FrancophonIA/ELRC3.0 huggingface dataset:
English: At a maternally toxic dose in rats (250 mg/kg/day), lower foetal viability and a higher incidence of a visceral malformation were observed at maternal exposure that was 510 times the maximum clinical dose of 15 mg/day.
Maltese: B'doża tossika għall-omm fil-firien (250 mg/kg/jum), kienu osservati vijabilità inqas tal-fetu u inċidenza ogħla ta' formazzjoni ħażina fil-vixxri b'esponiment tal-omm li kien 510 drabi akbar mill-ogħla doża klinika ta' 15-il mg/jum.
English: Ertugliflozin as add-on combination therapy with metformin A total of 621 patients with type 2 diabetes inadequately controlled on metformin monotherapy (≥ 1,500 mg/day) participated in a randomised, double-blind, multi-centre, 26-week, placebocontrolled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin.
Maltese: Ertugliflozin bħala terapija miżjuda flimkien ma' metformin Total ta' 621 pazjent b'dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'monoterapija ta' metformin (≥ 1,500 mg/jum) ipparteċipaw fi studju ta' 26 ġimgħa, arbitrarju, b'ħafna ċentri, ikkontrollat bil-plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin flimkien ma' metformin.
English: In the subgroup analyses in the broader pool of Phase 3 studies, subjects with eGFR < 60 mL/min/1.73 m2, subjects ≥ 65 years of age and subjects on diuretics had a higher incidence of volume depletion in the ertugliflozin groups relative to the comparator group (see sections 4.2 and 4.4).
Maltese: Fl-analiżi tas-sottogruppi fil-ġabra akbar ta' studji ta' Fażi 3, individwi b'eGFR < 60 mL/min/1.73 m2, individwi b'età ≥ 65 sena u individwi fuq id-dijuretiċi kellhom inċidenza ogħla ta' tnaqqis fil-volum fil-gruppi ta' ertugliflozin meta mqabbla mal-grupp ta' paragun (ara sezzjonijiet 4.2 u 4.4).
English: Ertugliflozin was not mutagenic or clastogenic with or without metabolic activation in the microbial reverse mutation, in vitro cytogenetic (human lymphocytes), and in vivo rat micronucleus assays.
Maltese: Ertugliflozin ma kienx mutaġeniku jew klastoġeniku b'attivazzjoni metabolika jew mingħajrha flanaliżi tal-mutazzjoni bil-maqlub tal-mikrobi, fl-analiżi ċitoġenika in vitro (limfoċiti umani), u flanaliżi tal-mikronukleju tal-ġurdien in vivo.
English: Initiation is not recommended in patients with a glomerular filtration rate less than 60 ml/min (see section 4.4).
Maltese: Il-bidu tiegħu mhuwiex rakkomandat f'pazjenti b'rata ta' filtrazzjoni mill-glomeruli anqas minn 60 ml/min (ara sezzjoni 4.4).
English: o Each Segluromet 2.5 mg/850 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Maltese: o Kull pillola miksija b'rita ta' Segluromet 2.5 mg/850 mg fiha 2.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg ta' metformin hydrochloride.
English: • Segluromet 2.5 mg/1,000 mg film-coated tablets (tablets) are pink, 19.1 x 10.6 mm oval, film-coated tablets debossed with “2.5/1000” on one side and plain on the other side.
Maltese: • Il-pilloli miksija b'rita (pilloli) Segluromet 2.5 mg/1,000 mg huma pilloli roża, ovali, 19.1 x 10.6 mm, miksija b'rita, imnaqqxa b'“2.5/1000” fuq naħa waħda u mingħajr marki fuq in-naħa l-oħra.
English: Food had no meaningful effect on AUCinf of ertugliflozin or metformin, but reduced mean ertugliflozin Cmax by approximately 41% and metformin Cmax by approximately 29% compared to the fasted condition.
Maltese: L-ikel ma' kellu l-ebda effett ta' sinifikat fuq l-AUCinf ta' ertugliflozin jew metformin, iżda naqqas ilmedja tas-Cmax ta' ertugliflozin b'madwar 41% u s-Cmax ta' metformin b'madwar 29% meta mqabbel ma' kundizzjoni ta' sawm.
English: Effects of age, body weight, gender and race
Maltese: Effetti tal-età, tal-piż tal-ġisem, tas-sess tal-persuna u tar-razza
English: • Ertugliflozin works by blocking the SGLT2 protein in your kidneys.
Maltese: • Ertugliflozin jaħdem billi jimblokka l-proteina SGLT2 fil-kliewi tiegħek.
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/850 mg
Maltese: KARTUNA TAN-NOFS MINGĦAJR IL-KAXXA Ċ-ĊELESTI - PAKKETTI MULTIPLISEGLUROMET 2.5 mg/850 mg
English: Factorial study with ertugliflozin and sitagliptin as add-on combination therapy with metformin A total of 1,233 patients with type 2 diabetes participated in a randomised, double-blind, multi-centre, 26-week, active-controlled study to evaluate the efficacy and safety of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg compared to the individual components.
Maltese: Total ta' 1,233 pazjent b'dijabete tat-tip 2 ipparteċipaw fi studju ta' 26 ġimgħa, arbitrarju, b'ħafna ċentri, ikkontrollat b'mod attiv, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin 5 mg jew 15-il mg flimkien ma' sitagliptin 100 mg imqabbel mal-komponenti individwali.
English: A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).
Maltese: Infezzjoni serja tat-tessut artab tal-ġenitali jew taż-żona bejn il-ġenitali u l-anus (ara s-sezzjoni “Twissijiet u prekawzjonijiet” għas-sintomi.
English: Segluromet 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Maltese: Segluromet 2.5 mg/1,000 mg pilloli miksija b'rita Kull pillola fiha 2.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 1,000 mg ta' metformin hydrochloride.
English: The most commonly reported adverse reactions across the clinical program were vulvovaginal mycotic infection, and other female genital mycotic infections.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni matul il-programm kliniku kollu kienu, infezzjoni mikotika fil-vulva u l-vaġina, u infezzjonijiet mikotiċi oħra fil-ġenitali tan-nisa.
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Maltese: Fatturi oħra ta' riskju għal aċidożi lattika huma konsum eċċessiv ta' alkoħol, insuffiċjenza tal-fwied, dijabete mhix ikkontrollata b'mod adegwat, ketosi, sawm fit-tul u kwalunkwe kondizzjonijiet assoċjati ma' ipoksja, kif ukoll l-użu fl-istess waqt ta' prodotti mediċinali li jistgħu jikkawżaw aċidożi lattika (ara sezzjonijiet 4.3 u 4.5).
English: Elderly patients may be at an increased risk of volume depletion.
Maltese: Pazjenti anzjani jistgħu jkunu f'riskju akbar ta' tnaqqis fil-volum.
English: MSD Polska Sp. z o.o.
Maltese: MSD Finland Oy
English: Volume depletion (ertugliflozin)
Maltese: Tnaqqis fil-volum (ertugliflozin)
English: In males, discontinuations due to genital mycotic infections occurred in 0.2% and 0% of patients treated with ertugliflozin and placebo, respectively.
Maltese: Fl-irġiel, it-twaqqif minħabba infezzjonijiet mikotiċi fil-ġenitali seħħ f'0.2% u 0% tal-pazjenti ttrattati b'ertugliflozin u bil-plaċebo, rispettivament.
English: As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Maltese: Bħala miżuri ta' prekawzjoni għandu jitqies li pazjenti b'riskju akbar ta' avvenimenti ta' amputazzjoni jiġu mmonitorjati b'attenzjoni u jingħataw pariri professjonali dwar l-importanza ta' kura ta' prevenzjoni tas-saqajn bħala rutina u li jżommu idratazzjoni adegwata.
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 2.5 mg/1000 mg
Maltese: KARTUNA TAN-NOFS MINGĦAJR IL-KAXXA Ċ-ĊELESTI - PAKKETTI MULTIPLISEGLUROMET 2.5 mg/1000 mg
English: Some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower limb amputation (mainly of the toe).
Maltese: Xi studji jindikaw li t-teħid ta' ertugliflozin jista' jkun li kkontribwixxa għal żieda fil-każijiet ta' amputazzjoni fir-riġel (l-aktar ta' saba tas-sieq).
English: Beige, 18 x 10 mm oval, film-coated tablet debossed with “2.5/850” on one side and plain on the other side.
Maltese: Pillola miksija b'rita, kannella fl-isfar, ovali, 18 x 10 mm, imnaqqxa b'“2.5/850” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: • Segluromet 2.5 mg/850 mg film-coated tablets (tablets) are beige, 18 x 10 mm oval, film-coated tablets debossed with “2.5/850” on one side and plain on the other side.
Maltese: • Il-pilloli miksija b'rita (pilloli) Segluromet 2.5 mg/850 mg huma pilloli kannella fl-isfar, ovali, 18 x 10 mm, miksija b'rita, imnaqqxa b'“2.5/850” fuq naħa waħda u mingħajr marki fuq innaħa l-oħra.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maltese: Data limitata minn provi kliniċi tissuġġerixxi li DKA sseħħ bi frekwenza komuni meta pazjenti b'dijabete tat-tip 1 jiġu ttrattati b'inibituri ta' SGLT2.
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/850 mg
Maltese: KARTUNA TAN-NOFS MINGĦAJR IL-KAXXA Ċ-ĊELESTI - PAKKETTI MULTIPLISEGLUROMET 7.5 mg/850 mg
English: The no-observed-effect level (NOEL) for neoplasia was 5 mg/kg/day (approximately 16 times human unbound exposure at the MRHD of 15 mg/day).
Maltese: Il-livell fejn ma ġie osservat l-ebda effett (NOEL, no-observed-effect level) għal neoplasja kien 5 mg/kg/jum (madwar 16-il darba aktar mill-esponiment għall-mediċina mhux marbuta fil-bniedem b'MRHD ta' 15-il mg/jum).
English: Initiation of this medicinal product is not recommended in patients with a GFR less than 60 ml/min (see section 4.4).
Maltese: Dan il-prodott mediċinali mhuwiex rakkomandat li jinbeda f'pazjenti b'GFR inqas minn 60 ml/min (ara sezzjoni 4.4).
English: INTERMEDIATE CARTON WITHOUT BLUE BOX - MULTIPACKS - SEGLUROMET 7.5 mg/1000 mg
Maltese: KARTUNA TAN-NOFS MINGĦAJR IL-KAXXA Ċ-ĊELESTI - PAKKETTI MULTIPLISEGLUROMET 7.5 mg/1000 mg
English: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analysed according to gender.
Maltese: Il-parametri farmakokinetiċi ta' metformin ma varjawx b'mod sinifikanti bejn individwi normali u pazjenti b'dijabete tat-tip 2 meta ġew analizzati skont is-sess tal-persuna.
English: Insulin and insulin secretagogues
Maltese: L-insulina u s-sustanzi li jikkawżaw it-tnixxija tal-insulina
English: A total of 1,326 patients with type 2 diabetes inadequately controlled on metformin monotherapy participated in a randomised, double-blind, multi-centre, 52-week, active comparator-controlled study to evaluate the efficacy and safety of ertugliflozin in combination with metformin.
Maltese: Total ta' 1,326 pazjent b'dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'monoterapija ta' metformin ipparteċipaw fi studju ta' 52 ġimgħa, arbitrarju, b'ħafna ċentri, ikkontrollat b'sustanza attiva ta' paragun, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin flimkien ma' metformin.
English: These increases in ertugliflozin AUC are not considered clinically relevant.
Maltese: Dan it-tnaqqis flesponiment għal ertugliflozin mhux meqjus li għandu importanza klinika.
English: Coadministration of metformin with
Maltese: metformin waħdu
English: Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha 7.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg metformin hydrochloride.
English: Hypoglycaemia with concomitant use of insulin and insulin secretagogues Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue, which are known to cause hypoglycaemia (see section 4.8).
Maltese: Ipogliċemija b'użu flimkien mal-insulina u ma' sustanzi li jikkawżaw it-tnixxija tal-insulina Ertugliflozin jista' jżid ir-riskju ta' ipogliċemija meta jintuża flimkien mal-insulina u/jew ma' sustanza li tikkawża t-tnixxija tal-insulina, li huma magħrufa li jikkawżaw l-ipogliċemija (ara sezzjoni 4.8).
English: Determination of foetal concentrations demonstrated a partial placental barrier to metformin.
Maltese: Id-determinazzjoni talkonċentrazzjonijiet fil-fetu uriet li l-plaċenta twaqqaf metformin b'mod parzjali.
English: , Vitamin B12 deficiency
Maltese: A10BD23.
English: EU/1/18/1265/008 (14 film-coated tablets) EU/1/18/1265/009 (28 film-coated tablets) EU/1/18/1265/010 (30x1 film-coated tablets) EU/1/18/1265/011 (56 film-coated tablets) EU/1/18/1265/012 (60 film-coated tablets) EU/1/18/1265/013 (168 film-coated tablets) EU/1/18/1265/014 (180 film-coated tablets) EU/1/18/1265/030 (196 (4 x 49) film-coated tablets)
Maltese: EU/1/18/1265/008 (14-il pillola miksija b'rita) EU/1/18/1265/009 (28 pillola miksija b'rita) EU/1/18/1265/010 (30x1 pillola miksija b'rita) EU/1/18/1265/011 (56 pillola miksija b'rita) EU/1/18/1265/012 (60 pillola miksija b'rita) EU/1/18/1265/013 (168 pillola miksija b'rita) EU/1/18/1265/014 (180 pillola miksija b'rita) EU/1/18/1265/030 (196 (4
English: o Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Maltese: o Kull pillola miksija b'rita ta' Segluromet 7.5 mg/1,000 mg fiha 7.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 1,000 mg ta' metformin hydrochloride.
English: In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Maltese: F'każijiet rari, ġiet irrappurtata fimosis u xi drabi saret ċirkonċiżjoni (ara sezzjoni 4.4).
English: Administration of ertugliflozin with a high-fat and high-calorie meal decreases ertugliflozin Cmax by 29% and prolongs Tmax by 1 hour, but does not alter AUC as compared with the fasted state.
Maltese: L-għoti ta' ertugliflozin ma' ikla b'ammont għoli ta' xaħam u ta' kaloriji jnaqqas is-Cmax ta' ertugliflozin b'29% u jtawwal it-Tmax b'siegħa, iżda ma jibdlix l-AUC meta mqabbel mal-istat ta' sawm.
English: EU/1/18/1265/022 (14 film-coated tablets) EU/1/18/1265/023 (28 film-coated tablets) EU/1/18/1265/024 (30x1 film-coated tablets) EU/1/18/1265/025 (56 film-coated tablets) EU/1/18/1265/026 (60 film-coated tablets) EU/1/18/1265/027 (168 film-coated tablets) EU/1/18/1265/028 (180 film-coated tablets) EU/1/18/1265/032 (196 (4 x 49) film-coated tablets)
Maltese: EU/1/18/1265/022 (14-il pillola miksija b'rita) EU/1/18/1265/023 (28 pillola miksija b'rita) EU/1/18/1265/024 (30x1 pillola miksija b'rita) EU/1/18/1265/025 (56 pillola miksija b'rita) EU/1/18/1265/026 (60 pillola miksija b'rita) EU/1/18/1265/027 (168 pillola miksija b'rita) EU/1/18/1265/028 (180 pillola miksija b'rita) EU/1/18/1265/032 (196 (4
English: Packs of 30x1 film-coated tablets in perforated unit dose blisters.
Maltese: Pakketti ta' 30x1 pillola miksija b'rita f'folji b'sarbut toqob biex tinqata' doża waħda.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Maltese: It-terapija tista' terġa' tinbeda mill-ġdid mhux qabel 48 siegħa wara l-kirurġija jew wara li tinbeda nutrizzjoni orali mill-ġdid u bil-kundizzjoni li l-funzjoni tal-kliewi tkun ġiet evalwata millġdid u nstabet li hija stabbli.
English: • Segluromet 7.5 mg/1,000 mg film-coated tablets (tablets) are red, 19.1 x 10.6 mm oval, film-coated tablets debossed with “7.5/1000” on one side and plain on the other side.
Maltese: Segluromet 7.5 mg/1,000 mg pilloli miksija b'rita Pillola miksija b'rita, ħamra, ovali, 19.1 x 10.6 mm, imnaqqxa b'“7.5/1000” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Each tablet contains 7.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 7.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 1,000 mg metformin hydrochloride.
English: EU/1/18/1265/001 (14 film-coated tablets) EU/1/18/1265/002 (28 film-coated tablets) EU/1/18/1265/003 (30x1 film-coated tablets) EU/1/18/1265/004 (56 film-coated tablets) EU/1/18/1265/005 (60 film-coated tablets) EU/1/18/1265/006 (168 film-coated tablets) EU/1/18/1265/007 (180 film-coated tablets) EU/1/18/1265/029 (196 (4 x 49) film-coated tablets)
Maltese: EU/1/18/1265/001 (14-il pillola miksija b'rita) EU/1/18/1265/002 (28 pillola miksija b'rita) EU/1/18/1265/003 (30x1 pillola miksija b'rita) EU/1/18/1265/004 (56 pillola miksija b'rita) EU/1/18/1265/005 (60 pillola miksija b'rita) EU/1/18/1265/006 (168 pillola miksija b'rita) EU/1/18/1265/007 (180 pillola miksija b'rita) EU/1/18/1265/029 (196 (4
English: Ertugliflozin 5 mg Ertugliflozin 15 mg Glimepiride
Maltese: Ertugliflozin 15-il mg + Sitagliptin
English: You may be more likely to get dehydrated if you:
Maltese: Huwa aktar probabbli li tiġi deidratat/a jekk inti:
English: • vaginal yeast infection (thrush)
Maltese: • tħossok imdardar/ra (nawsja)
English: EU/1/18/1265/015 (14 film-coated tablets) EU/1/18/1265/016 (28 film-coated tablets) EU/1/18/1265/017 (30x1 film-coated tablets) EU/1/18/1265/018 (56 film-coated tablets) EU/1/18/1265/019 (60 film-coated tablets) EU/1/18/1265/020 (168 film-coated tablets) EU/1/18/1265/021 (180 film-coated tablets) EU/1/18/1265/031 (196 (4 x 49) film-coated tablets)
Maltese: EU/1/18/1265/015 (14-il pillola miksija b'rita) EU/1/18/1265/016 (28 pillola miksija b'rita) EU/1/18/1265/017 (30x1 pillola miksija b'rita) EU/1/18/1265/018 (56 pillola miksija b'rita) EU/1/18/1265/019 (60 pillola miksija b'rita) EU/1/18/1265/020 (168 pillola miksija b'rita) EU/1/18/1265/021 (180 pillola miksija b'rita) EU/1/18/1265/031 (196 (4
English: 49 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 49 pillola miksija b'rita.
English: Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg ta' metformin hydrochloride.
English: Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.
Maltese: In-nuqqas ta' inferjorità jiġi ddikjarat meta l-upper bound tal-intervall ta' kunfidenza (CI, confidence interval) two-sided ta' 95% għad-differenza medja jkun inqas minn 0.3%. § p< 0.001 imqabbel ma' glimepiride.
English: Following administration of an oral C]-ertugliflozin solution to healthy subjects, approximately 41% and 50% of the drug-related radioactivity was eliminated in faeces and urine, respectively.
Maltese: Wara l-għoti ta' soluzzjoni ta' ertugliflozin [14C] mill-ħalq lil individwi f'saħħithom, madwar 41% u 50% tar-radjuattività marbuta mal-mediċina ġiet eliminata fl-ippurgar u fl-awrina, rispettivament.
English: Unlike sulphonylureas, metformin does not produce hypoglycaemia in either patients with type 2 diabetes or normal subjects, except in special circumstances (see section 4.5), and does not cause hyperinsulinaemia.
Maltese: B'differenza mis-sulphonylureas, metformin ma jipproduċix ipogliċemija la f'pazjenti b'dijabete tat-tip 2 u lanqas f'individwi normali, ħlief f'ċirkostanzi speċjali (ara sezzjoni 4.5), u ma jikkawżax iperinsulinemija.
English: o Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.
Maltese: o Kull pillola miksija b'rita ta' Segluromet 2.5 mg/1,000 mg fiha 2.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 1,000 mg ta' metformin hydrochloride.
English: Dysuria
Maltese: Pożoloġija
English: Metformin did not adversely affect developmental outcomes when administered to rats and rabbits at doses up to 600 mg/kg/day.
Maltese: Metformin ma affettwax b'mod avvers ir-riżultati tal-iżvilupp meta ngħata lill-firien u lill-fniek b'dożi sa 600 mg/kg/jum.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD23.
Maltese: Mediċini li jintużaw fid-dijabete, kombinazzjonijiet ta' mediċini li jbaxxu l-glucose fid-demm li jittieħdu mill-ħalq, Kodiċi ATC:
English: In an ongoing clinical study of ertugliflozin added to existing therapy in type 2 diabetes patients with a history of established cardiovascular disease, an approximately 1.2-1.6-fold increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with ertugliflozin.
Maltese: Fi studju kliniku li għadu għaddej ta' ertugliflozin miżjud ma' terapija eżistenti f'pazjenti bid-dijabete tat-tip 2 bi storja ta' mard kardjovaskulari stabbilit, ġiet osservata żieda ta' madwar 1.2-1.6 drabi filkażijiet ta' amputazzjoni fir-riġel (l-aktar ta' saba' tas-sieq), f'pazjenti ttrattati b'ertugliflozin.
English: • muscle cramps
Maltese: • ħalq xott
English: Based on a population pharmacokinetic analysis, age, body weight, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of ertugliflozin.
Maltese: Abbażi ta' analiżi farmakokinetika ta' popolazzjoni, l-età, il-piż tal-ġisem, is-sess tal-persuna u r-razza m'għandhom l-ebda effett important b'mod kliniku fuq il-farmakokinetika ta' ertugliflozin.
English: Pharmacologically mediated effects were observed in juvenile rats treated with ertugliflozin (see section 5.3).
Maltese: Ma kienu osservati l-ebda effetti ta' ertugliflozin jew metformin fuq il-fertilità fi studji fl-annimali (ara sezzjoni 5.3).
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people) Segluromet may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: Aċidożi lattika (rari ħafna, tista' taffettwa sa persuna 1 minn kull 10,000 persuna) Segluromet jista' jikkawża effett sekondarju rari ħafna, iżda serju ħafna imsejjaħ aċidożi lattika (ara sezzjoni “Twissijiet u prekawzjonijiet”).
English: What you need to know before you take Segluromet 3.
Maltese: X'għandek tkun taf qabel ma tieħu Segluromet 3.
English: Vulvovaginal mycotic infection and other female genital mycotic infections*
Maltese: Infezzjoni mikotika fil-vulva u fil-vaġina u infezzjonijiet mikotiċi oħra fil-ġenitali tan-nisa*,†,1
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue, or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi tad-dijabete għandu jitqies f'każ ta' sintomi mhux speċifiċi bħal nawsja, rimettar, anoreksja, uġigħ fl-addome, għatx eċċessiv, diffikultà fit-teħid tan-nifs, konfużjoni, għeja jew ngħas mhux tas-soltu.
English: • in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes
Maltese: • f'pazjenti fuq id-dożi massimi ttollerati tagħhom ta' metformin flimkien ma' prodotti mediċinali oħra għat-trattament tad-dijabete
English: Ertugliflozin was used as monotherapy in one trial and as add-on therapy in two trials (see section 5.1).
Maltese: Ertugliflozin intuża bħala monoterapija fi prova waħda u bħala terapija miżjuda m'oħra f'żewġ provi (ara sezzjoni 5.1).
English: Each tablet contains 2.5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 2.5 mg ta' ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 1000 mg ta' metformin hydrochloride.
English: • Segluromet 7.5 mg/850 mg film-coated tablets (tablets) are dark brown, 18 x 10 mm oval, film-coated tablets debossed with “7.5/850” on one side and plain on the other side.
Maltese: • Il-pilloli miksija b'rita (pilloli) Segluromet 7.5 mg/850 mg huma pilloli kannella skuri, ovali, 18 x 10 mm, miksija b'rita, imnaqqxa b'“7.5/850” fuq naħa waħda u mingħajr marki fuq innaħa l-oħra.