FrancophonIA/ELRC3.0 huggingface dataset:
English: However no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g., 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil, and 4% digoxin).
Maltese: Minħabba osservazzjonijiet ta' pawżi ventrikulari u bradikardija l-aktar asintomatiċi, għandha tittieħed kawtela meta jingħata Possia flimkien ma mediċini magħrufa li jikkawżaw bradikardija (ara sezzjoni 4.4). Madankollu m'hemmx evidenza ta' interazzjonijiet avversi klinikament sinifikanti fi provi PLATO wara li ingħata flimkien ma mediċina waħda jew aktar magħrufa li jikkawżaw bradikardija (eż. 96% imblukkaturi beta, 33% imblukkaturi tal-kanal tal-calcium diltiazem u verapamil, u 4% digoxin).
English: Holter Substudy
Maltese: Sodertalje Svezzja
English: Co-administration of ticagrelor with potent CYP3A inducers may decrease exposure and efficacy of ticagrelor (see section 4.4).
Maltese: L-għotja ta' ticagrelor f'daqqa ma' indutturi qawwija ta' CYP3A tista' tnaqqas lesponiment u l-effikaċja ta' ticagrelor (ara sezzjoni 4.4).
English: • Headache
Maltese: Qalba
English: AstraZeneca Pharma Poland Sp. z o.o.
Maltese: AstraZeneca S.p.A.
English: Similar increases in AUC and Cmax were observed for all atorvastatin acid metabolites.
Maltese: Żiediet simili fl-AUC u s-Cmax dehru għal metaboli kollha tal-aċidu ta' atorvastatin.
English: In PLATO study, patients on ticagrelor had a higher risk of hyperuricaemia than those patients receiving clopidogrel (see section 4.8).
Maltese: Fi studju PLATO, pazjenti fuq ticagrelor kellhom riskju għola ta' iperuriċemija minn dawk il-pazjenti li qed jirċievu clopidogrel (ara sezzjoni 4.8).
English: Uncommon (affects 1 to 10 users in 1,000)
Maltese: Mhux komuni (jaffettwaw minn 1 sa 10 minn kull 1000 li jużawh)
English: Absorption of ticagrelor is rapid with a median tmax of approximately 1.5 hours.
Maltese: L-assorbiment ta' ticagrelor huwa mgħaġġel b'tmax medjan ta' madwar 1.5 sigħat.
English: Cerebral haemorrhage, Haemorrhage intracranial, Haemorrhagic stroke, Dyspnoea, Dyspnoea exertional, Dyspnoea at rest, Nocturnal dyspnoea Gastrointestinal haemorrhage, Rectal haemorrhage, Intestinal haemorrhage, Melaena, Occult blood Gastrointestinal ulcer haemorrhage, Gastric ulcer haemorrhage, Duodenal ulcer haemorrhage, Peptic ulcer
Maltese: Fl-istudju PLATO, Possia ingħata ta' spiss ma' ASA, inibituri tal-pompi tal-protoni, statins, imblukkaturi tal-beta, inibituri tal-angiotensin converting enzyme u inblukkaturi tar-riċetturi talangiotensin hekk kif kien meħtieġ għall-kundizzjonijiet l-oħra li kienu jsofru minnhom għal żmien twil kif ukoll heparin, heparin ta' piż molekulari baxx u inibituri GpIIb/IIIa minn ġol vina għal perijodi qosra (ara sezzjoni 5.1).
English: The concomitant use of Possia with doses of simvastatin or lovastatin greater than 40 mg is not recommended (see section 4.4).
Maltese: L-użu ta' Possia f'daqqa ma' dożi ta' simvastatin jew lovastatin ogħla minn 40 mg mhux rakkomandat (ara sezzjoni 4.4).
English: In clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians.
Maltese: Fi studji ta' farmakoloġija klinika, l-esponiment (Cmax u AUC) għal ticagrelor f'individwi Ġappuniżi kienet madwar 40% (20% wara li taġġusta għallpiż tal-ġisem) ogħla meta mqabbel ma' dak fil-Kawkażi.
English: In patients with Acute Coronary Syndromes (ACS), premature discontinuation with any antiplatelet therapy, including Possia, could result in an increased risk of cardiovascular death, or myocardial infarction due to the patient's underlying disease.
Maltese: F'pazjenti b'Sindromi Koronarji Akuti (ACS), it-twaqqif prematur ta' kwalunkwe terapija kontra lplejtlets, inkluż Possia, jista' jwassal f'żieda ta' riskju ta' mewt kardjovaskulari, jew infart mijokardijaku minħabba l-marda tal-pazjent .
English: clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated, as co-administration may lead to a substantial increase in exposure to ticagrelor (see section 4.4 and 4.5).
Maltese: (clarithromycin, nefazadone, ritonavir, u azatanavir) huma mistennija li jkollhom effetti simili u l-użu tagħhom flimkien ma' Possia huwa kontra-indikat (ara sezzjoni 4.3 u 4.4).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Maltese: Effetti ta' Possia fuq prodotti mediċinali oħra
English: Based on a relationship observed in PLATO between maintenance ASA dose and relative efficacy of ticagrelor compared to clopidogrel, co-administration of Possia and high maintenance dose ASA (>300 mg) is not recommended (see section 5.1).
Maltese: Mir-relazzjoni li dehret fi-PLATO bejn id-doża ta' manteniment ASA u l-effikaċja relattiva ta' ticagrelor meta mqabbel ma' clopidogrel, l-għotja ta' Possia fl-istess ħin ma' doża ta' manteniment għolja ta' ASA (>300 mg) mhux rakkomandata (ara sezzjoni 5.1).
English: Ticagrelor does not interact with the ADP binding site itself, but interacts with platelet P2Y12 ADP-receptor to prevent signal
Maltese: Ticagrelor ma jinteraġixxix mas-sit innifsu fejn jeħel l-ADP, iżda jinteraġixxi mar-riċettur tal-P2Y12 ADP talplejtlets biex jevita li s-sinjal jibqa għaddej.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Maltese: • Meta tasal informazzjoni ġdida li jista jkollha impatt fuq l-ispeċifikazzjonijiet tas-sigurta kurrenti, il-pjan ta' Farmakoviġilanza jew l-attivitajiet li jnaqqsu r-riskju
English: Ticagrelor produced irregular cycles (mostly extended cycles) in female rats, but did not affect overall fertility in male and female rats.
Maltese: Ticagrelor ikkawża ċikli irregolari (fil-parti l-kbira itwal) fil-firien femminili, iżda ma kellux effett fuq il-fertilità b'mod ġenerali fil-firien maskili u femminili.
English: 6.6 Special precautions for disposal
Maltese: .2 Inkompatibilitajiet
English: In 2.2% of patients, investigators considered the dyspnoea causally related to treatment with Possia.
Maltese: Fi 2.2% tal-pazjenti, l-investigaturi ikkunsidraw dispneja bħala każwalment relatata ma Possia.
English: If the association cannot be avoided, their concomitant use should be made with caution (see section 4.5).
Maltese: Jekk ma jkunx jista' jiġi evitat li jingħataw f'daqqa, l-użu tagħhom f'daqqa għandu jingħata b'kawtela (ara sezzjoni 4.5).
English: • Feeling dizzy or like the room is spinning
Maltese: • Sensazzjoni ta' tingiż
English: Combined efficacy and safety composite
Maltese: Sommarju tal-profil tas-sigurtà
English: Package leaflet: Information for the user
Maltese: Sorsi oħra ta' informazzjoni
English: Co-administration of Possia and CYP3A4 substrates with narrow therapeutic indices (i.e., cisapride or ergot alkaloids) is not recommended, as ticagrelor may increase the exposure to these medicinal products (see section 4.4).
Maltese: L-għotja f'daqqa ta' Possia ma' sottostrati ta' CYP3A4 b'indiċi terapewtiċi dojoq (i.e. cisapride jew alkalojdi ergot) mhux rakkomandat, minħabba li ticagrelor jista' jżid l-esponiment ta' dawn il-mediċini (ara sezzjoni 4.4).
English: Switching from prasugrel to Possia has not been investigated.
Maltese: Qlib minn prasugrel għall-Possia ma ġiex investigat.
English: For gouty arthritis, the AEs reported were 0.2% for ticagrelor vs 0.1% for clopidogrel; none of these adverse events were assessed as
Maltese: Għall- artrite bil-gotta, l- AEs irrappurtati kienu 0.2% għall- ticagrelor vs. 0.1% għallclopidogrel; l-ebda minn dawn l-avvenimenti avversi ma kienu assessjati bħala każwalment relatati mill- investigaturi.
English: Exposure to ticagrelor and the active metabolite were approximately 20% lower in patients with severe renal impairment (creatinine clearance <30 ml/min) compared to subjects with normal renal function
Maltese: L-esponiment għal ticagrelor u l-metabolu attiv kienu madwar 20% aktar baxxi f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina < 30 mL/min) imqabbel ma' individwi b'funzjoni renali normali (ara sezzjoni 4.2).
English: Subcutaneous haematoma, Skin haemorrhage, Haemorrhage subcutaneous, Petechiae Contusion, Haematoma, Ecchymosis, Increased tendency to bruise, Traumatic haematoma Haematuria, Blood urine present, Haemorrhage urinary tract Vessel puncture site haemorrhage, Vessel puncture site haematoma, Injection site haemorrhage, Puncture site haemorrhage, Catheter site haemorrhage
Maltese: Iperuriċemija, uric acid fid-demm jiżdied b Emorraġija ċerebrali, Emorraġija fil-kranju, attakk ta' puplesija emorraġġiku, c Dispneja, Dispneja bl-eżerċizzju, Dispneja waqt is-serħan, Dispneja bil-lejl d
English: Creatinine elevations: In PLATO, serum creatinine concentration significantly increased by >30% in 25.5% of patients receiving ticagrelor compared to 21.3% of patients receiving clopidogrel and by >50% in 8.3% of patients receiving ticagrelor compared to 6.7% of patients receiving clopidogrel.
Maltese: 5% tal-pazjenti li kienu qed jirċievu ticagrelor meta mqabbla ma' 21.3% talpazjenti li kienu qed jirċievu clopidogrel u b'>50% f'8.3% tal-pazjenti li kienu qed jirċievu ticagrelor u 6.7% tal-pazjenti li kienu qed jirċievu clopidogrel.
English: The major metabolite of ticagrelor is AR-C124910XX, which is also active as assessed by in vitro binding to the platelet P2Y12 ADP-receptor.
Maltese: Il-metabolu ewlieni ta' ticagrelor huwa AR-C124910XX, li huwa attiv ukoll hekk kif stmat bittwaħħil tiegħu mar-riċettur-ADP P2Y12tal-plejtlets in vitro.
English: Other concomitant therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Offset of Action
Maltese: Intent invażiv
English: Co-administration of ticagrelor with doses of simvastatin exceeding 40 mg daily could cause adverse effects of simvastatin and should be weighed against potential benefits.
Maltese: L-għotja ta' ticagrelor ma' dożi ta' simvastatin ogħla minn 40 mg kuljum jista' jikkawża effetti avversi ta' simvastatin u għandha titqies mal-benefiċċji li jista' jkollu.
English: • You are taking any of the following medicines: ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS).
Maltese: • Jekk qed tieħu xi waħda minn dawn il-mediċini: ketoconazole (jintuża sabiex jikkura infezzjonijiet tal-fungu) clarithromycin (jintuża sabiex jikkura infezzjonijiet tal-batteri), nefazodone (anti-dipressant), ritonavir u atazanavir (jintuża sabiex jikkura l-infezzjoni tal-HIV
English: Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Maltese: It-tabib tiegħek jiddiskuti miegħek ilbenefiċċji u r-riskji li tieħu Possia waqt dan iż-żmien.
English: Experience beyond 12 months is limited.
Maltese: Esperjenza ta' aktar minn 12-il xahar hija limitata.
English: The primary route of elimination for the active metabolite is most likely via biliary secretion.
Maltese: Il-mezz ewlieni tal-eliminazzjoni tal-metabolu attiv huwa x'aktarx mis-sekrezzjoni tal-marrara.
English: Co-administration of ticagrelor with strong CYP3A4 inducers (e.g. rifampicin, dexamethasone, phenytoin, carbamazepine and phenobarbital) is discouraged, as co-administration may lead to a decrease in exposure and efficacy of ticagrelor (see section 4.5).
Maltese: (e.ż. rifampicin, dexamethasone, phenytoin, carbamazepine u phenobarbital) mhux inkuraġġat għax l-għoja flimkien tista twassal għal tnaqqis flesponiment u l-effikaċja ta' ticagrelor (ara sezzjoni 4.5).
English: Following an initial dose of ASA, Possia should be used with a maintenance dose of ASA of 75-150 mg (see
Maltese: Wara doża tal-bidu ta' ASA, Possia għandu jittieħed ma' doża ta' manteniment ta' ASA ta' 75 mg sa 150 mg (ara sezzjoni 5.1).
English: Ingestion of a high-fat meal resulted in a 21% increase in ticagrelor AUC and 22% decrease in the active metabolite Cmax but had no effect on ticagrelor Cmax or the AUC of the active metabolite.
Maltese: Il-biodisponibilità medja assoluta ta' ticagrelor kienet stmata 36%. Meta ittieħdet ikla b'kontenut għoli ta' xaħam kien hemm żieda ta' 21% fl-AUC ta' ticagrelor u tnaqqis ta' 22% tas-Cmax talmetabolu attiv iżda ma kellu l-ebda effett fuq is-Cmax ta' ticagrelor jew l-AUC tal-metabolu attiv.
English: However, due to potential pharmacodynamic interactions, caution should be exercised with the concomitant administration of Possia with medicinal products known to alter haemostasis (see section 4.4).
Maltese: Iżda, minħabba li jista' jkun hemm interazzjonijiet farmakodinamiċi, għandha ssir kawtela meta jingħata Possia f'daqqa ma' mediċini magħrufa li jibdlu l-emostasi (ara sezzjoni 4.4).
English: Treatment is recommended for up to 12 months unless discontinuation of Possia is clinically indicated (see section 5.1).
Maltese: Il-kura hija rakkomandata għal mill-anqas 12-il xahar sakemm ma jkunx indikat b'mod kliniku li Possia għandu jitwaqqaf (ara sezzjoni 5.1).
English: The safety and efficacy of Possia in children below the age of 18 in the approved adult indication has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Possia fi tfal taħt it-18-il sena fl-indikazzjoni appruvata fl-adulti ma ġietx stabbilita.
English: • unstable angina (angina or chest pain that is not well controlled).
Maltese: • anġina mhux stabbli (anġina jew uġigħ fis-sider li mhux ikkontrollat sew).
English: Co-administration of Possia and CYP3A4 substrates with narrow therapeutic indices (i.e., cisapride and ergot alkaloids) is not recommended, as ticagrelor may increase the exposure to these medicinal products (see section 4.5).
Maltese: L-għotja f'daqqa ta' Possia ma' sottostrati ta' CYP3A4 b'indiċi terapewtiċi dojoq (i.e. cisapride u alkalojdi ergot) mhux rakkomandat, minħabba li ticagrelor jista' jżid l-esponiment ta' dawn ilmediċini (ara sezzjoni 4.5).
English: Take the medicine pack with you.
Maltese: Mediċini oħra u Possia
English: Others
Maltese: ISEM
English: • Feeling short of breath - this is common.
Maltese: • Tħossok nifsek maqtuħ - din hija komuni.
English: Hyperuricaemia, Blood uric acid increased
Maltese: Żiediet fil-livelli ta' uric acid:
English: Procedural site haemorrhage i
Maltese: Simbolu tax-xemx/qamar
English: Discontinuation of treatment due to non-procedural bleeding was more common for ticagrelor (2.9%) than for clopidogrel (1.2%; p<0.001).
Maltese: It-twaqqif tal-kura minħabba fsada mhux relatata mal-proċedura kienet aktar komuni għal ticagrelor (2.9%) milli għal clopidogrel (1.2%; p<0.001).
English: The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history) This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history respectively; and 3.8% versus 1.4% with clopidogrel.
Maltese: Iż-żieda fil-pawżi ventrikulari fil-fażi akuta ta' ACS kienu aktar qawwija f'pazjenti fuq ticagrelor li fil-passat kellhom CHF (9.2% kontra 5.4% talpazjenti li ma kellhomx CHF fil-passat; għall-pazjenti fuq clopidogrel, 4.0% f'dawk bil- kontra 3.6% f'dawk mingħajr passat ta' CHF).
English: If clinically indicated, medicinal products that alter haemostasis should be used with caution in combination with Possia (see section 4.4).
Maltese: Jekk ikun indikat b'mod kliniku, mediċini li jibdlu l-emostasi għandhom jintużaw b'kawtela f'daqqa ma' Possia (ara sezzjoni 4.4).
English: • Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of Possia dosing.
Maltese: • Pazjenti li fl-istess ħin ikunu qed jingħataw prodotti mediċinali li jistgħu jżidu r-riskju ta' fsada (eż. mediċini kontra l-infjammazzjoni li mhumiex sterojdi (NSAIDs), antikoagulanti orali u/jew fibrinolitiċi fi żmien 24 siegħa minn meta tkun ittieħdet id-doża ta' Possia).
English: • You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Possia (listed in section 6).
Maltese: • jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal ticagrelor jew sustanzi oħra ta' Possia (elenkati f'sezzjoni 6)
English: • After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently.
Maltese: • Wara d-doża tal-bidu, id-doża normali hija ta' pillola waħda ta' 90 mg darbtejn kuljum sa 12-il xahar sakemm it-tabib tiegħek ma jgħidlekx mod ieħor.
English: Ticagrelor is also a P-gp substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
Maltese: Ticagrelor huwa wkoll sotto strat P-gp u inibitur dgħajjef ta' P-gP u jista' jżid l-esponiment ghas-sottostrati ta' P-gP.
English: There were no reported ADRs of haemarthrosis reported in the ticagrelor arm (n=9235) of the PLATO study, the frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate (based on 3/X, where X represents the total sample size e.g. 9235).
Maltese: Emorraġġija fil-vina li tkun ittaqbet, Emorraġġija fis-sit mnejn tingħata l-injezzjoni, Emorraġġija mnejn issir it-titqiba, Emorraġġija mnejn jitqiegħed il-katiter Ma kienx hemm ADRs irrappurtati dwar emoartrożi fil-fergħa ticagrelor (n=9235) tal-istudju PLATO, ilfrekwenza kienet ikkalkulata billi ntuża l-limitu ta' fuq ta' 95% tal-intervall ta' kunfidenza għall-punt stmat (ibbażat fuq 3/X, fejn X jirrappreżenta id-daqs tal-kampjun kollu eż.9235).
English: If a patient is to undergo elective surgery and antiplatelet effect is not desired, Possia should be discontinued 7 days prior to surgery (see section 5.1).
Maltese: Jekk pazjent ikollu jagħmel operazzjoni elettiva u l-effett ta' kontra l-plejtlets ma jkunx mixtieq, Possia għandu jitwaqqaf 7 tijiem qabel l-operazzjoni (ara sezzjoni
English: In rats minor developmental anomalies were seen at a maternal toxic dose (safety margin of 5.1).
Maltese: Fil-firien anomaliji żgħar tal-iżvilupp dehru b'dożi tossiċi għall-omm (marġini ta' sigurtà ta' 5.1).
English: Retroperitoneal haemorrhage, Constipation
Maltese: Disturbi gastro-intestinali Emorraġġija Gastrointestinalid
English: Acute Coronary Syndrome (ACS)
Maltese: Sindromu Koronarju Akut (ACS)
English: Opaque blisters (PVC/PVdC/aluminium).
Maltese: Folji blister opaki (PVC/PVdC/aluminju).
English: The mean Vd ranged between 63 - 276 l.
Maltese: Il-Vd medju varja bejn 63-276 l.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin iżid il-kapaċità ta' trasport ta' tipi speċifiċi ta' membrane glucose transporters (GLUT-1 u GLUT-4)
English: 14 tablets 28 tablets 56 tablets 180 tablets
Maltese: 14 pillola 28 pillola 56 pillola 180 pillola
English: Sulphonylurea (background metformin) Glimepiride*
Maltese: Sulphonylurea (metformin fl-sfond) Glimepiride*
English: Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanja.
English: Metabolism
Maltese: Metaboliżmu
English: PHARMACEUTICAL FORM AND CONTENTS 112 tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 112 pillola
English: Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)
Maltese: Terapija orali trippla (rosiglitazone, metformin u sulphonylurea) (ara sezzjoni 4.4)
English: 28 tablets 56 tablets 112 tablets 360 tablets
Maltese: 28 pillola 56 pillola 112 pillola 360 pillola
English: Date of latest renewal: 20 October 2008
Maltese: Data ta' l-aħħar tiġdid: 20 t'Ottubru 2008
English: Similar effects have been seen with other thiazolidinediones.
Maltese: Effetti simili ġew osservati wkoll b'thiazolidinediones.
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Maltese: Rosiglitazone wera inibizzjoni moderata ta' CYP2C8 (IC50 18 μM) u inibizzjoni baxxa ta' CYP2C9 (IC50 50 μM) in vitro (ara sezzjoni 4.5).
English: Gastrointestinal disorders gastrointestinal symptoms6
Maltese: Mard gastro-intestinali sintomi gastro-intestinali6
English: Very rare side effects
Maltese: Effetti sekondarji rari
English: Metformin (background sulphonylurea)
Maltese: Metformin (sulphonylurea fl-sfond)
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Maltese: Rosiglitazone huwa agonist selettiv fir-receptor nuklejari PPARγ (peroxisome proliferator activated receptor gamma) u huwa membru tal-klassi ta' aġenti anti-ipergliċemiċi thiazolidinedione.
English: • chest pain (angina)
Maltese: • uġigħ fis-sider (angina)
English: Myocardial Ischaemia
Maltese: Iskemja Mijokardijaka
English: Packs of 14, 28, 56, 112 (2x56), 168 (3x56) and 180 tablets.
Maltese: Pakki ta' 14, 28, 56,112 (2x56), 168 (3x56) u 180 pillola.
English: 1995.5 (682.6) mg *Similar relative effective doses (i.e approximately half maximal dose) for other sulphonylureas (glibenclamide and glicazide).
Maltese: (682.6) mg *Dożi effettivi relattivi simili (i.e madwar nofs id-doża massima) għal sulphonylureas oħra (glibenclamide u glicazide).
English: Avoid consumption of alcohol and medicinal products containing alcohol.
Maltese: Għandu jiġi evitat il-konsum ta' l-alkoħol u prodotti mediċinali li fihom l-alkoħol.
English: Pharmacovigilance system
Maltese: Sistema ta' farmakoviġilanza
English: Lactic acidosis
Maltese: Aċidożi Lattika
English: HR and CI for key secondary endpoints were: all-cause death (HR 0.86, CI 0.68-1.08), MACE (Major Adverse Cardiac Events - cardiovascular death, acute myocardial infarction, stroke) (HR 0.93, CI 0.74-1.15), cardiovascular death (HR 0.84, CI 0.59-1.18), acute myocardial infarction (HR 1.14, CI 0.80-1.63) and stroke (HR 0.72, CI 0.49-1.06).
Maltese: HR u CI għallendpoints sekondarji kruċjali kienu: mewt minn kull kawża (HR 0.86, CI 0.68-1.08), MACE (Major Adverse Cardiac Events - mewt kardjovaskulari, infart mijokardijaku akut, puplesija) (HR 0.93, CI 0.74-1.15), mewt kardjovaskulari (HR 0.84, CI 0.59-1.18), infart mijokardijaku akut (HR 1.14, CI 0.80-1.63) u puplesija (HR 0.72, CI 0.49-1.06).
English: The other ingredients are: sodium starch glycollate, hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, povidone (E1201), magnesium stearate, titanium dioxide (E171), macrogol, iron oxide yellow or red (E172).
Maltese: Is-sustanzi l-oħra huma: sodium starch glycollate, microcrystalline cellulose, lactose monohydrate, povidone (E1210), magnesium stearate. hypromellose (E464), titanium dioxide (171), macrogol, iron oxide yellow jew red (E172).
English: Rosiglitazone (either SU or metformin)
Maltese: Rosiglitazone (SU jew metformin)
English: Combination with insulin
Maltese: Kombinazzjoni ma' insulina
English: Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68, CI 0.55-0.85) during the course of the study (up to 72 months of treatment).
Maltese: Trattament b'rosiglitazone naqqas b'mod sinifikanti ir-riskju li jintlaħaq falliment tal-monterapija (FPG>10.0 mmol/L) b'63% meta mqabbla ma' glibenclamide (HR 0.37, CI 0.30-0.45) u b'32% meta mqabbla ma' metformin (HR 0.68, CI 0.55-0.85) waqt l-andament ta' listudju (sa 72 xahar ta' trattament).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 2003
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 20 t'Ottubru 2003
English: Packs of 28, 56, 112, 336 (3x112) and 360 tablets.
Maltese: Pakki ta' 28, 56, 112, 336 (3x112) u 360 pillola.