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Purevax RCP FeLV - patient leaflet, side effects, dosage

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Patient leaflet - Purevax RCP FeLV

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Purevax RCP FeLV 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 :

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

Manufacturer responsible for the 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 RCP FeLV

Lyophilisate and solvent for suspension for injection.

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

Per dose of 1 ml or 0.5 ml:

Lyophilisate:

Active substances:

Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)......­.............­.... > 109 CCID501

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.........­.............­.............­.............­.............­.............­.............­...23 ^g

Solvent:

Active substance:

FeLV recombinant canarypox virus (vCP97)......­.............­.............­.............­..... > 107.2 CCID501.

  • 1 cell culture infective dose 50%.

Lyophilisate: homogeneous beige pellet.

Solvent: clear colourless liquid with presence of cell debris in suspension.

Onsets of immunity:

  • – Rhinotracheitis, calicivirus 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 re-vaccination.

  • – Feline Leukaemia component: 1 year after the last re-vaccination.

  • 5. CONTRAINDI­CATIONS

None.

  • 6. ADVERSE REACTIONS

Transient apathy and anorexia as well as hyperthermia (lasting usually for 1 or 2 days) were commonly observed during safety and field studies. A local reaction (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most was commonly observed during safety and field studies.

A hypersensitivity reaction has been observed uncommonly in field studies,, 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 treated in 100 animals)

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

  • – 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 route.

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

Subsequent revaccinations:

  • – Feline leukaemia component: every year.

  • – Rhinotracheitis, calicivirosis and panleucopenia components: at intervals of up to three years.

  • 9. ADVICE ON CORRECT ADMINISTRATION

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.

  • 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 reconstitution according to directions: use immediately.

  • 12. SPECIAL WARNING(S)

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.

Pregnancy and lactation:

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.

Overdose (symptoms, emergency procedures, antidotes) :

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

Incompatibilities :

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.

  • 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 veterinary medicinal product is available on the website of the European Medicines Agency

  • 15. OTHER INFORMATION

Frequently Asked Questions

What is Purevax RCP FeLV and what does it do?

Purevax RCP FeLV is a vaccine designed to protect cats against infectious diseases, specifically feline rhinotracheitis, calicivirus, and feline leukemia virus (FeLV). It helps prevent these serious illnesses and keeps your cat healthy.

Is Purevax RCP FeLV safe for my cat?

Yes, Purevax RCP FeLV is considered safe for most cats. It has been tested for safety and efficacy, but as with any vaccine, it's important to discuss your cat's health history with your veterinarian.

When should I vaccinate my kitten with Purevax RCP FeLV?

Kittens should typically receive their first dose of Purevax RCP FeLV at around 8 weeks of age. Your vet will recommend a vaccination schedule to ensure your kitten is fully protected.

How often does my cat need the Purevax RCP FeLV booster?

After the initial series of vaccinations, your cat will need a booster dose every 1 to 3 years, depending on your vet's advice and your cat's risk factors.

Are there any side effects of Purevax RCP FeLV?

Some cats may experience mild side effects such as swelling at the injection site, lethargy, or a slight fever. These are usually temporary and resolve quickly. Rarely, more serious reactions can occur.

Can elderly cats receive the Purevax RCP FeLV vaccine?

Yes, elderly cats can receive the vaccine if they are otherwise healthy. Your veterinarian can assess their overall health before vaccination.

What if my cat has had a previous allergic reaction to vaccines?

If your cat has had an allergic reaction to vaccines in the past, consult your veterinarian. They may recommend alternative vaccination strategies or pre-medications to minimize risks.

Does Purevax RCP FeLV protect against all strains of feline leukemia virus?

Purevax RCP FeLV protects against the most common strains of feline leukemia virus but may not cover all variants. Regular veterinary check-ups are essential for monitoring your cat's health.

Can I give my cat Purevax RCP FeLV if it's sick?

It's generally recommended to wait until a cat has fully recovered from illness before vaccinating. Consult your veterinarian for personalized advice based on your cat’s condition.

How long does the immunity from Purevax RCP FeLV last?

The immunity provided by Purevax RCP FeLV typically lasts for up to three years; however, this can vary based on individual factors. Regular veterinary check-ups are important for assessing immunity.

Is it necessary to vaccinate indoor cats with Purevax RCP FeLV?

Even indoor cats can benefit from vaccination against diseases like FeLV. Consult your veterinarian to determine the best vaccination plan based on your indoor cat's lifestyle.

What should I do if I miss a scheduled vaccination for my cat?

If you miss a vaccination appointment, contact your vet to reschedule as soon as possible. They will provide guidance on how to proceed with the vaccination schedule.

Can I give my pregnant cat Purevax RCP FeLV?

Vaccination during pregnancy is generally not recommended unless absolutely necessary. Discuss options with your veterinarian to ensure the safety of both the mother and her kittens.

Will my cat experience pain after receiving Purevax RCP FeLV?

Some discomfort at the injection site is possible but should be minimal. If you notice excessive pain or swelling that lasts more than a few days, contact your veterinarian.

How should I care for my cat after they receive the Purevax RCP FeLV vaccine?

After vaccination, monitor your cat for any unusual reactions and ensure they have a quiet space to rest. If any concerning symptoms arise, reach out to your veterinarian immediately.

Can other pets in the household be vaccinated with Purevax RCP FeLV?

Purevax RCP FeLV is specifically formulated for cats. Other pets will require different vaccines that are appropriate for their species—consult your vet for details.

How can I prepare my cat for their appointment to get Vaccinated with Purevax RCP FeLV?

Keep your cat calm by bringing familiar items like their favorite blanket or toy and avoid feeding them immediately before the appointment if recommended by your vet.

Where can I get my cat vaccinated with Purevax RCP FeLV?

You can get Purevax RCP FeLV at most veterinary clinics or animal hospitals. Some shelters and community programs also offer vaccinations at low cost.

Is there an alternative to Purevax RCP FeLV if my cat cannot take it?

If Purevax RCP FeLV isn't suitable for your kitty due to health concerns or sensitivities, discuss alternative vaccines or preventive strategies with your veterinarian.