qanastek/EMEA-V3 huggingface dataset:
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Armi l- materjal ħażin billi tgħalli fil- misħun, taħraq jew tgħarraq ġo disinfettant approvat mill- Awtorita Kompetenti tal- pajjiż.
The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
L- istrejn tal - vaċċin tal - lewċemija fil- qtates huwa vajrus rikombinat tal- canarypox li jesprimi l- ġeni tal- env u gag ta ’ FeLV- A.
After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Wara t- tilqim, il - vajrus jesprimi l- 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 - lewkemjafil- qtates.
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju jingħata bir- riċetta tat- tabib
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)............................. ≥ 2.0 ELISA U.
Virus tal- Ħerpes attenwat tar- rhinotrakeite 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 Attenuated feline panleucopenia virus (PLI IV)............................................................ ≥ 103.5 CCID501 Excipient:
Chlamydophila felis attenwat (strejn 905)..................................................................... ≥ 103. 0 EID502 Virus attenwat tal- panlewkopenja fil- qtates (PLI IV)................................................... ≥ 103. 5 CCID501 Ingredjent mhux attiv:
Water for injections.................................................................................................................... q. s.
Gentamiċin, massimu ta ’.................................................................................................................
- against calicivirus infection to reduce clinical signs and excretion,
- kontra l- infezzjoni tal- Kaliċivirosi biex tnaqqas sinjali kliniċi u eskrezzjoni,
- against feline panleucopenia to prevent mortality and clinical signs.
- kontra l- panlewkopenja fil- qtates biex tipprevjeni mortalità u sinjali kliniċi
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus, Chlamydophila felis u panlewkopenja.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus, and Chlamydophila felis, and 3 years for panleucopenia component.
4. 3 Kontra indikazzjonijiet
2/ 17 4.5 Special precautions for use
2/ 18 4. 5 Prekawzjonijiet Speċjali għall- Użu
Use only in healthy animals
Uża biss f’ annimali f’ saħħithom.
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 ’ użu, jista ’ jkun hemm apatija li tgħaddi u anoreksja, 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 l- qattus jiġi eżaminat, ħakk u edema limitata) li tmur fi żmien ġimgħa jew ġimgħatejn l- iżjed.
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. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra 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 tiġi rikostitwita l- pritkuna imnixxfa bil- friża mas - solvent, skond din l- iskema ta ’ vaċċinazzjoni li ġejja:
Revaccination:
Ripetizzjoni tal- vaċċinazzjoni:
- for all components one year after the primary vaccination course,
- għall- komponenti kollha sena wara l- ewwel kors ta ’ vaċċinazzjoni,
- then every year for the rhinotracheitis, calicivirosis and chlamydiosis components, and
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, kaliċivirosi u klamidjosi, u
every three years for the panleucopenia component.
kull tliet snin għall- komponent tal- panlewkopenja
3/ 17 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
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 f’ sezzjoni 5, 4. ma ġew osservati, ħlief żieda fit- temperatura tal - ġisem li tista ’ f’ każi eċċezzjonali ddum għal 5 ijiem.
4.11 Withdrawal period(s)
3/ 18 4. 11 Perjodu ta 'Tiżmim
ATC Vet code:
Kodiċi ATĊ veterinarja:
QI06AJ03
Q106A103
Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis and feline panleucopenia.
Vaċċin kontra r- rhinotrakeite virali fil- qtates, kaliċivirosi fil- qtates, klamidjosi u panlewkopenja fil - qtates.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
Tistimola immunità attiva kontra l- virus tal- Ħerpes tar- rhinotrakeite fil- qtates, kaliċivirus fil- qtates, Chlamydophila felis u l- virus tal- panlewkopenja fil- qtates.
Do not mix with any other vaccine or immunological product, except those mentioned in section “ Interactions”.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra ħlief dawk imsemmija f’ sezzjoni “ Effetti fuq prodotti mediċinali oħra jew effetti oħra ”...
Use immediately after reconstitution.
18- il xahar Uża immedjatament wara li l- prodott jiġi rikostitwit.
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml 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.
4/ 17 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
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 disinfettant approvat mill - Awtorita Kompetenti tal- pajjiż.
5/ 17 ANNEX II
5/ 18 ANNESS II
7/ 17 ANNEX III
7/ 18 ANNESS III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
EXP (mm/ yyyy) Use immediately after reconstitution
EXP (XX/ SSSS)
EU/ 2/ 04/ 050/ 001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/ 2/ 04/ 050/ 002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/ 2/ 04/ 050/ 001 Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) EU/ 2/ 04/ 050/ 002 Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Purevax RCPCh lyophilisate for injection
Purevax RCPCh lajofiliżejt għall- injezzjoni.
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Purevax RCPCh solvent
Purevax RCPCh solvent
14/ 17 PACKAGE LEAFLET
14/ 18 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Purevax RCPCh Lyophilisate and solvent for suspension for injection
Purevax RCPCh Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
Purevax RCPCh Lyophilisate and solvent for suspension for injection.
Purevax RCPCh Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains).................... ≥ 2.0 ELISA U.
Virus tal- Ħerpes 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 Attenuated feline panleucopenia virus (PLI IV)........................................................... ≥ 103.5 CCID501 Excipient:
Chlamydophila felis attenwat (strejn 905)..................................................................... ≥ 103. 0 EID502 Virus attenwat tal- panlewkopenja fil- qtates (PLI IV)................................................... ≥ 103. 5 CCID501 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%
- 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, Chlamydophila felis and panleucopenia components.
15/ 18 Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus, Chlamydophila felis u panlewkopenja.
15/ 17 The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus, and Chlamydophila felis, and 3 years for panleucopenia component.
L- immunità tibqa sa ’ sena wara l- aħħar ripetizzjoni ta ’ vaċċinazzjoni għall- komponenti tar - rhinotrakeite, kaliċivirus u Chlamydophila felis, u 3 snin għall- komponent tal- panlewkopenja.
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 li tgħaddi u anoreksja, u ukoll żieda fit - temperatura tal- ġisem (li ddum normalment għal ġurnata jew tnejn).
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 tiġi rikostitwita l- pritkuna mnixxfa bil- friża mas - solvent, skond din l- iskema ta ’ vaċċinazzjoni li ġejja:
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.
- for all components one year after primary vaccination course,
- għall- komponenti kollha sena wara l- ewwel kors ta ’ vaċċinazzjoni,
- then every year for the rhinotracheitis, calicivirosis and chlamydiosis components, and
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, calicivirosis u chlamydiosis,
every three years for the panleucopenia component.
u kull tliet snin għall- komponent tal- panlewkopenja.
EPAR summary for the public This document is a summary of the European Public Assessment Report.
Sommarju ta ’ l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew.
What is Purevax RCP FeLV?
X’ inhu Purevax RCP FeLV?
Purevax RCP FeLV 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 feline panleucopenia virus (PLI IV), • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Purevax RCP FeLV huwa tilqima li fiha dawn is- sustanzi attivi: • rhinotracheitis herpesvirus tal- felini (FHV razza F2) imdgħajjef, • antiġeni calicivirosis (FCV razez 431 u G1) inattivati (maqtula), • vajrus attenwat tal- panleucopenia tal- felini (PLI IV), • vajrus tal- lewkemja tal- felini (FeLV) virus rekombinanti tal- canarypox (vCP97).
Purevax RCP FeLV is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RCP FeLV huwa lyophilisate (solidu imnixxef) u solvent li jinħall f’ sospensjoni għall- injezzjoni.
What is Purevax RCP FeLV used for?
Għalxiex jintuża Purevax RCP FeLV?
Purevax RCP FeLV 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), • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus), • feline leukaemia (an illness affecting the immune system caused by a retrovirus).
Purevax RCP FeLV jintuża fit- tilqim ta ’ qtates mill- età ta ’ 8 ġimgħat u aktar kontra dawn il - mardiet: • rhinotracheitis virali felina (marda tixbah lill- influwenza kkawżata mill- herpesvirus), • calicivirosis felin (marda tixbah lill- influwenza bl- infjammazzjoni tal- ħalq ikkawżata mill- calicivirus), • panleucopenia felina (marda serja li tikkawża dijarea bid- demm ikkawżata minn parvovirus), • lewkemja felina (marda li taffettwa lis- sistema immunitarja kkawżata minn retrovajrus).
The vaccine helps to reduce the symptoms of the diseases and 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 bil- calicivirus.
It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Tista ’ tgħin ukoll biex tipprevjeni mewta dovuta għal panleucopenia u timpedixxi milli FeLV jibqa ’ fid- demm.
After Purevax RCP FeLV has been made up, 1 ml is injected under the skin.
Wara li Purevax RCP FeLV jinħall, 1 ml minnu jiġi injettat taħt il- ġilda.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and feline leukaemia, and every three years for panleucopenia.
Il- qattus għandu jitlaqqam mill- ġdid għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim, u
(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 RCP FeLV 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 mbagħad kull sena għar- rhinotracheitis, calicivirosis u lewkemja felina u kull tliet snin għall - panleucopenia.
Purevax RCP FeLV is a vaccine.
Purevax RCP FeLV huwa vaċċin.
Purevax RCP FeLV contains small amounts of weakened or killed viruses that cause the diseases listed above, as well as two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘ recombinant DNA technology’.
Purevax RCP FeLV fih ammonti żgħar ta ’ vajrusis imdgħajfa jew maqtula li jikkawżaw il- mardiet elenkati hawn fuq, kif ukoll żewġ ġeni mill- FeLV imsejjaħ env u gag, li ddaħħlu f’ vajrus vector (ġarrier) ieħor imsejjaħ canarypox li juża ‘ teknoloġija rekombinanti tad- DNA ’.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Il- vajrus tal- canarypox ma jinxteridx u lanqas ma jimmultiplika fil- qtates iżda dawn jipproduċu proteini mill- ġeni ta ’ FeLV.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the FeLV proteins as ‘ foreign’ and makes antibodies against them.
Meta qattus jingħata tilqima, is- sistema immunitarja tagħraf il- vajrusijiet imdgħajfa jew maqtula u l- proteini ta ’ FeLV bħala ‘ barranin ’ u jagħmel antikorpi kontrihom.
The antibodies will help to protect against the diseases caused by these viruses.
Fil- ġejjieni, is - sistema immunitarja tkun kapaċi tipproduċi l- antikorpi iktar malajr meta terġa ’ tkun esposta għall- vajrusis.
How has Purevax RCP FeLV been studied?
Kif ġie studjat Purevax RCP FeLV?
The effectiveness of Purevax RCP FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus, parvovirus or leukaemia virus.
L- effettività ta ’ Purevax RCP FeLV ġiet studjata f’ diversi provi fil- kundizzjonijiet tal - laboratorji fejn il- qtates tlaqqmu u ġew infettati bil- herpesvirus, calicivirus, parvovirus jew lewkemja virulenti.
In the field the studies of Purevax RCP FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Fil- qasam, l- istudji ta ’ Purevax RCP FeLV ħarsu lejn l- iskeda bażika tat - tilqim (żewġ injezzjonijiet b’ bejn tlieta u erba ’ ġimgħat bejniethom) u t- tilqima booster (injezzjoni waħda biss).
They included young and adult cats of various breeds, but not young kittens.
Inkludew 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, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.
Il- mezz ewlieni tal- kejl ta ’ l- effettività kien il- livell ta ’ antikorpi fid- demm kontra l- vajrusis u l- batterji fit- tilqima, bl- eċċezzjoni tal- komponent ta ’ FeLV, li l- effettività tiegħu fil - prevenzjoni ta ’ infezzjoni diġà ntweriet fi studji oħra.
What benefit has Purevax RCP FeLV shown during the studies?
Liema benefiċċji ta ’ Purevax RCP FeLV intwerew f’ dan l- istudju?
In laboratory conditions Purevax RCP FeLV was demonstrated to provide protection against the diseases listed above.
F’ kundizzjonijiet tal- laboratorju, intwera li Purevax RCP FeLV jipprovdi protezzjoni kontra l - mardiet elenkati hawn fuq.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Fl- istudju tal- qasam dwar it- tilqima bażika kien hemm żieda fl - antikorpi kontra l- infezzjonijiet mir- rhinotracheitis herpesvirus felini, tal- calicivirus u tal - panleucopenia felina.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and feline panleucopenia remained stable at a high level or increased slightly.
Fl- istudju li analizza t- tilqima booster, il- livelli ta ’ l- antikorpi kontra l - infezzjonijiet mir- rhinotracheitis herpesvirus felini, tal- calicivirus u tal- panleucopenia felina u C. felis baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RCP FeLV?
X’ inhuma r- riskji assoċjati ma ’ Purevax RCP FeLV?
For a full list of the side-effects reported with Purevax RCP FeLV, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax RCP FeLV, ara l- Fuljett ta ’ Tagħrif.
Purevax RCP FeLV should not be used in pregnant cats.
Purevax RCP FeLV 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 għandu jfittex parir mediku minnufih u juri l- Fuljett ta ’ Tagħrif jew it- tikketta lit- tabib.
Why has Purevax RCP FeLV been approved?
Għaliex ġie approvat Purevax RCP FeLV?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP FeLV exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCP FeLV be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Purevax RCP FeLV jisbqu r- riskji għat- tilqim attiv ta ’ qtates li jkollhom iktar minn tmien ġimgħat kontra l- mardiet elenkati hawn fuq, u rrakkomanda li Purevax RCP FeLV jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Purevax RCP FeLV:
Informazzjoni oħra dwar Purevax RCP FeLV:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP FeLV to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Purevax RCP FeLV lil MERIAL fit- 23 ta ’ Frar 2005.
Invented Name
Speċi li
Target species
Kontenut
Route of administration
Perjodu ta ’
Content (concentration)
Amministrazzjoni
Withdrawal period
Tiżmim
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 Panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose FeLV recombinant canarypox virus (vCP97): at least 7.2 log 10 CCID50 per dose
Herpesvajrus attenwat tar- rinotrakeite Lajofiliżejt u fil- qtates (FHV strejn F2): mill- inqas solvent għal 4. 9 log 10 CCID50 għal kull doża. suspensjoni Antiġeni inattivati tal- Kaliċivirosi fil - għall- injezzjoni. qtates (strejn FCV 431 u FCV G1)
Lyophilisate and Cats solvent for suspension for injection
Qtates
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
10 fliexken ta ’ doża (lajofiliżejt) u 10 fliexken ta ’ ml
EU/ 2/ 04/ 048/ 002
EU/ 2/ 04/ 048/ 001
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 Panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose FeLV recombinant canarypox virus (vCP97): at least 7.2 log 10 CCID50 per dose
Herpesvajrus attenwat tar- rinotrakeite Lajofiliżejt u fil- qtates (FHV strejn F2): mill- inqas solvent għal 4. 9 log 10 CCID50 għal kull doża. suspensjoni
Lyophilisate and Cats solvent for suspension for injection
flixkun tal - ħġieġ ta ’ Tip I magħluq
Subcutaneous use
Mhux applikabbli
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
Antiġeni inattivati tal- Kaliċivirosi fil - qtates (strejn FCV 431 u FCV G1)
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
50 flixkun ta ’ ml (solvent)
1 dose of lyophilisate and 1ml of solvent
ta’ solvent
Not applicable
elastomer u ssiġillat b’ tapp ta ’ l - aluminju
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)......................................  104.9 CCID 50 1 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 feline panleucopenia virus (PLI IV)............................................................  103.5 CCID 50 1 Excipient:
Vajrus attenwat tal- panlewkopenja fil- qtates (PLI IV)................................................... ≥ 103. 5 CCID501 Ingredjent mhux attiv:
Gentamicin, at most..........................................................................................................................
Gentamiċin, massimu ta ’..................................................................................................................
FeLV recombinant canarypox virus (vCP97)................................................................  10 7.2 CCID 50 1 1: cell culture infective dose 50% For a full list of excipients, see section 6.1.
23 µg Solvent: vajrus rikombinant tal- canarypox FeLV (vCP97).......................................................... ≥ 107. 2 CCID501 1: doża infettiva tas- cell culture 50% Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus u panlewkopenja, u ġimgħatejn wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponent tal- lewkemija fil- qtates.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus and feline leukaemia components, and 3 years for panleucopenia component.
4. 3 Kontra indikazzjonijiet
In normal condition 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).
Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra Hemm informazzjoni dwar is- sigurtà u l- effiċjenza li turi li dan il vaċċin jista jiġi mħallat mas- sensiela ta ’ vaċċini mingħajr adjuvant tal- Merial għall- qtates u/ jew amministrat fl- istess ġurnata iżda mhux imħallat 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 tiġi rikostitwita l- pritkuna imnixxfa bil- friża mas - solvent, skond din l- iskema ta ’ vaċċinazzjoni li ġejja:
Revaccination:
Ripetizzjoni tal - vaċċinazzjoni:
- then every year for the rhinotracheitis, calicivirosis and feline leukaemia components, and every
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, kaliċivirosi u.
three years for the panleucopenia component.
lewkemja fil- qtates, u kull tliet snin għall- komponent tal- panlewkopenja
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 f’ 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/ 18 4. 11 Perjodu ta 'Tiżmim
ATC Vet Code:
ATĊ kodiċi veterinarja:
QI06AH
Q106AH
Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Vaċċin kontra l- rhinotrakeite virali fil- qtates, kaliċivirosi fil- qtates, panlewkopenja fil- qtates u lewkemja fil- qtates.
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Tistimola immunità attiva kontra l- herpesvajrus tar- rhinotrakeite fil- qtates, kaliċivirus fil- qtates, il - vajrus tal- panlewkopenja fil- qtates u l- vajrus tal- lewkemja fil- qtates.
The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
L- istrejn tal - vaċċin tal - lewkemja fil- qtates huwa vajrus rikombinat tal- canarypox li jesprimi l- ġeni tal- 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 normali, s- sotto- grupp A biss huwa infettiv u l - immunizzazzjoni kontra s- sotto- grupp A jipprovdi protezzjoni totali kontra A, B u C.
As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Konsegwentement, il- vaċċin jinduċi stat ta ’ immunità kontra l- vajrus tal - lewkemja fil- qtates.
Do not mix with any other vaccine or immunological product.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra ħlief dawk imsemmija f’ sezzjoni “ Effetti ”.
Store and transport refrigerated (2  C – 8  C) protected from light.
Aħżen u ttrasporta f’ temperaturi ta ’ 2°C – 8°C protett mid- dawl.
4/ 17 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4/ 18 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Name and address of the manufacturer(s)of the biological active substance(s)
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
7/ 17 LABELLING AND PACKAGE LEAFLET
7/ 18 ANNESS III
FHV (F2 strain).................................................................................................................  104.9 CCID 50 FCV (431 and G1 strains)...............................................................................................  2.0 ELISA U.
FHV (strejn F2).............................................................................................................. ≥ 104. 9 CCID501 FCV (strejn 431 u G1)..................................................................................................... ≥ 2. 0 ELISA U.
FPV (PLI IV).....................................................................................................................  103.5 CCID 50 FeLV recombinant canarypox virus (vCP97)....................................................................  107.2 CCID 50 Gentamicin, at most..........................................................................................................................
FPV (PLI IV).................................................................................................................. ≥ 103. 5 CCID501 Vajrus rikombinant tal- canarypox FeLV (vCP97)............................................................ ≥ 107. 2 CCID50 Gentamiċin, massimu ta ’.................................................................................................................
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.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TAL- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
EU/ 2/ 04/ 048/ 001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/ 2/ 04/ 048/ 002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/ 2/ 04/ 048/ 001 Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) EU/ 2/ 04/ 048/ 002 Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
Purevax RCP FeLV lyophilisate for injection
Purevax RCP FeLV lajofiliżejt għall- injezzjoni.
For animal treatment only
Għat- trattament tal- annimali biss.
Purevax RCP FeLV solvent
Purevax RCP FeLV solvent
Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Purevax RCP FeLV Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)......................................  104.9 CCID 50 1 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains).....................  2.0 ELISA U.
Herpesvajrus attenwat tar- rhinotrakeite fil- qtates (FHV strejn F2)................................ ≥ 104. 9 CCID501 Antiġeni inattivati tal- Kaliċivirosi fil- qtates (strejn FCV 431 u G1)............................ ≥ 2. 0 ELISA U.
Gentamicin, at most..........................................................................................................................
Gentamiċin, massimu ta ’.................................................................................................................
FeLV recombinant canarypox virus (vCP97).................................................................  107.2 CCID 50 1 1: cell culture infective dose 50%
23 µg Solvent: vajrus rikombinant tal- canarypox FeLV (vCP97).......................................................... ≥ 107. 2 CCID501 1: doża infettiva tas- cell culture 50%
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus u panlewkopenja, u ġimgħatejn wara l- ewwel kors ta ’ vaċċinazzjoni għall - komponent tal- lewkemija fil- qtates.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus and feline leukaemia components, and 3 years for panleucopenia component.
15/ 18 L- immunità tibqa sa ’ sena wara l- aħħar ripetizzjoni tal- vaċċinazzjoni għall- komponenti tar - rinotrakeite, kaliċivirus u lewkemja fil- qtates, u 3 snin għall- komponent tal- panlewkopenja.
Inject by subcutaneous route one 1 ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li tiġi rikostitwita l- pritkuna mnixxfa bil- friża mas - solvent, skond din l- iskema ta ’ vaċċinazzjoni li ġejja:
- first injection: from 8 weeks of age;
- l- ewwel injezzjoni: minn età ta ’ 8 ġimgħat,
- for all components one year after primary vaccination course;
- għall- komponenti kollha sena wara l- ewwel kors ta ’ vaċċinazzjoni,
- then every year for the rhinotracheitis, calicivirosis and feline leukaemia components, and every
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, kaliċivirosi u
three years for the panleucopenia component.
lewkemja fil- qtates, u kull tliet snin għall- komponent tal- panlewkopenja.
Safety and efficacy data are available which demonstrate that this vaccine can be 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 mħallat mas- sensiela ta ’ vaċċini mingħajr adjuvant tal- Merial għall- qtates u/ jew amministrat fl- istess ġurnata iżda mhux imħallat mal- vaċċin bl- adjuvant tal- Merial kontra r- rabbja.
Store and transport refrigerated (2  C – 8  C) protected from light.
Aħżen u ttrasporta f’ temperatura ta ’ 2°C – 8°C (fil- friġġ) protett mid- dawl.
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.
17/ 18 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- daqs tal- pakketti kollha jistgħu qegħdin fis- suq.
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- Calicivirosis fil- qtates (strejn FCV 431 u G1)............................ ≥ 2. 0 ELISA U.
Attenuated feline panleucopenia virus (PLI IV)............................................................. ≥ 103.5 CCID501 Excipient:
Vajrus attenwat tal- panlewkopenja fil- qtates (PLI IV)................................................... ≥ 103. 5 CCID501 Ingredjent mhux attiv:
Gentamicin, at most.......................................................................................................................
Gentamicin, massimu ta ’..............................................................................................................
16.5 µg Solvent:
16. 5 µg Solvent:
1 ml 1: cell culture 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% Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
- against calicivirus infection to reduce clinical signs and excretion,
- kontra l- infezzjoni tal- calicivirus biex tnaqqas sinjali kliniċi u eskrezzjoni,
- against feline panleucopenia to prevent mortality and clinical signs.
- kontra l- panlewkopenja fil- qtates biex tipprevjeni l- mortalità u sinjali kliniċi
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall- komponenti tar- rinotrakeite, kaliċivirus u panlewkopenja.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis and calicivirus, and 3 years for panleucopenia component.
4. 3 Kontra indikazzjonijiet
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 anoreksja li jgħaddu, u ukoll żieda fit - temperatura tal- ġisem (li ddum normalment għal ġurnata jew tnejn).
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li jiġi rikostitwit il- lajofiliżejt mas- solvent, skond din l - iskema ta ’ vaċċinazzjoni li ġejja:
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 ’ vaċċinazzjoni għandu jiġi mgħoti iżjed tard fl- età ta ’ 12 - il ġimgħa.
- for all components one year after primo-vaccination,
- għall- komponenti kollha sena wara l- ewwel kors ta ’ vaċċinazzjoni
- then every year for the rhinotracheitis and calicivirosis components, and every three years
- imbagħad kull sena għall- komponenti tar- rinotrakeite u kaliċivirosi u kull tliet snin
for the panleucopenia component.
għall- komponent tal- panlewkopenja
No effects 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 ‘ ġa imsemmija f’ sezzjoni “ Effetti mhux mixtieqa ”. ma ġew osservati, ħlief żieda fit- temperatura tal- ġisem li tista ’ f’ każi eċċezzjonali ddum għal 5 ijiem.
QI06AH09
Q106AH09
Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia.
Vaċċin kontra r- rinotrakeite virali fil- qtates, kaliċivirosi fil- qtates,, u panlewkopenja fil- qtates.
Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, and feline panleucopenia virus.
Tistimola immunità attiva kontra l- herpesvajrus tar- rinotrakeite fil- qtates, kaliċivirus fil- qtates, u l - vajrus tal- panlewkopenja fil- qtates.
Do not mix with any other vaccine or immunological product, except those mentioned in section “ Interactions”.
Tħallatx ma tilqim jew prodotti immunoloġiċi oħra ħlief dawk imsemmija fis- sezzjoni “ Effetti fuq prodotti mediċinali oħra ”.
Use immediately after reconstitution
18- il xahar Uża immedjatament wara li l- prodott jiġi rikostitwit.
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
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.
FPV (PLI IV)..................................................................................................................... ≥ 103.5 CCID50 Gentamicin, at most.......................................................................................................................
FPV (PLI IV).................................................................................................................. ≥ 103. 5 CCID501 Gentamiċin, massimu ta ’...............................................................................................................
EU/ 2/ 04/ 052/ 001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/ 2/ 04/ 052/ 002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/ 2/ 04/ 052/ 001 Lajofiliżejt (10 fliexken ta ’ doża) + solvent (10 fliexken ta ’ doża) EU/ 2/ 04/ 052/ 002 Lajofiliżejt (50 flixkun ta ’ doża) + solvent (50 flixkun ta ’ doża)
Purevax RCP lyophilisate for injection
Purevax RCP lajofiliżejt għall- injezzjoni.
Purevax RCP solvent
Purevax RCP solvent
Purevax RCP lyophilisate and solvent for suspension for injection.
Purevax RCP Lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
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
Purevax RCP lyophilisate and solvent for suspension for injection.
Purevax RCP lajofiliżejt u solvent għal suspensjoni għall- injezzjoni.
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.
Gentamicin, at most.......................................................................................................................
Gentamiċin, massimu ta ’..............................................................................................................
1 ml 1: cell culture infective dose 50%
Ilma għal injezzjoni q. s. ml 1: doża infettiva tas- cell culture 50%
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall - komponenti tar- rinotrakeite, kaliċivirus u panlewkopenja.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis and calicivirus, and 3 years for panleucopenia component.
L- immunità tibqa sa ’ sena wara l- aħħar ripetizzjoni tal - vaċċinazzjoni għall- komponenti tar - rinotrakeite u kaliċivirus, u 3 snin għall- komponent tal- panlewkopenja.
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Injetta taħt il- ġilda doża ta ’ ml ta ’ vaċċin wara li tiġi rikostitwita l- pritkuna mnixxfa bil- friża mas - solvent, skond din l- iskema ta ’ vaċċinazzjoni li ġejja:
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 ’ vaċċinazzjoni għandu jiġi mgħoti iżjed tard fl- età ta ’ 12- il ġimgħa.
- then every year for the rhinotracheitis and calicivirosis components, and every three years
- imbagħad kull sena għall- komponenti tar- rinotrakeite u kaliċivirosis u kull tliet snin
for the panleucopenia component.
għall- komponent tal- panlewkopenja.
SPECIAL STORAGE PRECAUTIONS
16/ 17 11 PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
Excipient:
Ingredjent mhux attiv:
Gentamicin, at most..................................................................................................................... .16.5 µg Solvent:
16. 5 µg Solvent:
1 ml 1: cell culture infective dose 50% For a full list of excipients, see section 6.1.
Ilma għall- injezzjonijiet................................................................................................................. q. s. ml 1: doża infettiva tas- cell culture 50% Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1.
- against calicivirus infection to reduce clinical signs and excretion.
- kontra l- infezzjoni tal- kaliċivirus biex tnaqqas sinjali kliniċi u eskrezzjoni
Onsets of immunity have been demonstrated 1week after primary vaccination course for rhinotracheitis and calicivirus components.
Ġie muri li l- bidu ta ’ l- immunità jseħħ ġimgħa wara l- ewwel kors ta ’ vaċċinazzjoni għall - komponenti tar- rinotrakeite u kaliċivirus.
The duration of immunity is 1 year after the last (re-)vaccination.
L- immunità tibqa sa ’ sena wara l- aħħar tilqima.
2/ 17 Special precautions to be taken by the person administering the veterinary medicinal product to animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
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- lajofiliżejt mas- solvent, skond din l- iskema ta ’ tilqim li ġejja:
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 ‘ ġa msemmija f’ sezzjoni “ Effetti mhux mixtieqa ”. ma ġew osservati, ħlief żieda fit- temperatura tal- ġisem li tista ’ f’ każi eċċezzjonali ddum għal 5 ijiem.
ATCvet code:
ATĊ kodiċi veterinarja:
QI06AH08
Q106AH08
Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
Vaċċin kontra r- rinotrakeite virali fil- qtates, u kaliċivirosi fil- qtates, Tistimola immunità attiva kontra l- herpesvajrus tar- rinotrakeite fil- qtates u kaliċivirus fil- qtates.
Do not mix with any other vaccine or immunological product, except those mentioned in section “ Interactions”.
Tħallatx ma xi vaċċin jew prodott immunoloġiku ieħor, ħlief dawk ‘ ġa msemmija fis- sezzjoni “ Effetti fuq prodotti mediċinali oħra ”.