FrancophonIA/ELRC3.0 huggingface dataset:
English: As a dual antiplatelet agent, DuoPlavin should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with other NSAIDs including Cox-2 inhibitors, heparin, glycoprotein IIb/IIIa inhibitors, selective serotonin reuptake inhibitors (SSRIs), thrombolytics, or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Maltese: Bħala sustanza li għandha azzjoni dupliċi kontra lplejtlets, DuoPlavin għandu jintuża b'kawtela ma' pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kondizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'NSAIDs oħra li jinkludu l-inibituri ta' Cox-2, heparin jew inibituri ta' glycoprotein IIb/IIIa, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta'fsada bħal pentoxifylline (ara sezzjoni 4.5) .
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis (including Henoch-Schönlein purpura*), hypotension
Maltese: Emorraġija serja, emorraġija ta' ġerħa ta' wara operazzjoni, vaskulite (li tinkludi Henoch-Schönlein purpura*), ipotensjoni
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets
Maltese: DuoPlavin 75 mg/75 mg pilloli miksijin b'rita DuoPlavin 75 mg/100 mg pilloli miksijin b'rita
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic enzymes*, abnormal liver function test, chronic hepatitis*
Maltese: epatite, livelli għoljin talenzimi tal-fwied*, test anormali tal-funzjoni talfwied, epatite kronika*
English: Following toxic doses (10 20 g), the plasma half-life may be increased to over 20 hours.
Maltese: Wara dożi tossiċi (10-20 g), il-half-life fil-plażma jista' jiżdied għal iktar minn 20 siegħa.
English: DuoPlavin 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow, engraved on one side with ‘C75' and ‘A75'on the other side.
Maltese: Il-pilloli miksijin b'rita (pilloli) ta' DuoPlavin 75 mg/75 mg huma ovali, daqsxejn konvessi miż-żewġ naħat, sofor u bin-numru ‘C75' imnaqqax fuq naħa waħda u n-numru ‘A75' imnaqqax fuq in-naħa loħra.
English: Following absorption, the ASA in DuoPlavin is hydrolyzed to salicylic acid with peak plasma levels of salicylic acid occurring within 1 hour of dosing, such that plasma levels of ASA are essentially undetectable 1.5-3 hours after dosing.
Maltese: Wara li jiġi assorbit, l-ASA f'DuoPlavin jiġi idrolizzat għal salicylic acid bl-ogħla livelli ta' salicylic acid fil-plażma jintlaħqu fi żmien siegħa minn wara li tittieħed id-doża, waqt li ftit li xejn ma ssib livelli ta' ASA fil-plażma wara 1.5- 3 sigħat mid-doża.
English: EU/1/10/619/008 14 film-coated tablets EU/1/10/619/009 28 film-coated tablets EU/1/10/619/010 30x1 film-coated tablet EU/1/10/619/011 50x1 film-coated tablet EU/1/10/619/012 84 film-coated tablets EU/1/10/619/013 90x1 film-coated tablet EU/1/10/619/014 100x1 film-coated tablet
Maltese: EU/1/10/619/008 14-il pillola miksija b'rita EU/1/10/619/009 28 pillola miksija b'rita EU/1/10/619/010 30 x 1 pillola miksija b'rita EU/1/10/619/011 50 x 1 pillola miksija b'rita EU/1/10/619/012 84 pillola miksija b'rita EU/1/10/619/013 90 x 1 pillola miksija b'rita EU/1/10/619/014 100 x 1 pillola miksija b'rita
English: NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq: sanofi-aventis groupe
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the group taking ASA alone.
Maltese: F'CLARITY, kien hemm żieda totali fid-dmija fil-grupp ta' clopidogrel + ASA kontra l-grupp li ħadu biss ASA .
English: The ASA in DuoPlavin is rapidly hydrolyzed in plasma to salicylic acid, with a half-life of 0.3 to 0.4 hours for ASA doses from 75 to 100 mg. Salicylic acid is primarily conjugated in the liver to form salicyluric acid, a phenolic glucuronide, an acyl glucuronide, and a number of minor metabolites.
Maltese: L-ASA f'DuoPlavin, malajr jiġi idrolizzat fil-plażma għal salicylic acid, b'half-life ta' 0.3 sa 0.4 sigħat għal dożi ta' ASA minn 75 mg sa 100 mg.
English: The clinical relevance is unknown.
Maltese: Ir-rilevanza klinika ta' din linterazzjoni hija inċerta.
English: Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Maltese: Il-bidla minn inibitur aktar qawwi tar-riċettur P2Y12 għal clopidogrel flimkien mal-aspirina wara lfażi akuta f'ACS ġiet evalwata f'żewġ studji mħallsin mill-investigutur u magħmula b'mod arbitrarju (ISS investigator-sponsored studies -TOPIC u TROPICAL ACS - b'tagħrif dwar ir-riżultat kliniku.
English: Not applicable
Maltese: .2 Inkompatibbilitajiet
English: DuoPlavin is supplied in cardboard cartons containing: - 14, 28 and 84 tablets in all-aluminium blisters - 30x1, 50x1, 90x1 and 100x1 tablet in all-aluminium perforated unit-dose blisters.
Maltese: DuoPlavin issibu f'kaxex tal-kartun li fihom: - 14, 28, 30 u 84 pillola ġo folji magħmulin kollha mill-aluminju.
English: There is a possible association between acetylsalicylic acid (ASA) and Reye's Syndrome when products containing ASA are given to children or adolescents with a viral infection.
Maltese: Hemm ilpossibbiltà ta' assoċjazzjoni bejn acetylsalicylic acid (ASA) u s-sindromu ta' Reye meta prodotti li fihom ASA jingħataw lit-tfal jew lill-adolexxenti li għandhom infezzjoni virali.
English: While you are taking DuoPlavin:
Maltese: Jek tinsa tieħu DuoPlavin:
English: Anaphylactic shock*, 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)**, aggravation of allergic symptoms of food allergy*
Maltese: Xokk anafilattiku*, mard ta' serum barrani,reazzjonijiet tattip anafilattiku, reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' 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 Ġappuniża)* sintomi allerġiċi ta' allerġija għall-ikel imorru għallagħar*
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum f'suġġetti b'mard renali sever (tneħħija talkrejatinina minn 5 sa 15 ml/min), l-inibizzjoni ta' l-agreggrazzjoni tal-plejtlets ikkawżata minn ADP kienet iktar baxxa (25%) minn dik osservata f'suġġetti b'saħħithom, madankollu, iż-żieda fil-ħin biex jieqaf id-demm kien simili għal dak osservat f'suġġetti b'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.
English: DuoPlavin 75 mg/100 mg film-coated tablets EU/1/10/619/008 - Cartons of 14 film-coated tablets in aluminium blister packs EU/1/10/619/009 - Cartons of 28 film-coated tablets in aluminium blister packs EU/1/10/619/010 - Cartons of 30x1 film-coated tablet in aluminium blister packs EU/1/10/619/011 - Cartons of 50x1 film-coated tablet in aluminium blister packs EU/1/10/619/012 - Cartons of 84 film-coated tablets in aluminium blister packs EU/1/10/619/013 - Cartons of 90x1 film-coated tablet in aluminium blister packs EU/1/10/619/014 - Cartons of 100x1 film-coated tablet in aluminium blister packs
Maltese: DuoPlavin 75 mg/100 mg pilloli miksijin b'rita EU/1/10/619/008 - Kaxex ta' 14-il pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/009 - Kaxex ta' 28 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/010 - Kaxex ta' 30 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum EU/1/10/619/011 - Kaxex ta' 50 x 1 pillola miksija b'rita f'pakketti ta' folji tal-aluminjum
English: In patients concomitantly receiving nicorandil and NSAIDs including ASA and LAS, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.5).
Maltese: F'pazjenti li fl-istess ħin qegħdin jirċievu wkoll nicorandil u NSAIDs inklużi ASA u LAS, hemm żieda fir-riskju għal kumplikazzjonijiet serji bħal ulċerazzjoni gastrointestinali, perforazzjoni u emorraġija (ara sezzjoni 4.5).
English: DuoPlavin 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Maltese: DuoPlavin 75 mg/75 mg pillola clopidogrel/acetylsalicylic acid
English: DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Maltese: DuoPlavin 75 mg/100 mg pillola clopidogrel/acetylsalicylic acid
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital or oestrogen.
Maltese: Ukoll, l-attivita` farmakodinamika ta' clopidogrel ma ġietx influwenzata b'mod sinifikanti mit-teħid flimkien ma' phenobarbital jew oestrogen.
English: DuoPlavin should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Maltese: DuoPlavin m'għandux jintuża f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: DuoPlavin contains lactose
Maltese: Kif jidher DuoPlavin u l-kontenut tal-pakkett
English: Acetylsalicylic acid inhibits platelet aggregation by irreversible inhibition of prostaglandin cyclo-oxygenase and thus inhibits the generation of thromboxane A2, an inducer of platelet aggregation and vasoconstriction.
Maltese: Acetylsalicylic acid jinibixxi l-aggregazzjoni ta' plejtlits permezz ta' l-inibizzjoni b'mod irriversibbli tal-prostaglandin cyclo-oxygenase u b'hekk jiġi inibit il-produzzjoni ta' thromoxane A2, li hija ssustanza li tikkawża l-aggregazzjoni tal-plejtlits u l-vasokostrizzjoni.
English: • This medicinal product must be administered under close medical supervision in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to risk of haemolysis (see section
Maltese: • Dan il-prodott mediċinali jrid jingħata taħt superviżjoni medika stretta f'pazjenti b'defiċjenza ta' glucose-6-phosphate dehydrogenase (G6PD) minħabba r-riskju ta' emolisi (ara sezzjoni 4.8).
English: Wed. Thu.
Maltese: T Tl E Ħ Ġ S Ħ
English: DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Maltese: DuoPlavin 75 mg/75 mg pilloli miksijin b'rita DuoPlavin 75 mg/100 mg pilloli miksijin b'rita clopidogrel/acetylsalicylic acid
English: Renal failure*, acute renal impairment (especially in patients with existing renal impairment, heart decompensation, nephritic syndrome, or concomitant treatment with diuretics)*, glomerulonephritis, blood creatinine increased
Maltese: Insuffiċjenza renali*, indeboliment renali akut (speċjalment f'pazjenti li diġà għandhom indeboliment renali, ilqalb ma tkunx qiegħda tikkumpensa, sindromu nefritiku jew kura flistess ħin b'dijuretiċi)*, glomerulonefrite, jiżdied il-livell tal-krejatinin fiddemm.
English: Jaundice (yellowing of skin and/or eyes); burning in stomach and/or esophagus (gullet); 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 foods, inflammation of small vessels.
Maltese: Suffejra (il-ġilda u/jew l-għajnejn jisfaru); ħruq fl-istonku u/jew fl-esofagu (gerżuma tal-ikel); uġigħ addominali sever flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet biex tieħu n-nifs, xi mdaqqiet 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 fil-ġilda; allerġija tal-ġilda; uġigħ fil-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdil fil-mod ta' kif jintiegħem l-ikel jew ma tibqax ittiegħem l-ikel , infjammazzjoni tal-arterji u l-vini ż-żgħar.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus ASA, and over 9,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurta` f'iktar minn 42,000 pazjent li ħadu sehem fi studji kliniċi, inklużi iktar minn 30,000 pazjent ikkurati b'clopidogrel flimkien ma' ASA u aktar minn 9,000 pazjent li kienu kkurati għal sena jew iktar.
English: DuoPlavin 75 mg/100 mg film-coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75' and ‘A100'on the other side.
Maltese: Il-pilloli miksijin b'rita (pilloli) ta' DuoPlavin 75 mg/100 mg huma ovali, daqsxejn konvessi miż-żewġ naħat, roża ċar u bin-numru ‘C75' imnaqqax fuq naħa waħda u n-numru ‘A100' imnaqqax fuq in-naħa l-oħra.
English: DuoPlavin 75 mg/75 mg film-coated tablets
Maltese: DuoPlavin 75 mg/75 mg pilloli miksijin b'rita
English: Mon. Tue.
Maltese: Deni, edima*
English: EU/1/10/619/001 14 film-coated tablets EU/1/10/619/002 28 film-coated tablets EU/1/10/619/003 30x1 film-coated tablet EU/1/10/619/004 50x1 film-coated tablet EU/1/10/619/005 84 film-coated tablets EU/1/10/619/006 90x1 film-coated tablet EU/1/10/619/007 100x1 film-coated tablet EU/1/10/619/015 30 film-coated tablets
Maltese: EU/1/10/619/001 14-il pillola miksija b'rita EU/1/10/619/002 28 pillola miksija b'rita EU/1/10/619/003 30 x 1 pillola miksija b'rita EU/1/10/619/004 50
English: DuoPlavin contains lactose.
Maltese: DuoPlavin fih il-lactose.
English: • nicorandil, medicine to treat cardiac chest pain,
Maltese: • Din il-mediċina ġiet mogħtija lilek biss.
English: Fever, edema*
Maltese: FULJETT TA' TAGĦRIF
English: Other interactions with ASA
Maltese: Interazzjonijiet oħra b'ASA
English: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
Maltese: • Sindromu koronarju akut mingħajr ma jkun elevat is-segment ST (anġina instabbli jew infart mijokardijaku mingħajr il-mewġa-Q) inklużi l-pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju
English: Salicylic acid in DuoPlavin has a plasma half-life of approximately 2 hours.
Maltese: Salicylic acid f'DuoPlavin għandu half-life fil-plażma ta' kważi sagħtejn.
English: Yellow, oval, slightly biconvex, engraved with «C75» on one side and «A75» on the other side.
Maltese: Sofor, ovali, daqsxejn konvessi fuq iż-żewġ naħat, imnaqqxin b'«C75» fuq naħa waħda u b'«A75» fuq in-naħa l-oħra.
English: Aluminium perforated unit-dose blisters in cardboard cartons containing 30x1, 50x1, 90x1 and 100x1 film-coated tablet.
Maltese: Folji mtaqqbin tal-aluminjum ta' doża waħda f'kaxxi tal-kartun li fihom 30 x 1,50 x 1,90 x 1 u 100 x 1 pillola miksija b'rita.
English: For the 14, 28 and 84 tablets pack sizes you can check the day on which you last took a tablet of DuoPlavin by referring to the calendar printed on the blister.
Maltese: Għall-pakketti ta' 14, 28 u 84 pillola, tista' tiċċekkja l-ġurnata li fiha ħadt l-aħħar il-pillola ta' DuoPlavin billi tirreferi għall-kalendarju stampat fuq il-folja.
English: Each tablet contains: 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Maltese: Kull pillola fiha:Clopidogrel 75 mg (bħala clopidogrel hydrogen sulphate) u 100 mg ta' acetylsalicylic acid.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Maltese: Kull pillola fiha 75 mg ta' clopidogrel (bħala hydrogen sulphate) u 75 mg ta' acetylsalicylic acid.
English: Renal excretion of unchanged active substance depends upon urinary pH. As urinary pH rises above 6.5, the renal clearance of free salicylate increases from <5% to >80%.
Maltese: Hekk kif il-pH ta' l-awrina togħla 'l fuq minn 6.5, it-tneħħija renali ta' salicylate li ma jkunx f'rabta mal-proteini jiżdied minn <5 % sa >80 %.
English: Each tablet contains: 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Maltese: Kull pillola fiha:Clopidogrel 75 mg (bħala clopidogrel hydrogen sulphate) u 75 mg ta' acetylsalicylic acid.
English: NAME OF THE MEDICINAL PRODUCT DuoPlavin 75 mg/100 mg tablet clopidogrel/acetylsalicylic acid
Maltese: DuoPlavin 75 mg/100 mg pilloli clopidogrel/acetylsalicylic acid
English: 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: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19 għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: If you have had a heart attack, it should be prescribed for at least four weeks.
Maltese: Minħabba li fih ASA, DuoPlavin huwa kontra-indikat waqt it-tielet trimestru tat-tqala.
English: This randomized, open-label trial included ACS patients requiring PCI.
Maltese: Din il-prova open-label u magħmula b'mod arbitrarju kienet tinkludi pazjenti ACS li kellhom bżonn ta' PCI.
English: DuoPlavin 75 mg/100 mg film-coated tablets
Maltese: DuoPlavin 75 mg/100 mg pilloli miksijin b'rita
English: At high ASA doses, the elimination of salicylic acid follows zero-order kinetics (i.e., the rate of elimination is constant in relation to plasma concentration), with an apparent half-life of 6 hours or higher.
Maltese: F'dożi għolja ta' ASA, l-eliminazzjoni ta' salicylic acid issegwi kinetika tat-tip zero-order (jiġifieri, ir-rata ta' eliminazzjoni hija kostanti fir-rigward tal-konċentrazzjoni filplażma), b'half-life apparenti ta' 6 sigħat jew iżjed.
English: You have been prescribed DuoPlavin in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina' or heart attack (myocardial infarction).
Maltese: Ingħatajt DuoPlavin minflok ma tingħata żewġ mediċini separati, clopidogrel u ASA, biex jgħin biex ma jifformawx ċapep tad-demm u dan għaliex kellek uġigħ sever f'sidrek magħruf bħala ‘unstable angina' jew ‘myocardial infarction' (attakk ta' qalb).
English: Repeat-dose toxicity studies have shown that levels up to 200 mg/kg/day are well tolerated in rats; dogs appear to be more sensitive, probably due to the high sensitivity of canines to the ulcerogenic effects of NSAIDs.
Maltese: Studji ta' tossiċità b'dożi ripetuti wrew li livelli sa 200 mg/kg/jum huma tollerati tajba fil-firien; klieb jidhru li huma iżjed sensittivi, probabilment minħabba li l-klieb huma sensittivi ħafna għall-effett ulċeroġeniku ta' l-NSAIDs.
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Maltese: Omeprazole 80 mg mogħti darba kuljum jew fl-istess ħin ma' clopidogrel jew b'differenza ta' 12il siegħa bejn it-teħid taż-żewġ mediċini naqqas l-espożizzjoni tal-metabolit attiv b'45 % ( id-doża ta' kkargar) u b'40 % (id-doża ta' manteniment).
English: Consequently, the concomitant use of NSAIDs including Cox-2 inhibitors is not recommended (see section 4.4).
Maltese: Minħabba f'hekk, l-użu flimkien mal-NSAID's inklużi l-inibituri Cox-2 mhux rakkomandat (ara sezzjoni 4.4).
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti migburin flimkien skond il-karatteristiċi tal-linja bażika, u t-tip ta' terapija fibrinolitika jew bit-terapija bl-eparina.
English: These results indicate that clopidogrel can be administered with pantoprazole.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu jkunu għal skop kummerċjali.
English: In CURE there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
Maltese: Fi CURE, ma kienx hemm eċċess ta' fsada maġġuri b'clopidogrel flimkien ma' ASA fis-7 ijiem ta' wara operazzjoni ta' bypass graft tal-qalb f'pazjenti li waqqfu t-terapija iktar minn ħamest ijiem qabel l-operazzjoni.
English: Colitis (including ulcerative or lymphocytic colitis), stomatitis, acute pancreatitis in the context of a hypersensitivity reaction due to acetylsalicylic acid*
Maltese: limfoċitika), stomatite, pankreatite akuta filkuntest ta' reazzjoni ta' sensittività eċċessiva minħabba acetylsalicylic acid*.
English: Antacids did not modify the extent of clopidogrel absorption.
Maltese: Antacids ma mmodifikawx kemm gie assorbit clopidogrel.
English: Conte nt
Maltese: Mnejn għandu jingħata
English: • Safety issues
Maltese: • Kwistjonijiet ta' sigurtà
English: Subsequently, Janssen Cilag submitted an application for mutual recognition of Priligy, 30 mg and 60 mg film-coated tablets in the following Member States: Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom.
Maltese: Sussegwentement, Janssen Cilag issottomettiet applikazzjoni għal rikonoxximent reċiproku ta' Priligy, pilloli miksija b'rita ta' 30 mg u 60 mg fl-Istati Membri li ġejjin: il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Greċja, Franza, l-Ungerija, l-Irlanda, l-Islanda , ilLitwanja, il-Lussemburgu, il-Latvja, Malta, l-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ir-Rumanija, isSlovenja, is-Slovakkja u r-Renju Unit.
English: Overall discussion and benefit/risk assessment
Maltese: Diskussjoni ġenerali u l-evalwazzjoni tal-benefiċċju/riskju
English: Priligy is a pharmacologic treatment approved for men with Premature Ejaculation (PE).
Maltese: Priligy huwa trattament farmakoloġiku approvat għall-irġiel bl-Eġakulazzjoni Prematura (PE).
English: Number of subjects
Maltese: Numru ta' suġġetti