FrancophonIA/ELRC3.0 huggingface dataset:
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
Maltese: Fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2, kura b'dapagliflozin uriet tnaqqis fil-FPG f'Ġimgħa 24: -1.19 mmol/L (-21.46 mg/dL) meta mqabbel ma' 0.27 mmol/L (-4.87 mg/dL) għall-plaċebo (p=0.001).
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Maltese: Il-valutazzjoni primarja tas-sigurtà u t-tollerabbiltà saret f'analiżi miġbura speċifikata minn qabel ta' 13-il studju kkontrollati bi plaċebo bi 2,360 individwu kkurati b'10 mg dapagliflozin u 2,295 ittrattati bi plaċebo.
English: In combination with metformin in drug-naive patients A total of 1,236 drug-naive patients with inadequately controlled type 2 diabetes (HbA1c ≥ 7.5% and ≤ 12%) participated in two active-controlled studies of 24 weeks duration to evaluate the efficacy and safety of dapagliflozin (5 mg or 10 mg) in combination with metformin in drug-naive patients versus therapy with the monocomponents.
Maltese: F'kombinazzjoni ma' metformin f'pazjenti li ma ġewx ikkurati preċedentement Total ta' 1,236 pazjent li ma ġewx ikkurati preċedentement b'dijabete tat-tip 2 mhux ikkontrollata b'mod adegwat (HbA1c ≥ 7.5% u ≤ 12%) ipparteċipaw f'żewġ studji kkontrollati b'mod attiv ta' durata ta' 24 ġimgħa sabiex jevalwaw l-effikaċja u s-sigurtà ta' dapagliflozin (5 mg jew 10 mg) f'kombinazzjoni ma' metformin f'pazjenti li ma ġewx ikkurati preċedentement kontra terapija bil-monokomponenti.
English: Renal composite endpoint defined as: sustained confirmed ≥ 40% decrease in eGFR to eGFR <60 mL/min/1.73 m 2 and/or end stage renal disease (dialysis ≥ 90 days or kidney transplantation, sustained confirmed eGFR < 15 mL/min/1.73 m 2) and/or renal or cardiovascular death.
Maltese: Punt tat-tmiem kompost renali defnit bħala: tnaqqis sostnut ikkonfermat ta' ≥ 40% fl-eGFR sa eGFR <60 mL/min/1.73 m 2 u/jew marda renali fl-aħħar stadju (dijaliżi ≥ 90 jum jew trapjant tal-kliewi, eGFR < 15 mL/min/1.73 m 2 sostnuta kkonfermata) u/jew mewt renali jew kardjovaskulari.
English: In the dapagliflozin cardiovascular outcomes study with 17,160 type 2 diabetes mellitus patients and a median exposure time of 48 months, a total of 6 cases of Fournier's gangrene were reported, one in the dapagliflozin-treated group and 5 in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin bi 17,160 pazjent bid-dijabete mellitus tat-tip 2 u żmien ta' esponiment medjan ta' 48 xahar, ġew irrapportati total ta' 6 każijiet ta' kankrena ta' Fournier, wieħed fil-grupp ikkuratt b'dapagliflozin u 5 fil-grupp ikkurat bi plaċebo.
English: Ebymect is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
Maltese: Ebymect huwa indikat għall-kura tad-dijabete (diabetes mellitus) tat-tip 2 bħala żieda mad-dieta u leżerċizzju:
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Maltese: Ġiet osservata żieda fl-inċidenza jew fis-severità tad-dilatazzjoni tal-pelvi renali fl-ulied adulti tal-ommijiet li ġew ittrattati, imma biss għall ogħla doża li ġiet ittestjata (l-esponimenti assoċjati materni u tal-frieħ għal dapagliflozin kienu 1,415-ildarba u 137 darba, rispettivament, iktar mill-valuri umani għad-doża massima rrakkomandata għallbnedmin).
English: These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti finnisa (8.4% u 1.2% għal dapagliflozin u plaċebo, rispettivament), u individwi li kellhom dawn linfezzjonijiet fil-passat kellhom aktar probabilita' li jerġgħu jkollhom infezzjoni.
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73 m2 (18.5% dapagliflozin 10 mg versus 9.3% placebo).
Maltese: Dawn irreazzjonijiet kienu aktar komuni f'pazjenti b'eGFR tal-linja bażi ≥ 30 u < 60 mL/min/1.73 m dapagliflozin 10 mg vs 9.3% plaċebo).
English: Dapagliflozin 10 mg demonstrated non-inferiority versus placebo for the composite of cardiovascular death, myocardial infarction or ischaemic stroke (one-sided p < 0.001).
Maltese: Dapagliflozin 10 mg wera nuqqas ta' inferjorità kontra plaċebo għall-kompost ta' mewt kardjovaskulari, infart mijokardijaku jew puplesija iskemika (p minn naħa waħda < 0.001).
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;
Maltese: L-analiżi tar-riżultati ta' pazjenti b'piż żejjed li ġew ittrattati b'metformin wara li d-dieta weħidha ma rnexxietx uriet: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete fil-grupp ta' metformin (29.8 avveniment/1,000 sena ta' pazjent) meta mqabbel mad-dieta weħidha (43.3 avveniment/1,000 sena ta' pazjent), p=0.0023, u meta mqabbel mal-gruppi tal-monoterapija ta' sulphonylurea flimkien mal-insulina (40.1 avveniment/1,000 sena ta' pazjent), p=0.0034; - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mewt relatata mad-dijabete: metformin 7.5 avvenimenti/1,000 sena ta' pazjent, dieta weħidha 12.7-il avveniment/1,000 sena ta' pazjent, p=0.017; - tnaqqis sinifikanti fir-riskju assolut ta' mortalità b'mod ġenerali: metformin 13.5-il avveniment/1,000 sena ta' pazjent imqabbel mad-dieta weħidha 20.6 avveniment/1,000 sena ta' pazjent, (p=0.011), u mqabbel mal-gruppi tal-monoterapija b'sulphonylurea flimkien mal-insulina 18.9-il avveniment/1,000 sena ta' pazjent (p=0.021); - tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11-il avveniment/1,000 sena ta' pazjent, dieta weħidha 18-il avveniment/1,000 sena ta' pazjent, (p=0.01).
English: In an add-on to insulin study up to 104 weeks, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects in dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Maltese: Fi studju dwar żieda mal-insulina sa 104 ġimgħat, ġew irrapportati episodji maġġuri ta' ipogliċemija f'0.5% u 1.0% tal-individwi f'10 mg dapagliflozin flimkien mal-insulina fil-ġimgħat 24 u 104,
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal glucose fid-demm, inqas minn 14 mmol/L (250 mg/dL).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Maltese: Ebymect fih inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment “mingħajr sodium”.
English: In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and
Maltese: IU kuljum u 18.3 IU kuljum mil-linja bażi (doża medja ta' 84 u 92 IU kuljum) filġimgħat 48 u 104, rispettivament.
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2,000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metformin (sa 2000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 7), u wasslet għal tnaqqis ikbar fl-FPG (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metformin).
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: Plaċebo + insulina ± prodotti mediċinali orali li jbaxxu l-glukożju LOCF: L-aħħar osservazzjoni (qabel id-data jew dakinhar tal-ewwel żieda fid-doża tal-insulina, jekk meħtieġ) miġjuba 'l quddiem L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju double-blind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju Żieda fid-dożi tal-insulina (inkluż insulina li taħdem għal żmien qasir, intermedja jew bażali) kienet permessa biss jekk il-pazjenti kienu jissodisfaw il-kriterji FPG definiti minn qabel Ħamsin fil-mija tal-pazjenti kienu fuq monoterapija bl-insulina fil-linja bażi; 50 % kienu fuq prodott jew żewġ prodotti mediċinali orali li jbaxxu l-glukożju miżjuda mal-insulina:
English: • Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Maltese: • Faxxite nekrotizzanti tal-perinew jew kankrena ta' Fournier, infezzjoni serja tat-tessut artab talġenitali jew tal-parti bejn il-ġenitali u l-anus, li tidher f'każijiet rari ħafna.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Maltese: Id-doża massima ta' kuljum ta' metformin preferibbilment għandha tinqasam fi 2 - 3 dożi kuljum.
English: p-values for the secondary endpoints and for single components are nominal.
Maltese: Il-valuri p għall-punti tat-tmiem sekondarji u għall-komponenti uniċi huma nominali..
English: Metformin may act via three mechanisms: by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; by delaying intestinal glucose absorption.
Maltese: Metformin jista' jaġixxi permezz ta' tliet mekkaniżmi: - bit-tnaqqis tal-produzzjoni tal-glukożju fil-fwied billi jimpedixxi l-glukoneoġenesi u l glikoġenoliżi; - billi jżid bi ftit is-sensittività għall-insulina, u b'hekk itejjeb it-teħid u l-użu periferiku tal-glukożju fil-muskoli; - billi jittardja l-assorbiment intestinali tal-glukożju.
English: Baseline (mean) Change from baseline Difference from dapagliflozin c
Maltese: Aħjar b'Dapagliflozin
English: Change from baseline Difference from placebo d
Maltese: Differenza minn dapagliflozin c
English: In type 1 diabetes mellitus studies, DKA was reported with common frequency.
Maltese: Fi studji tad-dijabete mellitus tat-tip 1, ġiet irrappurtata DKA bi frekwenza komuni.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80 % kienu fuq metformin waħdu, 12 % kienu fuq terapija ta' metformin flimkien ma' sulphonylurea, u lbqija kienu fuq prodotti mediċinali orali oħrajn li jbaxxu l-glukożju.
English: • Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).
Maltese: • Deidrazzjoni: telf eċċessiv ta' fluwidu mill-ġisem, ma jseħħx normalment (jista' jaffettwa sa persuna 1 minn kull 100 persuna).
English: Use in patients at risk for volume depletion and/or hypotension Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see section 5.1).
Maltese: Użu f'pazjenti f'riskju minħabba nuqqas fil-volum u/jew pressjoni baxxa tad-demm Minħabba l-mekkaniżmu ta' azzjoni tiegħu, dapagliflozin iżid id-dijureżi li tista' twassal għat-tnaqqis modest fil-pressjoni tad-demm li ġie osservat fl-istudji kliniċi (ara sezzjoni 5.1).
English: All randomised patients who took at least one dose of double-blind study medicinal product during the short-term double-blind period.
Maltese: Il-pazjenti randomizzati kollha li ħadu tal-inqas doża waħda ta' medikazzjoni tal-istudju double-blind matul ilperjodu double-blind fil-qosor.
English: If Fournier's gangrene is suspected, Ebymect should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk tiġi suspettata kankrena ta' Fournier, Ebymect għandu jitwaqqaf u għandha tinbeda kura minnufih (li tinkludi antibijotiċi u tneħħija kirurġika).
English: If no adequate strength of Ebymect is available, individual mono-components should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Ebymect, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: EU/1/06/350/001 Savene
Maltese: EU/1/06/350/001
English: concentrate: 25 ml (20 mg/ml); diluent: 500 ml
Maltese: 25 ml (20 mg/ml) solvent: 500 ml
English: 20 mg/ml
Maltese: Savene mg/ml
English: 10 vials + 3 bottles
Maltese: 10 kunjetti 3 flixken
English: Intravenous use powder: vial (glass); bottle (glass)
Maltese: Użu għal ġolvini trab: kunjett (ħġieġ); solvent: flixkun (ħġieġ)
English: Powder and solvent for concentrate for solution for infusion
Maltese: Trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni
English: 7 (7 x 1) vials + 7 (7 x 1) pre-filled solvent syringes + 7 (7 x 1) vial adapters + 7 (7 x 1) needles + 14 (7 x 2) swabs (multipack)
Maltese: 7 (7 x 1) kunjetti + 7 (7 x 1) siringi għassolvent mimlijin g]al-lest + 7 (7 x 1) adapters għall-kunjett + 7 (7 x 1) labar + 14 (7 x 2) -il garża (pakkett multiplu)
English: 7 (7 kits x (1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs)) (multipack)
Maltese: 7 (7 kitts x (kunjett 1+ siringa 1 għassolvent mimlija għal-lest + adapter 1 għallkunjett + labra 1 + 2 gareż)) (pakkett multiplu)
English: 1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs
Maltese: Daqs tal-pakkett kunjett 1 + siringa 1 għassolvent mimlija għal-lest + adapter 1 għallkunjett + labra 1 + 2 gareż
English: Prof Pieter de Graeff (the Netherlands)
Maltese: Pieter de Graeff (L-Olanda)
English: Dr Harald Enzmann (Germany)
Maltese: Dr Harald Enzmann (Il-Ġermanja)
English: EMA/103806/2010 Rev. 1 EMEA/H/A-29/1246
Maltese: EMEA/H/A-29/1246
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Teva outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Maltese: IlKumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Clopidogrel Teva huma akbar mir-riskji, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata filĠermanja u fl-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, ilLitwanja, il-Lussemburgu, l-Olanda, in-Norveġja, il-Polonja, ir-Rumanija, is-Slovakkja, Spanja, lIżvezja u r-Renju Unit.
English: in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ il-Ġermanja) ivvaluta mediċina bil-ħsieb li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dak il-pajjiż u fi Stati Membri oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, irRepubblika Ċeka, id-Danimarka, l-Estonja, il-Finalandja, Franza, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, l-Olanda, in-Norveġja, il-Polonja, ir-Rumanija, is-Slovakkja, Spanja, l-Iżvezja u r-Renju Unit).
English: What is Clopidogrel Teva?
Maltese: X'inhu Clopidogrel Teva?
English: Teva Pharma B.V. submitted Clopidogrel Teva to Germany for a decentralised procedure.
Maltese: Teva Pharma B.V. issottomattiet Clopidogrel Teva lill-Ġermanja għal proċedura diċentralizzata.
English: The active substance, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva, clopidogrel, hija inibitur tal-aggregazzjoni tal-plejtlits.
English: Clopidogrel Teva is a generic medicine based on a ‘reference medicine', Plavix which is authorised in the EU.
Maltese: Clopidogrel Teva hija mediċina ġenerika bbażata fuq il-‘mediċina ta' referenza', Plavix, li hija awtorizzata fl-UE.
English: Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Teva huwa prodott mediċinali li fih is-sustanza attiva clopidogrel.
English: 18 January 2010
Maltese: 18 ta' Jannar 2010
English: 4 June 2010
Maltese: 4 ta' Ġunju 2010
English: Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it.
Maltese: Clopidogrel base huwa inqas stabbli mill-forma tal-melħ, u BHA ġie inkluż fil-mediċina biex jistabilizzaha.
English: The company had chosen to use ‘clopidogrel base' as the form of the active substance in the medicine, and not a salt such as the ‘hydrogen sulfate salt' used in Plavix.
Maltese: Il-kumpanija għażlet li tuża ‘clopidogrel base' bħala l-forma tas-sustanza attiva fil-mediċina, u mhux melħ bħall-‘melħ hydrogen sulfate' użat fi Plavix.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Teva and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini lestiet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost Stati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Clopidogrel Teva u l-ismijiet assoċjati.
English: The grounds for the referral were concerns from Sweden that patients would be exposed to the antioxidant butylated hydroxyanisole (BHA) unnecessarily.
Maltese: Ir-raġunijiet għar-referenza kienu t-tħassib mill-Iżvezja li l-pazjenti kienu sejrin ikunu esposti għallantiossidant butylated hydroxyanisole (BHA) bla bżonn.
English: As, the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Maltese: Minħabba li l-Istati Membri ma setgħux jilħqu ftehim, l-aġenzija regolatorja tal-mediċini Ġermaniża irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fid-29 ta' Ottubru 2009.
English: It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke.
Maltese: Huwa jintuża fl-adulti biex jipprevjeni avvenimenti aterotrombotiċi (problemi kkawżati minn emboli tad-demm u t-twebbis tal-arterji) bħal attakk tal-qalb jew puplesija.
English: Why was Clopidogrel Teva reviewed?
Maltese: Għaliex ġie rivedut Clopidogrel Teva?
English: 18 February 2010
Maltese: 18 ta' Frar 2010
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Maltese: Dan iwaqqaf lill-plejtlits milli jsiru ‘jwaħħlu', u jnaqqas ir-riskju li jifforma embolu tad-demm u jgħin fil-prevenzjoni ta' attakk tal-qalb jew puplesija oħrajn.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Teva outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.
Maltese: Fuq il-bażi tad-dejta disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li l-benefiċċji ta' Clopidogrel Teva huma akbar mir-riskji u rrakkomanda li jingħata lawtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri kkonċernati kollha.
English: • There is insufficient data on Abseamed to know the size of any increased immunogenicity risk with sc use
Maltese: • Hemm informazzjoni insuffiċjenti fuq Abseamed biex ikun magħruf il-kobor ta' xi żieda firriskju ta' immunoġeniċità bl-użu minn taħt il-ġilda
English: The educational leaflet shall contain the following key elements:
Maltese: Il-fuljett edukattiv għandu jkun fih l-elementi importanti li ġejjin:
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zydelig (idelalisib).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għal Zydelig (idelalisib).
English: This review was initiated due to a reported increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups observed in three clinical trials (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
Maltese: Din ir-reviżjoni nbdiet minħabba rapporti ta' riskju akbar ta' mewt u inċidenza ogħla ta' avvenimenti avversi serji (SAE) fost individwi li kienu qed jirċievu idelalisib meta mqabbla mal-gruppi ta' kontroll osservati fi tliet provi kliniċi (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
English: • The PRAC noted that most of the serious adverse events reported in studies -0123, -0124 and -0125 were related to infections.
Maltese: • Il-PRAC innota li ħafna mill-avvenimenti avversi serji rrapportati fl-istudji -0123, -0124 u -0125 kienu relatati ma' infezzjonijiet.