Summary of medicine characteristics - Purevax RCCh
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
1. NAME OF THE VETERINARY MEDICINAL PRODUCTPurevax RCCh lyophilisate and solvent for suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONPer dose of 1 ml
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)......
Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)
Attenuated Chlamydophila felis (905 strain)..................................
Excipient:
Gentamicin, at most..........................................................................
> IO4.9 CCID501 > 2.0 ELISA U… > 103.0 EID502
Water for injection
-
1: cell culture infective dose 50%
-
2: egg infective dose 50%
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORMLyophilisate and solvent for suspension for
4.
4.1
Target species
Cats.
4.2
Indications for use
q.s. 1 ml
Active immunisation of ca 8 weeks and older:
-
– against feline viral rhinotracheitis to reduce clinical signs,
-
– against calicivirus infection to reduce clinical signs and excretion,
-
- against Chlamydophila felis infection to reduce clinical signs.
Onsets o rhinotrac
nity have been demonstrated 1 week after primary vaccination course for licivirus and Chlamydophila felis components.
n of immunity is 1 year after the last (re-)vaccination.
4.3 Contraindications
Do not use in pregnant animals.
The use is not recommended during lactation.
4.4 Special warnings
None.
4.5 Special precautions for use
Use only in healthy animals.
In case of accidental self-injection, seek medical advice immediately and sho the label to the physician.
This vaccine should not be handled by persons who are immunodeficient or taking
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
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:
-
– first injection: from 8 weeks of age,
-
– 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessaryNo effect other than those already mentioned in section 4.6 “Adverse reactions” have been obse except hyperthermia that may exceptionally last 5 days.
4.11 Withdrawal period(s)
Not applicable.
5. IMMUNOLOGICAL PROPERTIES
5. IMMUNOLOGICAL PROPERTIESATC Vet code: QI06AJ02
Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamy
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
6. PHARMACEUTICAL PARTICULARS6.1 List of excipientsSucrose
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
Store and transport refrigerated (2 °C – 8 °C) Protect from light.
Do not freeze.
6.5 Nature and composition of immediate packaging
6.5 Nature and composition of immediate packagingType 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
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
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such productsDispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/04/049/001–002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23/02/2005
Date of last renewal: 15/01/2010
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT15/01/2010
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)