FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site mass Chest discomfort Chest pain Pyrexia
Maltese: Massa fis-sit tal-injezzjoni Dwejjaq fis-sider
English: Liver toxicity defined as either:
Maltese: Kategorija farmakoterapewtika:
English: Lutetium-177 (177Lu) is a β- emitting radionuclide with a maximum penetration range in tissue of
Maltese: lutetium (177Lu) oxodotreotide huwa eliminat primarjament permezz tal-eliminazzjoni mill-kliewi:
English: PFS = Progression free survival; OS = Overall survival * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
Maltese: * Jinkludi fil-Parti anterjuri tal-intestini, fil-Parti tan-nofs tal-intestini u fil-Parti posterjuri tal-Intestini; **NETs fil-parti anterjuri tal-intestini minbarra tal-bronki u pankreatiċi
English: Amount
Maltese: U KWANTITATTIVA
English: Overall, the results of the dosimetric analysis performed in the NETTER-1 phase III dosimetry substudy and in the Erasmus phase I/II study are in agreement and indicate that Lutathera dose regimen (4 administrations of 7,400 MBq) is safe.
Maltese: NETTER-1 u fl-istudju tal-fażi I/II Erasmus jaqblu u jindikaw li l-kors tad-doża tal-Lutathera (7,400
English: When the recommended concomitant amino acids infusion is delivered over a 4 hour time span, a mean reduction in kidney radiation exposure of about 47% has been reported.
Maltese: Meta l-infużjoni ta' aċidi amminiċi konkomitanti rakkomandata tingħata matul perjodu ta' 4 sigħat, kien rapportat tnaqqis medju fl-esponiment għar radjazzjoni fil-kliewi ta' madwar 47%.
English: Secondary hypothyroidism Hypothyroidism Diabetes mellitus
Maltese: Kriterji-għal tossiċità li timmodifika d-doża
English: Most patients were Dutch (811) with the remaining (403) residents of various European and non-European countries.
Maltese: Il-maġġoranza tal-pazjenti kienu Olandiżi (811) bil-bqija (403) li kienu residenti ta' diversi pajjiżi Ewropej u mhux Ewropej.
English: The hazard ratio for Lutathera was 0.21 (95% CI: 0.14 - 0.33), indicating 79% reduction in the risk for a patient to progress or die under Lutathera compared to octreotide LAR.
Maltese: Il-proporzjon tal-periklu għal-Lutathera kien 0.21 (95% CI: 0.14
English: Pain
Maltese: Sider
English: 9 Includes Blood bilirubin increased and Hyperbilirubinaemia
Maltese: 9 Tinkludi Żieda fil-bilirubina fid-demm u Iperbilirubinemija
English: Taste disturbances,
Maltese: Rari ħafna,
English: System Organ Class
Maltese: Sistema talKlassifika talorgani
English: Ísland ratiopharm Oy
Maltese: Ísland ratiopharm Oy Finnland
English: • Pharmacovigilance system
Maltese: • Sistema ta' farmakoviilanza
English: Cytochrome P450 2C19 (CYP2C19)
Maltese: Cytochrome P450 (CYP2C19) Farmakoġenetika:
English: TevaNorway AS Tlf: 47 66 77 55 90
Maltese: Teva Norway AS Tlf: 47 66 77 55 90
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: Distribuzzjoni Clopidogrel u l-metabolit prinċipali (inattiv) ċirkolanti jintrabtu b'mod reversibbli in vitro mal-proteini umani tal-plażma (98% u 94% rispettivament).
English: HCS bvba H. Kennisstraat 53 B-2650 Edegem Belgium
Maltese: HCS bvba H. Kennisstraat 53 B-2650 Edegem
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: komuni (≥1/100 sa <1/10); mhux komuni (≥/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Fsada muskolu skeltrali (emartrożi), artrite, artralġja, majalġja
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Maltese: Mediċini li huma inibituri qawwijin jew moderati ta' CYP2C19 jinkludu, per eżempju omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine u efavirenz.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenika trombotika (TTP) (ara sezzjoni 4.4), anemija aplastika, panċitopenja, agranuloċitosi, tromboċitopenja severa, emofilja A
English: However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Maltese: clopidogrel u ASA ngħataw flimkien sa sena (ara sezzjoni 5.1).
English: After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Maltese: risponsi kontra l-plejtlits tnaqqsu fil-metabolizzaturi batuti b'IPA medju (5 μM ADP) ta' 24% (24 siegħa) u 37% (Jum 5) meta mqabbel ma' IPA ta' 39% (24 siegħa) u 58% (Jum 5) fil-metabolizzaturi estensivi u 37% (24 siegħa) u 60% (Jum 5) fil-metabolizzaturi intermedjarji.
English: EU/1/10/651/001 28 film-coated tablets EU/1/10/651/002 30 film-coated tablets EU/1/10/651/003 50 film-coated tablets EU/1/10/651/004 56 film-coated tablets EU/1/10/651/005 84 film-coated tablets EU/1/10/651/006 90 film-coated tablets EU/1/10/651/007 100 film-coated tablets EU/1/10/651/008 28x1 film-coated tablets EU/1/10/651/009 28x1 film-coated tablets (calendar pack) EU/1/10/651/010 30x1 film-coated tablets EU/1/10/651/011 50x1 film-coated tablets EU/1/10/651/012 56x1 film-coated tablets EU/1/10/651/013 84x1 film-coated tablets EU/1/10/651/014 90x1 film-coated tablets EU/1/10/651/015 100x1 film-coated tablets
Maltese: EU/1/10/651/001 28 pillola miksija b'rita EU/1/10/651/002 30 pillola miksija b'rita EU/1/10/651/003 50 pillola miksija b'rita EU/1/10/651/004 56 pillola miksija b'rita EU/1/10/651/005 84 pillola miksija b'rita EU/1/10/651/006 90 pillola miksija b'rita EU/1/10/651/007 100 pillola miksija b'rita EU/1/10/651/008 28x1 pillola miksija b'rita EU/1/10/651/009 28x1 pillola miksija b'rita (pakkett ta' xahar) EU/1/10/651/010 30x1 pillola miksija b'rita EU/1/10/651/011 50x1 pillola miksija b'rita EU/1/10/651/012 56x1 pillola miksija b'rita EU/1/10/651/013 84x1 pillola miksija b'rita EU/1/10/651/014 90x1 pillola miksija b'rita EU/1/10/651/015 100x1 pillola miksija b'rita
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: Vistor hf.
Maltese: HCS Bvba.
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: (RRR = 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR = 18.2%; CI: 6.5%, 28.
English: HCS bvba, H. Kennisstraat 53, B 2650 Edegem, Belgium
Maltese: HCS bvba H. Kennisstraat 53 B 2650 Edegem Il-Belġju
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Maltese: l-epidermide, Sindromu ta' Stevens Johnson, eritema multiforme), exanthematous pustulosis akuta u ġeneralizzata (AGEP), anġjoedima, sindromu ta' sensittività eċċessiva kkawżat mill-mediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS),
English: Date of first authorisation: 28 October 2010 Date of latest renewal: 16 June 2015
Maltese: Data tal-aħħar tiġdid: 16 ta‘ Ġunju 2015
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: In-numru ta' pazjenti li għaddew mill-punt primarju ta' tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9.3%) fil-grupp ikkurat bi clopidogrel u 719 (11.4%) fil-grupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%; p=0.00009) għall-grupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu kkurati b'mod konservattiv, 29% meta kellhom anġoplastija koronarja transluminali perkutanja
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Maltese: CYP2C19*4, *5, *6, *7, u *8.
English: • Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil.
Maltese: Qalba tal-pillola:microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000,u żejt ir-riġnu idroġenat Kisi tal-pillola:
English: OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister (OPA/Al/PVC-Al) containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton.
Maltese: Folji tal-OPA/Al/PVC-Aluminju li fihom 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita jew folji pperforati ta' doża wada (OPA/Al/PVC-Al) li fihom 28x1, 28x1 (pakkett ta' xahar), 30x1, 50x1, 56x1, 84x1, 90x1 u 100x1 pillola miksija b'rita ġo kartuna.
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 għallmaġġoranza tal-alleli b'funzjoni mnaqqsa fil-Kawkasi (85%) u Ażjatiċi (99%) ta' metabolizzaturi dgħajfa .Alleli oħra assoċjati ma' tnaqqis fil-metaboliżmu jew assenti huma inqas frekwenti u jinkludu
English: Luxembourg/Luxemburg Sanofi Belgium
Maltese: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland
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 osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fit tul (bħall- heparin/LMWH, antagonisti ta' GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi tar-riċetturi beta , u inibituri ta' ACE).
English: In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Maltese: Fi studju magħmul b'mod arbitrarju, b'grupp parallel u double-blind (CLARINET), 906 pazjenti pedjatriċi (trabi tat-twelid u tfal ċkejknin) b'mard tal-qalb konġenitali ċjanotiku u megħjuna b'devjazzjoni kirurġika ta' arterja sistemika għal dik pulmonarja, ġew mogħtija b'mod arbitrarju clopidogrel 0.2 mg/kg (n=467) jew plaċebo (n=439) flimkien ma' terapija konkomitanti ta' rutina sakemm kien hemm il-bżonn ta' kirurġija tat-tieni fażi.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinstab fuq is-sit elettroniku tal-Agenzija Ewropea għall-Mediċini (EMA): http://www.ema.europa.eu/
English: Do not take Clopidogrel HCS
Maltese: Tiħux Clopidogrel HCS
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Maltese: CYP2C19 (ultrarapidu, estensiv, intermedjarju u batut), ivvalorizza r-risponsi farmakokinetiċi u kontra l-plejtlits meta ngħataw 300 mg segwiti minn 75 mg /jum u 600 mg segwiti minn 150 mg/jum, kull wieħed għal total ta' 5 ijiem (stat fiss).
English: Plavix contains lactose
Maltese: Emofilja akkwiżita
English: Medicinal products associated with bleeding risk:
Maltese: Prodotti mediċinali assoċjati mar-riskju ta' fsada:
English: - efavirenz, a medicine to treat HIV (human immunodeficiency virus) 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), - carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija,
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,
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Clopidogrel
Maltese: Tbenġil
English: Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.
Maltese: Kaxxi jiġu f'daqsijiet ta' 28, 30, 50, 56, 84, 90 jew100 pillola miksija b'rita ġo folji jew kaxxi f'daqsijiet ta' 28x1, 28x1 (pakkett ta' xahar), 30x1, 50x1, 56x1, 84x1, 90x1 u 100x1 pilloli miksija b'rita ġo folji pperforati ta' doża unika
English: Hypromellose (E464) Lactose monohydrate Triacetin (E1518) Titanium dioxide (E171) Red iron oxide (E172)
Maltese: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172),
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Maltese: L-inċidenza taddmija klinikament sinifikanti kienet simili għal dik osservata meta sustanzi trombolitiċi u heparin jingħataw flimkien ma' ASA (ara sezzjoni 4.8).
English: • Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Maltese: yellow iron oxide (E172), talc u macrogol 3000..
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Maltese: riskju li ġejjin: età ≥ 75 sena jew età bejn 55 sa 74 sena u jew id-dijabete mellitus fejn ikun hemm il bżonn tat-terapija bil-mediċini jew passat mediku ta' MI ddokumentat jew mard tal-arterji koronarji ddokumentat; ikkurat/a għall-ipertensjoni sistemika; passat mediku ta' puplesija, attakk iskemiku mhux permanenti (TIA) jew embolu sistemiku li ma jkunx fis-CNS; tnaqqis fil-funzjoni tal-ventriklu tax-xellug bil-porzjon tal-ħruġ mill-ventriklu tax-xellug < 45 %; jew mard vaskulari periferiku ddokumentat.
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: l-intenzjoni tal-kura, ġew osservati 939 avveniment fil-grupp ta' clopidogrel u 1 020 avveniment b'ASA (tnaqqis tar-riskju relattiv (RRR) ta' 8.7%, [95% CI: minn 0.2 għal 16.4]; p=0.045), li jikkorrispondi, għal kull 1 000 pazjent ttrattati għal sentejn, ma' 10 [CI: minn 0 sa 20] pazjenti oħra li evitaw avveniment iskemiku ġdid.
English: 28 film-coated tablets 28x1 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 84x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets 100 film-coated tablets 100x1 film-coated tablets
Maltese: 28 pillola miksija b'rita 28x1 pillola miksija b'rita 30 pillola miksija b'rita 30x1 pillola miksija b'rita 50 pillola miksijin b'rita 50x1 pillola miksija b'rita 56 pillola miksija b'rita 56x1 pillola miksija b'rita 84 pillola miksija b'rita 84x1 pillola miksija b'rita 90 pillola miksija b'rita 90x1 pillola miksija b'rita 100 pillola miksija b'rita 100x1 pillola miksija b'rita
English: EU/1/10/651/001 Cartons of 28 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/002 Cartons of 30 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/003 Cartons of 50 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/004 Cartons of 56 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/005 Cartons of 84 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/006 Cartons of 90 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/007 Cartons of 100 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/008 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Maltese: EU/1/10/651/001 Kartun ta' 28 pillola miksija b'rita ġo folji tal-aluminju-OPA/Al/PVC EU/1/10/651/002 Kartun ta' 30 pillola miksija b'rita ġo folji tal-aluminju-OPA/Al/PVC EU/1/10/651/003 Kartun ta' 50 pillola miksija b'rita ġo folji tal-aluminju OPA/Al/PVC EU/1/10/651/004
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Maltese: thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Maltese: N = 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrastandard.
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeltrali, tat-tessut konnettiv u fl għadam
English: -4.0%; CI: -22.5 to 11.7 [p=0.639]).
Maltese: 38.3%; p=0.00001).
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Maltese: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477) u ACTIVE-A (n=601), kif ukoll bħala numru ta' studji ta' koorti ppubblikati Fi TRITON-TIMI 38 u 3 tal-istudji ta' koorti (Collet, Sibbing, Giusti), il-grupp ikkombinat ta' pazjenti bi stat intermedjarju jew batut kellhom rata ogħla ta' każijiet kardjovaskulari (mewt, infart mijokardjali u puplesija) jew trombożi bi stent meta mqabbel ma' metabolizzaturi estensivi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets-calendar pack)
Maltese: FOLJI (28x1 pillola miksija b'rita - ġo pakkett kalendarjan
English: Excipients
Maltese: Internazzjonali
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Maltese: Clopidogrel għandu jintuża b'kawtela f'pazjenti li jirċievu l-inibituri ta' glycoprotein IIb/IIIa flimkien mal-prodott mediċinali (ara sezzjoni 4.4).
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Maltese: Kategorija farmakoterapewtika: inibituri tal-aggregazzjoni tal-plejtlets eskl. heparin,
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità tqala u treddigħ
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, 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,
Maltese: o l-eparina jew xi mediċina oħra li tiġi injettata biex tnaqqas il-koagulazzjoni tad-demm, o ticlopidine, sustanza oħra kontra l-plejtlits, o inibitur selettiv tal-ġbir mill-ġdid ta' serotonin (li jinkludi iżda mhux limitat għal fluoxetine jew fluvoxamine), mediċini li ssoltu jintużaw fil-kura tad-dipressjoni, - omeprazole jew esomeprazole, mediċini li jittrattataw it-taqlib fl-istonku.
English: Pregnancy and breast-feeding
Maltese: pankreatite, kolite
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Clir SNC EXPIRY DATE EXP {MM/YYYY}
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-folja wara EXP.
English: 4x1 film-coated tablets 30x1 film-coated tablets 100x1 film-coated tablets 10x1 film-coated tablets
Maltese: Kartun ta' 30x1 pillola miksija b'rita ġo folji ta' doża waħda tal-aluminju
English: Magyarország SANOFI-AVENTIS Zrt.
Maltese: - Żomm dan il-fuljett.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: • Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Tromboċitopenika Trombotika jew TTP) li tinkludi deni u tbenġil taħt ilġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew tal-għajnejn (suffejra) (ara sezzjoni 4 'Effetti sekondarji possibbli').
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Maltese: Kull pillola fiha 75 mg ta' clopidogrel (bħala hydrochloride).
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Maltese: CYP2C19*2 u CYP2C19*3 ma jiffunzjonawx.
English: Fawdon
Maltese: Treddigħ
English: Clopidogrel HCS contains hydrogenated castor oil
Maltese: Clopidogrel HCS u acetylsalicylic acid.
English: Thu
Maltese: UŻU
English: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: Il-benefiċċju ta clopidogrel ma' ASA