 10 animals / 100 animals treated):
Transient apathy, anorexia, and hyperthermia1 (observed duriing 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 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 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.
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 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 formation. 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, panleucopenia or Chlamydophila 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 for all components one year after the primary vaccination course,
- subsequent revaccinations: Chlamydiosis and feline leukaemia components: every year. Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No effect other than those already mentioned in 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, Disodium hydrogen orthophosphate, Monopotassium phosphate anhydrous, Potassium chloride, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
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 (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 closure and sealed with an aluminium 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.
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.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
Vm 04491/5056
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax RCPCh FeLV 1 ml
GTIN:3661103006848
GTIN description:Purevax RCPCh FeLV 0.5 ml
GTIN:04028691579052