FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/679/007 14 kapsula iebsa
English: Patients receiving Pravafenix 40 mg/160 mg were compared to those receiving pravastatin 40 mg: Pravafenix significantly lowered non-HDL-C, LDL-C, TG and significantly increased HDL-C to a greater extent than pravastatin 40 mg (table).
Maltese: Pravafenix baxxa b'mod sinifikanti l-Kolesterol mhux HDL, il-Kolesterol LDL, it-TG u żied b'mod sinifikanti l-Kolesterol HDL f'miżura akbar minn pravastatin 40 mg (tabella).
English: Hepatobiliary disorders Transaminases increased.
Maltese: Żieda fit-transaminases.
English: • The active substances are fenofibrate and pravastatin.
Maltese: • Is-sustanzi attivi huma fenofibrate u pravastatin.
English: Pravastatin is contraindicated during pregnancy and should be administered to women of childbearing potential only when such patients are unlikely to conceive and have been informed of the potential risk.
Maltese: Pravastatin huwa kontra-indikat waqt it-tqala u għandu jingħata lil nisa li jista' jkollhom it-tfal biss meta ma jkunx probabbli li dawn il-pazjenti jikkonċepixxu u wara li jkunu ġew infurmati bir-riskju potenzjali.
English: (eructation)).
Maltese: notturja)
English: Pravafenix is used in addition to low fat diet in adults - To lower the level of your ‘bad' cholesterol (LDL cholesterol).
Maltese: Pravafenix jintuża flimkien ma' dieti b'ammont baxx ta' xa ħam fl-adulti - Biex ibaxxi l-livell tal-kolesterol il-“ħażin” tiegħek (kolesterol LDL).
English: Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
Maltese: Ammont żgħir ta' pravastatin jgħaddi fil-ħalib tas-sider tal-bniedem; għaldaqstant, pravastatin huwa kontra-indikat matul it-treddigħ (ara sezzjoni 4.3).
English: Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: - You have had photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid-modifying medicines) or ketoprofen (an anti-inflammatory medicine that can be used orally or on the skin for muscle and bone disorders, and orally for gout or period pain) - You suffer from gallbladder disease.
Maltese: - Kellek allerġija għad-dawl magħrufa (reazzjoni allerġika kkawżata mid-dawl tax-xemx jew minn espożizzjoni għal dawl UV) jew reazzjonijiet fototossiċi (ħsara għall-ġilda kkawżata minn espożizzjoni għal dawl tax-xemx jew dawl UV) matul il-kura b'fibrati (mediċini li jimmodifikaw il-lipidi) jew ketoprofen (mediċina għal kontra l-infjammazzjonijiet li tista' tintuża oralment jew fuq il-ġilda għal disturbi fil-muskoli u fl-għadam, u oralment għal gotta jew uġigħ tal-pirjid).
English: They may raise your risk of having heart problems.
Maltese: Jistgħu jżidu r-riskju tiegħek li jkollok problemi tal-qalb.
English: In total, these studies enrolled 1,637 patients who have not had an adequate response to treatment with pravastatin 40 mg monotherapy or simvastatin 20 mg in Europe and in the USA.
Maltese: B'kollox, dawn l-istudji rreġistraw 1,637 pazjent li ma kellhomx rispons adegwat għall-kura bi pravastatin 40 mg bħala monoterapija jew simvastatin 20 mg fl-Ewropa u fl-USA.
English: 92787 ISSY-LESMOULINEAUX Cedex 9 France
Maltese: 92787 ISSY-LESMOULINEAUX Cedex
English: Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Maltese: Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
English: Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240
Maltese: 5026 RH Tilburg PO Box 90240
English: Oreškovićeva 6H, 10010 Zagreb,
Maltese: Oreškovićeva 6H,
English: Queluz de Baixo 2734-503 Barcarena Portugal
Maltese: Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal
English: 56 Eirinis Ave., 151 21, Pefki,
Maltese: Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave., 151 21, Pefki, Greece
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse
Maltese: Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
English: Belgium Janssen-Cilag N.V. Antwerpseweg 15-17
Maltese: Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340
English: Janssen Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark
Maltese: Id-Danimarka Janssen Cilag A/S Bregnerødvej 133
English: Janssen-Cilag AS Drammensveien 288 NO-0283 Oslo Norway
Maltese: In-Norveġja Janssen-Cilag AS Drammensveien 288
English: Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Maltese: Vienna, Vorgartenstraße 206B Austria
English: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Maltese: High Wycombe Buckinghamshire HP12 4EG
English: Poland
Maltese: Belgium
English: Janssen-Cilag Pharmaceutical S.A.C.I.
Maltese: JANSSEN-CILAG, S.A.
English: Durogesic Matrix 100 µg/h
Maltese: Durogesic Matrix 100 µg/siegħa
English: Durogesic 12 microgrammes/h eure, dispositif transdermique
Maltese: Durogesic 12 microgrammes/heur e, dispositif transdermique
English: Durogesic Matrix 12 µg/h
Maltese: Durogesic Matrix 12-il µg/siegħa
English: Durogesic Matrix 25 µg/h
Maltese: Durogesic Matrix 25 µg/siegħa
English: Durogesic Matrix 75 µg/h
Maltese: Durogesic Matrix 75 µg/siegħa
English: Durogesic 12 mcg/h
Maltese: Durogesic 12 mcg/h 12-il µg/siegħa
English: Durogesic 75 microgrammes/h eure, dispositif transdermique
Maltese: Durogesic 75 microgrammes/sieg ħaeure, dispositif transdermique
English: Durogesic Matrix 50 µg/h
Maltese: Durogesic Matrix 50 µg/siegħa
English: Durogesic 75 mcg/h
Maltese: Durogesic 75 mcg/h 75 µg/siegħa
English: Durogesic 100 microgrammes/h eure, dispositif transdermique
Maltese: Durogesic 100 microgrammes/sieg ħaeure, dispositif transdermique
English: JANSSEN-CILAG SpA Via M. Buonarroti, 23
Maltese: Buonarroti, 23
English: Durogesic 50 microgrammes/h eure, dispositif transdermique
Maltese: Durogesic 50 microgrammes/sieg ħaeure, dispositif transdermique
English: Durogesic 25 microgrammes/h eure, dispositif transdermique
Maltese: Durogesic 25 microgrammes/sieg ħaeure, dispositif transdermique
English: JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid
Maltese: Paseo de Las Doce Estrellas, 5-7
English: Durogesic 25 mcg/h
Maltese: Durogesic 25 mcg/h 25 µg/siegħa
English: Durogesic 50 mcg/h
Maltese: Durogesic 50 mcg/h 50 µg/siegħa
English: Durogesic SMAT
Maltese: Il-Belġju
English: Luxembourg Janssen-Cilag N.V. Antwerpseweg 15-17
Maltese: Il-Lussemburgu Janssen-Cilag N.V.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju validu tal-karatteristiċi tal-prodott, tikketta u fuljett ta' tagħrif fih il-verżjonijiet finali miksuba matul il-proċedura mill-grupp ta' Koordinazzjoni.
English: Summary of product characteristics, labelling and package leaflet
Maltese: Sommarju tal-Karatteristiċi tal-Prodott, tikketta u fuljett ta' tagħrif
English: • the CVMP concluded that the benefit-risk balance for HIPRABOVIS PNEUMOS Emulsion for injection for cattle is unfavourable under the authorised conditions of use; therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion.
Maltese: • is-CVMP ikkonkluda li l-bilanċ tal-benefiċċju-risju għal HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-baqar huwa sfavorevoli taħt il-kundizzjonijiet awtorizzati ta' użu; għalhekk, skont l-Artikolu 83 (1)(a) tad-Direttiva 2001/82/KE, is-CVMP jirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji li saret referenza għalihom fl-Anness I tal-Opinjoni tas-CVMP.
English: Between 1 April 2010 and 28 February 2011, the overall EU incidence for adverse events reported following use of the product was estimated to be 0.048% (or ‘rare') between 1 April 2010 and 28 February 2011 and the incidence of fatalities was 0.0087% (or ‘very rare').
Maltese: Bejn l-1 ta' April 2010 u t-28 ta' Frar 2011, linċidenza totali ta' avvenimenti avversi fl-UE kienet stmata li kienet madwar 0.048% (jew ‘rara') u linċidenza ta' fatalitajiet kienet stmata li kienet madwar 0.0087% (jew ‘rari ħafna').
English: The greatest number of adverse events was reported in France.
Maltese: L-akbar numru ta' avvenimenti avversi kien irrappurtat fi Franza.
English: The marketing authorisation holder voluntarily stopped the sales of the product in March 2011, initially in France and subsequently in all other concerned EU Member States.
Maltese: F'Marzu 2011 id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq waqqaf volontarjament il-bejgħ talprodott, inizjalment fi Franza u sussegwentement fl-Istati Membri kollha kkonċernati tal-UE.
English: Belgium LABORATORIOS HIPRA, S.A. Avda.
Maltese: Il-Belġju LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is the only vaccine currently authorised in the EU with the combination of active components, Mannheimia haemolytica and Histophilus somni.
Maltese: HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat huwa l-uniku vaċċin attwalment awtorizzat fl-UE bil-kombinazzjoni tal-komponenti attivi, Mannheimia haemolytica u Histophilus somni.
English: The potential relation between the adverse events reported and possible endotoxin effects associated with the product was considered.
Maltese: Ġiet ikkunsidrata r-relazzjoni potenzjali bejn l-avvenimenti avversi rrapportati u possibbiltà tal-effetti ta' endotossini assoċjati mal-prodotti.
English: The marketing authorisations in Spain and Italy were suspended by the national competent authorities on 11 and 20 April 2011, respectively.
Maltese: Lawtorizzazzjonijiet għat-tqegħid fis-suq fi Spanja u fl-Italja kienu sospiżi mill-awtoritajiet nazzjonali kompetenti fil-11 u l-20 ta' April 2011, rispettivament.
English: It increases the range of available vaccine options.
Maltese: Dan iżid ilfirxa ta' alternattivi ta' vaċċini disponibbli.
English: Anaphylactic-type adverse events have been reported most frequently in three of the 16 Member States where the product is authorised, Belgium, France and Italy.
Maltese: Avvenimenti avversi tat-tip anafilattiku ġew irrapportati l-aktar ta' spiss fi tlieta mis-16-il Stat Membru fejn ilprodott huwa awtorizzat, il-Belġju, Franza u l-Italja.
English: In France, the incidence of anaphylactic-type events reported was estimated to be 0.177% or 1 affected animal for 560 treated animals.
Maltese: Fi Franza linċidenza ta' avvenimenti tat-tip anafilattiku rrapportata kienet stmata li kienet ta' 0.177% jew annimal wieħed affettwat għal kull 560 annimal ikkurat.
English: One clinical trial investigated the potential role of bovine respiratory syncytial virus vaccines as a potential predisposing factor to the adverse events after use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
Maltese: Prova klinika waħda investigat il-potenzjal tar-rwol ta' vaċċini kontra l-virus sinktjali respiratorju fil-bovini bħala fattur li potenzjalment jippredisponi għall-avvenimenti avversi wara l-użu ta' HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat.
English: The marketing authorisation holder should investigate the qualitative nature of the adverse events observed; investigate the potential factors that may explain the regional differences observed concerning the adverse events; and propose appropriate measures to mitigate the risk of occurrence of such adverse events to demonstrate a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jinvestiga n-natura kwalitattiva talavvenimenti avversi osservati; għandu jinvestiga l-fatturi potenzjali li jistgħu jispjegaw id-differenzi reġjonali osservati fir-rigward tal-avvenimenti avversi; u għandu jipproponi miżuri xierqa biex jittaffa rriskju ta' okkorrenza ta' avvenimenti avversi bħal dawn biex juri bilanċ favorevoli tal-benefiċċju-riskju għall-prodott meta użat skont ir-rakkomandazzjonijiet tas-sommarju tal-karatteristiċi tal-prodott.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that the pharmacovigilance data (adverse event reports) indicated that the frequency of reported events of anaphylactic-type reactions varied across the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkunsidra li d-dejta talfarmakoviġilanza (rapporti ta' avveniment avversi) indikat li l-frekwenza ta' avvenimenti ta' reazzjonijiet tat-tip anafilattiku rrapportata kienet tvarja madwar l-UE.
English: The Committee considered the possible role of additional contributory factors in relation to the adverse events reported, such as quality (batch)related effects, animal related effects (e.g. breed, age sensitivity); interactions; and/or geographical factors.
Maltese: Il-Kumitat ikkunsidra lpossibbiltà tal-irwol ta' fatturi kontributorji addizzjonali fir-rigward tal-avvenimenti avversi rrapportati, bħall-effetti relatati mal-kwalità (tal-lott), effetti relatati mal-annimal (eż. razza, sensittività tal-età);
English: Whilst acknowledging the inherent limitations of the pharmacovigilance data and the limited size of the clinical study conducted by the marketing authorisation holder, having evaluated the data available, the CVMP concluded that the above-mentioned findings provide evidence to suggest an association between the anaphylactic-type events observed and administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
Maltese: Filwaqt li rrikonoxxa l-limitazzjonijiet inerenti tad-dejta tal-farmakoviġilanza u d-daqs limitat tal-istudju kliniku li sar mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, wara li evalwa d-dejta disponibbli, is-CVMP ikkonkluda li s-sejbiet imsemmija hawn fuq jagħtu evidenza li tissuġġerixxi assoċjazzjoni bejn l-avvenimenti tat-tip anafilattiku osservati u l-għoti ta' HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat.
English: Benefit-risk evaluation
Maltese: 3. Valutazzjoni tal-benefiċċju-riskju
English: There are valid alternative therapeutic and management tools available on the EU market to control the diseases caused by Mannheimia haemolytica and Histophilus somni.
Maltese: Fis-suq tal-UE hemm disponibbli għodod terapewtiċi u ta' ġestjoni validi alternattivi biex jikkontrollaw il-mard ikkawżat minn Mannheimia haemolytica u Histophilus somni.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Maltese: HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat huwa vaċċin inattivat għat-tnaqqis tassinjali kliniċi u l-leżjonijiet fil-pulmun ikkawżati minn Mannheimia haemolytica serotip A1 u Histophilus somni fl-għoġġiela minn xahrejn ta' età.
English: To date no adverse events have been reported in the remaining 12 concerned Member States.
Maltese: S'issa l-ebda avvenimenti avversi ma ġew irrapportati filbqija tat-12-il Stat Membru kkonċernati.
English: The vaccine is expected to benefit herd health and welfare by reducing the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in cattle.
Maltese: Il-vaċċin mistenni jkun ta' benefiċċju għas-saħħa u l benesseri tal-merħla billi jnaqqas is-sinjali kliniċi u l-leżjonijiet fil-pulmun kkawżati bi Mannheimiahaemolytica serotip A1 u Histophilus somni fil-frat.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species and marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi li fuqhom għandu jintuża lprodott u detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: In the absence of an identified underlying cause for the adverse events observed at the time, the changes proposed to the summary of product characteristics (SPC) and product literature were, on the whole, not considered sufficient to minimise the risk of anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle under authorised conditions of use.
Maltese: Fin-nuqqas ta' kawża sottostanti identifikata għall-avvenimenti avversi osservata dak iż-żmien, it-tibdil propost fis-sommarju tal-karatteristiċi tal-prodott (SPC) u r-riċensjoni dwar il-prodott, fuq kollox, ma tqisux suffiċjenti biex jimminimizzaw ir-riskju ta' avvenimenti tat-tip anafilattiku wara l-għoti ta' HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat taħt il-kundizzjonijiet awtorizzati ta' użu.
English: Since October 2010, the number of reports resembling anaphylactic events, some of which were fatal, has increased, (from 12 to 24), most notably in four of the 16 European Union (EU) Member States where the product is authorised.
Maltese: Minn Ottubru 2010, in-numru ta' rapporti li jixbħu lil avvenimenti anafilattiċi żdied, li xi wħud minnhom kienu fatali, (minn 12 għal 24), l-aktar f'erbgħa mis-16-il Stat Membru tal-Unjoni Ewropea (UE) fejn ilprodott huwa awtorizzat.
English: The data evaluated indicate an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events, which has increased recently in some EU Member States.
Maltese: Id-dejta evalwata tindika assoċjazzjoni bejn il-vaċċinazzjoni tal-frat bi HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat u l-okkorrenza ta' avvenimenti tat-tip anafilattiku, li riċentement żdiedet f'xi Stati Membri tal-UE.
English: After evaluation of the adverse events, the French competent authority considered that the benefit-risk balance for the product was unfavourable and suspended the marketing authorisation in France as a precautionary measure until the cause of the adverse events could be identified and corrective measures implemented.
Maltese: Wara evalwazzjoni tal-avvenimenti avversi, l-awtorità kompetenti Franċiża kkunsidrat li l-bilanċ talbenefiċċju-riskju għall-prodott kien sfavorevoli u bħala miżura prekawzjonarja ssospendiet lawtorizzazzjoni għat-tqegħid fis-suq fi Franza sakemm il-kawża tal-avvenimenti avversi setgħat tiġi identifikata u jiġu implimentati miżuri korrettivi.
English: Hungary
Maltese: Qawwa
English: Although it was not clear whether such events represented ‘true' anaphylactic reactions or resulted from similar clinical signs due to anaphylactoid or endotoxin-related events, the term ‘anaphylactic-type' is used hereafter to describe the adverse events reported.
Maltese: Għalkemm ma kienx ċar jekk tali avvenimenti kinux jirrappreżentaw reazzjonijiet anafilattiċi ‘reali' jew jekk kinux riżultat ta' sinjali kliniċi simili minħabba avvenimenti relatati mal-anafilattojdi jew mal-endotossini, minn hawn 'il quddiem itterminu ‘tat-tip anafilattiku' sejjer jintuża biex jiddeskrivi l-avvenimenti avversi rrapportati.
English: Adverse events concerning anaphylactic-type reactions, some of which were fatal, have been reported in four EU Member States.
Maltese: Avvenimenti avversi li jikkonċernaw reazzjonijiet tat-tip anafilattiku, li xi wħud minnhom kienu fatali, ġew irrapportati f'erba' Stati Membri tal-UE.
English: • anaphylactic-type adverse events, some of which were fatal, reported after the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle indicates an association with the product;
Maltese: • l-avvenimenti avversi tat-tip anafilattiku, li xi wħud minnhom kienu fatali, irrapportati wara l-użu ta' HIPRABOVIS PNEUMOS Emulsjoni għal injezzjoni għall-frat jindikaw assoċjazzjoni mal-prodott;
English: EMA/463287/2015 EMEA/V/C/002804
Maltese: EMEA/V/C/002804
English: The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Fortekor Plus
Maltese: Informazzjoni oħra dwar Fortekor Plus
English: Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription.
Maltese: Fortekor Plus jiġi bħala pilloli (pimobendan 1.25 mg/benazepril kloridrat 2.5 mg u pimobendan 5 mg/benazepril kloridrat 10 mg) u jista' jinkiseb biss b'riċetta ta' tabib. Fortekor Plus jingħata darbtejn kuljum bejn wieħed u ieħor siegħa qabel it-tmigħ.
English: Pimobendan/benazepril hydrochloride
Maltese: Pimobendan/benazepril kloridrat
English: Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride.
Maltese: Fortekor Plus fih żewġ sustanzi attivi, il-pimobendan u l-benazepril kloridrat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fortekor Plus valida fl-Unjoni Ewropea kollha fit-8 ta' Settembru 2015.
English: This is a summary of the European public assessment report (EPAR) for Fortekor Plus.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fotekor Plus.
English: What are the risks associated with Fortekor Plus?
Maltese: X'inhuma r-riskji assoċjati ma' Fortekor Plus?
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Maltese: Il-benazeprilat huwa ‘inibitur tal-enzima li tikkonverti anġjotensin (ACE)'.
English: Why is Fortekor Plus approved?
Maltese: Għaliex ġie approvat Fortekor Plus?
English: Fortekor Plus is a veterinary medicine used to treat congestive heart failure in dogs.
Maltese: Fortekor Plus huwa mediċina veterinarja użata għall-kura ta' sinjali ta' indeboliment konġestiv tal-qalb fil-klieb.
English: Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery).
Maltese: Fortekor Plus m'għandux jingħata lil klieb b'kardjomijopatija ipertrofika (mard tal-muskolu tal-qalb fejn il-ħitan tal-qalb jeħxienu u jnaqqsu l-produzzjoni tad-demm), kundizzjonijiet kliniċi fejn il-produzzjoni mill-qalb ma tistax tiżdied minħabba raġunijiet funzjonali jew anatomiċi (eż. tidjiq tal-aorta jew talarterja pulmonari).
English: The most common side effects with benazepril are short-lived episodes of vomiting, incoordination or signs of tiredness.
Maltese: L-effetti sekondarji l-aktar komuni bil-benazepril huma episodji qosra ta' rimettar, nuqqas ta' koordinazzjoni jew sinjali ta' għeja.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Maltese: Il-benazepril huwa promediċina, sustanza kkonvertita f'benazeprilat fil-ġisem.
English: In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments.
Maltese: Fi studju fuq il-post li involva 67 kelb b'indeboliment konġestiv tal-qalb, il-kura b'Fortekor Plus tqabblet mal-pimobendan u l-benazepril mogħtija bħala kuri separati.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: L-inibituri tal-ACE jbaxxu l-produzzjoni ta' anġjotensin II, vażokostrittur qawwi (sustanza li ddejjaq il-vini).
English: For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u l-effetti sekondarji kollha rrappurtati b'Fortekor Plus, ara l-fuljett ta' tagħrif.