FrancophonIA/ELRC3.0 huggingface dataset:
English: * 1 g every 8 hours as a 4-hour infusion may be considered in patients with augmented renal clearance (particularly those with creatinine clearance (CrCl) ≥ 150 ml/min) and/or in infections due to non-fermenting gram-negative pathogens (such as Pseudomonas spp.
Maltese: * 1 g kull 8 sigħat bħala infużjoni ta' 4 sigħat jista jiġi kunsidrat f'pazjenti li għandhom tneħħija tal-krejatinina iktar b'saħħitha (speċjalment dawk li għandhom tneħħija tal-krejatinina (CrCl) >150 ml/min) u/jew f'infezzjonijiet b'patoġeni li huma gram-negattivi u li ma jiffermentawx (bħal Pseudomonas spp.
English: Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Maltese: Iġbed is-suspensjoni permezz ta' siringa u labra u żidha fil-borża tal-infużjoni li ikun fiha 100 ml jew ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għall-injezzjoni jew inkella soluzzjoni ta' dextrose 50 mg/ml (5%) għall-injezzjoni u ħallat biex tinħall kompletament.
English: This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Maltese: Din il-mediċina hija antibijotika li taħdem billi toqtol tipi differenti ta' batterji (mikrobi) li jikkawżaw infezzjonijiet f'diversi partijiet tal-ġisem.
English: Caution on the choice of antibiotic agent and dose should be taken when treating patients with late-onset ventilator-associated pneumonia (> 5 days hospitalisation) and in other nosocomial pneumonia cases where pathogens with decreased susceptibility are suspected or confirmed, such as Pseudomonas spp.
Maltese: Kawtela fl-għażla ta' mediċina antibijotika u d-doża għandha tittieħed meta jiġu trattati pazjenti bi pnewmonja assoċjata ma' l-użu ta' ventilatur fi stadju tardiv (> 5 ijiem fl-isptar) u f'każijiet ta' pnewmonja nosokomjali oħra fejn l-patoġeni b'suxxettibilità mnaqqsa huma suspettati jew ikkonfermati, bħal Pseudomonas spp.
English: The usual treatment duration of doripenem therapy ranges from 5-14 days and should be guided by the severity, site of the infection, infecting pathogen and the patient's clinical response.
Maltese: It-tul ta' kura b'terapija ta' doripenem ivarja bejn 5-14-il ġurnata u għandu jkun iggwidat mis-severità, mis-sit tal-infezzjoni, mill-patoġenu li jkun qed jikkawża l-infezzjoni u mir-rispons kliniku tal-pazjent.
English: Doribax dosage adjustment is necessary in patients receiving continuous renal replacement therapy (see section 4.2).
Maltese: Aġġustament tad-doża huwa neċessarju f'pazjenti li jkunu qed jirċievu terapija ta' rimpjazzament renali kontinwa (ara sezzjoni 4.2).
English: Eesti filiaal
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: These dosing recommendations were derived by modeling data from subjects with end stage renal disease receiving continuous renal replacement therapy, and take into consideration the potential increases in non-renal clearance of carbapenems in patients with acute renal insufficiency compared to patients with chronic renal impairment.
Maltese: Reazzjonijiet avversi li ġew identifikati waqt provi kliniċi u waqt esperjenza ta' wara t-tqegħid fis-suq b'Doribax huma elenkati hawn taħt skont il-kategorija ta' frekwenza.
English: Doribax 500 mg powder for solution for infusion
Maltese: Doribax 500 mg trab għal soluzzjoni għall-infużjoni
English: It has been shown that co-administration of doripenem and valproic acid significantly reduces serum valproic acid levels below the therapeutic range.
Maltese: Intwera li l-għoti flimkien ta' doripenem u valproic acid inaqqas b'mod sinifikanti l-livelli ta' valproic acid fis-serum taħt il-medda terapewtika.
English: JANSSEN-CILAG Ltd. Tel: +44 1494 567 444
Maltese: Tel: +44 1494 567 444
English: There is insufficient information to make dose adjustment recommendations in patients on intermittent haemodialysis or dialysis methods other than continuous renal replacement therapy (see section 4.2).
Maltese: M'hemmx biżżejjed informazzjoni sabiex isiru rakkomandazzjonijiet f'pazjenti fuq dijaliżi tad-demm intermittent jew metodi ta' dijaliżi oħrajn għajr terapija ta' rimpjazzament renali kontinwa (ara sezzjoni 4.2).
English: Suomi/Finland JANSSEN-CILAG OY Puh/Tel: +358 207 531 300
Maltese: Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel: + 372 617 7410
English: Doribax 250 mg powder for solution for infusion
Maltese: Doribax 250 mg trab għal soluzzjoni għall-infużjoni
English: The magnitude of this value, coupled with the significant decrease in the elimination of doripenem seen with concomitant probenecid administration, suggests that doripenem undergoes glomerular filtration, tubular secretion and re-absorption.
Maltese: Il-kobor ta' dan il-valur, flimkien ma' tnaqqis sinifikanti fleliminazzjoni ta' doripenem li tidher meta jingħata flimkien ma' probenecid, jissuġġerixxi li doripenem ikollu kemm filtrazzjoni glomerulari, tnixxija tubulari kif ukoll assorbiment mill-ġdid.
English: Doripenem inactivates multiple essential penicillin-binding proteins (PBPs) resulting in inhibition of cell wall
Maltese: Doripenem jiddiżattiva proteini multipli essenzjali li jintrabtu mal-penicillin (PBPs) li jirriżulta fl-impediment tas-sintesi tal-ħajt taċ-ċellula u sussegwentement il-mewt taċċellula.
English: Doripenem AUC was 13% higher in females compared to males.
Maltese: L-AUC ta' doripenem kienet 13% ogħla fin-nisa meta mqabbla mal-irġiel.
English: While antibiotics including Doribax kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Maltese: Filwaqt li l-antibijotiċi inkluż Doribax joqtlu ċerti batterji, batterji oħra u moffa jistgħu jkomplu jikbru aktar minn normal.
English: * species against which activity has been demonstrated in clinical studies species that show natural intermediate susceptibility species with > 50% acquired resistance in one or more Member State ^ all methicillin-resistant staphylococci should be regarded as resistant to doripenem
Maltese: speċi li intweriet attività kontrihom fil-provi kliniċi speċi li juru suxxettibilità intermedja naturali speċi b'>50% reżistenza akkwiżita f'wieħed mill-Istati Membri jew aktar ^ l-istaphylococci kollha li huma reżistenti għall-methicillin għandhom jiġu meqjusa bħala reżistenti għal-doripenem
English: Patient name:-------------------------Date ZYNQUISTA first prescribed:--------------------------Center name:--------------------------Treating HCP name:-----------------Treating HCP contact number:---------------------
Maltese: In-numru taċ-ċentru:--------------------------L-isem tal-HCP li qed jitratta:-----------------In-numru ta' kuntatt tal-HCP li qed jitratta:---------------------
English: Probable DKA
Maltese: DKA Probabbli
English: ‡ Defined as event that occurred between 00:00 and 05:59 hours.
Maltese: Definita bħala avveniment li seħħ bejn 00:00 u 05:59 ta' filgħodu.
English: Talc Indigo carmine aluminium lake (E132).
Maltese: Indigo carmine aluminium lake (E132).
English: Creatinine (mg/dL) eGFR (mL/min/1.73 m2)
Maltese: Kreatinina (mg/dL) eGFR (mL/min/1.73 m2)
English: M19 demonstrated inhibitory effects against OATP1B1/B3 and MRP2 in-vitro.
Maltese: M19 wera effetti inibitorji kontra OATP1B1/B3 u MRP2 in vitro.
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex France
Maltese: Sanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex Franza
English: Linearity/non-linearity
Maltese: Linearità/nuqqas ta' linerità
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave F - 33565 Carbon Blanc France
Maltese: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès et Lagrave F - 33565 Carbon Blanc Franza
English: Titanium dioxide (E171)
Maltese: Titanium dioxide (E171) Talc
English: - film-coating: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132).
Maltese: - kisja tar-rita: poly(vinyl alcohol); macrogol; titanium dioxide (E 171); talc; indigo carmine aluminium lake (E132).
English: Volume depletion*, c, †
Maltese: Tnaqqis fil-volum*, c, †
English: HbA1c < 7.0% at week 24, n (%)
Maltese: HbA1c < 7.0% f'ġimgħa 24, n (%)
English: Clinical stage
Maltese: Stadju Kliniku
English: Blood Ketone (betahydroxybutyrate)
Maltese: Keton fid-Demm (betahydroxybutyrate)
English: LS mean [95%CI]
Maltese: [95%CI]
English: Take the medicine pack with you.
Maltese: Ħu l pakkett tal-mediċini miegħek.
English: - Printing ink: shellac; iron oxide black (E172); propylene glycol.
Maltese: - linka tal-istampar: shellac; iron oxide black (E172); propylene glycol.
English: Elimination/excretion
Maltese: Eliminazzjoni/tneħħija
English: EU/1/19/1363/008 (200 mg - 2 packs of 100 film coated tablets)
Maltese: EU/1/19/1363/008 (200 mg - 2 pakketti ta' 100 pillola miksija b'rita)
English: Difference from placebo,
Maltese: medja Differenza mill-plaċebo,
English: Insulin + sotagliflozin
Maltese: Insulina + sotagliflozin
English: Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets).
Maltese: Daqsijiet tal-pakkett ta' 10, 20, 30, 60, 90, 100, 180 pillola miksija b'rita, u pakket multiplu ta' 200 pillola miksija b'rita (2 pakketti ta' 100 pillola miksija b'rita).
English: • phenytoin or phenobarbital (epilepsy medicines used to control fits)
Maltese: • phenytoin jew phenobarbital (mediċini tal-epilessija użati biex jikkontrollaw l-aċċessjonijiet)
English: M19 is an inducer and inhibitor of CYP3A4 and an inhibitor of CYP2D6.
Maltese: M19 huwa induttur u inibitur ta' CYP3A4 u inibitur ta' CYP2D6.
English: Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK06
Maltese: Mediċini użati fid-dijabete, inibituri tal-kotrasportatur 2 ta' sodium u glucose (SGLT2), Kodiċi ATC: A10BK06
English: Frequency of occurrence Very common Common
Maltese: Frekwenza li seħħew biha Komuni ħafna Komuni
English: EU/1/19/1363/001 10 film coated tablets EU/1/19/1363/002 20 film coated tablets EU/1/19/1363/003 30 film coated tablets EU/1/19/1363/004 60 film coated tablets EU/1/19/1363/005 90 film coated tablets EU/1/19/1363/006 100 film coated tablets EU/1/19/1363/007 180 film coated tablets EU/1/19/1363/008 200 (2x100) film coated tablets (multipack)
Maltese: EU/1/19/1363/001 10 pilloli miksija b'rita EU/1/19/1363/002 20 pillola miksija b'rita EU/1/19/1363/003 30 pillola miksija b'rita EU/1/19/1363/004 60 pillola miksija b'rita EU/1/19/1363/005 90 pillola miksija b'rita EU/1/19/1363/006 100 pillola miksija b'rita EU/1/19/1363/007 180 pillola miksija b'rita EU/1/19/1363/008 200 (2x100) pillola miksija b'rita (pakkett multiplu)
English: In in vitro studies, sotagliflozin did not inhibit CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4.
Maltese: Fi studji in vitro, sotagliflozin ma inibixxiex CYP 1A2, 2C9, 2C19, 2D6, jew 3A4, u lanqas induċa CYP 1A2, 2B6, jew 3A4.
English: Table 2: Tabulated list of adverse reactions System Organ class
Maltese: Tabella 2: Lista ta' reazzjonijiet avversi miġbura f'tabella
English: Sotagliflozin and M19 have no significant potential to inhibit OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3.
Maltese: Sotagliflozin u M19 ma kellhom l-ebda potenzjal sinifikanti li jinibixxu OCT1, OCT2, OAT1, OAT3, OATP1B1 u OATP1B3.
English: • The active substance is sotagliflozin.
Maltese: • Is-susttanza attiva hija sotagliflozin.
English: > 1.5-3.0 mmol/L Moderate
Maltese: > 1.5-3.0 mmol/L Ammont moderat
English: EU/1/19/1363/001 (200 mg - 10 film coated tablets) EU/1/19/1363/002 (200 mg - 20 film coated tablets) EU/1/19/1363/003 (200 mg - 30 film coated tablets) EU/1/19/1363/004 (200 mg - 60 film coated tablets) EU/1/19/1363/005 (200 mg - 90 film coated tablets) EU/1/19/1363/006 (200 mg - 100 film coated tablets) EU/1/19/1363/007 (200 mg - 180 film coated tablets)
Maltese: EU/1/19/1363/001 (200 mg - 10 pilloli miksija b'rita) EU/1/19/1363/002 (200 mg - 20 pillola miksija b'rita) EU/1/19/1363/003 (200 mg - 30 pillola miksija b'rita) EU/1/19/1363/004 (200 mg - 60 pillola miksija b'rita) EU/1/19/1363/005 (200 mg - 90 pillola miksija b'rita) EU/1/19/1363/006 (200 mg - 100 pillola miksija b'rita) EU/1/19/1363/007 (200 mg - 180 pillola miksija b'rita)
English: In vitro sotagliflozin was shown to have inhibitory effects on P-gp and breast cancer resistance protein (BCRP).
Maltese: In vitro sotagliflozin intwera li għandu effetti inibitorji fuq P-gp u fuq il-proteina ta' reżistenza talkanċer tas-sider (BCRP, breast cancer resistance protein).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: • The other ingredients are: - tablet core: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc.
Maltese: • Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), croscarmellose sodium, colloidal anhydrous silica; magnesium stearate; talc.
English: Zynquista is available in PVC/PCTFE/Aluminium opaque blisters.
Maltese: Zynquista huwa disponibbli f'folji opaki tal-PVC/PCTFE/Aluminju.
English: EU/1/19/1363/008 200 film-coated tablets (2 packs of 100)
Maltese: EU/1/19/1363/008 200 pillola miksijin b'rita (2 pakketti ta' 100)
English: • ritonavir (a medicine used to treat HIV infection)
Maltese: • ritonavir (mediċina użata biex tittrata infezzjoni tal-HIV)
English: Infections and infestations Female genital mycotic infections*,a, †
Maltese: Infezzjonijiet mikotiċi filġenitali fin nisa*,a, †
English: Based on in-vitro data, induction of CYP2C9, CYP2B6 and CYP1A2 cannot be ruled out.
Maltese: Abbażi ta' data in vitro, ma tistax tiġi eskluża induzzjoni ta' CYP2C9, CYP2B6 u CYP1A2.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100),
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: • digoxin or digitoxin (medicines used for heart problems).
Maltese: • digoxin jew digitoxin (mediċini użati għall-problemi tal-qalb).
English: Sotagliflozin was not mutagenic or clastogenic.
Maltese: Sotagliflozin ma kienx mutaġeniku jew klastoġeniku.
English: Zynquista 200 mg tablets sotagliflozin
Maltese: Zynquista 200 mg pilloli sotagliflozin
English: Sotagliflozin is a dual inhibitor of sodium glucose cotransporter type 1 (SGLT1) and SGLT2.
Maltese: Sotagliflozin huwa inibitur doppju tal-kotrasportatur tat-tip 1 ta' sodium u glucose (SGLT1) u SGLT2.
English: b Adverse event grouping, including, but not limited to, balanoposthitis, genital infections fungal, balanitis candida, epididymitis.
Maltese: b Grupp tal-avveniment avvers, jinkludi, iżda mhux limitat għal, balanopostite, infezzjoni bil-fungu filġenitali, balanite bil-kandida, epididimite.
English: Mean terminal T1/2 ranged from 21 to 35 hours for sotagliflozin and from 19 to 26 hours for M19.
Maltese: Medja tat-T1/2 terminali kienet fuq firxa minn 21 sa 35 siegħa għal sotagliflozin u minn 19 sa 26 siegħa għal M19.
English: • Sotagliflozin is not a substitute for insulin.
Maltese: • Sotagliflozin mhuwiex sostitut tal-insulina.
English: In patients 65 years and older, renal function and an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Maltese: F'pazjenti li għandhom 65 sena jew aktar, għandhom jitqiesu l-funzjoni tal-kliewi u ż-żieda fir-riskju ta' tnaqqis fil-volum (ara sezzjonijiet 4.4 u 4.8).
English: Rosuvastatin is a known OATP, BCRP and OAT3 substrate.
Maltese: Rosuvastatin huwa magħruf bħala sustrat ta' OATP, BCRP u OAT3.
English: Fifteen of the 35 cases (43%) experienced DKA with glucose values in the glycaemic range 8 to 14 mmol/L.
Maltese: Ħmistax mill-35 każ (43%) kellhom DKA b'valuri tal-glucose fil-medda gliċemika 8 sa 14 mmol/L.
English: The primary route of metabolism of sotagliflozin in humans is glucuronidation by the uridine 5'diphospho-glucuronosyltransferases primarly by UGT1A9, and to a much lesser extent by UGT1A1 and UGT2B7 as well as oxidation, by CYP3A4.
Maltese: Ir-rotta primarja tal-metaboliżmu ta' sotagliflozin fil-bniedem hija l-glukuronidazzjoni permezz taluridine 5'-diphospho-glucuronosyltransferases primarjament permezz ta' UGT1A9, u fi grad ħafna inqas permezz ta' UGT1A1 u UGT2B7 kif ukoll ossidazzjoni, permezz ta' CYP3A4.
English: The predominant metabolite detected in urine was M19, representing a mean of 33% of the administered radioactive dose.
Maltese: Il-metabolit predominanti nnutat fl-awrina kien M19, li jirrapreżenta 33% tad-doża radjuattiva mogħtija.
English: At screening the HbA1c was 8.21%, 8.26% and 8.20% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg.
Maltese: Fl-eżami ta' qabel id-dħul fl-istudju l-HbA1c kien 8.21%, 8.26% u 8.20% għall-insulina, insulina+sotagliflozin 200 mg u insulina+sotagliflozin 400 mg.
English: Insulin Insulin + sotagliflozi n 200 mg
Maltese: Insulina + sotagliflozi n 200 mg
English: Reduction in risk of documented hypoglycaemia, compared to insulin alone at threshold of ≤3.1 mmol/L (%)
Maltese: ipogliċemija dokumentata mqabbel mal-insulina waħedha b'limitu ta' ≤3.1 mmol/L (%)
English: Interaction studies in healthy volunteers showed that metformin, metoprolol, midazolam, rosuvastatin and oral contraceptives had no clinically relevant effect on the pharmacokinetics of sotagliflozin.
Maltese: Studji dwar interazzjoni li saru f'voluntiera f'saħħithom urew li metformin, metoprolol, midazolam, rosuvastatin u kontraċettivi orali ma kellhom l-ebda effett rilevanti b'mod kliniku fuq il farmakokinetika ta' sotagliflozin.
English: PVC/PCTFE/Aluminium opaque blisters.
Maltese: Folji opaki tal-PVC/PCTFE/Aluminju.
English: Sotagliflozin may cause intravascular volume contraction (see section 4.8).
Maltese: Sotagliflozin jista' jikkawża kontrazzjoni fil-volum intravaskulari (ara sezzjoni 4.8).
English: * 5.35% more time in range, correspond to 1.3 hours † 11.71% more time in range, correspond to 2.8 hours
Maltese: * 5.35% aktar ħin fil-medda, jikkorrispondi għal 1.3 sigħat † 11.
English: Table 5: Results of CGM sub study at week 24 (Pooled data, study 1 and study 2) Characteristic
Maltese: Riżultati tas-sottostudju CGM f'ġimgħa 24 (Ġabra ta' data, studju 1 u studju 2)
English: At screening the HbA1c was 8.42%, 8.35% and 8.38% for insulin, insulin+sotagliflozin 200 mg and insulin+sotagliflozin 400 mg.
Maltese: Fl-eżami ta' qabel id-dħul fl-istudju l-HbA1c kien 8.42%, 8.35% u 8.38% għall-insulina, insulina+sotagliflozin 200 mg u insulina+sotagliflozin 400 mg.
English: *Systolic blood pressure was assessed at week 16 † p <0.001 ‡ p=0.002
Maltese: * Il-pressjoni sistolika tad-demm ġiet stmata f'ġimgħa 16 †
English: If an enzyme inducer (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) must be co-administered with sotagliflozin, consider frequent monitoring of glucose level.
Maltese: Jekk induttur tal-enzimi (eż., rifampicin, phenytoin, phenobarbital, ritonavir) jkollu jingħata flimkien ma' sotagliflozin, qis il-monitoraġġ frekwenti tal-livell tal-glucose.
English: Placebo (N=526)
Maltese: Insulina (N=526)
English: • Sotagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity).
Maltese: • Sotagliflozin mhuwiex sostitut tal-insulina (u huwa ma jibdilx is-sensittività għall-insulina).
English: Impending DKA
Maltese: DKA Imminenti
English: Interaction studies conducted in healthy volunteers show that sotagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, metoprolol, midazolam and oral contraceptives.
Maltese: Studji dwar interazzjoni li saru f'voluntiera f'saħħithom urew li sotagliflozin ma kellu l-ebda effett rilevanti b'mod kliniku fuq il-farmakokinetika ta' metformin, metoprolol, midazolam u kontraċettivi orali.
English: Insulin + sotagliflozin 400 mg
Maltese: Insulina + sotagliflozin 400 mg
English: When sotagliflozin is incubated with UGT1A9, M19 was the main conjugate observed.
Maltese: Meta sotagliflozin inżamm taħt kondizzjonijiet favorevoli ma' UGT1A9, M19 kien il-konjugat prinċipali li ġie osservat.
English: If Fournier's gangrene is suspected, sotagliflozin should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, sotagliflozin għandu jitwaqqaf u jinbeda trattament filpront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: Zynquista 200 mg film-coated tablets (tablets) are oval, blue, with “2456” on one side printed in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).
Maltese: Il-pilloli Zynquista 200 mg miksija b'rita (pilloli) huma blu, ovali b'“2456” fuq naħa waħda stampata b'linka sewda (tul tal-pillola: 14.2 mm, wisa' tal-pillola: 8.7 mm).
English: In patients with eGFR <60 mL/min/1.73 m² a numerical HbA1c reduction was observed.
Maltese: F'pazjenti b'eGFR <60 mL/min/1.73 m² ġie osservat tnaqqis numeriku fl-HbA1c.
English: • blood tests may show increase related to kidney function (such as ‘creatinine').
Maltese: • testijiet tad-demm jistgħu juru żieda marbuta mal-funzjoni tal-kliewi (bħal ‘kreatinina').
English: In healthy subjects following the administration of a single dose of 400 mg [14C]-sotagliflozin indicated that sotagliflozin was extensively metabolized predominantly to M19 which represented 94% of the radioactivity in plasma.
Maltese: F'individwi f'saħħithom l-għoti ta' doża waħda ta' 400 mg sotagliflozin [14C] indikat li sotagliflozin jiġi metabolizzat b'mod estensiv l-aktar f'M19 li rrapreżenta 94% tar-radjuattività fil-plasma.
English: Systolic Blood Pressure in those with baseline SBP ≥ 130 mmHg*
Maltese: Pressjoni sistolika tad-demm f'dawk b'SBP ≥ 130 mmHg* fil-linja bażi
English: Blood creatinine increased/Glomerular filtration decreased and renal-related events Sotagliflozin was associated with decreases in mean eGFR at week 4 (-4.0% and -4.3% for sotagliflozin 200 mg and 400 mg) versus placebo (-1.3%) that were generally reversible during continuous treatment.
Maltese: Żieda fil-kreatinina fid-demm/Tnaqqis fil-filtrazzjoni mill-glomeruli u avvenimenti marbuta mal-kliewi Sotagliflozin ġie assoċjat ma' tnaqqis fl-eGFR f'ġimgħa 4 (-4.0% u -4.3% għal sotagliflozin 200 mg u 400 mg) versus plaċebo (-1.3%) li ġeneralment kien riversibbli waqt trattament kontinwu.
English: Navigant Germany GmbH Albrechtstr.
Maltese: Navigant Germany GmbH Albrechtstr. 10c 10117 Berlin il-Ġermanja
English: In the 3 Phase 3 randomized clinical studies in patients with type 1 diabetes, patients with eGFR < 45 mL/min/1.73 m2 were excluded, 79 patients exposed to sotagliflozin had an eGFR < 60 mL/min/1.73 m2 and 841 patients had an eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2.
Maltese: Fit-3 studji kliniċi arbitrarji ta' Fażi 3 f'pazjenti b'dijabete tat-tip 1, pazjenti b'eGFR < 45 mL/min/1.73 m2 ġew esklużi, 79 tal-pazjenti esposti għal sotagliflozin kellhom eGFR < 60 mL/min/1.73 m2 u 841 pazjent kellhom eGFR ≥ 60 sa ≤ 90 mL/min/1.73 m2.
English: Following the administration of a single dose of 400 mg [14C]-sotagliflozin, showed 57% and 37% of the radioactivity were excreted in the urine and faeces, respectively.
Maltese: Wara l-għoti ta' doża waħda ta' 400 mg sotagliflozin [14C], intwera li 57% u 37% tar-radjuattività tneħħew mal-awrina u mal-ippurgar, rispettivament.
English: Exposure was approximately 5 times (males) and 11 times (females) the clinical exposure at the Maximum Recommended Human Dose (MRHD) and caused reversible renal tubular dilation.
Maltese: L-esponiment kien madwar 5 darbiet (irġiel) u 11-il darba (nisa) aktar mill-esponiment kliniku bid-Doża Massima Rrakomandata għall-Bniedem (MRHD, Maximum Recommended Human
English: The mean BMI was 28 kg/m2 and 29% had SBP ≥ 130 mmHg.
Maltese: Il-medja tal-BMI kienet 28 kg/m2 u 29% kellhom SBP ≥ 130 mmHg.