FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10: SVR12 in study ASTRAL-1 by HCV genotype
Maltese: SVR12 fl-istudju ASTRAL-1 skont il-ġenotip tal-HCV
English: Ethinyl estradiol a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Maltese: Proporzjon medju (90% CI) tal-parametri farmakokinetiċi tal-prodotti mediċinali mogħtija flimkien tal-prodotti mediċinali tal-istudju waħedhom jew flimkien.
English: In one Phase 3 study in patients with decompensated cirrhosis who received Epclusa + RBV for 12 weeks, 3 patients (1 with genotype 1 and 2 with genotype 3) qualified for resistance analysis due to virologic failure.
Maltese: Fi studju wieħed ta' Fażi 3 f'pazjenti b'ċirrożi dikumpensata li rċivew Epclusa + RBV għal 12il ġimgħa, 3 pazjenti (1 b'ġenotip 1 u 2 b'ġenotip 3) ikkwalifikaw għal analiżi ta' reżistenza minħabba falliment viroloġiku.
English: Outcome for patients without SVR12 Ontreatment virologic failure
Maltese: Riżultat għal pazjenti mingħajr SVR12 Falliment viroloġiku waqt il-kura
English: 3a 4a
Maltese: 4a
English: Famotidine dosed simultaneously with Epclusad
Maltese: Famotidine iddożat flistess ħin ma' Epclusad
English: Rosuvastatin, at a dose that does not exceed 10 mg, may be administered with Epclusa.
Maltese: Rosuvastatin, f'doża li ma taqbiżx 10 mg, jista' jingħata ma' Epclusa.
English: SVR12 for selected subgroups are presented in Table 13.
Maltese: L-SVR12 għal sottogruppi magħżula huma ppreżentati f'Tabella 13.
English: Relapsea
Maltese: Tqala
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir.
Maltese: L-interazzjonijiet tal-prodott mediċinali deskritti huma bbażati fuq studji mwettqa b'sofosbuvir/velpatasvir jew velpatasvir u sofosbuvir bħala sustanzi individwali, jew huma interazzjonijiet imbassra tal-prodott mediċinali li jistgħu jseħħu b'sofosbuvir/velpatasvir.
English: Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Maltese: Rilpivirine ↔ ↔ ↔ Mhux meħtieġ aġġustament fiddoża ta' Epclusa jew emtricitabine/rilpivirine/ tenofovir disoproxil fumarate.
English: No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure.
Maltese: L-ebda pazjent b'infezzjoni bl-HCV ta' ġenotip 2 jew 4 fil-grupp ta' Epclusa + RBV għal 12-il ġimgħa ma kellu falliment viroloġiku.
English: The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Maltese: L-evalwazzjoni tas-sigurtà ta' Epclusa kienet ibbażata fuq dejta miġbura ta' studju kliniku tal-Fażi 3 minn pazjenti b'infezzjoni bl-HCV tal-ġenotip 1, 2, 3, 4, 5 jew 6 (b'ċirrożi kumpensata jew mingħajrha) u kienet tinkludi 1,035 pazjent li ngħataw Epclusa għal 12-il ġimgħa.
English: Treatment-naïve (n = 206)
Maltese: Qatt ma rċivew kura fil-passat (n = 206)
English: 28 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 pillola miksija b'rita
English: GT-1a (n = 66)
Maltese: (n = 66)
English: Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
Maltese: Studji f'annimali ma urewx effetti tossiċi ta' sofosbuvir jew velpatasvir fuq il-fertilità.
English: Table 17: SVR12 in study ASTRAL-5 by HCV genotype
Maltese: Tabella 17: SVR12 fl-istudju ASTRAL-5 skont il-ġenotip tal-HCV Epclusa għal 12-il ġimgħa (n = 106)
English: Treatmentexperienced (n = 71)
Maltese: (n = 71)
English: Epclusa 24 weeks
Maltese: Epclusa għal 24 ġimgħa
English: • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Maltese: • jekk bħalissa għandek infezzjoni jew kellek infezzjoni preċedenti bil-virus tal-epatite B, minħabba li t-tabib tiegħek jista' jkun irid jimmonitorjak aktar mill-qrib;
English: Severe RI (eGFR
Maltese: TAGĦRIF
English: SVR12 in patients with or without baseline NS5A RAVs in the Epclusa + RBV 12 week group for this study is shown in Table 8.
Maltese: L-SVR12 f'pazjenti b'NS5A RAVs fil-linja bażi jew mingħajrhom fil-grupp ta' Epclusa + RBV għal 12-il ġimgħa għal dan l-istudju hija murija f'Tabella 8.
English: Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Maltese: Oħrajn jinkludu pazjenti li ma kisbux SVR12 u ma ssodisfawx il-kriterji ta' falliment viroloġiku.
English: Baseline RAVs had no relevant impact on SVR12 rates in patients infected with genotype 1, 2, 4, 5 and 6 HCV, as summarised in Table 6.
Maltese: L-RAVs fil-linja bażi ma kellhom l-ebda impatt rilevanti fuq ir-rati ta' SVR12 f'pazjenti infettati bl-HCV ta' ġenotip 1, 2, 4, 5 u 6, kif muri fil-qosor f'Tabella 6.
English: Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Maltese: Il-pazjenti kienu magħżula b'mod każwali fi proporzjon ta' 1:1:1 għall-kura b'Epclusa + RBV għal 12-il ġimgħa jew Epclusa għal 24 ġimgħa.
English: Changes in the parameters found in the CPT score system in patients achieving SVR12 in ASTRAL-4 (all 3 regimens) are shown in Table 16.
Maltese: Bidliet fil-parametri li nstabu fis-sistema tal-punteġġ CPT f'pazjenti li kisbu SVR 12 f'ASTRAL-4 (it-3 korsijiet kollha) qed jintwerew f'Tabella 16.
English: Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
Maltese: SVR12 f'pazjenti b'Y93H fil-linja bażi u mingħajru, Punt ta' qtugħ ta' 1% (Grupp tal-Popolazzjoni tal-Analiżi ta' Reżistenza)
English: Treatment-naïve (n = 201)
Maltese: Qatt ma rċivew kura fil-passat (n = 201)
English: Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Maltese: Nota: Il-frekwenza tal-axxite fil-linja bażi kienet: 20% xejn, 77% ħafifa/moderata, 3% severa
English: All Subjects (n = 274)
Maltese: (n = 624)
English: In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Epclusa.
Maltese: Fi studji kliniċi, uġigħ ta' ras, għeja u dardir kienu l-avvenimenti avversi emerġenti għall-kura l-aktar komuni (inċidenza ta' ≥ 10%) rrappurtati f'pazjenti kkurati għal 12-il ġimgħa b'Epclusa.
English: GT-1a (n = 210)
Maltese: (n = 210)
English: In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
Maltese: F'dan is-sett ta' data limitata dwar issigurtà klinika, ir-rata ta' avvenimenti avversi u mwiet ma żdiditx b'mod ċar minn dak li hu mistenni f'pazjenti b'ESRD.
English: 86% (6/7)c a n = 4 for genotype 2 and n = 4 for genotype 4.
Maltese: n = 4 għal ġenotip 2 u n = 4 għal ġenotip 4
English: Omeprazole dosed simultaneously with Epclusad
Maltese: Omeprazole iddożat flistess ħin ma' Epclusad
English: Co-administration with proton pump inhibitors is not recommended.
Maltese: inibituri tal-pompa tal-protoni mhux rakkomandat.
English: Patients who have previously failed therapy with an NS5A-containing regimen Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Maltese: Epclusa + ribavirin għal 24 ġimgħa jistgħu jiġu kkunsidrati (ara sezzjoni 4.4).
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Epclusa for 12 weeks.
Maltese: Il-proporzjon ta' pazjenti li waqfu jieħdu l-kura b'mod permanenti minħabba avvenimenti avversi kien 0.2% u l-proporzjon ta' pazjenti li kellhom avvenimenti avversi severi kien 3.2% għal pazjenti li ngħataw Epclusa għal 12-il ġimgħa.
English: Phenobarbital (Induction of P-gp and CYPs)
Maltese: Fergħat tal-istudju (Għadd ta' pazjenti kkurati)
English: It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.
Maltese: Mhuwiex magħruf jekk sofosbuvir jew velpatasvir, iż-żewġ sustanzi attivi ta' Epclusa, jgħaddux fil-ħalib tas-sider uman.
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa.
Maltese: Jekk tirremetti wara li tieħu Epclusa, dan jista' jaffettwa l-ammont ta' Epclusa f'demmek.
English: GT = genotype a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Maltese: Id-denominatur għal rikaduta hu n-numru ta' pazjenti b'HCV RNA < LLOQ fl-aħħar evalwazzjoni tagħhom matul il-kura.
English: Patients with genotype 1, 2, 4 or 6 HCV infection were randomised in a 5:1 ratio to treatment with Epclusa for 12 weeks or placebo for 12 weeks.
Maltese: Pazjenti b'infezzjoni bl-HCV ta' ġenotip 1, 2, 4 jew 6 kienu magħżula b'mod każwali fi proporzjon ta' 5:1 għall-kura b'Epclusa għal 12-il ġimgħa jew plaċebo għal 12-il ġimgħa.
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa.
Maltese: Jekk qed tieħu antaċidu, ħudu talinqas 4 sigħat qabel jew talinqas 4 sigħat wara Epclusa.
English: Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Maltese: Adulti infettati bl-HCV ta' ġenotip 3 - ASTRAL-3 (studju 1140)
English: Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Maltese: Rosuvastatin (10 mg doża waħda)/velpatasvir (100 mg doża waħda)d
English: Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
Maltese: Mhuwiex probabbli li emodijaliżi tirriżulta fi tneħħija sinifikanti ta' velpatasvir, minħabba li velpatasvir jintrabat ħafna mal-proteina tal-plażma.
English: • rosuvastatin or other statins used to treat high cholesterol.
Maltese: • rosuvastatin jew statins oħra użati biex jikkuraw il-kolesterol għoli.
English: Combinations of these variants often showed greater reductions in susceptibility to velpatasvir than single RAVs alone.
Maltese: Interazzjonijiet ma' inibituri oħrajn ta' HMG-CoA reductase ma jistgħux jiġu esklużi.
English: Body weight did not have a clinically significant effect on sofosbuvir or velpatasvir exposure according to a population pharmacokinetic analysis.
Maltese: Il-piż tal-ġisem ma kellux effett klinikament sinifikanti fuq l-esponiment għal sofosbuvir jew velpatasvir skont analiżi farmakokinetika tal-popolazzjoni.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta korsijiet li fihom sofosbuvir jintużaw flimkien ma' amiodarone fl-istess ħin ma' mediċini oħrajn li jbaxxu r-rata ta' taħbit tal-qalb jew mingħajrhom (ara sezzjonijiet 4.4 u 4.5).
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Maltese: Wara doża waħda ta' 400 mg ta' [14C]-sofosbuvir f'individwi b'saħħithom, il-proporzjon tad-demm mal-plażma ta' radjuattività ta' [14C] kien ta' madwar 0.7.
English: It is recommended to separate antacid and Epclusa administration by 4 hours.
Maltese: Huwa rakkomandat li l-għoti ta' antaċidu u Epclusa jiġi separat b'4 sigħat.
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom and/or
Maltese: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, Renju Unit
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 16 July 2008
English: EU/1/08/464/017 100x1 film-coated tablets
Maltese: EU/1/08/464/017 100x1 pilloli miksija b'rita
English: Uxbridge UB8 1DH
Maltese: Uxbridge UB8 1DH Ir-Renju Unit
English: ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.
Maltese: Υιοσ Ε.Π.Ε.
English: Clopidogrel BMS contains lactose.
Maltese: Clopidogrel BMS fih lactose.
English: (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: Twaqqfu avvenimenti kardjovaskulari ġodda (punt primarju ta' tmien), 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, 3-6, 6-9 u 9-12 xhur, rispettivament.
English: Drugs that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine,
Maltese: Mediċini li jinibixxu CYP2C19 jinkludu omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine,
English: Tel.: + 36 1 301 9700 Malta
Maltese: Tel.: + 36 1 301 9700
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: L-użu ta' clopidogrel fi CURE kien assoċjat mat-tnaqqis fil-bżonn ta' kura trombolitika (RRR = 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR = 18.2%; CI: 6.5%, 28.
English: Excipients: each tablet contains 12 mg lactose and 13.2 mg hydrogenated castor oil.
Maltese: Sustanzi mhux attivi: kull pillola fiha 12 mg lactose u 13.2 mg castor oil idroġenat.
English: White (n=1356) Black (n=966) Chinese (n=573)
Maltese: Ċiniżi (n=573)
English: Slovenská republika
Maltese: Česká republika
English: 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: In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (<100mg: 2.6%; 100-200mg: 3.5%; >200mg: 4.9%) as was the major bleeding event rate for placebo+ASA (<100mg: 2.0%; 100-200mg: 2.3%; >200mg: 4.0%).
Maltese: F'CURE, ir-rata ta' avvenimenti ta' fsada maġġuri għal clopidogrel+ASA kienet tiddependi fuq iddoża ta' ASA (<100 mg: 2.6%; 100-200 mg: 3.5%; >200 mg: 4.9%) bħal ma' kienet ukoll ir-rata ta' avvenimenti ta' fsada maġġuri għal plaċebo+ASA(<100 mg: 2.0%; 100-200 mg: 2.3%; >200 mg: 4.0%).
English: Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated castor oil.
Maltese: Sustanzi mhux attivi: kull pillola fiha 3 mg lactose u 3.3 mg castor oil idroġenat
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Dermatite bulloża (nekroliżi tossika ta' lepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedima, raxx eritematika, urtikarja, ekżema, lichen planus
English: Clopidogrel BMS belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel BMS jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra lplejtlets.
English: If Clopidogrel BMS is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Maltese: Jekk Clopidogrel BMS huwa fornut ġo folji tal-PVC/PVDC/Aluminju, aħżen f'temperatura taħt 30°C.
English: In PVC/PVDC/aluminium blisters, store below 30°C.
Maltese: Fil-folji tal-PVC/PVDC/Aluminju, aħżen f'temperatura taħt 30°C.
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 hija definita skond dawn ilkonvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥/1,000 sa <1/100); rari (≥1/10,000 sa
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: 31.1%), 89.5%heparin, 78.7% imblokkaturi tar-riċetturi beta, 54.7% inibituri ACE u 63% statins.
English: BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Maltese: Bristol-Myers Squibb Gyógyszerkereskedelmi
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-website ta' l-Agenzija Ewropea dwar ilMediċini (EMEA): http://www.emea.europa.eu/
English: EU/1/08/464/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/464/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/464/015 - Pakketti ta' 4x1 pilloli miksijin b'rita ġo folji mtaqqbin ta' doża waħda kollha EU/1/08/464/016 - Pakketti ta' 30x1 pilloli miksijin b'rita ġo folji mtaqqbin ta' doża waħda kollha EU/1/08/464/017 - Pakketti ta' 100x1 pilloli miksijin b'rita ġo folji mtaqqbin ta' doża waħda kollha
English: The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-grupp studjat inkluda 27.8% nisa, 58.4% pazjenti ≥60 sena (26% ≥70 sena) u 54.5% tal-pazjenti li rċevew is
English: Tél: + 33 (0)810 410 500
Maltese: Bristol-Myers Squibb Sarl Tél: + 33 (0)810 410 500
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Maltese: Kategorija farmakoterapewtika: inibituri ta' l-aggregazzjoni tal-plejtlets eskl.heparin, Kodiċi ATC:
English: Clopidogrel BMS 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel BMS 75 mg
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 (PTCA) bi stent jew mingħajru u 10% meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG)).
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Maltese: Emorraġija serja, emorraġija ta' ferita minn operazzjoni, vaskulite, pressjoni baxxa Fsada fil-passaġġ respiratorju (emoptisi, emorraġija fil-pulmun), bronkospażmu, pulmonite interstizjali
English: 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: Clopidogrel BMS is supplied in cardboard cartons containing 4x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Maltese: Clopidogrel BMS huwa fornut f'kaxex tal-kartun li fihom 4x1, 30x1 u 100x1 pilloli ġo folji mtaqqbin ta' doża waħda magħmulin kollha kemm huma mill-aluminju.
English: PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PVDC/Aluminju jew folji kollha kemm huma ta' l-aluminju f'kaxxi tal-kartun li fihom 7, 14, 28, 30, 84, 90 u 100 pillola miksija b'rita.
English: The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial: 0-1 months (clopidogrel: 9.6%; placebo: 6.6%), 1-3 months (clopidogrel: 4.5%; placebo: 2.3%), 3-6 months (clopidogrel: 3.8%; placebo: 1.6%), 6-9 months (clopidogrel: 3.2%; placebo: 1.5%), 9-12 months (clopidogrel: 1.9%; placebo: 1.0%).
Maltese: 2.3%), 3-6 xhur (clopidogrel: 3.8%; plaċebo: 1.6%), 6-9 xhur (clopidogrel: 3.2%; plaċebo: 1.5%), 9-12 xhur (clopidogrel: 1.9%; plaċebo: 1.0%).
English: The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E171), and carnauba
Maltese: Is-sustanzi l-oħra huma mannitol (E421), castor oil idroġenat, microcrystalline cellulose, macrogol 6000 u hydroxypropylcellulose b'sostituzzjoni baxxa fil-qalba tal-pillola, u lactose (iz-zokkor li jinsab fil-ħalib), hypromellose (E464), triacetin (E1518), iron oxide aħmar (E172), titanium dioxide (E171), u carnauba wax fir-rita tal-pillola.
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-riskju relattiv ta' infart ġdid, puplesija jew il-mewt b'9% (p=0.002), li jirrappreżentaw tnaqqis assolut ta' 0.5% u 0.9%, rispettivament.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/Boxes of 30, 50x1, 90 or 100 tablets
Maltese: FOLJI/Kaxxi ta'30, 50x1, 90 jew 100 pillola)
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: F'CURE, 823 pazjent ingħataw terapija ta' antagonista għar-riċettur GPIIb/IIIa fl-istess ħin.
English: BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD
Maltese: Bristol-Myers Squibb Pharmaceuticals Ltd Tel:
English: There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% clopidogrel+ASA vs. 5.3% placebo+ASA).
Maltese: Ma kienx hemm eċċessi fi fsada maġġuri b'clopidogrel+ASA fis-7 ijiem ta' wara operazzjoni ta' trapjant ta' bajpass koronarju f'pazjenti li waqqfu l-kura iktar minn ħamest ijiem qabel l-operazzjoni (4.4% clopidogrel+ASA kontra 5.3% plaċebo + ASA).
English: HOW TO STORE CLOPIDOGREL BMS
Maltese: Clopidogrel BMS;
English: OY BRISTOL-MYERS SQUIBB (FINLAND) AB
Maltese: Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel:
English: BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.
Maltese: Belgique/België/Belgien Bristol-Myers Squibb Belgium S.A./N.V.
English: Bruising
Maltese: Lactose
English: This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are metabolised by Cytochrome P450 2C9.
Maltese: Potenzjalment dan jista jwassal għal livelli ogħla fil-plażma ta' prodotti mediċinali bħal phenytoin u tolbutamide u NSAIDs, li huma metabolizzati minn Cytochrome P450 2C9.
English: Other concomitant therapy:
Maltese: Farmakoġenetika: