FrancophonIA/ELRC3.0 huggingface dataset:
English: Teslova 26, 821 02, Bratislava Slovak Republic
Maltese: Teslova 26, 821 02, Bratislava Republika Slovakka
English: Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands
Maltese: Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Olanda
English: Teva Pharmaceuticals Bulgaria EOOD 15 N.V. Gogol str.
Maltese: Teva Pharmaceuticals Bulgaria EOOD 15 N.V.
English: Teva Sweden AB Box 1070
Maltese: Teva Svezja AB Box 1070
English: Czech Republic Abbott GmbH &Co.KG Max-Planck-Ring-2
Maltese: Republika Ċeka Abbott GmbH &Co.KG Max-Planck-Ring-2
English: 251 10 Helsingborg Sweden
Maltese: 251 10 Helsingborg Svezja
English: TEVA Pharmaceuticals Slovakia s.r.o.
Maltese: TEVA Pharmaceuticals Slovakkja s.r.o.
English: Abbott Scandinavia AB Box 509 169 29 Solna Sweden
Maltese: Abbott Scandinavia AB Box 509 169 29 Solna Svezja
English: Sandoz d.d., Verovskova 57 SI - 1000 Ljubljana Slovenia
Maltese: Sandoz d.d., Verovskova 57 SI - 1000 Ljubljana Slovenja
English: Abbott Laboratories Slovakia s.r.o.
Maltese: Abbott Laboratories Slovakkja s.r.o.
English: S.C. TERAPIA S.A. Str. Fabricii, nr. 124, Cluj-Napoca, Romania
Maltese: Fabricii, nr. 124, Cluj-Napoca, Rumanija
English: 821 08 Bratislava Slovak Republic
Maltese: 821 08 Bratislava
English: Abbott Laboratories Poland Sp. z o. o. ul.
Maltese: Abbott Laboratories Polonja Sp. z o. o.
English: Latvia
Maltese: Latvija
English: 10237 Prague 10 Dolni Mecholupy Czech Republic
Maltese: 10237 Prague 10 Dolni Mecholupy Republika Ċeka
English: Norway
Maltese: Norveja
English: Abbott GmbH Perfektastraße 84A A-1230 Wien Austria
Maltese: Abbott GmbH Perfektastraße 84A A-1230 Wien Awstrija
English: 53 Emilii Plater St.
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. 53 Emilii Plater St.
English: Abott GmbH Perfektastraße 84A A-1230 Wien Austria
Maltese: Abott GmbH Perfektastraße 84A A-1230 Wien Awstrija
English: Verovškova 57 1000 Ljubljana Slovenia
Maltese: Verovškova 57 1000 Ljubljana Slovenja
English: Verovskova 57 1000 Ljubljana Slovenia
Maltese: Verovskova 57 1000 Ljubljana Slovenja
English: In all trials including SCOUT the average weight loss with sibutramine was 2-4 kg more than with placebo.
Maltese: Fil-provi kollha, inkluż SCOUT, it-tnaqqis medju fil-piż b'sibutramine kien 2-4 kg aktar minn bi placebo.
English: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Maltese: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Ġermanja
English: Dolenjska c. 242c SI-1000 Ljubljana Slovenia
Maltese: Abbott Laboratories d.o.o. Dolenjska c. 242c SI-1000 Ljubljana Slovenja
English: Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue GR 17456, Alimos Athens
Maltese: Abbott Laboratories (Hellas) S.A. 512, Vouliagmenis Avenue
English: The SCOUT data shows a lower benefit compared to previous trials and to the meta-analysis by Rucker et al. (2007).
Maltese: Id-dejta ta' SCOUT turi benefiċċju aktar baxx meta mqabbel ma' provi preċedenti u mal-meta-analiżi magħmula minn Rucker et al.
English: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Maltese: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Ġermanja
English: C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
Maltese: C. F. Tietgens Boulevard 40 DK-5220
English: 94528 RUNGIS CEDEX FRANCE
Maltese: RUNGIS CEDEX Franza
English: With sibutramine treatment, only 30.4% of the patients were responders (defined as patients who lost at least 5% body weight within 3 months), compared with 19.5% of patients treated with placebo.
Maltese: Bit trattament ta' sibutramine, 30.4% biss tal-pazjenti rreaġixxew (definiti bħala pazjenti li tilfu millinqas 5% tal-piż tal-ġisem fi 3 xhur), meta mqabbel ma' 19.5% tal-pazjenti trattati bi plaċebo.
English: Abbot Scandinavia AB Box 509
Maltese: Abbott Scandinavia AB Box 509
English: A procedure under Article 107 of Directive 2001/83/EC was triggered in November 2009 based on preliminary results from SCOUT that suggested an increased cardiovascular risk with sibutramine treatment compared with placebo.
Maltese: F'Novembru 2009, ingħata bidu għal proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE fuq ilbażi ta' riżultati preliminari minn SCOUT li ssuġġerixxew riskju kardjovaskulari miżjud bittrattament ta' sibutramine meta mqabbel ma' plaċebo.
English: Belgium Abbott SA rue du Bosquet 2
Maltese: Belġjum Abbott SA rue du Bosquet 2
English: SCOUT was powered as a superiority study with the aim of showing a decrease in the CV primary outcome event (POE, including, non-fatal myocardial infarction (MI), non-fatal stroke resuscitated cardiac arrest and cardiovascular death due to MI or stroke) rate in the sibutramine treated patients compared to placebo.
Maltese: SCOUT sar bħala studju ta' superjorità bil-għan li juri tnaqqis fir-rata tal-avveniment ta' eżitu primarju CV (POE, inkluż infart mijokardijaku (myocardial infarction - MI) mhux fatali, arrest kardijaku kkawżat minn attakk mhux fatali u mewta kardjovaskulari minħabba MI jew puplesija) fil-pazjenti trattati b'sibutramine meta mqabbel ma' plaċebo.
English: Slovak Republic
Maltese: Republika Slovakka
English: Luxembourg Abbott Laboratoires 2,rue du Bosquet
Maltese: Lussemburgu Abbott Laboratoires 2,rue du Bosquet
English: Luxembourg Abbott Laboratoires 2, rue du Bosquet
Maltese: Lussemburgu Abbott Laboratoires 2, rue du Bosquet
English: Sibutramine should be used in conjunction with a reduced calorie diet and increased physical activity in - Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher.
Maltese: Sibutramine għandu jintuża flimkien ma' dieta b'inqas kaloriji u attività fiżika miżjuda fi - Pazjenti b'obeżità nutrittiva u indiċi tal-massa tal-ġisem (body mass index - BMI) ta' 30 kg/m2 jew aktar.
English: 10 mg Film-coated tablet oral use
Maltese: 10 mg Film-coated tablet Għal użu orali
English: 15 mg Film-coated tablet oral use
Maltese: 15 mg Film-coated tablet Għal użu orali
English: Abbott Laboratories Kft. Teve u. 1/a-c 1139 Budapest Hungary
Maltese: 1/a-c 1139 Budapest Ungerija
English: In the Lead-in Phase (during which all subjects were treated with sibutramine), the intent to treat (ITT) population achieved an initial mean weight loss of 2.6 kg with sibutramine treatment.
Maltese: Fil-Fażi tal-Bidu (Lead-in Phase) (li matulha s-suġġetti kollha ġew trattati b'sibutramine), il-popolazzjoni blintenzjoni għat-trattament (intent to treat - ITT) kisbet tnaqqis inizjali medju fil-piż ta' 2.6kg bittrattament bi sibutramine.
English: Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Maltese: Tietgens Boulevard 40 DK-5220
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted an opinion recommending the suspension of the Marketing Authorisations for all sibutramine-containing medicinal products (see Annex 1).
Maltese: Skont id-dispożizzjonijiet tal-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendata, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem tal-Aġenzija (Committee for Medicinal Products for Human Use - CHMP) adotta opinjoni li tirrakkomanda s-sospensjoni tal-Awtorizzazzjonijet għatTqegħid fis-Suq għall-prodotti mediċinali kollha li fihom sibutramine (ara l-Anness 1).
English: The proposed educational measures (including Direct Healthcare Professional Communication (DHPC) letters, Q&A documents, a call centre and a secure website and patient tracking log books) were not considered likely to decrease the risk for patients or allow the identification of patients with covert CV disease as atherosclerotic complications cannot be diagnosed by BP, HR or weight measurements.
Maltese: Il-miżuri edukattivi proposti (inklużi ittri ta' Komunikazzjoni Professjonali Diretta dwar il-Kura tas-Saħħa (Direct Healthcare Professional Communication - DHPC), dokumenti b'mistoqsija u tweġiba, ċentru ta' sejħiet u websajt sikur u reġistri għall-intraċċar ta' pazjenti) ma kinux ikkunsidrati bħala li x'aktarx inaqqsu r-riskju għall-pazjenti jew bħala li jippermettu l-identifikazzjoni ta' pazjenti b'mard CV moħbi għax kumplikazzjonijiet aterosklerotiċi ma jistgħux jiġu dijanjostikati permezz ta' kejlijiet ta' BP, HR jew it-tnaqqis fil-piż.
English: ANNEX III CONDITIONS FOR LIFTING THE SUSPENSION
Maltese: ANNESS III KUNDIZZJONIJIET GĦAT-TNEĦĦIJA TAS-SOSPENSJONI
English: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Maltese: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205
English: The CHMP considered that the currently approved indication and contraindications already provide substantial restrictions and that additional restrictions would not be practical.
Maltese: Is-CHMP jikkunsidra li l-indikazzjoni u l-kontraindikazzjonijiet approvati attwalment diġà jipprovdu restrizzjonijiet sostanzjali u li restrizzjonijiet addizzjonali ma jkunux prattiċi.
English: The CHMP adopted a List of Questions requesting the MAHs to discuss the results of SCOUT, focusing in particular on drop outs, adverse events, statistical data and the implications of the data on the benefit/risk balance and risk minimisation measures.
Maltese: Is-CHMP adotta Lista ta' Mistoqsijiet biex jitlob lill-MAHs jiddiskutu r-riżultati ta' SCOUT, b'attenzjoni partikolari fuq persuni li ma baqgħux jipparteċipaw, avvenimenti avversi, dejta statistika u l-implikazzjonijiet tad-dejta fuq il-bilanċ talbenefiċċji/riskji u miżuri għat-tnaqqis tar-riskji.
English: Data stratified by CV risk group shows that the “CV + DM” (cardiovascular disease plus Type 2 diabetes) group carried the highest risk of POE, followed by the “CV Only” (cardiovascular disease) group and the “DM Only” (Type 2 diabetes) group.
Maltese: Id-dejta stratifikata mill-grupp ta' riskju CV turi li l-grupp tas-“CV + DM” (mard kardjovaskluari u dijabete tat-Tip 2) kellu l-ogħla riskju ta' POE, segwit mill-grupp “CV Biss” (mard kardjovaskluari) u l-grupp “DM Biss” (dijabete tat-Tip 2).
English: Tietgens Boulevard 40 5220 Odense SØ Denmark
Maltese: Tietgens Boulevard 40 5220
English: - Patients with nutritional excess weight and a BMI of 27 kg/m2 or higher, if other obesity-related risk factors such as type 2 diabetes or dyslipidaemia are present.
Maltese: - Pazjenti b'piż żejjed nutrittiv u BMI ta' BMI of 27 kg/m2 jew aktar, jekk ikunu preżenti fatturi ta' riskju oħrajn relatati mal-obeżità bħal pereżempju d-dijabete tat-tip 2 jew dyslipidaemia.
English: The CHMP also requested a Scientific Advisory Group (SAG) Diabetes/Endocrinology meeting to be held in January to provide additional expert input.
Maltese: Is-CHMP talab ukoll li ssir laqgħa tal-Grupp Konsultattiv Xjentifiku (Scientific Advisory Group - SAG) għadDijabete/Endokrinoloġija f'Jannar biex tiġi pprovduta informazzjoni esperta addizzjonali.
English: Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules
Maltese: Sibutramine HCL monohydraat Sandoz 10 mg, harde Kapsuli
English: The CHMP also suggested that the influence of gender within this subgroup (61% females compared with 32-37% in the CV Only group and 36% in the CV + DM group) warrants consideration, as the Cox regression analysis suggests that females have a 40% lower risk of primary outcome than males.
Maltese: Is-CHMP issuġerixxa wkoll li l-influwenza tassess fi ħdan dan is-sottogrupp (61% nisa meta mqabbel ma' 32-37% fil-grupp ta' CV Biss u 36% filgrupp ta' CV + DM) titlob li tiġi kkunsidrata, minħabba li l-analiżi tar-regressjoni tal-Cox tissuġerixxi li n-nisa għandhom riskju aktar baxx b'40% ta' eżitu primarju mill-irġiel.
English: Sibutramine Hydrochloride 15mg Capsules
Maltese: Sibutramine Hydrochloride 15mg Kapsuli
English: Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules
Maltese: Sibutramine HCL monohydraat Sandoz 15 mg, harde Kapsuli
English: Sibutramine Hydrochloride 10mg Capsules
Maltese: Sibutramine Hydrochloride 10mg Kapsuli
English: Additionally, the CHMP noted the exclusion of 231 high-risk patients with increased HR and/or BP during the Lead-in Period, which is likely to dilute and underestimate the true risk of CV events in the sibutramine arm as such regular and careful BP and HR monitoring is unlikely to be fully implemented in clinical practice.
Maltese: Barra minn hekk, is-CHMP innota l-esklużjoni ta' 231 pazjent b'riskju għoli b'HR u/jew BR ogħla matul il-Perijodu tal-Bidu, li x'aktarx inaqqas u jagħti stima aktar baxxa tar-riskju ta' avvenimenti CV fil-grupp ta' sibutramine minħabba li tali monitoraġġ regolari u birreqqa tal-BP u tal-HR probabbilment ma jiġix implimentat fis-sħiħ fil-prattika klinika.
English: ABBOTT LABORATORIES, S.A. Avda.
Maltese: ABBOTT LABORATORIES, S.A. Avda. de Burgos
English: United Kingdom Teva UK Limited Brampton Road
Maltese: Teva UK Limited
English: Reductil 15 mg, capsules
Maltese: Reductil 15 mg, Kapsuli
English: Reductil 10 mg, capsules
Maltese: Reductil 10 mg, Kapsuli
English: SE-169 29, Solna Sweden
Maltese: SE-169 29, Solna Svezja
English: Reductil 15 mg, capsules, hard
Maltese: Reductil 15 mg, Kapsuli, hard
English: The Kaplan-Meier curve shows an early increased risk of POE and an even earlier increase for non-fatal POE.
Maltese: Il-kurva Kaplan-Meier turi riskju miżjud bikri ta' POE u żieda aktar bikrija għal POE mhux fatali.
English: Reductil 10 mg, capsules, hard
Maltese: Reductil 10 mg, Kapsuli, hard
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended for sibutramine-containing medicinal products,
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata għall-prodotti mediċinali li fihom sibutramine,
English: The Sibutramine Cardiovascular OUTcomes (SCOUT) study was initiated in January
Maltese: L-istudju tal-Eżiti Kardjovaskulari b'Sibutramine (Sibutramine Cardiovascular OUTcomes - SCOUT) beda f'Jannar 2003.
English: SIBUTRAL 10 mg, gélule 10 mg capsule oral use
Maltese: SIBUTRAL 10 mg, gélule 10 mg Kapsula
English: Sibutramine HCLmonohydraat 15 mg PCH, capsules
Maltese: Sibutramine HCLmonohydraat 15 mg PCH, Kapsuli
English: Sibutramine HCLmonohydraat 10 mg PCH, capsules
Maltese: Sibutramine HCLmonohydraat 10 mg PCH, Kapsuli
English: SIBUTRAL 15 mg, gélule 15 mg capsule oral use
Maltese: SIBUTRAL 15 mg, gélule 15 mg Kapsula
English: In patients treated according to the approved SPC, i.e. conformers, which accounted for less than 10% of enrolled patients, a numerically slightly increased risk of cardiovascular events was observed when compared to placebo, although the numbers are small and the confidence intervals are wide in this subgroup.
Maltese: F'pazjenti li ġew trattati skont l-SPC approvat, jiġifieri dawk li jikkonformaw, li kienu inqas minn 10% tal-pazjenti li ħadu sehem, kien osservat riskju numeriku kemmxejn miżjud ta' avvenimenti kardjovaskulari meta mqabbel ma' plaċebo, għalkemm in-numri huma żgħar u l-intervalli ta' kunfidenza huma wiesgħin f'dan is-sottogrupp.
English: Capsule, hard oral use
Maltese: Kapsula, iebsa Għal użu orali
English: Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use
Maltese: Zelium 10 mg Hartkapseln 10 mg Kapsula, iebsa
English: By the end of the Randomization Phase, patients on sibutramine achieved a further mean reduction in weight of 0.91 kg while the placebo group experienced a mean increase of 1.02 kg compared with baseline Randomization Phase measurements.
Maltese: Sal-aħħar tal-Fażi ta' Randomizzazzjoni, il-pazjenti li kienu qegħdin fuq sibutramine kisbu tnaqqis medju ieħor fil-piż ta' 0.91kg filwaqt li l-grupp ta' plaċebo kellu żieda medja ta' 1.02kg meta mqabbel mal-kejlijiet tal-linja bażika tal-Fażi ta' Randomizzazzjoni.
English: Marketing Authorisation Holder Invented Name
Maltese: Isem inventat
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic
Maltese: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Republika Ċeka
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic
Maltese: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Republika Ċeka
English: Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use
Maltese: Sibutramin Sandoz 10 mg 10 mg Kapsula, iebsa
English: Sibutramine is an orally administered serotonin and noradrenaline reuptake inhibitor that is indicated as adjunctive therapy for adult patients within a weight management programme, including weight loss and maintenance of weight loss.
Maltese: Sibutramine huwa inibitur tal-assorbiment mill-ġdid ta' serotonin u noradrenaline li jingħata b'mod orali u li huwa inidikat bħala terapija miżjuda għal pazjenti adulti fi ħdan programm tal-ġestjoni talpiż, inkluż it-tnaqqis fil-piż u ż-żamma tat-tnaqqis fil-piż.
English: 16929 Solna Sweden
Maltese: 16929 Solna Svezja
English: Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use
Maltese: Sibutramin Sandoz 15 mg 15 mg Kapsula, iebsa
English: LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use
Maltese: LINDAXA 15 mg, capsule 15 mg Kapsula, iebsa
English: Sibutramine Teva 10 mg Capsules
Maltese: Sibutramine Teva 10 mg Kapsuli
English: LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use
Maltese: LINDAXA 10 mg, capsule 10 mg Kapsula, iebsa
English: On the other hand, comparing sibutramine responders to placebo responders (a comparison that ignores the finding that more patients achieved 5% weight loss on sibutramine compared to placebo) reveals a number needed to be exposed to sibutramine of 347 for one extra CV event to occur.
Maltese: Minnaħa l-oħra, it-tqabbil ta' persuni trattati b'sibutramine li rreaġixxew u persuni trattati bi plaċebo li rreaġixxew (tqabbil li ma jqisx is-sejba li aktar pazjenti kisbu tnaqqis fil-piż ta' 5% b'sibutramine meta mqabbel ma' plaċebo) juri numru (ta' pazjenti) li jeħtieġu li jiġu esposti għal sibutramine ta' 347 biex iseħħ avveniment CV addizzjonali wieħed.
English: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic
Maltese: U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Republika Ċeka
English: • The Committee considered that the risk minimisation measures proposed by the MAHs will not ensure compliance with the SPC or adequately protect public health,
Maltese: • Il-Kumitat ikkunsidra li l-miżuri għat-tnaqqis tar-riskji proposti mill-MAHs ma jiżgurawx konformità mal-SPC jew ma jipproteġux b'mod adegwat is-saħħa pubblika,
English: 1074 Budapest Hungary
Maltese: Budapest Ungerija
English: 15 mg capsule oral use
Maltese: 15 mg Kapsula
English: Sibutramine Teva 15 mg Capsules
Maltese: Sibutramine Teva 15 mg Kapsuli
English: Sibutramina West Pharma 10 mg Capsule, hard oral use
Maltese: Sibutramina West Pharma 10 mg Kapsula, iebsa
English: Sibutramina West Pharma 15 mg Capsule, hard oral use
Maltese: Sibutramina West Pharma 15 mg Kapsula, iebsa
English: However, the MAHs were required to conduct a large cardiovascular outcome study designed to compare sibutramine to placebo under standard care for weight management in overweight or obese subjects aged 55 years or older, who were at risk of cardiovascular (CV) events on the basis of a history of documented disease or the presence of additional CV risk factors such as diabetes.
Maltese: Madankollu, l-MAHs kellhom iwettqu studju kbir fuq l-eżitu kardjovaskulari li huwa mfassal biex iqabbel sibutramine ma' plaċebo taħt kura standard għall-ġestjoni tal-piż f'suġġetti ħoxnin iżżejjed jew obeżi ta' età ta' 55 sena jew aktar, li kellhom riskju ta' avvenimenti kardjovaskulari (cardiovascular -CV) fuq il-bażi ta' passat ta' mard dokumentat jew il-preżenza ta' fatturi ta' riskju CV oħrajn bħad-dijabete.
English: An Article 31 referral was triggered in March 2002 due to safety concerns based on fatal adverse reactions.
Maltese: F'Marzu 2002, ingħata bidu għal referenza skont l-Artikolu 31 minħabba tħassib dwar is-sigurezza fuq il-bażi ta' reazzjonijiet avversi fatali.
English: 10 mg capsule oral use
Maltese: 10 mg Kapsula
English: U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Czech Republic
Maltese: U Kabelovny 130 Dolni Mecholupy 102 37 Praha 10 Republika Ċeka
English: SE-169 29 Solna Sweden
Maltese: SE-169 29 Solna Svezja
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Maltese: U kabelovny 130 102 37 Prague 10 Republika Ċeka
English: Sibutramine significantly increased blood pressure (BP) and heart rate (HR) when compared with placebo (although both reduced diastolic blood pressure and heart rate in patients losing weight) which may have contributed to the observed difference in CV event rates.
Maltese: Sibutramine għolla b'mod sinifikanti l-pressjoni taddemm (blood pressure - BP) u r-rata tat-tħabbit tal-qalb (heart rate - HR) meta mqabbel ma' plaċebo (għalkemm it-tnejn naqqsu l-pressjoni tad-demm dijastolika u r-rata tat-tħabbit tal-qalb f'pazjenti li kienu qegħdin jitilfu l-piż) li seta' kkontribwixxa għad-differenza osservata fir-rati tal-avveniment CV.
English: Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.º 24, rés-do-chão esq,
Maltese: Sidónio Pais, n.º 24, rés-do-chão esq,
English: Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral
Maltese: Sibutril 10 mg Kapsuli, hard 10 mg Kapsula, iebsa Għal użu orali
English: After 12 months of treatment no additional mean weight loss was achieved with sibutramine.
Maltese: Wara 12-il xhar trattament ma nkiseb l-ebda tnaqqis medju addizzjonali bi sibutramine.
English: Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av. Sidónio Pais, n.º 24, rés-do-chão esq
Maltese: Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda Av.
English: • The Committee concluded that the SCOUT study showed an increased risk of serious cardiovascular events in subjects with cardiovascular disease using sibutramine and because obese subjects are likely to be at risk of cardiovascular disease, the risks identified in the SCOUT study are considered relevant to the clinical use of sibutramine,
Maltese: • Il-Kumitat ikkonkluda li l-istudju SCOUT wera riskju miżjud ta' avvenimenti kardjovaskulari serji f'suġġetti b'mard kardjovaskulari bl-użu ta' sibutramine u minħabba l-fatt li s-suġġetti ħoxnin iżżejjed għandhom it-tendenza li jkollhom riskju ta' mard kardjovaskulari, ir-riskji identifikati fl-istudju SCOUT huma kkunsidrati rilevanti għall-użu klinku ta' sibutramine,
English: Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral
Maltese: Sibutril 15 mg Kapsuli, hard 15 mg Kapsula, iebsa Għal użu orali
English: Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use
Maltese: Zelium 15 mg Hartkapseln 15 mg Kapsula, iebsa
English: U Kabelovny 130 102 37 Praha 10 Czech Republic
Maltese: U Kabelovny 130 102 37 Praha 10 Republika Ċeka
English: Sibutramina Argam 10 mg Capsule, hard oral use
Maltese: Sibutramina Argam 10 mg Kapsula, iebsa Għal użu orali
English: 169 29 Solna Sweden
Maltese: 169 29 Solna Svezja
English: SILUTON 10 mg, capsule 10 mg Capsule, hard oral use
Maltese: SILUTON 10 mg, capsule 10 mg Kapsula, iebsa
English: SILUTON 15 mg, capsule 15 mg Capsule, hard oral use
Maltese: SILUTON 15 mg, capsule 15 mg Kapsula, iebsa
English: SIBUTRAMINA TEVA 15 mg Capsule, hard oral use
Maltese: SIBUTRAMINA TEVA 15 mg Kapsula, iebsa Għal użu orali
English: MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use
Maltese: MINIMACIN 10 mg, capsule 10 mg Kapsula, iebsa
English: MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use
Maltese: MINIMACIN 15 mg, capsule 15 mg Kapsula, iebsa
English: Moreover, although sophisticated CV screening tests are available such tests are neither reliable to predict future CV events nor practical for detection of CV disease prior to sibutramine treatment.
Maltese: Barra minn hekk, għalkemm testijiet ta' eżaminazzjoni CV sofistikati huma disponibbli, tali testijiet la huma affidabbli biex jipprevedu avvenimenti CV futuri u lanqas prattiċi għall-kxif ta' mard CV qabel it-trattament b'sibutramine.
English: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Maltese: KG Max-Planck-Ring 2 65205
English: Abbott Scandinavia AB P.O.
Maltese: Abbott Scandinavia AB P.O. Box 509
English: SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use
Maltese: SIBUTRAMIN SANDOZ 15 mg Kapsula, iebsa Għal użu orali
English: SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use
Maltese: SIBUTRAMIN SANDOZ 10 mg Kapsula, iebsa Għal użu orali