Purevax rcpch

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

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 CCID 1
50
Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... 2.0 ELISA U.
Attenuated Chlamydophila felis (905 strain) ..................................................................... 103.0 EID 2
50
Attenuated feline panleucopenia virus (PLI IV) ............................................................ 103.5 CCID 1
50

Excipient:
Gentamicin, at most .......................................................................................................................... 28 µg

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 PARTICULARS

4.1 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.

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.
Emesis (mostly within 24 to 48 hours) has been observed in very rare cases based on post-marketing
safety experience.
Transient hyperthermia and lethargy, sometimes associated with lameness, have been observed 1 to
3 weeks 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.
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.
live feline rhinotracheitis virus + inactivated feline calicivirus antigen + live
feline panleucopenia virus / parvovirus + live chlamydia.
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.
PHARMACEUTICAL PARTICULARS

6.1 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
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
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
10. DATE OF REVISION OF THE TEXT

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

PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.


ANNEX II

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S)AND
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

B.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

C. STATEMENT OF THE MRLs
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers of the biological active substances
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'aviation
69800 SAINT-PRIEST
FRANCE
Boehringer Ingelheim Animal Health France SCS
Laboratoire Lyon Gerland
254, Rue Marcel Mérieux
69007 LYON
FRANCE
Name and address of the manufacturer responsible for batch release
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'aviation
69800 SAINT-PRIEST
FRANCE
B.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Veterinary medicinal product subject to prescription.
C. STATEMENT OF THE MRLs
Not applicable.


ANNEX III

LABELLING AND PACKAGE LEAFLET


A. LABELLING


Plastic box of 10 bottles of lyophilisate and 10 bottles of solvent
Plastic box of 50 bottles of lyophilisate and 50 bottles of solvent

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh lyophilisate and solvent for suspension for injection.
2.
STATEMENT OF ACTIVE SUBSTANCES
Per dose of 1 ml or 0.5 ml:
FHV (F2 strain) ................................................................................................................. 104.9 CCID
50
FCV (431 and G1 strains) ............................................................................................... 2.0 ELISA U.
Chlamydophila felis (905 strain) .......................................................................................... 103.0 EID
50
FPV (PLI IV) .................................................................................................................... 103.5 CCID50.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
PACKAGE SIZE
Lyophilisate (10 x 1 dose) + solvent (10 x 1 ml)
Lyophilisate (50 x 1 dose) + solvent (50 x 1 ml)
Lyophilisate (10 x 1 dose) + solvent (10 x 0.5 ml)
Lyophilisate (50 x 1 dose) + solvent (50 x 0.5 ml
5.
TARGET SPECIES
Cats.
6.
INDICATION(S)

7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD(S)
Not applicable.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP (mm/yyyy)
Once reconstituted use immediately.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Protect from light.
Do not freeze.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read package leaflet.
13. THE WORDS 'FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only. To be supplied only on veterinary prescription.
14. THE WORDS 'KEEP OUT OF THE SIGHT AND REACH OF CHILDREN'
Keep out of the sight and reach of children.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/050/001 Lyophilisate (10 x 1 dose) + solvent (10 x 1 ml)
EU/2/04/050/002 Lyophilisate (50 x 1 dose) + solvent (50 x 1 ml)
EU/2/04/050/003 Lyophilisate (10 x 1 dose) + solvent (10 x 0.5 ml)
EU/2/04/050/004 Lyophilisate (50 x 1 dose) + solvent (50 x 0.5 ml)
17. MANUFACTURER'S BATCH NUMBER
Lot


MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Lyophilisate bottle

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)

3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 dose
4.
ROUTE(S) OF ADMINISTRATION
SC.
5.
WITHDRAWAL PERIOD(S)

6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP (mm/yyyy)
8.
THE WORDS 'FOR ANIMAL TREATMENT ONLY'
For animal treatment only.


MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Solvent bottle

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh solvent
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)

3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 ml or 0.5 ml
4.
ROUTE(S) OF ADMINISTRATION
SC.
5.
WITHDRAWAL PERIOD(S)

6.
BATCH NUMBER
Lot
7.
EXPIRY DATE
EXP (mm/yyyy)
8.
THE WORDS 'FOR ANIMAL TREATMENT ONLY'
For animal treatment only




B. PACKAGE LEAFLET
Purevax RCPCh 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 RCPCh
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 CCID 1
50
Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... 2.0 ELISA U.
Attenuated Chlamydophila felis (905 strain) ..................................................................... 103.0 EID 2
50
Attenuated feline panleucopenia virus (PLI IV) ............................................................ 103.5 CCID 1
50

Excipient:
Gentamicin, at most .......................................................................................................................... 28 µg

Solvent:
Water for injection....................................................................................................... q.s. 1 ml or 0.5 ml.
1 cell culture infective dose 50%
2 egg 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 Chlamydophila felis infection to reduce clinical signs,
-
against feline panleucopenia to prevent mortality and clinical signs.
rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Duration of immunity:
-
Rhinotracheitis, calicivirosis and panleucopenia components : 1 year after primary vaccination
and 3 years after the last re-vaccination
-
Chlamydophila felis 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.
Emesis (mostly within 24 to 48 hours) has been observed in very rare cases based on post-marketing
safety experience.
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).
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.
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.
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.
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.
Pregnancy and lactation:
Do not use during the whole pregnancy and lactation.
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.
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 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
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.
15. OTHER INFORMATION
The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year
after vaccination.
Plastic box containing:
10 x 1 dose of lyophilisate and 10 x 1 ml of solvent or
50 x 1 dose of lyophilisate and 50 x 1 ml of solvent or
10 x 1 dose of lyophilisate and 10 x 0.5 ml of solvent or
50 x 1 dose of lyophilisate and 50 x 0.5 ml of solvent.
Not all pack sizes may be marketed.