FrancophonIA/ELRC3.0 huggingface dataset:
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared with the group treated with glipizide (40.8%, 47% and 50.0%, respectively).
Maltese: rispettivament) esperjenza mill-inqas avveniment wieħed ta' ipogliċemija meta mqabbel mal-grupp ikkurat bi glipizide (40.8%, 47% u 50.0% rispettivament).
English: Diuretics
Maltese: MANIFATTURI
English: EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose)
Maltese: Xigduo 5mg/1000mg 60 pillola EU/1/13/900/011 Xigduo 5mg/1000mg 60 x 1 pillola (doża waħda)
English: The most commonly reported adverse reaction related to renal function was increased serum creatinine.
Maltese: L-iktar reazzjoni avversa komuni li ġiet irrapportata marbuta mal-funzjoni renali kienet iż żieda tal-kreatinina fis-serum.
English: The proportion of subjects remaining in the study at Week 104 and Week 208 was 56.2% and 39.7% for the group treated with dapagliflozin and 50.0% and 34.6% for the group treated with glipizide.
Maltese: Il-proporzjon ta' pazjenti li kien baqa' flistudju fil-Ġimgħa 104 u fil-Ġimgħa 208 kien ta' 56.2% u 39.7% għall-grupp ikkurat b'dapagliflozin u ta' 50.0% u 34.6% għall-grupp ikkurat bi glipizide.
English: - hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - diabetic ketoacidosis, diabetic pre-coma; - moderate and severe renal impairment (creatinine clearance < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
Maltese: - sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1 - ketoaċidożi tad-dijabete, stat dijabetiku ta' qabel il-koma; - indeboliment tal-kliewi moderat jew sever (tneħħija tal-kreatinina ta' < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.2, 4.4 u 5.2);
English: The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Maltese: L-effikaċja ta' dapagliflozin, li huwa komponent ta' dan il-prodott mediċinali, tiddependi mill-funzjoni renali, u l-effikaċja tonqos f'pazjenti li jkollhom indeboliment renali moderat u aktarx li tkun assenti f'pazjenti b'indeboliment renali sever (ara sezzjoni 4.2).
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73m2) this grouping of reactions were reported in 1.3% and 0.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: F'pazjenti b'funzjoni renali normali jew b'indeboliment renali ħafif (eGFR tal-linja bażi ≥ 60 mL/min/1.73m2) dan ir-raggruppament ta' reazzjonijiet ġie rrapportat f'1.3% u 0.8% tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo,
English: In addition, metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Maltese: Barra minn hekk, metformin jiġi eliminat mill kliewi, u l-insuffiċjenza renali moderata sa severa żżid ir-riskju ta' aċidożi lattika (ara sezzjoni 4.4).
English: Haematocrit values >55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Maltese: Valuri tal ematokrit >55% ġew irrapportati f'1.3% tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4% tal-individwi fuq plaċebo hIl-kura fit-tul b'metformin ġiet assoċjata ma' tnaqqis fl-assorbiment tal-vitamina
English: 2Sitagliptin 100 mg/day aLOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study cAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period dLeast squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + oral glucose-lowering medicinal product ***The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Maltese: Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukożju **valur-p < 0.05 kontra placebo + prodott mediċinali orali li jbaxxi l-glukożju ***Il-bidla perċentwali fil-piż tal-ġisem kienet analizzata bħala riżultat aħħari sekondarju ewlieni (p < 0.0001); il bidla assoluta fil-piż tal-ġisem (f'kg) ġiet analizzata b'valur-p nominali (p < 0.0001).
English: Hypoglycaemia (when used with SU or insulin)b
Maltese: SU jew malinsulina)b
English: Placebo BID
Maltese: Linja bażi
English: The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Maltese: L-effetti tat-tipjip, tad-dieta, ta' prodotti erbali u tal-użu tal-alkoħol fuq il-farmakokinetika ta'
English: Add-on combination Sulphonylurea + Metformin1
Maltese: Sulphonylurea + Metformin
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Maltese: Ġiet osservata żieda fl-inċidenza jew fis-severità tad-dilatazzjoni tal-pelvi renali fl-ulied adulti tal-ommijiet li ġew ittrattati, imma biss għall ogħla doża li ġiet ittestjata (l-esponimenti assoċjati materni u tal-frieħ għal dapagliflozin kienu 1,415-il darba u 137 darba, rispettivament, iktar mill-valuri umani għad-doża massima rrakkomandata għallbnedmin).
English: The no observed adverse effect level (NOAEL) for developmental toxicity, the lowest dose tested, is associated with a maternal systemic exposure multiple that is approximately 19 times the human value at the maximum recommended human dose.
Maltese: multiplu ta' esponiment sistemiku matern li huwa madwar 19-il darba iktar mill-valur uman għad-doża massima rrakkomandata għall-bnedmin.
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward bAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: L-aħħar osservazzjoni (qabel id-data jew dakinhar tal-ewwel żieda fid-doża tal-insulina, jekk meħtieġ) miġjuba 'l quddiem bL-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju double blind matul il-perjodu double-blind ta' terminu qasir cIl-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali orali li jbaxxi lglukożju *valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju 1Żieda fid-dożi tal-insulina (inkluż insulina li taħdem għal żmien qasir, intermedja jew bażali) kienet permessa biss jekk il-pazjenti kienu jissodisfaw il-kriterji FPG definiti minn qabel 2Ħamsin fil-mija tal-pazjenti kienu fuq monoterapija bl-insulina fil-linja bażi; 50% kienu fuq prodott jew żewġ prodotti mediċinali orali li jbaxxu l-glukożju miżjuda mal-insulina:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 1,000 mg ta' metformin hydrochloride.
English: EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Maltese: Xigduo 5mg/850mg 196 (2x98) pillola (pakkett multiplu)
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, treatment with dapagliflozin 10 mg resulted in a systolic blood pressure change from baseline of -3.7 mmHg and diastolic blood pressure of1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24.
Maltese: F'analiżi miġbura speċifikata minn qabel ta' 13-il studju kkontrollat bi plaċebo, il-kura b'10 mg dapagliflozin irriżultat f'bidla ta' -3.7 mmHg fil-pressjoni sistolika tad-demm mil-linja bażi u ta'1.8 mmHg fil-pressjoni dijastolika tad-demm kontra -0.5 mmHg fil-pressjoni sistolika tad-demm u
English: In an add-on to metformin and a sulphonylurea study, up to 24 weeks, minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.
Maltese: ipogliċemija fi 12.8% tal-individwi li rċevew dapagliflozin 10 mg u metformin u sulphonylurea u fi 3.7%
English: Creatinine renal clearance decreasedb Dyslipidaemiaj
Maltese: Tnaqqis fleliminazzjon i talkreatinina mill-kliewib Dislipidemjaj
English: Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products2
Maltese: Dapagliflozin 10 mg + insulina
English: • if you have problems with your liver.
Maltese: • jekk għandek xi problemi bil-kliewi.
English: At Weeks 24 and 104, minor episodes of hypoglycaemia were reported, respectively, in 40.3% and 53.1% of subjects who received dapagliflozin 10 mg plus insulin and in 34.0% and 41.6% of the subjects who received placebo plus insulin.
Maltese: 53.1% tal-individwi li rċevew 10 mg dapagliflozin flimkien mal-insulina u f'34.0% u f'41.6% tal-pazjenti li rċevew plaċebo flimkien mal-insulina.
English: Use in patients with renal impairment
Maltese: Popolazzjonijiet speċjali Indeboliment renali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/006
Maltese: EU/1/13/900/006
English: These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin-nisa (8.4% u 1.2% għal dapagliflozin u plaċebo, rispettivament), u individwi b'passat mediku ta' mard kellhom iktar ċans ta' infezzjoni li tirrepeti ruħha.
English: Malignancies
Maltese: Dijanjożi
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Maltese: Għandu jiġi evitat il-konsum tal-alkoħol u ta' prodotti mediċinali li fihom lalkoħol.
English: Race There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Maltese: Razza Ma kienx hemm differenzi klinikament rilevanti fl-esponimenti sistemiċi bejn ir-razez bojod, suwed jew
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Maltese: żied l-esponiment sistemiku (AUC) ta' metfromin b'50% u Cmax b'81%.
English: Avoid alcohol, including medicines containing alcohol, while taking this medicine since alcohol may increase the risk of lactic acidosis (see section 4 ‘Possible side effects').
Maltese: Evita l-alkoħol, inklużi mediċini li fihom l-alkoħol, waqt li tkun qed tieħu din il-mediċina peress li lalkoħol jista' jżid ir-riskju ta' aċidożi lattika (jekk jogħġbok ara sezzjoni 4 ‘Effetti sekondarji possibbli').
English: Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Maltese: d Infezzjoni tal-passaġġ urinarju tinkludi t-termini ppreferuti li ġejjin, elenkati f'ordni skont il-frekwenza rrapportata: infezzjoni fil-passaġġ urinarju, ċistite, infezzjoni tal-passaġġ urinarju b'Escherichia, infezzjoni tal-passaġġ ġenitourinarju, pajelonefrite,
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Sustanzi katajoniċi li jiġu eliminati permezz ta' tnixxija mit-tubuli tal-kliewi (eż. cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu għal sistemi komuni ta' trasport tubolari renali.
English: The treatment may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.
Maltese: Il-kura tista' terġa' tinbeda mhux qabel ma jgħaddu 48 siegħa wara kirurġija jew il-bidu mill-ġdid tan-nutrizzjoni orali u dan biss jekk tkun ġiet stabbilita funzjoni renali normali.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80% kienu fuq metformin waħdu, 12% kienu fuq terapija ta' metformin flimkien ma' sulphonylurea, u l-bqija kienu fuq prodotti mediċinali orali oħrajn li jbaxxu l-glukożju.
English: Treatment with dapagliflozin 10 mg plus metformin showed a numerical decrease in visceral adipose tissue compared with placebo plus metformin treatment in a magnetic resonance imaging substudy.
Maltese: Il kura b'10 mg dapagliflozin flimkien ma' metformin uriet tnaqqis numeriku fit-tessut xaħmi tal-vixxri meta mqabbel ma' kura bi plaċebo flimkien ma' metformin f'sottostudju tal-ħruġ tal-immaġni birreżonanza manjetika.
English: Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to accumulation of metformin, a component of this medicinal product.
Maltese: L-aċidożi lattika hija kumplikazzjoni metabolika rari ħafna, imma serja (b'mortalità għolja fin-nuqqas ta' kura immedjata) li tista' tiġri minħabba akkumulazzjoni ta' metformin, li huwa komponent ta' dan ilprodott mediċinali.
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Maltese: B12 fid-demm • abnormalitajiet fit-testijiet tal-funzjoni tal-fwied, infjammazzjoni fil-fwied (epatite)
English: EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets
Maltese: EU/1/13/900/001 Xigduo 5mg/850mg 14-il pillola EU/1/13/900/002 Xigduo 5mg/850mg 28 pillola EU/1/13/900/003 Xigduo 5mg/850mg 56 pillola EU/1/13/900/004
English: Therefore, this medicinal product must not be used in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2; see section 4.3).
Maltese: Għaldaqstant, dan il-prodott mediċinali m'għandux jintuża f'pazjenti b'indeboliment renali moderat sa sever (pazjenti b'CrCl < 60 ml/min jew b'rata stmata ta' filtrazzjoni glomerulari [eGFR] ta' < 60 ml/min/1.73 m2; ara sezzjoni 4.3).
English: Blood urea increased**
Maltese: Ħalq xott**
English: For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Maltese: Pazjenti li jaqilbu minn pilloli separati ta' dapagliflozin (doża totali ta' kuljum ta' 10 mg) u metformin għal Xigduo għandhom jirċievu l-istess doża ta' kuljum ta' dapagliflozin u metformin li diġà tkun qiegħda tittieħed jew l-eqreb doża terapewtikament xierqa ta' metformin.
English: EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose)
Maltese: Xigduo 5mg/850mg 60 x 1 pillola (doża waħda)
English: 10 tablets blister: {Sun/Moon symbol} 14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}
Maltese: Folja ta' 10 pilloli: {Simbolu ta' Xemx/Qamar}
English: Urinary tract infection
Maltese: Infezzjonijiet fil-passaġġ urinarju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/900/012
Maltese: EU/1/13/900/012
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u l-iżvilupp,
English: Dapagliflozin exposure was found to decrease with increased weight.
Maltese: dapagliflozin ma ġewx studjati.
English: • Xigduo 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets.
Maltese: • Xigduo 5 mg/1,000 mg are 10.5
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: peptide baxx jew dijabete awtoimmuni moħbija fl-adulti (LADA) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal teħid restritt tal-ikel jew deidrazzjoni severa, pazjenti li għalihom jitnaqqsu d-dożi tal-insulina u pazjenti b'rekwiżiti miżjuda tal-insulina minħabba mard mediku akut, kirurġija jew abbuż tal-alkoħol.
English: • if you have a condition called ‘diabetic ketoacidosis', a problem you can get with diabetes.
Maltese: • jekk tbati minn kundizzjoni li tissejjaħ ‘ketoaċidożi dijabetika', problema li jista' jkollok minħabba d-dijabete.
English: EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets
Maltese: EU/1/13/900/007 Xigduo 5mg/1000mg 14-il pillola EU/1/13/900/008 Xigduo 5mg/1000mg 28 pillola EU/1/13/900/009 Xigduo 5mg/1000mg 56 pillola EU/1/13/900/010
English: • dizziness
Maltese: Dijuretiċi
English: • if you are taking cimetidine, a medicine used to treat stomach problems.
Maltese: • jekk qed tieħu cimetidine, mediċina li tintuża għall-kura ta' problemi tal-istonku.
English: The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Maltese: Doża eċċessiva għolja jew riskji konkomitanti ta' metformin jistgħu jwasslu għal aċidożi lattika.
English: Content (concentratio n)
Maltese: Mnjen jingħata Il-Kontenut (Konċentrat)
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: Ir-Renju Unit Pharmapol ArzneimittelvertriebGmbH, Kaddenbusch 11, 25578 Daegeling, Germany
English: Strength Pharmaceutic al form
Maltese: Qawwa Għamla Farmaċewtika
English: Invented name/ Name
Maltese: LISTA TA`
English: Azilect rasagiline
Maltese: Azilect rasagilina
English: The full EPAR for Azilect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (1 mg).
Maltese: Jiġi bħala pilloli (1 mg).
English: The studies lasted 26 and 18 weeks, respectively.
Maltese: L-istudji damu 26 u 18-il ġimgħa rispettivament.
English: The active substance in Azilect, rasagiline, is a ‘monoamine oxidase-B inhibitor'.
Maltese: Is-sustanza attiva f'Azilect, rasagiline, hija ‘monoamine oxidase-B inhibitor'.
English: Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease.
Maltese: Azilect ġie studjat fi tliet studji prinċipali li b'kollox involvew 1,563 pazjent bil-marda ta' Parkinson.
English: This is a summary of the European public assessment report (EPAR) for Azilect.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Azilect.
English: The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa.
Maltese: Iż-żewġ studji l-oħra involvew total ta' 1,159 pazjent fl-istadju avvanzat tal-marda, fejn Azilect kien miżjud mal-kura eżistenti tal-pazjenti inkluż levodopa.
English: Azilect is a medicine that contains the active substance rasagiline.
Maltese: Azilect huwa mediċina li fih is-sustanza attiva rasagilina.
English: In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
Maltese: Fl-istudju fejn Azilect intuża waħdu, pazjenti li jieħdu 1 mg ta' mediċina darba kuljum kellhom qabża medja fil-kejl UPDRS ta' 0.13 punti fuq l-istudju ta' 26- ġimgħa minn valur tal-bidu ta' 24.69.
English: This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Maltese: Dan ġie mqabbel ma' żjieda ta' 4.07 punti fil-pazjenti li jieħdu plaċebo minn valur tal-bidu ta' 24.54.
English: Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort.
Maltese: Azilect ma għandux jintuża ma' inibituri monoamine oxidase oħrajn inklużi mediċini u preparazzjonijiet erbali mingħajr preskrizzjoni bħall-fexfiexa tar-raba' (St John's wort).
English: It was compared with placebo or entacapone (another medicine for Parkinson's disease).
Maltese: Tqabbel mal-plaċebo jew entacapone (mediċina oħra għall-marda ta' Parkinson).
English: It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Maltese: Din timblokka l-enzima monoamine oxidase tat-tip B, li tkisser id-dopamina tan-newtrożmettitur fil-moħħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Azilect fil-21 ta' Frar 2005.
English: The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS).
Maltese: Il-kejl prinċipali ta' effikaċja kien il-bidla fissintomi fuq 26 ġimgħa, kif ġie evalwat abbażi tal-iskala standard (Unified Parkinson's Disease Rating Scale, UPDRS).
English: What is the risk associated with Azilect?
Maltese: X'inhu r-riskju assoċjat ma' Azilect?
English: A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Maltese: Waqa' fil-kejl UPDRS juri titjib fis-sintomi, filwaqt li żjieda tindika li s-sintomi marru għall-agħar.