FrancophonIA/ELRC3.0 huggingface dataset:
English: A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Maltese: Ġie mfassal studju ta' 24 ġimgħa b'kontroll bi plaċebo biex jevalwa l-effikaċja u s-sigurtà ta' sitagliptin (100 mg darba kuljum) meta miżjud ma' glimepiride waħdu jew glimepiride flimkien ma' metformin.
English: 8501 Novo mesto
Maltese: 8501 Novo mesto Is-Slovenja
English: The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: 6.2 Incompatibilities Not applicable.
Maltese: .2 Inkompatibilitajiet
English: Retroperitoneal haemorrhage
Maltese: Emorraġija retroperitoneali
English: Mylan Kft Tel: 36 1 8026993
Maltese: Hungary Mylan Kft Tel: 36 1 8026993
English: - Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil - Film-coating: hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol.
Maltese: - Qalba tal-pillola: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (tip A), macrogol 6000, żejt ir-riġnu idroġenat, - Rita tal-pillola: hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol.
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 prinċipali (inattiv) ċirkolanti jintrabtu b'mod reversibbli in vitro mal-proteini umani tal-plażma (98% u 94% rispettivament).
English: Proton Pump Inhibitors (PPI):
Maltese: Inibituri tal-Pompa Protonika (PPI):
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, il-Ġermanja
English: In vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2 and CYP2B6.
Maltese: In vitro, din is-sensiela ta' reazzjonijiet metaboliċi sseħħ bl-intervent ta' CYP3A4, CYP2C19, CYP1A2 u CYP2B6.
English: INFORMATION IN BRAILLE Clopidogrel Qualimed 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Qualimed 75 mg
English: Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol.
Maltese: Prodotti mediċinali li jinibixxu CYP2C19 jinkludu omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine u chloramphenicol.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 21 ta' Settembru 2009
English: Thrombotic Thrombocytopenic Purpura (TTP)
Maltese: Purpura Trombotika Tromboċitopenika (TTP)
English: Mylan AB Tlf: + 46 8-555 227 50 (Sverige)
Maltese: Tlf: + 46 8-555 227 50 (Sverige)
English: France Qualimed
Maltese: Qualimed
English: Qualimed, 117 allee des Parcs, 69 800 Saint Priest, France
Maltese: ID-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Qualimed, 117 allee des Parcs, 69 800 Saint Priest, Franza
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Emorraġija muskoluskeletriku (emartrosi), artrite, artralġja, majalġjia
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
Maltese: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), u ACTIVE-A (n=601), kif ukoll numru ta' studji ko-orti ppubblikati.
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).
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 tiġi stmata mit-tagħrif disponibbli).
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Maltese: • Emorraġija patoloġika attiva bħal b'ulċera peptika jew emorraġija intrakranjali.
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Maltese: Alleli oħra assoċjati ma' metaboliżmu assenti jew imnaqqas huma anqas frekwenti u jinkludu CYP2C19*4, *5, *6, *7, u *8.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Maltese: In ġenerali, clopidogrel 75 mg/day kien paragunabbli ma' ASA 325 mg/day f'CAPRIE minkejja l-età, ġeneru sesswali u razza.
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 jikkorrispondi ma' metaboliżmu kompletament funzjonali filwaqt li l-alleli CYP2C19*2 u CYP2C19*3 mhumiex funzjonali.
English: Mylan AB Tel: + 46 8-555 227 50
Maltese: Tel: + 46 8-555 227 50
English: • Severe hepatic impairment.
Maltese: • Indeboliment epatiku sever.
English: Τηλ: +30 210 9936410
Maltese: Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 9936410
English: Glomerulonephritis, blood creatinine increased
Maltese: Glomerulonefrite, żieda tal-kreatinina fid-demm
English: Perforated unit dose blister of OPA/Al/PVC-Al containing 30x1 and 50x1 film-coated tablets in the box.
Maltese: Folja ipperforata ta' doża unikata' OPA/Al/PVC-Al li fihom 30x1 u 50x1 pillola miksija b'rita fil-kaxxa.
English: • Hepatic impairment
Maltese: • Indeboliment epatiku
English: - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and
Maltese: - fluconazole, voriconazole, ciprofloxacin, jew chloramphenicol, mediċini li jittrattaw infezzjonijiet tal batterja u tal-fungu,
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: Wara s-sistema ta' dożaġġ ta' 300 mg/75 mg, ir-risponsi kontra l-plejtlits tnaqqsu fil-metabolizzaturi dgħajfa b'IPA medja (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 intermedji.
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: L-istudju CAPRIE kien jinkludi 19,185 pazjent b'aterotrombosi li ntweriet permezz ta' infart mijokardjali riċenti (<35 jum), puplesija iskemika riċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit tal-arterji periferali (peripheral arterial disease (PAD)).
English: The clinical relevance of this interaction is uncertain.
Maltese: Ir-rilevanza klinika ta' din l-interazzjoni hija inċerta.
English: Rash, pruritus, skin bleeding (purpura)
Maltese: Raxx, ħakk, fsada tal-ġilda (purpura)
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Maltese: L-analiżi tal-mortalità totali bħala punt sekondarju ta' tmiem, m'urietx xi differenza sinifikanti bejn clopidogrel (5.8 %) u ASA (6.0 %).
English: There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Maltese: Ma kien hemm ebda differenza sinifikanti bejn il-gruppi fil-varjetà ta' riżultati finali primarji ta' mewt, trombożi tad-devjazzjoni kirurġika jew intervent tat-tip kardijaku sa qabel l-età ta' 120 ġurnata wara avveniment li kien ikkunsidrat ta' natura trombotika (89 [19.1%] għall-grupp ta' clopidogrel u 90 [20.5%] għall-grupp tal-plaċebo) (ara sezzjoni 4.2).
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 ta' emorraġija klinikament sinifikanti kienet simili ghal dik osservata meta sustanzi trombolitici u heparin jingħataw ma' ASA (ara sezzjoni 4.8).
English: Šmarješka cesta 6
Maltese: KRKA, d.d., Novo mesto Šmarješka cesta 6
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p = 0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Maltese: F'analiżi tas-sottogrupp permezz ta' kundizzjoni kwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-akbar (fejn intlaħqet rilevanza statistika b'p=0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR=23.7 %; CI: 8.9 sa 36.2) u aktar dgħajjef (mhux differenti b'mod sinifikanti minn ASA) f'pazjenti b'puplesija (RRR = 7.3 %; CI: -5.7 sa 18.7 [p=0.258]).
English: Boxes of 30x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Maltese: Kaxxi disponibbli ta' 30x1 u 50x1 pilloli miksija b'rita f'folji perforati ta' doża unika.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Maltese: It-tnaqqis kien assoċjat ma' tnaqqis ta' 39 % (id-doża ta' kkargar) u ta' 21 % (id-doża ta' manteniment) fl-inibizzjoni tal-aggregazzjoni tal-plejtlits.
English: This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Maltese: Dan kien assoċjat b'tnaqqis fl-inibizzjoni medja tal-aggregazzjoni tal-plejtlits b'15 % u b'11 % rispettivament.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (Boxes of 7, 14, 28, 30, 30x1, 50, 50x1, 56, 84, 90 and 100)
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI FOLJA (kaxex ta' 7, 14, 28, 30, 30x1, 50, 50x1, 56, 84, 90, jew 100 pillola)
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 mmetabolizzat permezz ta' żewġ sensiliet ta' reazzjonijiet metaboliċi: waħda bl-intervent ta' esterases u li twassal għallidroliżi fid-derivattiv inattiv tiegħu carboxylic acid (85% tal-metaboliti fiċ-ċirkulazzjoni), u waħda blintervent ta' ċitokromi P450 multipli. Clopidogrel jiġi mmetabolizzat l-ewwel f'metabolit intermedjarju 2oxo-clopidogrel.
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Maltese: Inibituri ta' Glycoprotein IIb/IIIa: clopidogrel għandu jintuża b'kawtela f'pazjenti li jirċievu l-inibituri ta' glycoprotein IIb/IIIa flimkien mal-prodott mediċinali (ara sezzjoni 4.4).
English: WHAT CLOPIDOGREL QUALIMED IS AND WHAT IT IS USED FOR Clopidogrel Qualimed belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Qualimed jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra lplejtlets.
English: CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite.
Maltese: CYP2C19 huwa involut fil-formazzjoni kemm tal-metabolit attiv kif ukoll tal-metabolit intermedjarju 2-oxoclopidogrel.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Maltese: Emorraġija gastrointestinali u retroperitoneali b'eżitu fatali, pankreatite, kolite (li jinkludi kolite ulċerattiva jew limfoċitika), stomatite
English: For further information please refer to section 5.1.
Maltese: (ara sezzjoni 5.1).
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Maltese: Fi TRITON-TIMI 38 u 3 mill-istudji ko-orti (Collet, Sibbing, Giusti) il-grupp imħallat ta' pazjenti li kienu metabolizzaturi intermedji jew dgħajfa kellhom rata ogħla ta' avvenimenti kardjovaskulari (mewt, infart mijokardijaku u puplesija) jew trombożi minn stent meta mqabbla ma' metabolizzaturi estensivi.
English: No antidote to the pharmacological activity of clopidogrel has been found.
Maltese: Ma nstabx antidotu għall-attività farmakoloġika ta' clopidogrel.
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw diversi prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vażodilaturi koronarji, sustanzi kontra d-dijabete (li jinkludu l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: Thrombocytopenia , leucopenia, eosinophilia
Maltese: Tromboċitopenija lewkopenija, esinofilja
English: Tests are available to identify a patient's CYP2C19 genotype.
Maltese: Jeżistu testijiet li jidentifikaw il-ġenotip CYP2C19 ta' pazjent.
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to
Maltese: Konsistenti ma' dawn ir-riżultati, f'meta-analiżi li inkludiet 6 studji ta' 335 suġġett ikkurat b'clopidogrel f'livell fiss, ġie muri li l-espożizzjoni tal-metabolit attiv tnaqqas b'28% għall-metabolizzaturi intermedji, u 72% għall-metabolizzaturi dgħajfa filwaqt li l-inibizzjoni tal-aggregazzjoni tal-plejtlits (5 μM ADP) tnaqqset b'differenzi fl-IPA ta' 5.9% u 21.4% rispettivament, meta mqabbel ma' metabolizzaturi estensivi.
English: Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Maltese: Kaxxi disponibbli f'7, 14, 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita ġo folji.
English: Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Maltese: Informazzjoni nkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika (PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew mill-osservazzjoni kif ukoll mill-istudji kliniċi.
English: A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Maltese: Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u heparin, li jista' jikkaġuna riskju ogħla ta' emorraġija.
English: Blister of OPA/Al/PVC-Al containing 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in the box.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' OPA/AL/PVC-Al li fihom 7, 14, 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita fil-kaxxa.
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Maltese: L-esperjenza terapewtika hija limitata f'pazjenti b'indeboliment renali (ara sezzjoni 4.4).
English: Musculoskeletal, connective tissue and bone
Maltese: Disturbi muskoluskeletriku, tessut konnettiv u fl-għadam
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 tal-alleli b'funzjoni mnaqqsa fil-Kawkasi u 99% f'metabolizzaturi dgħajfa Asjatiċi.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Maltese: Fil-metabolizzaturi dgħajfa, l-espożizzjoni tal-metabolit attiv tnaqqset b'63-71% meta mqabbla ma' metabolizzaturi estensivi.
English: - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
Maltese: - fluoxetine, fluvoxamine, jew moclobemide, mediċinii li jittrattaw d-dipressjoni, - carbamazepine, jew oxcarbazepine, mediċini li jittrattaw xi tip ta' epilessija, - ticlopidine, sustanzi oħra kontra l-plejtlets.
English: Acute liver failure, hepatitis, abnormal liver function test
Maltese: Insuffiċjenza akuta tal-fwied, epatite, test tal-funzjoni tal-fwied anormali
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Maltese: Ir-reazzjonijiet avversi klinikament rilevanti li ntwerew fl-istudji CAPRIE, CURE, CLARITY u COMMIT huma diskussi hawn taħt.
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Eliminazzjoni Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi fl-urina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
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: Studju tat-tip crossover f'40 suġġett f'saħħtu, 10 f'kull wieħed mill-erba' gruppi ta' metabolizzaturi ta' CYP2C19 (estremament mgħaġġel, estensiv, intermedju u dgħajjef), evalwa r-rispons farmakokinetiku u dak kontra l-plejtlits b'300 mg segwita b'75 mg/jum u 600 mg segwita b'150 mg/jum, kull wieħed għal total ta' 5 ijiem (livell fiss).
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: 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 tattieni fażi.
English: These may be the signs of an allergic reaction.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika.
English: For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Qualimed by referring to the calendar printed on the blister.
Maltese: Għad-daqsijiet tal-pakketti ta' 7 pilloli, 14-il pillola, 28, 56 u 84 pillola, inti tista' tiċċekkja d-data li fiha laħħar li ħadt il-pillola ta' Clopidrogel Mylan billi tirreferi għal kalendarju stampat fuq il-folja.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Maltese: Frekwenzi ppubblikati għall-ġenotipi ta' metabolizzaturi dgħajfa ta' CYP2C19 huma madwar 2% għall-Kawkasi, 4% għas-Suwed u 14% għaċ-Ċiniżi.
English: 100 film-coated tablets: EU/1/09/559/009
Maltese: EU/1/09/559/009
English: Very rare side effects: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste..
Maltese: (Effetti kollaterali rari ħafna: suffejra, uġigħ addominali severi bi jew mingħajr uġigħ fid-dahar; deni, diffikultajiet biex tieħu n-nifs assoċjati ma' tħarħir; reazzjonijiet allerġiċi ġeneralizzati, nefħa fil-ħalq, nfafet fuq il-ġilda; allerġiji fuq il-ġilda; infjammazzjoni tal-ħalq (stomatite) tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ tal-għadam; uġigħ muskolari, tibdiliet fil-mod ta' kif jintegħmu laffarijiet.
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Maltese: L-influwenza tal-ġenotip CYP2C19 fuq l-effetti kliniċi f'pazjenti kkurati bi clopidogrel ma ġietx evalwata f'provi prospettivi, randomised u kkontrollati.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Maltese: Dożi ripetuti ta' 75 mg kuljum ipproduċew inibizzjoni sostanzjali tal-aggregazzjoni tal-plejtlets indotti minn ADP mill-ewwel ġurnata; dan żied progressivament u laħaq livell fiss bejn Jum 3 u Jum 7.
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 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi tal-intenzjoni tal-kura, ġew osservati 939 każ fil-grupp ta' clopidogrel u 1,020 każ ma' ASA (tnaqqis tar-riskju relattiv, relative risk reduction (RRR)) 8.7 %, [95 % CI: 0.2 sa 16.4]; p = 0.
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Maltese: F'studju b'dożi li jibqgħu jogħlew u li sar f'86 tarbija tat-twelid jew tfal ċkejknin sa 24 xahar ta' età f'riskju ta' trombożi (PICOLO), clopidogrel ġie evalwat f'dożi konsekuttivi ta' 0.01, 0.1 u 0.2 mg/kg fit-trabi tattwelid u fit-tfal ċkejknin u 0.15 mg/kg fit-trabi tat-twelid biss.