FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: Não estão disponíveis dados de ensaios aleatorizados controlados com placebo relativamente ao ciprofibrato, mas não formam demonstradas diferenças na classe quanto aos efeitos sobre os marcadores substitutos.
Slovenian: Za ciprofibrat podatki randomiziranega in kontroliranega preskušanja niso na voljo, vendar v celotni skupini ni dokazanih razlik v nadomestnih kazalnikih učinka.
Portuguese: A eficácia e segurança a longo prazo dos fibratos actualmente autorizados foram examinadas principalmente em seis ensaios de grandes dimensões aleatorizados e controlados com placebo: o estudo HHS (Helsinki Heart Study) e o estudo VA-HIT (Veterans Affairs HDL Intervention Trial) com gemfibrozil, o estudo BIP (Bezafibrate Infarction Prevention) e o estudo LEADER (Lower Extremity Arterial Disease Event Reduction) com bezafibrato, o estudo FIELD (Fenofibrate Intervention in Event Lowering in Diabetes) e o estudo ACCORD (Action to Control Cardiovascular Risk in Diabetes) com fenofibrato.
Slovenian: Dolgoročna učinkovitost in varnost fibratov, za katere je trenutno izdano dovoljenje, sta bili v glavnem preučeni v šestih velikih randomiziranih in s placebom kontroliranih študijah: v študiji z nazivom Helsinško srce (Helsinki Heart, HHS) in intervencijskem preskušanju učinkov uravnavanja holesterola HDL, ki jo je sponzoriral ameriški urad za vojne veterane (Veterans Affairs HDL Intervention Trial, VA-HIT), so preučevali gemfibrozil, v študiji preprečevanja infarkcije s pomočjo bezafibrata (Bezafibrate Infarction Prevention, BIP) in študiji zmanjševanja dogodkov v zvezi z arterijskimi boleznimi spodnjih okončin (Lower Extremity Arterial Disease Event Reduction, LEADER) so preučevali bezafibrat, v intervencijski študiji zmanjševanja dogodkov pri sladkornih bolnikih s pomočjo fenofibrata (Fenofibrate Intervention in Event Lowering in Diabetes, FIELD) in študiji nadzorovanja kardiovaskularnega tveganja pri sladkornih bolnikih (Action to Control Cardiovascular Risk in Diabetes, ACCORD) pa so preučevali fenofibrat.
Portuguese: Apesar das diferenças na metodologia e nas populações estudadas, os principais ensaios sobre fibratos demonstraram que o tratamento com fibratos pode reduzir os eventos de doença cardíaca coronária, apesar de não existirem evidências claras de que possam reduzir a mortalidade por todas as causas na prevenção primária ou secundária de doença cardiovascular.
Slovenian: Kljub razlikam v metodologiji in študijskih populacijah so glavni preskusi s fibrati dokazali, da lahko zdravljenje z njimi zmanjša pogostost dogodkov v zvezi s koronarno boleznijo, ni pa jasnega dokaza, da lahko pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni znižajo umrljivost ne glede na vzrok smrti.
Portuguese: • O CHMP teve em conta dados adicionais publicados sobre os fibratos, incluindo os resultados do ensaio sobre lípidos ACCORD, os quais apoiavam a utilização de fenofibrato (cápsulas de 100, 300, 67, 200, 250 mg e comprimidos revestidos por película de 160 e 145 mg) como terapêutica adjuvante de estatinas em doentes com hiperlipidemia mista em alto risco cardiovascular quando os triglicéridos e o colesterol HDL não sejam adequadamente controlados com uma estatina em monoterapia.
Slovenian: • CHMP je upošteval dodatne objavljene podatke o fibratih, vključno z rezultati preskušanja v zvezi lipidi (ACCORD), ki potrjujejo koristi fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete), uporabljenega kot dodatek statinu pri zdravljenju pacientov s kombinirano hiperlipidemijo in visokim tveganjem za kardiovaskularne bolezni, kadar samo s statinom ni mogoče ustrezno nadzirati trigliceridov in holesterola HDL.
Portuguese: Dado que a eficácia terapêutica não pode ser obtida a partir dos dados fornecidos, a utilização de fibratos como tratamento de primeira linha nestas indicações deixou de justificar-se em relação a todos os fibratos, com a excepção do gemfibrozil que demonstrou benefícios na prevenção primária da morbilidade cardiovascular em homens quando não seja possível a utilização de uma estatina.
Slovenian: Ker iz zbranih podatkov ni mogoče dokazati terapevtske učinkovitosti, uporaba fibratov kot zdravila prve izbire pri teh indikacijah za vse fibrate ni več upravičena, razen za gemfibrozil, pri katerem je dokazana korist pri primarnem preprečevanju umrljivosti moških zaradi kardiovaskularnih bolezni, če ni mogoče uporabiti statina.
Portuguese: Reconhecendo igualmente que os ensaios proporcionaram evidências de que o gemfibrozil pode ser diferente do resto da classe e pode apresentar um perfil mais favorável, considerou-se que se justificava uma diferenciação nas indicações para o gemfibrozil de modo a incluir também o tratamento da hipercolesterolemia primária e a prevenção primária da morbilidade cardiovascular em homens quando uma estatina esteja contra-indicada ou não seja tolerada.
Slovenian: Poleg tega so upoštevani tudi s preskusi ugotovljeni dokazi, ki pričajo, da se gemfibrozil morda razlikuje od drugih fibratov v skupini in ima morda bolj ugoden profil; zato se šteje, da je diferenciacija pri danih indikacijah za gemfibrozil, ki naj vključuje še zdravljenje primarne hiperholesterolemije in primarno preprečevanje obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih je uporaba statina kontraindicirana ali pa ga ne prenašajo, upravičena.
Portuguese: • O CHMP concluiu, a partir dos dados fornecidos, que a eficácia terapêutica na prevenção primária ou secundária da doença cardiovascular de todos os fibratos é insuficiente, com a excepção do gemfibrozil que demonstrou benefício na prevenção primária da morbilidade cardiovascular em homens quando não seja possível utilizar uma estatina.
Slovenian: • Iz predloženih podatkov CHMP zaključuje, da pri primarnem ali sekundarnem preprečevanju kardiovaskularnih bolezni noben fibrat ni terapevtsko učinkovit, razen gemfibrozil, ki se je izkazal za koristnega pri primarnem preprečevanju obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih ni mogoče uporabljati statina.
Portuguese: Além disso, o fenofibrato demonstrou benefício como terapêutica adjuvante de estatinas, tal como detalhado em cima.
Slovenian: Kot je podrobneje opisano zgoraj, se je fenofibrat poleg tega izkazal za koristnega kot dodatek pri zdravljenju s statini.
Portuguese: Fundamentos para a alteração dos resumos das características do medicamento e dos folhetos informativos
Slovenian: Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo
Portuguese: No entanto, para determinadas doses de fenofibrato (cápsulas de 100, 300, 67, 200, 250 mg e comprimidos revestidos por película de 160 e 145 mg), os resultados do ensaio ACCORD sobre lípidos, em conjunto com estudos anteriores de resultados e meta-análises de ensaios sobre fibratos apoiam o benefício de uma terapêutica adjuvante na população dislipidémica, quando os triglicéridos e o colesterol HDL não sejam adequadamente controlados com uma estatina em monoterapia.
Slovenian: Vendar pa rezultati preskušanja ACCORD, kjer so spremljali lipide, skupaj s prejšnjimi rezultati študij in meta analizami preskušanj v zvezi s fibrati za določene odmerke fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete) potrjujejo korist pri dodatnem zdravljenju pri populaciji z dislipidemijo, kadar trigliceridov in holesterola HDL ni mogoče ustrezno nadzirati le s statinom.
Portuguese: o CHMP recomendou a alteração da autorização de introdução no mercado para a qual as secções relevantes dos resumos das características do medicamento e folhetos informativos se encontram estabelecidas no Anexo III para os medicamentos que contêm fenofibrato, bezafibrato, ciprofibrato e gemfibrozil (ver Anexo I).
Slovenian: CHMP priporoča spremembo dovoljenj za promet za zdravila, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil (glejte Dodatek I) in katerih ustrezna poglavja povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedeni v Dodatku III.
Portuguese: Globalmente, as evidências disponíveis sugerem que, apesar da presença prolongada dos fibratos no mercado, existem apenas evidências limitadas de um benefício clínico a longo prazo da sua utilização na prevenção primária ou secundária de doença cardiovascular.
Slovenian: Zbrani podatki, ki so na voljo, v splošnem kažejo, da je dokazov o dolgoročnih kliničnih koristih uporabe fibratov pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni le malo, čeprav so fibrati na trgu že dolgo.
Portuguese: Greece 17456
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Portuguese: Korinthos 20100 Greece
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Portuguese: S.C. VIM SPECTRUM S.R.L., Şoseaua Sighişoarei, Nr. 409, Corunca, jud Mureş Romania
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Portuguese: SANOFI AVENTIS CYPRUS LTD Charalambou Mouskou 14 2015 Strovolos
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Portuguese: 1A Pharma GmbH Stella-Klein-Löw-Weg 17, A1020 Wien
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Portuguese: LABORATORIO STADA, S.L.Frederic Mompou, 5 Sant Just Desvern08960 BARCELONA
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Portuguese: DK - D Alemanha Pfizer ApS Lautrupvang 8
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Portuguese: DE - Alemanha AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
Slovenian: DE - Nemčija AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
Portuguese: Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
Slovenian: JUBILANT PHARMACEUTICALS NV Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke
Portuguese: D-86156 Augsburg Germany
Slovenian: D-86156 Augsburg
Portuguese: D-90449 Nürnberg Germany
Slovenian: D-90449 Nürnberg Nemčija
Portuguese: UK - Reino Unido TILLOMED LABORATORIES LIMITED
Slovenian: TILLOMED LABORATORIES LIMITED
Portuguese: 65439 Flörsheim Germany
Slovenian: 65439 Flörsheim Nemčija
Portuguese: UK - Reino Unido Winthrop Pharmaceuticals Uk Limited
Slovenian: Winthrop Pharmaceuticals Uk Limited
Portuguese: S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu Nr.31, Sector 2
Slovenian: Str. Ştefan Mihăileanu Nr.31, Sector 2
Portuguese: 16th Km Marathonos Avenue Pallini Attikis 153 44 Greece
Slovenian: 16th Km Marathonos Avenue Pallini Attikis 153 44 Grčija
Portuguese: UK - Reino Unido ETHYPHARM 17/21 Rue Saint Matthieu Houdan, F-78550
Slovenian: 17/21 Rue Saint Matthieu Houdan, F-78550
Portuguese: LABORATORIOS MENARINI S.A Alfonso XII
Slovenian: ES - Španija LABORATORIOS MENARINI S.A Alfonso XII
Portuguese: Sanofi-Aventis Netherlands B.V.
Slovenian: Sanofi-Aventis Nizozemska B.V.
Portuguese: FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Greece
Slovenian: FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Grčija
Portuguese: UK - Reino Unido Solvay Healthcare Limited Mansbridge Road, West End, SOUTHAMPTON SO18 3JD United Kingdom
Slovenian: Solvay Healthcare Limited Mansbridge Road, West End, SOUTHAMPTON SO18 3JD Velika Britanija
Portuguese: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Slovenian: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Nemčija
Portuguese: D-10785 Berlin Germany
Slovenian: D-10785 Berlin