FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was a composite of cardiovascular and renal complications.
Maltese: Ittragward finali primarju kien taħlita ta‟ kumplikazzjonijiet kardjovaskulari u renali.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Maltese: (INKLUŻA L-KAXXA Ċ-ĊELESTI) LI JKUN FIHA FOLJI PCTFE/PVC
English: 98 film-coated tablets
Maltese: 98 pillola miksija b‟rita
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Maltese: Għalkemm din ma ġietx investigata għal aliskiren, huwa magħruf li P-gp jikkontrolla wkoll it-teħid ta‟ varjetà ta‟ sottostrati mit-tessuti u inibituri ta‟ P-gp jistgħu jżidu l-proporzjon tal-konċentrazzjoni tat-tessuti mal-plażma.
English: The usual dose of Sprimeo for patients aged 65 years or older is 150 mg.
Maltese: Id-doża li s-soltu tingħata lil pazjenti ta‟ etajiet minn 65 sena ‟l fuq hija ta‟ 150 mg.
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Maltese: Għalhekk, interazzjonijiet minħabba l-inibizzjoni jew linduzzjoni ta‟ l-isoenzimi CYP450 mhumiex mistennija.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Sprimeo 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Maltese: Matul medda ta‟ 12-il ġimgħa, ilmonoterapija b‟aliskiren naqqset il-pressjoni sistolika/dijastolika tad-demm b‟14.0/5.1 mmHg, meta mqabbel mal-11.
English: Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole or verapamil (see section
Maltese: Għalhekk, għandha ssir kawtela meta aliskiren jingħata ma‟ inibituri ta‟ P-gp moderati bħal ketoconazole jew verapamil (ara sezzjoni
English: In this study, aliskiren 300 mg was compared to placebo when added to standard of care which included either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker.
Maltese: F‟dan l-istudju, aliskiren 300 mg kien imqabbel ma‟ plaċebo meta ġie miżjud ma‟ standard ta‟ kura li kien jinkludi jew impeditur tal-enzima li tikkonverti angiotensin, jew imblokkatur tar-riċetturi ta‟ angiotensin.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets
Maltese: 7 pilloli miksijin b‟rita 14-il pillola miksija b‟rita 28 pillola miksija b‟rita 30 pillola miksija b‟rita 50 pillola miksija b‟rita 56 pillola miksija b‟rita
English: In a study conducted in patients with end stage renal disease (ESRD) receiving haemodialysis, dialysis clearance of aliskiren was low (< 2% of oral clearance).
Maltese: Fi studju mwettaq f‟pazjenti b‟mard renali fl-aħħar stadju (ESRD) mogħtija l-emodijalisi, it-tneħħija ta‟ aliskiren waqt id-dijalisi kien baxx (< 2% tat-tneħħija orali).
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: L-użu konkomitanti ta‟ aliskiren ma‟ ARBs jew ACEIs huwa kontra-indikat f‟pazjenti b‟dijabete mellitus jew b‟indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: EU/1/07/407/001-010 EU/1/07/407/021-030
Maltese: EU/1/07/407/021-030
English: No controlled clinical data are available on the use of Sprimeo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Maltese: M‟hemmx tagħrif kliniku kkontrollat dwar l-użu ta‟ Sprimeo f‟pazjenti bi stenożi tal-arterja renali unilaterali jew bilaterali, jew fi stenożi f‟kilwa waħda.
English: You may need to stop Sprimeo.
Maltese: Jista‟ jkun li jkollok twaqqaf Sprimeo.
English: What Sprimeo looks like and contents of the pack Sprimeo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Sprimeo 150 mg pilloli miksijin b‟rita huma pilloli roża ċar, konvessi miż-żewġ naħat, tondi, ittimbrati „IL‟ fuq naħa u „NVR‟ fuq in-naħa l-oħra.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Fi żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
English: No additional blood pressure lowering effect was detected with 300 mg aliskiren compared to 150 mg aliskiren.
Maltese: Ma deher l-ebda effett ta‟ tnaqqis ieħor fil-pressjoni tad-demm meta ngħataw 300 mg aliskiren imqabbel ma‟ 150 mg aliskiren.
English: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Maltese: Il-fertilità, l-iżvilupp ta‟ qabel u wara t-twelid ma kienux effettwati fil-firien b‟dożi sa 250 mg/kg/jum.
English: Packs containing 98 (2x49) or 280 (20x14) tablets are multi-packs.
Maltese: Pakketti li jkun fihom 98 (2x49) jew 280 (20x14) pillola huma pakketti b‟ħafna.
English: As for any medicine that acts directly on the RAAS, Sprimeo should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Maltese: Bħal kull mediċina oħra li taħdem direttament fuq irRAAS, Sprimeo m‟għandux jintuża waqt l-ewwel trimestru tat-tqala jew f‟nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it-tieni u t-tielet trimestri (ara sezzjoni 4.3).
English: HOW TO STORE SPRIMEO
Maltese: deċiżjoni talKummissjoni
English: Component of a multipack comprising 3 packs, each containing 28 tablets.
Maltese: Jagħmel parti minn pakkett b‟ħafna li jkun fih 3 pakketti, kull wieħed ikun fih 28 pillola.
English: In experimental animals, it has been shown that P-gp is a major determinant of Sprimeo bioavailability.
Maltese: F‟annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-biodisponibilità ta‟ Sprimeo.
English: In the event of any signs suggesting a hypersensitivity reaction/angioedema (in particular difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, extremities, eyes, lips and/or tongue, dizziness) patients should discontinue treatment and contact the physician (see section 4.4).
Maltese: Każijiet ta‟ anġjoedima jew sintomi li jissuġġerixxu anġjoedima (nefħa fil-wiċċ, fix-xofftejn, filgerżuma u/jew fl-ilsien) kienu rrappurtati wkoll fl-esperjenza ta‟ wara t-tqegħid fis-suq.
English: Serum potassium: Increases in serum potassium have been observed with aliskiren and these may be exacerbated by concomitant use of other agents acting on the RAAS or by NSAIDs.
Maltese: Żidiet tal-potassium fis-serum ġew osservati b‟aliskiren, u dawn jistgħu jiġu aggravati bl-użu konkomitanti ta‟ aġenti oħra li jaħdmu fuq l-RAAS jew bl-użu ta‟ NSAIDs.
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3, 4.4 and 5.1).
Maltese: L-użu ta‟ aliskiren ma‟ ARBs jew ACEIs huwa kontra-indikat f‟pazjenti b‟dijabete mellitus jew b‟indeboliment renali (GFR < 60 ml/min/1.73 m2) u mhuwiex rakkomandat f‟pazjenti oħra (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: In addition, an updated RMP should be submitted:
Maltese: Emoglobina u ematokrit:
English: You should not take Sprimeo together with grapefruit juice.
Maltese: M‟għandekx tieħu Sprimeo mal-meraq tal-grejpfrut.
English: Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side.
Maltese: Pillola ħamra ċar, konvessa miż-żewġ naħat, f‟għamla ovali, ittimbrata „IU‟ fuq naħa u „NVR‟ fuq innaħa l-oħra.
English: Common (affecting less than 1 in 10 patients): Diarrhoea, joint pain (arthralgia), high level of potassium in the blood, dizziness.
Maltese: Effetti komuni (jeffettwaw anqas minn 1 f‟kull 10 pazjenti): Dijarrea, uġigħ fil-ġogi (artralġja), livell għoli ta‟ potassium fid-demm, sturdament.
English: EU/1/07/407/011-020 EU/1/07/407/031-040
Maltese: EU/1/07/407/031-040
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients
Maltese: L-użu konkomitanti ta‟ Sprimeo ma‟ ARBs jew ACEIs huwa kontra-indikat f‟pazjenti b‟indeboliment renali (GFR < 60 ml/min/1.73 m2) (ara sezzjoni
English: MA (EU) number
Maltese: Numru ta' l-EU
English: Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Poznańska 12 05-850 Ożarów Mazowiecki Poland
Maltese: Poznańska 12 05-850 Ożarów Mazowiecki
English: MSD France
Maltese: France MSD France
English: Opaque blisters (PVC/PE/PVDC and aluminum).
Maltese: Folji opaki (PVC/PE/PVDC u aluminju).
English: - The active substance is sitagliptin.
Maltese: - Is-sustanza attiva hija sitagliptin.
English: Rare: reduced number of platelets
Maltese: Rari: numru mnaqqas ta' plejtlets
English: MSD Italia S.r.l.
Maltese: Ιtalia MSD Italia S.r.l.
English: See section 4.4.
Maltese: Ara sezzjoni 4.4. ‡
English: The absolute bioavailability of sitagliptin is approximately 87 %.
Maltese: Ilbijodisponibiltà assoluta ta' sitagliptin hija bejn wieħed u ieħor 87 %.
English: (pancreatitis).
Maltese: (ipogliċemija).
English: Hazard Ratio (95% CI)
Maltese: (95 % CI)
English: Tel. +48 22 721 40 00 bioinfo@bioton.pl
Maltese: +48 22 721 40 00 bioinfo@bioton.pl
English: 2031 BN Haarlem The Netherlands
Maltese: Waarderweg 39 2031 BN Haarlem L-Olanda
English: Packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Maltese: Pakketti ta' 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'rita u 50 x 1 pillola miksija b'rita f'folji perforati ta' dożi uniċi.
English: Hypoglycaemia has been reported in combination with sulphonylurea (4.7 %-13.8 %) and insulin (9.6 %) (see section 4.4).
Maltese: Ipogliċemija kienet irrappurtata flimkien ma' sulphonylurea (4.7 %-13.8 %) u l-insulina (9.6 %) (ara sezzjoni 4.4).
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) e-mail@msd.de
English: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Maltese: Shotton Lane, Cramlington Northumberland NE23 3JU
English: MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no
Maltese: Tlf: +47 32 20 73 00 msdnorge@msd.no
English: In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and organic anion transporter-3 (OAT3).
Maltese: Studji ta' transport in vitro wrew li sitagliptin huwa sustrat għal p-glycoprotein u organic anion transporter-3 (OAT3).
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 16 December 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Marzu 2010
English: Faes Farma, S.A. Tel: +34 900 460 153 aweber@faes.es
Maltese: Tel: +34 900 460 153 aweber@faes.es
English: Merck Sharp & Dohme, inovativna zdravila d.o.o.
Maltese: Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.
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 sustrat għat-trasportatur-3 tal-anjonu organiku uman (hOAT-3 - human organic anion transporter-3), li jista' jkun involut fl-eliminazzjoni renali ta'
English: Gastrointestinal disorders constipation
Maltese: Disturbi gastrointestinali stitikezza
English: The renal clearance was approximately 350 ml/min.
Maltese: It-tneħħija renali hija bejn wieħed u ieħor 350 ml/min.
English: Common: flu
Maltese: Komuni: influwenza
English: Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Maltese: Frekwenza mhux magħrufa kondizzjonijiet ta' taqxir fil-ġilda inkluż is sindrome ta' Stevens-Johnson *,†
English: p-value
Maltese: Valur p†
English: Merck Sharp & Dohme Romania S.R.L.
Maltese: România Merck Sharp & Dohme Romania S.R.L.
English: Merck Sharp & Dohme Ireland (Human Health) Limited
Maltese: Ireland Merck Sharp & Dohme Ireland (Human Health)
English: Musculoskeletal and connective tissue disorders arthralgia
Maltese: Distubi muskoluskeletriċi u tat-tessuti konnettivi artralġja*
English: Danmark MSD Danmark ApS Tlf: +45 4482 4000 dkmail@merck.com
Maltese: Tlf: +45 4482 4000 dkmail@merck.com
English: Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Maltese: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b)
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 kienx jinibixxi transport permezz ta' OAT3 (IC50=160 µM) jew p-glycoprotein (sa 250 µM) f'konċentrazzjonijiet fil-plażma terapewtikament relevanti.
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Maltese: Ġew irrappurtati reazzjonijiet avversi serji inkluż pankrejatite u reazzjonijiet ta' sensittivtà eċċessiva.
English: Ristaben is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: Ristaben huwa membru ta' klassi ta' sustanzi anti-ipergliċemiċi orali li jissejħu inibituri ta' dipeptidyl peptidase 4 (DPP-4).
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
Maltese: Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
English: as triple oral therapy in combination with
Maltese: bħala terapija orali tripla f'kombinazzjoni ma'
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 biddilx b'mod sinifikanti l-effetti farmakokinetiċi ta' metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontraċettivi orali, u dan ipprovda evidenza in vivo ghal tendenza baxxa ta'interazzjonijiet ma' sustrati ta' CYP3A4, CYP2C8, CYP2C9, jew trasportatur organiku katjoniku (OCT).
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: The potential risk for humans is unknown.
Maltese: Il-potenzjal ta' riskju filbnedmin mhux magħruf.
English: The fraction of sitagliptin reversibly bound to plasma proteins is low (38 %).
Maltese: Il-porzjon ta' sitagliptin li hu marbut b'mod reversibbli mal-proteini tal-plażma huwa baxx (38 %).
English: Mean baseline HbA1c (%)
Maltese: Linja bażi medja HbA1c (%)
English: Sitagliptin 100 mg once daily (N= 193) Sitagliptin 100 mg once daily (N= 229)
Maltese: Sitagliptin 100 mg darba kuljum (N= 229)
English: Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29 % (0.01), 95 % CI (-0.32, -0.27); p < 0.001.
Maltese: Matul l-istudju, il-medja totali stmata (SD) tad-differenza f'HbA1c bejn il-gruppi ta' sitagliptin u lplaċebo kienet 0.29 % (0.01), CI ta' 95 % (-0.32, -0.27); p < 0.001.
English: Pharmacotherapeutic group: Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH01
Maltese: Mediċini użati fid-dijabete, inibituri ta' dipeptidyl peptidase 4 (DPP-4), Kodiċi ATC:
English: as monotherapy
Maltese: bħala monoterapija
English: Film coating: poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Maltese: talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
English: The apparent terminal t1/2 following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Maltese: Il-half-life terminali t1/2 apparenti wara doża orali ta' 100 mg ta' sitagliptin kienet ta' madwar 12.4-il siegħa.
English: Secondary Outcome
Maltese: Riżultat Sekondarju
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Maltese: Tagħrif in vitro wera li sitagliptin mhux inibitur tal-isoenzimi CYP, CYP3A4, 2C8, 2C9, 2D6, 1A2,
English: Incidence rate per patientyears* N (%)
Maltese: pazjent* N (%)
English: The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 1.3 %; metformin, 1.9 %).
Maltese: L-inċidenza ta' ipogliċemija ma kinitx ferm differenti bejn il-gruppi tal-kura (sitagliptin, 1.3 %; metformin, 1.9 %).
English: Merck Sharp & Dohme B.V. Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
English: The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
Maltese: Incretins huma parti mis-sistema endoġena li hija involuta fir-regolazzjoni fiżjoloġika tal-omeostażi tal-glucose.
English: Merck Sharp & Dohme Ges.m.b.H.
Maltese: Österreich Merck Sharp & Dohme Ges.m.b.H.
English: Metabolism and nutrition disorders hypoglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni ipogliċemija†
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti kif ġej: 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) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 50 x 1 pillola miksija b'rita
English: The mean dose of metformin was approximately 1,900 mg per day.
Maltese: Id-doża medja ta' metaformin kienet madwar 1,900 mg kuljum.
English: Respiratory, thoracic and mediastinal disorders interstitial lung disease
Maltese: Disturbi respiratorji, toraċiċi u medjastinali mard tal-interstizju tal-pulmun*
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4 and 4.8).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1 (ara sezzjoni 4.4 u 4.8).
English: Body weight decreased from baseline in both groups (sitagliptin, -0.6 kg; metformin -1.9 kg).
Maltese: Il-piż tal-ġisem naqas mil-linja bażi fiż-żewġ gruppi (sitagliptin, -0.6 kg; metformin -1.9 kg).
English: The tablet film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Maltese: 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), u yellow iron oxide (E172).
English: Baseline HbA1c was 8.74 % and baseline insulin dose was 37 IU/day.
Maltese: L-HbA1c fil-linja bażi kien ta' 8.74 % u d-doża tal-insulina fil-linja bażi kienet ta' 37 IU/jum.
English: All stroke (fatal and non-fatal)
Maltese: (fatali u mhux fatali)
English: After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (Per-Protocol Analysis).
Maltese: Wara 54 ġimgħa, it-tnaqqis medju ta' HbA1c mill-linja bażi kien -0.76 % b'sitagliptin u -0.64 % bi glipizide (Analiżi skont il-Protokoll).
English: Merck Sharp & Dohme d.o.o.
Maltese: Hrvatska Merck Sharp & Dohme d.o.o.
English: All myocardial infarction (fatal and non-fatal)
Maltese: Il-puplesiji kollha (fatali u mhux fatali)
English: HbA1c (%) at week 18.
Maltese: HbA1c (%) f'ġimgħa 18.
English: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Maltese: Tel: 8007 4433 (+356 99917558) malta_info@merck.com
English: • a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control.
Maltese: • agonist ta' peroxisome proliferator-activated receptor gamma (PPARγ) (jiġifieri thiazolidinedione) meta l-użu ta' agonist ta' PPARγ huwa xieraq u meta d-dieta u l-eżerċizzju flimkien mal-agonist ta' PPARγ waħedhom ma jipprovdux kontroll glikemiku adegwat.
English: The incidence of hypoglycaemia was similar across treatment groups.
Maltese: Linċidenza ta' ipogliċemija kienet simili għall-gruppi ta' trattament kollha.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' inibituri ta' DPP-4 ġie assoċjat ma' riskju li tiżviluppa pankreatite akuta.
English: The effect of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
Maltese: effett ta' inibituri qawwija ta' CYP3A4 fil-każ ta' indeboliment renali ma ġiex valutat fi studju kliniku.
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Maltese: Dawn ir-reazzjonijiet jinkludu anafilassi, anġjodema u kundizzjonijiet ta' ġilda li titqaxxar inkluż is-sindromu ta' Stevens-Johnson.
English: Adverse reactions are listed below (Table 1) by system organ class and frequency.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt (Tabella 1) skont is-sistema tal-klassifika tal-organi u l frekwenza.
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Maltese: Dawn kienu jinkludu ipogliċemija (frekwenza komuni ħafna b'sulphonylurea flimkien ma' metformin), influwenza (komuni bl-insulina (flimkien ma' metformin jew mingħajru)), nawsja u rimettar (komuni b'metformin), gass (komuni b'metformin jew pioglitazone), stitikezza (komuni b'sulphonylurea flimkien ma' metformin), edima periferali (komuni b'pioglitazone jew b'pioglitazone flimkien ma' metformin), ħedla ta' ngħas u dijarea (mhux komuni b'metformin), u ħalq xott (mhux komuni blinsulina (flimkien ma' metformin jew mingħajru)).
English: SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com
Maltese: Tel: +371 67364224 msd_lv@merck.com
English: Nervous system disorders headache
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras
English: Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com
Maltese: Tel: +46 77 5700488 medicinskinfo@merck.com
English: The incidence of hypoglycaemia in the sitagliptin group (4.9 %) was significantly lower than that in the glipizide group (32.0 %).
Maltese: L-inċidenza ta' ipogliċemija fil-grupp li kien qed jieħu sitagliptin (4.9 %) kienet inqas b'mod sinifikanti minn dik tal-grupp fuq glipizide (32.0 %).
English: The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Maltese: Ma ġietx stabbilita r-relevanza klinika ta' hOAT-3 fit-trasport ta' sitagliptin.