FrancophonIA/ELRC3.0 huggingface dataset:
English: EMA/403410/2014 EMEA/H/C/001087
Maltese: EMEA/H/C/001087
English: Olazax olanzapine
Maltese: Olazax olanzapina
English: It is available as tablets (5, 7.5 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli (5, 7.5, 10, 15 u 20 mg).
English: The usual dose range is between 5 and 20 mg per day.
Maltese: Iddoża normali tvarja bejn 5 u 20 mg kuljum.
English: The full EPAR for Olazax 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: The active substance in Olazax, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olazax, l-olanzapina, hija mediċina antipsikotika.
English: This is a summary of the European public assessment report (EPAR) for Olazax.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Olazax.
English: Olazax is a medicine containing the active substance olanzapine.
Maltese: Olazax hu mediċina li fiha s-sustanza attiva olanzapina.
English: Olazax is a ‘generic medicine'.
Maltese: Olazax huwa ‘mediċina ġenerika'.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għall-imblokkar tar-riċetturi għannewrotrażmettituri 5-idrossitriptamina ((5-hydroxytrypamine) imsejħa wkoll serotonina) u dopamina.
English: Olazax is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olazax jintuża wkoll fil-kura ta' episodji moderati sa severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: This means that Olazax is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Maltese: Dan ifisser li Olazax huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Zyprexa.
English: The CHMP concluded that, in accordance with EU requirements, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Olazax wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Zyprexa.
English: Because Olazax is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zyprexa.
Maltese: Peress li Olazax huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza Zyprexa.
English: Why has Olazax been approved?
Maltese: Għaliex ġie approvat Olazax?
English: What is Olazax?
Maltese: X'inhu Olazax?
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Hija magħrufa bħala antipsikotiku ‘atipiku' minħabba li hija differenti mill-mediċini antipsikotiċi iktar antiki li ilhom disponibbli sa millħamsinijiet.
English: The recommended starting dose of Olazax depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fil-kura
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax on 11 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Olazax fil-11 ta' Diċembru 2009.
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-iskiżofrenija hija marda mentali li għandha għadd ta' sintomi, inklużi disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (id-dehra u s-smigħ ta' affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin żbaljat).
English: Because Olazax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Peress li Olazax huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċini ta' referenza.
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Maltese: Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom tnaqqis fil-funzjoni tal-fwied jew tal-kliewi tagħhom jista' jkollhom bżonn ta' doża inizjali iktar baxxa ta' 5 mg kuljum.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Maltese: Jista' jintuża wkoll biex jipprevjeni li sintomi ta' dawn l-episodji jerġgħu jitfaċċaw f'adulti b'disturb bipolari (marda mentali b'perjodi jalternaw bejn burdata tajba ħafna u depressjoni) li jkunu rrispondew għal kors inizjali ta' kura.
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal f'Zyprexa, ilbenefiċċju huma akbar mir-riskju identifikat.
English: Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Maltese: Peress li dawn in-newrotrażmettituri huma involuti fl-iskiżofrenija u fid-disturbi bipolari, l-olanzapina tgħin fin-normalizzazzjoni tal-attività tal-moħħ, bit-tnaqqis tas-sintomi ta' dan il-mard.
English: Other information about Olazax
Maltese: Informazzjoni oħra dwar Olazax
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: For more information about treatment with Olazax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 07-2014.
Maltese: Dan issommarju ġie aġġornat l-aħħar f'07-2014.
English: The full EPAR for Capecitabine Teva 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: This summary was last updated in 03-2012.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'03-2012.
English: It is available as tablets (150 and 500 mg).
Maltese: Jiġi f'pilloli (150 u 500 mg).
English: EPAR summary for the public capecitabine
Maltese: Sommarju tal-EPAR għall-pubbliku kapesitabina
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Capecitabine Teva.
English: Capecitabine Teva is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Capecitabine Teva jittieħed darbtejn kuljum b'dożi ta' bejn 625 u 1,250 mg għal kull metru kwadru tassuperfiċje tal-ġisem (li jiġi kkalkulat permezz tat-tul u l-piż tal-pazjent).
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Teva has been shown to have comparable quality and to be bioequivalent to Xeloda.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Capecitabine Teva wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Xeloda.
English: Capecitabine Teva is a medicine that contains the active substance capecitabine.
Maltese: Capecitabine Teva huwa prodott mediċinali li fih is-sustanza attiva kapesitabina.
English: The active substance in Capecitabine Teva, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Capecitabine Teva, il-kapesitabina, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer) li jkunu parti mill-grupp tal-‘antimetaboliti'.
English: What are the benefits and risks of Capecitabine Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Capecitabine Teva?
English: Capecitabine Teva is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Maltese: Capecitabine Teva jintuża flimkien ma' medicini oħra kontra l-kanċer, inklużi mediċini kontra l-kanċer li jkun fihom il-platinu bħaċ-ċisplatina;
English: What is Capecitabine Teva?
Maltese: Għal xiex jintuża Capecitabine Teva?
English: Capecitabine Teva tablets should be swallowed with water within the 30 minutes after a meal.
Maltese: Il-pazjent għandu jibla' l-pilloli ta' Capecitabine Teva mal-ilma sa 30 minuta wara l-ikel.
English: Why has Capecitabine Teva been approved?
Maltese: Għaliex ġie approvat Capecitabine Teva?
English: This means that Capecitabine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Maltese: Capecitabine Teva huwa ‘mediċina ġenerika' Dan ifisser li Capecitabine Teva huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Xeloda.
English: Capecitabine Teva is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Maltese: • kanċer tal-kolon (tal-musrana l-għamja). Capecitabine Teva jintuża waħdu jew ma' mediċini oħra kontra l-kanċer f'pazjenti li kienu sottoposti għal intervent kirurġiku għal kanċer tal-kolon tal-‘fażi III' jew ‘fażi C ta' Dukes';
English: Capecitabine Teva is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Maltese: • kanċer tas-sider lokalment avvanzat jew metastatiku (kanċer tas-sider li beda jinfirex ma' partijiet oħra tal-ġisem). Capecitabine Teva jintuża ma' docetaxel (mediċina oħra kontra l-kanċer) wara li jkun falla trattament bl-antraċiklini (tip ieħor ta' mediċini kontra l-kanċer).
English: Because Capecitabine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Capecitabine Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Capecitabine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Maltese: Peress li Capecitabine Teva huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet biex jiġi stabbilit jekk din il-mediċina hijiex bijoekwivalenti għall-mediċina ta' referenza, Xeloda.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Teva on 20 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Capecitabine Teva fil-XX ta' 20
English: Via della Chimica, 9 36100 Vicenza Italy
Maltese: Via della Chimica, 9 36100 Vicenza L-Italja
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Zambon N.V./S.A.
Maltese: België/Belgique/Belgien/ Luxembourg/Luxemburg Zambon N.V./S.
English: Impulse control disorders (ICDs)
Maltese: Disturbi fil-kontroll tal-impulsi (ICDs)
English: Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red (E172) Mica (E555)
Maltese: Macrogol (6000)Titanium dioxide (E171) Iron oxide aħmar (E172) Mica (E555)
English: LS Diff vs Placebo
Maltese: Diff LS vs Plaċebo
English: Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
Maltese: Microcrystalline cellulose Crospovidone tip A Magnesium stearate Silica, colloidal anhydrous
English: EU/1/14/984/001 EU/1/14/984/002 EU/1/14/984/003 EU/1/14/984/004 EU/1/14/984/005
Maltese: EU/1/14/984/001 EU/1/14/984/002 EU/1/14/984/003 EU/1/14/984/004
English: 20091 Bresso (MI) - Italy Tel: +39 02 665241
Maltese: 20091 Bresso (MI) - L-Italja Tel: +39 02 665241
English: EU/1/14/984/006 EU/1/14/984/007 EU/1/14/984/008 EU/1/14/984/009 EU/1/14/984/010
Maltese: EU/1/14/984/007 EU/1/14/984/008 EU/1/14/984/009 EU/1/14/984/010
English: 95% CI p-value
Maltese: 95% CI valur-p
English: - Pethidine (a strong pain killer).
Maltese: - Pethidine (analġesiku qawwi).
English: Dose (mg/day) (a)
Maltese: Doża (mg/jum) (a)
English: Plasma protein binding of safinamide is 88-90%.
Maltese: It-twaħħil tal-proteina mal-plażma ta' safinamide huwa ta' 88-90%.
English: The elimination half-life of safinamide is 20-30 hours.
Maltese: Il-half-life ta' eliminazzjoni ta' safinamide hija 20-30 siegħa.
English: Antidepressants
Maltese: Antidipressanti
English: PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pakketti b'folji tal-PVC/PVDC/Aluminju ta' 14, 28, 30, 90 u 100 pillola.
English: At concentrations of 50µM, safinamide inhibited OATP1A2 and OATP2P1.
Maltese: F'konċentrazzjonijiet ta' 50 µM, safinamide inibixxa OATP1A2 u OATP2P1.
English: (SETTLE) (24 weeks)
Maltese: (SETTLE) (24 ġimgħa)
English: The metabolite NW-1153 is a substrate for OAT3 at clinically relevant concentrations.
Maltese: Il-metabolit NW-1153 huwa substrat għal OAT3 f'konċentrazzjonijiet klinikament relevanti.
English: Least Square Difference vs Placebo mITT Population: Study 016/018 - Placebo (n=212), safinamide 50 mg/day (n=217) and 100 mg/day (n=216), and SETTLE - Placebo (n=270), safinamide 50-100 mg/day (n=273).
Maltese: Popolazzjoni mITT: Studju 016/018 - Plaċebo (n=212), safinamide 50 mg/jum (n=217) u 100 mg/jum (n=216), u SETTLE - Plaċebo (n=270), safinamide 50-100 mg/jum (n=273).
English: D- 73614 Schorndorf Germany
Maltese: D- 73614 Schorndorf Il-Ġermanja
English: - The other ingredients are: - Tablet core: microcrystalline cellulose, crospovidone type A, magnesium stearate, silica colloidal anhydrous - Tablet coating: hypromellose, macrogol (6000), titanium dioxide (E171), iron oxide red (E172), mica (E555).
Maltese: Qalba tal-pillola: microcrystalline cellulose, crospovidone tip A, magnesium stearate, silica colloidal anhydrous Kisja tal-pillola: hypromellose, macrogol (6000), titanium dioxide (E171), iron oxide red (E172), mica (E555).
English: C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Maltese: madwar 30% tal-AUC0-24h,tar-radjuattività totali indikattiva ta' metaboliżmu estensiv.
English: The systemic exposure of NW-1153 is low (1/10 of parent safinamide).
Maltese: L-espożizzjoni sistemika talNW-1153 hija baxxa (1/10 ta' safinamide prinċipali).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskuloskeletriċi u tattessuti konnettivi
English: UPDRS III (c) Baseline (b)
Maltese: UPDRS III (c) Linja Bażi (b)
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati taħt l-intestaturi tal-frekwenza permezz tal-konvenzjonijiet li ġejjin: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The ‘N-dealkylated acid' (NW-1689) undergoes conjugation with glucuronic acid yielding its acyl glucuronide.
Maltese: L-'N-dealkylated acid' (NW-1689) jgħaddi minn konjugazzjoni b'glucuronic acid li ma teċċedix l-acyl glucuronide tiegħu.
English: Concomitant treatment with pethidine (see sections 4.4 and 4.5).
Maltese: Kura konkomitanti b'pethidine (ara sezzjonijiet 4.4 u 4.5).
English: Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic/tetracyclic antidepressants and MAO inhibitors (see section 4.4).
Maltese: Ġew irrapportati reazzjonijiet avversi serji bl-użu konkomitanti ta' inibituri selettivi ta' serotonin (SSRIs), inibituri ta' norepinephrine ta' serotonin (SNRIs), antidipressanti triċikliċi/tetraċikliċi u inibituri MAO (ara sezzjoni 4.4).
English: Palpitations, tachycardia, sinus bradycardia, arrhythmia
Maltese: Palpitazzjonijiet, takikardija, bradikardija tas-sinusite, arritmija
English: Preliminary in vitro studies have shown that safinamide is not a substrate for the transporters P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 or OAT2P1.
Maltese: Studji in vitro preliminari wrew li safinamide mhuwiex substrat għat-trasportaturi P-gp, BCRP, OAT1B1, OAT1B3, OATP1A2 jew OAT2P1.
English: In vitro metabolism studies have indicated that there is no meaningful induction or inhibition of cytochrome P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A3/5 at concentrations which are relevant (Cmax of free safinamide 0.4 µM at 100 mg/day) in man.
Maltese: Studji tal-metaboliżmu in vitro indikaw li ma hemm ebda induzzjoni jew inibizzjoni sinifikanti taċ-ċitokroma P450, CYP2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A3/5 f'konċentrazzjonijiet li huma relevanti (Cmax ta' safinamide ħieles 0.4 µM f'100 mg/jum) fil-bniedem.
English: Secondary efficacy parameters included OFF Time, UPDRS II and III (Unified Parkinson's Disease Rating Scale - sections II and III), and CGI-C (Clinical Global Impression of Change)
Maltese: Il-parametri sekondarji tal-effikaċja jinkludu Ħin OFF, UPDRS II u III (Skala ta' Klassifikazzjoni Unifikata tal-Marda ta' Parkinson - sezzjonijiet II u III), u CGI-C (Impressjoni Globali
English: Concomitant treatment with other monoamine oxidase (MAO) inhibitors (see sections 4.4 and 4.5).
Maltese: Kura konkomitanti ma' inibituri oħrajn ta' monoamine oxidase (MAO) (ara sezzjonijiet 4.4 u 4.5).
English: Acrochordon, melanocytic naevus, seborrhoeic keratosis, skin papilloma
Maltese: Akrokordon, naevus melanoċitiku, keratożi seborreika, papilloma tal-ġilda
English: Finally the ‘N-dealkylated acid' (NW-1689) is formed by oxidative cleavage of the amine bond of either safinamide (minor) or the primary safinamide acid metabolite (NW-1153) (major).
Maltese: Finalment l-'N-dealkylated acid' (NW-1689) huwa ffurmat minn qsim ossidattiv tal-bond tal-amine ta' safinamide (minuri) jew il-metabolit ta' safinamide acid primarju (NW-1153) (ewlieni).
English: There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products.
Maltese: Kien hemm rapporti ta' interazzjonijiet ma' prodotti mediċinali bl-użu konkomitanti tal-inibituri MAO u prodotti mediċinali simpatomimetiċi.
English: Responder analyses (post-hoc) (e) n(%) ON time increase ≥60 minutes p-value ≥60 minutes increase ON time and decrease in OFF time and ≥ 30% improvement UPDRS III p-value
Maltese: ≥60 minuta żieda ħin ON u tnaqqis fil-ħin OFF u żieda ta' ≥ 30% f'UPDRS III valur-p
English: Safinamide inhibits OCT1 in vitro at clinically relevant portal vein concentrations.
Maltese: Safinamide jinibixxi OCT1 in vitro f'konċentrazzjonijiet tal-vina portali klinikament relevanti.
English: Safinamide may transiently inhibit BCRP in vitro.
Maltese: Safinamide jista' jinibixxi l-BCRP maż-żmien in vitro.
English: Amidase present in blood, plasma, serum, simulated gastric fluid and simulated intestinal fluid as well as human carboxylesterases hCE-1 and hCE-2 are not responsible for the biotransformation of safinamide to NW-1153.
Maltese: Amidażi preżenti fid-demm, plażma, serum, fluwidu gastriku simulat u fluwidu intestinali simulat kif ukoll fil-karbossilesterażi tal-bniedem hCE-1 u hCE-2 mhumiex responsabbli mill-bijotrasformazzjoni ta' safinamide f'NW-1153.
English: The efficacy of safinamide as add-on treatment in mid-to late-stage PD (LSPD) patients with motor fluctuations, currently receiving L-dopa alone or in combination with other PD medicinal products, was evaluated in two double-blind, placebo-controlled studies: Study SETTLE (Study 27919; 50-100 mg/day; 24 weeks), and Study 016/018 (50 and 100 mg/day; 2-year, double-blind, placebo-controlled study).
Maltese: L-effikaċja ta' safinamide bħala kura ta' żieda f'pazjenti fi stadju medju sa avvanzat (LSPD) bi flutwazzjonijiet motorji, li bħalissa qed jirċievu L-dopa waħdu jew flimkien ma' prodotti mediċinali PD oħra, ġiet evalwata fi studji kkontrollati bi plaċebo, double-blind: Studju SETTLE (Studju 27919; 50-100 mg/jum; 24 ġimgħa), u Studju 016/018 (50 u 100 mg/jum; studju ta' sentejn ikkontrollat bi plaċebo, double-blind).
English: What Xadago contains - The active substance is safinamide.
Maltese: X' fih Xadago - Is-sustanza attiva hija safinamide.
English: Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase -B inhibitors, ATC code: N04BD03.
Maltese: Mediċini kontra l-marda ta' Parkinson, impedituri ta' monoamine oxidase -B, Kodiċi ATC:
English: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V. Tlf/Puh/Tel: + 47 815 300 30
Maltese: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V.
English: Eosinophilia, lymphopenia
Maltese: Eosinofilja, limfopenja
English: There have been reports of medicinal product interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors.
Maltese: Kien hemm rapporti ta' interazzjonijiet ma' prodotti mediċinali bl-użu konkomitanti ta' dextromethorphan u inibituri MAO mhux selettivi.
English: Another pathway involves oxidative cleavage of the ether bond forming ‘O-debenzylated safinamide' (NW-1199).
Maltese: Mogħdija oħra tinvolvi qsim ossidattiv tal-bond tal-ether li jifforma ‘O-debenzylated safinamide' (NW-1199).
English: Not applicable
Maltese: Inkompatibbiltajiet
English: Metabolite NW-1153 is not a substrate for OCT2, or OAT1, but it is substrate for OAT3.
Maltese: NW-1153 mhijiex substrat għal OCT2, jew OAT1, iżda hija substrat għal OAT3.
English: Dopaminergic side effects
Maltese: Effetti sekondarji dopaminerġiċi
English: Substance-related radioactivity was largely excreted in urine (76%) and only to a low extent in faeces (1.5%) after 192 hours.
Maltese: Ir-radjuattività relatata mas-sustanza kienet prinċipalment eliminata fl-awrina (76%) u sa ċertu punt biss fl-ippurgar (1.5%) wara 192 siegħa.
English: The volume of distribution (Vss) is approximately 165 L which is 2.5-fold of body volume indicating extensive extravascular distribution of safinamide.
Maltese: Il-volum ta' distribuzzjoni (Vss) huwa madwar 165 L li huwa 2.5-drabi l-volum tal-ġisem, li jindika distribuzzjoni extravaskulari estensiva ta' safinamide.
English: NW-1153 is not an inhibitor of OCT2, MATE1, or MATE2-K up to concentrations of 5µM.
Maltese: NW-1153 mhijiex inibitur ta' OCT2, MATE1, jew MATE2-K sa konċentrazzjonijiet ta' 5 µM.
English: Xadago 50 mg tablets safinamide
Maltese: Xadago 50 mg pilloli safinamide
English: Safinamide's metabolism is not dependent on Cytochrome P450 (CYP) based enzymes.
Maltese: Ilmetaboliżmu ta' safinamide ma jiddependix minn enżimi bbażati fuq iċ-Ċitokroma P450 (CYP).