qanastek/EMEA-V3 huggingface dataset:
In accordance with Council Regulation (EEC) No 2377/ 90, as amended and in accordance with Article 34.4b of Regulation (EC) No 726/ 2004 of 31 March 2004.
Skond ir- Regoalment tal- Kunsill (KE) Nru 2377/ 90, kif emendat u skond l- Artikolu 34. 4b tar - Regolament (KE) Nru 726/ 2004 tal- 31 ta ’ Marzu 2004. >
Firocoxib is included in Annex III of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Firocoxib huwa inkluż fl- Anness III tar- Regolament tal- Kunsill (KE) Nru 2377/ 90 skond it- tabella li jmiss:
Pharmacologically active substance(s)
Sustanza( i)
Marker residue
Residwu li
Animal species
Speċje ta ’
Muscle Fat Liver Kidney
Xaham Fwied Kilwa
Provisional MRLs expire on 1.7.2007
provvisori jiskadu fl - 1. 7. 2007
8/ 17 ANNEX III
8/ 17 ANNESS III
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 17 TAGHRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton box labelling
Tikketta tal- kaxxa tal- kartun
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OHRA
1 syringe.
Siringa.
TARGET SPECIES
SPECI GHALXIEX JUWA INDIKAT IL- PRODOTT
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Ghat- taffija ta ’ l- uġigh u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite u għat- tnaqqis tat- tizpip assoċjat fiż- żwiemel.
26 days.
26 ġurnata.
Do not use in mares producing milk for human consumption.
Tużax f’ debba li tipproduċi l- ħalib għall- użu tal- bniedem.
EXP {month/ year} Once broached, use within 3 months.
EXP {xahar / sena} La darba jinfetaħ, uża fi żmien 3 xhur
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn kundizzjonijiet speċjali biex jinħażen.
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France.
MERIAL, 29 avenue Tony Garnier, FR- 69007 Lyon, France
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR ŻGĦIR IMMEDJAT
Syringe labelling
Tikkettar tas- siringa
EQUIOXX 8.2 mg/ g oral paste for horses
EQUIOXX 8. 2 mg/ g pejst għall- ħalq għaż- żwiemel
Firocoxib 8.2 mg/ g
KWANTITA ’ TAS- SUSTANZA ATTIVA/ SUSTANZI ATTIVI
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BHALA PIZ, VOLUM JEW NUMRU TA ’ DOZI
7.32 g of oral paste
7. 32 g ta ’ pejst għall- ħalq.
Oral use.
Mill- ħalq
WITHDRAWAL PERIOD
ZMIEN TA ’ TIZMIM
Do not use in mares producing milk for human consumption.
Tużax f’ debbiet li jipproduċu l- ħalib għall- użu tal- bniedem.
EXP {month/ year} Once broached, use within 3 months.
EXP {xahar/ sena} Ladarba miftuħ, uża fi żmien 3 xhur.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM “ GHAL TRATTAMENT TAL’ ANNIMALI BISS ”
For animal treatment only.
Ghat- trattament tal- annimali biss.
EQUIOXX 8.2 mg/ g oral paste for horses
14/ 17 FULJETT TA ’ TAGĦRIF FIL- PAKKETT EQUIOXX 8. 2 mg/ g pejst tal- ħalq għaż- żwiemel
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ
MERIAL, 29 avenue Tony Garnier, 69007 Lyon, France.
MERIAL, 29 avenue Tony Garnier, FR- 69007 Lyon, France
MERIAL, 4 chemin du Calquet, FR-31300 Toulouse, France.
2.
EQUIOXX 8.2 mg/ g oral paste for horses.
EQUIOXX 8. 2 mg/ g pejst tal- ħalq għaż- żwiemel
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Biex ittaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite fiż- żwiemel u biex tnaqqas it- tizpip assoċjat fiż- żwiemel
CONTRAINDICATIONS
KONTRAINDIKAZZJONIJET
Typically, these lesions are mild and resolve without treatment, but oral lesions may be associated with salivation and labial and tongue oedema.
Tipikament, dawn il - leżjonijiet huma ħfief u jmorru mingħajr kura, izda l - leżjonijiet orali jistgħu jkunu assoċjati mal- formazzjoni tal- bżieq u edema tax - xufftejn u ta ’ l- ilsien.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days.
0. 1 mg firocoxib għal kull kg ta ’ piż tal- ġisem, darba kuljum sa 14- il ġurnata.
Withdrawal period:
Laħam u l- ġewwieni:
Do not use in mares producing milk for human consumption.
26 ġurnata Tużax f’ debba li tipproduċi l- ħalib għall- konsum tal- bniedem.
This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m’ għandux bżonn ta ’ kundizzjonijiet speċjali għal- ħażna.
Do not use after the expiry date stated on the label.
Tużax wara d- data tal- iskadenza fuq it- tikketta.
Shelf-life after first opening the syringe:
Żmien li l- prodott mediċinali veterinarju jibqa tajjeb wara li tiftah is- siringa:
3 months.
3 xhur
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Jekk ikun hemm xi effetti kollaterali, l- użu tal- prodott għandu jitwaqqaf u jittieħed il- parir ta ’ tabib veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity.
Evita l- użu f’ annimali deidrati, hypovolaemic jew hypotensive, peress li jista ’ jkun hemm riskju potenzjali ta ’ żieda ta ’ tossiċità fil- kliewi.
Pregnant women should avoid contact with the medicinal product.
Nisa fi stat ta ’ tqala għandhom jevitaw kuntatt mal- prodott mediċinali.
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects.
NSAIDs oħra, dijuretiċi u sustanzi li għandhom kapaċita ’ għolja li jeħlu mal- proteini jistgħu jikkompetu mal- prodott u jwasslu għall- effetti tossiċi.
Do not use concomitantly with corticosteroids or other NSAIDs.
Tuzax fl- istess ħin ma kortikosterojdi jew NSAIDs oħra.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed.
16/ 17 Kura minn qabel b’ sustanzi oħra ta ’ kontra l- infjammazzjoni tista iżżied l- effetti mhux mixtieqa jew toħloq oħrajn u għaldaqstant għandu jiġi osservat perijodu mingħajr kura b’ dawn il- prodotti.
16/ 17 Concomitant treatment with molecules displaying action on renal flow (e. g. diuretics) should be subject to clinical monitoring.
L- użu flimkien ma molekuli li jaġixxu fuq il- flussu tal- kliewi (bħal dijuretiċi) għandu jsir taħt monitoraġġ kliniku.
No data on use during pregnancy is available in horses.
M’ hemm l- ebda informazzjoni fiż- żwiemel.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lit- tabib veterinarju tiegħek kif tiddisponi minn mediċini li m’ għandekx bżonn iżjed.
These measures should help to protect the environment.
Dawn il - miżuri għandhom jgħinu biex jipproteġu l- ambjent.
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Il- Firocoxib hija mediċina anti- infjammatorja mhux sterojdi (NSAID) li tappartjeni għall- grupp Coxib, li taġixxi b’ inibizzjoni selettiva ta ’ cyclooxygenase- 2 (COX- 2) – sintesi medjata tal- prostaglandin.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L - għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) fuq il- bażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
This document cannot replace a face-to-face discussion with your veterinarian.
Dan id- dokument ma jistax jissostitwixxi diskussjoni ras imb’ ras mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk inti teħtieġ aktar informazzjoni dwar il - kondizzjoni medika jew dwar it- trattament ta ’ l- annimal tiegħek, jekk jogħġbok ikkuntattja lill - veterinarju tiegħek.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Eurican Herpes 205?
X’ inhu Eurican Herpes 205?
Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection.
Eurican Herpes 205 huwa trab u solvent li jsir emulsjoni għal injezzjoni.
Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 µg.
Eurican Herpes 205 fih is - sustanza attiva antiġen tal- virus tal- ħerpes tal- klieb (razza F205) f’ doża ta ’ 0. 3 sa 1. 75 µg.
What is Eurican Herpes 205 used for?
Għal x’ hiex jintuża Herpes 205?
Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.
Eurican Herpes 205 jintuża għall- immunizzazzjoni ta ’ klieb nisa għall- prevenzjoni ta ’ mortalità, sinjali kliniċi u feriti fi ġriewi kkawżati minn infezzjonijiet bil- virus tal- ħerpes tal- klieb akkwistat fl - ewwel ftit jiem ta ’ ħajja.
Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses.
Eurican Herpes 205 jingħata bħala żewġ dożi subkutanji (taħt il- ġilda) ta ’ 1 ml kull waħda.
The first injection is given either when the bitch is on heat or 7 – 10 days after the date of mating.
L- ewwel injezzjoni tingħata jew meta l- kelba tkun sħuna jew 7 – 10 ijiem wara d- data tat- tgħammir.
The second injection is given 1 to 2 weeks before the expected date of whelping.
It- tieni injezzjoni tingħata ġimgħa sa ġimagħtejn qabel id- data mistennija tat- twelid.
The bitch should be revaccinated in the same way during each pregnancy.
Il- kelba għandha titlaqqam mill- ġdid bl- istess mod matul kull tqala.
How does Eurican Herpes 205 work?
Kif jaħdem Eurican Herpes 205?
Eurican Herpes 205 contains small amounts of canine herpes virus antigens.
Eurican Herpes 205 fih ammonti żgħar ta ’ antiġens tal- virus tal- ħerpes tal- klieb.
When injected, this small exposure helps the dog’ s immune system to synthesize antibodies against the canine herpes virus and to neutralize it.
Meta injettat, din l - espożizzjoni żgħira tgħin lis- sistema immuni tal- kelb sabiex tissintezzizza antikorpi kontra l- virus tal - ħerpes tal- klieb u biex tinnewtralizzah.
Once vaccinated, bitches will, through colostrum, give those antibodies to puppies.
Ladarba mlaqqmin, il- klieb nisa jgħaddu dawn l- antikorpi lill - ġriewi permezz tal- ħalib tagħhom.
When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection.
Meta esposti għall- virus tal- ħerpes tal- klieb aktar tard f’ ħajjithom, il- ġriewi jew ma jiġux infettati jew ikollhom infezzjoni ferm inqas serja.
Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.
Eurican Herpes 205 huwa maħsub sabiex jipproteġi l- ġriewi kontra din l- infezzjoni matul l- ewwel jiem ta ’ ħajjithom.
How has the effectiveness of Eurican Herpes 205 been studied?
Kif ġiet studjata l- effikaċja ta ’ Eurican Herpes 205?
Eurican Herpes 205 has been studied in three laboratory studies and two field trials.
Eurican Herpes 205 ġie studjat fi tliet studji tal- laboratorju u f’ żewġ provi kliniċi.
In one field trial the serological response (antibody production) was measured.
Fi prova klinika, ġie mkejjel ir- rispons seroloġiku (produzzjoni ta ’ antikorpi).
In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel.
Fi studju ieħor, sar studju ta ’ l- effett tat - tilqim fuq l- abbiltà tal- klieb nisa li jwelldu f’ marqad tal- klieb infettat.
The first laboratory study tested the dose needed to provide protection.
L- ewwel studju tal - laboratorju ttestja d- doża meħtieġa sabiex tiġi pprovduta l- protezzjoni.
The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus.
It- tieni studju twettaq sabiex juri l- protezzjoni tal- ġriewi minn klieb nisa mlaqqmin mill- virus tal- ħerpes tal- klieb.
Here Eurican Herpes 205 was compared with no vaccination (controls).
Hawnhekk, Eurican Herpes 205 tqabbel mingħajr tilqim (kontrolli).
The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.
L- aħħar wieħed wera li l - induzzjoni ta ’ antikorpi hija ekwivalenti meta l- klieb nisa jitlaqqmu dakinhar li jkunu sħan jew 7- 10 ijiem wara d- data tat- tgħammir.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Eurican Herpes 205 shown during the studies?
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċju wera Eurican Herpes 205 waqt l- istudji?
Eurican Herpes 205 showed good protection from canine herpes virus.
Eurican Herpes 205 wera protezzjoni tajba kontra l- virus tal- ħerpes tal- klieb.
In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived..
Fl- istudju għall- wiri tal - protezzjoni tal- ġriewi (minn klieb nisa mlaqqmin) mill- virus tal- ħerpes tal- klieb, għexu aktar minn 80% tal- ġriewi mill- klieb nisa mlaqqmin.
What are the side effects of Eurican Herpes 205?
X’ inhuma l- effetti sekondarji ta ’ Eurican Herpes 205?
The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals.
L- injezzjoni ta ’ Eurican Herpes 205 tista ’ tikkawża edema temporanja (fluwidi taħt il- ġilda) fis- sit ta ’ l- injezzjoni f’ sa 10% ta ’ l- annimali.
This side effect usually disappears within one week.
Dan l- effett sekondarju normalment jisparixxi fi żmien ġimgħa.
Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.
F’ każijiet rari, jista ’ jkun hemm reazzjonijiet (allerġiċi) ta ’ sensittività eċċessiva li jistgħu jkunu jeħtieġu trattament.
Eurican Herpes 205 contains mineral oil.
Eurican Herpes 205 fih żejt minerali.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger.
Injezzjoni aċċidentali tista ’ tikkaġuna ugigħ gravi u nefħa, partikolarment jekk injettata f’ ġog jew f’ subgħa – f’ każijiet rari tista ’ tikkaġuna t- telf ta ’ subgħa.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Jekk xi ħadd jiġi aċċidentalment injettat b’ dan il- prodott, għandu jfittex immedjatament parir mediku anki jekk jiġi injettat biss ammont żgħir.
The Package Leaflet should be taken to the doctor.
Il- Fuljett ta ’ Tagħrif għandu jittieħed lit- tabib.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Jekk l- uġigħ jippersisti għal aktar minn 12- il siegħa wara l- eżami mediku, it- tabib għandu jiġi kkuntattjat mill- ġdid
Why has Eurican Herpes 205 been approved?
Għaliex Eurican Herpes 205 ġie approvat?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus.
Il- Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Eurican Herpes 205 huma akbar minn kwalunkwe riskju li t- tilqima għall- klieb nisa b’ saħħithom jista ’ jkollha kontra l- virus tal- ħerpes tal- klieb.
They recommended that Eurican Herpes 205 should be given a marketing authorisation.
Huma rrakkomandaw li Eurican Herpes 205 għandu jingħata awtorizzazzjoni tal- kummerċ.
The benefit- risk balance may be found in module 6 of this EPAR.
Il- bilanċ benefiċċju- riskju jista ’ jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Eurican Herpes 205:
Tagħrif ieħor dwar Eurican Herpes 205:
The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni tal- kummerċ valida madwar l- Unjoni Ewropea kollha, għal Eurican Herpes 205 lil Merial fis- 26 ta ’ Marzu 2001.
Information on the prescription status of this product may be found on the labelling.
Tagħrif dwar l- istejtus tal- preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketti.
This summary was last updated in 11-2006.
Dan is- sommarju ġie aġġornat l- aħħar fi 11- 2006.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar- rakkomandazzjonijiet fuq il- kundizzjonijiet ta ’ l- użu.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament mediku ta ’ l- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
What is Fevaxyn Pentofel?
X’ inhu Fevaxyn Pentofel?
Fevaxyn Pentofel is a vaccine for cats which is a solution for injection in a prefilled syringe.
Fevaxyn Pentofel hu tilqima għall- qtates li jikkonsisti minn soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Fevaxyn Pentofel contains the following inactivated viruses:
Fevaxyn Pentofel jikkonsisti minn dawn il- vajrusijiet inattivati:
Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Leukaemia Virus, and the inactivated bacterium Feline Chlamydia psittaci.
Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Leukaemia Virus, u l - batterju inattivat Feline Chlamydia psittaci.
What is Fevaxyn Pentofel used for?
Għal xiex jintuża Fevaxyn Pentofel?
Fevaxyn Pentofel is used to immunise healthy cats of 9 weeks or older against Feline Panleukopenia and Feline Leukaemia and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci.
Fevaxyn Pentofel jintuża għat- tlaqqim ta ’ qtates f’ saħħithom ta ’ 9 ġimgħat jew iktar kontra l- Feline Panleukopenia u l- Feline Leukaemia u kontra l- mardiet respiratorji kkawżati mill- Feline Rhinotracheitis virus, Feline Calicivirus u Feline Chlamydia psittaci.
The contents of the prefilled syringe are shaken and given by subcutaneous (under the skin) injection.
Il- kontenut tas- siringa mimlija għal- lest jitħawwad u jingħata b’ injezzjoni taħt il- ġilda.
For cats 9 weeks and older, two doses are given at an interval of 3 to 4 weeks.
Għall- qtates ta ’ 9 ġimgħat jew iktar, iż- żewġ dożi jingħataw f’ intervall ta ’ bejn 3 u 4 ġimgħat.
An additional dose is recommended for kittens living in high-risk areas for Feline Leukaemia Virus whose first dose was administered before 12 weeks of age.
Huwa rrakkomandat li tingħata doża oħra għal qtates żgħar li jgħixu f’ postijiet b’ riskju kbir għall- Feline Leukaemia Virus li l- ewwel doża tiegħu tingħata qabel l- età ta ’ 12- il ġimgħa.
Fevaxyn Pentofel is then given once every year.
Fevaxyn Pentofel imbagħad jingħata darba kull sena.
How does Fevaxyn Pentofel work?
Kif jaħdem Fevaxyn Pentofel?
Fevaxyn Pentofel contains small amounts of four inactivated viruses and one inactivated bacterium.
Fevaxyn Pentofel fih ammonti żgħar ta ’ erba ’ vajrusijiet inattivati u batterju wieħed inattivat.
When injected, this small exposure helps the cat’ s immune system to recognise and attack the viruses and bacterium.
Meta injettat din l- espożizzjoni limitata tgħin lis- sistema immunitarja tal- qattus sabiex tagħraf u tatakka l - vajrusijiet u l- batterji.
When exposed to any of these viruses and bacterium later in life, the cat will either not become infected or will have a much less serious infection.
Meta jiġi espost għal kwalunkwe minn dawn il- vajrus jew batterji iktar tard matul il- ħajja il- qattus jew ma jiġix infettat jew ikollu infezzjoni ħafna inqas serja.
How has the effectiveness of Fevaxyn Pentofel been studied?
Kif ġiet studjata l- effikaċja ta ’ Fevaxyn Pentofel?
Fevaxyn Pentofel has been studied against Feline Leukaemia, against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci, as well as against disease caused by Feline Panleukopenia virus.
Fevaxyn Pentofel ġie studjat kontra l- Feline Leukaemia, kontra l- mardiet respiratorji kkawżati mill - Feline Rhinotracheitis virus, Feline Calicivirus u Feline Chlamydia psittaci, kif ukoll kontra l- mardiet ikkawżati mill- Feline Panleukopenia virus.
In addition, studies in cats of various breeds were carried out to observe any side effects of Fevaxyn Pentofel after the first and second vaccinations.
Barra minn hekk, saru studji fil- qtates ta ’ diversi razez biex ikunu osservati xi effetti sekondarji ta ’ Fevaxyn Pentofel wara l- ewwel u t- tieni tilqima.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Fevaxyn Pentofel shown during the studies?
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ inhu l- benefiċċju ta ’ Fevaxyn Pentofel li ntwera f’ dan l- istudju?
Fevaxyn Pentofel has been shown to be effective against Feline Leukaemia, against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci, as well as against disease caused by Feline Panleukopenia virus.
Intwera li Fevaxyn Pentofel kien effettiv kontra l- Feline Leukaemia, kontra l- mardiet respiratorji kkawżati mill- Feline Rhinotracheitis virus, Feline Calicivirus u Feline Chlamydia psittaci, kif ukoll minn mardiet ikkawżati mill- Feline Panleukopenia virus.
In the trial to observe side effects, there were no side effects in 94.2% of cats for the first vaccination and no side effects observed for 99% of cats for the second vaccination.
Fl- istudju biex jiġu osservati l- effetti sekondarji, f’ 94. 2% tal- qtates ma kienx hemm effetti sekondarji għall- ewwel tilqima u f’ 99% tal- qtates ma kien osservat l- ebda effett sekondarju għat- tieni tilqima.
What are the side effects of Fevaxyn Pentofel?
X’ inhuma l- effetti sekondarji ta ’ Fevaxyn Pentofel?
Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating), and/ or depression, which usually disappear within 24 hours.
Xi qtates imlaqqma jistgħu jiżviluppaw reazzjonijiet għat- tilqima, li jistgħu jinkludu deni temporanju, remettar, anoressija (nuqqas ta ’ aptit), u/ jew dipressjoni, li ġeneralment jieqfu fi żmien 24 siegħa.
Occasionally there is swelling, pain, pruritus (itching) or hair loss at the injection site.
Kultant ikun hemm infiħ, uġigħ, prurite (ħakk) jew twaqqigħ ta ’ pil fejn tkun ingħatat it- titqiba.
In very rare cases there is an anaphylactic reaction (severe allergy) with oedema (fluid under the skin), pruritus, respiratory and cardiac distress, severe gastrointestinal signs or shock during the first hours after vaccination.
F’ każijiet rari ħafna jista ’ jkun hemm reazzjoni anafilattika (allerġija severa) b’ nefħa (fluwidu taħt il - ġilda), prurite, stress respiratorju jew tal- qalb, sinjali gastrointestinali severi jew xokk matul l- ewwel ftit sigħat wara t- tilqima.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Xi prekawzjonijiet trid tieħu l- persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal?
Fevaxyn Pentofel contains mineral oil.
Fevaxyn Pentofel fih żejt minerali.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger.
Injezzjoni aċċidentali tista ’ twassal għal uġigħ u nefħa qawwija, partikolarment jekk tiġi injettata f’ ġog jew f’ seba ’ – li rarament twassal għat- telfien ta ’ seba ’.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Jekk xi ħadd jiġi aċċidentalment injettat b’ dan il- prodott, għandu jkellem tabib immedjatament anke jekk jiġi injettat biss b’ ammont żgħir ħafna.
The Package Leaflet should be taken to the doctor.
Il- Fuljett ta ’ Tagħrif għandu jittieħed għand it- tabib.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Jekk l- uġigħ jippersisti għal iktar minn 12- il siegħa wara l- eżaminazzjoni medika, it- tabib għandu jiġi kkuntattjat mill- ġdid.
Why has Fevaxyn Pentofel been approved?
Għaliex ġie approvat Fevaxyn Pentofel?
The Committee for Medicinal, Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of 9 weeks or older against feline viruses.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ Fevaxyn Pentofel huma ikbar minn kwalunkwe riskju għat- tilqim ta ’ qtates f’ saħħithom ta ’ 9 ġimgħat jew iktar kontra l- vajrusijiet felini.
They recommended that Fevaxyn Pentofel should be given a marketing authorisation.
Huma rrakkomandaw li Fevaxyn Pentofel għandu jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fevaxyn Pentofel:
Tagħrif ieħor dwar Fevaxyn Pentofel:
The European Commission granted a marketing authorisation valid throughout the European Union, for Fevaxyn Pentofel to Fort Dodge Laboratories Ireland on 5 February 1997.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Fevaxyn Pentofel valida fl - Unjoni Ewropea kollha lil Fort Dodge Laboratories Irlanda fil- 5 ta ’ Frar 1997.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il- prodott jista ’ jinstab fuq it- tikketta/ il- pakkett ta ’ barra.
This summary was last updated in 11-2006.
Dan is- sommarju ġie aġġornat l- aħħar f’ Novembru 2006.
Invented name
Kummerċjali Qawwa Għamla
Strength
Farmaċewtika
Pharmaceutical Form
Speċi li għandu l- prodott fuqhom jintuża
Target Route of species administration
Mod ta ’ Amministrazzjoni Ippakkjar Kontenut Daqs talpakkett
R. P.≥ 1.65-≤ 2.15
- Virus inattivat tal - Panleukopenia fil - felini (strejn CU4) P. R. ≥9. 5 - ≤12. 25
3 ml disposable 1 ml polypropylene syringes sealed with rubber tips
Siringa li tuża u tarmi tal -
10 pre-filled Not applicable syringes per cardboard box
Kaxxa li fiha 10 siringi mimlijin bil -
Inactivated Feline Rhinotracheitis virus (605 strain):
- Kaliċivirus inattivat tal- felini (strejn
R. P.≥ 1.60-≤ 2.10
lest ta ’ doża waħda
Inactivated Chlamydophila felis (Cello strain):
255) P. R. ≥1. 65 - ≤2. 15 - Virus inattivat tar- Rhinotracheitis fil - felini (strejn 605) P. R. ≥1. 60 - ≤2. 10 - Chlamydophila felis Inattivat (strejn Cello) P. R. ≥2. 00 - ≤2. 30 - Virus Inattivat tal- Leukemia fil- felini (strejn 61E) P. R. ≥1. 45 - ≤2. 0
R. P.≥ 2.00-≤ 2.30
Is- siringi huma ssiġillati bi truf tal- lastku
Inactivated Feline Leukemia Virus (61E strain):
u 10 labar sterili
3 ml disposable 1 ml polypropylene syringes sealed with rubber tips
Siringa li tuża u 1 ml tarmi tal -
20 pre-filled Not applicable syringes per cardboard box
u 20 labar sterili
25 pre-filled Not applicable syringes per cardboard box
u 25 labar sterili
Fevaxyn Pentofel, solution for injection, for cats
Fevaxyn Pentofel, soluzzjoni għal injezzjoni, għal qtates
Per dose of 1ml (single dose syringe):
Doża waħda ta ’ 1 ml fiha (siringa ta ’ doża waħda):
Active components Inactivated Feline Panleukopenia Virus (CU4 strain)
Sustanzi Attivi Virus inattivat tal- Panleukopenia fil - felini (strejn CU4)
Relative Potency (R. P.) 9.50 - 12.25
Potenza Relattiva (P. R.) 9. 50 - 12. 25
Inactivated Feline Calicivirus (255 strain)
Kaliċivirus inattivat tal- felini (strejn 255)
Inactivated Feline Rhinotracheitis Virus (605 strain)
Virus inattivat tar- Rhinotracheitis fil - felini (strejn 605)
Inactivated Chlamydophila felis (Cello strain)
Chlamydophila felis Inattivat (strejn Cello)
Inactivated Feline Leukemia Virus (61E strain) Adjuvants
Virus Inattivat tal- Leukemia fil- felini (strejn 61E) Sustanza Miżjuda
For a full list of excipients, see Section 6.1
Għal- lista sħiħa ta ’ l- ingredjenti (mhux attivi), ara s- sezzjoni 6. 1
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l - prodott
S
Għall- immunizzazzjoni attiva ta ’ qtates ta ’ l- eta ’ ta ’ 9 ġimgħat jew ikbar li jkunu b’ saħħithom, kontra l- Panlewkopenija fil- felini u l- virusis tal- Lewkimja fil- felini u kontra mard respiratorju ikkawżat mill- virus tar- Rinotrakeite, Kaliċivirus u Chlamydophila felis fil- felini.
4.3 Contraindications
2/ 21 4. 3 Kontra indikazzjonijiet
Vaccination does not affect the course of FeLV infection in cats already infected with FeLV at the time of vaccination, implying that such cats will excrete FeLV irrespective of vaccination; consequently, these animals will constitute a hazard to susceptible cats in their environment.
It- tilqim ma jeffettwax il- kors tal- infezzjoni FeLV fi qtates li diġa huma nfettati bil- FeLV fil- ħin tat- tilqim, għaliex dawn il- qtates joħorġu l- FeLV irrispettivament mit- tilqim; konsegwentement, dawn l- annimali jistgħu ikunu ta ’ periklu għal qtates suxxettibbli fl- ambjent tagħhom.
It is therefore recommended that cats with a significant risk of having been exposed to FeLV be tested for FeLV antigen prior to vaccination.
Huwa għaldaqstant rakkommandat li qtates b’ riskju għoli li ġew esposti għal FeLV, jiġu eżaminati għal antiġen tal- FeLV qabel ma jiġu mlaqqma.
Test negative animals can be vaccinated, while test-positive cats should be isolated from other cats and retested within 1-2 months.
Annimali li ġew eżaminati bħala negattivi, jistgħu jiġu mlaqqma, waqt li qtates li ġew eżaminati u nstabu pożittivi għandhom jiġu iżolati minn qtates oħra u jerġgħu jiġu eżaminati fi żmien xahar- xahrejn.
2/ 19 Cats positive at the second testing should be considered as being permanently infected with FeLV and should be handled accordingly.
Qtates li huma pożittivi fit- tieni eżami għandhom jiġu kkunsidrati bħala li huma permanentament infettati bil- FeLV u għandhom jiġu trattati skond il- każ.
Cats negative at second testing can be vaccinated since, in all likelihood, they have overcome the FeLV infection.
Qtates li huma negattivi fit- tieni eżami jistgħu jiġu mlaqqma, minħabba, li fi kwalunkwe każ, għelbu l- infezzjoni FeLV.
In case of anaphylactoid reaction, adrenaline should be administered intramuscularly.
F’ każ ta ’ reazzjoni anafilattojde, l- adrenalina għandha tingħata ġol- muskolu.
Vaccination of FeLV positive cats is of no benefit.
It- tilqima għal qtates li huma pożittivi għal FeLV ma hi ta ’ ebda siwi.
See Section 4.4 for further details.
Ara Sezzjoni 4. 4 għal aktar dettalji.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek jista 'jirriżulta f' uġigħ kbir u nefħa speċjalment jekk tinjetta f' ġog jew subgħa u f' każijiet rari jista ’ jkun il- kawża li jkollok taqta' subgħajk jekk ma tikkonsultax tabib mill- ewwel.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Jekk tiġi injettat bi żball b' dan il- prodott, fittex għajnuna medika mill- ewwel, anke jekk ammont żgħir ħafna ġie njettat u ħu l- fuljetta ta 'nformazzjoni miegħek.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ idum għal aktar minn 12- il siegħa, wara l- eżami mediku, erġa 'kellem lit- tabib.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il- prodott tista 'tikkawza nefħa intensa, li tista' per ezempju tikkawza nekrożi iskimika u anke il - bżonn li jinqata 'xi subgħa.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata MILL- EWWEL u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata il- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm il- laħam tas- subgħa u t- tendin tal- muskolu.
4.6 Adverse reactions (frequency and seriousness)
3/ 21 4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
Vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/ or depression which usually disappear within 24 hours.
F’ każijiet rari, qtates mlaqqma jistgħu jiżviluppaw reazzjonijiet ta ’ wara t- tilqima li jinkludu deni għal żmien qasir, anoreksja u/ jew dipressjoni li ġeneralment jisparixxu wara 24 siegħa.
A local reaction with swelling, pain, pruritis or hair loss at the injections site may be observed.
Xi drabi tista ’ tiġi osservata reazzjoni lokali b’ nefħa, uġigħ, ħakk jew telf ta ’ pil fil- post tal - injezzjoni.
In very rare cases an anaphylactoid reaction with oedema, pruritis, respiratory and cardiac distress, severe gastrointestinal signs or shock has been seen during the first hours after vaccination.
F’ każijiet veru rari, reazzjoni anafilattojde b’ edema, ħakk, tbatija respiratorja u kardijaka, sinjali gastrointestinali qalila jew xokk ġew osservati waqt l- ewwel sigħat wara t- tilqima.
See Section 4.5 for guidance about treatment.
Ara Sezzjoni 4. 5 (Prekawzjonijiet speċjali għall- użu) biex tkun taf kif għandek timxi dwar it- trattament.
The safety of the vaccine in pregnant queens has not been investigated.
Il- ħarsien tas- saħħa ta ’ din it- tilqima fi qtates tqal ma ġietx investigata.
Vaccination of pregnant queens is not recommended.
Tilqim ta ’ qtates nisa li huma tqal mhux rakkommandat
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
M' hemmx informazzjoni dwar is- sigurtà u l- effiċjenza ta ’ din it- tilqima jekk tintuża flimkien ma ’ kwalunkwe prodott veterinarju ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Għalhekk id- deċiżjoni li tuża din it- tilqima qabel jew wara xi prodott veterinarju ieħor għandha ssir fuq bażi ndividwali.
The contents of the single dose syringe should be shaken well and administered aseptically by subcutaneous injection.
Il- kontenut tas- siringa li diġa ġiet mimlija għandu jiġi mħawwad sew u amministrat b’ mod asettiku permezz ta ’ injezzjoni taħt il- ġilda.
When administering the product, care must be taken to attach the enclosed sterile needle aseptically to the syringe before use.
Meta tamministra l- prodott, għandek tieħu ħsieb biex twaħħal il- labra sterilizzata (li tinstab f’ dan il- pakkett) b’ mod asettiku mas- siringa qabel l- użu.
3/ 19 Basic vaccination of cats 9 weeks and older: two doses at an interval of 3 to 4 weeks.
Tilqima bażika ta ’ qtates ta ’ l- eta ’ ta ’ 9 ġimgħat jew ikbar: żewġ dożi f’ intervall ta ’ bejn 3 sa 4 ġimgħat.
An additional dose is recommended for kittens living in high-risk FeLV environments whose first dose was administered before 12 weeks of age.
Doża addizzjonali hija rakkommandata għal friegħ ta ’ qtates li jgħixu f’ ambjent li għandu riskju għoli ta ’ FeLV fejn l- ewwel doża ġiet amministrata qabel l- eta ’ ta ’ 12- il ġimgħa.
Revaccination: one vaccination annually.
Rivaċċinazzjoni: tilqima waħda kull sena.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn)
No undesirable effects other than those observed and mentioned in section 4.6 “ Adverse Reactions” have been observed.
L- ebda effetti mhux mixtieqa ma ġew osservati ħlief dawk li ġew osservati u msemmija fis - sezzjoni “ Effetti mhux mixtieqa ”.
5.
4/ 21 5.
ATC vet code:
Kodiċi tal- vet ATC:
Fevaxyn Pentofel stimulates the development of active immunity against Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Chlamydophila felis and Feline Leukaemia Virus.
Fevaxyn Pentofel jistimula l- iżvilupp tal- immunità attiva kontra l- Virus Panleukopenia fil- felini, Virus Rhinotracheitis fil- felini, Kaliċivirus fil- felini, Chlamydophila felis u Virus tal- Leukemia fil- felini.
Eagles Earles Minimal Essential Medium with Hepes buffer and Lactalbumin hydrolysate
Eagles Earles Minimal Essential Medium ma ’ Hepes buffer u Lactalbumin hydrolysate
Do not mix with any other veterinary medicinal product.
Tħallatx ma ’ tilqim jew prodotti immunoloġiċi oħra.
Store and transport refrigerated (2oC – 8 oC) Do not freeze.
Tiffriżax.
6.5 Nature and composition of immediate packaging
In- natura u l- għamla ta ’ l- ewwel ippakkjar
Single dose disposable polypropylene syringes containing one dose (l ml) of vaccine.
Siringa li tuża u tarmi tal- polipropilin li fiha doża waħda (1 ml) ta ’ tilqima.
The syringes are sealed with rubber tips.
Is- siringi huma ssiġillati bi truf tal- lastku.
Packaging:
Ippakkjar:
One cardboard box containing 10, 20 or 25 single dose (1 ml) pre-filled syringes and 10, 20 or 25 sterile needles respectively.
Kaxxa waħda tal- kartun li fiha 10, 20 jew 25 siringi ta ’ doża waħda (1 ml), li diġa mimlija u 10, 20 jew 25 labar sterilizzati rispettivament.
4/ 19 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- prodott mediċinali veterinarji mhux użata jew materjal ieħor, għar- rimi li huwa derivat minn dawn il- prodotti
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
7.
5/ 21 7.
MARKETING AUTHORISATION HOLDER
L- ENTITÀ LI GĦANDHA L- AWTORIZZAZZJONI TAL- KUMMERĊ.
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, L- Irlanda
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
AWTORIZZAZZJONI
5 February 1997 Date of last renewal:
5 ta ’ Frar 1997 Data ta ’ l- aħħar reviżjoni:
27 February 2007
27 ta ’ Frar 2007
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
5/ 19 ANNEX II
6/ 21 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIOLOĠIĊI ATTIVI U SID TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L - UŻU
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MIS- SID L- AWTORIZZAZZJONI TALKUMMERĊ
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIOLOĠIĊI ATTIVI U SID L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Names and addresses of the manufacturers of the biological active substances
Isem u indirizz tal- manufatturi tas- sustanzi bioloġiċi attivi
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo l- Irlanda
Fort Dodge Charles City 2000 Rockford Road Charles City Iowa 50616 USA
Fort Dodge Charles City 2000 Rockford Road Charles City Iowa 50616 l- Istati Uniti
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR IL- PROVISTA U L- UŻU
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
7/ 19 ANNEX III
8/ 21 ANNESS III
9/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
10 x 1 ml single dose syringes 20 x 1 ml single dose syringes 25 x 1 ml single dose syringes
10 siringi ta ’ doża waħda x 1 ml 20 siringa ta ’ doża waħda x 1 ml 25 siringa ta ’ doża waħda x 1 ml
Inactivated adjuvanted vaccine for cats.
Tilqima aġuvantata inattivata għal qtates
Per dose of 1ml:
Doża waħda ta ’ 1 ml fiha:
Inactivated FPV (RP 9.50 - 12.25); FCV (RP 1.65 – 2.15); FVR (RP 1.60 – 2.10); Chlam (RP 2.00 – 2.30); FeLV (RP 1.45 – 2.0)
FPV inattivat (RP 9. 50 – 12. 25); FCV (RP 1. 65 – 2. 15); FVR (RP 1. 60 - 2. 10); Chlam (RP 2. 00 – 2. 30); FeLV (RP 1. 45 – 2. 0)
10 x 1 ml single dose syringes 20 x 1 ml single dose syringes 25 x 1 ml single dose syringes
10 siringi ta ’ doża waħda x 1 ml 20 siringa ta ’ doża waħda x 1 ml 25 siringa ta ’ doża waħda x 1 ml.
Cats
Qtates.
S
Immunizzazzjoni attiva ta ’ qtates ta ’ l- eta ’ ta ’ 9 ġimgħat jew ikbar li jkunu b’ saħħithom, kontra l - Panleukopenia fil- felini u l- Leukemia fil- felini u kontra mard respiratorju ikkawżat mill- virus tar - Rhinotracheitis, Kaliċivirus u Chlamydophila felis fil- felini.
METHOD AND ROUTE(S) OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI
Administer aseptically by subcutaneous injection.
Agħti b’ mod asettiku b’ injezzjoni taħt il- ġilda.
Accidental injection is dangerous – read package leaflet before use.
Jekk tinjetta bi żball huwa perikoluż – aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
Store and transport refrigerated (2°C - 8°C).
Aħżen u ttrasporta ġo friġġ (2°C – 8°C).
Keep the syringes in the outer carton in order to protect from light.
Żomm is- siribgi fil- pakkett ta ’ barra sabiex tipproteġi mid- dawl
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPECJALI GĦAR- RIMI TA ’ PRODOTT MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Disposal: read package leaflet.
Rimi: aqra l- fuljett tat- tagħrif fil- pakkett.
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - għandu jingħata biss bi preskrizzjoni medika
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo, l- Irlanda
11/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13/ 21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Fevaxyn Pentofel for cats
Fevaxyn Pentofel għal qatates
1 ml (1 dose)
1 ml (doża waħda).
EXP {month/ year}
Għal użu taħt il- ġilda.
Fevaxyn Pentofel, solution for injection, for cats
15/ 21 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Fevaxyn Pentofel, soluzzjoni għal injezzjoni, għal qatates
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Sid l- Awtorizzazzjoni tal- Kummerċ u l- manifattur Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo l- Irlanda
Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo Ireland
Manifattur li jħalli l- konsenja tmur fis- suq Fort Dodge Laboratories Ireland Finisklin Industrial Estate Sligo l- Irlanda
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U SUSTANZI OHRA
Active components Inactivated Feline Panleukopenia Virus (CU4 strain)
Sustanzi Attivi Virus inattivat tal - Panleukopenia fil - felini (strejn CU4)
Inactivated Feline Leukaemia Virus (61E strain) Adjuvants
Virus Inattivat tal- Leukemia fil- felini (strejn 61E) Sustanza Miżjuda
For the active immunisation of healthy cats 9 weeks or older against Feline Panleukopenia and Feline Leukaemia viruses and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydophila felis.
Għall- immunizzazzjoni attiva ta ’ qtates ta ’ l- eta ’ ta ’ 9 ġimgħat jew ikbar li jkunu b’ saħħithom, kontra l- Panlewkopenija fil- felini u l- Lewkimja fil- felini u kontra mard respiratorju ikkawżat mill- virus tar- Rinotrakeite, Kaliċivirus u Chlamydophila felis fil- felini.
CONTRAINDICATIONS
KONTRAINDIKAZJONIJIET
Do not use in pregnant cats.
Tużax fuq qtates tqal
No undesirable effects other than those mentioned above have been observed.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Il- kontenut tas- siringa li diġa ġiet mimlija għandu jiġi mħawwad sew u amministrat b’ mod asettiku permezz ta ’ injezzjoni taħt il- ġilda.
The contents of the single dose prefilled syringe should be shaken well and administered aseptically by subcutaneous injection.
Il- kontenut tas- siringa li diġa ġiet mimlija għandu jiġi mħawwad sew u amministrat b’ mod asettiku permezz ta ’ injezzjoni taħt il- ġilda.
Primary vaccination of cats 9 weeks and older: two doses at an interval of 3 to 4 weeks.
Tilqima bażika ta ’ qtates ta ’ l- eta ’ ta ’ 9 ġimgħat jew ikbar: żewġ dożi f’ intervall ta ’ bejn 3 sa 4 ġimgħat.
Keep the syringes in the outer carton in order to protect from light.
Żomm is- siringi fil- pakkett ta ’ barra sabiex tipproteġi mid- dawl.
Cats positive at the second testing should be considered as being permanently infected with FeLV and should be handled accordingly.
Qtates li huma pożittivi fit- tieni eżami għandhom jiġu kkunsidrati bħala li huma permanentament infettati bil- FeLV u għandhom jiġu trattati skond il- każ.
Do not mix with any other veterinary medicinal product.
Tħallatx ma ’ xi prodott veterinarju ieħor.
Special precautions for use in animals
Prekawzjonijiet speċjali għal użu fl- annimali
In case of an anaphylactoid reaction, adrenaline should be administered intramuscularly.
F’ każ ta ’ reazzjoni anafilattojde, l- adrenalina għandha tingħata ġol- muskolu.