FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine contains five types of live rotavirus strains.
Maltese: It-tilqima fiha ħames tipi ta' razez ta' rotavirus ħaj.
English: The first dose may be administered from the age of 6 weeks and no later than the age of 12 weeks.
Maltese: L-ewwel doża tista' tingħata mill-età ta' 6 ġimgћat u mhux iktar tard mill-eta' ta' 12-il ġimgћa.
English: Claims database analysis (US)
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Uncommon Nasopharyngitis, otitis media
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English:  2.2 x 10 6 IU
Maltese:  2.2 x 10 6
English: This Finnish Extension Study (FES) included a subset of 20,736 subjects that had been enrolled previously in REST.
Maltese: Din l-Estensjoni tal-Istudju Finlandiż (FES - Finnish Extension Study) kienet tinkludi sottosett ta' 20,736 individwu li qabel kienu ddaħħlu f'REST.
English: Saxenda contains the active substance liraglutide.
Maltese: Saxenda fih is-sustanza attiva liraglutide.
English: The full EPAR and risk management plan summary for Saxenda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Saxenda.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Saxenda.
English: The starting dose is 0.6 mg per day.
Maltese: Id-doża tal-bidu hija ta' 0.6 mg kuljum.
English: • who are obese (have a body-mass index - BMI - of 30 or more);
Maltese: • li huma obeżi (li għandhom indiċi tal-massa tal-ġisem- BMI - ta' 30 jew aktar);
English: Other information about Saxenda
Maltese: Informazzjoni oħra dwar Saxenda
English: The active substance in Saxenda, liraglutide, is a ‘glucagon-like peptide-1 (GLP-1) receptor agonist' that is already authorised in the EU as Victoza at lower doses (up to 1.8 mg per day) for the treatment of type 2 diabetes.
Maltese: Is-sustanza attiva f'Saxenda, il-liraglutide, hija ‘agonista tar-riċettur glucagon-like peptide-1 (GLP-1)' li hija diġà awtorizzata fl-UE bħala Victoza f'dożi aktar baxxi (sa 1.8 mg kuljum) għall-kura tad-dijabete tat-tip 2.
English: • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).
Maltese: • li għandhom piż żejjed (għandhom BMI bejn 27 u 30) u kumplikazzjonijiet relatati mal-piż bħal dijabete, livelli għoljin b'mod anomalu ta' xaħam fid-demm, pressjoni tad-demm għolja jew apnea ostruttiva waqt l-irqad (interruzzjoni frekwenti tan-nifs waqt l-irqad).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Saxenda on 23 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Saxenda fit-23 ta' Marzu 2015.
English: Why is Saxenda approved?
Maltese: Għaliex ġie approvat Saxenda?
English: What are the risks associated with Saxenda?
Maltese: X'inhuma r-riskji assoċjati ma' Saxenda?
English: Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment).
Maltese: Saxenda ntwera li huwa effikaċi fit-tnaqqis tal-piż tal-ġisem f'5 studji ewlenin li involvew aktar minn 5,800 pazjent obeżi jew b'piż żejjed u li damu sa 56 ġimgħa, li fihom Saxenda tqabbel ma' plaċebo (kura finta).
English: Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo.
Maltese: Meta wieħed iħares lejn ir-riżultati tal-5 studji f'daqqa, Saxenda f'doża ta' kuljum ta' 3 mg wassal għal tnaqqis ta' 7.5% fil-piż tal-ġisem, meta mqabbel ma' tnaqqis ta' 2.3% fil-pazjenti li kienu qegħdin jieħdu il-plaċebo.
English: Saxenda is injected once per day, preferably at the same time every day.
Maltese: Saxenda jiġi injettat darba kuljum, preferibbilment fl-istess ħin kuljum.
English: The dose is then increased each week by 0.6 mg to a maximum of 3.0 mg per day.
Maltese: Id-doża mbagħad tiżdied kull ġimgħa b'0.6 mg sa massimu ta' 3.0 mg kuljum.
English: A risk management plan has been developed to ensure that Saxenda is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Saxenda jintuża bl-aktar mod sigur possibbli.
English: Saxenda is a medicine used along with diet and exercise to help manage weight in adults:
Maltese: Saxenda huwa mediċina użata flimkien ma' dieta u eżerċizzju biex tgħin tiġġestixxi l-piż fl-adulti:
English: Regarding safety, the most common side effects with Saxenda relate to the stomach and gut such as nausea.
Maltese: Fir-rigward tas-sigurtà, l-effetti sekondarji l-aktar komuni b'Saxenda huma relatati mal-istonku u l-imsaren bħal nawżja.
English: When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted.
Maltese: Meta ċ-ċifri għall-istudji ewlenin kienu analizzati mill-ġdid permezz ta' metodu aktar konservattiv li kien jassumi li l-pazjenti li ma lestewx l-istudju (madwar 30%) ma raw l-ebda titjib, kien osservat tnaqqis simili iżda iżgħar fil-piż b'Saxenda.
English: The CHMP considered that Saxenda has a modest (particularly in men) but still clinically relevant effect on weight loss.
Maltese: Is-CHMP ikkunsidra li Saxenda għandu effett żgħir (b'mod partikolari fl-irġiel) iżda xorta klinikament rilevanti fuq it-tnaqqis fil-piż.
English: Treatment with Saxenda should be stopped if patients have not lost at least 5% of their initial body weight after 12 weeks of treatment with 3 mg of Saxenda per day.
Maltese: Il-kura b'Saxenda għandha titwaqqaf jekk il-pazjenti ma jkunux tilfu tal-anqas 5% tal-piż tal-ġisem inizjali tagħhom wara 12-il ġimgħa ta' kura b'3 mg ta' Saxenda kuljum.
English: What measures are being taken to ensure the safe and effective use of Saxenda?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Saxenda?
English: Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Maltese: Il-pazjenti fl-istudji ngħataw il-mediċina bħala parti mill-programm ta' tnaqqis fil-piż li kien jinvolvi konsulenza u pariri dwar dieta u eżerċizzju.
English: It is not intended to provide practical advice on how to use Saxenda.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Saxenda.
English: How does Saxenda work?
Maltese: X'inhu Saxenda u għal xiex jintuża?
English: The most common side effects with Saxenda (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, diarrhoea and constipation.
Maltese: L-effetti sekondarji l-aktar komuni b'Saxenda (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawżja (tħossok ma tiflaħx), rimettar, dijarea u stitikezza.
English: See section 2, Do not take Ristfor.
Maltese: Ara sezzjoni 2, Tiħux Ristfor.
English: 2031 BN Haarlem The Netherlands
Maltese: 2031 BN Haarlem
English: See section 4.4.
Maltese: †Ara sezzjoni 4.4.
English: Metformin is contraindicated.
Maltese: Metformin huwa kontraindikat.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and absolute frequency (Table 1).
Maltese: klassi ta' sistema ta' organi u frekwenza assoluta (Tabella 1).
English: Gastrointestinal disorders diarrhoea
Maltese: Disturbi gastrointestinali dijarea
English: Danmark MSD Danmark ApS Tlf: +45 4482 4000 dkmail@merck.com
Maltese: MSD Danmark ApS Tlf: +45 4482 4000 dkmail@merck.com
English: The mean Vd ranged between 63 - 276 L.
Maltese: Il-Vd medju jvarja bejn 63 - 276 L.
English: Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets.
Maltese: Pakketti ta' 14, 28, 56, 60, 112, 168, 180, 196 pillola miksija b'rita, pakketti multipli li fihom 196 (2 pakketti ta' 98) u 168 (2 pakketti ta' 84) pillola miksija b'rita.
English: Hypoglycaemia has been reported in combination with sulphonylurea (13.8%) and insulin (10.9%).
Maltese: Ipogliċemija kienet irrappurtata flimkien ma' sulphonylurea (13.8%) u l-insulina (10.9%).
English: Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulphonylureas or meglitinides, biguanides, peroxisome proliferator-activated receptor gamma (PPAR) agonists, alpha-glucosidase inhibitors, and amylin analogues.
Maltese: Sitagliptin huwa differenti fl-istruttura kimika u azzjoni farmakoloġika minn analogi GLP-1, insulin, sulphonylureas jew meglitinides, biguanides, agonisti peroxisome proliferator-activated receptor gamma (PPARγ), impedituri alpha-glucosidase, u analogi amylin.
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Maltese: In vitro, sitagliptin ma impedixxiex trasport medjat minn OAT3 (IC50=160 µM) jew p-glycoprotein (sa 250 µM) f'konċentrazzjonijiet fil-plażma terapewtikament relevanti.
English: MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no
Maltese: MSD (Norge) AS Tlf: +47 32 20 73 00
English: In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and organic anion transporter-3 (OAT3).
Maltese: Studji ta' trasport in vitro urew li sitagliptin huwa sottostrat għal p-glycoprotein u organic anion transporter-3 (OAT3).
English: Tablet core microcrystalline cellulose (E460) povidone K29/32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Maltese: Fil-qalba tal-pillola: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauril sulfate, u sodium stearyl fumarate.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 16 December 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Marzu 2010
English: • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Maltese: • sitagliptin jappartieni għall-klassi ta' mediċini msejħin impedituri DPP-4 (impedituri dipeptidyl peptidase-4 )
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Maltese: Dawn ir-reazzjonijiet inkludew anafilassi, anġjoedima, u kundizzjonijiet esfoljattivi tal-ġilda nkluż is-sindromu ta' Stevens-Johnson.
English: The absolute bioavailability of sitagliptin is approximately 87 %.
Maltese: sitagliptin hija madwar 87 %.
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isoenzymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Maltese: Tagħrif in vitro wera li sitagliptin mhuwiex impeditur ta' iżoenzimi CYP CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 jew 2B6, u mhuwiex induttur ta' CYP3A4 u CYP1A2.
English: Multi-pack containing 196 (2 packs of 98) film-coated tablets Multi-pack containing 168 (2 packs of 84) film-coated tablets
Maltese: Pakkett multiplu li fih 196 (2 pakketti ta' 98) pillola miksija b'rita Pakkett multiplu li fih 168 (2 pakketti ta' 84) pillola miksija b'rita
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
Maltese: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
English: Musculoskeletal and connective tissue disorders arthralgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja*
English: Immune system disorders hypersensitivity reactions including anaphylactic responses
Maltese: Disturbi fis-sistema immuni reazzjonijiet ta' sensittività eċċessiva inkluż risponsi anafilattiċi *,†
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u fl-anzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: Sitagliptin and metformin
Maltese: Sitagliptin u metformin
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: Ir-rata ta' eliminazzjoni ta' metformin mill-kliewi hija ta' > 400 mL/min, li tindika li metformin huwa eliminat permezz ta' filtrazzjoni glomerulari u tnixxija tubulari.
English: HbA1c (%) at week 26.
Maltese: HbA1c (%) f'ġimgħa 26.
English: • metformin belongs to a class of medicines called biguanides.
Maltese: • metformin jappartieni għall-klassi ta' mediċini msejħin biguanides.
English: Detailed information on this medicine is available on the website of the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Maltese: Fi studji kliniċi, sitagliptin ma bidilx b'mod sinifikanti l-farmkokinetika ta' metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontraċettivi orali, li tipprovdi evidenza in vivo ta' tendenza baxxa f'li jikkaġuna interazzjonijiet ma' sottostrati ta' CYP3A4, CYP2C8, CYP2C9, u t-trasportatur katijoniku organiku (OCT).
English: Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Maltese: Sitagliptin huwa sottostrat għal trasportatur-3 anijonju organiku tal-bniedem (hOAT-3), li jista' jkun involut f'eliminazzjoni ta' sitagliptin mill-kliewi.
English: The fraction of sitagliptin reversibly bound to plasma proteins is low (38 %).
Maltese: Il-frazzjoni ta' sitagliptin marbut riversibbilment mal proteini fil-plażma huwa wieħed baxx (38 %).
English: Table 3: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Maltese: Tabella 3: Rati tar-Riżultati Komposti Kardjovaskulari u Riżultati Sekondarji l-Aktar Importanti
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Maltese: Ġew irrappurtati reazzjonijiet avversi serji inkluż pankreatite u reazzjonijiet ta' sensittività eċċessiva.
English: The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Maltese: Ir-relevanza klinika ta' hOAT-3 fit-trasport ta' sitagliptin ma ġietx stabbilita.
English: • vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
Maltese: • vandetanib, mediċina użata għat-trattament ta' tip speċifiku ta' kanċer tat-tirojde (kanċer medullari tat-tirojde)
English: Maximum daily dose is 2000 mg.
Maltese: Doża massima ta' kuljum hi 2000 mg.
English: EU/1/10/620/002 EU/1/10/620/003 EU/1/10/620/004 EU/1/10/620/005 EU/1/10/620/006 EU/1/10/620/007 EU/1/10/620/008 EU/1/10/620/017 EU/1/10/620/019 EU/1/10/620/020
Maltese: EU/1/10/620/005 EU/1/10/620/006 EU/1/10/620/007 EU/1/10/620/008 EU/1/10/620/017 EU/1/10/620/019 EU/1/10/620/020
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %.
Maltese: 0.25 mg digoxin flimkien ma' 100 mg ta' sitagliptin kuljum għal 10 ijiem, l-AUC ta' digoxin filplażma żdiedet b'medja ta' 11 %, u s-Cmax tal-plażma b'medja ta' 18 %.
English: Ristfor combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Ristfor jikkumbina żewġ prodotti mediċinali kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni kumplimentari biex jitjieb il-kontroll gliċemiku f'pazjenti b'dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP-4), u metformin hydrochloride, li hu membru tal-klassi biguanide.
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
Maltese: • mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib)
English: The incidence of hypoglycaemia in the sitagliptin group (4.9 %) was significantly lower than that in the glipizide group (32.0 %).
Maltese: inċidenza ta' ipogliċemija fil-grupp ta' sitagliptin (4.9 %) kienet ferm aktar baxxa minn dik fil-grupp ta' glipizide(32.0 %).
English: The apparent terminal t½ following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Maltese: It- t½ terminali apparenti wara doża orali ta' 100 mg ta' sitagliptin kienet madwar 12.4-il siegħa.
English: OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Maltese: Trasport ta' sitagliptin medjat minn OAT3 kien imfixkel minn probenecid in vitro, għalkemm hemm ftit riskju ta' interazzjoni klinikament sinifikanti.
English: Maximum daily dose is 3000 mg.
Maltese: Doża massima ta' kuljum hi 3000 mg.
English: The incidence of hypoglycaemia was 24.9 % for patients treated with sitagliptin, metformin, and insulin and 37.8 % for patients treated with placebo, metformin, and insulin.
Maltese: L-inċidenza ta' ipogliċemija kienet ta' 24.9 % għall-pazjenti kkurati b'sitagliptin, metformin, u insulina u ta' 37.8 % f'pazjenti kkurati bi plaċebo, metformin, u insulina.
English: Maximum daily dose is 25 mg.
Maltese: Doża massima ta' kuljum hi 25 mg.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 µg/mL, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, livelli massimi ta' metformin filplażma (Cmax) ma qabżux 5 µg/mL, anke b'dożi massimi.
English: Sitagliptin accumulates only minimally with multiple doses.
Maltese: Sitagliptin jakkumula minimament biss b'dożi multipli.
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 - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mortalità relatata mad-dijabete: metformin 7.5 episodji/1,000 pazjenti-snin, dieta waħidha 12.7-il episodju/1,000 pazjenti-snin, p=0.017 - tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5-il episodju/1,000 pazjenti-snin kontra dieta waħidha 20.6 episodju/1,000 pazjenti-snin, (p=0.011), u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina 18.9-il episodju/1,000 pazjenti-snin (p=0.021) - tnaqqis sinifikanti fir-riskju assolut ta' infart majokardjali: metformin 11-il episodju/1,000 pazjenti-snin, dieta waħidha 18-il episodju/1,000 pazjenti-snin, (p=0.01).
English: Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of ciclosporin increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively.
Maltese: Għoti flimkien ta' doża orali waħda ta' 100 mg ta' sitagliptin u doża orali waħda ta' 600 mg ta' ciclosporin żied l-AUC u s-Cmax ta' sitagliptin b'madwar 29 % u 68 %, rispettivament.
English: Approximately 79 % of sitagliptin is excreted unchanged in the urine.
Maltese: Madwar 79% ta' sitagliptin huwa eliminat mhux mibdul fl-awrina.
English: Very rare: decreased vitamin B12 levels, hepatitis (a problem with your liver), hives, redness of the skin (rash) or itching
Maltese: Rari ħafna: tnaqqis fil-livelli ta' vitamina B12, epatite (problema tal-fwied), ħorriqija, ħmura tal-ġilda
English: Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Maltese: Żidiet minimi fi QTc, mhux ikkunsidrati klinikament relevanti, kienu osservati fi studju f'doża ta' 800 mg sitagliptin.
English: No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR]  60 mL/min).
Maltese: [GFR - glomerular filtration rate] ≥ 60 mL/min).
English: The effects of potent CYP3A4 inhibitors in the setting of renal impairment have not been assessed in a clinical study.
Maltese: L-effetti ta' impedituri qawwija ta' CYP3A4 fl-isfond ta' indeboliment tal-kliewi ma ġewx stmati fi studju kliniku.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimola sintesi ta' glajkoġen intraċellolari billi jaħdem fuq glycogen synthase.
English: 84 film-coated tablets.
Maltese: 84 pillola miksija b'rita.
English: In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Maltese: Barra minn hekk, il-kisja tarrita fiha: poly (vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), u iron oxide black (E172).
English: Sitagliptin 50 mg + metformin 500 mg (N=183)
Maltese: Sitagliptin 50 mg + metformin 500 mg
English: The reduction in HbA1c for patients treated with sitagliptin, metformin, and insulin was -1.35 % compared to -0.90 % for patients treated with placebo, metformin, and insulin, a difference of -0.45 % [95 % CI: -0.62, -0.29].
Maltese: It-tnaqqis fl-HbA1c għall-pazjenti kkurati b'sitagliptin, metformin, u insulina kien ta' -1.35 % meta mqabbel ma' -0.90 % għall-pazjenti kkurati bi plaċebo, metformin, u insulina, differenza ta' -0.45 % [CI ta' 95 %: -0.
English: Sitagliptin may be a mild inhibitor of p-glycoprotein in vivo.
Maltese: Sitagliptin jista' jkun impeditur dgħajjef ta' p-glycoprotein in vivo.
English: HbA1c (%) at week 24.
Maltese:  HbA1c (%) f'ġimgħa 24. ¶
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Maltese: L-evalwazzjoni għandha tinkludi elettroliti u ketoni fis-serum, zokkor fid-demm, u, jekk indikati, livelli ta' pH, lactate, pyruvate, u metformin fid demm.
English: Do not store above 30°C.
Maltese: Taħżinx f'temperatura ogħla minn 30°C.
English: Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Maltese: Frekwenza mhux magħrufa kondizzjonijiet ta' taqxir tal-ġilda inkluż issindrome ta' Stevens-Johnson*,†