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Purevax RCP (attenuated feline rhinotracheitis herpesvirus...) – Package leaflet - QI06AH

Updated on site: 09-Feb-2018

Medication name: Purevax RCP
ATC: QI06AH
Substance: attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) /inactivated feline calicivirosis antigens (FCV 431 and G1 strains) / attenuated feline panleucopenia virus (PLI IV)
Manufacturer: Merial

PACKAGE LEAFLET FOR:

Purevax RCP lyophilisate and solvent for 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: MERIAL

29, avenue Tony Garnier 69007 Lyon

FRANCE

Manufacturer responsible for the batch release: MERIAL

Laboratoire Porte des Alpes Rue de l’aviation

69800 Saint-Priest FRANCE

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax RCP lyophilisate and solvent for suspension for injection.

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

Per 1 ml dose:

 

Lyophilisate:

≥ 104.9 CCID501

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) .......................................

Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens..........................

≥ 2.0 ELISA U.

Attenuated feline panleucopenia virus (PLI IV) .............................................................

≥ 103.5 CCID501

Excipient:

 

Gentamicin, at most.......................................................................................................................

16.5 µg

Solvent:

 

Water for injection q.s. ...................................................................................................................

1 ml.

1 cell culture infective dose 50%.

 

4.

INDICATION(S)

 

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 feline panleucopenia to prevent mortality and clinical signs.

Onsets of immunity have been demonstrated 1 week after primary vaccination course for the rhinotracheitis, calicivirus and panleucopenia components.

The duration of immunity after the last re-vaccination is 3 years for rhinotracheitis, calicivirosis and panleucopenia components.

5.CONTRAINDICATIONS

Do not use in pregnant animals.

The use is not recommended during lactation

6.ADVERSE REACTIONS

In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days). A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.

In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Cats.

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

Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:

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 or panleucopenia components are expected to be present (e.g. in kittens of 9–12 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 one year after the primary vaccination course,

-subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.

9.ADVICE ON CORRECT ADMINISTRATION

Use immediately after reconstitution.

10.WITHDRAWAL PERIOD

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.

12.SPECIAL WARNING(S)

Special precautions for use in animals:

Use in healthy animals only.

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.

Pregnancy and lactation:

Do not use in pregnant animals.

The use is not recommended during lactation.

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 administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.

Overdose (symptoms, emergency procedures, antidotes):

No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.

Incompatibilities:

Do not mix with Merial adjuvanted vaccine against rabies.

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

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER INFORMATION

Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent. Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent. Not all pack sizes may be marketed.

The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.

To be supplied only on veterinary prescription.

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