FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: L-MAH għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni ta' Ġunju 2006 preżentata fit-Taqsima 1.8.1 ta' l-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq, qiegħda f'postha u tiffunzjona qabel ma l-prodott jitqiegħed fis-suq u waqt li l-prodott ikun fis-suq.
English: Patients who required thrombolysis or embolectomy or vena cava filter were excluded.
Maltese: Pazjenti li kellhom bżonn tromboliżi, embolektomija jew li jiddaħħal filter ġol-vena cava kienu esklużi.
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Maltese: OASIS 5 kien studju double-blind, mhux magħmul fuq bażi ta' xi għażla, u biex juri li m'hemmx inferjurità, bl-użu ta' 2.5 mg fondaparinux taħt il-ġilda darba kuljum kontra 1 mg/kg enoxaparin taħt il-ġilda darbtejn kuljum f'madwar 20,000 pazjent b'UA/NSTEMI.
English: In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine clearance ranging between 20 to 50 ml/min.
Maltese: Għall-ewwel injezzjoni b'Quixidar hu importanti li jkun hemm aderenza stretta mal-ħin f'pazjenti li jgħaddu minn kirurġija, li għandhom ≥ 75 sena, u/jew b'piż tal-ġisem < 50 kg u/jew indeboliment renali bi clearance tal-krejatinina ta' bejn 20 u 50 ml/min.
English: For patients with body weight < 50 kg, the recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg.
Maltese: Għal pazjenti b' piż ta' < 50 kg, id-doża rakkomandata hija ta' 5 mg.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorization Holder:
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq u l-Manifattur Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq:
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Maltese: Il-benefiċċji ta' mortalita' li ntwera fil grupp fondaparinux baqgħet hekk sa l-aħħar ta' l-insegwiment fil-180 jum.
English: Rare: rash erythematous
Maltese: Rari: raxx bi ħmura
English: NAME OF THE MEDICINAL PRODUCT Quixidar 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Maltese: Quixidar 7.5 mg/0.6 ml soluzzjoni għal injezzjoni.
English: Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).
Maltese: Quixidar huwa mediċina li tgħin biex tipprevjeni l-formazzjoni ta' għoqiedi tad-demm fil-vini u arterji (aġent antitrombotiku).
English: • bruising or swelling (oedema)
Maltese: JIS [xahar/sena]
English: Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Maltese: Komuni: fsada (ematoma, ematurja, emoptisis, fsada talħanek)
English: • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Maltese: • Tinjettax Quixidar ġo muskolu (b'mod intramuskolari).
English: Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Maltese: Quixidar hu mediċina li tittratta jew tghin biex tipprevjeni l-formazzjoni ta' għoqiedi tad-demm filvini u arterji (aġent antitrombotiku).
English: Usual dose
Maltese: Tqala u Treddigħ
English: The MAHs should provide within three months a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information adopted by the CHMP as part of the referral procedure EMEA/H/A-31/881.
Maltese: Il-MAHs għandhom jipprovdu protokoll iddettaljat (eż. studji ta' l-użu tal-mediċina jew stħarriġ magħmul permezz ta' konnessjoni ta' reġistrazzjonijiet) għas-segwiment fuq perjodu ta' żmien twil ta' l-adeżjoni ma' u l-effikaċja tal-bidliet għat-tagħrif dwar il-prodott adottati mis-CHMP bħala parti mill-proċedura ta' referenza EMEA/H/A-31/881.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
Maltese: ANNESS IV KUNDIZZJONIJIET TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: National Competent Authorities shall ensure that the following condition is fulfilled by the Marketing Authorisation Holders:
Maltese: Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza (RMS), għandhom jassiguraw li l-kundizzjoni li ġejja tiġi sodisfatta mid-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Erythema 2, Pruritus 2, Urticaria
Maltese: Eritema2, Prurite2, Urtikarja2
English: Subgroup analysis
Maltese: Analiżi ta' sottogrupp
English: System Organ Class Frequency
Maltese: Klassi tas-Sistemi u tal-Organi Frekwenza
English: See subsections below for additional information.
Maltese: Ara s-sottosezzjonijiet taħt għal informazzjoni addizzjonali. ‡
English: * See Section 4.4.
Maltese: * Ara Sezzjoni 4.4. †
English: Date of first authorisation: 23 March 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta 'Marzu 2018
English: Gastrointestinal symptoms
Maltese: Sintomi gastrointestinali§
English: CYP-mediated (oxidative) metabolism of ertugliflozin is minimal (12%).
Maltese: Il-metaboliżmu medjat minn CYP (ossidattiv) ta' ertugliflozin huwa minimu (12%).
English: Þ,1
Maltese: BUNà,1
English: • decreased vitamin B12 levels.
Maltese: Rari ħafna • tnaqqis fil-livelli tal-vitamina B12.
English: Liver function test abnormal 2, Hepatitis
Maltese: Riżultat mhux normali ta' test tal-funzjoni tal-fwied2, Epatite2
English: Segluromet is available in Alu/PVC/PA/Alu blisters.
Maltese: Segluromet huwa disponibbli f'folji tal-Alu/PVC/PA/Alu.
English: In in vitro studies, ertugliflozin and ertugliflozin glucuronides did not inhibit or inactivate CYPs 1A2, 2C9, 2C19, 2C8, 2B6, 2D6, or 3A4, and did not induce CYPs 1A2, 2B6, or 3A4.
Maltese: Fi studji in vitro, ertugliflozin u l-glukuronidi ta' ertugliflozin la inibixxew u lanqas inattivaw CYPs 1A2, 2C9, 2C19, 2C8, 2B6, 2D6, jew 3A4, u ma induċewx CYPs 1A2, 2B6, jew 3A4.
English: Hypoglycaemia (ertugliflozin)
Maltese: Ipogliċemija (ertugliflozin)
English: Patients [N (%)] with HbA1c < 7% 66 (26.4)
Maltese: Pazjenti [N (%)] b'HbA1c < 7% 66 (26.4) Piż tal-Ġisem (kg)
English: Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 ml/min)
Maltese: Adulti b'funzjoni normali tal-kliewi (rata ta' filtrazzjoni mill-glomeruli [eGFR, glomerular filtration rate] ≥ 90 ml/min)
English: Multipack: 196 (4 packs of 49) film-coated tablets
Maltese: Pakkett multiplu: 196 (4 packs of 49) pillola miksija b'rita
English: Necrotising fasciitis of the perineum (Fournier's gangrene)*
Maltese: Fasciitis nekrotika tal-perineum (Kankrena ta' Fournier)*
English: Sitagliptin 100 mg
Maltese: 100 mg
English: Ertugliflozin in combination with metformin
Maltese: Ertugliflozin u Metformin
English: Ertugliflozin is not a substrate of organic anion transporters (OAT1, OAT3), organic cation transporters (OCT1, OCT2), or organic anion transporting polypeptides (OATP1B1, OATP1B3) in vitro.
Maltese: Ertugliflozin mhuwiex sustrat tat-trasportaturi tal-anjoni organiċi (OAT1, OAT3, organic anion transporters), tat-trasportaturi tal-katjoni organiċi (OCT1, OCT2, organic cation transporters), jew tal-polypeptides li huma trasportaturi tal-anjoni organiċi (OATP1B1, OATP1B3, organic anion transporting polypeptides) in vitro.
English: • hepatitis (a liver problem)
Maltese: • epatite (problema fil-fwied)
English: There is limited experience with Segluromet in patients ≥ 75 years of age.
Maltese: Hemm esperjenza limitata b'Segluromet f'pazjenti li għandhom età ta' ≥ 75 sena.
English: In vitro assessment of ertugliflozin
Maltese: Valutazzjoni in vitro ta' ertugliflozin
English: Iron oxide red (E172)
Maltese: Iron oxide aħmar (E172)
English: Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily.
Maltese: Il-pazjenti rċevew ertugliflozin 5 mg (N=519), ertugliflozin 15-il mg (N=510), jew plaċebo (N=515) darba kuljum.
English: • Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
Maltese: • Inibituri ta' OCT2 (bħal cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) jistgħu jnaqqsu l-eliminazzjoni ta' metformin mill-kliewi u għalhekk iwasslu għal żieda fil-konċentrazzjoni ta' metformin fil-plażma.
English: Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were LDL-C 5.8% and 8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, HDL-C 6.2% and 7.6% versus 1.9%.
Maltese: Þ Bidliet perċentwali medji mil-linja bażi għal ertugliflozin 5 mg u 15-il mg versus plaċebo, rispettivament, kienu LDL-C 5.8% u 8.4% versus 3.2%; kolesterol totali 2.8% u 5.7% versus 1.1%; madankollu, HDL-C 6.2% u 7.6% versus 1.9%.
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.)
Maltese: (Għal riżultati tal-istudji dwar kombinazzjonijiet u effetti fuq il-kontroll gliċemiku, ara sezzjonijiet 4.4, 4.5, u 5.1.)
English: Efficacy in patients with baseline HbA1c ≥ 9%
Maltese: Effikaċja f'pazjenti b'HbA1c ≥ 9% fil-linja bażi
English: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)
Maltese: • Ertugliflozin jappartieni għall-grupp ta' mediċini msejħa inibituri tal-kotrasportatur 2 ta' sodium u glucose (SGLT2, sodium u glucose co-transporter-2).
English: No potential acute symptoms and signs of overdose were identified.
Maltese: Ma ġiet identifikata l-ebda possibiltà ta' sintomi u sinjali akuti ta' doża eċċessiva.
English: Pool of placebo-controlled trials
Maltese: Ġabra ta' provi kkontrollati bil-plaċebo
English: Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.
Maltese: Ertugliflozin huwa sustrat tat-trasportaturi tal-glikoproteina P (P-gp, P-glycoprotein) u tal-proteina ta'
English: • have had a lower limb amputation.
Maltese: • qatt kellek amputazzjoni fir-riġel.
English: A clinically relevant effect with other inducers (e.g., carbamazepine, phenytoin, phenobarbital) is not expected.
Maltese: M'huwiex mistenni effett rilevanti b'mod kliniku b'indutturi oħra (eż., carbamazepine, phenytoin, phenobarbital).
English: The mean daily dose of glimepiride was 3.0 mg (see Table 5).
Maltese: Iddoża medja ta' kuljum ta' glimepiride kienet 3.0 mg (ara Tabella 5).
English: See “Description of selected adverse reactions” for frequencies and see section 4.4.
Maltese: Ara “Deskrizzjoni ta' reazzjonijiet avversi magħżula” għallfrekwenzi u ara sezzjoni 4.4.
English: Some medicinal products can adversely affect renal function, which may increase the risk of lactic acidosis, e.g., NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: Kombinazzjonijiet li jeħtieġu prekawzjonijiet għall-użu Xi prodotti mediċinali jistgħu jaffettwaw il-funzjoni tal-kliewi b'mod avvers, li jista' jżid ir-riskju ta' aċidożi lattika, eż., NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri talenzima li tikkonverti angiotensin (ACE, angiotensin-converting enzyme), antagonisti tar-riċettur ta' angiotensin II u dijuretiċi, speċjalment dijuretiċi loop.
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separat.
English: • Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Maltese: • Indutturi ta' OCT1 (bħal rifampicin) jistgħu iżidu l-assorbiment gastrointestinali u l-effikaċja ta' metformin.
English: How to store Segluromet 6.
Maltese: Kif taħżen Segluromet 6.
English: Coadministration of simvastatin with ertugliflozin resulted in a 24% and 19% increase in AUC and Cmax of simvastatin, respectively, and 30% and 16% increase in AUC and Cmax of simvastatin acid,
Maltese: L-għoti ta' simvastatin flimkien ma' ertugliflozin wassal għal żieda ta' 24% u 19% fl-AUC u s-Cmax ta' simvastatin, rispettivament, u żieda ta' 30% u 16% fl-AUC u s-Cmax tal-aċidu ta' simvastatin, rispettivament.
English: Gastrointestinal disorders Very common
Maltese: Disturbi gastrointestinali Komuni ħafna
English: Across the clinical program for ertugliflozin, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients (see section 4.4).
Maltese: Matul il-programm kliniku għal ertugliflozin, ketoaċidożi ġiet identifikata fi 3 minn 3,409 (0.1%) pazjenti ttrattati b'ertugliflozin u 0.0% tal-pazjenti ttrattati b'sustanza ta' paragun (ara sezzjoni 4.4).
English: The absolute bioavailability of a metformin hydrochloride 500-mg tablet given under fasting conditions is approximately 50-60%.
Maltese: Il-bijodisponibbiltà assoluta ta' pillola ta' 500 mg metformin hydrochloride mogħtija f'kundizzjonijiet ta' sawm hija madwar 50-60%.
English: o Segluromet 2.5 mg/1,000 mg tablets and Segluromet 7.5 mg/1,000 mg tablets: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), carnauba wax (E903).
Maltese: o Pilloli Segluromet 2.5 mg/1,000 mg u pilloli Segluromet 7.5 mg/1,000 mg: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide aħmar (E172), carnauba wax (E903).
English: Segluromet with alcohol
Maltese: Segluromet ma' alkoħol
English: - severe renal failure (GFR less than 30 ml/min), end-stage renal disease (ESRD), or patients on dialysis (see section 4.4); - acute condition with the potential to alter renal function, such as: dehydration, severe infection, shock; - acute or chronic disease that may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment; - acute alcohol intoxication, alcoholism.
Maltese: - stat ta' qabel koma tad-dijabete; - insuffiċjenza severa tal-kliewi (GFR anqas minn 30 ml/min), marda tal-kliewi fl-aħħar stadju (ESRD, end-stage renal disease), jew pazjenti fuq id-dijalisi (ara sezzjoni 4.4); - kondizzjoni akuta bil-possibbiltà li tbiddel il-funzjoni tal-kliewi, bħal: deidratazzjoni, infezzjoni severa, xokk; - mard akut jew kroniku li jista' jikkaġuna ipoksja tat-tessut, bħal: insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku riċenti, xokk; - indeboliment tal-fwied; - intossikazzjoni akuta bl-alkoħol, alkoħoliżmu.
English: • The other ingredients are: o Tablet core: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulfate (E487), magnesium stearate (E470b).
Maltese: o Qalba tal-pillola: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulfate (E487), magnesium stearate (E470b).
English: These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks.
Maltese: Din id-data tirrifletti esponiment ta' 1,029 pazjent għal ertugliflozin b'tul medju ta' esponiment ta' madwar 25 ġimgħa.
English: • Film coating: o Segluromet 2.5 mg/850 mg tablets and Segluromet 7.5 mg/850 mg tablets: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).
Maltese: o Pilloli Segluromet 2.5 mg/850 mg u pilloli Segluromet 7.5 mg/850 mg: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide aħmar (E172), iron oxide isfar (E172), iron oxide iswed (E172), carnauba wax (E903).
English: 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), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Includes: thirst and polydipsia.
Maltese: Jinkludi: għatx u polidipsja.
English: • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
Maltese: • f'pazjenti li diġà qed jiġu ttrattati bil-kombinazzjoni ta' ertugliflozin u metformin bħala pilloli separati.
English: Discontinue when GFR is persistently less than 45 ml/min.
Maltese: Waqqaf meta l-GFR tkun b'mod persistenti anqas minn 45 ml/min.
English: 30x1 film-coated tablets
Maltese: 30x1 pillola miksija b'rita
English: For ertugliflozin 5 mg and 15 mg, respectively, the placebo-corrected reductions in FPG were 1.92 and 2.44 mmol/l as monotherapy, 1.48 and 2.12 mmol/l as add-on to metformin, and 1.40 and 1.74 mmol/l as add-on to metformin and sitagliptin.
Maltese: Għal ertugliflozin 5 mg u 15-il mg, rispettivament, it-tnaqqis fl-FPG ikkoreġut mill-plaċebo kien 1.92 u 2.44 mmol/l meta mogħti bħala monoterapija, 1.48 u 2.12 mmol/l meta mogħti flimkien ma' metformin, u 1.40 u 1.74 mmol/l meta mogħti flimkien ma' metformin u sitagliptin.
English: • Metformin belongs to a group of medicines called biguanides.
Maltese: • Metformin jappartieni għall-grupp ta' mediċini msejħa biguanides.
English: As add-on to metformin, ertugliflozin 5 mg and 15 mg resulted in statistically significant placebo-corrected reductions in SBP of 3.7 mmHg and 4.5 mmHg, respectively.
Maltese: Bħala terapija miżjuda ma' metformin, ertugliflozin 5 mg u 15-il mg wassal għal tnaqqis sinifikanti b'mod statistiku kkoreġut bil-plaċebo fl-SBP ta' 3.7 mmHg u 4.5 mmHg, rispettivament.
English: Diabetic ketoacidosis*
Maltese: [DKA, diabetic ketoacidosis]);
English: The pack sizes are 14, 28, 56, 60, 168, and 180 film-coated tablets in non-perforated blisters, multipack containing 196 (4 packs of 49) film coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters.
Maltese: Id-daqsijiet tal-pakketti huma 14, 28, 56, 60, 168, u 180 pillola miksija b'rita f'folji mingħajr sarbut toqob, pakkett multiplu li fih 196 (4 pakketti ta' 49) pillola miksija b'rita f'folji mingħajr sarbut toqob u 30x1 pillola miksija b'rita f'folji mtaqbin b'sarbut toqob biex tinqata' doża waħda.
English: Ertugliflozin 5 mg Ertugliflozin 15 mg
Maltese: Ertugliflozin 5 mg Ertugliflozin 15-il mg
English: Hepatic impairment Segluromet is contraindicated in patients with hepatic impairment (see sections 4.3 and 4.4).
Maltese: Segluromet huwa kontraindikat f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.3 u 4.4).
English: Packs of 14, 28, 56, 60, 168, and 180 film-coated tablets in non-perforated blisters and multipacks containing 196 (4 packs of 49) film-coated tablets in non-perforated blisters.
Maltese: Pakketti ta' 14, 28, 56, 60, 168, u 180 pillola miksija b'rita f'folji mingħajr sarbut toqob u pakketti multipli li fihom 196 (4 pakketti ta'49) pillola miksija b'rita f'folji mingħajr sarbut toqob.
English: • have kidney problems.
Maltese: • għandek problemi fil-kliewi.
English: In three placebo-controlled studies, ertugliflozin resulted in statistically significant reductions in FPG.
Maltese: Fi tliet studji kkontrollati bil-plaċebo, ertugliflozin wassal għal tnaqqis sinifikanti b'mod statistiku flFPG.
English: Effects of other medicinal products on the pharmacokinetics of ertugliflozin Metabolism by UGT1A9 and UGT2B7 is the primary clearance mechanism for ertugliflozin.
Maltese: Effetti ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' ertugliflozin Il-metaboliżmu permezz ta' UGT1A9 u UGT2B7 huwa l-mekkaniżmu primarju ta' tneħħija għal ertugliflozin.
English: In patients with moderate renal impairment taking insulins, SU, or meglitinides as background medication, documented hypoglycaemia was 36%, 27% and 36% for ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively (see sections 4.2, 4.4, and 4.5).
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi li kienu qed jieħdu insulini, SU, jew meglitinides bħala mediċina fl-isfond, l-ipogliċemija dokumentata kienet 36%, 27% u 36% għal ertugliflozin 5 mg, ertugliflozin 15-il mg, u plaċebo, rispettivament (ara sezzjonijiet 4.2, 4.4, u 4.5).
English: Most toxicity was consistent with pharmacology related to urinary glucose loss and included decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism, gluconeogenesis and electrolyte imbalances, and urinary changes such as polyuria, glucosuria, and calciuria.
Maltese: Il-biċċa l-kbira tat-tossiċità kienet konsistenti ma' farmakoloġija marbuta mat-telf tal-glucose fl-awrina u kienet tinkludi tnaqqis fil-piż u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidratazzjoni, tnaqqis fil-glucose fis-serum u żidiet f'parametri oħra tas-serum li jirriflettu żieda fil-metaboliżmu tal-proteina, glukoneoġenesi u żbilanċ fl-elettroliti, u bidliet fl-awrina bħal poliurja, glukosurja, u kalċjurja.
English: In controlled clinical studies of metformin in patients with type 2 diabetes, the antihyperglycaemic effect was comparable in Whites (n=249), Blacks (n=51), and Hispanics (n=24).
Maltese: Fi studji kliniċi kkontrollati ta' metformin f'pazjenti b'dijabete tat-tip 2, l-effett antiipergliċemiku kien kumparabbli fil-Bojod (n=249), fis-Suwed (n=51), u fl-Ispaniċi (n=24).
English: Segluromet contains two active substances, ertugliflozin and metformin.
Maltese: Segluromet fih żewġ sustanzi attivi, ertugliflozin u metformin.
English: The steady state mean plasma AUC and Cmax were 398 ng∙hr/ml and 81 ng/ml, respectively, with 5 mg ertugliflozin once daily treatment, and 1,193 ng∙hr/ml and 268 ng/ml, respectively, with 15 mg ertugliflozin once daily treatment.
Maltese: Ilmedja tal-AUC u tas-Cmax fil-plażma fi stat fiss kienu 398 ng∙siegħa/ml u 81 ng/ml, rispettivament, bi trattament b'5 mg ertugliflozin darba kuljum, u 1,193 ng∙siegħa/ml u 268 ng/ml, rispettivament, bi trattament bi 15-il mg ertugliflozin darba kuljum.
English: Ertugliflozin or ertugliflozin glucuronides do not meaningfully inhibit P-gp, OCT2, OAT1, or OAT3 transporters or transporting polypeptides OATP1B1 and OATP1B3 at clinically relevant concentrations in vitro.
Maltese: Ertugliflozin jew il-glukuronidi ta' ertugliflozin ma jinibixxux b'mod sinifikanti lit-trasportaturi P-gp, OCT2, OAT1, jew OAT3 jew lill-polypeptides trasportaturi OATP1B1 u OATP1B3 f'konċentrazzjonijiet rilevanti b'mod kliniku in vitro.
English: Segluromet is expected to have diminished efficacy in elderly patients with renal impairment (see sections 4.2 and 4.8).
Maltese: Segluromet huwa mistenni li jkollu effikaċja mnaqqsa f'pazjenti anzjani b'indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.8).
English: In females, discontinuation due to genital mycotic infections occurred in 0.6% and 0% of patients treated with ertugliflozin and placebo, respectively (see section 4.4).
Maltese: Fin-nisa t-twaqqif minħabba infezzjonijiet mikotiċi fil-ġenitali seħħ f'0.6% u 0% tal-pazjenti ttrattati b'ertugliflozin u plaċebo, rispettivament (ara sezzjoni 4.4).
English: , Haemoglobin increased ß,1
Maltese: Ipogiċemija*,†,1
English: Glucocorticoids (given by systemic and local routes), beta 2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (mogħtija mir-rotot sistemiċi u lokali), agonisti ta' beta 2, u dijuretiċi minnhom infushom għandhom attività iperġliċemika.