qanastek/EMEA-V3 huggingface dataset:
Use immediately after reconstitution.
Uża immedjatament wara r- rikostituzzjoni.
Do not mix with any other vaccine or immunological product, except those mentioned below.
Tħallatx ma xi prodott immunoloġiku ieħor ħlief dawk imsemmija hawn taħt.
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.
No effect other than those already mentioned in section “ Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
L- ebda effett ħlief dawk diġà msemmija fit- taqsima “ Effetti mhux mixtieqa” ma ġew osservati wara li ngħataw bosta dożi, ħlief żieda fit- temperatura tal- ġisem li tista ’, f’ każi eċċezzjonali, iddum għal 5 ijiem.
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.
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- daqs tal- pakketti kollha jistgħu qegħdin fis- suq.
What is Purevax RCP?
X’ inhu Purevax RCP?
Purevax RCP 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).
Purevax RCP huwa vaċċin li fiha dawn is- sustanzi attivi: • rhinotracheitis herpesvirus felin (razza FHV F2) imdgħajjef, • antiġeni tal- calicivirosis (razez FCV 431 u G1) inattivati (maqtula), • virus tal- panleucopenia feline imdgħajjef (PLI IV).
Purevax RCP is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RCP huwa lyophilisate (solidu imnixxef) u solvent li jinħall f’ sospensjoni għall - injezzjoni.
What is Purevax RCP used for?
Għalxiex jintuża Purevax PRC?
Purevax RCP 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).
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 ikkawżat mill- calicivirus), • panleukopenija feline (marda serja li tikkawża dijarrea bid- demm li hija dovuta għal parvorajrus).
It can also prevent death due to panleucopenia.
Tista ’ tgħin ukoll biex jipprevjeni l- mewt mill - panleucopenia.
After Purevax RCP has been made up, 1 ml is injected under the skin.
Wara li Purevax PRC 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- anqas 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 jkunu intirtu 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 and calicivirosis, and every three years for panleucopenia.
Il- qattus għandu jitlaqqam mill- ġdid għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim, u mbagħad kull sena għar- rhinotracheitis u l- calicivirosis, u kull tliet snin għall- panleucopenia.
(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 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 RCP is a vaccine.
Purevax PRC huwa vaċċin.
Purevax RCP contains small amounts of weakened or killed viruses that cause the diseases listed above.
Purevax PRC fih ammonti żgħar ta ’ vajrusis imdgħajjfa 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 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 jerġgħu jiġu esposti għall- vajrusis.
How has Purevax RCP been studied?
Kif ġie studjat Purevax RCP?
The effectiveness of Purevax RCP has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or parvovirus.
L- effettività ta ’ Purevax PRC ġiet studjata f’ diversi studji fil- kundizzjonijiet tal- laboratorji fejn il- qtates tlaqqmu u ġew infettati bil- herpesvirus, parvovirus jew calcivirus virulenti.
In the field, the studies of Purevax RCP 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- anqas injezzjoni waħda).
The studies 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 RCP shown during the studies?
Liema benefiċċji ta ’ Purevax PRC intwerew f’ dan l- istudju?
In laboratory conditions Purevax RCP 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, calicivirus infection, and feline panleucopenia viruses.
Fl- istudju dwar it- tilqima bażika kien hemm żieda fl- antikorpi kontra l- infezzjonijiet mill- vajrusis felini tal- herpesvirus, tar- rinotrakeite u 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 mill- vajrusis felini tal- herpesvirus, tar- rinotrakeite u tal- calicivirus u tal - panleucopenia felina baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RCP?
X’ inhuma r- riskji assoċjati ma ’ Purevax PRC?
For a full list of the side-effects reported with Purevax RCP, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax PRC, ara l- Fuljett ta ’ Tagħrif.
Purevax RCP should not be used in pregnant cats.
Purevax PRC m’ għandux jintuża fi qtates tqal.
Why has Purevax RCP been approved?
Għaliex ġie approvat Purevax PRC?
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Purevax RCP lil MERIAL fit- 23 ta ’ Frar 2005.
EU Number
Isem
Strength
Speċi li fuqhom
Pharmaceutical Target
Mod ta ’
Route of
Kontenut
Content
Perjodu ta ’
Package
Numru ta ’ l- UE
Withdrawal
kummerċjali
Form
Farmaċewti ka
species administration
għandu jintuża l- prodott
(concentration)
Amministrazzjoni
size
Ippakkjar
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
Herpesvajrus attenwat tar - Lajofiliżejt u rinotrakeite fil- qtates (FHV solvent għal strejn F2): mill- inqas 4. 9 log suspensjoni 10 CCID50 għal kull doża. għall - Antiġeni inattivati tal - injezzjoni.
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
10 fliexken u ml ta ’ doża (lajofiliżejt) u 10 fliexken
Not Applicable
ta ’ ml (solvent)
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
50 flixkun ta ’ doża ta’ lajofiliżejt Mhux applikabbli doża u ml ta’ solvent (lajofiliżejt) u 50 flixkun ta ’ ml (solvent)
1 dose of lyophilisate and 1ml of solvent
Kaliċivirosi fil- qtates (strejn FCV 431 u FCV G1) mill - inqas 2. 0 ELISA U għal kull doża Vajrus attenwat tal - panlewkopenja fil- qtates (PLI IV) mill- inqas 3. 5 log 10 CCID50 għal kull doża
What is Purevax RCPCh?
X’ inhu Purevax RCPCh?
Purevax RCPCh 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), • attenuated feline panleucopenia virus (PLI IV). • Purevax RCPCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RCPCh huwa tilqima li fiha dawn is- sustanzi attivi: • herpesvirus imdgħajjef tar- rinotrakeite (rhinotracheitis) tal- felini (FHV razza F2), • antiġeni inattivati (maqtula) tal- kaliċivirosi (FCV razez 431 u G1), • Chlamydophila felis (razza 905) imdgħajjef, • vajrus imdgħajjef tal- panlewkopenja (panleucopenia) tal- felini (PLI IV),
What is Purevax RCPCh used for?
Għalxiex jintuża Purevax RCPCh?
Purevax RCPCh 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), • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus).
Purevax RCPCh jintuża fit- tilqim ta ’ qtates mill- età ta ’ 8 ġimgħat u aktar kontra dawn il - mardiet: • rinotrakeite virali felina (marda tixbah lill- influwenza kkawżata mill- herpesvirus), • kaliċivirosi felin (marda tixbah lill- influwenza bl- infjammazzjoni tal- ħalq ikkawżata minn kaliċivajrus, • klamidjosi (chlamydiosis) (marda tixbah lill- influwenza kkawżata mill- batterju C. felis), • panlewkopenja felina (marda serja li tikkawża dijarrea bid- demm ikkawżata minn parvovajrus.
The vaccine helps to reduce the symptoms of the diseases.
It- tilqima tgħin fit- tnaqqis tas- sintomi tal- mardiet.
It also helps to reduce viral excretion in case of calicivirus infection.
Tgħin ukoll fit- tnaqqis ta ’ l- eskrezzjoni virali fil- każ ta ’ infezzjoni bil- kaliċivajrus.
It can also prevent death due to panleucopenia.
Tista ’ tgħin ukoll biex tipprevjeni mewta dovuta għal panlewkopenja.
After Purevax RCPCh has been made up, 1 ml is injected under the skin.
Wara li Purevax RCPCh 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 chlamydiosis, and every three years for panleucopenia.
Il- qattus għandu jitlaqqam mill- ġdid għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim, u mbagħad kull sena għar- rinotrakeite, kaliċivirosi u klamidjosi u kull tliet snin għall - panlewkopenja.
(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 RCPCh 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 RCPCh?
Purevax RCPCh is a vaccine.
Purevax RCPCh huwa vaċċin.
Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.
Purevax RCPCh fih ammonti żgħar ta ’ vajrusijiet imdgħajfa jew maqtula li jikkawżaw il- mardiet elenkati 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 qattus jingħata tilqima, is- sistema immunitarja tagħraf il- vajrusijiet imdgħajfa jew maqtula u l- batterji mdgħajfa bħala ‘ barranin ’ u jagħmel antikorpi kontrihom.
The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Fil- ġejjieni, is - sistema immunitarja tkun kapaċi tipproduċi l- antikorpi iktar malajr meta jerġa ’ jkun espost għall- vajrusijiet jew batterji.
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- vajrusijiet iktar tard fil - ħajja, il- qattus jew ma jiġix infettat jew ikollu infezzjoni ħafna inqas serja.
How has Purevax RCPCh been studied?
Kif ġie studjat Purevax RCPCh?
The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus, C. felis or parvovirus.
Felis jew parvovajrus virulenti.
In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
L- istudji fuq il- post ta ’ Purevax RCPCh ħarsu lejn l- iskeda bażika tat- tilqim (żewġ injezzjonijiet b’ bejn tlieta u erba ’ ġimgħat bejniethom) u t- tilqima booster (injezzjoni waħda biss).
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- effikaċja kien il- livell ta ’ antikorpi fid- demm kontra l- vajrusijiet u l- batterji fit - tilqima.
What benefit has Purevax RCPCh shown during the studies?
Liema benefiċċji ta ’ Purevax RCPCh intwerew f’ dan l- istudju?
In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
F’ kundizzjonijiet tal- laboratorju, intwera li Purevax RCPCh 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 dwar it- tilqima bażika kien hemm żieda fl- antikorpi kontra l- infezzjonijiet mill- herpesvirus rinotrakeite felina, mill- infezzjoni bil- kaliċivajrus u tal- panlewkopenja felina.
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 tiġi osservata 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, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Fl- istudju li analizza t - tilqima booster, il- livelli ta ’ l- antikorpi kontra l- infezzjonijiet mill- herpesvirus rinotrakeite, tal- kaliċivajrus u tal- panlewkopenja felina u C. felis baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RCPCh?
X’ inhuma r- riskji assoċjati ma ’ Purevax RCPCh?
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 temporanja (nuqqas ta ’ interess fl- ambjent ta ’ madwarhom) u anoressija (nuqqas ta ’ aptit), kif ukoll ipertermja (temperatura għolja tal - ġisem) li ddum jum jew tnejn.
For a full list of the side-effects reported with Purevax RCPCh, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax RCPCh, ara l- Fuljett ta ’ Tagħrif.
Purevax RCPCh should not be used in pregnant cats.
Purevax RCPCh 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 min jiġi f’ kuntatt ma ’ l- annimal?
The vaccine should not be handled by people with a weak immune system.
It- tilqima ma għandhiex tintmiss minn persuni li għandhom 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 xi persuna minn dawn imsemmija hawn fuq tinjetta lilha nfisha, din għandha tgħid lit- tabib li l- persuna ġiet injettata b’ tilqima li kien fiha kompenent ħaj ta ’ chlamydial..
Why has Purevax RCPCh been approved?
Għaliex ġie approvat Purevax RCPCh?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCPCh be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Purevax RCPCh jisbqu r- riskji għat- tilqim attiv ta ’ qtates li jkollhom iktar minn tmien ġimgħat kontra l- mardiet elenkati hawn fuq, u rrakkomanda li Purevax RCPCh jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Purevax RCPCh:
Informazzjoni oħra dwar Purevax RCPCh:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Purevax RCPCh lil MERIAL fit- 23 ta ’ Frar 2005
Invented
Qawwa
Pharmaceutical Target Route of
Speċi li Mod ta ’
Package
Daqs tal - Perjodu ta ’
species administration
Farmaċewt fuqhom Amministrazzjoni ika għandu jintuża l - prodott
(concentration)
pakkett Tiżmim Mhux
EU/ 2/ 04/ 050/ 001
doża EU/ 2/ 04/ 050/ 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 Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose Attenuated feline panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose
Taħt il- ġilda
Lyophilisate and solvent for suspension for injection
flixkun tal - ħġieġ ta ’ Tip
Cats
10 fliexken ta’ lajofiliż applikabbli
Subcutaneous use
RCPCh
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
qtates (FHV strejn F2): mill- inqas 4. 9 log u solvent 10 CCID50 għal kull doża.
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
I magħluq b’ tapp tal - butyl elastomer u ssiġillat b’ tapp ta ’ l - aluminju
1 dose of Not lyophilisa applicable te and 1ml of solvent
ta ’ doża ejt u ml (lajofiliżejt) ta’ solvent u 10 fliexken ta ’ ml (solvent)
EU/ 2/ 04/ 050/ 002
Mhux doża 50 flixkun EU/ 2/ 04/ 050/ 002
Subcutaneous use
(lajofiliżejt)
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
inattivati tal- Kaliċivirosi fil- qtates (strejn
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
(solvent)
1 dose of Not lyophilisa applicable te and 1ml of solvent
ssiġillat b’ tapp ta ’ l - aluminju
What is Purevax RCPCh FeLV?
X’ inhu Purevax RCPCh FeLV?
Purevax RCPCh 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 Chlamydophila felis (905 strain), • attenuated feline panleucopenia virus (PLI IV), • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Purevax RCPCh FeLV huwa tilqima li fiha dawn is- sustanzi attivi: • Herpesvirus imdgħajjef tar- rinotrakeite tal- felini (FHV razza F2), • antiġeni inattivati (maqtula) tal- kaliċivirosi (FCV razez 431 u G1), • Chlamydophila felis (razza 905) imdgħajjef, • vajrus imdgħajjef tal- panlewkopenja tal- felini (PLI IV), • vajrus tal- lewkemja tal- felini (FeLV) vajrus rekombinanti tal- canarypox (vCP97).
Purevax RCPCh FeLV is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Purevax RCPCh FeLV huwa lijofilizzat (lyophilisate) (solidu imnixxef) u solvent li jinħall f’ sospensjoni għall- injezzjoni.
What is Purevax RCPCh FeLV used for?
Għalxiex jintuża Purevax RCPCh FeLV?
Purevax RCPCh 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), • chlamydiosis (a flu-like illness caused by the bacterium C. felis), • 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 RCPCh FeLV jintuża fit- tilqim ta ’ qtates mill- età ta ’ 8 ġimgħat u aktar kontra dawn il- mardiet: • rinotrakeite virali felina (marda tixbah lill- influwenza kkawżata mill- herpesvirus), • kaliċivirosi felin (marda tixbah lill- influwenza bl- infjammazzjoni tal- ħalq ikkawżata mill- kaliċivajrus), • klamidjożi (marda tixbah lill- influwenza kkawżata mill- batterju C. felis), • panlewkopenja felina (marda serja li tikkawża dijarrea bid- demm ikkawżata minn parvovajrus), • lewkemja felina (marda li taffettwa lis- sistema immunitarja kkawżata minn retrovajrus).
It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Tista ’ tgħin ukoll biex tipprevjeni mewta dovuta għal panlewkopenja u timpedixxi milli FeLV jibqa ’ fid- demm.
After Purevax RCPCh FeLV has been made up, 1 ml is injected under the skin.
Wara li Purevax RCPCh FeLV jinħall, 1 ml minnu jiġi injettat taħt il- ġilda.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- qattus għandu jitlaqqam mill- ġdid għall- komponenti kollha sena wara l- ewwel kors 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 RCPCh 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 ta ’ tilqim, u mbagħad kull sena għar- rinotrakeite, kaliċivirosi, klamidiosi u lewkemja felina u kull tliet snin għall- panlewkopenja.
Purevax RCPCh FeLV is a vaccine.
Purevax RCPCh FeLV huwa vaċċin.
Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria 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 RCPCh FeLV fih ammonti żgħar ta ’ vajrusijiet 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, the FeLV proteins, and the weakened bacteria as ‘ foreign’ and makes antibodies against them.
Meta qattus jingħata tilqima, is- sistema immunitarja tagħraf il - vajrusijiet imdgħajfa jew maqtula, il- proteini ta ’ FeLV, u l- batterji mdgħajfa bħala ‘ barranin ’ u jagħmel antikorpi kontrihom.
The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Fil- ġejjieni, is- sistema immunitarja tkun kapaċi tipproduċi l - antikorpi iktar malajr meta jerġgħu jiġu esposti għall- vajrusijiet jew batterji.
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- vajrusijiet iktar tard fil- ħajja, il- qattus jew ma jiġix infettat jew ikollu infezzjoni ħafna inqas serja.
How has Purevax RCPCh FeLV been studied?
Kif ġie studjat Purevax RCPCh FeLV?
The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus.
L- effikaċja ta ’ Purevax RCPCh FeLV ġiet studjata f’ diversi provi fil- kundizzjonijiet tal - laboratorji fejn il- qtates tlaqqmu u ġew infettati bil- herpesvirus, kaliċivirus, C. felis, parvovajrus jew lewkemja virulenti.
In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and the booster vaccination (only one injection).
Fuq il- post, l- istudji ta ’ Purevax RCPCh FeLV ħarsu lejn l- iskeda bażika tat- tilqim (żewġ injezzjonijiet b’ bejn tlieta u erba ’ ġimgħat bejniehom) u t - tilqima booster (injezzjoni waħda biss).
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria 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- effikaċja kien il- livell ta ’ antikorpi fid- demm kontra l- vajrusijiet u l- batterji fit- tilqima, bl- eċċezzjoni tal- komponent ta ’ FeLV, li l- effikaċja tiegħu fil- prevenzjoni ta ’ infezzjoni diġà ntweriet fi studji oħra.
What benefit has Purevax RCPCh FeLV shown during the studies?
Liema benefiċċji ta ’ Purevax RCPCh FeLV intwerew f’ dan l- istudju?
In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
F’ kundizzjonijiet tal- laboratorju, intwera li Purevax RCPCh 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 dwar it- tilqima bażika kien hemm żieda fl - antikorpi kontra l- infezzjonijiet mill- herpesvirus rinotrakeite tal- felini, tal- kaliċivajrus u tal - panlewkopenija felina.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Fl- istudju li analizza t - tilqima booster, il- livelli ta ’ l- antikorpi kontra l- infezzjonijiet mill- herpesvirsus rinotrakeite tal- felini, tal- kaliċivajrus u tal- panlewkopenja felina u C. felis baqgħu stabbli jew żdiedu bi ftit.
What is the risk associated with Purevax RCPCh FeLV?
X’ inhuma r- riskji assoċjati ma ’ Purevax RCPCh FeLV?
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 temporanja (nuqqas ta ’ interess fl- ambjent ta ’ madwarhom) u anoressija (nuqqas ta ’ apatit), kif ukoll ipertermja (temperatura għolja tal - ġisem) li ddum jum jew tnejn.
For a full list of the side-effects reported with Purevax RCPCh FeLV, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati ma ’ Purevax RCPCh FeLV, ara l- Fuljett ta ’ Tagħrif.
Purevax RCPCh FeLV should not be used in pregnant cats.
Purevax RCPCh FeLV m’ għandux jintuża fi qtates tqal.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
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 RCPCh FeLV been approved?
It- tilqima ma għandhiex tintmiss minn persuni
The Committee for Medicinal Products
li għandhom sistema immunitarja dgħajfa.
for Veterinary Use (CVMP) concluded that the
Għaliex ġie approvat Purevax RCPCh FeLV?
benefits of Purevax RCPCh FeLV exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCPCh FeLV be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Purevax RCPCh 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 RCPCh FeLV jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Purevax RCPCh FeLV:
Informazzjoni oħra dwar Purevax RCPCh FeLV:
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV to MERIAL on 23 February 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Purevax RCPCh FeLV lil MERIAL fit- 23 ta ’ Frar 2005
EU
Isem
harmaceutical
Speċi li Mod ta ’
Target
Ippakkjar
Packaging
Daqs tal -
Package
kummerċjali
Withdrawal
pakkett
Number
Tiżmim
Name
EU/ 2/ 04/ 047/ 001
Form
Purevax
species
Lajofiliżejt u
administration
Qtates
size
flixkun tal -
Period
doża
EU/ 2/ 04/ 047/ 001
Mhux
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 doses Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 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
Antiġeni inattivati tal - suspensjoni
Lyophilisate and solvent for suspension for injection
10 fliexken ta’ lajofiliżejt applikabbli u ml ta ’ doża
Cats
G1) mill- inqas 2. 0 ELISA U għal kull doża
Subcutaneous use
b’ tapp tal - butyl
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
(lajofiliżejt) ta’ solvent u 10
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
Chlamydophila felis attenwat fil- qtates (strejn 905): mill- inqas 3. 0 log 10 EID50 għal kull doża Virus attenwat tal- panlewkopenja fil- qtates (PLI IV):) mill- inqas 3. 5 log 10 CCID50 għal kull doża.
1 dose of lyophilisate and 1ml of solvent
elastomer u ssiġillat b’ tapp ta ’ l - aluminju
Not applicable
fliexken ta ’ ml (solvent)
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 doses Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 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
Antiġeni inattivati tal - suspensjoni Kaliċivirosi fil- qtates (strejn FCV 431 u FCV għall- injezzjoni.
Lyophilisate and solvent for suspension for injection
G1) mill- inqas 2. 0 ELISA U għal kull doża
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
50 flixkun doża Mhux ta ’ doża ta’ lajofiliżejt applikabbli (lajofiliżejt) u ml u 50 flixkun ta’ solvent ta ’ ml
1 dose of lyophilisate and 1ml of solvent
Virus rikombinant tal- canarypox FeLV (vCP97): mill- inqas 7. 2 log 10 CCID 50 għal kull doża
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 CCID 50 1 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 EID 50 2 Virus attenwat tal- panlewkopenja fil- qtates (PLI IV)..................................................... ≥ 103. 5 CCID 50 1 Ingredjent mhux attiv:
Gentamicin, at most........................................................................................................................ .34 µg Solvent:
Gentamiċin, l- iżjed...........................................................................................................................
FeLV recombinant canarypox virus (vCP97)................................................................ ≥ 107.2 CCID501 1: cell culture infective dose 50% 2: egg infective dose 50% For a full list of excipients, see section 6.1.
34 µg Solvent: virus rikombinant tal- canarypox FeLV (vCP97)........................................................... ≥ 107. 2 CCID 50 1 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.
- against feline viral rhinotracheitis to reduce clinical signs,
- kontra r- rhinotrakeite 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 ekskreta,
- against Chlamydophila felis infection to reduce clinical signs,
- kontra l- infezzjoni tal- Chlamydophila felis biex tnaqqas sinjali kliniċi
- against feline panleucopenia to prevent mortality and clinical signs,
- kontra l- panlewkopenja fil- qtates biex tipprevjeni mortalità u sinjali kliniċi
- against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
- kontra l- lewċemija biex tipprevjeni viraemia persistenti u sinjali kliniċi tal- marda.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Ġie muri li l- bidu ta ’ l- immunità jibda ġimgħa wara l- ewwel kors ta ’ tilqim għall- komponenti tar - rinotrakeite, kaliċivirus, Chlamydophila felis u panlewkopenja, u ġimgħatejn wara l- ewwel kors ta ’ tilqim għall- komponent tal- lewkemija fil- qtates.
The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus, Chlamydophila felis and feline leukaemia components, and 3 years for panleucopenia component.
4. 3 Kontra indikazzjonijiet
4.4 Special warnings
2/ 18 4. 4 Twissijiet speċjali
2/ 18 4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu Prekawzjonijiet speċjali għall- użu fl- annimali
Special precautions for use in animals
Uża biss f’ annimali f’ saħħithom.
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Huwa rakkomandat li jsir test għal FeLV antigenaemia qabel it- tilqim.
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 tabib mal- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun ġewwa l- pakkett jew it- tikketta.
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1or 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).
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.
The reaction was transient.
Din ir- reazzjoni kienet transitorja.
The use is not recommended during lactation
L- użu tiegħu mhux rakkomandat fi żmien il- ħalib.
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- sigurta ’ u l- effiċjenza li turi li dan il- vaċċin jista jiġi 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 li ġejja:
Primary vaccination course:
L- ewwel kors ta ’ tilqima:
Revaccination:
3/ 18 Tilqim mill- ġdid:
- for all components one year after the primary vaccination course,
- għall- komponenti kollha sena wara l- ewwel kors ta ’ tilqim,
- then every year for the rhinotracheitis, calicivirosis, chlamydiosis and feline leukaemia
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, kaliċivirosi, klamidjosi u.
components, and every three years for the panleucopenia component.
lewkemja fil- qtates, u kull tliet snin għall- komponent tal- panlewkopenja
3/ 18 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 “ Effetti mhux mixtieqa ”. ma ġew osservati, ħlief żieda fit- temperatura tal- ġisem li tista ’ f’ każi eċċezzjonali ddum għal 5 ijiem.
ATC Vet code:
Kodici ATĊ veterinarja:
Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis, feline panleucopenia and feline leukaemia.
Vaċċin kontra l- rhinotrakeite virali fil- qtates, kaliċivirosi fil- qtates, klamidjosi, panlewkopenja fil - qtates u lewkemja fil- qtates.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis, feline panleucopenia virus and feline leukaemia virus.
Tistimola immunità attiva kontra l- virus tal- ħerpes tar- rhinotrakeite fil- qtates, kaliċivirus fil- qtates, Chlamydophila felis, il- virus tal- panlewkopenja fil- qtates u l- virus 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 virus 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.
After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Wara t- tilqim, il - virus 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- virus tal - lewkemja fil- qtates.
6.1 List of excipients
Lista ta ’ ingredjenti 6. 1
Sucrose Sorbitol Dextran 40 Casein hydrolysate Collagen hydrolysate Salts
Sukrozju Sorbitol Dextran 40 Casein hydrolysate Collagen hydrolysate Melħ
4/ 18 6.5 Nature and composition of immediate packaging
4/ 18 6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
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
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 diżinfettant approvat mill- Awtorita Kompetenti tal- pajjiż.
5/ 18 ANNEX II
5/ 18 ANNESS II
Name and address of the manufacturers of the biological active substance(s)
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
7/ 18 ANNEX III
7/ 18 ANNESS III
9/ 18 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
FHV (F2 strain)................................................................................................................ ≥ 104.9 CCID50 FCV (431 and G1 strains).............................................................................................. ≥ 2.0 ELISA U.
FHV (strejn F2).............................................................................................................. ≥ 104. 9 CCID 50 1 FCV (strejn 431 u G1)..................................................................................................... ≥ 2. 0 ELISA U.
11/ 18 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 FeLV lyophilisate for injection
Purevax RCPCh FeLV lajofiliżejt għall- injezzjoni.
12/ 18 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 FeLV solvent
Purevax RCPCh FeLV solvent
14/ 18 PACKAGE LEAFLET
14/ 18 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
Purevax RCPCh FeLV Lyophilisate and solvent for suspension for injection.
Purevax RCPCh FeLV 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- rhinotrakeite fil- qtates (FHV strejn F2)......................... ≥ 104. 9 CCID 50 1 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 EID 50 2 Virus attenwat tal- panlewkopenja fil- qtates (PLI IV)................................................... ≥ 103. 5 CCID 50 1 Ingredjent mhux attiv:
FeLV recombinant canarypox virus (vCP97)................................................................ ≥ 107.2 CCID501 1: cell culture infective dose 50% 2: egg infective dose 50%
34 µg Solvent: virus rikombinant tal- canarypox FeLV (vCP97)........................................................... ≥ 107. 2 CCID 50 1 1: doża infettiva tas- cell culture 50% 2: doża infettiva tal- bajda 50%
- against calicivirus infection to reduce clinical signs and excretion,
- kontra l- infezzjoni tal- kaliċivirus biex tnaqqas sinjali kliniċi u eskreta,
- against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
- kontra l- lewkemja biex tipprevjeni viraemia persistenti u sinjali kliniċi tal- marda.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
15/ 18 Ġie muri li l- bidu ta ’ l- immunità jibda ġimgħa wara l- ewwel kors ta ’ tilqim għall- komponenti tar - rinotrakeite, kaliċivirus, Chlamydophila felis, u panlewkopenja, u ġimgħatejn wara l- ewwel kors ta ’ tilqim għall- komponent tal- lewkemija fil- qtates.
15/ 18 The duration of immunity is 1 year after the last (re-)vaccination for rhinotracheitis, calicivirus, Chlamydophila felis and feline leukaemia components, and 3 years for panleucopenia component
L- immunità tibqa sa ’ sena wara l- aħħar tilqima għall- komponenti tar- rhinotrakeite, kaliċivirus, Chlamydophila felis 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 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 li ġejja:
In the presence of high levels of maternally derived 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 ’ tilqim,
- then every year for the rhinotracheitis, calicivirosis, chlamydiosis and feline leukaemia
- imbagħad kull sena għall- komponenti tar- rhinotrakeite, kaliċivirosi, klamidjosi u
components, and every three years for the panleucopenia component.
lewkemja fil- qtates, u kull tliet snin għall- komponent tal- panlewkopenja.
Do not mix with any other vaccine or immunological product.
Tħallatx ma xi vaċċin jew prodott immunoloġiku ieħor.
It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Huwa rakkomandat li jsir test għal FeLV antiġenemija qabel it- tilqim.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
F' każ li tinjetta lilek innifsek bi żball, fittex tabib mal- ewwel u qis li turih il- fuljett ta 'informazzjoni li jkun ġewwa l- pakkett jew it- tikketta.
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 klamidja ħajja.