qanastek/EMEA-V3 huggingface dataset:
Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Immunizzazjoni attiva tal- qtates ta ’ tmien ġimgħat jew akbar kontra l- lewċemija fil- qattus biex tipprevjeni viraemja persistenti u sinjali kliniċi tal- marda relatata.
Onset of immunity has been demonstrated 2 weeks after primary vaccination course.
Il- bidu ta ’ l- immunità jseħħ ġimagħtejn wara l- ewwel kors ta ’ tilqim.
The duration of immunity is one year after the last vaccination.
It- tul ta ’ l - immunità huwa ta ’ sena wara l- aħħar tilqima.
Do not use in pregnant animals.
Tużax waqt it- tqala.
Use is not recommended during lactation.
L- użu tiegħu fi żmien il- ħalib m’ huwiex rakkomandabbli.
Vaccinate only healthy animals..
- Laqqam biss annimali f’ saħħithom.
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination..
- Huwa rakkomandabbli li jsir test għal FeLV antiġenaemja qabel it- tilqim.
Vaccination of FeLV positive cats is of no benefit.
- It- tilqim ta ’ qtates positivi għal FeLV m’ għandu l- ebda benefiċċju.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ li tinjetta lilek innifsek, fittex tabib mal- ewwel u qis li turih il- fuljett ta 'tagħrif li jkun ġol - pakkett jew it- tikketta.
2 4.6 Adverse reactions (frequency and seriousness)
2 4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment..
- F’ ċirkostanzi eċċezzjonali, jista ’ jkun hemm reazzjoni ta ’ ipersensitività li tista ’ tirrikjedi kura
A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks..
- Jista ’ jkun hemm għoqda żgħira (< 2 cm) temporanja fil- post tal- injezzjoni li tinżel fi żmien ġimgħa
Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
- Jista ’ jkun hemm letarġija li tgħaddi u ipertermja għal ġurnata, f’ każi eċċezzjonali, għal jumejn.
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and rabies components).
Hemm informazzjoni dwar is- sigurtà u l- effiċjenza li turi li dan il- vaċċin jista jiġi amministrat fl- istess ġurnata iżda ma jistax jintuża flimkien ma vaċċini tal- Merial bl’ adjuvant magħhom (diversi għaqdiet tal- komponenti tar- rhinotrakeite virali fil- qtates, kaliċivirosis, panlewkopenja u rabbja).
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/ or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Hemm informazzjoni dwar is- sigurtà u l- effiċjenza li turi li dan il- vaċċin jista jiġi użat flimkien mas - serje ta - vaċċini mingħajr adjuvant tal- Merial (diversi għaqdiet tal- komponenti tar- rhinotrakeite virali fil- qtates, kaliċivirosis, panlewkopenja u klamydiosis) u/ jew amministrat fl- istess ġurnata iżda mhux użat flimkien mal- vaċċin tal- Merial bl- adjuvant kontra r- rabbja.
Inject by subcutaneous route one 1-ml dose of vaccine according to the following schedule:
Injetta taħt il- ġilda doża ta ’ ml tal- vaċċin rikostitwit skond din l- iskema li ġejja:
first injection: from 8 weeks of age, second injection:
Tilqima basika: l- ewwel injezzjoni: minn età ta ’ 8 ġimgħat. it- tieni injezzjoni:
3 to 5 weeks later.
3 sa ’ 5 ġimgħat wara.
Revaccination:
Tilqim mill- ġdid:
annual
Kull sena.
No undesirable effect has been observed after the administration of several doses except those mentioned in the “ Adverse reactions” section.
L- ebda effett mhux mixtieq ma ġie osservat wara l- amministrazzjoni ta ’ diversi dożi ħlief dawk imsemmija fis- sezzjoni “ Effetti mhux mixtieqa ”.
IMMUNOLOGICAL PROPERTIES
Q106AD
Vaccine against feline leukaemia.
6. 1 Lista ta ’ ingredjenti
The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
6. 2 Inkompatibilitajiet
QI06AD
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra ħlief mal- vaċċini mingħajr adjuvant tal- Merial.
PHARMACEUTICAL PARTICULARS
6. 3 Żmien ta 'kemm il- prodott idum tajjeb
6.1 List of excipients
Uża immedjatament wara li jinfetaħ.
Salts Water for injections.
Tagħrif speċjali dwar kif għandu jinħażen
6.2 Incompatibilities
Tiffriżax.
Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
6.3 Shelf life
In- natura tal- materjal tal- ewwel ippakkjar:
2 years Use immediately after broaching.
- flixkun tal- ħġieġ ta ’ l- Ewwel Tip.
Special precautions for storage
- egħluq: tapp tal- butyl elastomer issiġillat b’ tapp tal- aluminju.
Do not freeze.
Ippakkjar:
6.5 Nature and composition of immediate packaging
doża flixkun ta ’ suspensjoni:
Nature of primary packaging elements:. type I glass bottle.. closure: butyl elastomer closure, sealed with an aluminium cap
- kaxxa ta ’ 10 x flixkun.
Packaging:
- kaxxa ta ’ 20 x flixkun.
1 dose bottle of suspension:. box of 10 x 1 bottles.. box of 20 x 1 bottles.. box of 50 x 1 bottles.
- kaxxa ta ’ 50 x flixkun.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Armi l- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo diżinfettant approvat mill- Awtorità Kompetenti tal- pajjiż.
MERIAL 29 avenue Tony Garnier F-69007 LYON FRANCE
MERIAL 29 Avenue Tony Garnier F- 69007 LYON FRANCE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U S - SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOT
Name and address of the manufacturer of the biological active substance(s) MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F-69800 SAINT PRIEST FRANCE
Isem u indirizz tal- manufattur tas- sustanza( i) bioloġika( ċi) attiva( i) MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 SAINT PRIEST FRANCE
Not applicable
Mhux appklikabbli.
LABELLING AND PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF U TIKKETTA
9 PARTICULARS TO APPEAR ON THE OUTER PACKAGE {NATURE/ TYPE}
9 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
suspension
Suspensjoni
FeLV recombinant Canarypox virus (vCP97)......... ≥ 10 7.2 CCID50
FeLV vajrus rikombinant tal- Canarypox (vCP97)...... > 10 7. 2 CCID50
1-ml suspension (50 bottles)
10 dożi: ml suspensjoni (10 fliexken) 20 doża: ml suspensjoni (20 flixkun) 50 doża: ml suspensjoni (50 flixkun)
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel tuża.
Subcutaneous use.
Għal taħt il- ġilda.
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel tuża.
EXP (dd/ mm/ yy) Use immediately after broaching
EXP {ġurnata/ xahar / sena} Uża immedjatament wara li jiġi rikostitwit.
Store and transport at 2°C – 8°C (in a refrigerator), protected from light.
Aħżen f' temperaturi bejn 2°C - 8°C (fil- friġġ), protett mid- dawl.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'MEDIĊINA MHUX UŻATA JEW MATERJAL ĦAŻIN IEĦOR, JEKK IKUN IL- KAŻ
For animal treatment only - to be supplied only on veterinary prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I FIR- REĠISTRU TAL- KOMUNITA TA ’ PRODOTTI MEDIĊINALI
1-ml suspension (50 bottles)
EU/ 2/ 00/ 019/ 005 10 dożi: ml suspensjoni (10 flixken) EU/ 2/ 00/ 019/ 006 20 doża: ml suspensjoni (20 flixkun) EU/ 2/ 00/ 019/ 007 50 doża: ml suspensjoni (50 flixkun)
11 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
{suspension}
{suspensjoni}
Purevax FeLV suspension for injection
Purevax FeLV suspensjoni għall- injezzjoni.
Read the package leaflet before use
Aqra l- fuljett informattiv qabel l- użu.
Subcutaneous use
Taħt il- ġilda.
13 PACKAGE LEAFLET Purevax FeLV Suspension for injection
13 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Purevax FeLV Suspensjoni għall- injezzjoni.
Marketing authorisation holder MERIAL 29 avenue Tony Garnier F-69007 LYON FRANCE
Sid l- Awtorizzazzjoni tal- Kummerċ MERIAL 29 avenue Tony Garnier F- 69007 LYON FRANCE
Manufacturing authorisation holder responsible for batch release MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F-69800 SAINT PRIEST FRANCE
MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 SAINT PRIEST FRANCE
Purevax FeLV Suspension for injection
Purevax FeLV Suspensjoni għall- injezzjoni.
FeLV recombinant Canarypox virus (vCP97)......... ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
FeLV vajrus rikombinant tal- Canarypox (vCP97)...... > 10 7. 2 CCID50 (doża infettiva tas- cell culture 50%)
A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks.
- Jista ’ jkun hemm għoqda żgħira (< 2 cm) temporanja fil- post tal- injezzjoni li tinżel fi żmien
Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
ġimgħa sa ’ 4 ġimgħat.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
- Jista ’ jkun hemm letarġija li tgħaddi u ipertermja għal ġurnata, f’ każi eċċezzjonali, għal jumejn.
Basic vaccination:
Taħt il- ġilda Doża ta ’ ml tal- vaċċin rikostitwit skond din l- iskema li ġejja:
Shake well before use.
Ħawwad sewwa wara li jiġi rikostitwit.
Keep out of the reach and sight of children..
- Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Store and transport at 2°C – 8°C (in a refrigerator), protected from light.
- Aħżen fil- friġġ (2°C – 8°C) protett mid- dawl.
Do not freeze..
Tiffriżax.
Use immediately after broaching..
- Uża immedjatament wara li jiġi rikostitwit.
Do not use after the expiry date stated on the label.
- Tużax wara d- data ta ’ skadenza fuq it- tikketta.
Vaccinate only healthy animals.
Laqqam biss annimali f’ saħħithom.
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Huwa rakkomandabbli li jsir test għal FeLV antiġenaemja qabel it- tilqim.
Vaccination of FeLV positive cats is of no benefit.
It- tilqim ta ’ qtates positivi għal FeLV m’ għandu l- ebda benefiċċju.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Jekk tiġi njettat bi żball b' dan il- prodott, fittex għajnuna medika, u ħu l- fuljett ta 'tagħrif miegħek.
15 No undesirable effect has been observed after the administration of several doses except those mentioned in the “ Adverse reactions” section.
15 L- ebda effett mhux mixtieq ma ġie osservat wara l- amministrazzjoni ta ’ diversi dożi ħlief dawk imsemmija fis- sezzjoni “ Effetti mhux mixtieqa ”.
Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
Tħallatx ma xi vaċċin jew prodott immunoloġiku ieħor ħlief il- vaċċini tal- Merial mingħajr adjuvant.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Armi l- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo diżinfettant approvat mill- Awtorita Kompetenti tal- pajjiż.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu.
Vaccine against feline leukaemia.
Vaċċin kontra l- lewċemija fil- qtates.
The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
L- istrejn tal- vaċċin huwa vajrus rikombinant tal- canarypox li jesprimi il- ġeni env u gag ta ’ FeLV- A.
Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C.
F’ kundizzjonijiet ta ’ barra, is- sotto- grupp A huwa infettiv u l- immunizzazjoni kontra is- sotto- grupp A jipprovdi protezzjoni totali kontra A, B u C.
After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Wara t- tilqim, il- vajrus jesprimi il- proteini protettivi, iżda ma jirreplikax fil- qattus.
As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Konsegwentement, il- vaċċin jinduċi stat ta ’ immunità kontra l- vajrus tal - lewċemija fil- qattus.
Box of 20 x 1 bottles.
Kaxxa ta ’ 10 x 2 fliexken Kaxxa ta ’ 20 x 2 fliexken.
Box of 50 x 1 bottles.
Kaxxa ta ’ 50 x 2 fliexken.
To be supplied only on veterinary prescription.
Għandu jingħata bir- riċetta tal- veterinarju.
EPAR summary for the public This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew.
What is Purevax RC?
X’ inhu Purevax RC?
Purevax RC is a vaccine containing the following active substances: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain), • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains).
Purevax RC huwa vaċċin li fih dawn is- sustanzi attivi: • rhinotracheitis herpesvirus felin (razza FHV F2) imdgħajjef, • antiġeni tal- calicivirosis (razez FCV 431 u G1) inattivati (maqtula).
Purevax RC is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RC huwa lyophilisate (solidu imnixxef) u solvent li jinħallu f’ sospensjoni għall - injezzjoni.
What is Purevax RC used for?
Għalxiex jintuża Purevax RC?
Purevax RC is used to vaccinate cats from the age of 8 weeks against the following diseases: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus), • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus).
Purevax RC jintuża fit- tilqim ta ’ qtates mill- età ta ’ 8 ġimgħat ’ il fuq kontra dawn il- mardiet: • rinotrakeite virali felina (marda tixbah lill- influwenza kkawżata mill- herpesvirus), • calicivirosis felin (marda tixbah lill- influwenza bl- infjammazzjoni tal- ħalq ikkawżata mill- calicivirus).
The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection.
It- tilqima tgħin fit- tnaqqis tas- sintomi tal- mardiet u tgħin ukoll fit- tnaqqis ta ’ l- eskrezzjoni virali fil- każ ta ’ infezzjoni tal- calicivirus.
After Purevax RC has been made up, 1 ml is injected under the skin.
Wara li Purevax RC jinħall, 1 ml minnu jiġi injettat taħt il- ġilda.
The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later.
L- ewwel injezzjoni għandha tingħata lill- qtates li jkollhom ta ’ l- inqas tmien ġimgħat, bit- tieni injezzjoni tingħata bejn tlieta u erba ’ ġimgħat wara.
If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Jekk il- qattus ikollu livelli għoljin ta ’ antikorpi li jintirtu mill- omm, l - ewwel tilqima għandha titbiegħed sa ma jkollu 12- il ġimgħa.
The cat should be revaccinated for all components one year after the first vaccination course, then every year.
Il- qattus għandu jitlaqqam mill - ġdid għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim, u mbagħad kull sena.
How does Purevax RC work?
Kif jaħdem Purevax RC?
Purevax RC is a vaccine.
Purevax RC huwa vaċċin.
Purevax RC contains small amounts of weakened or killed viruses that cause the diseases listed above.
Purevax RC fih ammonti żgħar ta ’ vajrusis imdgħajfa jew maqtula li jikkawżaw il- mardiet imsemmija hawn fuq.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘ foreign’ and makes antibodies against them.
Meta l- qattus jingħata t- tilqima, is- sistema immunitarja tagħraf il- vajrusis imdgħajfa jew maqtula bħala ‘ barranin ’ u huwa jagħmel antikorpi kontriehom.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Fil- ġejjieni, is- sistema immunitarja tkun kapaċi tipproduċi l- antikorpi iktar malajr meta jerġgħu jiġu esposti għall -
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged How has Purevax RC been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged vajrusis.
The effectiveness of Purevax RC has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus and calicivirus.
L- effettività ta ’ Purevax RC ġiet studjata f’ diversi studji fil- kundizzjonijiet tal- laboratorji fejn il- qtates tlaqqmu u ġew infettati bil- herpesvirus u calcivirus virulenti.
In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Fl- istudji ta ’ Purevax RC li ħares lejn l- iskeda bażika tat- tilqim (żewġ injezzjonijiet b’ bejn tlieta u erba ’ ġimgħat bejniehom) u t- tilqima booster (ta ’ l- anqas injezzjoni waħda).
They included young and adult cats of various breeds, but not young kittens.
Ġew inklużi diversi razez ta ’ qtates żgħażagħ u adulti, iżda mhux frieħ.
The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Il- mezz ewlieni tal- kejl ta ’ l- effettività kien il- livell ta ’ l- antikorpi fid- demm kontra l- vajrusis fit- tilqima.
What benefit has Purevax RC shown during the studies?
Liema benefiċċji ta ’ Purevax RC intwerew f’ dan l- istudju?
In laboratory conditions Purevax RC was demonstrated to provide protection against the diseases listed above.
F’ kundizzjonijiet tal- laboratorju, intwera li Purevax RC jipprovdi protezzjoni kontra l- mardiet imsemmija hawn fuq.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Fl- istudju dwar it- tilqima bażika kien hemm żieda fl- antikorpi kontra l - infezzjonijiet tal- herpesvirus tar- rinotrakeite felina u tal- calicivirus.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly.
Fl- istudju li analizza t - tilqima booster, il- livelli ta ’ l- antikorpi kontra l- infezzjonijiet tal- herpesvirus tar- rinotrakeite felina u tal- calicivirus baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RC?
X’ inhuma r- riskji assoċjati ma ’ Purevax RC?
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Xi drabi, il- qtates jiżviluppaw apatija (nuqqas ta ’ interess fl- ambjent ta ’ madwarhom) u anoressija (nuqqas ta ’ apatija), kif ukoll temperatura għolja li ddum jum jew tnejn.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Jista ’ jkun hemm reazzjoni lokali fis- sit ta ’ l- injezzjoni, b’ uġigħ ħafif meta jintmess, ħakk jew nefħa, li tisparixxi fi żmien ġimgħa jew tnejn.
For a full list of the side-effects reported with Purevax RC, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax RC, ara l- Fuljett ta ’ Tagħrif.
Purevax RC should not be used in pregnant cats.
Purevax RC m’ għandux jintuża fi qtates tqal.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Xi prekawzjonijiet irid jieħu min jagħti l- mediċina jew jiġi f’ kuntatt ma ’ l- annimal?
In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Jekk min jagħti l- mediċina jitniggeż biha bi żball għandu jitlob parir mediku immedjatament u juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Purevax RC been approved?
Għaliex ġie approvt Purevax RC?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RC be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (is- CVMP) ikkonkluda li l - benefiċċji ta ’ Purevax RC jisbqu r- riskji għat- tilqim attiv ta ’ qtates li jkollhom iktar minn tmien ġimgħat kontra l- mardiet imsemmija hawn fuq, u rrakkomanda li Purevax RC jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Purevax RC:
Tagħrif ieħor dwar Purevax RC:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Purevax RC lil MERIAL fit- 23 ta ’ Frar 2005.
This summary was last updated on 25 January 2008.
Dan is- sommarju ġie aġġornat l- aħħar fil- 25 ta ’ Jannar 2008.
Invented Strength
Isem kummerċjali
Content
Għamla Farmaċewtika
Package
Speċi li fuqhom għandu jintuża l - prodott
Withdrawal
Mod ta ’ Amministrazzjo ni
Name
Ippakkjar
species administration
Daqs tal- pakkett
(concentration) size
Perjodu ta ’ Tiżmim
Purevax RC
flixkun tal -
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose
10 fliexken ta’ lajofiliżejt u
Lyophilisate and solvent for suspension for injection
solvent għal
Cats
ta ’ doża
Subcutaneous use
rinotrakeite fil -
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
suspensjoni għall -
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
(lajofiliżejt)
1 dose of lyophilis ate and 1ml of solvent
ml ta’ solvent
Not applicable
mill- inqas 4. 9
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose
Herpesvajrus attenwat tar - rinotrakeite fil - qtates (FHV strejn F2):
Lyophilisate and solvent for suspension for injection
Lajofiliżejt u solvent għal suspensjoni għall - injezzjoni.
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
flixkun tal - ħġieġ ta ’ Tip I magħluq b’ tapp tal - butyl
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
50 flixkun doża ta ’ doża ta’ lajofiliżejt u (lajofiliżejt) ml ta’ solvent u 50 flixkun ta ’ ml
1 dose of lyophilis ate and 1ml of solvent
elastomer u ssiġillat b’ tapp ta ’ l - aluminju
Not applicable
(solvent)
What is Purevax RCCh?
X’ inhu Purevax RCP?
Purevax RCCh is a vaccine containing the following active substances: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain), • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains), • attenuated Chlamydophila felis (905 strain).
Purevax RCP huwa vaċċin li fih dawn is- sustanzi attivi: • rhinotracheitis herpesvirus felin (razza FHV F2) imdgħajjef, • antiġeni tal- calicivirosis (razez FCV 431 u G1) inattivati (maqtula), • Chlamydophila felis imdgħajjef (razza 905).
Purevax RCCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RCP hu lyophilisate (solidu imnixxef) u solvent li jinħallu f’ sospensjoni għall - injezzjoni.
What is Purevax RCCh used for?
Għalxiex jintuża Purevax PRC?
Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus), • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus), • chlamydiosis (a flu-like illness caused by the bacterium C. felis).
Purevax RCP jintuża fit- tlaqqim ta ’ qtates mill- età ta ’ 8 ġimgħat ’ il fuq kontra dawn il - mardiet: • rinotrakeite virali felina (marda tixbah lill- influwenza kkawżata mill- herpesvirus), • calicivirosis felin (marda tixbah lill- influwenza bl- infjammazzjoni tal- ħalq ikkawżata mill- calicivirus), • chlamydiosis (marda tixbah lill- influwenza kkawżata mill- batterju C. felis).
It also helps to reduce viral excretion in case of calicivirus infection.
It- tilqima tgħin fit- tnaqqis tas- sintomi tal- mardiet u tgħin ukoll fit- tnaqqis ta ’ l- eskrezzjoni virali fil- każ ta ’ infezzjoni tal- calicivirus.
After Purevax RCCh has been made up, 1 ml is injected under the skin.
Wara li Purevax PRC jinħall, 1 ml minnu jiġi injettat taħt il- ġilda.
If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Jekk il- qattus ikollu livelli għoljin ta ’ antikorpi li jintirtu mill- omm, l- ewwel tilqima għandha titbiegħed sa ma jkollu 12- il ġimgħa.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis.
Il- qattus għandu jitlaqqam mill- ġdid għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim, u mbagħad kull sena għar- rhinotracheitis, il- calicivirosis u l- chlamydiosis.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged How does Purevax RCCh work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged Kif jaħdem Purevax PRC?
Purevax RCCh is a vaccine.
Purevax PRC huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi ‘ jgħallmu ’ lis- sistema immunitarja (id - difiżi naturali tal- ġisem) kif tiddefendi ruħha kontra l- mard.
Purevax RCCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.
Purevax PRC fih ammonti żgħar ta ’ vajrusis imdgħajfa jew maqtula li jikkawżaw il- mardiet imsemmija hawn fuq.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘ foreign’ and makes antibodies against them.
Meta l- qattus jingħata t- tilqima, is- sistema immunitarja tagħraf il- vajrusis imdgħajfa jew maqtula bħala ‘ barranin ’ u jagħmel antikorpi kontriehom.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Fil- ġejjieni, is- sistema immunitarja tkun kapaċi tipproduċi l- antikorpi iktar malajr meta jerġgħu jiġu esposti għall- vajrusis.
When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Meta jkun espost għal kwalunkwe mill- vajrusis iktar tard fil- ħajja, il- qattus jew ma jiġix infettat jew ikollu infezzjoni ħafna inqas serja.
How has Purevax RCCh been studied?
Kif ġie studjat Purevax RCP?
The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis.
L- effettività ta ’ Purevax PRC ġiet studjata f’ diversi studji fil- kundizzjonijiet tal- laboratorji fejn il- qtates tlaqqmu u ġew infettati bil- herpesvirus, calicivirus jew C. felis.
In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
L- istudji ta ’ Purevax PRC ħarsu lejn l- iskeda bażika tat- tilqim (żewġ injezzjonijiet b’ bejn tlieta u erba ’ ġimgħat bejniehom) u t- tilqima booster (ta ’ l- inqas injezzjoni waħda).
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Il- mezz ewlieni tal- kejl ta ’ l- effettività kien il- livell ta ’ l- antikorpi fid- demm kontra l- vajrusis fit- tilqima.
What benefit has Purevax RCCh shown during the studies?
Liema benefiċċji ta ’ Purevax PRC intwerew f’ dan l- istudju?
In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above.
F’ kundizzjonijiet tal- laboratorju, intwera li Purevax PRC jipprovdi protezzjoni kontra l - mardiet imsemmija hawn fuq.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Fl- istudju dwar it- tilqima bażika kien hemm żieda fl- antikorpi kontra l- infezzjonijiet mill- vajrusis felini tal- herpesvirus, tar- rinotrakeite u tal- calicivirus.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Ma kienx possibbli li wieħed jara jekk hemmx żieda fl- antikorpi kontra C. felis minħabba livelli għoljin ta ’ antikorpi fil- qtates fil- bidu ta ’ l- istudju.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly.
Fl- istudju li ħares lejn it- tilqima bil - booster, il- livelli ta ’ l- antikorpi kontra l- herpesvirus tar- rinotrakeite, infezzjoni tal- calicivirus u C. felis baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RCCh?
X’ inhuma r- riskji assoċjati ma ’ Purevax PRC?
For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax PRC, ara l- Fuljett ta ’ Tagħrif.
Purevax RCCh should not be used in pregnant cats.
Purevax PRC m’ għandux jintuża fi qtates tqal.
In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Jekk min jagħti l- mediċina jitniggeż biha bi żball, dan għandu jitlob parir mediku immedjatament u juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
The vaccine should not be handled by people with a weak immune system.
It- tilqima m’ għandhiex tinżamm minn persuni b’ sistema immunitarja dgħajfa.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Jekk dawn il- persuni jitniggżu bi żball, għandhom jgħidu lit- tabib tagħhom li tniggżu b’ tilqima ħajja bil- chlamydia.
Why has Purevax RCCh been approved?
Għaliex ġie approvat Purevax RCCh?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
ġimgħat jew aktar kontra l- mard elenkat fuq, u rrakkomanda li Purevax RCCh jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċju- riskju jista ’ jinstab fil - modulu 6 ta ’ dan l- EPAR.
Other information about Purevax RCCh:
Informazzjoni oħra dwar Purevax RCCh:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Purevax RCCh lil MERIAL fit- 23 ta ’ Frar 2005.
Pharmaceutical
Għamla Farmaċewtika
Route of
Mod ta ’ Amministrazzjoni
Package
Daqs tal - pakkett
Withdrawal
Perjodu ta ’ Tiżmim
Name
EU/ 2/ 04/ 049/ 001 Purevax RCCh
Form
Herpesvajrus attenwat tar - rinotrakeite fil- qtates (FHV
administration
Lajofiliżejt u solvent għal
(concentration)
Taħt il- ġilda
size
flixkun tal - ħġieġ ta ’ Tip I
period
10 fliexken
EU/ 2/ 04/ 049/ 001
doża ta’ lajofiliżejt u
Purevax RCCh
Mhux applikabbli
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose
strejn F2): mill- inqas 4. 9 log suspensjoni għall -
Lyophilisate and solvent for suspension for injection
magħluq
Subcutaneous use
ml ta’ solvent
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
b’ tapp tal - butyl
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
(lajofiliżejt) u 10 fliexken
1 dose of lyophilisate and 1ml of solvent
elastomer u ssiġillat b’ tapp ta ’ l- aluminju
Not applicable
ta ’ ml (solvent)
EU/ 2/ 04/ 049/ 002
EU/ 2/ 04/ 049/ 002 Purevax RCCh
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose
Antiġeni inattivati tal -
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
50 flixkun ta ’ doża doża ta’ lajofiliżejt u (lajofiliżejt) u ml ta’ solvent 50 flixkun ta ’ ml (solvent)
1 dose of lyophilisate and 1ml of solvent
Mhux applikabbli
Not applicable
elastomer u ssiġillat b’ tapp ta ’ l- aluminju
Active substances:
Sustanzi Attiv/ i:
Per 1-ml dose:
Għal kull doża ta ’ ml:
Freeze-dried pellet:
Pritkuna imnixxfa bil- friża:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)............................. ≥ 2.0 ELISA U.
Herpesvajrus attenwat tar- rinotrakeite fil- qtates (FHV strejn F2)................................... ≥ 104. 9 CCID501 Antiġeni inattivati tal- Kaliċivirosi fil- qtates (strejn FCV 431 u G1)............................... ≥ 2. 0 ELISA U.
Attenuated Chlamydophila felis (905 strain).................................................................... ≥ 103.0 EID502 Excipient:
Chlamydophila felis attenwat (strejn 905)...................................................................... ≥ 103. 0 EID502 Ingredjent mhux attiv:
Gentamicin, at most........................................................................................................................ .28 µg Solvent:
28 µg Solvent:
1 ml 1: cell culture infective dose 50% 2: egg infective dose 50% For a full list of excipients, see section 6.1.
Ilma għal injezzjoni........................................................................................................................ q. s. ml 1: doża infettiva tas- cell culture 50% 2: doża infettiva tal- bajda 50% Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Lyophilisate and solvent for suspension for injection.
Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
Cats.
Qtates.
4.2 Indications for use
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l- prodott.
Active immunisation of cats aged 8 weeks and older:
Immunizzazzjoni attiva tal- qtates ta ’ 8 ġimgħat u akbar:
- against feline viral rhinotracheitis to reduce clinical signs,
- kontra r- rinotrakeite virali fil- qtates biex tnaqqas sinjali kliniċi,
- against calicivirus infection to reduce clinical signs and excretion,
- kontra l- infezzjoni tal- kaliċivirus biex tnaqqas sinjali kliniċi u eskrezzjoni,
- against Chlamydophila felis infection to reduce clinical signs.
- kontra l- infezzjoni tal- Chlamydophila felis biex tnaqqas sinjali kliniċi
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus u Chlamydophila felis.
The duration of immunity is 1 year after the last (re-)vaccination.
L- immunità tibqa sa ’ sena wara l- aħħar vaċċinazzjoni.
Do not use in pregnant animals.
Tużax f’ annimali li huma tqal.
The use is not recommended during lactation.
L- użu tiegħu mhux rakkomandat fi żmien il- ħalib.
2/ 17 4.5 Special precautions for use
2/ 17 4. 5 Prekawzjonijiet Speċjali għall- Użu
Use only in healthy animals.
Uża biss f’ annimali f’ saħħithom.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ li tinjetta lilek innifsek bi żball, fittex parir mediku mal- ewwel u qis li lit- tabib turih il- fuljett ta 'informazzjoni li jkun ġewwa l- pakkett jew it- tikketta.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive drugs.
Nies li huma immunodefiċjenti jew qed jieħdu mediċini biex titrażżan l- immunità għandhom jevitaw li jmissu dan il- vaċċin.
If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Jekk tinjetta lilek innifsek bi żball, fittex tabib mal- ewwel u għidlu li ġejt injettat b’ vaċċin bi chlamydia ħajja.
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
F’ kundizzjonijiet normali ta’ l- użu, jista ’ jkun hemm apatija u anoressja li jgħaddu, u ukoll żieda fit - temperatura tal- ġisem (li ddum normalment għal ġurnata jew tnejn).
A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Jista ’ jkun hemm reazzjoni lokali (uġigħ meta tingħafas il- parti eżaminata, ħakk u edema limitata) li tmur fi żmien ġimgħa jew ġimgħatejn l- iżjed.
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
F’ ċirkostanzi eċċezzjonali, jista ’ jkun hemm reazzjoni ta ’ ipersensitività, li tista ’ tirrikjedi kura sintomatika xierqa.
In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
F’ każi rari ħafna, fi qtates adulti ġew osservati żieda fit- temperatura u telqa, xi kultant assoċjati ma tizpip, minn ġimgħa sa tliet ġimgħat wara t- tilqima booster.
The reaction was transient
Din ir- reazzjoni kienet transitorja.
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.
Hemm informazzjoni dwar is- sigurtà u l- effiċjenza li turi li dan il- vaċċin jista jintuża mal- vaċċin tal - Merial mingħajr adjuvant kontra l- lewkemja fil- qtates u/ jew amministrat fl- istess ġurnata iżda mhux jintuża mal- vaċċin bl- adjuvant tal- Merial kontra r- rabbja.
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li jiġi rikostitwit il- lajfiliżejt mas- solvent, skond din l - iskema ta ’ tilqim li ġejja:
Primary vaccination course:
L- ewwel kors ta ’ vaċċinazzjoni:
- first injection: from 8 weeks of age,
- l- ewwel injezzjoni: minn età ta ’ 8 ġimgħat,
- second injection:
- it- tieni injezzjoni:
3 to 4 weeks later.
3 sa ’ 4 ġimgħat wara.
In the presence of high levels of maternally derived specific antibodies, the primary vaccination course should be delayed until 12 weeks of age.
Fil- preżenza ta ’ livelli għolja ta ’ antikorpi speċifiċi derivati mill- omm, l- ewwel kors ta ’ tilqim għandu jiġi mgħoti iżjed tard fl- età ta ’ 12 il- ġimgħa.
Revaccination: every year.
Ripetizzjoni tal- vaċċinazzjoni: kull sena.
No effect other than those already mentioned in section “ Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
L- ebda effett ħlief dawk imsemmija fis- sezzjoni “ Effetti mhux mixtieqa ” ma ġew osservati, ħlief żieda fit- temperatura tal- ġisem li tista ’ f’ każi eċċezzjonali ddum għal 5 ijiem.
3/ 17 4.11 Withdrawal period(s)
3/ 17 4. 11 Perjodu ta 'Tiżmim
ATC Vet code:
ATĊ kodiċi veterinarja:
QI06AJ02
Q106AJ02
Vaccine against feline viral rhinotracheitis, feline calicivirosis and chlamydiosis.
Vaċċin kontra r- rinotrakeite virali fil- qtates, kaliċivirosi fil- qtates u klamidjosi.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Tistimola immunità attiva kontra l- herpesvajrus tar- rinotrakeite fil- qtates, kaliċivirus fil- qtates u Chlamydophila felis.
Sucrose Sorbitol Dextran 40 Casein hydrolysate Collagen hydrolysate Salts
Sukrożju Sorbitol Dextran 40 Casein hydrolysate Collagen hydrolysate Melħ
Do not mix with any other vaccine or immunological product, except those mentioned in section “ Interactions”.
Tħallatx ma vaċċini jew prodotti immunoloġiċi oħra ħlief dawk imsemmija f’ sezzjoni “ Effetti ”.
Use immediately after reconstitution
18 il- xahar Uża immedjatament wara li l- prodott jiġi rikostitwit.
Store and transport refrigerated (2 °C – 8 °C) protected from light.
Aħżen u ttrasporta f’ temperaturi ta ’ 2°C – 8°C protett mid- dawl.
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.
Flixkun tal- ħġieġ ta ’ Tip I li fih doża ta ’ lajofiliżejt u flixkun tal- ħġieġ ta ’ Tip I li fih ml ta ’ solvent, it - tnejn magħluqin b’ tapp tal- butyl elastomer u ssiġillati b’ tapp ta ’ l- aluminju.
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.
Pakkett li għandu 10 fliexken ta ’ doża ta ’ lajofiliżejt u 10 fliexken ta ’ ml ta ’ solvent Pakkett li għandu 50 flixkun ta ’ doża ta ’ lajofiliżejt u 50 flixkun ta ’ ml ta ’ solvent Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Eħles mill- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo diżinfettant approvat mill - Awtorita kompetenti tal- pajjiż.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
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 Laboratorju ta ’ Lyon Porte des Alpes Rue de l’ aviation 69800 SAINT- PRIEST France
Merial Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON France
Merial Laboratorju ta ’ Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON France
Merial Laboratory of Lyon Porte des Alpes Rue de l’ aviation 69800 SAINT-PRIEST France
Merial Laboratorju ta ’ Lyon Porte des Alpes Rue de l’ aviation 69800 SAINT- PRIEST France
FHV (F2 strain)................................................................................................................ ≥ 104.9 CCID50 FCV (431 and G1 strains).............................................................................................. ≥ 2.0 ELISA U.
FHV (strejn F2)............................................................................................................... ≥ 104. 9 CCID501 FCV (strejn 431 u G1)..................................................................................................... ≥ 2. 0 ELISA U.
Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
Subcutaneous use.
Taħt il- ġilda.
EXP (mm/ yyyy) Use immediately after reconstitution.
EXP (XX/ SSSS) Uża immedjatament wara li jiġi rikostitwit.
Store and transport refrigerated (2 °C – 8 °C) protected from light.
Aħżen u ttrasporta f’ temperatura ta ’ 2°C - 8°C (ġo friġġ) protett mid- dawl.
EU/ 2/ 04/ 049/ 001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/ 2/ 04/ 049/ 002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/ 2/ 04/ 049/ 001 Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) EU/ 2/ 04/ 049/ 002 Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
Purevax RCCh lyophilisate for injection
Purevax RCCh lajofiliżejt għall- injezzjoni.
Subcutaneous route
Taħt il- ġilda.
EXP (mm/ yyyy)
EXP (xx/ ssss)
Purevax RCCh solvent
Purevax RCCh solvent
14/ 17 PACKAGE LEAFLET
14/ 17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Purevax RCCh Lyophilisate and solvent for suspension for injection.
Purevax RCCh Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
MERIAL 29, avenue Tony Garnier F-69007 Lyon France
Sid l- Awtorizzazzjoni tal- Kummerċ MERIAL 29, avenue Tony Garnier F- 69007 Lyon France
MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
Manifattur li jħalli l- konsenja tmur fis- suq MERIAL Laboratoire Porte des Alpes Rue de l’ Aviation F- 69800 Saint Priest France
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains).................... ≥ 2.0 ELISA U.
Herpesvajrus attenwat tar- rinotrakeite fil- qtates (FHV strejn F2)................................ ≥ 104. 9 CCID501 Antiġeni inattivati tal- Kaliċivirosi fil- qtates (strejn FCV 431 u G1)............................ ≥ 2. 0 ELISA U.
Attenuated Chlamydophila felis (905 strain).................................................................... ≥ 103.0 EID502 Excipient:
Chlamydophila felis attenwat (strejn 905)..................................................................... ≥ 103. 0 EID502 Ingredjent mhux attiv:
1 ml 1: cell culture infective dose 50% 2: egg infective dose 50%
Ilma għal injezzjoni....................................................................................................................... q. s. ml 1: doża infettiva tas- cell culture 50% 2: doża infettiva tal- bajda 50%
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ, ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus u Chlamydophila felis.
In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Din ir- reazzjoni kienet transitorja.
The reaction was transient If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li jiġi rikostitwit il- lajfiliżejt mas- solvent, skond din l - iskema ta ’ vaċċinazzjoni li ġejja:
Revaccination:
Ripetizzjoni tal- vaċċinazzjoni: kull sena.