Purevax Rabies - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Purevax Rabies suspension for injection

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France SCS

Laboratoire Porte des Alpes

Rue de l'Aviation

69800 Saint Priest

FRANCE

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax Rabies suspension for injection

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT

Each dose of 1 ml contains:

Active substance:

Rabies recombinant canarypox virus (vCP65) > 10 6.8 FAID*50

• *Fluorescent assay infectious dose 50 %

Light pink to pale yellow homogeneous suspension

• 4. INDICATION

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.

• 5. CONTRAINDI­CATIONS

None

• 6. ADVERSE REACTIONS

In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days. Most of these reactions were noted during the 2 days following the vaccine injection.

A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most.

Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cats

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

Administer one dose of 1 ml according to the following vaccination scheme:

Primary vaccination course : 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.

• 9. ADVICE ON CORRECT ADMINISTRATION

Apply usual aseptic procedures.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C-8 °C).

Protect from light.

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.

Shelf life after first opening the container: use immediately.

• 12. SPECIAL WARNING(S)

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 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.

Pregnancy and lactation:

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.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product except those mentioned above.

Overdose:

No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of 10 doses. The reactions may last longer.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION