Patient leaflet - Purevax RCCh
O'
ackage leaflet or
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)
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 reacti symptomatic treatment.
In very rare cases, hyperthermia and lethargy sometim one to three weeks following booster vaccination in adu
may occur, which may require appropriate
s associated with lameness has been observed lt cats. The reaction was transient
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant animals.
The use is not recommended durin
n.
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 with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
4.9 Amounts t
ministered and administration route
Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Primary vaccination course:
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– first injection: from 8 weeks of age,
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– second injection: 3 to 4 weeks later.
Where high levels of maternal antibodies against R, C or Ch components are expected to be present (e.g. in kittens of 9–12 weeks of age borne 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: every year.
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4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No effect other than those already mentioned in section 4.6 “Adverse reactions” have been obse except hyperthermia that may exceptionally last 5 days.
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4.11 Withdrawal period(s)
Not applicable.
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5. IMMUNOLOGICAL PROPERTIES
ATC Vet code: QI06AJ02
Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamy
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
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6. 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 orthophosph
Monopotassium phosphate anhydrous 6.2 Incompatibilitie
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia
6.3 Shelf li
Shelf life of the veterinary medicinal product as packaged for sale:18 months. Shelf life after reconstitution: use immediately after reconstitution
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C) Protect from light.
Do not freeze.
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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 of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
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
Qj
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
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7. MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 LYON
FRANCE
xď
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8. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/049/001–002
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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23/02/2005
Date of last renewal: 15/01/2010
,O
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10. DATE OF REVISION OF THE TEXT
15/01/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
A.
MANUFACTURER(S) OF THE BI MANUFACTURING AUTHORISA BATCH RELEASE
ANNEX II
CAL ACTIVE SUBSTANCE(S) AND HOLDER(S) RESPONSIBLE FOR
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
STATEMENT
D.
E MRLs
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
Merial
Laboratory of Lyon Porte des Alpes
Rue de l’aviation
69800 SAINT-PRIEST
France
Merial
Laboratory of Lyon Gerland
254, Avenue Marcel Mérieux
69007 LYON
France
Name and address of the manufacturer responsible
Merial
Laboratory of Lyon Porte des Alpes
Rue de l’aviation
69800 SAINT-PRIEST
France
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR REST
REGARD TO THE SAFE
ONS OF THE MARKETING AUTHORISATION WITH EFFECTIVE USE OF THE PRODUCT
Not applicable
THE MRLs
D.
Not applicable
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Pack of 10 bottles of lyophilisate and 10 bottles of solvent
Pack of 50 bottles of lyophilisate and 50 bottles of solvent
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCCh lyophilisate and solvent for suspension for injection
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 1ml:
FHV (F2 strain)..........................
FCV (431 and G1 strains)..........
Chlamydophila felis (905 strain)
Gentamicin, at most....................
> 104.9 CCID50 > 2.0 ELISA U… > 103.0 EID50................28 Mg
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4. PACKAGE SIZE
Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml)
Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Cats.
5. TARGET SPECIES
6. INDICATION(S)
Read the pac
efore use.
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7. METHOD AND ROUTE(S) OF ADMINISTRATION
Subcut
use.
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8. WITHDRAWAL PERIOD
Not applicable.
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9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
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10. EXPIRY DATE
EXP (mm/yyyy)
Use immediately after reconstitution.
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11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 °C – 8 °C) Protect from light.
Do not freeze.
EU/2/04/049/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
17. MANUFACTURER’S BATCH NUMBER
Lot
PACKAGE LEAFLET FOR:
Purevax RCCh
Lyophilisate and solvent for suspension for injection.
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AN THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BA RELEASE, IF DIFFERENT
Marketing authorisation holder : MERIAL
29, avenue Tony Garnier
F-69007 Lyon
France
Manufacturer for the batch release :
MERIAL
Laboratoire Porte des Alpes
Rue de l'Aviation
F-69800 Saint Priest
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCCh
Lyophilisate and solvent for suspension for injection.
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1ml:
Lyophilisate:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)...............
Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains)
Attenuated Chlamydophila
Excipient:
Gentamicin, at most
05 strain)
> 104.9 CCID501 > 2.0 ELISA U… > 103.0 EID502
Solvent:
Water for in
q.s. 1 ml
1: cell cul
2: egg infe
DICATION(S)
Active immunisation of cats aged 8 weeks and older:
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– against feline viral rhinotracheitis to reduce clinical signs,
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– against calicivirus infection to reduce clinical signs and excretion,
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- against Chlamydophila felis infection to reduce clinical signs.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
The duration of immunity is 1 year after the last (re-)vaccination.
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.
In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed
one to three weeks following booster vaccination in adult cats. The reaction was transient
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 SPECIE
TE(S) AND METHOD OF ADMINISTRATION
Inject by subcutaneous route one dose
solvent, according to the following vaccination scheme:
of vaccine after reconstitution of the lyophilisate with the
Primary vaccination course: – first injection: from 8
– second injection: 3 to
eks of age, eeks later.
Where high levels of maternal antibodies against R, C or Ch 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: every year.
9. ADVICE ON CORRECT ADMINISTRATION
Use immediately after reconstitution.
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.
-
10. WITHDRAWAL PERIOD
Not applicable.
-
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (2 °C – 8 °C)
Protect from light.
Do not freeze.
cy
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12. SPECIAL WARNING(S)
Use only in healthy animals.
Qy
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.
Do not use in pregnant animals.
The use is not recommended during lactation.
No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANYDispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
15/01/2010
Detailed information on this product is available on the website of the European Medicines Agency (EMEA)
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15. OTHER INFORMATION