NOAH Compendium

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Date: Tuesday, April 30, 2024 2:20

Release 2.141
Purevax RC lyophilisate and solvent for suspension for injection (GB)
 
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%
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 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 (frequency and seriousness)
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 / 1,000 animals treated):
Hypersensitivity reaction3
Very rare
(<1 animal / 10,000 animals treated, including isolated reports)
Emesis4
1 lasting usually for 1 or 2 days
2 slight pain at palpation, itching or limited oedema disappearing within 1 or 2 weeks at most
3 may require appropriate symptomatic 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 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 section “Contact details” of the package leaflet.
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 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 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No effect other than those already mentioned under 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, Water for injections
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.
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.
Disposal
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 04491/5052
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