FrancophonIA/ELRC3.0 huggingface dataset:
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 varjeta` ta' prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers, ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vasodilataturi koronarji, sustanzi kontra d-dijabete (inkluża l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Maltese: Saru numru ta' studji kliniċi oħra bi clopidogrel u prodotti mediċinali oħra li ngħataw flimkien biex tiġi investigata l-possibilita` ta' interazzjonijiet farmakodinamiċi u farmakokinetiċi.
English: Other medicines and Clopidogrel Zentiva
Maltese: Mediċini oħra u Clopidogrel Zentiva
English: Clopidogrel Zentiva is supplied in cardboard cartons containing: 7, 14, 28, 30, 50, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Maltese: - 7, 14, 28, 30, 50, 84, 90 u 100 pilloli ġo folji tal-PVC/PVDC/Aluminju jew ġo folji magħmulin kollha mill-aluminju, - 50x1 pilloli f'folji tal-PVC/PVDC/Aluminju jew f'folji mtaqqbin b'doża waħda kollha kemm huma ta' l-aluminju.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: Effetti sekondarji rari ħafna(jistgħu jaffettwaw sa 1 minn kull 10,000 persuni:
English: - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, or other anti-retroviral medicines (used 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, - opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids (used to treat severe pain).
Maltese: - efavirenz, jew mediċini oħra antiretrovirali (użati għat-trattament tal-infezzjonijiet mill-HIV), - carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija, - moclobemide, mediċina għat-trattament tad-dipressjoni, - repaglinide, mediċina għat-trattament tad-dijabete,
English: Clopidogrel Zentiva 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Zentiva 300 mg
English: If Clopidogrel Zentiva is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Fil-folji tal-PVC/PVDC/Aluminju, aħżen f'temperatura taħt 30°C.
English: Clopidogrel Zentiva is supplied in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Maltese: Clopidogrel Zentiva huwa fornut f'kaxex tal-kartun li fihom 4x1, 10x1, 30x1 u 100x1 pilloli ġo folji mtaqqbin ta' doża waħda magħmulin kollha kemm huma mill-aluminju.
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: 14 film--coated tablets 28 film-coated tablets 30 film-coated tablets 50x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 7 film-coated tablets 50 film-coated tablets
Maltese: 14 -il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 50x1 pilloli miksijin b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita 7 pilloli miksija b'rita 50 pillola miksija b'rita
English: EU/1/08/465/015 4x1 film-coated tablets EU/1/08/465/016 30x1 film-coated tablets EU/1/08/465/017 100x1 film-coated tablets EU/1/08/465/020 10x1 film-coated tablets
Maltese: EU/1/08/465/015 4x1 pilloli miksija b'rita EU/1/08/465/016 30x1 pilloli miksija b'rita EU/1/08/465/017 100x1 pilloli miksija b'rita EU/1/08/465/020 10x1 pilloli miksija b'rita
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Maltese: thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4) *, sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bis-sottotip HLA DRA4 (aktar frekwenti filpopolazzjoni
English: Clopidogrel Zentiva 300-mg film-coated tablets (tablets) are oblong, pink, engraved on one side with the number ‘300' and on the other side with the number ‘1332'.
Maltese: Il-pilloli miksija b'rita ta' Clopidogrel Zentiva 300 mg (pilloli) huma oblungi, ta' kulur roża, binnumru ‘300' imnaqqax fuq naħa waħda u n-numru ‘1332' imnaqqax fuq in-naħa l-oħra.
English: The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the de escalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondaryendpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Maltese: fil-grupp ta' kontroll; p mhux inferjuri =0.0115), u l-anqas fil-punt finali sekondarju prinċipali fsada BARC ≥2 ((5%) fil-grupp ta' tnaqqis fil-qawwa kontra 6% fil-grupp ta' kontroll (p=0.23)).
English: The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Maltese: Is-sustanzi l-oħra huma (ara sezzjoni 2 ‘Clopidogrel Zentiva fih il-lactose' u ‘Clopidogrel Zentiva fih castor oil idroġenat'):
English: A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Maltese: 54.6 % l-inibituri ACE u 25.4 % l-istatins.
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%) filgrupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%;
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: 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħra standard.
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Maltese: Suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet finnifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati ( per eżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin); nefħa fil-ħalq; infafet filġilda; reazzjoni allerġika fil-ġilda; uġigħ fil-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdiliet fil-mod ta' kif jintiegħem likel jew ma tibqax ittiegħem l-ikel.
English: Clopidogrel Zentiva 75 mg film-coated tablets Clopidogrel Zentiva 300 mg film-coated tablets
Maltese: Clopidogrel Zentiva 75 mg pilloli miksijin b'rita Clopidogrel Zentiva 300 mg pilloli miksijin b'rita
English: Clopidogrel Zentiva 75 mg film-coated tablets EU/1/08/465/001 - Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/08/465/003 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/08/465/005 - Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/08/465/007 - Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/08/465/009 - Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters
Maltese: EU/1/08/465/001 - Kaxex ta' 14-il pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/002 - Kaxex ta' 14-il pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/003 - Kaxex ta' 28 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/004 - Kaxex ta' 28 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/005 - Kaxex ta' 30 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/006 - Kaxex ta' 30 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/007 - Kaxex ta' 50x1 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/008 - Kaxex ta' 50x1 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/009 - Kaxex ta' 84 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/010 - Kaxex ta' 84 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/011 - Kaxex ta' 90 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/012 - Kaxex ta' 90 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/013 - Kaxex ta' 100 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/014
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall galactose, nuqqas ta' Lapp lactase jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti bejn iż-żewġ gruppi fir-rata ta' fsada li twassal għall-mewt (1.1% fil-grupp clopidogrel + ASA u 0.7% fil-grupp plaċebo +ASA ) u fir-rata ta'
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged
Maltese: Ir-riżultat primarju , taħlita ta' mewt kardjovaskulari, puplesija, vaskularazzjoni urġenti mill-ġdid u fsada BARC (Bleeding Academic Research Consortium) ≥2 f'sena wara ACS, seħħ f'43 pazjent (13.4%) fil-grupp DAPT ta' tnaqqis fil-qawwa u f'85 pazjent (26.
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Maltese: Madwar 88 % tal pazjenti rċevew fl-istess ħin ASA (b'varjazzjoni minn 1 sa 23 mg/kg/jum).
English: Clopidogrel Zentiva 300 mg film-coated tablets Pink, oblong, engraved with «300» on one side and «1332» on the other side.
Maltese: Roża, oblunga, b'«300» imnaqqax fuq naħa waħda u «1332» imnaqqax fuq in-naħa l-oħra.
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Clopidogrel Zentiva 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat millADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' Clopidogrel Zentiva.
English: Wed
Maltese: NUMRUI
English: In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Maltese: 75 sena kien inqas minn dak osservat f'pazjenti ≤75 sena.
English: It also contains: hydrogenated castor oil and lactose.
Maltese: TA' EĊĊIPJENTI Fiha wkoll: lactose u castor oil idroġenat.
English: EXP {MM/YYYY}
Maltese: F'studju ta'
English: INSTRUCTIONS ON USE 16.
Maltese: ≥ 75 sena.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
Maltese: Għall-pakketti ta' 7, 14, 28 u 84 pilloli, tista' tiċċekkja l-ġurnata li fiha ħadt l-aħħar il-pillola ta' Clopidogrel Zentiva billi tirreferi għall-kalendarju stampat fuq il-folja.
English: Excipients
Maltese: Ematoma
English: EU/1/08/465/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/465/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/465/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/465/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/019 - Cartons of 7 film-coated tablets in all aluminium blisters EU/1/08/465/021 - Cartons of 50 film-coated tablets in PVC/PVDC/Alu blisters
Maltese: - Kaxex ta' 100 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/018 - Kaxex ta' 7 pilloli miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/08/465/019 - Kaxex ta' 7 pilloli miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/08/465/021 - Kaxex ta' 50 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fil livell tal-metabolit attiv ta' clopidogrel .
English: This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged
Maltese: Din id-differenza statistikament sinifikanti kienet ikkawżata l-iżjed minħabba li kien hemm inqas avvenimenti ta' fsada ,mingħajr ma ġiet irrapportata ebda differenza fil-punti finali iskemiċi (p=0.36), waqt li BARC ≥2 episodji ta' fsada seħħ b'mod anqas frekwenti fil-grupp ta' DAPT
English: Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.
Maltese: Kull pillola miksija b'rita fiha 12 mg ta' lactose u 13.3 mg ta' castor oil idroġenat Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u siġurtà
English: Clopidogrel Zentiva 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Maltese: ta' kulur roża, bin-numru ‘75' imnaqqax fuq naħa waħda u n-numru ‘1171' imnaqqax fuq in-naħa l oħra.
English: Core:
Maltese: Tel:
English: even if their signs of illness are the same as yours.
Maltese: operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: Clopidogrel Zentiva 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Maltese: Clopidogrel Zentiva 75 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrogen sulphate). Eċċipjenti b'effett magħruf:
English: Gynaecomastia
Maltese: Zentiva
English: - Clopidogrel Zentiva 300 mg film-coated tablets
Maltese: - Clopidogrel Zentiva 300 mg pilloli miksija b'rita
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni(jistgħu jaffettwaw sa 1 minn kull 100 persuni:
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Maltese: L-età medja kienet ta' 71 sena, 41.6 % tal-pazjenti kellhom
English: Clopidogrel Zentiva 300 mg tablets clopidogrel
Maltese: Clopidogrel Zentiva 300 mg pilloli miksijin b'rita
English: - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Maltese: Infart mijokardijaku akut b'segment ST elevat, flimkien ma' ASA f'pazjenti ittrattati bil mediċini u eliġibbli għat-terapija trombolitika
English: Clopidogrel Zentiva is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Zentiva jittieħed mill-adulti biex inaqqas ir-riskju li ċapep tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombożi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti sekondarji rari(jistgħu jaffettwaw sa 1 minn kull 1000 persuni:
English: Clopidogrel Zentiva 75 mg tablets clopidogrel
Maltese: Clopidogrel Zentiva 75 mg pilloli miksijin b'rita
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: Infart mijokardijaku reċenti (MI), puplesija reċenti jew mard periferali stabbilit ta' l-arterji L-istudju CAPRIE kien jinkludi 19,185 pazjent bi trombożi fil-vini li ntweriet permezz ta' infart mijokardijaku reċenti (<35 jum), puplesija iskemika reċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit ta' l-arterji periferali (PAD).
English: Recent ischaemic stroke
Maltese: Ir-Repubblika Ċeka
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Retroperitoneal haemorrhage
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Clopidogrel Zentiva contains lactose
Maltese: Kif jidher Clopidogrel Zentiva u l-kontenut tal-pakkett
English: Clopidogrel Zentiva 300 mg film-coated tablets Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Maltese: Kull pillola miksija b'rita fiha 3 mg ta' lactose u 3.3 mg ta' castor oil idroġenat Clopidogrel Zentiva 300 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 300 mg ta' clopidogrel (bħala hydrogen sulphate).
English: Marketing Authorisation Holder: Zentiva k.s.
Maltese: Magyarország Zentiva, k.s.
English: Clopidogrel Zentiva 300 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Zentiva 300 mg pilloli miksija b'rita clopidogrel
English: PV-Estonia@zentiva.com
Maltese: PV-Finland@zentiva.com
English: The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life tat-tneħħija tal-metabolit prinċipali ċirkolanti kien 8 sigħat wara amministrazzjoni waħda u ripetuta.
English: Clopidogrel Zentiva 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Zentiva 75 mg pilloli miksija b'rita clopidogrel
English: - Clopidogrel Zentiva 75 mg film-coated tablets
Maltese: - Clopidogrel Zentiva 75 mg pilloli miksijin b'rita
English: PV-Norway@zentiva.com
Maltese: PV-Greece@zentiva.com
English: Sun
Maltese: JIS
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r riskju tal-prodott mediċinali.
English: Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010 PV-Germany@zentiva.com
Maltese: Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00 PV-Poland@zentiva.com
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurta` f'iktar minn 44,000 pazjent li pparteċipaw fi studji kliniċi,
English: Bleeding at puncture site
Maltese: toraċiċi u medjastinali
English: • The active substance is stiripentol.
Maltese: • Is-sustanza attiva hi stiripentol.
English: Франция/ Francie/ Frankrig/ Frankreich/ Γαλλία/ France/ Francia/ Prantsusmaa/ Ranska/ Franciaország/ Frakkland/France/ Prancūzija/ Francija/ Franza/ Frankrijk/ Frankrike/ Francja/ Franţa/ Francúzsko
Maltese: Франция/ Francie/ Frankrig/ Frankreich/ Γαλλία/ France/ Francia/ Prantsusmaa/ Ranska/ Franciaország/ Frakklandi/France/ Prancūzija/ Francija/ Franza/ Frankrijk/ Frankrike/ Francja/ Franţa/ Francúzsko
English: AT/BE/BG/CY/DK/EE/EL/ES/FR/HR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
Maltese: AT/BE/BG/CY/DK/EE/EL/ES/FR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
English: • hyperkinesis (exaggerated movements);
Maltese: • iperkinesi (movimenti esaġerati);
English: Tmax was similar with both formulations.
Maltese: Tmax kien simili għaż-żewġ formulazzjonijiet.
English: - Statins (atorvastatin, simvastatin, etc.)
Maltese: - Statins (atorvastatin, simvastatin, eċċ.)
English: System Organ Class (MedDRA terminology)
Maltese: Sistema tal-Klassifika tal-Organi (Reġsitru ta' MedDRA)
English: Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany
Maltese: Desitin Arzneimittel GmbH Weg beim Jäger 214
English: Carbamazepine, phenytoin and phenobarbital
Maltese: Carbamazepine, phenytoin u phenobarbital
English: The 95% CI of the difference was 42.2-85.7.
Maltese: Il-95% CI tad-differenza kien 42.2-85
English: (E132).
Maltese: indigotin (E132).
English: Effect of formulation
Maltese: Effett ta' formulazzjoni
English: - Chlorpromazine Stiripentol enhances the central depressant effect of chlorpromazine.
Maltese: - Chlorpromazine Stiripentol ikabbar l-effett dipressanti ċentrali ta'chlorpromazine.
English: BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais FRANCE
Maltese: BIOCODEX 1 avenue Blaise Pascal, 60000
English: - Cisapride, halofantrine, pimozide, quinidine, bepridil Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular.
Maltese: - Cisapride, halofantrine, pimozide, quinidine, bepridil Riskju miżjud ta' arritmiji kardijaċi u arritmija torsades de pointes/wave burst in partikolari.