FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study in patients with bipolar disorder, patients taking 4.5 mg of Adasuve had an average fall in PEC score of 8.2 points, and patients taking 9.1 mg had an average fall of 9.2 points.
Maltese: Fl-istudju fuq pazjenti b'disturb bipolari, pazjenti li kienu qed jieħdu 4.5 mg ta' Adasuve kellhom tnaqqis medju fil-punteġġ PEC ta' 8.2 punti, u pazjenti li kienu qed jieħdu 9.1 mg kellhom tnaqqis medju ta' 9.2 punti.
English: Regarding its safety, most side effects are comparable to those of other antipsychotic medicines.
Maltese: Fir-rigward tas-sigurtà tiegħu, ħafna mill-effetti sekondarji huma komparabbli ma' dawk ta' mediċini antipsikotiċi oħra.
English: Adasuve is used to rapidly control mild to moderate agitation in adults with schizophrenia or bipolar disorder.
Maltese: Adasuve jintuża biex b'mod rapidu jikkontrolla aġitazzjoni minn ħafifa sa moderata f'adulti bi skizofrenija jew b'disturb bipolari.
English: This compared with a fall of 5.8 points in patients taking placebo.
Maltese: Dan meta mqabbel ma' tnaqqis ta' 5.8 punti f'pazjenti li kienu qed jieħdu l-plaċebo.
English: This compared with a fall of 4.7 points in patients taking placebo.
Maltese: Dan meta mqabbel ma' tnaqqis ta' 4.7 punti f'pazjenti li kienu qed jieħdu lplaċebo.
English: A fall in PEC score indicates an improvement in symptoms.
Maltese: Tnaqqis fil-punteġġ PEC jindika titjib fis-sintomi.
English: The CHMP noted that the administration of Adasuve is non-invasive.
Maltese: Is-CHMP innota li l-għoti ta' Adasuve mhuwiex invażiv.
English: The CHMP concluded that Adasuve has been demonstrated to rapidly control (within minutes) mild to moderate agitation in patients with schizophrenia or bipolar disorder who are cooperative with using an inhaler.
Maltese: Is-CHMP ikkonkluda li Adasuve intwera li b'mod rapidu (f'minuti) jikkontrolla aġitazzjoni minn ħafifa sa moderata f'pazjenti bi skiżofrenija jew b'disturb bipolari li lesti jużaw inalatur.
English: In studies in agitated patients, bronchospasm was reported as an uncommon but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short acting beta-agonist.
Maltese: Fi studju fuq pazjenti aġitati, bronkospażmu kien irrapportat bħala reazzjoni avversa mhux komuni imma serja, filwaqt li f'individwi b'mard fil-passaġġi tal-arja, bronkospażmu kien irrapportat b'mod komuni u ħafna drabi kien jeħtieġ kura b'beta-agonista li jaġixxi fuq perjodu qasir.
English: The potential risk of bronchospasm is considered manageable and has been adequately addressed through risk minimisation measures.
Maltese: Ir-riskju potenzjali ta' bronkospażmu huwa kkunsidrat maniġġabbli u ġie adegwatament indirizzat permezz ta' miżuri għall-minimizzazzjoni tarriskji.
English: The most common side effects with Adasuve are dysgeusia (taste disturbances), sedation or somnolence (sleepiness) and dizziness.
Maltese: L-effetti sekondarji l-aktar komuni b'Adasuve huma disgewsja (disturbi fit-togħma), sedazzjoni jew ngħas (ħedla) u sturdament.
English: What is the risk associated with Adasuve?
Maltese: X'inhu r-riskju assoċjat ma' Adasuve?
English: It is available as an inhalation powder in a portable inhaler device for single use (4.5 mg and 9.1 mg).
Maltese: Jiġi bħala trab li jittieħed man-nifs f'inalatur li jista' jinġarr li jintuża darba biss (4.5 mg u 9.1 mg).
English: Why has Adasuve been approved?
Maltese: Għaliex ġie approvat Adasuve?
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: L-iskizofrenija hija marda mentali li għandha għadd ta' sintomi, inkluż ħsieb u diskors diżorganizzat, alluċinazzjonijiet (tisma' jew tara affarijiet li mhumiex hemm), suspetti u delużjonijiet (ħsibijiet żbaljati).
English: Other information about Adasuve
Maltese: Informazzjoni oħra dwar Adasuve:
English: What measures are being taken to ensure the safe use of Adasuve?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Adasuve?
English: What is Adasuve?
Maltese: Għal xiex jintuża Adasuve?
English: An airway-opening medicine called a short-acting beta agonist should also be available for the treatment of patients who develop bronchospasm (excessive and prolonged contraction of the airway muscles).
Maltese: Għandu wkoll ikun hemm disponibbli mediċina li tiftaħ il-passaġġi tal-arja magħrufa bħala beta agonist li taġixxi fuq perjodu qasir għall-kura ta' pazjenti li jiżviluppaw bronkospażmi (kontrazzjonijiet eċċessivi u fit-tul tal-muskoli tal-passaġġi tal-arja).
English: Since these neurotransmitters are involved in agitation in schizophrenia and bipolar disorder, loxapine helps to normalise the activity of the brain, reducing agitation.
Maltese: Peress li dawn in-newrotrasmettituri huma involuti fl-aġitazzjoni fl-iskizofrenija u fid-disturb bipolari, loxapine jgħin biex jinnormalizza lattività tal-moħħ, u jnaqqas l-aġitazzjoni.
English: Agitation is a known complication of both mental illnesses.
Maltese: L-aġitazzjoni hija komplikazzjoni magħrufa taż-żewġ mard mentali.
English: This summary was last updated in 2-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi 2-2013.
English: The CHMP concluded that the benefits of Adasuve outweigh its risks and recommended that it be granted marketing authorisation.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Adasuve jegħlbu r-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Adasuve been studied?
Maltese: Kif ġie studjat Adasuve?
English: Treatment with Adasuve is started with the inhalation of a single dose of 9.1 mg.
Maltese: Kura b'Adasuve tinbeda bit-teħid man-nifs ta' doża unika ta' 9.1 mg.
English: Adasuve has been studied in two main studies.
Maltese: Adasuve ġie studjat f'żewġ studji ewlenin.
English: The effects of Adasuve were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Adasuve ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bnedmin.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli tal-moħħ permezz ta' ‘newrotrasmettituri', kimiċi li jippermettu li ċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: If considered necessary the doctor may prescribe a second dose of 9.1 mg after two hours.
Maltese: Jekk jitqies meħtieġ it-tabib jista' jippreskrivi t-tieni doża ta' 9.1 mg wara sagħtejn.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: Kundizzjonijiet jew restrizzjonijiet rigward l-użu sigur u effettiv tal-prodott mediċinali
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Maltese: • kawtela fl-użu fl-anzjani fid-dawl tar-riskji relatati ma' l-età (b'mod partikolari l-kanċer talbużżieqa, ksur u insuffiċjenza tal-qalb).
English: • This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Maltese: • Dan il-pakkett edukattiv huwa mmirat biex isaħħaħ l-għarfien ta' riskji importanti identifikati ta' kanċer tal-bużżieqa u insuffiċjenza tal-qalb u r-rakkomandazzjonijiet ġenerali maħsuba biex jottimizzaw il-marġni benefiċċju-riskju dwar il-pazjent.
English: • The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Maltese: • Il-pakkett edukattiv għat-tabib għandu jkun fih: Is-Sommarju tal-Karatteristiċi tal-Prodott, fuljett ta' tagħrif, u Gwida biex jippreskrivi.
English: The Prescriber Guide should highlight the following:
Maltese: Il-Gwida biex jippreskrivi għandha tenfasizza li ġej:
English: • The risk of bladder cancer risk and relevant risk minimisation advice.
Maltese: • Ir-riskju taċ-ċans tal-kanċer tal-bużżieqa u parir rilevanti biex jitnaqqas ir-riskju.
English: 112 tablets.
Maltese: 112-il pillola.
English: “EXP”.
Maltese: "EXP”/”JIS”.
English: EU/1/08/485/001 7 tablets EU/1/08/485/002 14 tablets EU/1/08/485/003 28 tablets EU/1/08/485/004 30 tablets EU/1/08/485/005 56 tablets EU/1/08/485/006 60 tablets EU/1/08/485/007 90 tablets EU/1/08/485/008 112 tablets EU/1/08/485/009 180 tablets EU/1/08/485/010 336 tablets
Maltese: EU/1/08/485/001 7 pilloli EU/1/08/485/002 14-il pillola EU/1/08/485/003 28 pillola EU/1/08/485/004 30 pillola EU/1/08/485/005 56 pillola EU/1/08/485/006 60 pillola EU/1/08/485/007 90 pillola EU/1/08/485/008 112-il pillola EU/1/08/485/009 180 pillola EU/1/08/485/010
English: • The active substance is vildagliptin.
Maltese: • Is-sustanza attiva hi vildagliptin.
English: Digoxin (Pgp substrate), warfarin (CYP2C9 substrate)
Maltese: Digoxin (sottostrat Pgp), warfarin (sottostrat CYP2C9)
English: 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
Maltese: 7 pilloli 14-il pillola 28 pillola 30 pillola 56 pillola 60 pillola 90 pillola 112-il pillola 180 pillola 336 pillola
English: Do not take Jalra:
Maltese: Tiħux Jalra:
English: (type A) and magnesium stearate.
Maltese: (tip A) u magnesium stearat
English: Multipack: 336 (3 packs of 112) tablets.
Maltese: 336 (3 pakketti ta' 112) pillola
English: Medical attention may be needed.
Maltese: Jista' jkun hemm bżonn attenzjoni medika.
English: Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.
Maltese: Vildagliptin, membru tal-klassi islet enhancer, huwa inibitur qawwi u silettiv DPP-4.
English: Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 Novembru 2008
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH02
Maltese: Mediċini li jintużaw fid-dijabete, impedituri dipeptidyl peptidase (DPP-4), Kodiċi ATC: A10BH02
English: Combination with pioglitazone, metformin and glyburide
Maltese: Kombinazzjoni ma' pioglitazone, metformin u glyburide
English: Jalra 50 mg tablets
Maltese: Jalra 50 mg pilloli
English: Manufacturer Novartis Pharma GmbH Roonstraße 25
Maltese: Novartis Pharma GmbH Roonstraße 25
English: The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel-Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)].
Maltese: L-endpoint kompost ta' avvenimenti kardjovaskulari avversi ewlenin (MACE - major adverse cardiovascular events) aġġudikati inkluż infart mijokardijaku akut, puplesija jew mewt kardjovaskulari kien simili għal vildagliptin kontra komparaturi attivi u tal-plaċebo kkombinati [ilproporzjon tar-riskju Mantel-Haenszel (M-H RR - Mantel-Haenszel risk ratio) ta' 0.82 (CI ta' 0.61-1.11)].
English: * p< 0.05 for comparison versus placebo + comparator
Maltese: * p< 0.05 għat-tqabbil kontra plaċebo + kumparatur
English: Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Maltese: Għalhekk, vildagliptin x'aktarx ma jeffettwax ittneħħija metabolika ta' medikazzjonijiet li jiġu metabolizzati permezz ta' CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 jew CYP 3A4/5.
English: * p< 0.05 for comparison versus placebo
Maltese: * p< 0.05 għat-tqabbil kontra plaċebo
English: Mean baseline HbA1c (%)
Maltese: Medja ta' HbA1c fillinja bażi (%)
English: One side is debossed with “NVR”, and the other side with “FB”.
Maltese: Naħa waħda mnaqqxa b'“NVR”, u n-naħa l-oħra b'“FB”.
English: Add-on / Combination studies Vildagliptin 50 mg twice daily + metformin (N=143) Vildagliptin 50 mg daily + glimepiride (N=132) Vildagliptin 50 mg twice daily + pioglitazone (N=136) Vildagliptin 50 mg twice daily + metformin + glimepiride (N=152)
Maltese: Studji miżjuda/Kombinazzjoni Vildagliptin 50 mg darbtejn kuljum + metformin (N=143) Vildagliptin 50 mg kuljum + glimepiride (N=132) Vildagliptin 50 mg darbtejn kuljum + pioglitazone (N=136) Vildagliptin 50 mg darbtejn kuljum + metformin + glimepiride (N=152)
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Maltese: B'600 mg, individwu wieħed kellu edema tas-saqajn u l-idejn, u żiediet tal-krejatinina phosphokinase (CPK), aspartate amintotransferase (AST), proteina reattiva-C (CRP) u livelli ta' mijoglobina.
English: Jalra contains lactose
Maltese: Jalra fih lactose
English: In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Maltese: Studji in vitro wrew li vildagliptin ma jikkawżax limpediment/induzzjoni ta' l-enzimi CYP 450.
English: Jalra 50 mg tablets vildagliptin
Maltese: Jalra 50 mg pilloli vildagliptin
English: • The other ingredients are lactose anhydrous, microcrystalline cellulose, sodium starch glycolate
Maltese: • Is-sustanzi l-oħra huma lactose anhydrous, microcrystalline cellulose, sodium starch glycolate
English: Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
Maltese: Vildagliptin ma kienx mutaġeniku f'testijiet konvenzjonali in vitro u in vivo għal ġenotossiċità.
English: As with other oral antidiabetic medicinal products the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
Maltese: Bħal prodotti mediċinali antidijabetiċi orali oħrajn l-effett ipogliċemiku ta' vildagliptin jista' jitnaqqas b'ċerti sustanzi attivi, inklużi thiazides, kortikosterojdi, prodotti tat-tirojde u simpatomimetiċi.
English: EU/1/08/485/011 336 tablets (3 packs of 112)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/485/011 336 pillola (3 pakketti ta' 112)
English: Combination with metformin and a sulphonylurea
Maltese: Kombinazzjoni ma' metformin u xi sulphonylurea
English: Table 7 Post-marketing adverse reactions
Maltese: Tabella 7 Reazzjonijiet avversi wara t-tqegħid fis-suq
English: The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the glucuronide (BQS867) and the amide hydrolysis products (4% of dose).
Maltese: Il-metabolu maġġuri (LAY 151) huwa inattiv mill-lat farmakoloġiku u huwa l-prodott ta' l-isdroliżi tal-parti cyano, li tgħodd għal 57% tad-doża, segwit mill-prodotti tal-glucuronide (BQS867) u ta' l-idroliżi ta' l-amide (4% tad-doża).
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 the available data).
Maltese: Il-frekwenzi huma definiti 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: EU/1/08/485/001-011
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/485/001-011
English: • Uncommon : Diarrhoea, flatulence
Maltese: • Mhux komuni: Dijarea, gass
English: Urticaria Exfoliative and bullous skin lesions, including bullous pemphigoid
Maltese: Leżjonijiet fil-ġilda esfoljattivi u bl-infafet, inkluż pemphigoid blinfafet
English: Confirmed heart failure (HF) events defined as HF requiring hospitalisation or new onset of HF were reported in 41 (0.43%) vildagliptin-treated patients and 32 (0.45%) comparator-treated patients with M-H RR 1.08 (95% CI 0.68-1.70).
Maltese: Avvenimenti ta' insuffiċjenza tal-qalb (HFheart failure) ikkonfermata definiti bħala HF li teħtieġ dħul l-isptar jew bidu ġdid ta' HF kienu rrappurtati f'41 (0.43%) pazjent ittrattati b'vildagliptin u 32 (0.45%) pazjent ittrattati b'sustanza ta' paragun b'M-H RR ta' 1.08 (CI ta' 95% 0.68-1.70).
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Maltese: Il-medja tal-volum tad-distribuzzjoni ta' vildagliptin fi stat fiss wara li jingħata minn ġol-vina (Vss) hija 71 litru, li jindika distribuzzjoni ekstravaskulari.
English: Vildagliptin was associated with fewer hypoglycaemic events (0.7%) than gliclazide (1.7%).
Maltese: Vildagliptin kien assoċjat ma' anqas każijiet ta' ipogliċemija (0.7%) milli kien gliclazide (1.7%).
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Maltese: L-għotja ta' vildagliptin twassal għal impediment mgħaġġel u komplet ta' l-attività DPP-4, li twassal għal livelli endoġeni ogħla ta' waqt is-sawm u wara l-ikel ta' ormoni inkretin GLP-1 (peptidu 1 li jixbah il-glukagon) u GIP (polypeptidu insulinotropiku dipendenti fuq glucose).
English: Information regarding overdose with vildagliptin is limited.
Maltese: Informazzjoni dwar doża eċċessiva b'vildagliptin hija limitata.
English: Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent.
Maltese: Vildagliptin mhux metabolizzat b'enzimi cytochrome P450 f'ammont li jista' jiġi kwantifikat.
English: After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Maltese: Wara li jingħata minn ġol-vina f'individwi b'saħħithom, it-tneħħija totali tal-plażma u renali ta' vildagliptin huma 41 u 13 l/h rispettivament.
English: In controlled clinical trials with the combination of vildagliptin 50 mg + a sulphonylurea, the overall incidence of withdrawals due to adverse reactions was 0.6% in the vildagliptin 50 mg + sulphonylurea vs 0% in the placebo + sulphonylurea treatment group.
Maltese: Fi provi kliniċi bil-kontroll meta vildagliptin 50 mg ingħata ma' sulphonylurea, l-inċidenza globali tattwaqqif minħabba reazzjonijiet avversi kienet 0.6% fil-grupp ta' kura b'vildagliptin 50 mg ma' sulphonylurea kontra 0% fil-grupp bil-plaċebo ma' sulphonylurea.
English: Study 2301: Vildagliptin 50 mg twice daily (N=90) Study 2384: Vildagliptin 50 mg twice daily (N=79)
Maltese: Vildagliptin 50 mg darbtejn kuljum (N=90) Studju 2384:
English: Contains lactose (see leaflet for further information).
Maltese: TA' EĊĊIPJENTI Fih lactose (ara l-fuljett għal aktar informazzjoni).
English: Jalra 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Maltese: Jalra 50 mg pilloli jiġu f'pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f'pakketti b'ħafna li fihom 3 kartuni, li kull waħda minnhom fiha 112-il pilloli.
English: No data are available (see also section 5.1).
Maltese: Dejta mhux disponibbli (ara wkoll sezzjoni 5.1).
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista jkun hemm fuq innies, mhux magħruf.
English: Aluminium/Aluminium (PA/Al/PVC//Al) blister Available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks containing 336 (3 packs of 112) tablets.
Maltese: Jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f'pakketti b'hafna li jkollhom 336 (3 pakketti ta' 112) pilloli.
English: The safety and efficacy of Jalra in children and adolescents (< 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Jalra fi tfal u adolexxenti (< 18-il sena) ma ġewx determinati s'issa.
English: No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
Maltese: Ma dehrux differenzi ta' rilevanza klinika fil-farmakokinetika ta' vildagliptin bejn individwi b'saħħithom maskili u femminili f'medda wiesa' ta' etajiet u indiċi tal-massa tal-ġisem (BMI).
English: The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.
Maltese: L-inċidenza ta' edema periferali meta kien miżjud vildagliptin 100 mg kuljum ma' doża massima ta' pioglitazone fl-isfond (45 mg darba kuljum) kienet 7.0%, imqabbla ma' 2.5% għall-pioglitazone flisfond waħdu.
English: Mean reductions were -1.20% with vildagliptin and -1.48% with rosiglitazone in patients with mean baseline HbA1c of 8.7%.
Maltese: Il-medji tat-tnaqqis kienu -1.20% b'vildagliptin u -1.48% b'rosiglitazone f'pazjenti bil-linja bażi ta' HbA1c ta' 8.7%.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Maltese: Vildagliptin għandu potenzjali baxx għal interazzjonijiet meta jingħata flimkien ma' prodotti mediċinali.
English: AUC of the metabolites LAY151 and BQS867 increased on average about 1.5, 3 and 7-fold in patients with mild, moderate and severe renal impairment, respectively.
Maltese: LAUC tal-metaboliti LAY151 u BQS867 żdiedet b'medja ta' madwar 1.5, 3 u 7 darbiet aktar f'pazjenti b'indeboliment ħafif, moderat u qawwi tal-kliewi, rispettivament.
English: An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and 100 mg/kg (16-fold human exposure), respectively.
Maltese: Dehret żieda fl-inċidenza ta' adenokarċenomi tal-mammarji u haemangiosarcomas b'doża mingħajr effett ta' 500 mg/kg (59-darba l-esponiment fil-bniedem) u 100 mg/kg (16-il darba lesponiment fil-bniedem), rispettivament.
English: Table 8 Key efficacy results of vildagliptin in placebo-controlled monotherapy trials and in add-on combination therapy trials (primary efficacy ITT population)
Maltese: Tabella 8 Riżultati importanti dwar l-effikaċja ta' vildagliptin fi provi b'monoterapija kontrollati bi plaċebo u fi provi b'terapija ta' kombinazzjoni miżjuda (l-effikaċja ewlenija tal-popolazzjoni ITT)
English: Doses higher than 100 mg are not recommended.
Maltese: Dożi ogħla minn 100 mg mhumiex rakkomandati.
English: Jalra should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Maltese: Jalra mgħandux jintuża f'pazjenti b'indeboliment tal-fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il-kura > 3 darbiet il-limitu ta' fuq tan-normal (ULN) (ara wkoll sezzjonijiet 4.4 u 5.2).
English: The incidence of hypoglycaemia in the overall population was 4.7% and 5.6% in the vildagliptin and placebo groups, respectively.
Maltese: L-inċidenza ta' ipogliċemija fil-popolazzjoni sħiħa kienet ta' 4.7% u ta' 5.6% fil-gruppi mogħtija vildagliptin u plaċebo, rispettivament.
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Jalra 100 mg daily were 1.4 and 2.7 kg, respectively.
Maltese: Fl-istudju biż-żieda ta' pioglitazone, il-piż assolut jiżdied bil-plaċebo u b'Jalra 100 mg kuljum kienu 1.4 u 2.7 kg rispettivament.
English: • Common: Dizziness
Maltese: • Komuni: Sturdament
English: In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to gliclazide (up to 320 mg/day).
Maltese: Waqt prova klinika li damet għaddejja sentejn, vildagliptin (50 mg darbtejn kuljum) tqabbel ma' gliclazide (sa 320 mg kuljum).