FrancophonIA/ELRC3.0 huggingface dataset:
English: Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.
Maltese: Jinarc intwera li huwa effettiv biex idewwem il-formazzjoni taċ-ċisti meta mqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew adulti b'marda poliċistika tal-kliewi awtosomali dominanti li kellhom marda li kienet qiegħda tipprogressa malajr.
English: By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.
Maltese: Billi jimblokka r-riċetturi ta' vasopressin fil-kliewi, Jinarc jdewwem il-formazzjoni taċ-ċisti.
English: How is Jinarc used?
Maltese: Kif jintuża Jinarc?
English: Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment.
Maltese: Il-pazjenti għandhom ukoll jiġu mmonitorjati għal sintomi ta' ħsara fil-fwied (bħal telf ta' aptit, nawsja u rimettar, ħakk, għeja u uġigħ fin-naħa tal-lemin ta' fuq tażżaqq) waqt il-kura.
English: The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition.
Maltese: L-Aġenzija nnutat il-ħtieġa mhux sodisfatta għal kuri għall-marda poliċistika tal-kliewi awtosomali dominanti u kkunsidrat li Jinarc huwa effettiv biex idewwem ilformazzjoni taċ-ċisti u t-tnaqqis fil-funzjoni tal-kliewi f'pazjenti bil-kondizzjoni.
English: Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.
Maltese: Il-pazjenti għandhom jixorbu ħafna ilma jew fluwidi oħrajn (ħlief meraq tal-grejpfrut) waqt il-kura.
English: 4 December 2015
Maltese: 4 ta' Diċembru 2015
English: EMA/HMPC/333915/2015 Corr.1
Maltese: EMA/HMPC/333915/2015
English: Comfrey root EMA/HMPC/333915/2015
Maltese: Widnet il-għomor EMA/HMPC/333915/2015
English: Further information on the HMPC assessment of comfrey root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom Widnet il-għomor, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC also noted 4 clinical studies carried out with a different comfrey preparation (not covered by this summary).
Maltese: L-HMPC innota wkoll 4 studji kliniċi mwettqa bi preparazzjoni ta' Widnet il-għomor differenti (mhux koperta b'dan is-sommarju).
English: Comfrey root is the common name for the root of the plant Symphytum officinale L. This summary covers Comfrey root medicines containing a specific herbal preparation, which is obtained by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in alcohol).
Maltese: Widnet il-għomor li fihom preparazzjoni erbali, li hija miksuba bl-estrazzjoni tal-etanol (teknika użata għall-estrazzjoni ta' komposti minn materjal tal-pjanta billi dawn jiddewbu fl-alkoħol).
English: However, the amount of pyrrolizidine alkaloids has to be specified in each comfrey root medicine and patients should not be exposed to more than 0.35 microgram of pyrrolizidine alkaloids per day.
Maltese: Madankollu, l-ammont ta' alkalojdi pirroliżidiniċi għandu jiġi speċifikat f'kull mediċina li fiha Widnet il-għomor u l-pazjenti ma għandhomx jiġu esposti għal aktar minn 0.35 mikrogrammi ta' alkolojdi pirroliżidiniċi kuljum.
English: Comfrey root
Maltese: Widnet il-għomor
English: These medicines should only be used in adults and should not be taken for longer than 10 days.
Maltese: Dawn il-mediċini għandhom jintużaw biss f'adulti u ma għandhomx jittieħdu għal iktar minn 10 t'ijiem.
English: Herbal medicines containing this comfrey root preparation are available in semi-solid forms (such as creams or ointments) to be applied to the skin.
Maltese: Mediċini erbali li fihom Widnet il-għomor normalment huma disponibbli f'għamliet semi-solidi (bħal kremi u ingwenti) li għandhom jiġu applikati fuq il-ġilda.
English: Comfrey root contains substances known as pyrrolizidine alkaloids, which have toxic effects on the liver when taken by mouth.
Maltese: Widnet il-għomor fiha sustanzi magħrufin bħala alkolojdi pirroliżidiniċi, li għandhom effetti tossiċi fuq ilfwied meta jittieħdu mill-ħalq.
English: The HMPC conclusions on the use of comfrey root medicines for the relief of symptoms of minor sprains and bruises are based on their ‘traditional use' in these conditions.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini li fihom Widnet il-għomor għas-solliev tas-sintomi ta' liwi minuri u tbenġil huma bbażati fuq l-‘użu tradizzjonali' tagħhom f'dawn il-kondizzjonijiet.
English: Further information on the risks associated with comfrey root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom Widnet il-għomor, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: What is comfrey root?
Maltese: Widnet il-għomor?
English: • The active substance is clopidogrel.
Maltese: • Is-sustanza attiva hi clopidogrel.
English: 75 mg-325 mg daily).
Maltese: 75 mg-325 mg kuljum).
English: Date of first authorisation: 28 July 2009 Date of latest renewal: 16 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Lulju 2009 Data tal-aħħar tiġdid: 16 ta' Mejju 2014
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Maltese: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir-Renju Unit
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Każijiet kardjovaskulari ġodda (punt aħħari ta' riferiment primarju) kienu evitati, bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) u 14% (CI: -31.6, 44.2), waqt l-intervalli ta' studju ta' 0-1, 1-3, 36, 6-9 u 9-12 xhur, rispettivament.
English: Pharmacodynamic effects
Maltese: Effetti farmakodimaniċi
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 4000
Maltese: Hypromellose (E464) Titanium dioxide (E171) Macrogol 4000
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: F'CURE, 823 (6.6%) pazjent ingħataw terapija ta' antagonista għar-riċettatur GPIIb/IIIa fl istess ħin.
English: − Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132).
Maltese: - Il-kisi tal-pillola: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
English: Clopidogrel Teva contains lactose
Maltese: Clopidogrel Teva fih lactose
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: Clopidogrel u l-metabolit (mhux attiv) ċirkolanti prinċipali jintrabtu b'mod riversibbli in vitro mal-proteini umani tal-plażma (98% u 94% rispettivament).
English: The mean CHADS2 score was 2.0 (range 0-6).
Maltese: kien ta' 2.0 (marġni ta' 0-6).
English: * Information related to clopidogrel with frequency “not known”.
Maltese: * Informazzjoni li għandha x'taqsam ma' clopidogrel bi frekwenza “mhux magħrufa”.
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: B'kollox total ta' 99.7% pazjenti rċevew fibrinolitiċi (speċifiċi għal fibrin: 68.7%, mhux speċifiċi għal fibrin: 31.1%), 89.5% heparin, 78.7% imblokkaturi beta, 54.7% impedituri ACE u 63% statins.
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Maltese: Il-popolazzjoni ta' pazjenti kienu jinkludu 19.7% nisa u 29.2% pazjenti ≥ 65 years.
English: Each film-coated tablet contains 59.05 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 59,05 mg ta' lactose (bħala monohydrate).
English: TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
Maltese: TROPICAL-ACS ( L-Ittestjar tas-Sensibilità għall-Inibizzjoni tal-Plejtlits fuq Trattament Kroniku kontra lPlejtlits għal Sindromi Koronarji Akuti - Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
English: TEVA PHARMA, S.L.U Tél: +(34) 91 387 32 80
Maltese: L.U Tél: +(34) 91 387 32 80
English: • Adult patients suffering from acute coronary syndrome:
Maltese: • Pazjenti adulti li għandhom is-sindromu koronarju akut:
English: While you are taking Clopidogrel Teva:
Maltese: Tiħux Clopidogrel Teva:
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Maltese: CYP2C19 b'kontribuzzjonijiet minn bosta enzimi CYP oħra li jinkludu CYP1A2, CYP2B6 u CYP3A4.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Maltese: Ir-reazzjonijiet avversi klinikament rilevanti li ġew osservati fl-istudji CAPRIE, CURE, CLARITY, COMMIT u ACTIVEA huma diskussi hawn taħt.
English: Renal impairment
Maltese: Indeboliment renali.
English: The cumulative incidence of all bleeding events (BARC class 1 to 5) was 9% (114 events) in the guided de-escalation group versus 11% (137 events) in the control group (p=0.14).
Maltese: L-inċidenza kumulattiva tal-avvenimenti kollha ta' fsada (klassi 1 sa 5 ta' BARC) kienet ta' 9% (114-il avveniment) fil-grupp iggwidat ta' tnaqqis filqawwa kontra 11% (137 avveniment) fil-grupp ta' kontroll (p=0.14).
English: • The other ingredients are (see section 2 ‘Clopidogrel Teva contains lactose'):
Maltese: • Is-sustanzi l-oħra huma (ara sezzjoni 2 ‘Clopidrogel Teva fih lactose):
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated vegetable oil Sodium laurilsulfate
Maltese: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (tip A)
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Maltese: L-allel CYP2C19*1 jikkorispondi għal metaboliżmu funzjonali sħiħ waqt li l-alleli CYP2C19*2 u CYP2C19*3 mhumiex funzjonali.
English: Clopidogrel Teva contains sodium
Maltese: Clopidogrel Teva fih sodium
English: hypersensitivity reaction due to clopidogrel*
Maltese: sensittività eċċessiva għal clopidogrel*
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Maltese: L-alleli CYP2C19*2 u CYP2C19*3 jgħoddu għall-maġġoranza ta' alleli b'funzjoni mnaqqsa fil-bniedem Kawkasi (85%) u (99%) f'metabolizzaturi batuti Ażjatiċi.
English: In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Maltese: F'pazjenti b'MI akut bis-segment ST elevat, is-sigurtà u l-effikaċja ta' clopidrogel ġew evalwati f'2 studji każwali, ikkontrollati bi plaċebo u double-blind, CLARITY u COMMIT.
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: Emorraġija gastrointestinali , dijarea, uġigħ addominali, dispepsja
English: EU/1/09/540/008 30 film-coated tablets EU/1/09/540/009 100 film-coated tablets
Maltese: EU/1/09/540/008 30 pillola miksija b'rita EU/1/09/540/009 100 pillola miksija b'rita
English: In vitro and in vivo, clopidogrel is metabolised according to two main metabolic pathways: one mediated by esterases and leading to hydrolysis into its inactive carboxylic acid derivative (85% of circulating metabolites), and one mediated by multiple cytochromes P450.
Maltese: In vitro u in vivo, clopidogrel jiġi metabolizzat f'żewġ passaġġi metaboliċi ewlenin: wieħed permezz ta' esterases u li jwassal għall-idrolisi fid-derivat mhux attiv ta' carboxylic acid (85% ta' metaboliti ċirkolanti), u l-passaġġ l-ieħor li jsir permezz ta' cytochromes multipli ta' P450.
English: The clinical relevance of this interaction is uncertain.
Maltese: Ir-rilevanza klinika ta' din l-interazzjoni għadu mhux stabbilit.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Maltese: Dan il-benefiċċju ġie l-iktar mit-tnaqqis li kien statistikament sinifikanti ta' l-inċidenza ta' MI [287 (4.6%) fil-grupp ittrattat bi clopidogrel u 363 (5.8%) fil-grupp ittrattat bi plaċebo].
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Maltese: L-għadd ta' pazjenti li għaddew mill-punt ta' riferiment primarju tat-tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI), jew puplesija] kien 582 (9.3%) fil-grupp trattat b'clopidogrel u 719 (11.4%) filgrupp trattat bi plaċebo, tnaqqis ta' 20% fir-risku relattiv (95 % CI ta' 10%-28%; p=0.00009) għall-grupp ittrattat b'clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu trattati b'mod konservattiv, 29% meta kellhom angoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10% meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG)).
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Maltese: L-assorbiment huwa mill-inqas ta' 50%, skont leliminazzjoni fl-urina tal-metaboliti ta' clopidogrel.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers.
Maltese: Prodotti mediċinali sustrati ta' CYP2C8: intwera f'volontiera b'saħħithom, li clopidogrel iżid l-espożizzjoni ta' repaglinide.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Maltese: Ulċera gastrika u ulċera duwodenali, gastrite, remettar,
English: Tests are available to identify a patient's CYP2C19 genotype.
Maltese: Hemm tests disponibbli sabiex jidentifikaw il-ġenotip ta' CYP2C19.
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Maltese: Metaboliżmu sussegwenti tal-metabolit intermedjarju 2-oxo-clopidogrel jirriżulta filformazzjoni tal-metabolit attiv, derivat ta' thiol ta' clopidogrel.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Maltese: Ma dehrux differenzi sostanzjali fl-espożizzjoni attiva tal-metabolit u l-impediment medju ta' aggregazzjoni ta' plejtlits (IPA) bejn il-metabolizzaturi ultrarapidi, estensivi u intermedjarji.
English: Other medicines and Clopidogrel Teva
Maltese: Mediċini oħra u Clopidrogel Teva
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR=43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR=18.2%; CI: 6.5%, 28.3%).
Maltese: 24.3%, 57.5%) u impedituri ta' GPIIb/IIIa (RRR=18.2%; CI: 6.5%, 28.
English: At Day 14, platelet function testing (PFT) was performed.
Maltese: F'Ġurnata 14, sar l-ittestjar tal-funzjoni tal-plejtlits (PFT - platelet function testing).
English: o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - anti-retroviral medicines (medicines to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
Maltese: - efavirenz, mediċina għat-trattament tal-infezzjonijiet mill-HIV (virus tal-immunodefiċjenza umana), - mediċini antiretrovirali (mediċini għall-kura ta' infezzjonijiet bl-HIV), - carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija, - moclobemide, mediċini li jikkuraw id-dipressjoni, - repaglinide, mediċina għat-trattament tad-dijabete,
English: EU/1/09/540/001 14x1 film-coated tablets EU/1/09/540/002 28x1 film-coated tablets EU/1/09/540/003 30x1 film-coated tablets EU/1/09/540/004 50x1 film-coated tablets EU/1/09/540/005 84x1 film-coated tablets EU/1/09/540/006 90x1 film-coated tablets EU/1/09/540/007 100x1 film-coated tablets
Maltese: EU/1/09/540/001 14x1-il pillola miksija b'rita EU/1/09/540/002 28x1 pillola miksija b'rita EU/1/09/540/003 30x1 pillola miksija b'rita EU/1/09/540/004 50x1 pillola miksija b'rita EU/1/09/540/005 84x1 pillola miksija b'rita EU/1/09/540/006 90x1 pillola miksija b'rita EU/1/09/540/007 100x1 pillola miksija b'rita
English: The clinical benefit provided by the more potent P2Y12 inhibitors, ticagrelor and prasugrel, in their pivotal studies is related to a significant reduction in recurrent ischaemic events (including acute and subacute stent thrombosis (ST), myocardial infarction (MI), and urgent revascularization).
Maltese: Il-benefiċċju kliniku pprovdut mill-inibituri aktar potenti ta' P2Y12 , ticagrelor u prasugrel, fl-istudji prinċipali tagħhom huwa relatat mat-tnaqqis sinifikanti f'avvenimenti iskemiċi rikorrenti (li jinkludu trombożi akuta u subakuta minħabba stent (ST - stent thrombosis ), infart mijokardijaku (MI - myocardial infarction ), u vaskularazzjoni urġenti mill-ġdid.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC Code: B01AC04.
Maltese: Sustanzi antitrombotiċi, inibituri tal-aggregazzjoni tal-plejtlets li jeskludu heparin, Kodiċi ATC:
English: How to store Clopidogrel Teva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Maltese: Il-pazjenti ngħataw clopidogrel (300 mg bħala doża inizjali, segwita b'75 mg/day, n=1,752) jew plaċebo (n=1,739), it-tnejn flimkien ma' ASA (150 sa 325 mg bħala doża inizjali, segwiti b'75 sa 162 mg/jum), sustanza fibrinolitika u,
English: Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p=0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Maltese: Clopidogrel naqqas b'mod sinifikanti r-riskju relattiv tal-mewt minn kwalunkwe kawża b'7% (p=0.029), u r-risku relattiv tal-kombinazzjoni tal-infart mill-ġdid, puplesija jew mewt b'9 % (p=0.002), li jirrappreżenta tnaqqis assolut ta' 0.5% u 0.9%, rispettivament.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: artrite, artralġja, majalġjia
English: One side of the tablet is debossed with the number “93”.
Maltese: Naħa waħda mill-pillola tkun intaljata b'“93”.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Maltese: 600 mg/150 mg, l-espożizzjoni attiva għall-metabolit kien ikbar minn dak tal-programm ta' kura ta' 300 mg/75 mg.
English: EU/1/09/540/010 14x1 film-coated tablets EU/1/09/540/011 28x1 film-coated tablets EU/1/09/540/012 30x1 film-coated tablets EU/1/09/540/013 50x1 film-coated tablets EU/1/09/540/014 84x1 film-coated tablets EU/1/09/540/015 90x1 film-coated tablets EU/1/09/540/016
Maltese: EU/1/09/540/010 14x1-il pillola miksija b'rita EU/1/09/540/011 28x1 pillola miksija b'rita EU/1/09/540/012 30x1 pillola miksija b'rita EU/1/09/540/013 50x1 pillola miksija b'rita EU/1/09/540/014 84x1 pillola miksija b'rita EU/1/09/540/015 90x1 pillola miksija b'rita EU/1/09/540/016 100x1 pillola miksija b'rita EU/1/09/540/017 28x1 pillola miksija b'rita
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: Il-frekwenza tagħhom hi definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Clopidogrel Teva is supplied in:
Maltese: Clopidrogel Teva:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: L-għadd ta' pazjenti li kellhom punt ta' riferiment aħħari ko-primarju (mewt CV, MI, puplesija jew iskemija refrattorja) kien 1,035 (16.5%) fil-grupp ittrattat bi clopidogrel u 1,187 (18.8%) fil-grupp ittrattat bi plaċebo, tnaqqis ta' 14% fir-riskju relattiv (95% CI of 6%-2%, p=0.0005) għall-grupp ittrattat bi clopidogrel.
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Maltese: Il-benefiċċji osservat bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari ohra akuti u fuq perijodu ta' żmien twil (bħal heparin/LMWH, antagonisti GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi beta, u impedituri ACE).