FrancophonIA/ELRC3.0 huggingface dataset:
English: No statistically significant differences were found between treatment arms in global measures of Quality of Life.
Maltese: Ma nstabet l-ebda differenza statistikament sinifikanti bejn il-gruppi ta' kura fil-kejl globali talKwalità tal-Ħajja.
English: Preclinical data have demonstrated that trabectedin is a substrate to P-gp.
Maltese: Dejta ta' qabel l-użu kliniku wera li trabectedin huwa sottostrat għal P-gp.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Efficacy results from Study ET743-SAR-3007 Endpoints / Study population Trabectedin Dacarbazine Hazard Ratio / Odds Ratio p value Primary endpoint n=384
Maltese: Riżultati tal-effikaċja minn Studju ET743-SAR-3007
English: - The other ingredients are sucrose, potassium dihydrogen phosphate, phosphoric acid (for pH-adjustment) and potassium hydroxide (for pH-adjustment).
Maltese: - Is-sustanzi mhux attivi l-oħra huma sucrose, potassium dihydrogen phosphate, phosphoric acid (sabiex ikun jista' jiġi aġġustat il-pH) u potassium hydroxide (sabiex ikun jista' jiġi aġġustat ilpH).
English: - Neutropenia < 500/mm3 lasting for more than 5 days or associated with fever or infection - Thrombocytopenia < 25,000/mm3 - Increase of bilirubin > ULN and/or alkaline phosphatase > 2.5 x ULN
Maltese: - Newtropenija < 500/mm3 li ddum għal aktar minn 5 ijiem jew li hi assoċjata ma' deni jew infezzjoni - Tromboċitopenija < 25,000/mm3
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/417/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/417/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/417/001
English: (combination therapy), which has not recovered by day 21 - Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
Maltese: (terapija kombinata), li ma rkupratx sa jum 21 - Reazzjonijiet avversi oħra ta' grad 3 jew 4 (bħalma huma dardir, rimettar, għeja kbira)
English: Grades 3 or 4 neutropenia and thrombocytopenia associated with Yondelis therapy have been very commonly reported.
Maltese: Newtropenija u tromboċitopenija fi gradi 3 u 4 assoċjati ma' terapija b'Yondelis ġew irrappurtati b'mod komuni ħafna.
English: The use of any diluent other than 50 mg/ml (5%) glucose solution for infusion may cause precipitation of PLD.
Maltese: kwalunkwe dilwent ieħor minbarra soluzzjoni għall-infużjoni ta' 50 mg/ml (5%) glucose jista' jikkawża preċipitazzjoni ta' PLD.
English: Fatal adverse reactions have occurred in 1.9% and 0.9% of patients treated with the monotherapy and combination regimens respectively.
Maltese: Reazzjonijiet avversi fatali seħħew f'1.9% u 0.9% tal-pazjenti kkurati b'korsijiet ta' monoterapija u ta'
English: Patients should seek advice on ovules or sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with Yondelis.
Maltese: Pazjenti għandhom ifittxu parir dwar il-konservazzjoni tal-ovuli u tal-isperma qabel il-kura minħabba r-riskju ta' infertilità irriversibbli minħabba t-terapija b'Yondelis.
English: Pregnancy
Maltese: Disġewsja
English: Yondelis monotherapy and combination regimens must not be used in patients with creatinine clearance < 30 ml/min and < 60 ml/min respectively (see section 4.2).
Maltese: Korsijiet ta' Yondelis bħala monoterapija u bħala terapija kombinata m'għandhomx jintużaw f'pazjenti b'rata ta' tneħħija tal-krejatinina ta' < 30 ml/min u < 60 ml/min rispettivament (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Maltese: IL-PRODOTT MEDIĊINALI Yondelis 1 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Their finding of possible or probable trabectedin causality in 5 of 6 fatal cases among 14 probable CLS cases warrants an update of the SmPC within this procedure to reflect there are cases with a fatal outcome.
Maltese: każijiet fatali fost 14-il każ ta' CLS probabbli teħtieġ aġġornament tas-SmPC fi ħdan din ilproċedura biex tirrifletti li hemm każijiet b'riżultat fatali.
English: Systemic exposure after intravenous administration as a constant rate infusion is dose proportional at doses up to and including 1.8 mg/m2.
Maltese: L-espożizzjoni sistemika wara għoti fil-vini bħala infużjoni b'rata kostanti huwa proporzjonali maddoża f'dożi sa u li jinkludu 1.8 mg/m2 .
English: Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Maltese: Yondelis flimkien ma' pegylated liposomal doxorubicin (PLD) huwa indikat għall-kura ta' pazjenti b'kanċer tal-ovarju li rkada sensittiv għall-platinum.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mg trabectedin
Maltese: INDIVIDWALI 1 mg trabectedin
English: Extravasation Soft tissue necrosis
Maltese: Effetti ta' sustanzi oħra fuq trabectedin
English: Maximum fetal tissue radioactivity concentration was similar to that in maternal plasma or blood.
Maltese: Il-konċentrazzjoni massima ta' radjuattività fit-tessut fetali kienet simili għal dik fil-plażma jew fid-demm tal-omm.
English: - Hypersensitivity to trabectedin or to any of the excipients listed in section 6.1 - Concurrent serious or uncontrolled infection - Breast-feeding (see section 4.6) - Combination with yellow fever vaccine (see section 4.4)
Maltese: - Sensittività eċċessiva għal trabectedin jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1 - Infezzjoni fl-istess ħin serja jew mhux ikkontrollata - Treddigħ (ara sezzjoni 4.6) - Teħid flimkien ma' vaċċin tad-deni l-isfar (ara sezzjoni 4.4)
English: 12 months PFS rate (95% CI) (%) Independent oncology review, all randomised n=336
Maltese: Analiżi onkoloġika indipendenti, magħżula b'mod każwali kollha n=336
English: Neutropenia Thrombocytopenia Anaemia
Maltese: Rimettar Stitikezza Dijarea Stomatite
English: Rhabdomyolysis has been uncommonly reported, usually in association with myelotoxicity, severe liver function test abnormalities and/or renal or multiorgan failure.
Maltese: Rabdomijolisi ġiet irrrappurtata mhux komuni, ġeneralment assoċjata ma' majelotossiċità, anormalitajiet severi tal-funzjoni tal-fwied u/jew kollass tal-kliewi jew ta' diversi organi flimkien.
English: When Yondelis is used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Maltese: Meta Yondelis jintuża flimkien ma' PLD, l-pajp ta' ġol-vina għandu jitlaħlaħ sew b'soluzzjoni għall infużjoni ta' 50 mg/ml (5%) glucose wara l-għoti ta' PLD u qabel l-għoti ta' Yondelis.
English: They were often the result of a combination of events including pancytopenia, febrile neutropenia, some of them with sepsis, hepatic involvement, renal or multiorgan failure and rhabdomyolysis.
Maltese: Huma ta' spiss kienu riżultat ta' taħlita ta' reazzjonijiet inkluż panċitopenija, newtropenija bid-deni, xi wħud b'sepsi, involviment tal-fwied, insuffiċjenza tal-kliewi jew ta' diversi organi, u rabdomijolisi.
English: Liver function tests predicting severe toxicity (meeting Hy´s law) and clinical manifestations of severe hepatic injury were uncommon with a lower than 1% incidence of individual signs and symptoms including jaundice, hepatomegaly or liver pain.
Maltese: Testijiet tal-funzjoni tal-fwied li jbassru tossiċità severa (li tilħaq il-liġi ta' Hy) u manifestazzjonijiet kliniċi ta' ħsara epatika severa ma kinux komuni b'inċidenza aktar baxxa minn 1% ta' sinjali u sintomi individwali li jinkludu suffejra, epatomegalija jew uġigħ fil-fwied.
English: Colony stimulating factors can be administered for haematologic toxicity according to local standard practice.
Maltese: Fatturi li jistimulaw il-kolonji jistgħu jingħataw għal tossiċità ematoloġika skont il-prattika standard lokali.
English: It is recommended to monitor patients for clinical cardiac signs or symptoms.
Maltese: Huwa rrakkomandat li l-pazjenti jiġu mmonitorjati għal sinjali jew sintomi kliniċi tal-qalb.
English: Fertility studies with trabectedin were not performed but limited histopathological changes were observed in the gonads in the repeat dose toxicity studies.
Maltese: Ma sarux studji fuq fertilità bi trabectedin iżda bidliet istopatoloġiċi ristretti kienu osservati fil-gonadi fl-istudji ta' tossiċità tad-dożi ripetuti.
English: Trabectedin has been shown to exert antiproliferative in vitro and in vivo activity against a range of human tumour cell lines and experimental tumours, including malignancies such as sarcoma, breast, non-small cell lung, ovarian and melanoma.
Maltese: tumur tal-bniedem, li jinkludu tumuri malinni sperimentali bħalma huma sarkoma, tas-sider, ta' ċelluli mhux żgħar tal-pulmun, tal-ovarju u melanoma.
English: Overall survival in platinum-sensitive population (Final analysis n=316 events) n=218
Maltese: Sopravivenza globali f'popolazzjoni sensittiva għall-platinum (Analiżi finali n=316-il avveniment)
English: Yondelis 1 mg: Each vial of powder contains 1 mg of trabectedin.
Maltese: Kunjett 1 fih 1 mg trabectedin
English: Trabectedin extravasation may cause tissue necrosis requiring debridement.
Maltese: trabectedin, peress li r-riskju ta' epatotossiċità jista' jiżdied.
English: For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m2 of body surface area.
Maltese: Għall-kura ta' sarkoma tat-tessut l-artab, id-doża li ġeneralment tingħata hi ta' 1.5 mg/m2 ta' erja superfiċjali tal-ġisem.
English: Trabectedin was administered as a 24-hour intravenous infusion every 21 days.
Maltese: Trabectedin ingħata bħala infużjoni ġol-vina ta' 24 siegħa kull 21 jum.
English: Hepatobiliary disorders
Maltese: Tromboċitopenija
English: To minimize the risk of PLD infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute.
Maltese: Biex jitnaqqas ir-riskju ta' reazzjonijiet għallinfużjoni ta' PLD, id-doża tal-bidu tingħata b'rata ta' mhux akar minn 1 mg/minuta.
English: • decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John's Wort (Hypericum perforatum, an herbal medicine for depression)) or
Maltese: • jitnaqqsu (pereżempju: mediċini li fihom rifampicin (għal infezzjonijiet bil-batterji),
English: Yondelis 1 mg powder for concentrate for solution for infusion.
Maltese: Yondelis 1 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed grade 3 elevations of AST and ALT in 12% and 20% of cycles respectively.
Maltese: L-analiżi ta' kull ċiklu li saret f'pazjenti kkurati b'korsijiet ta' monoterapija wriet żidiet ta' grad 3 ta' AST u ALT fi 12% u 20% taċ-ċikli rispettivament.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta tal-kunjett wara EXP.
English: If central venous access is not feasible and a peripheral venous line has to be used, add the reconstituted solution to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion).
Maltese: Jekk aċċess venuż ċentrali ma jkunx possibbli u tkun trid tintuża linja ġo` vina periferali, is-soluzzjoni rikostitwita għandha tiġi miżjuda ġo borża tal-infużjoni li fiha ≥ 1,000 ml ta' dilwent (soluzzjoni għallinfużjoni ta' sodium chloride 9 mg/ml (0.9%) jew soluzzjoni għall-infużjoni ta' glucose 50 mg/ml
English: Dyspnoea Cough
Maltese: Sogħla
English: Dose adjustments during treatment
Maltese: Sopravivenza Mingħajr Progressjoni
English: These trials evaluated a total of 100 patients with lipo- and leiomyosarcoma and 83 patients with other types of sarcoma.
Maltese: Dawn il-provi evalwaw total ta' 100 pazjent b'lipo- u lejomijosarkoma u 83 pazjent b'tipi oħra ta' sarkoma.
English: Chemical and physical stability has been demonstrated for 30 hours up to 25ºC.
Maltese: L-istabbilità kimika u fiżika baqgħet sa 30 siegħa f'temperatura sa 25ºC.
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin.
Maltese: Kunjett tal-ħġieġ bla kulur Tip I b'tapp tal-lastku butyl mgħotti b'siġill tal-aluminju flip-off li fih 0.25 mg ta' trabectedin.
English: Patients with elevated serum bilirubin levels must not be treated with trabectedin (see section 4.2).
Maltese: Pazjenti b'livelli ta' bilirubin fis serum għoljin m'għandhomx jiġu ttrattati b'trabectedin (ara sezzjoni 4.2).
English: Yondelis is a powder for concentrate for solution for infusion.
Maltese: Yondelis ma għandux jintuża matul tqala.
English: In this trial trabectedin was administered either at 1.5 mg/m2 as a 24-hour intravenous infusion every 3 weeks or at 0.58 mg/m2 weekly as a 3-hour intravenous infusion for 3-weeks of a 4-week cycle.
Maltese: F'din il-prova trabectedin ingħata jew f'1.5 mg/m2 bħala infużjoni ġol-vini ta' 24 siegħa kull 3 ġimgħat jew f'0.58 mg/m2 kull ġimgħa bħala infużjoni ġol-vini għal 3 ġimgħat fuq ċiklu ta' 4 ġimgħat.
English: Each carton contains 1 vial of either 0.25 mg or 1 mg of trabectedin.
Maltese: Kunjett 1 fih 0.25 mg trabectedin
English: Combination of trabectedin with phenytoin or live attenuated vaccines is not recommended and with yellow fever vaccine is specifically contraindicated (see section 4.3).
Maltese: Irġiel f'età fertili għandhom jużaw kontraċezzjoni effettiva waqt il-kura u 5 xhur wara l-kura (ara sezzjoni 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 1 mg vial
Maltese: Tikketta tal-kunjett - Kunjett ta' 1 mg
English: Independent radiology review, measurable disease *
Maltese: Analiżi radjoloġika indipendenti,
English: Potassium hydroxide (for pH-adjustment)
Maltese: phenobarbital (għal epilessija) jew St.
English: No data are available comparing Yondelis+PLD to a platinum-based regimen in platinum-sensitive patients.
Maltese: L-ebda tagħrif ma huwa disponibbli li jqabbel Yondelis+PLD ma' kors ibbażat fuq platinum f'pazjenti li għandhom rispons favorevoli għal platinum.
English: Two in vivo drug-drug interaction phase 1 studies have confirmed trends toward increased and decreased trabectedin exposures when administered with ketoconazole and rifampicin, respectively.
Maltese: Żewġ studji ta' fażi 1 ta' interazzjoni bejn mediċina u oħra in vivo kkonfermaw tendenzi għal espożizzjonijiet miżjudin jew imnaqqsa ta' trabectedin meta mogħtija ma' ketoconazole u rifampicin,
English: Renal toxicological findings were detected in multi-cycle toxicity studies conducted in monkeys.
Maltese: Proċeduri għal manipulazzjoni u rimi xieraq ta' prodotti mediċinali ċitotossiċi għandhom jiġu segwiti.
English: - if you are breast-feeding.
Maltese: Aħżen fi friġġ.
English: Studies including patients with renal insufficiency (creatinine clearance < 30 ml/min for the monotherapy, and < 60 ml/min for the combination regimen) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
Maltese: Ma sarux studji li inkludew pazjenti b'insuffiċjenza tal-kliewi (rata ta' tneħħija talkrejatinina < 30 ml/min għall-korsijiet ta' monoterapija, u < 60 ml/min għal terapija kombinata) ma sarux u għaldaqstant Yondelis m'għandux jintuża f'din il-popolazzjoni ta' pazjenti (ara sezzjoni 4.4).
English: Grade 4 elevations of AST and ALT occurred in 1% and 2% of cycles respectively.
Maltese: 2% taċ-ċikli rispettivament.
English: Women of childbearing potential must use effective contraception during treatment and 3 months thereafter, and immediately inform the treating physician if a pregnancy occurs (see section 5.3).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt il-perijodu ta' kura u sa 3 xhur wara t-trattament, u għandhom jinfurmaw lit-tabib kuranti immedjatament jekk ikun hemm tqala (ara s-sezzjoni 5.3).
English: NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion.
Maltese: Yondelis 0.25 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Pyrexia
Maltese: Newtropenija
English: 16 November 2015
Maltese: 16 ta' Novembru 2015
English: Posology Adults with normal renal function (GFR ≥ 90 mL/min)
Maltese: Pożoloġija Adulti b'funzjoni renali normali (GFR≥ 90 mL/min)
English: Ebymect with alcohol
Maltese: Ebymect u alkoħol
English: EU/1/15/1051/001 EU/1/15/1051/002 EU/1/15/1051/003 EU/1/15/1051/004 EU/1/15/1051/005
Maltese: EU/1/15/1051/001 EU/1/15/1051/002 EU/1/15/1051/003 EU/1/15/1051/004
English: • Metformin is contraindicated in patients with GFR of < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Maltese: • Metformin huwa kontraindikat f'pazjenti b'GFR ta' < 30 mL/min u għandu jintwaqqaf temporanjament jekk ikun hemm kundizzjonijiet li jbiddlu l-funzjoni renali (ara sezzjoni 4.3).
English: Ebymect 5 mg/850 mg film-coated tablets EU/1/15/1051/001 5 mg/850 mg 14 tablets EU/1/15/1051/002 5 mg/850 mg 28 tablets EU/1/15/1051/003 5 mg/850 mg 56 tablets EU/1/15/1051/004 5 mg/850 mg 60 tablets EU/1/15/1051/005 5 mg/850 mg 60 x 1 tablet (unit dose) EU/1/15/1051/006 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita EU/1/15/1051/001 5mg/850mg 14-il pillola EU/1/15/1051/002 5mg/850mg 28 pillola EU/1/15/1051/003 5mg/850mg 56 pillola EU/1/15/1051/004 5mg/850mg 60 pillola EU/1/15/1051/005 5mg/850mg 60 x 1 pillola (doża waħda)
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides -2.7 % versus -0.7 %.
Maltese: Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5 % kontra 0.0 %; kolesterol HDL 6.0 % kontra 2.7 %; kolesterol LDL 2.9 % kontra1.0 %; trigliċeridi -2.7 % kontra - 0.7 %.
English: Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
Maltese: Vulvovaginite, balanite u infezzjonijiet ġenitali relatati jinkludu, eż. it-termini ppreferuti predefiniti: infezzjoni mikotika vulvovaġinali, infezzjoni vaġinali, balanite, infezzjoni fungali ġenitali, kandidjażi vulvovaġinali, vulvovaginite, balanite candida, kandidjażi ġenitali, infezzjoni ġenitali, infezzjoni ġenitali fl-irġiel, infezzjoni fil-pene, vulvite, vaginite batterjali, axxessi vulvali.
English: Do not take Ebymect
Maltese: Tiħux Ebymect
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from Baseline Difference from Placebo c
Maltese: (95 % CI) Individwi (%) li kisbu: HbA1c < 7 % Aġġustat għal-linja bażi Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza minn Plaċebo c
English: In an add-on to metformin and a sulphonylurea study, up to 24 weeks, minor episodes of hypoglycaemia were reported in 12.8 % of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7 % of subjects who received placebo plus metformin and a sulphonylurea.
Maltese: F'żieda għal studju ta' metformin u sulphonylurea, sa 24 ġimgħa, ġew irrapportati episodji minuri ta' ipogliċemija fi 12.8 % tal-individwi li rċevew dapagliflozin 10 mg u metformin u sulphonylurea u fi 3.7 % tal-individwi li rċevew plaċebo u metformin u sulphonylurea.
English: • If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
Maltese: • Jekk il-funzjoni renali taqa' taħt GFR < 60 ml/min, il-kura għandha titwaqqaf.
English: The mean steady-state volume of distribution of dapagliflozin was 118 liters.
Maltese: Il-volum medju ta' distribuzzjoni fi stat fiss ta' dapagliflozin kien ta' 118-il litru.
English: Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day; Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Maltese: QD: darba kuljum; BID: darbtejn kuljum Metformin ≥ 1500 mg kuljum; Sitagliptin 100 mg kuljum LOCF: L-aħħar osservazzjoni (qabel is-salvataġġ fil-każ ta' pazjenti salvati) miġjuba 'l quddiem Studju fuq 16-il ġimgħa kkontrollat bi plaċebo L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju double-blind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra placebo + prodott mediċinali orali li jbaxxi l-glukożju Il-bidla perċentwali fil-piż tal-ġisem kienet analizzata bħala riżultat aħħari sekondarju ewlieni (p < 0.0001); il-bidla assoluta fil-piż tal-ġisem (f'kg) ġiet analizzata b'valur-p nominali (p < 0.0001).
English: Ebymect has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2).
Maltese: Intwera li Ebymect huwa bijoekwivalenti għal dapagliflozin u metformin amministrati flimkien (ara sezzjoni 5.2).
English: • if you are using certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Maltese: • jekk qed tuża ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tarriċetturi ta' angiotensin II).
English: EU/1/15/1051/009 5 mg/1000 mg 56 tablets EU/1/15/1051/010 5 mg/1000 mg 60 tablets EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Maltese: Ebymect 5 mg/1,000 mg pilloli miksijin b'rita EU/1/15/1051/007 5 mg/1000 mg 14-il pillola EU/1/15/1051/008 5 mg/1000 mg 28 pillola EU/1/15/1051/009 5 mg/1000 mg 56 pillola EU/1/15/1051/010 5 mg/1000 mg 60 pillola EU/1/15/1051/011 5 mg/1000 mg 60 x 1 pillola (doża waħda)
English: Ebymect 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Maltese: Ebymect 5 mg/1,000 mg pilloli dapagliflozin/metformin HCl
English: Ebymect combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Ebymect jgħaqqad żewġ prodotti mediċinali għal kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni differenti u kumplimentari biex itejjeb il-kontroll gliċemiku f'pazjenti bid-dijabete tat-tip 2: dapagliflozin, impeditur tal-kotrasportatur 2 tas-sodium-glucose (SGLT2), u metformin hydrochloride, membru talklassi biguanide.