FrancophonIA/ELRC3.0 huggingface dataset:
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: Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality)
Maltese: Puplesija Mhux Fatali * B'kollox kien hemm 153 individwu (5.7%) fil-grupp ta' alogliptin u 173 individwu (6.5%) fil-grupp tal-plaċebo li mietu (mortalità minn kull kawża)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/001-026
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/843/001-026
English: Vipdomet is available in blister packs containing 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 tablets and in multipacks comprising 2 packs each containing 98 film-coated tablets.
Maltese: Vipdomet huwa disponibbli f'pakketti b'folji li fihom 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 200 pilloli u f'pakketti multipli li fihom 2 pakketti ta' 98 pillola miksja b'rita kull wieħed.
English: It also increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Huwa jżid ukoll il-kapaċità ta' ġarr ta' tipi speċifiċi ta' trasportaturi tal-glukożju fir-riti (GLUT-1 u GLUT-4).
English: In the alogliptin group, 11.3% of patients experienced a MACE compared to 11.8% of patients in the placebo group.
Maltese: alogliptin, 11.3% tal-pazjenti kellhom MACE meta mqabbel ma' 11.8% tal-pazjenti fil-grupp tal-plaċebo.
English: Medicinal products with intrinsic hyperglycaemic activity Glucocorticoids (given by systemic and local routes), beta-2-agonists and diuretics (see also section 4.4) have intrinsic hyperglycaemic activity.
Maltese: Prodotti mediċinali b'attività ipergliċemika intrinsika Glukokortikojdi (mogħtija permezz ta' rotot sistemiċi u lokali), agonisti ta' beta-2 u dijuretiċi (ara wkoll sezzjoni 4.4) għandhom attività ipergliċemika intrinsika.
English: A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = >50 to ≤80 mL/min), moderate (CrCl = ≥30 to ≤50 mL/min), severe (CrCl = <30 mL/min) and end-stage renal disease on haemodialysis.
Maltese: Doża waħda ta' 50 mg alogliptin kienet mogħtija lil 4 gruppi ta' pazjenti bi gradi diversi ta' indeboliment tal-kliewi (CrCl permezz tal-formula Cockcroft-Gault): ħafifa (CrCl = >50 sa ≤80 mL/min), moderata (CrCl = ≥30 sa ≤50 mL/min), severa (CrCl = <30 mL/min) u mard tal-kliewi tal-aħħar stadju fuq emodijalisi.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu: 196 (2 pakketti ta' 98) pillola miksija b'rita
English: LOCF = last observation carried forward *Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Maltese: LOCF = last observation carried forward - l-aħħar osservazzjoni mmexxija 'l quddiem * Noninferjorità u superjorità murija statistikament †
English: INFORMATION IN BRAILLE Vipdomet 12.5 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Vipdomet 12.5 mg/850 mg
English: Adults (≥18 years old) with normal renal function (glomerular filtration rate (GFR)≥90 mL/min) The dose should be individualised on the basis of the patient's current treatment regimen.
Maltese: Adulti (≥18-il sena) b'funzjoni renali normali (filtrazzjoni glomerulari stmata (GFR)≥90 mL/min) Id-doża għandha tkun individwalizzata abbażi tal-programm ta' kura attwali tal-pazjent.
English: However, it may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Maltese: B12 (eż. anemija megaloblastika).
English: INFORMATION IN BRAILLE Vipdomet 12.5 mg/1,000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Vipdomet 12.5 mg/1,000 mg
English: Alogliptin is a potent and highly selective inhibitor of DPP-4, >10,000-fold more selective for DPP-4 than other related enzymes including DPP-8 and DPP-9.
Maltese: Alogliptin huwa impeditur qawwi u selettiv ħafna ta' DPP-4, >10,000-darba aktar silettiv għal DPP-4 minn enzimi relatati oħra fosthom DPP-8 u DPP-9.
English: Results from clinical interaction studies also demonstrate that there are no clinically relevant effects of gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 inhibitor), cyclosporine (a p-glycoprotein inhibitor), voglibose (an alpha-glucosidase inhibitor), digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin.
Maltese: Riżultati minn studji ta' interazzjoni klinika juru wkoll li m'hemm l-ebda effetti klinikament rilevanti ta' gemfibrozil (impeditur ta' CYP2C8/9), fluconazole (impeditur ta' CYP2C9), ketoconazole (impeditur ta' CYP3A4), cyclosporine (impeditur ta' p-glycoprotein), voglibose (impeditur ta' alfa-glucosidase), digoxin, metformin, cimetidine, pioglitazone jew atorvastatin fuq il-farmakokinetika ta' alogliptin.
English: A study conducted in seven normal healthy volunteers showed that cimetidine (400 mg twice daily) increased metformin systemic exposure (area under the curve, AUC) by 50% and Cmax by 81%.
Maltese: Studju li sar f'seba' voluntiera b'saħħithom normali wera li cimetidine (400 mg darbtejn kuljum) żied l-espożizzjoni sistemika ta' metformin (erja taħt il-kurva, AUC) b'50% u Cmax bi 81%.
English: - alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Maltese: - alogliptin jappartjeni għal grupp ta' mediċini li jissejħu impedituri ta' DPP-4 (impedituri ta' dipeptidyl peptidase-4).
English: Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with metformin (n=203)
Maltese: Studji b'terapija kombinata aġġuntiva bil-plaċebo bħala kontroll Alogliptin 25 mg darba kuljum ma' metformin (n = 203)
English: Total and peak exposure to alogliptin increased proportionately across single doses of 6.25 mg up to 100 mg alogliptin (covering the therapeutic dose range).
Maltese: L-espożizzjoni totali u massima għal alogliptin żdied proporzjonalment f'medda ta' dożi singoli ta' 6.25 mg sa 100 mg alogliptin (li jkopru medda tad-dożi terapewtiċi).
English: Alogliptin exists predominantly as the (R)-enantiomer (>99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Maltese: Alogliptin jeżisti prinċipalment bħala l-(R)-enantiomer (>99%) u jgħaddi minn ftit jew xejn konverżjoni kirali in vivo għall-(S)-enantiomer.
English: Table 2: Change in HbA1c (%) from baseline with alogliptin 25 mg at Week 26 by placebo-controlled study (FAS, LOCF)
Maltese: Tabella 2: Studju dwar bidla fl-HbA1c (%) mil-linja bażi b' alogliptin 25 mg f'Ġimgħa 26 bi plaċebo (FAS, LOCF)
English: Alogliptin 25 mg once daily with a thiazolidinedione ± metformin or a sulphonylurea (n=195)
Maltese: Alogliptin 25 mg darba kuljum ma' thiazolidinedione ± metformin jew sulphonylurea (n = 195)
English: Alogliptin 25 mg once daily with a thiazolidinedione + metformin vs a titrating thiazolidinedione + metformin
Maltese: Alogliptin 25 mg darba kuljum b'thiazolidinedione + metformin vs thiazolidinedione ittitrat u metformin
English: Nervous system disorders headache common common metallic taste common
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras komuni komuni togħma metallika komuni
English: However, mean peak plasma concentrations of alogliptin and metformin were decreased by 13% and 28% when Vipdomet was administered with food, respectively.
Maltese: Madankollu, l-ogħla konċentrazzjonijiet medji fil-plażma ta' alogliptin u metformin tnaqqsu bi 13% u 28% meta Vipdomet kien mogħti mal-ikel, rispettivament.
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), not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In these studies, 696 alogliptin/metformin-treated patients were ≥ 65 years old.
Maltese: F'dawn l-istudji, 696 pazjent trattat b'alogliptin/metformin kellhon ≥65 sena.
English: 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 60 film-coated tablets 98 film-coated tablets 112 film-coated tablets 120 film-coated tablets 180 film-coated tablets 196 film-coated tablets 200 film-coated tablets
Maltese: 10 pilloli miksija b'rita 14-il pillola miksija b'rita 20 pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 98 pillola miksija b'rita 112-il pillola miksija b'rita 120 pillola miksija b'rita 180 pillola miksija b'rita 196 pillola miksija b'rita 200 pillola miksija b'rita
English: The overall incidence of episodes of severe hypoglycaemia was comparable in patients treated with 25 mg alogliptin or 12.5 mg alogliptin, and lower than the incidence in patients treated with active control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Maltese: L-inċidenza globali ta' episodji ta' ipogliċemija severa kienet komparabbli f'pazjenti kkurati b'25 mg ta' alogliptin jew alogliptin 12.5 mg, u inqas millinċidenza f'pazjenti kkurati b'kontroll attiv jew plaċebo (0.1%, 0.1%, 0.4% u 0.4%, rispettivament).
English: PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 98 pilloli miksija b'rita
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8) - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR <30 mL/min) - Acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - Acute or chronic disease which may cause tissue hypoxia (see section 4.4) such as: - cardiac or respiratory failure - recent myocardial infarction - shock - Hepatic impairment (see section 4.4) - Acute alcohol intoxication, alcoholism (see sections 4.4 and 4.5)
Maltese: - Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 jew storja medika ta' reazzjoni serja ta' sensittività eċċessiva, li tinkludi reazzjoni anafilattika, xokk anafilattiku, u anġjoedema, għal kwalunkwe inibituri ta' peptidylpeptidase-4 (DPP-4) (ara sezzjonijiet 4.4 u 4.8) - Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika) - Prekoma dijabetika - Insuffiċjenza renali severa (GFR <30 mL/min) - Kondizzjonijiet akuti bil-potenzjal li l-funzjoni renali tinbidel bħal: - deidratazzjoni - infezzjoni severa - xokk
English: Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
Maltese: Alogliptin huwa prinċipalment eliminat mhux mibdul fl-awrina u l-metaboliżmu bis-sistema tal-enzimi ta' cytochrome (CYP) P450 hu negliġibbli (ara sezzjoni 5.2).
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, angiotensinconverting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, impedituri tal-enzima li tikkonverti angiotensin (ACE, angiotensin converting enzyme), antagonisti tar-riċetturi ta' angiotensin II u dijuretiċi, speċjalment dijuretiċi loop.
English: For symptoms see section “Warnings and precautions”.
Maltese: Għas-sintomi ara sezzjoni “Twissijiet u prekawzjonijiet”.
English: Studies in pregnant rats with alogliptin plus metformin as combination treatment have shown reproductive toxicity (see section 5.3) at approximately 5-20 times (for metformin and alogliptin respectively) the human exposure at the recommended dose.
Maltese: Studji fil-firien tqal b'alogliptin flimkien ma' b'metformin bħala trattament ta' kombinazzjoni urew effetti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3) b'madwar 5-20 darba (għal metformin u alogliptin rispettivament) tal-esponiment tal-bniedem fid-doża rakkomandata.
English: Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Vipdomet (see section 4.4).
Maltese: Il-pankreatite akuta hija reazzjoni avversa serja attribwita għall-komponent ta' alogliptin f'Vipdomet (ara sezzjoni 4.4).
English: Alogliptin 25 mg once daily with a sulphonylurea (n=197)
Maltese: Alogliptin 25 mg darba kuljum ma' sulphonylurea (n=197)
English: Metabolism and nutrition disorders lactic acidosis very rare vitamin B12 deficiency very rare hypoglycaemia common common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni aċidożi lattika rari ħafna defiċjenza ta' vitamina
English: Alogliptin as add-on therapy to metformin
Maltese: Alogliptin bħala terapija aġġuntiva ma' metformin
English: Interactions with metformin
Maltese: Interazzjonijiet ma' metformin
English: In rats no treatment-related foetal abnormalities occurred following concomitant administration at exposure margins of approximately 28- to 29-fold for alogliptin and 2- to 2.5-fold for metformin at the maximum recommended human dose of 25 mg/day and 2,000 mg/day, respectively.
Maltese: Fil-firien l-ebda anormalità tal-feti relatata mal-kura ma seħħet wara l-għoti fl-istess ħin fil-marġini ta' esponiment ta' madwar 28 sa 29 darba għal alogliptin u minn 2 sa 2.5 darbiet għal metformin fid-doża massima rakkomandata għall-bniedem ta' 25 mg/jum u 2,000 mg/jum, rispettivament.
English: Significantly more patients receiving 12.5 mg alogliptin and 1.000 mg metformin hydrochloride twice daily (59.5%) achieved target HbA1c levels of < 7.0% compared to those receiving either 12.5 mg alogliptin twice daily alone (20.2%, p<0.001) or 1,000 mg metformin hydrochloride twice daily alone (34.3%, p<0.001) at Week 26.
Maltese: B'mod sinifikanti aktar pazjenti li rċevew 12.5 mg alogliptin u 1,000 mg metformin hydrochloride darbtejn kuljum (59.5%) kisbu livelli fil-mira ta' HbA1c ta' < 7.0% meta mqabbel ma' dawk li qed jirċievu jew 12.5 mg ta' alogliptin darbtejn kuljum biss (20.2%, p<0.001) jew 1,000 mg metformin hydrochloride darbtejn kuljum waħdu (34.3%, p<0.001) f'Ġimgħa 26.
English: Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) b'fojl tal-aluminju li tista' timbotta minnha.
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 12.5 mg alogliptin, active control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively).
Maltese: F'analiżi miġbura tat-tagħrif minn 12-il studju, l-inċidenza globali ta' kull episodju ta' ipogliċemija kien aktar baxx f'pazjenti kkurati b'alogliptin 25 mg milli f'pazjenti kkurati b'alogliptin 12.5 mg, kontroll attiv jew plaċebo (3.6%, 4.6%, 12.9% u 6.2%, rispettivament).
English: The pharmacokinetics of alogliptin in children and adolescents <18 years old has not been established.
Maltese: Il-farmakokinetiċi ta' alogliptin fi tfal u adolexxenti ta' <18-il sena ma ġietx determinata.
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' pillola ta' 500 mg jew 850 mg metformin hydrochloride hija ta' madwar 50-60% f'individwi b'saħħithom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA ((B'KAXXA BLU)) PAKKETTI MULTIPLI BISS (2X98 PILLOLI)
English: Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: The combination revealed teratogenic potential in small numbers of foetuses (microphthalmia, small eye bulge and cleft palate) at higher doses of metformin (exposure margins of approximately 20-fold and 5- to 6-fold the maximum recommended human dose for alogliptin and metformin, respectively).
Maltese: Il-kombinazzjoni żvelat potenzjal teratoġeniku f'numri żgħar ta' feti (mikroftalmija, nefħa żgħira fl-għajnejn u palat mixquq) f'dożi ogħla ta' metformin (marġini ta' esponiment ta' madwar 20 darba u 5 sa 6 darbiet tad-doża massima rakkomandata għall-bniedem għal alogliptin u metformin, rispettivament).
English: Vipdomet combines two antihyperglycaemic medicinal products with complementary and distinct mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, and metformin, a member of the biguanide class.
Maltese: Vipdomet jikkombina żewġ prodotti mediċinali li jaġixxu kontra l-iperġliċemija b'mekkaniżmi ta' azzjoni komplimentari u distinti sabiex jitjieb il-kontroll gliċemiku f'pazjenti b'dijabete mellitus ta' tip 2: alogliptin, impeditur ta' dipeptidyl-peptidase-4 (DPP-4) inhibitor, u metformin, membru talklassi ta' biguanides.
English: More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Maltese: Aktar pazjenti li rċevew 25 mg alogliptin u metformin (48.5%) kisbu livelli mmirati ta' HbA1c ta' ≤7.0% meta mqabbel ma' dawk li rċevew glipizide u metformin (42.8%) (p=0.004).
English: Other reactions such as upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, gastroesophageal reflux disease, pruritus, rash, hypoglycaemia may occur commonly (≥ 1/100 to < 1/10) (see section 4.4) which are attributed to Vipdomet.
Maltese: Reazzjonijiet oħrajn bħal infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju, nażofarinġite, uġigħ ta' ras, gastroenterite, uġigħ addominali, dijarea, rimettar, gastrite, mard tar-rifluss gastroesofagali, ħakk, raxx, ipogliċemija jseħħu komuni (≥1/100 sa <1/10) (ara sezzjoni 4.4) li huma attribwiti għal Vipdomet.
English: Very rare: - Decreased vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint,
Maltese: B12 jew anemija; sintomi jinkludu għeja, letarġija, iħossok ħażin,
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-proporzjon mhux assorbit irkuprat mill-ippurgar kien ta' 20-30%.
English: The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26- and 39-weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended total daily dose of 25 mg alogliptin.
Maltese: Il-livell ta' effetti avversi mhux osservati (NOAEL - no-observed adverse effect level) fl-istudji dwar tossiċità b'doża ripetuta fil-firien u l-klieb li damu sejrin sa 26 u 39 ġimgħa, rispettivament, ipproduċew marġni ta' espożizzjoni li kienu madwar 147 u 227 darba rispettivament, l-espożizzjoni fil-bniedem fid-doża totali rrakkomandata għal kuljum ta' alogliptin 25 mg.
English: LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
Maltese: Medji tal-Least squares aġġustati għal stat ta' terapija antiipergliċemika fil-passat u valuri fillinja bażi * p<0.001 mqabbel mal-plaċebo jew ma' plaċebo+kura kombinata
English: Cationic medicinal products
Maltese: Prodotti mediċinali katijoniċi
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Huwa preżunt li l-farmakokinetika tal-assorbiment ta' metformin mhix lineari.
English: Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Maltese: Is-sintomi jistgħu jinkludu: rogħda, għaraq, ansjetà, vista mċajpra, xufftejn inemnmu, sfurija,
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-trabi tattwelid li mhux eskluż.
English: Other medicines and Vipdomet
Maltese: Mediċini oħra u Vipdomet
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 ketones fis-serum, glukosju fid-demm u, jekk ikun indikat, il-livelli ta' pH, lactate, pyruvate u metformin fid-demm.
English: The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Maltese: Iż-żieda ta' alogliptin 25 mg darba kuljum ma' terapija bi 30 mg pioglitazone flimkien ma' metformin hydrochloride (doża medja = 1,867.9 mg) irriżultat f'titjib mil-linja bażi fl-HbA1c fil-Ġimgħa 52 li t-tnejn ma kinux inferjuri u statistikament superjuri għal dawk prodotti mit-terapija bi pioglitazone 45 mg u metformin (doża medja = 1,847.6 mg, Tabella 3).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/025 196 (2x98) film-coated tablets (multipack)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/843/025 196 (2x98) pilloli miksija b'rita (pakkett multiplu)
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva f'dożi klinikament rilevanti (ara 5.3).
English: Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Maltese: B'mod sinifikanti aktar pazjenti li rċevew alogliptin 25 mg flimkien ma' pioglitazone 30 mg u metformin (33.2%) kisbu livelli fil-mira tal-livelli ta' HbA1c ta' ≤7.0% meta mqabbla ma' dawk li rċevew pioglitazone 45 mg u metformin (21.3%) f'Ġimgħa 52 (p<0.
English: In vitro studies suggest that alogliptin does not inhibit nor induce CYP 450 isoforms at concentrations achieved with the recommended dose of 25 mg alogliptin (see section 5.2).
Maltese: Studji in vitro jissuġġerixxu li alogliptin ma jxekkilx u lanqas jinduċi iżoformi ta' CYP 450 f'konċentrazzjonijiet miksuba bid-doża rakkomandata ta' 25 mg alogliptin (ara sezzjoni 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/026 196 (2x98) film-coated tablets (multipack)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/843/026 196 (2x98) pilloli miksija b'rita (packet multiplu)
English: Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
Maltese: Vipdomet huwa indikat fit-trattament ta' persuni adulti li għandhom 18-il sena jew aktar b'dijabete mellitus ta' tip 2: