FrancophonIA/ELRC3.0 huggingface dataset:
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni kienet spiċċat u s-CHMP kien ta opinjoni negattiva.
English: • together with trastuzumab and carboplatin (another anticancer medicine).
Maltese: • flimkien ma' trastuzumab u carboplatin (mediċina oħra kontra l-kanċer).
English: What is Taxotere/Docetaxel Winthrop?
Maltese: X'inhu Taxotere/Docetaxel Winthrop?
English: Taxotere/Docetaxel Winthrop is an anticancer medicine.
Maltese: Taxotere/Docetaxel Winthrop huwa mediċina ta' kontra l-kanċer.
English: On 14 November 2008, Sanofi-Aventis Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Taxotere/Docetaxel Winthrop, to add the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Maltese: Fl-14 ta' Novembru 2008, Sanofi-Aventis Pharma S.A. uffiċjalment innotifikat lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal indikazzjoni ġdida għal Taxotere/Docetaxel Winthrop, bħala addizzjoni għat-trattament ta' pazjenti b'kanċer tas-sider operabbli b'iperesprezzjoni tat-tumuri tagħhom ta' HER2 f'kombinazzjoni ma' trastuzumab, bi jew mingħajr carboplatin.
English: • together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide;
Maltese: • flimkien ma' trastuzumab (mediċina oħra kontra l-kanċer), wara kura b'doxorubicin u ċiklofosfamide;
English: The active substance in Taxotere/Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the ‘taxanes'.
Maltese: Is-sustanza attiva f'Taxotere/Docetaxel Winthrop, docetaxel, tappartjeni għall-grupp ta' mediċini kontra l-kanċer magħruf bħala ‘tassani'.
English: • the combination of Taxotere/Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.
Maltese: • il-kombinazzjoni ta' Taxotere/Docetaxel Winthrop, trastuzumab u carboplatin għal 18-il ġimgħa.
English: • the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by
Maltese: • il-kombinazzjoni ta' doxorubicin u ċiklofosfamide għal 12-il ġimgħa, segwiti b'
English: Taxotere/Docetaxel Winthrop is a concentrate and solvent, which are made up into a solution for infusion (drip into a vein).
Maltese: Taxotere/Docetaxel Winthrop huwa konċentrat u solvent, li jitħalltu f'soluzzjoni għall-infużjoni (dripp ġol-vina).
English: The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/Docetaxel Winthrop, carboplatin and trastuzumab.
Maltese: Is-CHMP kien imħasseb ukoll li l-kumpanija ma pprovdietx prova klinika suffiċjenti biex tiġġustifika l-użu talkombinazzjoni ta' Taxotere/Docetaxel Winthrop, carboplatin u trastuzumab.
English: Taxotere/Docetaxel Winthrop is also used in advanced or metastatic non-small cell lung cancer, in prostate cancer, in metastatic gastric adenocarcinoma (a type of stomach cancer) and in advanced head and neck cancer.
Maltese: Taxotere/Docetaxel Winthrop jintuża wkoll f'kanċer tal-pulmun b'ċelloli mhux żgħar fi stadju avvanzat jew metastatiku, f'kanċer tal-prostata, f'adenokarċinoma gastrika metastatika (tip ta' kanċer tal-istonku) u f'kanċer avvanzat tar-ras u tal-għonq.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Maltese: Docetaxel jimblokka l-kapaċità taċ-ċelloli li jeqirdu l‘iskeletru' intern li jħallihom jinqasmu u jimmultiplikaw.
English: Taxotere/Docetaxel Winthrop has been studied in one main study involving over 3,000 women with HER2-expressing breast cancer that could be treated with surgery.
Maltese: Taxotere/Docetaxel Winthrop ġie studjat fi studju ewlieni li jinvolvi aktar minn 3,000 mara b'kanċer tas-sider b'espressjoni ta' HER2 li jista' jkun ittrattat kirurġikament.
English: Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Taxotere/Docetaxel Winthrop
Maltese: Mistoqsijiet u Tweġibiet dwar l-irtirar tal-applikazzjoni għal modifika flawtorizzazzjoni għat-tqegħid fis-suq għal Taxotere/Docetaxel Winthrop
English: Taxotere/Docetaxel Winthrop was expected to be used in addition to surgery to remove the tumour in the following treatment combinations:
Maltese: Taxotere/Docetaxel Winthrop kien mistenni li jintuża bħala addizzjoni għall-intervent kirurġiku biex ineħħi t-tumur fil-kombinazzjonijiet ta' trattament li ġejjin:
English: What were the reasons given by the company to withdraw the application?
Maltese: Fejn kienet waslet l-evalwazzjoni tal-applikazzjoni qabel din ġiet irtirata?
English: Taxotere/Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be ‘expressing' large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.
Maltese: Taxotere/Docetaxel Winthrop kien mistenni li jintuża wkoll f'kanċer tas-sider li jista' jkun ittrattat kirurġikament meta l-kanċer ikun intwera li qed ‘jesprimi' ammonti kbar ta' HER2: dan huwa tip ta' kanċer li jipproduċi (jesprimi) proteina speċifika msejħa HER2 fi kwantitajiet kbar fil-wiċċ ta' ċelloli tat-tumur.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Maltese: Abbażi tal-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fi żmien l-irtar, il-CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Taxotere/Docetaxel Winthrop fit-trattament ta' pazjenti b'kanċer tas-sider operabbli b'iperesprezzjoni tat-tumuri tagħhom ta' HER2 f'kombinazzjoni ma' trastuzumab, bi jew mingħajr carboplatin.
English: Taxotere/Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab;
Maltese: Taxotere/Docetaxel Winthrop għal 12-il ġimgħa, waħdu jew f'kombinazzjoni ma' trastuzumab.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Taxotere/Docetaxel Winthrop?
Maltese: Għal xiex kien mistenni li jintuża Taxotere/Docetaxel Winthrop?
English: What is happening for Taxotere/Docetaxel Winthrop for the treatment of other types of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer?
Maltese: X'jiġri b'Taxotere/Docetaxel Winthrop għat-trattament ta' tipi oħrajn ta' kanċer tas-sider, kanċer tal-pulmun b'ċelloli mhux żgħar, kanċer tal-prostata, adenokarċinoma gastrika u kanċer tar-ras u tal-għonq?
English: In these patients, Taxotere/Docetaxel Winthrop is used in addition to surgery to remove the tumour, together with doxorubicin and cyclophosphamide (other anticancer medicines).
Maltese: F'dawn il-pazjenti, Taxotere/Docetaxel Winthrop jintuża bħala addizzjoni għall-intervent kirurġiku biex jitneħħa t-tumur, flimkien ma' doxorubicin u ċiklofosfamide (cyclophosphamide, mediċini kontra l-kanċer oħrajn).
English: The study compared the effectiveness of the following treatment combinations, which were used in addition to surgery:
Maltese: L-istudju qabbel l-effikaċja talkombinazzjonijiet ta' trattament li ġejjin, li ntużaw bħala addizzjoni għall-intervent kirurġiku:
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Taxotere/Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Maltese: Ma hemm l-ebda konsegwenza fuq l-użu ta' Taxotere/Docetaxel Winthrop fl-indikazzjonijiet awtorizzati, fejn il-bilanċ bejn il-benefiċċju u r-riskju jibqa' invarjat.
English: de Castilla, 2.
Maltese: A.U Avda. de Castilla, 2.
English: 2ª planta.
Maltese: Berlin. 2ª planta.
English: G. LYRA 25, KIFISSIA
Maltese: LYRA 25, KIFISSIA
English: Wincentego st. Pola 21 58-500, Jelenia Góra, Poland
Maltese: Pola 21 58-500, Jelenia Góra, Poland
English: Slovak Republic ratiopharm International GmbH
Maltese: Is-Slovakkja ratiopharm International GmbH
English: Av. José MalhoaEdifício Malhoa Plaza nº piso-escritório 2.2 1070-325 Lisboa Portugal
Maltese: José MalhoaEdifício Malhoa Plaza nº piso-escritório 2.2 1070-325 Lisboa Portugal
English: IAMATICA MON. LTD CHALANDRIOU 6A AGIA PARASKEVI
Maltese: LTD CHALANDRIOU 6A AGIA PARASKEVI
English: ALFA WASSERMANN SPA via Enrico Fermi, 1
Maltese: WASSERMANN SPA via Enrico Fermi, 1
English: SANOFI AVENTIS, S.A.Josep Plá, 2
Maltese: AVENTIS, S.A.Josep Plá, 2
English: Novartis Norge AS, Postboks 4284 Nydalen
Maltese: Novartis Norge AS, Postboks 4284
English: 200UI/1d.
Maltese: IU/1 d.
English: ANFARM HELLAS PERIKLEOUS 53-57 ATHENS
Maltese: HELLAS PERIKLEOUS 53-57 ATHENS
English: MEDHEL HELLAS PHARMACEUTICAL INDUSTRY
Maltese: MEDHEL HELLAS PHARMACEUTICAL
English: Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Maltese: Edifício 7 - 3º Piso 2740-244
English: Sanofi Aventis France 1-13 boulevard Romain Rolland
Maltese: France 1-13 boulevard Romain Rolland
English: Calcitonin Sandoz 100 I.E. / Sprühstoß Nasenspray
Maltese: Calcitonin Sandoz 100 I.E. / Sprühstoß
English: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040 OriggioVARESE
Maltese: NOVARTIS FARMA SPA Largo Umberto Boccioni, 1 21040
English: LEOVAN M. LEON AND CO
Maltese: LEON AND CO
English: RAFARM A.E.B.E.
Maltese: A.E.B.E.
English: GENEPHARM SA 18TH KM MARATHONOS AVENUE
Maltese: SA 18TH KM MARATHONOS AVENUE
English: Alfa Wassermann S.p.A.
Maltese: Wassermann S.p.A.
English: PHARM LTD ARKOLEON 11
Maltese: LTD ARKOLEON 11
English: ADEPHARM MARNI 54
Maltese: MARNI 54
English: ALFA WASSERMANN, S.P.A.Via Enrico Fermi, 1 Alanno Scalo (Pescaro) 65020 ITALIA
Maltese: WASSERMANN, S.P.A.Via Enrico Fermi, 1 Alanno Scalo (Pescaro) 65020
English: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020 Wien, Austria
Maltese: Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 A-1020
English: FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES ACHAIAS AND TRIZOINIAS NEA KIFISSIA 14564
Maltese: FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES ACHAIAS AND TRIZOINIAS NEA
English: Germany mibe GmbH Arzneimittel Münchener Str. 15
Maltese: Il-Ġermanja mibe GmbH Arzneimittel Münchener Str. 15
English: 30TH KM ATHENSLAVRION AVENUE MARKOPOULO 19003
Maltese: KM ATHENSLAVRION AVENUE MARKOPOULO 19003
English: Calcitonin-CT 100 I.E./0,1ml Nasenspray 100 IU / dose
Maltese: Calcitonin-CT 100 I.E./0,1ml Nasenspray 100
English: Calcitonin 'Novartis' 200 I.E. - Nasalspray
Maltese: Calcitonin 'Novartis' 200 I.E.
English: REMEDINA ABEE GOUNARI 25 & AREOS KAMATERO ATTIKIS
Maltese: GOUNARI 25 & AREOS KAMATERO ATTIKIS
English: Calcitonin 'Novartis' 100 I.E. - Nasalspray
Maltese: Calcitonin 'Novartis' 100 I.E.
English: PHARMACEUTICAL INDUSTRY
Maltese: PHARMACEUTICAL
English: EVAGGELOS KALOFOLIAS IAPHARM MENANDROU 54
Maltese: EVAGGELOS KALOFOLIAS IAPHARM
English: PHARMACEUTICALS ABE SPYROU VRETOU 10 METAMORFOSI 14452
Maltese: PHARMACEUTICALS ABE SPYROU VRETOU 10
English: A. HATZIANTONOGLOUVELTIPHARM LTD DELIGIORGI 55-57
Maltese: LTD DELIGIORGI 55-57
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
Maltese: Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II, Torre Fernão de Magalhães10 Esqº
Maltese: João II, Torre Fernão de Magalhães10
English: Novartis Healthcare A/S, Lyngbyvej 172, DK-2100 Østerbro, Denmark
Maltese: Novartis Healthcare A/S, Lyngbyvej 172, DK-2100
English: Osteodon 200 IU.
Maltese: Osteodon 200 I.U.
English: CALSYNAR 50 UI polvo y disolvente para solución inyectable
Maltese: UI polvo y disolvente para solución inyectable
English: CALSYNAR 200 UI solucion para pulverizacion nasal en envase unidosis
Maltese: UI solucion para pulverizacion nasal en envase unidosis
English: MEDA PHARMA S.A.U Avda.
Maltese: MEDA PHARMA S.
English: Calcitonin-ratiopharm 200 Nasal
Maltese: Calcitonin-ratiopharm 200
English: 200 IU/dose, 2000 IU/ML
Maltese: IU/doża, 2000
English: PALLINI ATTIKIS 15353
Maltese: ATTIKIS 15353
English: PALLINI ATTIKIS 15352
Maltese: ATTIKIS 15352
English: Iceland
Maltese: L-Islanda
English: PALLINI ATTIKIS 15351
Maltese: ATTIKIS 15351
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13452
Maltese: AVENUE 137, KAMATERO 13452
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13451
Maltese: AVENUE 137, KAMATERO 13451
English: Ratiopharm GmbH Graf-Arco-Str. 3., Ulm
Maltese: Ratiopharm GmbH Graf-Arco-Str.
English: PHARMACEUTICALS FYLIS AVENUE 137, KAMATERO 13453
Maltese: AVENUE 137, KAMATERO 13453
English: Miacalcic Nasal 200 200 IU
Maltese: Miacalcic Nasal 200 200
English: Miacalcic Nasal 200 Nasal Spray Solution 200IU/dose
Maltese: Nasal Spray Solution 200IU/dose
English: Miacalcic Solution for Injection 100IU/ml solution for injection subcutaneous, intramuscular and intravenous use
Maltese: Miacalcic Solution for Injection 100IU/ml subcutaneous, intramuscular and użu għal ġol-vini
English: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario, 14 03006 Alicante
Maltese: ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A Sagitario,
English: Karil 200 I.E. Nasenspray
Maltese: Karil 200 I.E.
English: Graf-Arco-Strasse 3, Ulm D-89070
Maltese: Graf-Arco-Strasse 3, Ulm
English: ROTTAPHARM HELLAS ACHAIAS AND TRIZOINIAS NEA KIFISSIA 14564
Maltese: HELLAS ACHAIAS AND TRIZOINIAS NEA
English: Slovak Republic
Maltese: Is-Slovakkja
English: 200IU in 1ml
Maltese: IU/0.1 ml
English: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Maltese: Calcitonine-Sandoz 100 IE/ml, oplossing voor injectie en infusie soluzzjoni għallinjezzjoni/infużjoni użu għal taħt il-ġilda, użu għal ġol-muskoli, użu għal ġol-vini
English: Calcitonina de Salmão Tolife 200 UI solução para pulverização nasal
Maltese: Calcitonina de Salmão Tolife 200
English: MIACALCIC 100 UI solución inyectable y para perfusión
Maltese: UI solución inyectable y para perfusión
English: MENANDROU 54 ATHENS 10432
Maltese: ATHENS 10432
English: Calcitonin 'Novartis' 100 I.E./ml - Lösung zur Injektion und Infusion solution for injection/infusion subcutaneous use, intramuscular use, intravenous use
Maltese: Calcitonin 'Novartis' 100 I.E./ml - Lösung zur Injektion und Infusion soluzzjoni għallinjezzjoni/infużjoni użu għal taħt il-ġilda, użu għal ġol-muskoli, użu għal ġol-vini
English: Calcitonina Wander 200 200 IU/dose nebuliser solution nasal use
Maltese: Calcitonina Wander 200 200
English: CALCITONINA ALMIRALL 100 UI solución inyectable
Maltese: CALCITONINA ALMIRALL 100
English: TONOCALCIN 100 IU nosová aerodisperzia 100 IU/0,1 ml
Maltese: IU nosová aerodisperzia 100
English: KARANIKOLOPOULOSKAKLAMANI VALAORITOU 7
Maltese: VALAORITOU 7
English: TONOCALCIN 200 IU nosová aerodisperzia 200 IU/0,1 ml
Maltese: IU nosová aerodisperzia 200
English: Austria
Maltese: Wien, Austria
English: CALCITONINA HUBBER 200 UI solución para pulverización nasal multidosis
Maltese: UI solución para pulverización nasal multidosis
English: S.J.A.
Maltese: I.E.
English: Luxembourg
Maltese: Il-Lussemburgu
English: CALCITONINratiopharm 200 NE/adag oldatos orrspray
Maltese: CALCITONINratiopharm 200
English: CALSYNAR 200 UI solucion para pulverizacion nasal
Maltese: UI solucion para pulverizacion nasal
English: 200 IU
Maltese: OSPOR 200
English: Miacalcic 200 Spray Nasal
Maltese: Miacalcic Nasal 200
English: 100 IU/1ML AMP solution for injection intramuscular use
Maltese: IU/1ML AMP
English: Pharmaceuticals UK Ltd. Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom
English: CALCITONIN / TARGET 100 IU/DOSE nasal spray, solution nasal use
Maltese: CALCITONIN / TARGET 100 IU/DOŻA sprej għall-imnieħer, soluzzjoni
English: CALCITONINA HUBBER 100 UI solución inyectable
Maltese: CALCITONINA HUBBER 100
English: 2200 i.e./ml
Maltese: IU/ML
English: 200 IU / metered dose
Maltese: IU/doża metrika
English: blister (alu/alu)
Maltese: Folja (alu/alu)
English: Immediate Packaging
Maltese: Daqs talpakkett
English: EU Number
Maltese: Numru ta' l-EU
English: Pack size bottle (HDPE)
Maltese: Flixkun (HDPE)
English: Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Preferred Term
Maltese: Terminu preferit
English: Acute generalized exanthematus pustulosis (AGEP), angioedema
Maltese: Acute generalized exanthematus pustulosis (AGEP), anġjoedima
English: Paediatric population:
Maltese: Popolazzjoni pedjatrika:
English: Hepatitis
Maltese: Epatite
English: Palpitations, extrasystoles, tachycardia
Maltese: Palpitazzjonijiet, extrasistoli, takikardija
English: 4.1 Therapeutic indications
Maltese: 4.3 Kontra-indikazzjonijiet
English: Rash, pruritus, urticaria.
Maltese: Raxx, ħakk, urtikarja
English: System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi Frekwenza
English: Agranulocytosis Thrombocytopenia Thrombocytopenic purpura
Maltese: Agranuloċitosi Tromboċitopenija Purpura tromboċitopenika
English: Anti-ischemic effects are achieved without concomitant haemodynamic effects.
Maltese: L-effetti anti-iskemiċi jinkisbu mingħajr effetti emodinamiċi konkomitanti.
English: Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restlessleg syndrome, other related movement disorders, usually reversible after treatment discontinuation
Maltese: Sintomi ta' Parkinson (tregħid, akinesija, ipertonija), instabilità fil-mixja, sindrome tassaqajn bla kwiet, disturbi oħra relatati filmoviment, ġeneralment riversibbli wara t-twaqqif tal-kura
English: However, in the subgroup of symptomatic patients (n= 1574) defined in a post-hoc analysis, trimetazidine (140 mg) significantly improved total exercise duration (+23.8 s versus +13.1 s placebo; p=0.001) and time to onset of angina (+46.3 s versus +32.5 s placebo; p=0.005).
Maltese: Madankollu, fis-sottogrupp tal-pazjenti sintomatiċi (n= 1574) definit f'analiżi post-hoc, trimetazidine (140 mg) tejjeb b'mod sinifikanti d-dewmien totali tal-eżerċizzju (+23.8 s kontra +13.1 s plaċebo; p=0.001) u l-ħin sal-bidu ta' anġina (+46.3 s kontra +32.5 s plaċebo; p=0.005).
English: Constipation
Maltese: Astenja
English: Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation.
Maltese: Trimetazidine jimpedixxi l--ossidazzjoni tal-aċidi xaħmija billi jimblokka l-long-chain 3-ketoacylCoA thiolase, li żżid l-ossidazzjoni tal-glukożju.
English: A significant difference was also evidenced for the time to onset of angina pectoris (p=0.049).
Maltese: Dehret ukoll differenza sinifikanti fil-ħin sal-bidu ta' anġina pectoris (p=0.049).
English: In a 1962 patients three-month randomised, double-blinded study (Vasco study) on top of atenolol 50 mg/d, two dosages of trimetazidine (70 mg/d and 140 mg/d) were tested versus placebo.
Maltese: Fi studju double-blind, randomizzat, ta' tliet xhur fuq 1962 pazjent (Studju Vasco) flimkien ma' atenolol 50 mg/ġurnata, ġew ittestjati żewġ dożi ta' trimetazidine (70 mg/ġurnata u 140 mg/ġurnata) kontra l-plaċebo.
English: Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.
Maltese: Trimetazidine huwa indikat fl-adulti bħala terapija addizzjonali għat-trattament sintomatiku ta' pazjenti b'anġina pectoris stabbli li ma jkunux ikkontrollati adegwatament bi jew li jkunu intolleranti għat-terapiji preferiti kontra l-anġina.
English: In a 426-patients randomized, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p<0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
Maltese: METs, p=0.001, ħin sa depressjoni ta' 1 mm fis-segment ST +33.4 s, p=0.003, ħin sal-bidu ta' anġina +33.9 s, p<0.001, attakki ta' anġina/ġimgħa -0.73, p=0.014 u konsum ta' nitrati li jaħdmu malajr/ġimgħa, -0.63, p=0.032, mingħajr bidliet emodinamiċi.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: Annex III Emendi għas-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi talprodott u tal-fuljett ta' tagħrif
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Maltese: F'pazjenti b'indeboliment moderat fil-kliewi (tneħħija tal-kreatinina ta' [30-60] ml/min) (ara sezzjonijiet 4.4 u 5.2), id-doża rakkomandata hija pillola waħda ta' 20 mg jew 1 ml (20 qatra) ta' soluzzjoni għall-qtar orali darbtejn kuljum, jiġifieri waħda filgħodu u waħda filgħaxija waqt l-ikel.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Maltese: F'pazjenti b'indeboliment moderat fil-kliewi (tneħħija tal-kreatinina ta' [30-60] ml/min) (ara sezzjonijiet 4.4 u 5.2), id-doża rakkomandata hija pillola waħda ta' 35 mg filgħodu matul ilkolazzjon.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20mg or 1 ml (20 drops) of oral drop solution twice daily, i.e., one in the morning and one in the evening during meals.
Maltese: F'pazjenti b'indeboliment moderat fil-kliewi (tneħħija tal-kreatinina ta' [30-60] ml/min), id-doża rakkomandata hija pillola waħda ta' 20 mg jew 1 ml (20 qatra) ta' soluzzjoni għall-qtar orali darbtejn kuljum, jiġifieri waħda filgħodu u waħda filgħaxija waqt l-ikel.
English: Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected: - moderate renal impairment (see sections 4.2 and 5.2), - elderly patients older than 75 years old (see section 4.2)
Maltese: Għandha ssir attenzjoni meta trimetazidine jingħata lil pazjenti li fihom jista' jkun mistenni esponiment akbar: - indeboliment moderat fil-kliewi (ara sezzjonijiet 4.2 u 5.2), - pazjenti anzjani ta' 'l fuq minn 75 sena (ara sezzjoni 4.2)
English: Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting
Maltese: Uġigħ addominali, dijarea, dispepsja, dardir u rimettar
English: The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
Maltese: Is-seħħ ta' disturbi fil-moviment bħas-sintomi ta' Parkinson, is-sindrome tas-saqajn bla kwiet, tregħid u instabilità fil-mixja għandhom iwasslu għat-twaqqif definittiv ta' trimetazidine.
English: Pregnancy and breast-feeding
Maltese: Disturbi fil-qalb
English: The recommended dose of <invented name> 20mg/ml solution is 20 drops to be taken three times a day during meals.
Maltese: Id-doża rakkomandata ta' <Isem ivvintat> 20 mg/ml soluzzjoni hija 20 qatra li għandhom jittieħdu tliet darbiet kuljum waqt l-ikel.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast.
Maltese: F'pazjenti b'indeboliment moderat fil-kliewi (tneħħija tal-kreatinina ta' [30-60] ml/min), id-doża rakkomandata hija pillola waħda ta' 35 mg filgħodu matul il-kolazzjon.