qanastek/EMEA-V3 huggingface dataset:
Spironolactone and its active metabolites (including 7α -thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.
Spironolakton u l- metaboliti attivi tiegħu (li jinkludu 7α- thiomethyl- Spironolakton u canrenone) jaħdmu bħala antagonisti speċifiċi ta ’ aldosterone u jeżerċitaw l- effetti tagħhom billi jorbtu kompetitivament mar- riċettur tal- mineralokortikojde li huwa lokalizzat fil- kliewi, il- qalb jew il- vażi tad- demm.
Spironolactone is a natriuretic drug (historically described as a soft diuretic).
Spironolakton huwa mediċina natrijuretika (storikament deskritt bħala dijuretiku artab).
In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.
Fil- kilwa Spironolakton jimpedixxi ż- żamma tas- sodjum indott minn aldosterone li jwassal għall- eliminazzjoni tas- sodjum u sussegwentement ta ’ l- ilma, u żamma ta ’ potassjum.
4/ 25 The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure.
L- effetti renali ta ’ Spironolakton u l- metaboliti tiegħu jwasslu għal tnaqqis fil- volum ta ’ barra ċ- ċelloli u konsegwentement fi tnaqqis tat- tagħbija kardijaka ta ’ qabel u pressjoni fl- atriju tax- xellug.
The result is an improvement in heart function.
Ir- riżultat huwa titjib fil- funzjoni tal- qalb.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
4/ 25 Fis- sistema kardjovaskulari, Spironolakton jimpedixxi l- effetti detrimentali ta ’ aldosterone.
Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.
Għalkemm il- mekkaniżmu ta ’ azzjoni preċiż s’ issa mhuwiex mfisser b’ mod ċar, aldosterone jippromwovi l- fibrożi mijokardijali, mudellar mijokardijali u vaskulari mill- ġdid u l- funzjoni ħażina ta ’ l- endotilju.
In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
F’ mudelli sperimentali fil- klieb, kien muri li terapija fuq tul ta ’ żmien ma ’ antagonist ta ’ aldosterone jimpedixxi l- funzjoni ħażina progressiva tal- ventrikolu tax- xellug u jimmodera l- immudellar mill- ġdid tal- ventrikolu tax- xellug fi klieb b’ falliment kroniku tal- qalb.
In a clinical trial, dogs treated with spironolactone in addition to standard therapy (ACE-inhibitors) demonstrated a reduction in cardiovascular disease deterioration compared to dogs treated with standard therapy alone.
Fi prova klinika, il- klieb ittrattati bi Spironolakton f’ żieda ma ’ terapija standard (impedituri ACE) urew tnaqqis fid- deterjorament ta ’ mard kardjovaskulari mqabbel ma ’ klieb ittrattati b’ terapija standard waħeda.
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “ aldosterone escape”.
Meta intuża f’ kombinazzjoni ma ’ impedituri- ACE, Spironolakton jista ’ jikkuntrarja l- effetti ta ’ “ ħarba ta ’ aldosterone ”.
A slight increase in aldosterone blood levels may be observed in animals on treatment.
Żieda żgħira fil- livelli ta ’ aldosterone fid- demm jistgħu jkunu osservati f’ annimali fuq trattament.
This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
Din hija maħsuba li hija minħabba l- attivazzjoni ta ’ mekkaniżmi ta ’ feedback mingħajr konsegwenzi klinċi avversi.
There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.
Jista ’ jkun hemm ipertrofija relatata mad- doża taż- żona glomerulosa adrenali f’ rati ta ’ dożi għoljin.
The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is unstable at assay.
Il- farmakokinetika ta ’ Spironolakton hija bażżata fuq il- metaboliti tiegħu, peress li l- kompost ġenitur mhuwiex stabbli fl- assaġġ.
Absorption After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
Assorbiment Wara l- għoti ta ’ Spironolakton mill- ħalq lil klieb, kien muri li t- tliet metaboliti kisbu livelli ta ’ 32 sa 49% tad- doża amministrata.
Food increases the bioavailability to 80 to 90%.
L- ikel iżid il- bijodisponibiltà għal 80 sa 90%.
Following oral administration of 2 to 4 mg/ kg, absorption increases linearly over the range.
Wara t- teħid mill- ħalq ta ’ 2 sa 4 mg/ kg, l- assorbiment jiżdied b’ mod lineari fuq il- medda.
After multiple oral doses of 2 mg spironolactone per kg for 10 consecutive days, no accumulation is observed.
Wara dożi orali multipli ta ’ 2 mg Spironolakton għal kull kg, għal 10 ijiem konsekuttivi, ma kienet osservata l- ebda akkumulazzjoni..
Mean Cmax of 382 µg/ l and 94 µg/ l are achieved for the primary metabolites, 7α -thiomethyl- spironolactone and canrenone, after 2 and 4 hours, respectively.
Cmax medju ta ’ 382 µg/ l u 94 µg/ l jinkisbu għal metaboliti primarji, 7α- thiomethyl- Spironolakton u canrenone, wara 2 u 4 sigħat, rispettivament.
Steady-state conditions are reached by day 2.
Kundizzjonijiet ta ’ stat fiss huma miksuba sa jum 2.
Distribution The mean volumes of distribution (Vss) of 7α -thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Distribuzzjoni Il- volumi medji ta ’ distribuzzjoni (Vss) ta ’ 7α- thiomethyl- Spironolakton u canrenone huma madwar 153 litri u 177 litri rispettivament.
The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially distributed to the gastro-intestinal tract, kidney, liver and adrenal glands.
Il- ħin ta ’ residenza medju tal- metaboliti jvarja minn 9 sa 14- il siegħa u huma preferenzjalment distribwiti lejn il- passaġġ gastrointestinali, kliewi, fwied u glandoli adrenali.
Metabolism Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7α - thiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
Metaboliżmu Spironolakton huwa metabolizzat malajr u kompletament mill- fwied għal metaboliti attivi tiegħu, 7α - thiomethyl- Spironolakton u canrenone, li huma l- metaboliti primarji fil- kelb.
Elimination Spironolactone is mainly excreted via its metabolites.
Eliminazzjoni Spironolakton huwa prinċipalment eliminat permezz tal- metaboliti tiegħu.
Plasma clearance of canrenone is 1.45±0.39 l/ h/ kg and 7α -thiomethyl-spironolactone is 0.89±0.44 l/ h/ kg.
Ir- rata ta ’ eliminazzjoni mill- plażma ta ’ canrenone hija ta ’ 1. 45±0. 39 l/ h/ kg u ta ’ 7α- thiomethyl- Spironolakton hija ta ’ 0. 89±0. 44 l/ h/ kg.
After oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
Wara l- għoti mill- ħalq ta ’ Spironolakton radjotikketat lill- kelb, 70% tad- doża kienet rikoverata mill- ippurgar u 20% mill- awrina.
Beef flavouring Mannitol Sodium laurilsulfate Microcrystalline cellulose Povidone Sorbitol Talc Magnesium stearate
Essenza taċ- ċanga Mannitol Sodium laurilsulfate Microcrystalline cellulose Povidone Sorbitol Talc Magnesium stearate
3 years as packaged for sale.
3 snin kif ippakkjat għal bejgħ.
Partially used tablets should be stored in the original blister pack.
Pilloli parzjalment użati għandhom jinżammu fl- istrixxa oriġinali.
Blister packs (polyamide/ aluminium/ polyvinyl chloride/ /aluminium) in a cardboard box.
Materjal tal- kontenitur prinċipali Pakketti bl- istrixxi (poli- amid/ aluminjum/ klorid tal- polyvinil / aluminjum) f’ kaxxa tal- kartun.
Box containing 3 blisters of 10 tablets Box containing 18 blisters of 10 tablets
Daqsijiet tal- pakketti Kaxxa bi 3 strixxi ta ’ 10 pilloli Kaxxa fiha 18- il strixxa b’ 10 pilloli
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Franza
EU/ 2/ 07/ 074/ 001 – 002 (10 mg tablets) EU/ 2/ 07/ 074/ 003 – 004 (40 mg tablets) EU/ 2/ 07/ 074/ 005 – 006 (80 mg tablets)
EU/ 2/ 07/ 074/ 001 – 002 (pilloli ta ’ 10 mg) EU/ 2/ 07/ 074/ 003 – 004 (pilloli ta ’ 40 mg) EU/ 2/ 07/ 074/ 005 – 006 (pilloli ta ’ 80 mg)
7/ 25 ANNEX II
7/ 25 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IS- SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS
KONDIZZJONIJIET
RESTRICTIONS
RESTRIZZJONIJIET
OF
TA '
THE
L -
AUTHORISATION REGARDING SUPPLY OR USE
AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVISTA JEW L- UŻU
OF
TA ’
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
Très le Bois F-22600 Loudeac France
Très le Bois 22600 LOUDEAC Franza
Veterinary medicinal product subject to prescription.
Sabiex jiġi mogħti biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur għal din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma lil Kummissjoni Ewropea dwar il- pjanijiet ta ’ kummerċ għal prodott mediċinali awtorizzat b’ din id- deċiżjoni.
9/ 25 ANNEX III
9/ 25 ANNESS III
11/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton box labelling – 10 mg tablets
It- tikketta fuq il- kaxxa tal- kartun – pilloli ta ’ 10 mg
PRILACTONE 10 mg tablets for dogs Spironolactone.
PRILACTONE 10 mg pilloli għal klieb Spironolakton.
Each tablet contains 10 mg spironolactone
Kull pillola fiha 10 mg Spironolakton
30 tablets 180 tablets
30 pillola 180 pillola
Store partially used tablets in the original blister pack.
Aħżen il- pilloli parzjalment użati fil- blister oriġinali.
Disposal: read package leaflet.
Rimi: aqra l- fuljett tat- tagħrif.
For animal treatment only – to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss – sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne Franza
EU/ 2/ 07/ 074/ 001 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 002 (18 blisters of 10 tablets)
EU/ 2/ 07/ 074/ 001 (3 strixxi ta ’ 10 pilloli) EU/ 2/ 07/ 074/ 002 (18- il strixxa ta ’ 10 pilloli)
13/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton box labelling – 40 mg tablets
It- tikketta fuq il- kaxxa tal- kartun – pilloli ta’ 40 mg
PRILACTONE 40 mg tablets for dogs Spironolactone.
PRILACTONE 40 mg pilloli għal klieb Spironolakton.
Each tablet contains 40 mg spironolactone.
Kull pillola fiha 40 mg Spironolakton
For animal treatment only – to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
EU/ 2/ 07/ 074/ 003 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 004 (18 blisters of 10 tablets)
EU/ 2/ 07/ 074/ 003 (3 blisters ta ’ 10 pilloli) EU/ 2/ 07/ 074/ 004 (18- il blister ta ’ 10 pilloli)
15/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton box labelling – 80 mg tablets
It- tikketta fuq il- kaxxa tal- kartun – pilloli ta ’ 80 mg
PRILACTONE 80 mg tablets for dogs Spironolactone.
PRILACTONE 80 mg pilloli għal klieb Spironolakton.
Each tablet contains 80 mg spironolactone.
Kull pillola fiha 80 mg Spironolakton
Store partially used tablets in the original blister pack.
Aħżen pilloli parzjalment użati fil- blister oriġinali.
For animal treatment only - to be supplied only on veterinary prescription.
Għal trattament ta ’ l- annimali biss - sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
EU/ 2/ 07/ 074/ 005 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 006 18 blisters of 10 tablets
EU/ 2/ 07/ 074/ 005 (3 blisters ta ’ 10 pilloli) EU/ 2/ 07/ 074/ 006 (18- il strixxa ta ’ 10 pilloli)
MANUFACTURER’ S BATCH NUMBER
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
17/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
17/ 25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
Blister foil of 10 tablets
Blisters ta ’ 10 pilloli
PRILACTONE 10 mg tablets Spironolactone
PRILACTONE 10 mg pilloli Spironolakton
18/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18/ 25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
PRILACTONE 40 mg tablets Spironolactone
PRILACTONE 40 mg pilloli Spironolakton
{month/ year}
{xahar/ sena
19/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19/ 25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS
PRILACTONE 80 mg tablets Spironolactone
PRILACTONE 80 mg pilloli Spironolakton
21/ 25 PACKAGE LEAFLET
21/ 25 FULJETT TA ’ TAGĦRIF FIL- PAKKETT
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France Tel: + 33 (0) 5 57 55 40 40 e-mail: contact@ceva. com
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Franza Tel: + 33 (0) 5 57 55 40 40 Fax: + 33 (0) 5 57 55 40 06 e- mail: prilactone@ ceva. com
CEVA SANTE ANIMALE Z. I.
Manifattur li jħalli l- konsenja tmur fis- suq CEVA SANTE ANIMALE Z. I.
Très le Bois 22600 Loudéac France
Très le Bois 22600 LOUDEAC Franza
Excipients include beef flavouring.
Sustanzi mhux attivi jinkludu t- togħma taċ- ċanga.
PRILACTONE tablets are used in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Il- pilloli PRILACTONE jintużaw f’ kombinazzjoni ma ’ terapija standard, (li jinkludi appoġġ dijuretiku, meta meħtieġ) għat- trattament ta ’ falliment tal- qalb konġestiv ikkaġunat minn rigurġitazzjoni valvulari fil- klieb.
Do not use in pregnant or lactating animals or in animals used for, or intended for use in breeding.
Tużax meta l- annimali jkunu tqal jew waqt it- treddiegħ jew f’ annimali miżmuma bil- ħsieb tat - tnissil.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Tużax dan il- prodott fi klieb li jsofru miinn ipoadrenokortiċiżmu, iperkalemija jew iponatremija..
Do not use in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/ dysfunction).
Tużax flimkien ma ’ mediċini ta ’ kontra l- infjammazzjoni mhix sterojdi (NSAIDs) fi klieb b’ insuffiċjenza renali (indeboliment renali/ funzjoni ħażina).
A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.
Atrofija prostatika riversibbli (tnaqqis fid- daqs) ta ’ spiss tiġi osservata fi klieb irġiel sħaħ.
2 mg of spironolactone per kg of body weight once daily.
2 mg ta ’ Spironolakton għal kull kg ta ’ piż korporali darba kuljum
BODYWEIGHT 1 to 2.5 kg
1 sa 2. 5 kg
PRILACTONE PRILACTONE 10 mg Tablets 40 mg Tablets ½
Pilloli ta ’ 10 mg ½
PRILACTONE 80 mg Tablets
Pilloli ta ’ 80 mg
The tablet can either be mixed with a small amount of food offered prior to the main meal, or administered directly into the mouth after feeding.
Il- pillola tista ’ jew titħallat b’ ammont żgħir ta ’ ikel qabel l - ikla prinċipali jew tingħata direttament ġol- ħalq wara l- ikel.
Partially used tablets should be stored in the original blister pack.
Pilloli parzjalment użati għandhom jinżammu fl- istrixxa oriġinali
Do not use after the expiry date (EXP) which is stated on the carton and blister label.
Tużax wara d- data ta ’ l- iskadenza (JIS) fuq il- kartuna jew fuq it- tikketta tal- blister.
Special precautions for use in animals Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors.
Prekawzjonijiet speċjali għall- użu fl- annimali Il- funzjoni tal- kliewi u l- livelli ta ’ potassju fis- serum għandhom ikunu evalwati qabel jinbeda trattament ikkombinat bi Spironolakton u impedituri ACE.
Unlike in humans, an increased incidence of hyperkalaemia (raised blood potassium levels) was not observed in studies in dogs with this combination.
Inċidenza akbar ta ’ iperkalemija ma kinitx osservata fi provi kliniċi magħmulin fuq klieb b’ din il- kombinazzjoni, mhux bħal fil- bnedmin.
However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia.
Madankollu, fil- klieb b’ indeboliment fil- kliewi monitoraġġ regolari fuq il- funzjoni tal- kliewi u l- livelli ta ’ potassju fis- serum huwa rakkomandat peress li jista ’ jkun hemm riskju ogħla ta ’ iperkalemija.
Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see Contraindications).
Sorveljanza tal- funzjoni renali tagħhom u l- livelli tal- potassjum fil- plażma hija rakkomandata qabel il- bidu u waqt it- trattament b’ terapija kombinata (ara Kontra indikazzjonijiet).
As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the product to growing dogs.
Peress li Spironolakton għandu effett anti- androġeniku, mhuwiex rakkomandat li tamministra l- prodott lill- klieb li jkunu għadhom qed jikbru.
As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the product in dogs with liver dysfunction.
Peress li Spironolakton ikollu bijotrasformazzjoni epatika estensiva (fwied), attenzjoni għandha tingħata meta l- prodott jintuża fi klieb bi problemi tal- fwied.
Special precautions to be taken by the person administering the veterinary medicinal product to animals May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the product.
Jista ’ jikkaġuna sensittivita fil- ġilda: persuni li huma magħrufin li huma allerġiċi għal spirolakton m’ għandhomx jmissu dan il- prodott.
Interactions In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
Interazzjonijiet Fi studji kliniċi, PRILACTONE kien mogħti flimkien ma ’ furosemide u pimobendan mingħajr evidenza ta ’ reazzjonijiet avversi assoċjati.
As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Peress li l- indiċi terapewtiku għad- digoxin huwa dejjaq ħafna, huwa rakkomandat li tissorvelja mill- qrib klieb li qed jingħataw kemm digoxin u kemm Spironolakton
The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
L- amministrazzjoni jew ta ’ deoxycorticosterone jew ta ’ NSAIDs ma ’ Spironolakton tista ’ twassal għal tnaqqis moderat fl- effetti natrijuretiċi (tnaqqis ta ’ l- eliminazzjoni tas- sodju fl- awrina) ta ’ spironaolactone.
Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc) may potentially lead to hyperkalaemia.
Amministrazzjoni konkomitanti ta ’ spirolactone ma ’ impedituri- ACE u mediċini li ma jaħlux il- potassjum (bħal imblokkaturi tar- riċetturi ta ’ anġjotensin, imblokkaturi- ß, imblokkaturi tal- kanali tal- kalċjum, eċc.) jistgħu potenzjalment iwasslu għal iperkalemija.
(See Special precautions for use in animals).
(Ara Prekawzjonijiet speċjali għall- użu fl- annimali).
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
Spironolakton jista ’ jikkaġuna kemm induzzjoni u kemm impediment ta ’ l- enżimi ċitokromi P450 u għaldaqstant jistgħu jaffettwaw il- metaboliżmu ta ’ mediċini oħra li jutilizzaw dawn il- mogħdijet metaboliċi.
24/ 25 Overdose After administration of up to 10 times the recommended dose (20 mg/ kg) to healthy dogs, dose- dependent adverse effects were noted (see Adverse Reactions).
Doża eċċessiva Wara l- għoti sa 10 darbiet id- doża rakkomandata (20 mg/ kg) lil klieb f’ saħħithom, effetti avversi dipendenti fuq id- doża kienu nnotati (ara Reazzjonijiet Mhux Mixtieqa).
It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes.
F’ każ ta ’ inġestjoni aċċidentali massiva mill- kelb, ma hemm l- ebda antidotu jew trattament speċifiku Għaldaqstant huwa rrakkomandat li tinduċi r- remettar, il- ħasil ta ’ l- istonku (jiddependi fuq l- istima tar- riskju) u sorveljanza tal- elettroliti.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jgħinu sabiex tipproteġi l- ambjent.
PRILACTONE tablets are supplied in blister packs with 30 or 180 tablets per pack.
Il- pilloli PRILACTONE jiġu f’ pakketti ta ’ blisters ta ’ 30 jew 180 pillola f’ kull pakkett.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet kollha jitqegħdu fis- suq.
Pharmacodynamic properties Spironolactone and its active metabolites (including 7α -thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.
Kwalitajiet farmakodinamiċi Spironolakton u l- metaboliti attivi tiegħu (li jinkludu 7α- thiomethyl- Spironolakton u canrenone) jaħdmu bħala antagonisti speċifiċi ta ’ aldosterone u jeżerċitaw l- effetti tagħhom billi jorbtu kompetitivament mar- riċettur tal- mineralokortikojde li huwa lokalizzat fil- kliewi, il- qalb jew il- vażi tad- demm.
In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.
Fil- kilwa Spironolakton jimpedixxi ż- zamma tas- sodjum indott minn aldosterone li jwassal għall- eliminazzjoni tas- sodjum u sussegwentement ta ’ l- ilma, u żamma ta ’ potassjum.
The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure.
L- effetti renali ta ’ Spironolakton u l- metaboliti tiegħu jwasslu għal tnaqqis fil- volum ta ’ barra ċ- ċelloli u konsegwentement fi tnaqqis tat- tagħbija kardijaka tal - pressjoni fl- atriju tax- xellug.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Fis- sistema kardijovaskulari, Spironolakton jimpedixxi l- effetti detrimentali ta ’ aldosterone.
Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.
Għalkemm il- mekkaniżmu ta ’ azzjoni preċiż tal- aldosterone s’ issa mhuwiex magħruf b’ mod ċar, dan jippromwovi l- fibrożi mijokardijali, mudellar mill- ġdid mijokardijali u vaskulari u l- funzjoni ħażina ta ’ l- endotilju.
In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
F’ mudelli sperimentali fil- klieb, kien muri li terapija fuq tul ta ’ żmien ma ’ antagonist ta ’ aldosterone jimpedixxi l- funzjoni ħażina progressiva tal- ventrikolu tax- xellug u jimmodera l- immudellar mill- ġdid tal- ventrikolu tax- xellug fi klieb b’ falliment tal- qalb kroniku.
In a clinical trial, dogs treated with spironolactone in addition to standard therapy (ACE-inhibitors) demonstrated a reduction in cardiovascular disease deterioration compared to dogs treated with standard therapy alone.
Fi prova klinika, il- klieb ittrattati bi Spironolakton f’ żieda ma ’ terapija standard (impedituri ACE) urew tnaqqis fil- morbidità ta ’ mard kardjovaskulari mqabbel ma ’ klieb ittrattati b’ terapija standard waħedha.
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “ aldosterone escape”.
Meta intuża f’ kombinazzjoni ma ’ impedituri- ACE, spironolakton jista ’ jikkontrabatti l- effetti ta ’ “ ħarba ta ’ aldosterone ”.
A slight increase in aldosterone blood levels may be observed in animals on treatment.
Żieda żgħira fil- livelli ta ’ aldosterone fid- demm jistgħu jkunu osservati f’ annimali fuq trattament. Jista ’ jkun hemm ipertrofija taż- żona glomeruloża adrenali relatata mad- doża.
This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
Din hija maħsuba li hija minħabba l- attivazzjoni ta ’ mekkaniżmi ta ’ rispons, mingħajr konsegwenzi kliniċi kuntrarji.
What is Profender?
X' inhu Profender?
Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel.
Profender huwa mediċina kontra l- parassiti li fih żewġ sustanzi attivi, emodepside u praziquantel.
Modified-release means that the tablets release their active substances over a few hours.
Profender huwa disponibbli bħala soluzzjoni ċara ta 'lewn isfar fil- kannella għall - użu fil- qtates, u bħala pilloli b' rilaxx modifikat għall- klieb, dan ifisser li l- pilloli jerħu s- sustanzi attivi tagħhom fi żmien ftit sigħat.
Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 size of pipettes for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Is- soluzzjoni Profender hija ppakkjata f' forma ta 'pipetti għal użu lokalizzat (spot- on) li diġà huma mimlijin bil- kwantità adegwata ta' Profender meħtieġa għat- trattament ta 'qattus wieħed (pipetti bi tliet dożi skont il- piż tal- qattus) u f' forma ta' flixkun għal aktar minn doża waħda għal użu esklussiv fil- kirurġija veterinarja, f' liema każ il- veterinarju, qabel l- applikazzjoni, ikejjel il - volum eżatt ta 'Profender li jeħtieġ għal kull qattus.
Profender tablets are bone-shaped, and available in three different strengths to cover a range of dog weights (small, medium or large dogs).
Il- pilloli ta 'Profender għandhom forma ta' għadma u huma disponibbli fi tliet qawwiet differenti biex ikopru piżijiet differenti tal- klieb (klieb żgħar, ta 'daqs medju u kbar).
The tablets have a break-line.
Il- pilloli għandhom linja fin- nofs biex tinqasam.
What is Profender used for?
Għal xiex jintuża Profender?
Profender is used to treat cats and dogs that have, or are at risk of catching, “ mixed” (caused by more than one parasite) parasitic infections.
Profender jintuża għat- trattament ta 'klieb u qtates li jsofru minn, jew f' riskju ta' infezzjonijiet minn parassiti "diversi" (ikkawżati minn aktar minn parassita wieħed).
Profender works for infections caused by certain types of roundworms and tapeworms.
Profender jaħdem kontra l- infezzjonijiet ikkawżati minn ċerti tipi ta 'ħniex (nematodi) u duda (ċestodi).
Profender is given as a single treatment.
Profender jingħata bħala trattament wieħed.
Cats are treated using the Profender spot-on solution range.
Il- qtates huma ttrattati bl- użu tal- firxa ta 'soluzzjoni għal użu lokalizzat (spot- on) ta' Profender.
The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat ’ s skin, after parting the fur on the back of its neck at the base of its head.
Il- kwantità adegwata ta 'Profender (il- kontenut ta' pipetta mimlija jew il- volum imkejjel mill - veterinarju) hija applikata fuq il- ġilda tal- qattus, wara li jitferraq il- pil fuq wara tal- għonq fit - tarf ta 'isfel tar- ras.
Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting.
Il- klieb huma ttrattati bl- użu tal- pilloli b' rilaxx modifikat ta 'Profender, li jingħataw oralment meta l- kelb ikun fi stat ta' sawm.
The correct number of tablets or half tablets to use is calculated based on the dog’ s weight.
L- għadd adegwat ta 'pilloli jew nofs pilloli li għandhom jintużaw huwa kkalkolat skont il- piż tal- kelb.
How does Profender work?
Kif jaħdem Profender?
Reproduction is authorised provided the source is acknowledged How has Profender been studied?
Reproduction is authorised provided the source is acknowledged Iż- żewġ sustanzi attivi fi Profender jinteraġixxu ma 'partijiet differenti tas- sistemi tal- parassiti.
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 fil - klieb kif ukoll is- sigurtà fil- bnedmin (nies f' kuntatt mal- prodott) u għall- ambjent.
The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe.
L- effikaċja ta 'kull wieħed mill- prodotti kontra l- ħniex u d- dud speċifiċi ġiet studjata kemm fi studji f' laboratorju kif ukoll fi studji ta' skala wiesgħa (wieħed għall- ispot- on tal- qtates u ieħor għall- pilloli għall- klieb) li twettqu f' bosta lokalitajiet differenti fl- Ewropa kollha.
In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with parasitic gastrointestinal roundworms or tapeworms, were treated either with Profender or another medicine which is authorised in the European Union for this indication.
F' kull wieħed mill- istudji fuq il- post, ġew infettati b' mod naturali annimali ta 'varji razez, etajiet u piżijiet differenti minn ħniex u dud bħala parassiti gastrointestinali u ġew ittrattati bi Profender jew b' mediċina oħra awtorizzata fl- Unjoni Ewropea għal din l- indikazzjoni.
The comparator was selamectin in cats, and milbemycin oxime and praziquantel in dogs.
Il- mediċina tat- tqabbil (comparator) kien is- selamektina (selamectin) għall- qtates u milbemycin oxime u praziquantel għall- klieb.
The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal’ s faeces after treatment.
L- effikaċja tkejlet billi ġie osservat l- għadd ta 'bajd tad- dud jew il- biċċiet tad- dud li ġew eliminati mill- feċi tal- annimal wara t- trattament.
What benefit has Profender shown during the studies?
Liema benefiċċju wera Profender waqt l- istudji mwettqa?
The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender is as effective as the comparator medicine.
Ir- riżultati mill- istudji f' laboratorju u mill- istudji fuq il- post, kemm fil- qtates kif ukoll fil- klieb, urew li Profender huwa aktar effikaċi bħala mediċina tat- tqabbil.
Over 90% of cats and 99% of dogs have no roundworm or tapeworm infection after treatment with Profender.
Wara t- trattament bi Profender, aktar minn 90% tal- qtates u 99% tal- klieb ma sofrewx minn infezzjonijiet mill- ħniex jew mid - dud.
What is the risk associated with Profender?
X' inhu r- riskju assoċjat bi Profender?
In cats, in very rare cases, the cat might salivate or vomit after treatment.
F' każijiet rari ħafna, wara t- trattament, fil- qtates jista 'joħroġilhom il- bżieq jew jirremettew.
This is thought to occur as a result of the cat licking the application site straight after treatment.
Dan huwa maħsub li jseħħ bħala konsegwenza tal- fatt li l- qattus jilgħaq il- punt tal- applikazzjoni immedjatament wara t- trattament.
In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat ’ s skin.
F' każijiet rari ħafna, huwa possibbli li jaqbdu ħakk, infjammazzjoni jew telf tal- pil temporanju fil- punt fejn ġie applikat il- prodott fuq il- ġilda tal - qattus.
These signs disappear without further treatment.
Dawn is- sinjali jitilqu mingħajr ebda trattament ulterjuri.
No side effects have been reported in dogs.
Ma ġie rrappurtat l- ebda effett sekondarju għall- klieb.
Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).
Profender ma għandux jintuża f' anninali ta 'età żgħira (qtates b' età inqas minn 8 ġimgħat jew li jiżnu inqas minn 0. 5 kg, jew ġriewi ta' età inqas minn 12- il ġimgħa jew li jiżnu inqas minn 1 kg).
As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet.
Bħal fil- każ ta 'prodotti oħra ta' dan it- tip, Profender għandu jintuża fuq qtates u klieb morda biss wara valutazzjoni mwettqa mill- veterinarju tar- relazzjoni bejn ir- riskji u l- benefiċċji.
Profender should not be used for any other animal species.
Profender ma għandux jintuża għal xi speċijiet ta 'annimal oħra.
Profender should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Profender ma għandux jitħalla jidħol f' kuntatt mal- ilma f' wiċċ l- art, billi jista 'jkun ta' ħsara għall- organiżmi akkwatiċi.
Spot-on for Cats:
Użu spot- on għall- qtates:
As a precautionary measure, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry.
Bħala miżura ta 'prekawzjoni, għandu jiġi evitat kull kuntatt tal- ġilda mal- kontenut tal- pipetta u l- annimali ma għandhomx jitmellsu, jitnaddfu jew jitħallew jilagħqu lil xulxin sakemm il- punt fejn ikun ġie applikat ikun nixef.
Frequent users of the product (for example, professional cat breeders) and women who are or could be pregnant, are advised to wear disposable gloves when using the product.
Jingħata parir lill- utenti frekwenti tal- prodott (pereżempju, il - professjonisti tat- trobbija tal- qtates) u lin- nisa li huma jew jistgħu jkun tqal biex, meta jużaw il - prodott, jilbsu ingwanti li jintremew wara l- użu.
When administering Profender, users should not smoke, eat or drink, and should wash their hands thoroughly after use.
Waqt li jingħata Profender, l- utenti ma għandhomx ipejpu, jieklu jew jixorbu, u għandhom jaħslu idejhom sew wara l- użu.
If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.
Jekk ikun Paġna 2/ 3 ©EMEA 2008 hemm esponiment aċċidentali għall- prodott, l- għajnejn għandhom jitlaħalħu sew bl- ilma jew il - ġilda għandha tinħasel bis- sapun u l- ilma.
The solvent in Profender may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Is- solvent fi Profender jista 'jtebba' ċerti materjali fosthom ġilda, drappijiet, plastiks u wċuħ lesti, għalhekk, kuntatt bejn il- prodott u dawn l- uċuħ għandu jiġi evitat.
Tablets for Dogs:
Użu tal- pilloli għall- klieb:
Users should wash their hands after administering the tablets to the dog.
Wara li jagħtu l- pilloli lill- kelb, l- utenti għandhom jaħslu idejhom.
Why has Profender been approved?
Għaliex ġie approvat Profender?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Profender exceed the risks for cats or dogs suffering from, or at risk from, mixed parasitic infections, and recommended that Profender be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta 'Profender huma ogħla mir- riskji għall- klieb u l- qtates li jbatu minn, jew f' riskju ta' infezzjoni minn parassiti "diversi", u jirrakkomanda li Profender jingħata awtorizzazzjoni għat- tqegħid fis - suq.
The benefit- risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn il- benefiċċji u r- riskji jista 'jiġi kkonsultat fil- modulu 6 ta' dan l- EPAR.
Other information about Profender:
Aktar tagħrif dwar Profender:
The European Commission granted a marketing authorisation valid throughout the European Union for Profender to Bayer HealthCare AG (now Bayer Animal Health GmbH) on 27 July 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Profender lil Bayer HealthCare AG (illum Bayer Animal Health GmbH) fis- 27 ta 'Lulju 2005.
Information on the prescription status of this product may be found on the outer package.
L- informazzjoni dwar l- istat tal- preskrizzjoni ta 'dan il- prodott tista' tiġi kkonsultata fuq it- tikketta jew fuq il- pakkett ta 'barra.
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Paġna 3/ 3 ©EMEA 2008
EU Number
Speċi li fuqhom
Invented Name
Mod ta ’
Strengths
Kontenut
Pharmaceutical
Daqs tal -
Target
Perjodu
Route of
Numru ta ’ l- UE
Packaging
Isem kummerċjali
Package size
Għamla Farmaċewtika
Withdrawal
għandu jintuża l - prodott
Form
Amministrazzjoni
species
Ippakkjar
administration
pakkett
period
ta ’ Tiżmim
Profender spot-on solution
Profender - taħlita likwida għal użu lokalizzat fuq qtates żgħar
85.8 mg/ ml
85. 8 mg/ ml praziquantel 21. 4 mg/ ml emodepside
Spot-on solution
Taħlita likwida għall- użu lokalizzat
Spot-on use
Użu lokaliżżat
Pipette (PP)
Pipetta (PP) b’ għatu tal - kamin (PP)
21.4 mg/ ml emodepside
Mhux applikabbli.
Spot-on solution
Taħlita likwida għall- użu Qtates lokalizzat
Pipette (PP)
Pipetta( PP) b’ għatu tal - kamin (PP)
12 pipettes
12 – il pipetta
20 pipettes
20 pipetta
40 pipettes
40 pipetta
Profender spot-on solution
Profender - taħlita likwida għal użu lokalizzat fuq qtates ta ’ daqs medju.
for medium cats
Speċi li fuqhom
praziquantel &
Kontenut
with screw
Daqs tal -
21.4 mg/ ml emodepside
Għamla Farmaċewtika
cap (PP)
pakkett
80 pipettes
80 pipetta
Profender spot-on solution
Profender - taħlita likwida għal użu lokalizzat fuq qtates kbar.
Profender spot-on solution
Profender - taħlita likwida għal użu lokalizzat fuq qtates.
Bottle (glass)
Flixkun (ħġieġ)
praziquantel &
Flixkun wieħed
Profender tablets for small 15 mg praziquantel & 3
15 mg praziquantel 3 mg emodepside
Modified-release
Pillola li terħi il b' mod modifikat
Oral use
- mediċina Klieb
Blister
Użu orali
-release Dogs Oral use Blister -
Folja -
mg emodepside
Mhux applikabbli.
dogs
2/ 3
mg emodepside
Speċi li fuqhom
tablets
Perjodu
(Alu/ Alu)
Ippakkjar
10 tablets
10 pilloli
24 tablets
24 pillola
50 tablets
50 pillola
Profender tablets for
Pilloli Profender għal Klieb ta’ daqs Medju
50 mg praziquantel &
50 mg praziquantel 10 mg emodepside
10 mg emodepside
Mhux applikabbli.
6 tablets
6 pilloli
102 tablets
102 pilloli
Profender tablets for large 150 mg praziquantel &
Pilloli Profender għal Klieb Kbar
Modified-release
150 mg praziquantel Pillola li terħi il 30 mg emodepside b' mod modifikat
30 mg emodepside
Mhux applikabbli.
52 tablets
52 pillola
1 [Single-dose pipettes]
1 [Pipetti ta ’ doża waħda]
Profender spot-on solution for small cats Profender spot-on solution for medium cats Profender spot-on solution for large cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates kbar.
Profender contains 21.4 mg/ ml emodepside and 85.8 mg/ ml praziquantel.
Profender fih 21. 4 mg/ ml emodepsajd u 85. 8 mg/ ml prazikwantel.
Each unit dose (pipette) of Profender delivers:
Kull doża (pipetta) ta ’ Profender fiha:
Emodepside
Emodepsajd
Praziquantel
Prazikwantel
Profender for Small Cats (≥ 0.5 - 2.5 kg)
Profender għall- qtates żgħar (≥ 0. 5 - 2. 5 kg)
0.35 ml
0. 35ml
Profender for Medium Cats (> 2.5 – 5 kg)
Profender għall- qtates ta ’ daqs medju (> 2. 5 - 5kg)
Profender for Large Cats (> 5 – 8 kg)
Profender għall- qtates kbar (> 5 - 8 kg)
5.4 mg/ ml butylhydroxyanisole (E320; as antioxidant)
5. 4 mg/ ml butylhydroxyanisole (E320; bħala antiossidant)
Clear yellow to brown solution.
Taħlita għal użu lokalizzat Taħlita ta ’ kulur isfar ċar li jista jkangi fil- kannella
For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:
Għal qtates li qed isofru minn, jew huma fil- periklu ta´infezzjonijiet ikkawżati minn parassiti diversi ta ’ dawn l- ispeċi:
Roundworms (Nematodes) Toxocara cati (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma tubaeforme (mature adult, immature adult and L4)
Ħniex (Nematodi) Toxocara cati (adulti maturi, adulti mmaturi, L4 u L3) Toxascaris leonina (adulti maturi, adulti mmaturi u L4) Ancylostoma tubaeforme (adulti maturi, adulti mmaturi u L4)
2 Tapeworms (Cestodes) Dipylidium caninum (adult) Taenia taeniaeformis (adult) Echinococcus multilocularis (adult)
2 Ħniex (Cestodi) Dipylidium caninum (adult) Taenia taeniaeformis (adult) Echinococcus multilocularis (adult)
Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.
Tużax fuq qtates li għandhom inqas minn 8 ġimgħat jew li jiżnu inqas minn 0. 5 kg.
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product.
L- użu ta ’ xampu jew l- għads ta ’ l- annimal ġo l- ilma eżatt wara t- trattament jista´ jnaqqas l- effett tal - prodott.
Treated animals therefore should not be bathed until the solution has dried.
Għalhekk annimali li ġew trattati m`għandhomx jiġu maħsula qabel ma ’ t- taħlita tkun nixfet.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Reżistenza tal- parassita għal kull klassi ta ’ antiħelmentiċi tista ’ tiżviluppa meta jkun hemm użu spiss u ripetut ta ’ antiħelmentiċi ta ’ dik il- klassi.
Apply only to the skin surface and on intact skin.
Applika biss fuq il- wiċċ tal- ġilda u fuq ġilda ntatta.
Do not administer orally or parenterally.
Tapplikax oralment jew parenteralment.
Avoid the treated cat or other cats in the household licking the site of application while it is wet.
Tħallix il- qattus li ġie trattat jew qtates oħra fid- dar jilgħaqu l- parti trattata waqt li din tkun għadha mxarrba.
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 benefit-risk assessment for these animals.
Għalhekk dan il- prodott għandu biss jiġi wżat wara valutazzjoni tar- riskju u benefiċċju fuq dawn l- annimali.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif ta ’ ġol- pakkett qabel tuża.
Do not smoke, eat or drink during application.
Tpejjipx, tiekolx jew tixrob waqt li qed tuża l- prodott.
Avoid direct contact with application area while it is wet.
Evita kuntatt dirett mal- parti fejn tapplika l- prodott, meta din tkun imxarrba.
Keep children away from treated animals during that time.
Waqt il- perjodu tat - trattament, tħallix tfal imissu l- annimali.
Wash hands after use.
Aħsel idejk sew wara li tuża.
If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
F’ każ li l- prodott jiġu f’ kuntatt ma ’ l- għajnejn, baħbaħ malajr b’ ħafna ilma.
If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
Jekk sintomi fil- ġilda jew fl- għajnejn jippersistu, jew fil- każ li l- prodott jiġi inġestit aċċidentalment, kellem lit- tabib u urih l- fuljett ta ’ tagħrif ta ’ ġol- kaxxa.
Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product.
It- tfal m’ għandux ikollhom kuntatt twil u intensiv (per. eż. jorqdu) mal- qtates trattati matul l- ewwel 24 siegħa wara l- applikazzjoni tal- prodott.
Frequent users of the product (for example, veterinarians, professional cat breeders) should wear disposable gloves when administering the product.
Dawk li jużaw dan il- prodott sikwit, (eż. veterinarji, nies li jrabbu l- qtates professjonalment) għandhom jużaw ingwanti, li jintużaw darba biss u wara jintremew, kull darba li l- prodott jiġi użat.
Although the product was well tolerated by pregnant cats, studies performed in rats and rabbits suggest that emodepside may interfere with embryo-foetal development.
Għalkemm il- prodott ġie ttollerat minn qtates tqal, studji li saru fuq firien u fniek juru li emodepsajd jista ’ jaffettwa l- iżvilupp tal- fetu fil- ġuf.
Therefore, women of child- bearing potential should avoid contact with, or wear disposable gloves when administering, the product.
Għalhekk nisa li jistgħu jkunu tqal għandhom jevitaw kuntatt mal- prodott u għandhom jilbsu l- ingwanti kull meta jużawh.
The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces.
Is- solvent li hemm fil- prodott jista´ jtebba ’ materjali differenti, fosthom ġild, drapp, plastik u wċuħ illostrati.
Allow the application site to dry before permitting contact with such materials.
Tħallix l- parti t´applikazzjoni tagħmel kuntatt ma´ dawn it- tipi ta’ materjali, qabel ma tinxef.
Echinococcosis represents a hazard for humans.
L- ekinokokkosi hija ta ’ periklu fl- uman.
As Echinococcosis is a notifiable disease to the OIE, specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Billi l- ekinokokkosi hija marda li għandha tkun notifikata lil OIE, tagħrif speċifiku fuq it- trattament u monitoraġġ, u fuq is- sigurta ’ tal- persuni għandu jiġi akkwistat mingħand l- awtorita ’ relevanti u kompetenti.
This is thought to occur as a result of the cat licking the application site immediately after treatment.
Jista ’ jkun hemm każijiet rarissimi ta ’ tbeżliq u rriġettar.
In very rare cases following administration of Profender transient alopecia, pruritus and/ or inflammation were observed at the application site.
Huwa maħsub li dan jiġri meta l- qattus jilgħaq partijiet t’ applikazzjoni, direttament wara t- trattament. F`każijiet rarissimi ġew osservati alopecia riversibbli, pruritus u/ jew infjammazzjoni fejn ġie applikat il- prodott.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- tqala, fi żmien il- ħalib jew meta jbidu l- bajd
Can be used during pregnancy and lactation.
Jista ’ jintuża waqt it- tqala u fi żmien il- ħalib.
Emodepside is a substrate for P-glycoprotein.
Emodepsajd huwa substrat tal- p- glajkoprotejn.
Co-treatment with other drugs that are P-glycoprotein substrates/ inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions.
Trattament flimkien ma ’ mediċina oħra li hija substrat/ inibitur tal- p- glajkoprotejn (eż. ivermektina, u lattoni makroċikliċi oħra kontra l- parassiti, eritromiċina, prednisolon u ċiklosporin) jista ’ jirriżulta f’ effetti farmakokinetiċi mediċinali.
The potential clinical consequences of such interactions have not been investigated.
Il - konsegwenzi kliniċi potenzjali t’ effetti bħal dawn għadhom ma ġewx investigati.
Dosage and Treatment Schedule
Skeda tad- doża u trattament
The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.
Id- dożi minimi rakkomandati huma ta´ 3 mg emodepsajd għal kull kg piż tal- ġisem u 12 mg praziquantel għal kull kg piż tal- ġisem, li jiġu ekwivalenti għal 0. 14 ml Profender għal kull kg piż tal - ġisem.
Body Weight of Cat (kg)
Qies tal- Pipetta għall- użu
Pipette size to be used
Prazikwantel
Volume (ml)
Qattus [kg]
Emodepside (mg/ kg bw)
[mg/ kg piż tal - ġisem]
Praziquantel (mg/ kg bw)
[mg/ kg piż tal - ġisem]
≥ 0.5 - 2.5 > 2.5 - 5 > 5 - 8
≥ 0. 5 – 2. 5 > 2. 5 - 5
Profender for Small Cats Profender for Medium Cats Profender for Large Cats
Profender għall- qtates żgħar Profender għall- qtates ta ’ daqs medju
0.35 0.70 1.12
1. 12
3 - 15 3-6 3 - 4.8
3 – 4. 8
12 - 60 12 - 24 12 - 19.2
12 – 19. 2
Use an appropriate combination of pipettes
Agħżel qisien adattati ta ’ pipetti
A single administration per treatment is effective.
Amministrazzjoni waħda għal kull trattament hija effettiva.
Method of administration
Metodu t ’ amministrazzjoni
Remove one pipette from package.
Neħħi pipetta waħda mill- pakkett.
Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.
Aqleb l - għatu ta´taħt fuq u użah biex tilwi u tneħhi s- siġill tal- pipetta.
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.