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Purevax RCP - patient leaflet, side effects, dosage

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Patient leaflet - Purevax RCP

B. PACKAGE LEAFLET

PACKAGE LEAFLET

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 :

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 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)......­.............­.............­.......> 104.9 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.........­.............­.............­.............­.............­.............­.............­.............­.............­......16.5 ^g

Solvent:

Water for injection q.s..........­.............­.............­.............­.............­.............­.............­......1 ml or 0.5 ml 1 cell culture infective dose 50%.

Lyophilisate: homogeneous beige pellet.

Solvent: clear colourless liquid.

  • 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.

Onset 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.

  • 5. CONTRAINDI­CATIONS

None.

  • 6. ADVERSE REACTIONS

Transient apathy and anorexia as well as hyperthermia (lasting usually for 1or 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 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 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 one year after the primary vaccination course, – subsequent revaccinations: at intervals of up to 3 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: clear slightly yellow 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 bottle 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 :

None.

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 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 administrated 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.

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 Boehringer Ingelheim 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

Frequently Asked Questions

What is Purevax RCP used for?

Purevax RCP is a vaccine designed to protect dogs against rabies, canine parvovirus, canine distemper, and canine adenovirus. It helps to keep your furry friend safe from these serious diseases.

How is Purevax RCP administered to my dog?

Purevax RCP is given as an injection, typically administered by a veterinarian. Most dogs receive this vaccine as part of their regular vaccination schedule.

Is Purevax RCP safe for my puppy?

Yes, Purevax RCP is safe for puppies. It can be given starting from around 6 to 8 weeks of age, but your veterinarian will recommend the best timing based on your puppy's health.

What are the possible side effects of Purevax RCP?

Most dogs tolerate the vaccine well. Some mild side effects may include slight swelling at the injection site, lethargy, or a mild fever. Serious side effects are rare.

How often does my dog need the Purevax RCP vaccine?

Dogs typically need a booster shot every one to three years after their initial vaccination. Your veterinarian will provide guidance based on your dog's health and local regulations.

Can my dog have an allergic reaction to Purevax RCP?

While allergic reactions are rare, they can occur. Signs may include difficulty breathing, swelling of the face or paws, or hives. Contact your vet immediately if you notice any of these symptoms.

What should I do if my dog misses a Purevax RCP vaccination?

If your dog misses a scheduled vaccination, contact your veterinarian as soon as possible. They may recommend rescheduling the missed shot or administering a booster.

Can I give Purevax RCP to a pregnant dog?

Consult your veterinarian before vaccinating a pregnant dog with Purevax RCP. They will assess the situation and advise on the best course of action.

Is there any specific care needed after my dog receives Purevax RCP?

After receiving Purevax RCP, monitor your dog for any unusual reactions and avoid strenuous activities for 24 hours post-vaccination.

Does Purevax RCP protect against all diseases in dogs?

No, while Purevax RCP protects against rabies, parvovirus, distemper, and adenovirus, it does not cover other diseases like Lyme disease or kennel cough.

What should I do if my dog shows side effects after the vaccination?

If you observe any side effects that concern you, contact your veterinarian immediately for advice or further evaluation.

Can adult dogs receive their first dose of Purevax RCP?

Yes, adult dogs can receive their first dose of Purevax RCP if they have not been vaccinated before. They'll need follow-up doses as recommended by your vet.

What is the cost of Purevax RCP vaccination?

The cost can vary by location and veterinary practice. It's best to check with your local vet for specific pricing regarding the Purevax RCP vaccine.

How effective is Purevax RCP in preventing diseases?

Purevax RCP is highly effective in preventing rabies and other targeted diseases when administered according to veterinary guidelines.

Do I need to have my dog vaccinated even if they stay indoors?

Yes, even indoor dogs should be vaccinated against rabies and other diseases as they can still be exposed through visiting pets or animals in the area.

Will my dog's lifestyle affect how often they need vaccinations like Purevax RCP?

Yes, factors such as lifestyle, exposure risks (like traveling or going to parks), and local laws may influence how often your dog needs vaccinations.

Can I find out about upcoming vaccinations through reminders?

Many veterinary clinics offer reminder services via email or text messages for upcoming vaccinations like Purevax RCP. Check with your vet!

Is it necessary to vaccinate my dog if they have already had the diseases before?

Vaccination is still recommended even if a dog has previously had certain diseases because immunity can wane over time.

Are there alternative vaccines to Purevax RCP available?

Yes, there are other vaccines available that protect against similar disease profiles; consult with your veterinarian about options that may suit your pet's needs better.