Purevax RCPCh - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Purevax RCPCh lyophilisate and solvent for suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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 G1 strains) antigens.....­.............­.............­.... > 2.0 ELISA U.

Attenuated Chlamydophila felis (905 strain).­.............­.............­.............­.............­.............­.... > 103.0 EID502

Attenuated feline panleucopenia virus (PLI IV)..........­.............­.............­.............­............ > 103.5 CCID501

Excipient:

Gentamicin, at most.........­.............­.............­.............­.............­.............­.............­.............­.............­.........28 pg

Solvent:

Water for injections...­.............­.............­.............­.............­.............­.............­.............­....... q.s. 1 ml or 0.5 ml.

• 1 cell culture infective dose 50%

• 2 egg infective dose 50%

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: homogeneous beige pellet.

Solvent: clear colourless liquid.

4. CLINICAL PARTICULARS4.1 Target species

Cats.

• 4.2 Indications for use, specifying the target species

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 Chlamydophila felis 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 rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.

Duration of immunity:

• – Rhinotracheitis, calicivirosis and panleucopenia components: 1 year after primary vaccination course and 3 years after the last re-vaccination

• – Chlamydophila felis component: 1 year after the last re-vaccination.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

• 4.5 Special precautions for use

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.

This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products. If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.

• 4.6 Adverse reactions (frequency and seriousness)

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.

Transient hyperthermia and lethargy, sometimes associated with lameness, have been observed 1 to 3 weeks following booster vaccination in adult cats, in very rare cases, based on post marketing safety experience.

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).

• 4.7 Use during pregnancy, lactation or lay

Do not use during the whole pregnancy and lactation.

4.8 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 administered 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.

• 4.9 Amounts to be administered and administration route

Subcutaneous route.

Reconstitute gently the vaccine in order to obtain a uniform suspension with limited foam formation. Visual appearance after reconstitution: clear slightly yellow suspension.

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, panleucopenia or Chlamydophila 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 must be carried out

• – Chlamydiosis component: every year.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.

• 4.11 Withdrawal period(s)

Not applicable.

• 5. IMMUNOLOGICAL PROPERTIES

ATCvet code: QI06AJ03.

Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis and feline panleucopenia. Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia vi­rus.

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

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Sucrose

Sorbitol

Dextran 40

Casein hydrolysate

Collagen hydrolysate

Dipotassium phosphate

Potassium dihydrogen phosphate

Potassium hydroxide

Sodium chloride

Disodium hydrogen orthophosphate

Monopotassium phosphate anhydrous

6.2 Major incompatibilities

Do not mix with Boehringer Ingelheim adjuvanted vaccine against rabies.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after reconstitution according to directions: use immediately.

6.4 Special precautions for storage

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

Protect from light.

Do not freeze.

• 6.5 Nature and composition of immediate packaging

Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml or 0.5 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.

Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.

Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.

Plastic box containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 0.5 ml of solvent.

Plastic box containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 0.5 ml of solvent.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/04/050/001–004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23/02/2005

Date of last renewal: 14/01/2010