qanastek/EMEA-V3 huggingface dataset:
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ”
For animal treatment only.
Għal trattament ta ’ l- annimali biss.
22/ 34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
FULJETT TA ’ TAGĦRIF FIL- PAKKETT
32 ml bottle
Acticam 1. 5 mg/ ml suspensjoni orali għall- klieb
NAME OF THE VETERINARY MEDICINAL PRODUCT
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ U TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
QUANTITY OF THE ACTIVE SUBSTANCE(S)
ISEM TAL- PRODOTT MEDIĊINALI VETERINARJU
1.5 mg/ ml
Acticam 1. 5 mg/ ml Suspensjoni orali għall- klieb Meloxicam
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( I) U INGREDJENT( I) OĦRA
32 ml
Meloxicam 1. 5 mg/ ml (ekwivalenti għal 0. 05 mg kull qatra)
ROUTE(S) OF ADMINISTRATION
INDIKAZZJONI( JIET)
Avoid introduction of contamination during use.
Għas- serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku.
WITHDRAWAL PERIOD
KONTRA- INDIKAZZJONIJIET
Not applicable.
Tużax fuq annimali tqal jew li qed ireddgħu.
BATCH NUMBER
EFFETTI MHUX MIXTIEQA
< Batch > {number}
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek.
7.
23/ 30 7.
EXPIRY DATE
SPEĊI LI GĦALIHOM HUWA INDIKAT IL- PRODOTT
9 months.
Klieb
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA ’ AMMINISTRAZZJONI
2.
Dożaġġ It- trattament tal- bidu tikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid - doża tal- manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
Meloxicam
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Acticam tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ mard kroniku muskolu- skeletriku, jista ’ jvarja matul iż- żmien.
1.5 mg/ ml
Mod ta ’ kif u mnejn jingħata
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Biex jingħata mill- ħalq jew imħallat ma ’ l- ikel jew direttamemt fil- ħalq.
100 ml
Doża tal- bidu:
ROUTE(S) OF ADMINISTRATION
4 qtar / kg ta ’ piż tal- ġisem Doża tal- manteniment:
2.
2 qatriet / kg ta ’ piż tal- ġisem
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Il- proċedura tad- dożaġġ bl- użu tas- siringa tal- kejl:
1 ml of solution for injection contains 5 mg of meloxicam.
Agħfas ’ l isfel u ħoll it- tapp tal- flixkun.
Other substances: ethanol anhydrous 150 mg
Waħħal is- siringa tad- dożaġġ mal- qattara tal - flixkun billi timbotta bil- mod.
PHARMACEUTICAL FORM
Aqleb il- flixkun/ is- siringa ta ’ taħt fuq.
Solution for injection.
Imbotta l- planġer ’ l isfel u battal il- kontenut tas- siringa fuq l- ikel jew direttament ġol - ħalq.
PACKAGE SIZE
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem.
10 ml
It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 10 ijiem, l- ebda titjib kliniku ma jkun evidenti.
Read the package leaflet before use.
24/ 30 Evita li tintroduċi xi kontaminazzjoni waqt l- użu.
Do not use in pregnant or lactating animals.
PARIR SABIEX TAMMINISTRA B’ MOD KORRETT
For animal treatment only - to be supplied only on veterinary prescription.
Għandha tingħata attenzjoni partikulari fir- rigward ta ’ l- eżattezza tad- dożaġġ.
Meloxicam.
Jekk jogħġbok segwi bl - attenzjoni l- istruzzjonijiet tal- veterinarju.
10 ml.
10.
ROUTE(S) OF ADMINISTRATION
PERJODU TA ’ TIŻMIM
For animal treatment only.
Mhux applikabbli.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
To be administered mixed with food.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Thus for the first day, twice the maintenance volume will be required.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kundizzjoni speċjali sabiex jinħażen.
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Iż- żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- kontenitur għall- ewwel darba:
Particular care should be taken with regard to the accuracy of dosing.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
SPECIAL STORAGE PRECAUTIONS
TWISSIJA( IJIET) SPEĊJALI
Keep out of the reach and sight of children.
Prekawzjonijiet għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
9 months.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
Do not use after expiry date stated on the carton and the bottle.
Dan il- prodott għall- klieb m’ għandux jintuża għall- qtates għax mhuwiex adattat għall- użu f’ din l - ispeċi.
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Nies li huma sensittivi għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
This product for dogs should not be used in cats as it is not suitable for use in this species.
Użu fit- tqala u fi żmien il- ħalib Ara sezzjoni `Kontra- indikazzjonijiet´.
Other NSAIDS, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Interazzjonijiet NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglikosidi u sustanzi oħra li jeħlu ħafna mal- proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
Acticam must not be administered in conjunction with other NSAIDS or glucocorticosteroids.
Acticam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma jibda t- trattament.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Fil- perjodu mingħajr trattament, madankollu, għandu jkun ikkunsidrat il- karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
In case of accidental ingestion, seek medical advice immediately and show this package insert or the label to the physician.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
SPECIAL 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
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Materjali għar- rimi għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT FIL- PAKKETT
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
Pack sizes 10 ml bottle 32 ml bottle 100 ml bottle
Flixkun ta ’ 10, 32 jew 100 ml.
31/ 34 PACKAGE LEAFLET
26/ 30 FULJETT TA ’ TAGĦRIF FIL- PAKKETT:
Acticam 5 mg/ ml solution for injection for dogs and cats
Acticam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
Marketing authorisation holder:
Sid l- Awtorizzazzjoni tal- Kummerċ
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni ta ’ l- ovarjo- isterektomija u ta ’ wara operazzjoni minuri tat - tessut artab.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Reazzjonijiet avversi tipiċi ta ’ Mediċini Mhux Sterojdi Kontra l- Infjammazzjoni (NSAIDs) bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl- ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħrajn li mhumiex imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA ’ AMMINISTRAZZJONI
Dogs: single administration of 0.2 mg meloxicam/ kg body weight (i. e.
Klieb: għoti ta ’ darba ta ’ 0. 2 mg meloxicam / kg ta ’ piż tal- ġisem (i. e.
0.4 ml/ 10 kg).
0. 4 ml/ 10 kg).
Cats: single administration of 0.3 mg meloxicam/ kg body weight (i. e.
Qtates: għoti ta ’ darba ta ’ 0. 3 mg meloxicam / kg ta ’ piż tal- ġisem (i. e.
0.06 ml/ kg).
0. 06 ml/ kg).
Dogs Musculo-skeletal disorders: single subcutaneous injection.
Mard muskolu- skeletriku: injezzjoni waħda taħt il- ġilda.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni (matul perjodu ta ’ 24 siegħa): injezzjoni waħda ġol- vina jew taħt il- ġilda qabel l- operazzjoni, pereżempju meta jkun qed jingħata l- loppju.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni ta ’ l- ovarjo- isterektomija u ta ’ wara operazzjoni minuri tat - tessut artab: injezzjoni waħda taħt il- ġilda qabel l- operazzjoni, pereżempju meta jkun qed jingħata l - loppju.
28 days.
28 jum.
Do not use after the expiry date stated on the carton and the vial.
Tużax wara d- data ta ’ l- iskadenza (EXP) fuq il- kartuna u l- flixkun.
33/ 34 12.
28/ 30 12.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Biex itaffi l- uġigħ ta ’ wara l- operazzjoni fil- qtates, is- sigurtà kienet dokumentata biss wara loppju b’ thiopental/ halothane.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Prekawzjonijiet għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
Acticam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
Concurrent administration of potential nephrotoxic drugs should be avoided.
Kwalunkwe follow- up orali li bl- użu ta ’ meloxicam jew NSAIDs oħrajn m’ għandhomx jingħataw lill - qtates, minħabba li korsijiet adattati tad- dożaġġ għal dawn il- kuri follow- up ma kinux stabbiliti.
In animals at anaesthetic risk (e. g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
Prekawzjonijiet li għandhom jittieħdu mill- persuna li tamministra l- prodott Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
F’ każ li tinjetta b’ mod aċċidentali lilek innifsek, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
Interazzjonijiet NSAIDs oħrajn, dijuretiċi, antikoagulanti, antibijotiċi aminoglycoside u sustanzi oħra li jeħlu ħafna mal- proteini, jistgħu jikkompetu għat- twaħħil u b’ hekk iwasslu għal effetti tossiċi.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Acticam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
In the case of overdosage symptomatic treatment should be initiated.
L- għoti flimkien ta ’ mediċini nefrotossiċi qawwija għandu jiġi evitat.
For post-operative pain relief in cats, safety has only been documented after thiopental/ halothane anaesthesia.
Meta l - loppju u NSAID jingħataw flimkien, ma jistax jiġi eskluż li jista ’ jkun hemm riskju għall- funzjoni tal - kliewi.
People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
It- trattament minn qabel b’ sustanzi anti- infjammatorji jista ’ jirriżulta f’ effetti avversi addizzjonali jew miżjuda, u għalhekk għandu jiġi osservat perjodu ta ’ 24 siegħa mingħajr trattament b’ mediċini bħal dawn, qabel ma jibda t- trattament Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Doża eċċessiva F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Biex itaffi l- uġigħ ta ’ wara l- operazzjoni, is- sigurtà kienet dokumentata biss wara loppju b’ thiopental/ halothane.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Materjali għar- rimi għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT FIL- PAKKETT
Pack sizes Single 10 ml injection vial.
Kunjett ta ’ l- injezzjoni ta ’ 10 ml.
EPAR summary for the public
ADVOCATE Sommarju ta ’ l- EPAR għall- pubbliku
This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew.
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), fuq il- bażi tad- dokumentazzjoni provduta, 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 wiċċ imb’ wiċċ mal- veterinarju tiegħek.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Jekk tixtieq iktar informazzjoni dwar il- kundizzjoni jew it- trattament ta ’ l- annimal tiegħek, 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 tixtieq iktar informazzjoni fuq il- bażi tar- rakkomandazzjonijiet tal - CVMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Advocate?
X’ inhu Advocate?
Advocate is a clear yellow to brownish antiparasitic solution that contains two active substances, imidacloprid and moxidectin.
Advocate huwa soluzzjoni trasparenti ta 'kulur isfar fil- kannella għal kontra l- parassiti li fih żewġ sustanzi attivi, imidacloprid u moxidectin.
Advocate comes in different strengths and pack sizes, depending on whether it is for use on cats or on dogs, and on the size of the animal being treated.
Advocate jiġi f' żewġ qawwiet u daqsijiet tal- pakkett differenti, jiddipendi fuq jekk huwiex għal użu fuq il- klieb jew fuq il- qtates, u fuq id- daqs ta 'l- annimal li jkun ser jiġi trattat.
What is Advocate used for?
Għal x' hiex jintuża Advocate?
The Package Leaflet includes detailed information on how long the product works against each parasite for, and how often Advocate treatments should be given.
Advocate jintuża għal klieb u qtates li jkunu qed ibatu minn, jew li qegħdin f' riskju li jieħdu infezzjonijiet minn taħlita ta ’ parassiti (ikkawżati minn bosta tipi differenti ta 'parassiti): • għat- trattament u l- prevenzjoni ta' infestazzjonijiet mill- briegħed fil- qtates u l- klieb • bħala parti minn strateġija għat- trattament ta ’ dermatite allerġika tal- briegħed (reazzjoni allergika għall- gdim tal- bergħud) fil- klieb u l- qtates • għat- trattament ta ’ infestazzjonijiet tad- dud fil- widnejn fil- klieb u l- qtates • għat- trattament ta ’ infestazzjonijiet minn qamel li jigdem fil- klieb • għat- trattament ta ’ mard tal- ġilda fil- klieb ikkawżat minn dud parassita (sarcoptic mange u demodicosis) • għall- prevenzjoni ta ’ mard tal- heartworm fil- klieb u l- qtates • għat- trattament tal- mard tal- heartworm Franċiż fil- klieb • għat- trattament ta ’ infezzjonijiet ikkawżati minn ċertu roundworms gastrointestinali fil- qtates u fil - klieb (kif speċifikat fil- Fuljett ta ’ Tagħrif) Il- Fuljett ta ’ Tagħrif jinkludi informazzjoni dettaljata fuq kemm idum biex jaħdem il- prodott kontra kull parassita, u kemm spiss għandhom jingħataw trattamenti b’ Advocate.
Advocate is applied to cats and dogs from pre-filled spot-on pipettes.
Advocate jiġi applikat fuq il- qtates u l- klieb permezz ta ’ pipetti mimlijin għal- lest.
These are small plastic containers which are already filled with the correct amount of Advocate needed to treat one cat or dog.
Dawn huma kontenituri żgħar tal- plastik li jkunu diġà mimlijin bl- ammont korrett ta ’ Advocate meħtieġ għat - trattament ta ’ kelb jew qattus wieħed.
Advocate for Cats is available in 2 different size pipettes for different cat weights.
Advocate għall- qtates jiġi f’ pipetti ta ’ żewġ daqsijiet għall - qtates b’ piżijiet differenti.
Advocate for dogs is available in 4 different size pipettes for different dog weights.
Advocate għall- klieb jiġi f’ 4 daqsijiet ta ’ pipetti differenti għal piżijiet differenti tal- klieb.
The contents of a full pipette is applied onto the animal’ s skin, after parting the fur.
Il- kontenut ta ’ pipetta mimlija jiġi applikat fuq il- ġilda ta ’ l- annimal, wara li jinferaq il- pil.
In cats, the product is applied to the cat’ s neck at the base of the skull.
Fil- qtates, il- prodott jiġi applikat fuq għonq il- qattus, fuq in- naħa ta ’ taħt tal- kranju.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fil- klieb jiġi applikat bejn l - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 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 How does Advocate work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 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 għadam ta ’ l- ispalel fin- naħa t’ isfel ta ’ ras il- kelb, iżda għal klieb akbar (aktar minn 25kg), il- prodott għandu jiġi applikat fi 3 jew 4 postijiet tul id- dahar tal- kelb, waqt li dan ikun bil- wieqfa, minn bejn l - għadam ta ’ l- ispalel sat- tarf ta ’ denbu.
The two active substances in Advocate interact with receptors in the parasites.
Iż- żewġ sustanzi attivi f’ Advocate jinteraġixxu mar- riċetturi tal- parassiti.
Imidacloprid interferes with certain specific receptors (nicotinergic acetylcholine receptors) in the nervous systems of lice and fleas, which results in their subsequent paralysis and death.
Imidacloprid jinterferixxi ma ’ ċerti riċetturi speċifiċi (riċetturi nicotinergic acetylcholine) fis- sistema nervuża tal- briegħed, u dan iwassal għal paraliżi u mewt ta ’ dawn l- organiżmi.
Moxidectin interferes with different receptors (GABA and glutamate-gated chloride channels) in the other parasites, leading to their paralysis, death and expulsion.
Moxidectin jinterferixxi ma ’ riċetturi differenti (GABA u glutamate- gated chloride channels) fil- parassiti l- oħra, u dan iwassal għal paraliżi, mewt u t - tneħħija tagħhom.
How has Advocate been studied?
Kif ġie studjat Advocate?
Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment.
Ingħatat informazzjoni dwar il- kwalità farmaċewtika, it- tolleranza tal- prodotti fil- qtates u l- klieb, is - sigurtà fil- bnedmin (nies f’ kuntatt mal- prodott) u s- sigurtà għall- ambjent.
The effectiveness of the products against the specified parasites was investigated in laboratory studies.
L- effikaċja tal- prodotti kontra l- parassiti speċifikati ġiet investigata fi studji ġol- laboratorju.
Subsequently the efficacy was confirmed in several field studies in cats and dogs, which were conducted in several different European geographical locations.
Sussegwentement l- effikaċja ġiet ikkonfermata f’ diversi oqsma ta ’ studji fil- klieb u l- qtates, li saru f’ diversi lokalitajiet ġeografiċi Ewropej.
Cats and dogs from various breeds, age groups and weights were treated.
Ġew trattati qtates u klieb ta ’ razez, età u piż differenti.
The effectiveness of the product was measured by looking at the number of live parasites at various times after treatment.
L - effikaċja tal- prodott ġiet imkejla billi tqies in- numru ta ’ parassiti ħajjin wara diversi applikazzjonijiet tat- trattament.
What benefit has Advocate shown during the studies?
X’ benefiċċji ta ’ Advocate intwerew waqt dawn l- istudji?
The results of the laboratory and field trials in cats and dogs showed that Advocate is effective, when used as detailed in the Package Leaflet (see “ What is Advocate used for? ” above, or for more details see the Package Leaflet).
Ir- riżultati tal- provi li saru fil- laboratorju u l- qasam naturali fil- qtates u l- klieb urew li Advocate huwa effettiv meta jintuża kif inhu spjegat fid- dettall fil- Fuljett ta ’ Tagħrif (ara “ Għal x’ hiex jintuża Advocate? ” fuq, jew għal aktar dettall ara l- Fuljett ta ’ Tagħrif).
What is the risk associated with Advocate?
X’ inhuma r- riskji assoċjati ma ’ Advocate?
In both cats and dogs the most common side effects are local reactions at the place where the product has been applied, such as temporary itchiness, and on rare occasions, greasy fur and redness of the skin.
Kemm fil- klieb kif ukoll fil- qtates l- iktar effetti sekondarji komuni huma reazzjonijiet lokali fil- post fejn ġie applikat il- prodott, bħal ħakk temporanju, u f’ okkażjonijiet rari, pil żejtni u ħmura tal- ġilda.
Vomiting has also occurred rarely.
F’ każijiet rari, kien hemm ukoll rimettar.
These signs disappear without further treatment.
Dawn is- sinjali jitilqu malli jitwaqqaf it- trattament.
If a cat or dog licks the application area, it might salivate a lot for a short period and then might show signs such as a lack of muscular co-ordination, shaking, abnormal breathing and/ or vomiting.
Jekk qattus jew kelb jilgħaq il- post fejn ġie applikat il- prodott, jista ’ jibda jbeżlaq ħafna għal ftit żmien u mbagħad jista ’ juri sinjali ta ’ nuqqas ta ’ koordinament muskolari, rogħda, nifsijiet anormali u/ jew rimettar.
Dogs and cats weighing less than 1 kg should only be treated after special consideration by the veterinarian.
Klieb u qtates li jiżnu inqas minn 1 kg għandhom jiġu trattati biss wara konsiderazzjoni speċjali mill - veterinarju.
Advocate should not be used in young cats that are under 9 weeks of age.
Advocate m’ għandux jintuża fi qtates iżgħar minn 9 ġimgħat.
Advocate should not be used in young dogs that are under 7 weeks of age.
Advocate m’ għandux jintuża fi klieb iżgħar minn 7 ġimgħat.
As with other products of this type, Advocate should not be used in sick or ill cats or dogs.
Bħal prodotti oħra ta ’ dan it- tip, Advocate m’ għandux jintuża fi klieb jew qtates morda.
As Advocate comes in different strengths depending on whether it is for use on cats or on dogs, it is very important that the cat products should only be used for cats, and the dog products for dogs.
Minħabba li Advocate jiġi f’ qawwiet differenti li jiddependu fuq jekk huwiex se jintuża għall- klieb jew għall - qtates, huwa importanti ħafna li l- prodotti tal- qtates jintużaw biss għall- qtates, u l- prodotti tal- klieb jintużaw għall- klieb biss.
Neither product should be used for any other animal species.
L- ebda prodott minn dawn m’ għandu jintuża għal xi speċi ta ’ annimal ieħor.
Advocate has harmful effects on aquatic organisms and so the product should not be allowed to enter ditches, ponds or streams.
Advocate għandu effetti ħżiena fuq organiżmi akwatiċi u allura l- prodott m’ għandux jitħalla jidħol ġo gandotti, vaski jew nixxijat.
Dogs should not be allowed to swim in ditches, ponds or streams for 4 days after treatment.
Il- klieb m’ għandhomx jitħallew jgħumu fil- gandotti, vaski jew nixxijat għal 4t ijiem wara t- trattament.
When administering Advocate, the user should not smoke, eat or drink, and should wash their hands thoroughly after use.
X’ inhuma l- prekawzjonijiet li għandha tieħu persuna li tagħti l- mediċina jew li tiġi f’ kuntatt ma ’ l- annimal.
Page 2/ 3
Paġna 2/ 3
People with a known sensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Nies b’ sensitività għal alkoħol benzyl, imidacloprid jew moxidectin għandhom jamministraw il - prodott b’ kawtela.
The solvent in Advocate may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Is- solvent f’ Advocate jista ’ jtebba ċerti materjali inkluż ġilda, drappijiet, plastiks u wċuħ lesti, għalhekk kuntatt bejn il- prodott u dawn l- uċuħ għandu jiġi evitat.
Why has Advocate been approved?
Għaliex ġie approvat Advocate?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Advocate exceed the risks for cats and dogs suffering from, or at risk from, mixed parasitic infections, and recommended that Advocate be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ Advocate jisbqu ir- riskji għall- klieb u l- qtates li jbatu minn, jew li qegħdin f’ riskju ta ’ infezzjoni minn taħlita ta ’ parassiti, u jirrakommanda li Advocate jingħata awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il - bilanċ bejn ir- riskju u l- benefiċċju jinsab fil- modulu 6 ta ’ dan l- EPAR.
Other information about Advocate:
Tagħrif ieħor dwar Advocate:
The European Commission granted a marketing authorisation valid throughout the European Union for Advocate to Bayer HealthCare AG (previously called Bayer AG) on 2 April 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Advocate lil Bayer HealthCare AG (preċedentament magħrufa bħala Bayer AG) fit- 2 ta ’ April 2003.
Information on the prescription status of this product may be found on the outer package.
Tagħrif dwar l- istatus tal- preskrizzjoni ta ’ dan il- prodott jinsab fil- pakkett ta ’ naħa ta ’ barra.
This summary was last updated in August 2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ Awwissu 2007.
Advocate spot-on solution for small cats Advocate spot-on solution for large cats
Advocate - taħlita likwida għal użu lokalizzat fuq qtates kbar
Advocate for cats contains 100 mg/ ml imidacloprid and 10 mg/ ml moxidectin.
Advocate għall- qtates fih 100 mg/ ml Imidakloprid u 10 mg/ ml Moksidektin
Each unit dose (pipette) delivers:
Kull doża waħda ta´Advocate tagħti:
Unit Dose
Doża waħda 0. 4 ml
Imidacloprid
Imidakloprid 40 mg
Moxidectin
Moksidektin 4 mg
Advocate for small cats (≤ 4 kg) Advocate for large cats (> 4-8 kg)
Advocate għall- qtates kbar (4- 8 kg)
Benzyl alcohol Butylhydroxytoluene 1 mg/ ml (E 321; as antioxidant).
Benzyl alcohol 1 mg/ ml butylhydroxytoluene( E321; bħala antiossidant)
Spot-on solution Clear yellow to brownish solution
Taħlita għal użu lokalizzat Taħlita safra ċara fil- kannella
Cats
Qtates
For cats suffering from, or at risk from, mixed parasitic infections:
Għall- qtates li qed isofru minn, jew huma fil- periklu ta´ nfezzjonijiet kawżati minn parassiti diversi:
For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament ta ’ l - infezzjoni tad- dudu tal- widna (Otodectes cynotis), prevenzjoni ta´mard tad- dudu tal- qalb (larva L3 u L4 tad- Dirofilaria immitis) u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat - Toxocara cati u Ancylostoma tubaeforme).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Il- prodott jista´jiġi wżat bħala parti mill- istrateġija tat- trattament tad- dermatite kawżata mill- allerġija tal- briegħed.
Do not use in kittens under 9 weeks of age.
Tużax fuq qtates li huma iżgħar minn 9 ġimgħat.
Do not use in the case of hypersensitivity to the active substances or to any of the excipients.
Tużax f’ każ ta’ sensittivita eċċessiva għal- sustanzi attivi jew għal xi wieħed mill- eċipjenti
For dogs, the corresponding “ Advocate for dog ” product, which contains 100 mg/ ml imidacloprid and 25 mg/ ml moxidectin, must be used.
Għall - klieb għandu jintuża il- prodott apposta għalihom “ Advocate għall- klieb ”, li fih 100 mg/ ml Imidakloprid u 25 mg/ ml Moksidektin.
2 4.4 Special warnings
2 4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott >
Please refer to section 4.5.
Jekk jogħġbok irreferi għal sezzjoni 4. 5.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product.
Kuntatt qasir ta´l- annimal ma´l- ilma, f´okkażżjoni waħda jew tnejn, bejn it- trattamenti ta´ kull xahar m´huwiex mistenni li jnaqqas sinifikament l- effiċjenza tal- prodott.
However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.
Għaldaqstant, l- użu frekwenti tax - xampu jew l- immersjoni tal- annimal ġo l- ilma wara t- trattament, jista´ jnaqqas l- effiċjenza tal- prodott.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Resistenza tal- parassita għal xi klassi partikulari ta´sustanza kontra d- dud tista´ tiżviluppa wara li jsir użu frekwenti u repetut ta´din is- sustanza ta´din il- klassi.
The treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment.
Trattamenti fuq annimali li jiżnu inqas minn 1 kg għandhom jiġu bbazati fuq valutazzjoni tar- riskju u benefiċċju.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.
Hemm esperjenza limita fuq l- użu tal- prodott fuq annimali morda u debboli, għalhekk il - prodott m´għandux jiġi wżat fuq bażi ta´valutazzjoni tar- riskju u benefiċċju fuq dawn l- annimali.
Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/ or other animals.
Għandha tingħata attenzjoni biex il- kontenut tal- pipetta jew id- doża applikata ma tiġix f´kuntatt ma´ l - għajnejn jew ma´ ħalq l- annimal li jiġi trattat jew annimali oħra.
Do not allow recently treated animals to groom each other.
Tħallix annimali li ġew trattati riċentament jilagħqu lil xulxin.
Oral uptake by Collies, Old English Sheepdogs and related breeds or crossbreeds should be prevented.
Klieb tar- razza Collies, Old English Sheepdogs u razzez simili jew taħlit ta ’ razzez simili m’ għandhomx jitħallew jilgħaqu l- prodott.
It is recommended that cats living in, or travelling to areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease.
Huwa rrikommandat illi qtates li jgħixu jew li jiġu meħuda f´postijiet fejn jgħix id- dudu tal- qalb, jiġu trattati kull xahar bil- prodott ħalli jiġu pproteġuti mill- marda tad- dudu tal- qalb.
Whilst the accuracy of diagnosis of feline heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat aged over 6 months, before beginning prophylactic treatment, as use of the product on cats which have adult heartworms may cause serious adverse effects, including death.
Minħabba l- fatt li l - akkuratezza tad- dijanjosi tal- infezzjoni tad- dudu tal- qalb fil- qtates hija limitata, huwa rrikommandat illi jsiru provi biex isir l- eżami fuq l- istat tad- dudu tal- qalb fuq qtates li għandhom il- fuq minn 6 xhur qabel ma jintbeda t- trattament profilaktiku, għaliex meta jintuża l- prodott fuq il- qtates li għandhom dudu tal- qalb adult, dan jista´ jikkawża effetti avversarji serji, inkluż il- mewt.
If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.
Jekk id- dijanjosi hija t´ infezzjoni ta´dudu tal- qalb adult, din trid tiġi trattata skond l- istudju tax- xjenza kurrenti.
Avoid contact with skin, eyes or mouth.
Evita kuntatt mal- ġilda, għajnejn jew ħalq.
Do not eat, drink or smoke during application.
Tiekolx, tixrobx u tpejjipx waqt l- applikazzjoni.
Wash hands thoroughly after use.
Aħsel idejk sew wara li tuża.
After application do not stroke or groom animals until the application site is dry.
Tmellisx jew tippetna l- annimal wara l- applikazzjoni qabel ma ’ tinxef il- parti fejn tapplika.
In case of accidental spillage onto skin, wash off immediately with soap and water.
Jekk aċċidentalment il- prodott jixxerred fuq il- ġilda, aħsel malajr bl- ilma u s- sapun.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Nies li għandhom sensittivita kbira għall- benzyl alcohol Imidakloprid u Moksidektin għandhom jamministraw il- prodott b´kawtela.
In very rare cases the product may cause skin sensitisation or transient skin reactions (for example allergy, irritation or tingling).
F´okkażżjonijiet rari ħafna sensittivita` tal- ġilda jew rejazzjonijiet tal- ġilda li jgħaddu (eż. allerġija, irritazzjoni, tniggis) jistgħu jinħassu meta jiġi wżat il- prodott.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
Jekk aċcidentalment il- prodott imiss ma´ l- għajnejn, dawn għandhom jiġi mlaħalħin sewwa bl- ilma.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.
Jekk sintomi ta´ l- għajnejn jew ġilda jkomplu, jew il- prodott jiġi aċċidentalment miblugħ, fittex tabib mall- ewwel u qis li turih il- pakkett jew il- fuljett t 'informazzjoni li jkun fih ġewwa.
The solvent in Advocate may stain certain materials including leather, fabrics, plastics and finished surfaces.
Is- solvent li hemm fl- Advocate jista´jċappas materjal differenti inklużiv ġild, drapp, plastik u wċuħ illustrati.
Allow the application site to dry before permitting contact with such materials.
Ħalli l- parti t´ applikazzjoni tinxef qabel ma tagħmel kuntatt ma´ dan il- materjal.
Use of the product may result in transient pruritus in cats.
L- użu tal- prodott jista´jikkawża prurite li jgħaddi, fuq il- qtates.
On rare occasions greasy fur, erythema and vomiting can occur.
F´okkażjonijiet rari jista´ jikkawża pil żejtni, eritema u jista´jikkawża wkoll rriġettar.
These signs disappear without further treatment.
Dawn is- sinjali jisparixxu mingħajr ma jsir ebda trattament ieħor.
If the animal licks the application site after treatment, transient neurological signs may be observed infrequently (see section 4.10 –).
Jekk l -
3 The product tastes bitter.
3 annimal jilgħaq il- post ta´ l- applikazzjoni wara t- trattament, sintomi newroloġici li jgħaddu, jistgħu jiġu kultant osservati (ara sezzjoni 4. 10) Il- prodott għandu togħma morra.
Salivation may occasionally occur if the animal licks the application site immediately after treatment.
Bżieq jista´ jifforma kull tant jekk l- annimal jilgħaq il- post t´applikazzjoni hekk kif jiġi trattat.
This is not a sign of intoxication and disappears within some minutes without treatment.
Dan m´huwiex sinjal t´ intoksikazzjoni u tisparixxi fi ftit minuti mingħajr xi trattament.
Correct application will minimise licking of the application site.
Jekk il- prodott jiġi applikat tajjeb, inqas jista ’ jilgħaq l- annimal il- post t´applikazzjoni.
The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence.
F’ każi rari, il- prodott jista’ jikkawża sensazzjoni fuq il- post t’ applikazzjoni li ġġib magħha tibdil temporanju fl- imġieba, bħal- telqa, tqanqil u nuqqas ta ’ aptit.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Il- Ħarsien tas- Saħħa tal- Prodott mediċinali veterinarju ma ġiex stabbilit waqt it- tqala u fi żmien il - ħalib.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Studji fil- laboratorju bl- użu t´Imidakloprid u Moksidektin fuq il- far u l- fniek ma pprovdewx evidenza ta 'ħsara fit- tqala, ħsara lill- fetu jew ħsara lill- omm.
Use only according to the risk-benefit assessment by the responsible veterinarian.
Uża biss skond il- valutazzjoni tar- riskju u benefiċċju tal- veterinarju responsabbli.
During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
Waqt il- kura ta´ l- Advocate ma jista´jiġi amministrat l- ebda Laktonju Makroċikliku ieħor kontra l - parrassiti
No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
L- ebda reazzjoni ma ġiet osservata meta l- Advocate jintuża flimkien ma kwalunkwe prodott ieħor li jingħata regolari, jew proċeduri mediċinali jew kirurġici
Dosage schedule:
Skeda tad- doża
The recommended minimum doses are 10 mg/ kg bodyweight imidacloprid and 1.0 mg/ kg bodyweight moxidectin, equivalent to 0.1ml/ kg bodyweight Advocate for cats.
Id- dożi minimi rrikkmandati huma ta´10mg Imidakloprid għal kull kg użin tal- ġisem. u 1. 0 mg Moksidektin għal kull kg użin tal- ġisem, li jiġu ekwivalenti għal 0. 1ml Advocate għall- qtates, għal kull kg użin tal- ġisem.
The treatment schedule should be based on the local epidemiological situation.
L- iskeda ta´ trattament għandha tiġi bbażata fuq il- sitwazzjoni epidemjoloġika.
Weight of cat [kg]
Użin tal - qattus [kg]
Pipette size to be used
Qies tal- pipetta għall- użu
Volume Imidacloprid Moxidectin [ml] [mg/ kg bw] [mg/ kg bw]
Imidakloprid [mg/ kg użin tal - ġisem]
Advocate for small cats
Advocate għall- qtates żgħar
minimum of minimum of 10 1
Minimu ta´ 10
> 4 - 8 kg
> 4- 8 kg
Advocate for large cats
Advocate għall- qtates kbar
10 - 20
10- 20
the appropriate combination of pipettes
Il- kombinazzjoni adattata tal- pipetti
Flea treatment and prevention
Trattament u prevenjoni tal- briegħed
One treatment prevents future flea infestation for 4 weeks.
Trattament wieħed jippreveni t- tixrid ta´ briegħed għall - 4 ġimgħat.
Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions.
Pupa li tkun qiegħda fl- inħawi tista´titfaċċa wara 6 ġimgħat jew aktar wara li l- kura tiġi mibdija, jiddependi fuq il- kundizzjonijiet tal - klima.
Therefore, it may be necessary to combine Advocate treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings.
Għalhekk jista´jkun neċessarju illi barra t- trattament ta´ l- Advocate ikun hemm ukoll trattament fuq l- ambjent sabiex jinqered iċ- ċiklu ta´ ħajja tal- briegħed fl- inħawi.
This can result in a more rapid reduction in the household flea population.
Dan jista´jwassal għal tnaqqis aktar mgħaġġel tan- numru ta´ briegħed fid- dar.
The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Il- prodott għandu jiġi amministrat f´ intervalli ta´xahar meta jiġi użat bħala parti mill- istrateġija għall- kura ta´dermatite kawżata minn allerġija għall - briegħed.
Treatment of ear mite infestation (Otodectes cynotis)
4 Trattament ta ’ l- infezzjoni tad - dudu tal- widna (Otodectes cynotis)
A single dose of the product should be administered.
Doża waħda biss tal- prodott għandha tiġi amministrata.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Eżami ieħor minn veterinarju huwa rrikmandat peress li biċċa mill- l- annimali jirrikjedu t- tieni trattament.
Do not apply directly to the ear canal.
Tapplikax direttament fil- kanal tal- widna.
Heartworm prevention
Prevenzioni tad- dudu tal- qalb.
4 Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms.
Qtates li jgħixu jew li jiġu meħuda f´postijiet fejn jgħix id- dudu tal- qalb, jistgħu jkunu nfettati bid- dud tal- qalb adult.
Therefore prior to treatment with Advocate, the advice provided in section 4.5. should be considered.
Għalhekk qabel il- kura tal- Advocate, l- avviż li huwa pprovdut f´sezzjoni 4. 5 għandu jiġi kkunsidrat.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present.
Għall- prevenzjoni tal- marda tad- dudu tal- qalb, il- prodott għandu jiġi applikat regularment f´intervalli ta´xahar waqt iż- żmien tas- sena meta n- nemus (li permezz tagħhom jinġarru u jinfirxu l- larva tad- dud tal- qalb) huma preżenti.
The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes.
Il- prodott jista´jiġi amministrat matul is- sena kollha jew ta´ l- inqas xahar qabel l- ewwel espożizzjoni mistennija ta´nemus.
To establish a treatment routine, it is recommended that the same day or date be used each month.
Biex tistabilixxi rutina ta´ kura, huwa rrikommandat illi tiġi użata l- istess ġurnata jew data kull xahar.
When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication.
Meta tiġi biex tibdel prodott għall- prevenzjoni tad - dudu tal- qalb fi programm ta´prevenzjoni għad- dudu tal- qalb, l- ewwel trattament bl- Advocate għandu jiġi mogħti fi żmien xahar ta´ l- aħħar doża tal- medikazzjoni ta´qabel.
In non-endemic areas there should be no risk of cats having heartworm.
F´postijiet fejn ma jgħix id- dudu tal- qalb, m´għandux ikun hemm riskju li l- qtates jieħdu d- dudu tal - qalb.
Therefore they can be treated without special precautions.
Għalhekk għandhom jiġu trattati mingħajr prewkawzjonijiet speċjali.
Roundworm and hookworm treatment
Trattament għall- ħniex
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms.
F´postijiet fejn fejn jgħix id- dudu tal- qalb, trattament ta´ kull xahar inaqqas ir- riskju li jerġa jkun hemm infezzjoni kkaġunata speċjalment mill- ħniex.
In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
F´postijiet li mhumiex endemiċi għad- dudu tal - qalb, il- prodott jista´ jiġi wżat bħala programm ta´ prevenzjoni kontra l- briegħed u ħniex gastro - intestinali.
Method of administration
Metodu t´amministrazzjoni
For external use only.
Ġħall- użu estern biss.
Remove one pipette from the package.
Neħħi pipetta waħda mill- pakkett.
Then hold the pipette in an upright position, and twist and pull off the cap.
Żomm il- pipetta tħares il- fuq, issa ilwi u iġbed il- għatu ´l barra.
Reverse the cap and use it to twist and remove the seal from the pipette, as shown.
Aqleb l- għatu ta´taħt fuq u użah biex tilwi u tneħhi il- qfil tal- pipetta, kif jidher fl- istampa.
Part the fur on the cat's neck at the base of the skull until the skin is visible.
Ofroq il- pil fuq l- għonq tal- qattus fit- tarf tal- kranju sakemm tidher il- ġilda.
Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas il- pipetta bis- sħih kemm il- darba biex tbattal il- kontenut direttament fuq il- ġilda.
Application at the base of the skull will minimise the opportunity for the cat to lick the product.
Applikjazzjoni fit- tarf tal- kranju tnaqqas l- opportunita` ´l qattus biex jilgħaq il- prodott.
Apply only to undamaged skin.
Applika biss fuq ġilda ntatta
5 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
5 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.
Id- doża rrikmandata ġiet ittollerata sa 10 darbiet mill- qtates, mingħajr l- ebda evidenza t´effetti avversarji jew sinjali kliniċi mhux mixtieqa.
The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns.
Il- prodott ġie amministrat sa 5 darbiet bid- doża rrikkmandata fuq frieħ ta´qtates kull ġimgħatejn għal - 6 trattamenti, u ma kienx hemm affari serji ta´ sigurta.
Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
Midriasi li tgħaddi, tbeżzieq, irreġettar u respirazzjoni mgħaġġla li tgħaddi ġew osservati.
After accidental oral ingestion, transient neurological signs such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.
Wara li l- prodott jittieħed aċcidentalment orali, sintomi newroloġiċi li jgħaddu bħal għejja, tregħid ma´kullimkien, sinjali fl- għajnejn (twessiegħ fit- toqba tal- mamma tal- għajn, ftit akkomodazzjoni ta´l - għajn, oxxillazzjoni kontinwa waħda ġo l- oħra tal- boċċi tal- għajnejn), respirazzjoni li mhix normali, tbeżżieq u rriġettar jistgħu jsiru kultant.
In case of accidental oral uptake, symptomatic treatment should be administered.
Fil- każ li l- prodott jittieħed aċcidentalment orali, trattament simptomatiku għandu jiġi amministrat.
There is no known specific antidote.
Ma hemmx antidot specifiku magħruf.
The use of activated charcoal may be beneficial.
L- użu ta´ karbonju attivat jista´jkun ta´ benefiċċju.
Pharmacotherapeutic group: therapeutic antiparasitic agent; ATC-vet code:
Grupp Farmako- terapewtiku: sustanza terapewtika kontra l- parassiti; Kodici ATC veterinarja: