FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of data on final height comes from 13 Genotropin subjects in the Bechtold study, where many of the confounding factors were not adequately addressed, therefore it is not possible to draw conclusions from these data.
Maltese: Ilmaġġoranza tad-dejta dwar it-tul finali ġejja minn 13-il suġġett b'Genotropin fl-istudju Bechtold, fejn ħafna mill-fatturi ta' tħassib ma ġewx indirizzati b'mod adegwat, għaldaqstant mhuwiex possibbli li jinkisbu konklużjonijiet minn din id-dejta.
English: EMA/398383/2014 EMEA/H/C/000262
Maltese: EMEA/H/C/000262
English: The full EPAR for Enbrel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Enbrel was also compared with placebo in 51 children with polyarticular juvenile idiopathic arthritis, 205 adults with psoriatic arthritis, 357 adults with ankylosing spondylitis, 1,263 adults and 211 children with plaque psoriasis, as well as in 225 patients with non-radiographic axial spondyloarthritis.
Maltese: Enbrel tqabbel ukoll ma' plaċebo f'51 tifel u tifla bl-artrite idjopatika ġuvenili poliartikulari, 205 adulti bl-artrite psorijatika, 357 adult bi spondilite ankilosanti, u 1,263 adult u 211-il tifel u tifla bi psorijażi bil-qoxra, kif ukoll f'255 pazjent bi spondiloartrite sksjali mhux radjografika.
English: Enbrel is an anti inflammatory medicine.
Maltese: Enbrel huwa mediċina antiinfjammatorja.
English: Other information about Enbrel
Maltese: Informazzjoni oħra dwar Enbrel
English: Enbrel is a medicine that contains the active substance etanercept.
Maltese: Enbrel huwa mediċina li fiha s-sustanza attiva etanercept.
English: This is a summary of the European public assessment report (EPAR) for Enbrel.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Enbrel.
English: • moderate to severe rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults (aged 18 years or over).
Maltese: • artrite rewmatika moderata sa severa (marda tas-sistema immunitarja li tikkawża infjammazzjoni fil-ġogi) f'adulti (minn 18-il sena 'l fuq).
English: Etanercept is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) that makes them able to produce etanercept.
Maltese: L-etanercept jiġi prodott b'metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA': hija magħmula minn ċelloli li jkunu rċevew ġene (DNA), li jagħmilhom possibbli biex jipproduċu l-etanercept.
English: For adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Maltese: Għall-adulti, id-doża rakkomandata normali hija 25 mg darbtejn fil-ġimgħa jew 50 mg darba fil-ġimgħa.
English: The active substance in Enbrel, etanercept, is a protein that has been designed to block the activity of a chemical messenger in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Enbrel, l-etanercept, hija proteina li tfasslet biex timblokka l-attività ta' messaġġier kimiku fil-ġisem magħruf bħala fattur tan-nekrożi tumorali (TNF).
English: In the fourth study, Enbrel was compared with methotrexate in 632 patients who had not taken methotrexate before.
Maltese: Fir-raba' studju, Enbrel tqabbel mal-metotressat f'632 pazjent li qatt qabel ma kienu ħadu l-metotressat.
English: • Severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray.
Maltese: • Spondiloartrite aksjali mhux radjografika severa (marda infjammatorja kronika tal-ispina) meta jkun hemm sinjali oġġettivi ta' infjammazzjoni iżda l-ebda anormalità ma tidher fuq raġġi x.
English: The most common side effects with Enbrel (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Maltese: L-effetti sekondarji l-aktar komuni b'Enbrel (li dehru f'iktar minn pazjent 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (inkluż dmija, tbenġil, ħmura, ħakk, uġigħ u nefħa), u infezzjonijiet (inkluż irjiħat, u infezzjonijiet fil-pulmun, fil-bużżieqa tal-awrina u fil-ġilda).
English: The fifth study compared the effectiveness of Enbrel, methotrexate and a combination of both in 686 patients.
Maltese: Il-ħames studju qabbel leffikaċja ta' Enbrel, tal-metotressat u tal-kombinazzjoni tagħhom it-tnejn f'686 pazjent.
English: Patients who take Enbrel must be given the special alert card that summarises important safety information about the medicine.
Maltese: Il-pazjenti li jieħdu Enbrel għandhom jingħataw skeda ta' twissija speċjali li tinkludi sommarju talinformazzjoni importanti dwar is-sigurtà tal-mediċina.
English: adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment.
Maltese: adolexxenti li għandhom bejn 12 u 17-il sena li jkollhom artrite psorjatika (marda li tikkawża rqajja ħomor, bil-qoxra fuq il-ġilda u infjammazzjoni tal-ġogi) u li ma jkunux irrispondew b'mod adegwat għall-metotressat jew li ma jistgħux jiħduh;
English: One of these studies examined Enbrel's effects as an add-on to methotrexate in 89 patients.
Maltese: Wieħed minn dawn l-istudji eżamina l-effetti ta' Enbrel bħala żieda mal-metotressat f'89 pazjent.
English: A risk management plan has been developed to ensure that Enbrel is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Enbrel jintuża bl-aktar mod sigur possibbli.
English: What is the risk associated with Enbrel?
Maltese: X'inhu r-riskju assoċjat ma' Enbrel?
English: • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults who have not responded adequately to other treatments;
Maltese: • spondilite ankilosanti severa (marda li tikkawża infjammazzjoni fil-ġogi tas-sinsla tad-dahar) f'adulti li ma jkunux irrispondew b'mod adegwat għal kuri oħra;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enbrel on 3 February 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Enbrel fit-3 ta' Frar 2000.
English: The studies in children with polyarticular juvenile idiopathic arthritis and plaque psoriasis were followed up with long term studies to assess the safety of long term treatment in children.
Maltese: L-istudji fit-tfal bl-artrite idjopatika ġuvenili poliartikulari u bil-psorijażi bil-qoxra ġew segwiti bi studji fit-tul sabiex issir evalwazzjoni tas-sigurtà ta' kura fit-tul fit-tfal.
English: • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in the following groups:
Maltese: • ċerti forom tal-artrite idjopatika ġuvenili (marda rari li tfeġġ fit-tfulija li tikkawża infjammazzjoni ta' ħafna ġogi) fil-gruppi li ġejjin:
English: Overall, in the studies of rheumatoid arthritis, about two-thirds of the patients receiving Enbrel had a reduction in symptoms of 20% or more after three months.
Maltese: B'mod ġenerali, fl-istudji dwar l-artrite rewmatojde, madwar żewġ terzi tal-pazjenti li kienu qed jieħdu Enbrel kellhom tnaqqis fis-sintomi ta' 20% jew iktar wara tliet xhur.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults with moderate to severe disease and in patients from the age of six years with long-term severe disease;.
Maltese: • psorijażi bil-qoxra (marda li tikkawża rqajja' ħomor bil-qoxra fuq il-ġilda) f'adulti morda moderatament sa serjament u f'pazjenti minn sitt snin 'il fuq li jkollhom marda severa fit-tul.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Maltese: Billi jimblokka t-TNF, l-etanercept inaqqas l-infjammazzjoni u sintomi oħra tal-mard.
English: Enbrel is used with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient.
Maltese: Enbrel jintuża mal-metotressat (mediċina li taġixxi fuq issistema immunitarja) f'adulti morda moderatament sa serjament jew li ma jkunux irrispondew b'mod adegwat għal kuri oħra, jew waħdu jekk il-metotressat ma jkunx jaqbel mal-pazjent.
English: How does Enbrel work?
Maltese: X'inhu Enbrel?
English: In the study of patients who had not taken methotrexate before, those receiving 25 mg Enbrel twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
Maltese: Fl-istudju ta' pazjenti li qatt qabel ma kienu ħadu lmetotressat, dawk li kienu qed jieħdu 25 mg Enbrel darbtejn fil-ġimgħa kellhom inqas ħsara fil-ġogi minn dawk li kienu qed jieħdu l-metotressat waħidha wara 12 u 24 xahar.
English: For the full list of all side effects reported with Enbrel, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Enbrel, ara l-fuljett ta' tagħrif.
English: The company that makes Enbrel will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled pen correctly) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Maltese: Il-kumpanija li timmanifattura Enbrel se tipprovdi materjal edukattiv għat-tobba li mistennija jippreskrivu l-prodott (biex jgħallmu lill-pazjenti kif jużaw il-pinna mimlija minn qabel b'mod korrett) u għall-pazjenti (sabiex ikunu jistgħu jagħrfu kwalunkwe effett sekondarju serju, u jkunu jafu meta għandhom ifittxu attenzjoni urġenti mit-tabib tagħhom).
English: What is Enbrel?
Maltese: Kif jaħdem Enbrel?
English: Formodual 100/6 Mikrogramm/Sprüh stoß,
Maltese: Mikrogramm/Sprü hstoß,
English: 63, Ag. Dimitriou Str., GR 174 56 Alimos, Greece
Maltese: Dimitriou Str., GR 174 56
English: United Kingdom
Maltese: UK
English: Chiesi Limited, Cheadle Royal Business Park, Highfield, Cheadle, Cheshire SK8 3GY, UK
Maltese: Ir-Renju Unit Chiesi Limited, Cheadle Royal Business Park, Highfield,
English: Chiesi Pharmaceuticals GmBH Gonzagagasse 16/6 Vienna A-1010 Austria
Maltese: Is-Slovenja Chiesi Pharmaceuticals GmBH Gonzagagasse 16/16 Vienna
English: Belgium Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122
Maltese: Il-Finlandja Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122 Italy
English: Luxembourg Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122
Maltese: Il-Ġermanja Chiesi Farmaceutici S.p.A. via Palermo 26/A , Parma 43122 Italy
English: ATCvet code: QC03DA01.
Maltese: QC03DA01.
English: 5 to 10 kg 10 to 15 kg 15 to 20 kg 20 to 30 kg 30 to 40 kg 40 to 50 kg 50 to 60 kg
Maltese: 5 sa 10 kg 10 sa 15 kg 15 sa 20 kg 20 sa 30 kg 30 sa 40 kg 40 sa 50 kg 50 sa 60 kg
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Maltese: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Franza
English: Tel: + 33 (0) 5 57 55 40 40 Fax : + 33 (0) 5 57 55 41 98
Maltese: Faks: + 33 (0) 5 57 55 41 98
English: Très le Bois 22600 Loudéac France
Maltese: 22600 Loudéac
English: Pharmacotherapeutic group: Aldosterone antagonist.
Maltese: Grupp Farmako-terapewtiku: antagonista ta' aldosterone.
English: 30 tablets 180 tablets
Maltese: 180 pillola
English: Spironolactone.
Maltese: Spironolakton.
English: Food increases the bioavailability from 80 % to 90 %.
Maltese: L-ikel iżid il-bijodisponibiltà minn 80 % sa 90%.
English: Lot {number}
Maltese: {xahar/sena}
English: 1 to 2.5 kg
Maltese: 1 sa 2.5 kg
English: Symptomatic treatment, e.g., fluid therapy, should be provided.
Maltese: Trattament simptomatiku, eż. terapija bil-fluwidi, għandu jkun ipprovdut.
English: Date of first authorisation: 20 June 2007 Date of last renewal: 22 May 2012
Maltese: Data tal-aħħar tiġdid: 22 ta 'Mejju 2012
English: 2.5 to 5 kg
Maltese: 2.5 sa 5 kg
English: Spironolactone
Maltese: Spironolakton
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża Eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk neċessarji
English: The mean volumes of distribution (Vss) of 7α-thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres, respectively.
Maltese: Il-volumi medji ta' distribuzzjoni (Vss) ta' 7α-thiomethyl-Spironolakton u canrenone huma madwar 153 litri u 177 litri rispettivament.
English: Polyamide/aluminium/polyvinyl chloride//aluminium blisters containing 10 tablets.
Maltese: Strixxi li fihom 10 pilloli tal-Poliamide/aluminju/polyvinyl chloride//aluminju.
English: Magnesium stearate
Maltese: Sterat tal-magnesju
English: In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Maltese: Fis-sistema kardijovaskulari, spironolakton jimpedixxi l-effetti detrimentali ta' aldosterone.
English: Sodium laurilsulfate Microcrystalline cellulose Povidone
Maltese: Lawrisulfat tas-sodju Mikrokristallina ċellulosi Povidone
English: Beef flavouring Mannitol
Maltese: Essenza taċ-ċanga Mannitol
English: Plasma clearance of canrenone is 1.45±0.39 l/h/kg and 7α-thiomethyl-spironolactone is 0.89±0.44 l/h/kg.
Maltese: 39 l/h/kg u ta' 7α-thiomethyl-Spironolakton hija ta' 0.89±0.44 l/h/kg.
English: Dogs
Maltese: Biss
English: C. STATEMENT OF THE MRLs
Maltese: TAL-MRLs
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' sustanzi
English: Blister - 10 mg tablets, 40 mg tablets and 80 mg tablets
Maltese: Strixxi - Pilloli ta' 10 mg, pilloli ta' 40 mg u pilloli ta' 80 mg
English: Ceva Santé Animale Z.I.
Maltese: Ceva Santé Animale Z.I. Très le Bois 22600
English: Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7αthiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
Maltese: Spironolakton huwa metabolizzat malajr u kompletament mill-fwied għal metaboliti attivi tiegħu, 7αthiomethyl-Spironolakton u canrenone, li huma l-metaboliti primarji fil-kelb.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMEA) http://www.ema.europa.eu/.
English: Cardboard box containing 3 or 18 blisters of 10 tablets.
Maltese: Kaxxa tal-kartun bi 3 strixxi jew 18-il strixxa ta' 10 pilloli
English: Mean Cmax of 382 μg/l and 94 μg/l are achieved for the primary metabolites, 7αthiomethyl-spironolactone and canrenone, after 2 and 4 hours, respectively.
Maltese: Cmax medju ta' 382 μg/l u 94 μg/l jinkisbu għal metaboliti primarji, 7α-thiomethyl-Spironolakton u canrenone, wara
English: Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see section 4.3).
Maltese: Sorveljanza tal-funzjoni renali tagħhom u l-livelli tal-potassjum fil-plażma hija rakkomandata qabel il-bidu u waqt it-trattament b'terapija kkombinata (ara sezzjoni 4.3).
English: Bottle containing 30 tablets packed in a cardboard box.
Maltese: Flixkun li fih 30 pillola ppakkjati ġo kaxxa tal-kartun.
English: Bottle of 30 tablets
Maltese: DAQS TAL-PAKKETT 30 pillola
English: There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.
Maltese: Jista' jkun hemm ipertrofija taż-żona glomeruloża adrenali relatata mad-doża.
English: Pack sizes
Maltese: DIKJARAZZJONI
English: 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.
Maltese: L-amministrazzjoni jew ta' deoxycorticosterone jew ta' NSAIDs ma' spironolakton tista' twassal għal tnaqqis moderat fl-effetti natrijuretiċi (tnaqqis ta' l-eliminazzjoni tas-sodjum fl-awrina) ta' spironolactone.
English: 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.
Maltese: 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.
English: EXP: {month/year}
Maltese: EXP.
English: 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 (see section 4.5).
Maltese: Amministrazzjoni konkomitanti ta' spironolakton ma' impedituri-ACE u mediċini li ma jaħlux ilpotassjum (bħal imblokkaturi tar-riċetturi ta' anġjotensin, imblokkaturi-ß, imblokkaturi tal-kanali talkalċjum, eċc.) jistgħu potenzjalment iwasslu għal iperkalemija (ara sezzjoni 4.5).
English: Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see section "Contraindications").
Maltese: 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).
English: 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.
Maltese: 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.
English: Spironolactone Ceva 10 mg contains 10 mg spironolactone Spironolactone Ceva 40 mg contains 40 mg spironolactone Spironolactone Ceva 80 mg contains 80 mg spironolactone
Maltese: U INGREDJENT(I) OĦRA Spironolactone Ceva 10 mg fih 10 mgspironolakton Spironolactone Ceva 40 mg fih 40 mgspironolakton Spironolactone Ceva 80 mg fih 80 mg spironolakton
English: Spironolactone is a natriuretic drug (historically described as a soft diuretic).
Maltese: Spironolakton huwa mediċina natrijuretika (storikament deskritt bħala dijuretiku artab).
English: Ceva Santé Animale ensures that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Maltese: Ceva Santé Animale jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta f'Parti I tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq, qegħda f'postha u qed tiffunzjona qabel u waqt li l-prodott mediċinali veterinarju jkun fis-seħħ.
English: CEVA
Maltese: ISEM
English: After multiple oral doses of 2 mg spironolactone/ kg for 10 consecutive days, no accumulation is observed.
Maltese: Wara dożi orali multipli ta' 2 mg spironolakton/ kg, għal 10 ijiem konsekuttivi, ma kienet osservata l-ebda akkumulazzjoni.
English: Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
Maltese: Klieb ittrattati bi Spironolakton u NSAIDS flimkien għandhom jiġu idratati korrettament.
English: Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and Angiotensin Converting Enzyme (ACE) inhibitors.
Maltese: Il-funzjoni tal-kliewi u l-livelli ta' potassju fis-serum għandhom ikunu evalwati qabel jinbeda trattament ikkombinat bi spironolakton u impedituri tal-Enzima li Tikkonverti Angiotensin (ACE).
English: Administer 2 mg/kg of body weight of spironolactone once daily.
Maltese: Agħti 2 mg/kg ta' piż korporali ta' spironolakton darba kuljum.
English: In a clinical study investigating the survival time in dogs with congestive heart failure, there was a 65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in combination with standard therapy compared to dogs treated with standard therapy alone.
Maltese: F'studju kliniku li investiga ż-żmien tas-sopravivenza fil-klieb b'insuffiċjenza konġestiva tal-qalb, kien hemm 65% tnaqqis fir-riskju relattiv ta' mortalità ta' 15-il xahar fi klieb ikkurati b'spironolactone ikkumbinat ma' terapija stàndard meta mqabbla ma terapija standard waħidha.
English: Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dysfunction).
Maltese: Tużax flimkien ma' Mediċini Antinfjammatorji Mhux Sterojdi (NSAIDs) fuq klieb b'insuffiċjenza renali (indeboliment/funzjoni ħażin tal-kliewi).
English: As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the veterinary medicinal product in dogs with liver dysfunction.
Maltese: Peress li spironolakton ikollu bijotrasformazzjoni epatika estensiva (fwied), attenzjoni għandha tingħata meta l-prodott mediċinali veterinarju jintuża fi klieb bi problemi tal-fwied.
English: BODYWEIGHT Spironolactone Ceva 10 mg
Maltese: Spironolactone Ceva 10 mg
English: Do not use after the expiry date which is stated on the carton and blister label after EXP.
Maltese: Tużax wara d-data tal-iskadenza li hi dikjarata fuq il-kartuna jew fuq it-tikketta tal-blister wara EXP.
English: Spironolactone Ceva 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.
Maltese: Il-pilloli Spironolactone Ceva 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.
English: EU/2/07/074/005 (3 blisters of 10 tablets) EU/2/07/074/006 (18 blisters of 10 tablets)
Maltese: EU/2/07/074/006 (18-il strixxa ta' 10 pilloli)
English: Furosemide and pimobendan have been used together with Spironolactone Ceva in dogs with heart failure without any clinical evidence of adverse reactions.
Maltese: Furosemide u pimobenden intużaw flimkien bi Spironolactone Ceva fi klieb b'falliment kardijaku mingħajr evidenza klinka ta' reazzjonijiet avversi.
English: EU/2/07/074/007 EU/2/07/074/008 EU/2/07/074/009
Maltese: EU/2/07/074/008
English: The veterinary medicinal product should be administered with food.
Maltese: Il-prodott mediċinali veterinarju għandu jiġi mogħti ma' l-ikel.
English: Number of # tablets BODYWEIGHT Spironolactone Ceva 10 mg
Maltese: PIŻ TAL-ĠISEM Spironolactone Ceva 10 mg
English: 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.
Maltese: 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.
English: Cardboard box - 10 mg tablets, 40 mg tablets and 80 mg tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun - pilloli ta' 10 mg, pilloli ta' 40 mg u pilloli ta' 80 mg
English: OTHER INFORMATION Pack sizes:
Maltese: Daqsijiet tal-pakketti:
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: L-MANIFATTUR RESPONSABBLI
English: EU/2/07/074/001 (3 blisters of 10 tablets) EU/2/07/074/002 (18 blisters of 10 tablets)
Maltese: EU/2/07/074/002 (18-il strixxa ta' 10 pilloli)
English: Store partially used tablets in the original blister.
Maltese: Pilloli parzjalment użati għandhom jinżammu fil-flixkun oriġinali.
English: Oral use.
Maltese: Mhux Applikabbli.