FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that the last dose be given to the child by the age of 20 to 22 weeks.
Maltese: Huwa rrakkomandat li l-aħħar doża tingħata meta t-tarbija jkollha minn 20 sa 22 ġimgħa.
English: When a baby is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally and carry the same or very similar antigens.
Maltese: Meta tarbija tingħata t-tilqima, is-sistema immunitarja (is-sistema li tiġġieled kontra l-mard) toħloq antikorpi kontra dawn l-antiġeni, li jgħinu fil-prevenzjoni ta' infezzjonijiet ikkawżati minn rotaviruses li jiżviluppaw b'mod naturali u jġorru l-istess antiġeni jew oħrajn simili ħafna.
English: The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'RotaTeq (li dehru f'aktar minn pazjent 1 minn kull 10) kienu piressija (deni), dijarrea u remettar.
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Maltese: B'mod rari ħafna (li deher f'inqas minn pazjent 1 minn kull 10,000), ġiet irrappurtata kundizzjoni serja msejħa intussuxezzjoni (fejn parti mill-musrana tintewa f'parti oħra tal-musrana, li jwassal għal imblokk) wara l-użu ta' vaċċini tar-rotavirus.
English: Why has RotaTeq been approved?
Maltese: Għaliex ġie approvat RotaTeq?
English: A risk management plan has been developed to ensure that RotaTeq is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li RotaTeq jintuża bl-aktar mod sigur possibbli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq on 27 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal RotaTeq valida fl-Unjoni Ewropea kollha fis-27 ta' Ġunju 2006.
English: An antigen is a specific structure that the body can recognise as ‘foreign' and against which the body can make an antibody, a special protein that can neutralise or destroy the antigen.
Maltese: Antiġen huwa struttura speċifika li l-ġisem jista' jagħrafha bħala ‘barranija' u jista' joħloq antikorp kontriha, proteina speċjali li tista' tinnewtralizza jew tkisser l-antiġen.
English: What is the risk associated with RotaTeq?
Maltese: X'inhu r-riskju assoċjat ma' RotaTeq?
English: The number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq.
Maltese: L-għadd ta' każi ta' rotavirus gastroenterite kkaġunat mill-viruses bl-istess antiġeni tal-vaċċin naqas wara l-vaċċinazzjoni b'RotaTeq.
English: What is RotaTeq?
Maltese: Kif jintuża RotaTeq?
English: The main measure of effectiveness, which was studied in 6,000 babies, was the number of babies who developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Maltese: Ilkejl ewlieni tal-effikaċja, li ġiet studjata f'6,000 tarbija, kien l-għadd ta' trabi li żviluppaw ir-rotavirus gastroenterite matul l-istaġun sussegwenti ta' rotavirus (iż-żmien tas-sena meta huwa magħruf li rrotaviruses jiċċirkolaw u jikkawżaw infezzjoni, is-soltu matul ix-xhur friski tax-xitwa sal-bidu tarrebbiegħa).
English: RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past.
Maltese: RotaTeq ma għandux jintuża fuq trabi li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanza attiva jew għal xi ingredjent ieħor tiegħu, jew li jkunu wrew sinjali ta' allerġija wara l-għoti ta' doża ta' RotaTeq jew ta' xi tilqima oħra kontra r-rotavirus fl-imgħoddi.
English: RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' RotaTeq huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Maltese: RotaTeq jista' jingħata lil trabi prematuri, dment li t-tqala tkun damet mill-inqas 25 ġimgħa.
English: For the full list of all side effects reported with RotaTeq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'RotaTeq, ara l-fuljett ta' tagħrif.
English: About half of the babies received RotaTeq, and the others received placebo (a dummy vaccine).
Maltese: Madwar nofs it-trabi ngħataw RotaTeq, u n-nofs l-ieħor ingħataw plaċebo (vaċċin finta).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RotaTeq, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' RotaTeq, inklużi l-prekawzjonijiet xierqa li jridu jkunu segwiti millprofessjonisti tal-kura tas-saħħa u l-pazjenti.
English: How does RotaTeq work?
Maltese: Għal xiex jintuża RotaTeq?
English: How has RotaTeq been studied?
Maltese: Kif ġie studjat RotaTeq?
English: Ref. EMEA/270168/2008
Maltese: EMEA/331182/2008
English: What is DuoCover?
Maltese: X'inhi DuoCover?
English: It was to be available as tablets containing 75 mg clopidogrel plus 75 mg acetylsalicylic acid, and as tablets containing 75 mg clopidogrel plus 100 mg acetylsalicylic acid.
Maltese: Din kellha tkun disponibbli bħala pilloli li fihom 75mg ta' clopidrogel u 75mg ta' aċidu aċetilsaliċiliku, u pilloli li fihom 75mg clopidogrel u 100mg ta' aċidu aċetilsaliċiliku.
English: On 23 May 2008, Bristol Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoCover for the prevention of atherothrombotic events.
Maltese: Fit-23 ta' Mejju 2008, Bristol Myers Squibb Pharma EEIG għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) li kienet tixtieq tirtira l-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq għal DuoCover, għat-trattament ta' każijiet aterotrombotiċi.
English: It was expected to be used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as ‘acute coronary syndrome'.
Maltese: Kienet mistennija li tintuża sabiex tipprevjeni każijiet aterotrombotiċi (problemi ikkawżati minn emboli u minn arterji li jkunu ibbiesu) f'pazjenti li jkollhom kundizzjoni magħrufa bħala ‘sindromu koronarju akut'.
English: Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for the prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
Maltese: Clopidrogel waħdu kien ġie approvat mill-UE taħt l-ismijiet Iscover u Plavix, għall-prevenzjoni ta' każijiet aterotrombotiċi, flimkien ma' aċidu aċetilsaliċiliku f'pazjenti b'sindromu koronarju akut.
English: How is DuoCover expected to work?
Maltese: Kif inhi mistennija li taħdem DuoCover?
English: DuoCover was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Maltese: DuoCover kienet mistennija li tintuża f'pazjenti adulti li kienu diġà qed jieħdu clopidrogel u aċidu aċetilsaliċiliku f'pilloli separati.
English: It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: Kienet ukoll mistennija li tintuża f'pazjenti li ma kelhomx dan il-qari mhux normali fuq lECG, fil-każ li kellhom anġina mhux stabbli (uġigħ sever fis-sider) jew infart mijokardiku ‘non-Qwave' u li jkun iddaħlilhom stent (tubu qasir li jibqa' fl-arterja biex iwaqqafha milli tingħalaq).
English: This included patients who were having an acute myocardial infarction (heart attack) with an ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thought that they would have benefited from the treatment.
Maltese: Dan kien jinkludi pazjenti li kien qed ikollhom infart mijokardiku akut (attack tal-qalb) b'elevazzjoni tas-segment ST' (qari mhux normali fuq lelettrokardjogramm jew l-ECG) fil-każ li t-tabib ikun ikkunsidra li l-pazjenti kienu jibbenefikaw mittrattament.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoCover?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għall-pazjenti li kienu qed jieħdu sehem fi studji kliniċi / programmi ta' użu b'kumpassjoni b'DuoCover?
English: The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoCover or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Maltese: Il-kumpanija infurmat lis-CHMP li ma kien hemm l-ebda konsegwenza għall-pazjenti li kienu ippjanati sabiex jiġu inklużi fil-provi kliniċi b'DuoCover jew għall-pazjenti li kienu attwalment inklużi fil-provi kliniċi bi clopidrogel u bl-aċidu aċetilsaliċiliku bħala mediċini separati.
English: DuoCover is a medicine containing two active substances clopidogrel and acetylsalicylic acid in one tablet.
Maltese: DuoCover hija mediċina li fiha żewġ sustanzi attivi clopidogrel u aċidu aċetilsaliċiliku li jinsabu f'pillola waħda.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP kien evalwa t-tweġibiet mill-kumpanija għal-lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendent li baqgħu ma ġewx solvuti.
English: The active substances in DuoCover, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoCover to reduce the number of tablets the patients need to take every day.
Maltese: Is-sustanzi attivi f'DuoCover, clopidogrel u aċidu aċetilsaliċiliku jinsabu mħallata f'pillola waħda f'DuoCover sabiex jitnaqqas in-numru ta' pilloli li l-pazjenti jkollhom bżonn jieħdu kuljum.
English: MSD Italia S.r.l.
Maltese: Italia MSD Italia S.r.l.
English: Acute pancreatitis a,*,b,2
Maltese: Pankreatite akutaa,*,b,2
English: Steglujan is available in Alu/PVC/PA/Alu blisters.
Maltese: Steglujan huwa disponibbli f'folji tal-Alu/PVC/PA/Alu.
English: • osteoarthritis
Maltese: • osteoartrite
English: Hypoglycaemia has been reported in combination with sulphonylurea (4.7%-13.8%) and insulin (9.6%) (see section 4.4).
Maltese: Ipogliċemija ġiet irrappurtata flimkien ma' sulphonylurea (4.7%-13.8%) u mal-insulina (9.6%) ara sezzjoni 4.4).
English: Patients [N (%)] with HbA1c < 7% 66 (26.4) Body weight (kg)
Maltese: Pazjenti [N (%)] b'HbA1c < 7% 66 (26.4) Piż tal-ġisem (kg)
English: EU/1/18/1266/007 (14 film-coated tablets) EU/1/18/1266/008 (28 film-coated tablets) EU/1/18/1266/009 (30 film-coated tablets) EU/1/18/1266/010 (30x1 film-coated tablets) EU/1/18/1266/011 (84 film-coated tablets) EU/1/18/1266/012 (90 film-coated tablets) EU/1/18/1266/014 (98 film-coated tablets)
Maltese: EU/1/18/1266/007 (14-il pillola miksija b'rita) EU/1/18/1266/008 (28 pillola miksija b'rita) EU/1/18/1266/009 (30 pillola miksija b'rita) EU/1/18/1266/010 (30x1 pillola miksija b'rita) EU/1/18/1266/011 (84 pillola miksija b'rita) EU/1/18/1266/012 (90 pillola miksija b'rita) EU/1/18/1266/014 (98 pillola miksija b'rita)
English: Microcrystalline cellulose (E460) Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Sodium stearyl fumarate (E487) Magnesium stearate (E470b)
Maltese: Microcrystalline cellulose (E460) Calcium hydrogen phosphate (anidru) Croscarmellose sodium Sodium stearyl fumarate (E487) Magnesium stearate (E470b)
English: EU/1/18/1266/001 (14 film-coated tablets) EU/1/18/1266/002 (28 film-coated tablets) EU/1/18/1266/003 (30 film-coated tablets) EU/1/18/1266/004 (30x1 film-coated tablets) EU/1/18/1266/005 (84 film-coated tablets) EU/1/18/1266/006 (90 film-coated tablets) EU/1/18/1266/013 (98 film-coated tablets)
Maltese: EU/1/18/1266/001 (14-il pillola miksija b'rita) EU/1/18/1266/002 (28 pillola miksija b'rita) EU/1/18/1266/003 (30 pillola miksija b'rita) EU/1/18/1266/004 (30x1 pillola miksija b'rita) EU/1/18/1266/005 (84 pillola miksija b'rita) EU/1/18/1266/006 (90 pillola miksija b'rita) EU/1/18/1266/013 (98 pillola miksija b'rita)
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1)
Maltese: (Għal riżultati tal-istudji dwar kombinazzjonijiet u effetti fuq il-kontroll gliċemiku, ara sezzjonijiet 4.4, 4.5, u 5.1.)
English: Across the 3 studies, 16.2% to 29.9% of patients were ≥ 65 years of age and 2.3% to 2.8% were ≥ 75 years of age.
Maltese: Fit-3 studji, 16.2% sa 29.9% talpazjenti kellhom età ≥ 65 sena u 2.3% sa 2.8% kellhom età ≥ 75 sena.
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' inibituri ta' dipeptidyl peptidase-4 (DPP-4) ġie assoċjat ma' riskju li tiżviluppa pankreatite akuta.
English: Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172) Carnauba wax (E903)
Maltese: Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Iron oxide aħmar (E172) Iron oxide isfar (E172) Iron oxide iswed (E172) Carnauba Wax (E903)
English: See “Description of selected adverse reactions” for frequencies and see section 4.4.
Maltese: Ara “Deskrizzjoni ta' reazzjonijiet avversi magħżula” għall-frekwenzi u ara sezzjoni 4.4.
English: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)
Maltese: sodium u glucose (SGLT2, sodium u glucose co-transporter-2).
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 fl-HbA1c bejn il-gruppi ta' sitagliptin u talplaċebo kienet 0.29 % (0.01), CI ta' 95 % (-0.32, -0.27); p < 0.001.
English: Do not take Steglujan
Maltese: Tiħux Steglujan
English: Myalgia a,2
Maltese: Mijalġja a,2
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 inibixxiex transport permezz ta' OAT3 (IC50=160 µM) jew p-glycoprotein (sa 250 µM) f'konċentrazzjonijiet rilevanti b'mod terapewtiku fil-plażma.
English: Exfoliative skin conditions including Stevens-Johnson syndrome a,
Maltese: Kondizzjonijiet ta' tqaxir fil-ġilda inkluż is-sindrome ta' Stevens-Johnsona,*,2
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyses the incretin hormones to produce inactive products.
Maltese: L-attività ta' GLP-1 u GIP hija limitata mill-enzima DPP-4, li malajr tidrolizza l-ormoni incretin biex tipproduċi prodotti inattivi.
English: There is limited experience with Steglujan in patients ≥ 75 years of age.
Maltese: Hemm esperjenza limitata b'Steglujan f'pazjenti ta' ≥ 75 sena.
English: In vitro transport studies showed that sitagliptin is a substrate for P-gp and OAT3.
Maltese: Studji ta' transport in vitro wrew li sitagliptin huwa sustrat għal P-gp u OAT3.
English: Мерк Шарп и Доум България ЕООД Teл.
Maltese: България Мерк Шарп и Доум България ЕООД
English: Hazard Ratio (95% CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95%) valur p†
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Maltese: Ġew irrappurtati reazzjonijiet avversi serji inklużi pankreatite u reazzjonijiet ta' sensittività eċċessiva.
English: Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were LDL-C 5.8% and 8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, HDL-C 6.2% and 7.6% versus 1.9%.
Maltese: Bidliet perċentwali medji mil-linja bażi għal ertugliflozin 5 mg u 15-il mg versus plaċebo, rispettivament, kienu LDL-C 5.8% u 8.4% versus 3.2%; kolesterol totali 2.8% u 5.7% versus 1.1%. madankollu, HDL-C 6.2% u 7.6% versus 1.9%.
English: o Tablet coat: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).
Maltese: o Kisja tal-pillola: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide aħmar (E172), iron oxide isfar (E172), iron oxide iswed (E172), carnauba wax (E903).
English: • Sitagliptin belongs to a group of medicines called DPP-4 (dipeptidyl peptidase-4) inhibitors.
Maltese: • Sitagliptin jappartieni għall-grupp ta' mediċini msejħa inibituri ta' DPP-4 (dipeptidyl peptidase-4).
English: • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Maltese: • f'pazjenti li diġà qed jiġu ttrattati bil-kombinazzjoni ta' ertugliflozin u sitagliptin bħala pilloli separati.
English: Sitagliptin is not a substrate for OCT2 or OAT1 or peptide transporter 1/2 (PEPT1/2) transporters.
Maltese: Sitagliptin mhux sustrat għat-trasportaturi OCT2 jew OAT1 jew għat-trasportatur 1/2 talpeptides (PEPT1/2, peptide transporter 1/2).
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-anjoni organiċi talbniedem (hOAT-3, human organic anion transporter-3), li jista' jkun involut fl-eliminazzjoni ta' sitagliptin mill-kliewi.
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 OCT. Sitagliptin may be a mild inhibitor of P-gp in vivo.
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, u OCT. Sitagliptin jista' jkun inibitur ħafif ta' P-gp in vivo.
English: The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
Maltese: L-incretins huma parti minn sistema endoġena li hija involuta fir-regolazzjoni fiżjoloġika tal-omeostasi tal-glucose.
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: Data in vitro uriet li sitagliptin mhuwiex inibitur tal-isoenzimi CYP, CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 jew 2B6, u mhuwiex induttur ta' CYP3A4 u CYP1A2.
English: • bullous pemphigoid (a type of skin blister)
Maltese: • pemfigoid bulluż (tip ta' nuffata fil-ġilda)
English: Steglujan 5 mg/100 mg film-coated tablets EU/1/18/1266/001
Maltese: Pilloli Steglujan 5 mg/100 mg miksijin b'rita EU/1/18/1266/001
English: Steglujan 15 mg/100 mg film-coated tablets EU/1/18/1266/007
Maltese: Pilloli Steglujan 15 mg/100 mg miksijin b'rita EU/1/18/1266/007
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Maltese: Dawn ir-reazzjonijiet jinkludu anafilassi, anġjoedima u kondizzjonijiet ta' ġilda li titqaxxar inkluża s-sindrome ta' Stevens-Johnson.
English: Patients with an eGFR < 30 ml/min/1.73 m2 were not to be enrolled in the study.
Maltese: Pazjenti b'eGFR < 30 ml/min/1.73 m2 ma ġewx irreġistrati fl-istudju.
English: Efficacy in patients with baseline HbA1c ≥ 10%
Maltese: Effikaċja f'pazjenti b'HbA1c ≥ 10% fil-linja bażi
English: • The other ingredients are: o Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate (anhydrous), croscarmellose sodium, sodium stearyl fumarate (E487), magnesium stearate (E470b).
Maltese: o Qalba tal-pillola: microcrystalline cellulose (E460), calcium hydrogen phosphate (anidru), croscarmellose sodium, sodium stearyl fumarate (E487), magnesium stearate (E470b).
English: Patients [N (%)] with HbA1c <7% Body Weight (kg)
Maltese: u CI ta' Pazjenti [n (%)] b'HbA1c < 7% Piż tal-ġisem (kg)
English: In drug interaction studies, sitagliptin did not have clinically meaningful effects on the pharmacokinetics of the following: metformin, rosiglitazone, glyburide, simvastatin, warfarin, and oral contraceptives.
Maltese: Effetti ta' sitagliptin fuq prodotti mediċinali oħra Fi studji dwar interazzjoni bejn il-mediċini, sitagliptin ma kellux effetti ta' sinifikat kliniku fuq ilfarmakokinetika ta' dawn li ġejjin: metformin, rosiglitazone, glyburide, simvastatin, warfarin, u kontraċettivi mill-ħalq.
English: After 26-weeks of treatment, the combination of ertugliflozin 5 mg or 15 mg and sitagliptin 100 mg resulted in statistically significant reductions in systolic blood pressure (SBP) compared to sitagliptin alone (-2.8 and -3.0 mmHg for E5/S100 and E15/S100 respectively) or placebo (-4.4 and -6.4 mmHg for E5/S100 and E15/S100, respectively).
Maltese: Wara trattament ta' 26 ġimgħa, il-kombinazzjoni ta' ertugliflozin 5 mg jew 15-il mg u sitagliptin 100 mg wasslet għal tnaqqis sinifikanti b'mod statistiku fil-pressjoni sistolika tad-demm (SBP, systolic blood pressure) meta mqabbla ma' sitagliptin waħdu (-2.8 u -3.0 mmHg għal E5/S100 u E15/S100 rispttivament) jew plaċebo (-4.4 u -6.4 mmHg għal E5/S100 u E15/S100, rispettivament).
English: Other medicines and Steglujan
Maltese: Mediċini oħra u Steglujan
English: Steglujan is expected to have diminished efficacy in elderly patients with renal impairment (see sections 4.2 and 4.8).
Maltese: Steglujan huwa mistenni li jkollu effikaċja mnaqqsa f'pazjenti anzjani b'indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.8).
English: The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Maltese: Ma ġietx stabbilita r-rilevanza klinika ta' hOAT-3 fit-trasport ta' sitagliptin.
English: The combination of ertugliflozin 5 or 15 mg with sitagliptin resulted in statistically significant placebo-corrected reductions in 2-hour PPG of 3.46 and 3.87 mmol/l.
Maltese: Il-kombinazzjoni ta' ertugliflozin 5 jew 15-il mg ma' sitagliptin wasslet għal tnaqqis sinifikanti b'mod statistiku kkoreġut mill-plaċebo ta' 3.46 u 3.87 mmol/l fil-PPG wara sagħtejn.
English: Arthralgia a,2
Maltese: Artralġja a,2
English: Ertugliflozin and Sitagliptin
Maltese: Ertugliflozin u Sitagliptin
English: In vitro studies indicate that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Maltese: Studji in vitro indikaw li l-enzima primarja responsabbli għall-metaboliżmu limitat ta' sitagliptin kienet CYP3A4, b'kontribuzzjoni minn CYP2C8.