FrancophonIA/ELRC3.0 huggingface dataset:
English: Initial Therapy (twice daily)
Maltese: Terapija tal-bidu (darbtejn kuljum):
English: A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
Maltese: Studju ta' 24 ġimgħa kkontrollat bi plaċebo li kien jinvolvi 660 pazjent ġie mfassal biex jevalwa leffikaċja u s-sigurtà ta' kif sitagliptin (100 mg darba kuljum) inaqqas il-bżonn tal-insulina meta jiżdied ma' insulin glargine flimkien ma' metformin (mill-inqas 1,500 mg) jew mingħajru waqt terapija aktar intensa bl-insulina.
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Maltese: Instabu traċċi ta' sitt metaboliti u mhumiex mistennija li jikkontribwixxu għall-attività inibitorja ta' DPP-4 fil-plażma kontra sitagliptin.
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Maltese: II. Suġġetti anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta' sitagliptin filplażma madwar 19 % aktar għoljin meta mqabbla ma' suġġetti iżgħar.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g., megaloblastic anaemia).
Maltese: B12 li b'mod rari ħafna tista' twassal għal defiċjenza sinifikanti b'mod kliniku ta' vitamina
English: Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Maltese: Sitagliptin huwa impeditur qawwi u selettiv bil-bosta ta' l-enzima DPP-4 u f'konċentrazzjonijiet terapewtiċi ma jimpedixxix l-enzimi relatati mill-qrib DPP-8 jew DPP-9.
English: Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Maltese: Sitagliptin huwa primarjament eliminat mhux mibdul fl-awrina, u l-metaboliżmu huwa passaġġ minuri.
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Maltese: Sinjali fiżiċi ta' qasir żmien relatati mal-kura, xi wħud minnhom jissuġġerixxu tossiċità newrali, bħalma huma teħid ta' nifs b'ħalq miftuħ, tnixxija ta'saliva, emesi ta' ragħwa bajda, atassja, tregħid, tnaqqis fl-attività, u/jew qagħda mħattba kienu osservati fi klieb f'livelli ta' esponiment ta' madwar 23 darba l-livell ta' esponiment kliniku.
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9).
Maltese: Ma hemm l-ebda esperjenza klinika f'pazjenti b'indeboliment sever tal-fwied(punteġġ Child-Pugh > 9).
English: Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations.
Maltese: Effetti ta' sitagliptin fuq prodotti mediċinali oħrajn Digoxin:
English: In addition, osteoarthritis and pain in extremity were reported with frequency uncommon (> 0.5 % higher among sitagliptin users than that in the control group).
Maltese: Barra dan, osteoartrite u uġigħ fl-idejn u fis-saqajn kienu rrappurtati bi frekwenza mhux komuni (> 0.5 % ogħla fost dawk li jużaw sitagliptin minn dawk fil-grupp ta' kontroll).
English: Ristfor is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Maltese: Ristfor huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament fil preżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: Tel: +39 06 361911 medicalinformation.it@merck.com
Maltese: medicalinformation.it@merck.com
English: Placebo-corrected mean change in HbA1c (%) (95 % CI)
Maltese: Bidla medja f'HbA1c ikkoreġuta bi plaċebo (%)
English: EU/1/10/620/010 EU/1/10/620/011 EU/1/10/620/012 EU/1/10/620/013 EU/1/10/620/014 EU/1/10/620/015 EU/1/10/620/016 EU/1/10/620/018 EU/1/10/620/021 EU/1/10/620/022
Maltese: EU/1/10/620/016 EU/1/10/620/018 EU/1/10/620/021 EU/1/10/620/022
English: No metabolites have been identified in humans.
Maltese: L-ebda metaboliti ma ġew identifikati fil-bnedmin.
English: In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Maltese: Fi studju fattorjali kkontrollat bi plaċebo ta' 24 ġimgħa ta' terapija tal-bidu, sitagliptin 50 mg darbtejn kuljum f'kumbinazzjoni ma' metformin (500 mg jew 1,000 mg darbtejn kuljum) ġab titjib sinifikanti f'parametri gliċemiċi meta mqabbel ma' monoterapija kemm wieħed u kemm bl-ieħor.
English: Biotransformation Metformin is excreted unchanged in the urine.
Maltese: Metformin huwa eliminat mhux mibdul fl-awrina.
English: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.
Maltese: multidrug and toxin extrusion] bħal ranolazine, vandetanib, dolutegravir, u cimetidine) jista' jżid l esponiment sistemiku għal metformin u jista' jżid ir-riskju għal aċidożi lattika.
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Maltese: Il metaboliżmu jista' jkollu rwol aktar sinifikanti fl-eliminazzjoni ta' sitagliptin fl-isfond ta' indeboliment tal-kliewi sever jew mard tal-kliewi tal-aħħar fażi (ESRD).
English: A bioequivalence study in healthy subjects demonstrated that the Ristfor (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Maltese: Studju ta' bijoekwivalenza f'suġġetti b'saħħithom wera li pilloli ta' kumbinazzjoni Ristfor (sitagliptin/metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta' sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
English: Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Maltese: mhumiex mistennija interazzjonijiet sinifikanti b'impedituri oħrajn tal-glikoproteina p.
English: When Ristfor is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: sulphonylurea, tista' tkun meħtieġa doża aktar baxxa ta' sulphonylurea biex tnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Maltese: F'pazjenti b'funzjoni tal-kliewi normali, il-metaboliżmu, inkluż dak permezz ta' CYP3A4, għandu biss rwol żgħir fir-rata ta' eliminazzjoni ta' sitagliptin.
English: The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Id-doża għandha tipprovdi sitagliptin 50 mg darbtejn kuljum (doża totali ta' kuljum 100 mg) u doża ta' metformin simili għad-doża li diġà qegħda tittieħed.
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Maltese: L-AUC ta' sitagliptin żdied b'mod proporzjonali għad-doża.
English: Frequency not known urticaria
Maltese: Frekwenza tar-reazzjoni avversa
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Maltese: metformin¶ li diġà tkun qiegħda tittieħed (N=152)
English: • specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
Maltese: • mediċini speċifiċi għall-kura ta' ażma fil-bronki (simpatomimetiċi-β)
English: The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Maltese: Iż-żieda ta' sitagliptin mal-insulina ġabet titjib sinifikanti fil-parametri gliċemiċi.
English: Film coating poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
Maltese: titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
Maltese: Τηλ: 80000 673 (+357 22866700)
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 litres.
Maltese: Distribuzzjoni Il-medja tal-volum ta' distribuzzjoni fi stat fiss wara doża waħda intravenuża ta' 100 mg sitagliptin lil suġġetti b'saħħithom huwa madwar 198 litru.
English: Table 1: The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin and metformin alone, and post-marketing experience
Maltese: Tabella 1: Il-frekwenza tar-reazzjonijiet avversi identifikati minn studji kliniċi kkontrollati bi plaċebo ta' sitagliptin u metformin waħedhom, u minn esperjenza ta' wara t-tqegħid fis-suq
English: Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Maltese: p-glycoprotein, li jista' jkun ukoll involut fil-medjazzjoni ta' l-eliminazzjoni ta' sitagliptin millkliewi.
English: Tel: + 385 1 6611 333 croatia_info@merck.com
Maltese: Tel: + 385 1 6611 333
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Wieħed jassumi li l farmakokinetika ta' assorbiment ta' metformin mhix linejari.
English: UAB “Merck Sharp & Dohme” Tel. +370 5 278 02 47 msd_lietuva@merck.com
Maltese: +370 5 278 02 47 msd_lietuva@merck.com
English: • dolutegravir, a medicine used to treat HIV infection
Maltese: • ranolazine, mediċina użata għat-trattament tal-anġina • dolutegravir, mediċina użata għat-trattament ta' infezzjoni bl-HIV
English: Uncommon nausea
Maltese: Mhux komuni
English: For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Maltese: Għal pazjenti mhux ikkontrollati adegwatament fuq terapija doppja kombinata b'insulina u d-doża massima ttollerata ta' metformin
English: 112 film-coated tablets
Maltese: 112-il pillola miksija b'rita
English: Gastrointestinal symptoms were reported very commonly in clinical studies and post-marketing use of metformin.
Maltese: Sintomi gastrointestinali ġew irrappurtati b'mod komuni ħafna minn studji kliniċi ta' metformin u mill-użu tiegħu wara t-tqegħid fis-suq.
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
Maltese: Meta mqabbla ma' individwi normali f'saħħithom bħala kontroll, l-AUC ta' sitagliptin fil-plażma żdiedet b'madwar 1.2 drabi u 1.6 drabi f'pazjenti b'indeboliment ħafif tal-kliewi (GFR ≥ 60 sa
English: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Maltese: Sitagliptin jitfaċċa f'ammonti konsiderevoli ġol-ħalib ta' firien li jkunu qegħdin ireddgħu (proporzjon ħalib/plażma: 4:1).
English: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Maltese: Tel: 8007 4433 (+356 99917558)
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete filgrupp ta' metformin (29.8 episodju/1,000 pazjenti-snin) kontra dieta waħidha (43.3 episodju /1,000 pazjenti-snin), p=0.0023, u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina (40.1 episodju /1,000 pazjenti-snin), p=0.0034
English: Dose-proportionality was not established for Cmax and C24hr (Cmax increased in a greater than dose-proportional manner and C24hr increased in a less than dose-proportional manner).
Maltese: Il-proporzjonalità tad-doża ma kinitx stabbilita għas-Cmax u s-C24hr (Cmax żdiedet b'mod akbar mill-mod proporzjonali għad-doża u s- C24hr żdiedet b'mod inqas mill-mod proporzjonali għad-doża).
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Maltese: Dawn il-karatteristiċi ma kellhom l-ebda effett klinikament sinifikanti fuq il-farmakokinetika ta' sitagliptin abbażi ta' analiżi ta' dejta farmakokinetika mħallta ta' Fażi I u fuq analiżi farmakokinetika ta' popolazzjoni ta' dejta ta' Fażi I u Fażi
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Fil-bnedmin, metformin għandu effetti favorevoli fuq il-metaboliżmu tal-lipidi, indipendentement mill-azzjoni tiegħu fuq il-gliċemija.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50 mg) in patients with varying degrees of chronic renal impairment compared to normal healthy control subjects.
Maltese: sitagliptin (50 mg) f'pazjenti bi gradi li jvarjaw ta' indeboliment tal-kliewi kroniku meta mqabbla ma' suġġetti ta' kontroll normali b'saħħithom.
English: Secondary cardiovascular endpoints included the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; first occurrence of the individual components of the primary composite; all-cause mortality; and hospital admissions for congestive heart failure.
Maltese: Skopijiet finali kardjovaskluari sekondarji kienu jinkludu l-ewwel okkorrenza ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, jew puplesija mhux fatali; l-ewwel okkorrenza tal komponenti individwali tal-kompost primarju; mortalità minn kull kawża; u rikoverar l-isptar minħabba insuffiċjenza konġestiva tal-qalb.
English: Studies of sitagliptin in combination with metformin In a 24-week, placebo-controlled clinical study to evaluate the efficacy and safety of the addition of sitagliptin 100 mg once daily to ongoing metformin, sitagliptin provided significant improvements in glycaemic parameters compared with placebo.
Maltese: Fi studju kliniku kkontrollat bi plaċebo ta' 24 ġimgħa biex jevalwa l-effikaċja u s-sigurtà taż-żieda ta' 100 mg sitagliptin darba kuljum ma' metformin li diġà jkun qiegħed jittieħed, sitagliptin ġab titjib sinifikanti f'parametri gliċemiċi meta mqabbel ma' plaċebo.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Maltese: żmien medju jew żmien twil: metformin inaqqas il-kolesterol totali, LDLc u l-livelli ta' trigliċeridi.
English: Ristfor 50 mg/850 mg film-coated tablets
Maltese: Ristfor 50 mg/850 mg pilloli miksijin b'rita
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Maltese: Fi studju kliniku, sitagliptin kellu effett żgħir fuq konċentrazzjonijiet ta' digoxin fil-plażma li jindika li sitagliptin jista' jkun impeditur dgħajjef ta' p-glycoprotein.
English: Ristfor 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Ristfor 50 mg/1,000 mg pilloli miksijin b'rita sitagliptin/metformin hydrochloride
English: Patients treated with sitagliptin had a modest increase in body weight (+1.1 kg) compared to those given placebo.
Maltese: Pazjenti kkurati b'sitagliptin kellhom żieda modesta fil-piż (+1.1 kg) meta mqabbla ma' dawk li ngħataw plaċebo.
English: Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Maltese: Ġie mfassal studju kkontrollat bi plaċebo ta' 24 ġimgħa sabiex jevalwa l-effikaċja u s-sigurtà ta' sitagliptin (100 mg darba kuljum) miżjud ma' insulina (f'doża stabbli għal mill-inqas 10 ġimgħat) flimkien ma' jew mingħajr metformin (għallinqas 1,500 mg).
English: There have been no therapeutic clinical trials conducted with Ristfor tablets however bioequivalence of Ristfor with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Ma saru l-ebda provi terapewtiċi kliniċi b'pilloli Ristfor, madankollu ntweriet il-bijoekwivalenza ta' Ristfor ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/1,000 mg film-coated tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TAN-NOFS għal Pakketti multipli 2 pakketti - mingħajr kaxxa blu50 mg/1,000 mg pilloli miksijin b'rita
English: * All Patients Treated Population (an intention-to-treat analysis).
Maltese: * Popolazzjoni Pazjenti Kollha Ikkurati (analiżi intenzjoni-li-tikkura). †
English: Plasma protein binding is negligible.
Maltese: L-irbit ma' proteini fil-plażma huwa negliġibbli.
English: Reduction in fasting plasma glucose (FPG) was observed at 3 weeks, the first time point at which FPG was measured.
Maltese: Tnaqqis fiz-zokkor fi stat ta' sawm (FPG) kien osservat fi 3 ġimgħat, l-ewwel darba meta tkejjel l-FPG.
English: Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Maltese: Sitagliptin phosphate huwa impeditur attiv li jittieħed mill-ħalq, qawwi, ferm selettiv ta' l-enzim dipeptidyl peptidase 4 (DPP-4) għall-kura ta' dijabete tip 2.
English: Merck Sharp & Dohme B.V. Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Tel.: 0800 9999000 (+31 23 5153153)
English: Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).
Maltese: Xi pazjenti kellhom dijarea, dardir, gass, stitikezza, uġigħ fl-istonku jew rimettar meta bdew kombinazzjoni ta' sitagliptin u metformin flimkien (il-frekwenza hija komuni).
English: Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Maltese: Ġie mfassal studju kkontrollat bi plaċebo ta' 24 ġimgħa biex jevalwa l-effikaċja u s-sigurtà ta' sitagliptin (100 mg darba kuljum) miżjud ma' glimepiride (waħdu jew f'kumbinazzjoni ma' metformin).
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Maltese: Huwa ma jqanqalx tnixxija ta' insulina u għaldaqstant ma jipproduċix ipogliċemija.
English: Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility.
Maltese: Fertilità Dejta dwar l-annimali ma tindikax li kura b'sitagliptin għandha effett fuq il-fertilità tal-annimali maskili u femminili.
English: A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Maltese: Dejta limitata tissuġġerixxi li l-użu ta' metformin f'nisa tqal mhuwiex assoċjat ma żieda fir-riskju ta' formazzjoni difettuża.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Maltese: Funzjoni renali Il-GFR għandha tiġi evalwata qabel jinbeda t-trattament u b'mod regolari wara dan (ara sezzjoni 4.2).
English: Common constipation
Maltese: Komuni stitikezza
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta' sitagliptin u 1,000 mg ta'
English: C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing.
Maltese: Eliminazzjoni Wara għoti ta' doża [14C]sitagliptin orali lil suġġetti b'saħħithom, madwar 100 % tar-radjuattività kienet eliminata fl-ippurgar (13 %) jew l-awrina (87 %) fi żmien ġimgħa mid-dożaġġ.
English: Ristfor 50 mg/850 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli miksijin b'rita Ristfor 50 mg/850 mg sitagliptin/metformin hydrochloride
English: Week 1, 2, 3, 4 Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
Maltese: Jum 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
English: tmax is between 3 and 8 hours.
Maltese: tmax hija bejn 3 u 8 sigħat.
English: Oral solution 50 ml
Maltese: Soluzzjoni orali 50 ml
English: INSTRUCTIONS ON USE 16.
Maltese: STRUZZJONIJIET DWAR L-UŻU 16.
English: SYSTEM ORGAN CLASS
Maltese: TAL-KLASSIFIKA TALORGANI
English: Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see section 4.4.
Maltese: Kull millilitru ta' soluzzjoni fiha 100 mg sorbitol (E 420) u 0.5 mg potassju, ara sezzjoni 4.4.
English: EU/1/12/799/028 500 ml (10 bottles of 50 ml)
Maltese: EU/1/12/799/028 500 ml (10 x 50 ml)
English: Memantine has an absolute bioavailability of approximately 100%.
Maltese: Memantine għandu bijodisponibilità assoluta ta' madwar 100%.
English: Week 2 (day 8-14):
Maltese: Ġimgħa 2 (jum 8-14):
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Maltese: Ma nstab l-ebda metaboliżmu katalizzat minn cytochrome P 450 in vitro.
English: Date of first authorisation: 22 Nov 2012 Date of latest renewal: {DD month YYYY}
Maltese: Data ta' l-ewwel awtorizzazzjoni: 22 novembru 2012 Data ta' l-aħħar tiġdid: {JJ xahar SSSS}
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Maltese: Memantine m'għamilx impediment fuq CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monoxygenase li fih flavin, epoxide hydrolase jew sulfejxin in vitro.
English: Immune systeme disorders
Maltese: Disturbi fis-sistema immuni
English: Psychotic reactions2
Maltese: Mhux magħruf Reazzjonijiet psikotiċi2
English: Linearity
Maltese: Linjarità
English: About 45% of memantine is bound to plasma-proteins.
Maltese: Madwar 45% ta' memantine jeħel mal-proteini tal-plażma.
English: Mon → Tue → Wed → Thu → Fri → Sat → Sun
Maltese: Żomm tazza bi ftit ilma jew mgħarfa taħt iż-żennuna.