NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Sunday, May 19, 2024 1:37

Release 6.96
Purevax Rabies suspension for injection (GB)
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Purevax Rabies
Product index: Purevax Rabies
Incorporating:
Qualitative and quantitative composition
Each dose of 1 ml contains:
Active substance: Rabies recombinant canarypox virus (vCP65) ≥ 106.8 FAID*50
*Fluorescent assay infectious dose 50%
For the full list of excipients, see Pharmaceutical Particulars section.
Pharmaceutical form
Light pink to pale yellow homogeneous suspension for injection.
Clinical particulars
Target species
Cats.
Indications for use
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity after primary vaccination: 1 year.
Duration of immunity after revaccination: 3 years.
Contra-indications
None.
Special warnings
None.
Special precautions for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily. 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:
Very rare
(< animal / 10,000 animals treated, including isolated reports):
Apathy1-2, mild anorexia2, hyperthermia2-3
Injection site reactions (pain, swelling, warmth and erythema)4
Hypersensitivity reaction5
1 Slight
2 Usually lasting 1 or 2 days, Most of these reactions were noted during the 2 days following the vaccine injection.
3 Above 39.50C
4 Pain at palpation; limited swelling that may become nodular; usually disappearing within 1 or 2 weeks at most.
5 Which may require symptomatic treatment
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 section “Contact details” of the package leaflet.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of Boehringer Ingelheim non-adjuvanted vaccine against feline leukaemia.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Boehringer Ingelheim non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Amount(s) to be administered and administration route
Subcutaneous use.
Apply usual aseptic procedures.
Administer one dose of 1 ml according to the following vaccination scheme:
Primary vaccination: 1 injection from 12 weeks of age.
Revaccination: 1 year after primary vaccination, then at intervals of up to 3 years.
Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries. Veterinary surgeons may wish to consider two vaccinations. The best time for a blood sample to be taken is around 28 days after vaccination.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those already mentioned under Adverse reactions have been observed after the administration of 10 doses. The reactions may last longer.
Pharmaceutical particulars
Excipients
Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except those mention under Interactions.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Protect from light. Do not freeze.
Immediate packaging
Box of 2 vials of 1 dose.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Marketing Authorisation Number
UK(GB): Vm 04491/5051
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Purevax Rabies suspension for injection 2 x 1 dose vials
GTIN:3661103039303