FrancophonIA/ELRC3.0 huggingface dataset:
English: The extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state.
Maltese: L-ammont ta' assorbiment ta' levodopa (AUCinf) kien simili (żieda ta' 13 %) għal dak osservat fl-istat sajjem.
English: Baseline, mean Change at endpoint Difference (95% CI) p-value
Maltese: Differenza (95 % CI) valur p
English: The ingredients in the hard capsule shell are indigo carmine (E132) lake, yellow iron oxide (E172), titanium dioxide (E171) and gelatine
Maltese: L-ingredjenti fil-qoxra tal-kapsula iebsa huma indigo carmine (E132) lake, iron oxide isfar (E172), titanium dioxide (E171) u ġelatina
English: Effect of levodopa and carbidopa on the metabolism of other medicinal products
Maltese: Effett ta' levodopa u carbidopa fuq il-metaboliżmu ta' prodotti mediċinali oħra
English: Figure 1: Mean concentration-time profiles of levodopa plasma concentrations in 22 adults following a single oral dose of 2 Numient 195 mg levodopa/48.75 mg carbidopa capsules
Maltese: Figura 1: Medja ta' konċentrazzjoni fil-ħin ta' profili ta' konċentrazzjonijiet ta' levodopa fil-plażma f'22 adult wara doża orali waħda ta' żewġ kapsuli Numient 195 mg levodopa/48.75 mg carbidopa
English: The bioavailability of carbidopa from this medicinal product relative to immediate release levodopa and carbidopa tablets was approximately 50%.
Maltese: prodott mediċinali relatat mar-reħi tal-mediċina immedjat tal-pilloli levodopa u carbidopa kien bejn wieħed u ieħor 50 %.
English: Non-selective monoamine oxidase inhibitors must be discontinued at least 2 weeks prior to treatment initiation with the modified-release levodopa/carbidopa capsule medicinal product (see section 4.3).
Maltese: Inibituri mhux selettivi ta' monoamine oxidase għandhom jitwaqqfu mill-inqas ġimagħtejn qabel ilbidu tal-kura tal-prodott mediċinali tal-kapsula li terħi l-mediċina b'mod modifikat levodopa/carbidopa (ara sezzjoni 4.3).
English: The two major metabolic pathways are decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT).
Maltese: Iż-żewġ mogħdijiet metaboliċi ewlenin huma dekarbosslazzjoni permezz tad-dopa decarboxylase (DDC) u O-methylation bilcatechol-O-methytransferase (COMT).
English: Levodopa/Carbidopa
Maltese: Levodopa/Carbidopa/Entacapone;
English: In patients with Parkinson's disease, multiple-dose pharmacokinetics was comparable to single-dose pharmacokinetics, i.e. there was a minimal accumulation of levodopa from the modified-release levodopa/carbidopa medicinal product.
Maltese: F'pazjenti bil-marda tal-Parkinson, farmakokinetiċi ta' doża multipla kien komparabbli ma' farmakokinetiċi ta' doża waħda, jiġifieri kien hemm akkumulazzjoni minima ta' levodopa mill-prodott mediċinali li jerħi levodopa/carbidopa b'mod modifikat.
English: The active substances of Numient are levodopa and carbidopa Each 95 mg/23.75 mg modified-release hard capsule contains 95 mg levodopa and 23.75 mg carbidopa (as monohydrate)
Maltese: Is-sustanzi attivi ta' Numient huma levodopa u carbidopa Kull 95 mg/23.75 mg Kapsula iebsa li terħi mediċina b'mod modifikatat fiha 95 mg levodopa u 23.75 mg carbidopa (bħala monohydrate)
English: How to store Numient
Maltese: X'fih Numient
English: 4 hard capsules 95 mg/23.75 mg TID
Maltese: 4 kapsuli ibsin 95 mg/23.75 mg TID
English: There are no data on the effects of levodopa or carbidopa on human fertility.
Maltese: M'hemmx dejta fuq l-effetti ta'levodopa jew carbidopafuq il-fertilità umana.
English: Oculogyric crises, activation of latent Horner's syndrome, blepharospasm
Maltese: Kriżijiet okulogiriċi, attivazzjoni tassindromu moħbi ta' Horner, blefarospażmu
English: Total daily dose of levodopa in immediate release levodopa/DDC inhibitor (mg)
Maltese: Doża totali ta' kuljum ta' levodopa (mg) f'levodopa/inibitur ta' DDC/entacapone
English: carbidopa belongs to a group of medicines called ‘aromatic amino acid decarboxylase inhibitors'.
Maltese: - carbidopa jappartjeni għal grupp ta' mediċini msejħa ‘inibituri decarbossilas aromatiċi tal-amino aċidi'.
English: 3 hard capsules 95 mg/23.75 mg TID
Maltese: 3 kapsuli ibsin 95 mg/23.75 mg TID
English: Dark saliva, bruxism, hiccups, sialorrhoea
Maltese: Bżieq skur, tgħażżiż tas-snien, sulluzzu, sialorrhoea
English: pruritus (see section 4.3) purpura, urticaria (see section 4.3), hair loss, exanthema, dark sweat
Maltese: purpura HenochSchönlein, urtikarja (ara Sezzjoni 4.3), telf ta' xagħar, eksantema, għaraq skur
English: In vivo, co-administration of Numient with up to 40% volume-to-volume (v/v) alcohol did not result in dosedumping of levodopa or carbidopa.
Maltese: In vivo, ko-amministrazzjoni ta' Numient b'sa 40 % volum għal volum (v/v) alkoħol ma rriżultax f'dożi maħżuna ta' levodopa jew carbidopa.
English: Elevated AST, ALT, LDH, bilirubin, blood sugar, creatinine, uric acid; lowered values of haemoglobin and haematocrit; blood in urine
Maltese: Livelli għoljin ta' AST, ALT, LDH, bilirubina, zokkor fid-demm, kreatinina, uric acid; valuri mbaxxija ta' emoglobina u ematokrit; demm flawrina
English: The other ingredients are cellulose, microcrystalline, mannitol, tartaric acid, ethylcellulose, hypromellose, sodium starch glycolate, sodium laurilsulfate, povidone, talc, methacrylic acidmethyl methacrylate copolymers (1:1), methacrylic acid - methyl methacrylate copolymers (1:2), triethyl citrate, croscarmellose sodium and magnesium stearate
Maltese: L-ingredjenti l-oħra huma ċelluloża, microcrystalline, mannitol, aċidu tartariku, etilċelluloża, hypromellose, sodium starch glycolate, sodium laurilsulfate, povidone,
English: 950 to 1249
Maltese: Minn 950 sa 1,249
English: Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Maltese: Numient huwa assoċjat man-ngħas u b'mod rari ħafna kien assoċjat ma' episodji ta' ngħas eċċessiv bi nhar u rqad li jiġi f'daqqa.
English: The most frequently reported adverse reactions with Numient were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti b'Numient kienu dardir, li jseħħ f'madwar 12 % tal-pazjenti kollha; sturdament; uġigħ ta' ras u diskinesja li kull waħda minnhom isseħħ f'madwar 8 % tal-pazjenti kollha; u nuqqas ta' rqad li jseħħ f'madwar 6 % tal-pazjenti kollha.
English: Table 4: Mean change from baseline in UPDRS Part II plus Part III score at week 30 (or at early termination) in levodopa naïve patients with Parkinson's disease (APEX-PD)
Maltese: UPDRS Parti II flimkien ma' Parti III riżultat f'ġimgħa 30 (jew fi tmiem bikri) f'pazjenti li huma “levodopa naïve” bil-marda tal-Parkinsons (APEX-PD)
English: Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7).
Maltese: Levodopa kien assoċjat man-ngħas u ma' episodji ta' rqad f'daqqa (ara sezzjoni 4.7).
English: Effects of levodopa on fertility were evaluated in mouse studies (see section 5.3).
Maltese: Effetti ta' levodopa fuq il-fertilità kienu evalwati fi studji fuq il-ġrieden (ara sezzjoni 5.3).
English: Inhibition or induction effects of levodopa and carbidopa have not been investigated.
Maltese: Inibizzjoni jew effetti ta' induzzjoni ta' levodopa u carbidopa ma ġewx investigati.
English: Each double-blind study period lasted 2 weeks.
Maltese: Kull perjodu mill-istudju double-blind ħa ġimagħtejn.
English: Opaque, white, high-density polyethylene (HDPE) bottle with polypropylene screw closure.
Maltese: Opak, abjad, flixkun tal-polietilene ta' densita għolja (HDPE) b'għeluq tal-kamin polipropiline.
English: SB-6018 blue ink Shellac (E904) Propylene glycol Indigo carmine (E132), lake
Maltese: SB-6018 linka blu Shellac (E904)
English: The dose was increased starting on Day 4 and the highest target dose (390 mg levodopa/97.5 mg carbidopa TID) was achieved by Day 22.
Maltese: Id-doża żdiedet mir-4 Ġurnata u l-ogħla doża fil-mira (390 mg levodopa/97.5 mg carbidopa TDK) inkiseb sat-22 Ġurnata.
English: subcutaneous tissue disorders hyperhidrosis, rash (see section 4.3)
Maltese: Fwawar, iperidrożi, raxx (ara sezzjoni 4.3)
English: There was no evidence of period, sequence/carry-over effects in the ASCEND-PD study (p-values all > 0.10).
Maltese: M'hemm ebda evidenza talperjodu, is-sekwenza u l-effetti ta' trasferiment fl-istudju ASCEND-PD (il-valuri p kollha > 0.10).
English: This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Maltese: Dan il-ħsieb u l-imġiba anormali jista' jikkonsistu minn wieħed jew iktar ta' varjetà ta' manifestazzjonijiet inklużi l-ansjetà, dipressjoni, ħsibijiet ta' paranojde, delużjonijiet, alluċinazzjonijiet, konfużjoni, imġiba simili tal-psikotiku, diżorjentament, imġiba aggressiva, aġitazzjoni u delirju.
English: Patients receiving the modified-release levodopa/carbidopa medicinal product initiated treatment at 95 mg levodopa/23.75 mg carbidopa three times daily (TID).
Maltese: Pazjenti li qed jirċievu lprodott mediċinali li jerħi levodopa/carbidopa b'mod modifikat bi trattament mibdi ta' 95 mg levodopa/23.75 mg carbidopa tliet darbiet kuljum (TDK).
English: Products containing ferrous sulphate and levodopa/carbidopa should be administered separately with the longest possible time interval between administrations (see section 4.2).
Maltese: Prodotti li fihom is-sulfat tal-ħadid u levodopa/carbidopa għandhom jiġu amministrati separatament bl-itwal intervall tal-ħin possibli bejn l-amministrazzjonijiet (ara sezzjoni 4.2).
English: Anticholinergic medicinal products may impair the effect of levodopa, due to a delayed absorption.
Maltese: Ilprodotti mediċinali antikolinerġiċi jistgħu jfixklu l-effett ta' levodopa, minħabba assorbiment imdewwem.
English: Dystonia, on and off phenomenon, dyskinesia, somnolence, gait disturbance, dizziness, worsening of Parkinson's disease, paraesthesia, headache, tremor
Maltese: Distonja, fenomenu filli preżenti u filli le, diskinesija, ngħas, disturb fil-mixja, sturdament, aggravar tal-marda talParkinson, parasteżija, uġigħ ta' ras, rogħda
English: Pyridoxine is not effective in reversing the actions of this combination medicinal product.
Maltese: Pyridoxine mhuwiex effettiv sabiex ireġġa' lura lazzjonijiet ta' din il-kombinazzjoni ta' dan il-prodott mediċinali.
English: A total of 471 included patients had been maintained on a stable regimen of at least 400 mg per day of levodopa prior to entry into the trial.
Maltese: Total li inkluda 471 pazjent inżammu fuq reġim stabbli ta' mill-inqas 400 mg kuljum ta' levodopa qabel ma ġew irreġistrati fil-prova.
English: In healthy adults, oral administration of the modified-release levodopa/carbidopa medicinal product after a high-fat, high-calorie meal reduced levodopa Cmax by 21%.
Maltese: F'adulti b'saħħithom, l-għoti orali tal-prodott mediċinali li jerħi levodopa/carbidopa b'mod modifikat wara ikla li fiha ħafna xaham u ħafna kaloriji naqqas is-Cmass ta' levodopa bil-21 %.
English: Orthostatic hypotension (see section 4.4 and 4.9), hypertension (see section
Maltese: Pressjoni baxxa ortostatika (ara sezzjoni 4.4 u 4.9), pressjoni għolja (ara sezzjoni 4.5)
English: *In the ADVANCE-PD study an Analysis of Covariance (ANCOVA) model for End of Study was used with treatment and centres as main effects and interaction term for treatment by centre and baseline as covariate.
Maltese: *Fl-istudju ADVANCE-PD, intuża mudell tal-Analizi tal-Kovarjanza (ANCOVA) għat-Tmiem tal-Istudju mal-kura u ċ-ċentri bħala effetti ewlenin u terminu ta' interazzjoni għall-kura skont iċ-ċentru u l-linja bażi bħala ko-varjant.
English: There is limited experience with a total daily dose of more than 1,170 mg of levodopa when administered in levodopa-naïve patients.
Maltese: Hemm esperjenza limitata bid-doża totali ta' kuljum ta' aktar minn 1,170 mg ta' levodopa meta jingħata lill-pazjenti li huma ‘levodopa-naïve'.
English: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and levodopa/carbidopa.
Maltese: Kien hemm rapporti rari ta' reazzjonijiet avversi, li jinkludu pressjoni għolja u diskinesja, li jirriżultaw minn użu konkomitanti ta' antidipressanti triċikliċi u levodopa/carbidopa.
English: Table 2: Guidelines for initial conversion from immediate release levodopa/DDC inhibitor plus catechol-Omethyl transferase (COMT) inhibitors (such as entacapone) to Numient in Parkinson's disease patients Total daily dose of levodopa (mg) in levodopa/DDC inhibitor/entacapone
Maltese: Tabella 2: Linji gwida għat-tneħħija inizjali minn levodopa/inibitur ta' DDC li jerħu l-mediċina b'mod immedjat flimkien ma' inibituri tal-catechol-O-methyl transferase (COMT) (bħal entacapone) u poġġuti għal fuq Numient f'pazjenti bil-marda tal-Parkinson.
English: The final total daily dose of levodopa from Numient is about double that of the final total daily dose of levodopa from immediate release tablets while the final total daily dose of levodopa from Numient is about three times that of the final total daily dose of levodopa from the combination of levodopa/DDC inhibitor/entacapone.
Maltese: It-total finali tad-doża ta' kuljum ta' levodopa minn Numient huwa madwar id-doppju dak tat-total finali tad-doża ta' kuljum ta' levodopa li jerħi l-mediċina b'mod immedjat tal-mediċina filwaqt li ttotal finali tad-doża ta' kuljum ta' levodopa minn Numient huwa madwar tliet darbiet dak tat-total finali tad-doża ta' kuljum ta' levodopa mill-kombinazzjoni ta' levodopa/inibitur ta' DDC/entacapone.
English: 195 mg/48.75 mg modified-release hard capsules Each capsule contains 195 mg levodopa and 48.75 mg carbidopa (as monohydrate)
Maltese: Kull 195 mg/48.75 mg kapsula iebsa li terħi mediċina b'mod modifikat t fiha 195 mg levodopa u 48.75 mg carbidopa (bħala monohydrate)
English: The effectiveness of Numient in patients with early Parkinson's disease was established in a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group, 30-week clinical trial in 381 patients who had a median disease duration of 1 year and limited or no prior exposure to levodopa and dopamine agonists.
Maltese: L-effettività ta' Numient f'pazjenti fi stadju kmieni tal-marda tal-Parkinsons kien stabbilit fi studji kliniċi ta' 30 ġimgħa randomizzati, double-blind, ikkontrollat bil-plaċebo, b'doża fissa, grupp parallel f'381 pazjentli kellhom tul ta' żmien tal-marda medjan ta' sena u limitati jew mingħajr ebda espożizzjoni minn qabel għal levodopa u agonisti tad-dopamina.
English: Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnoea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leucocytosis, myoglobinuria, and increased serum myoglobin have been reported.
Maltese: Sejbiet newroloġiċi, inkluż l-ebusija tal-muskolu, movimenti involontarji, sensi mibdula, tibdil fl-istat mentali; distubri oħra bħad-disfunzjoni awtonomika, takikardija, takipnea, għaraq, pressjoni għolja jew pressjoni baxxa; sejbiet tal-laboratorju bħal elevazzjoni tal-kreatina talfosfokinasi, lektoċitosi, majoglobinurja, u żieda fis-serum tal-mijoglobina ġew irrapportati.
English: Each capsule contains 95 mg of levodopa and 23.75 mg of carbidopa (as monohydrate).
Maltese: Kull kapsula fiha 95 mg ta' levodopa u 23.75 mg ta' carbidopa (bħala monohydrate).
English: 245 mg/61.25 mg modified-release hard capsule Blue body and a blue cap of 23 x 9 mm imprinted with “IPX066” and “245” in blue ink.
Maltese: 245 mg/61.25 mg kapsula iebsa li terħi l-mediċina b'mod modifikat Parti blu u b'għatu blu ta' 23 × 9 mm stampati b' “IPX066” u “245” b'linka blu.
English: if you are allergic to levodopa or carbidopa, or any of the other ingredients of this medicine (listed in section 6); if you have narrow-angle glaucoma (an eye disorder); if you have phaeochromocytoma (a rare tumour of the adrenal gland); if you are taking certain medicines for treating depression [non-selective monoamine oxidase (MAO) inhibitors].
Maltese: jekk inti allerġiku għal levodopa jew carbidopa, jew kull ingredjent ieħor ta' din il-mediċina (elenkati fis-sezzjoni 6); jekk għandek glawkoma ta' angolu dejjaq (disturb fl-għajn); jekk tbati minn feokromoċitoma (tumur rari tal-glandola adrenali); jekk qed tieħu ċerti mediċini biex tikkura d-dipressjoni [inibituri mhux selettivi ta' monoamine oxidase (MAO)].
English: Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g. hypotension, sinus tachycardia) and more severe psychiatric problems at higher doses.
Maltese: Dożi ta' ftit grammi jistgħu jirriżultaw f'disturbi CNS, bi probabbiltà dejjem tikber ta' disturbi kardjovaskulari (pressjoni baxxa, sinus takikardija) u problemi psikjatriċi iktar severi f'dożi aktar għoljin.
English: Henoch-Schönlein
Maltese: Ir-Renju Unit
English: Excessive or dark-coloured saliva, grinding of the teeth, hiccups Hair loss, rash (including a severe rash called Henoch-Schönlein purpura), dark-coloured sweat
Maltese: Bżieq eċċessiv jew skur, theżżiż tas-snien, sulluzzu Telf ta' xagħar, raxx (inkluż raxx sever imsejjaħ Henoch-Schönlein purpura), għaraq skur
English: Numient 195 mg/48.75 mg modified-release hard capsules EU/1/15/1044/007 (25 modified-release hard capsules) EU/1/15/1044/008 (100 modified-release hard capsules) EU/1/15/1044/009 (240 modified-release hard capsules)
Maltese: Numient 195 mg/48.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat EU/1/15/1044/007 (25 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/008 (100 kapsuli ibsin li jerħu mediċina b'mod modifikat) EU/1/15/1044/009 (240 kapsuli ibsin li jerħu mediċina b'mod modifikat)
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jista' jaffettwa sa persuna 1 minn kull 10 persuni) Tnaqqis fil-piż
English: Numient 95 mg/23.75 mg modified-release hard capsules Numient 145 mg/36.25 mg modified-release hard capsules Numient 195 mg/48.75 mg modified-release hard capsules Numient 245 mg/61.25 mg modified-release hard capsules levodopa/carbidopa
Maltese: Numient 95 mg/23.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat Numient 145 mg/36.25 mg kapsuli ibsin li jerħu mediċina b'mod modifikat Numient 195 mg/48.75 mg kapsuli ibsin li jerħu mediċina b'mod modifikat Numient 245 mg/61.25 mg kapsuli ibsin li jerħu mediċina b'mod modifikat levodopa/carbidopa
English: 145 mg/36.25 mg modified-release hard capsules Each capsule contains 145 mg levodopa and 36.25 mg carbidopa (as monohydrate)
Maltese: Kull 145 mg/36.25 mg kapsula iebssa li terħi mediċina b'mod modifikat t fiha 145 mg levodopa u 36.25 mg carbidopa (bħala monohydrate)
English: Suicide attempt (see section 4.4), disorientation, dopaminergic dysregulation syndrome, euphoria, increased libido
Maltese: Tentattiv ta' suwiċidju (ara sezzjoni 4.4), diżorjentament, sindromu ta' diregulazzjoni dopaminerġika, ewforija, żieda fillibido
English: Levodopa/carbidopa preparations may provide a false-positive test result for ketone bodies, if a test strip is used for determining any ketonuria.
Maltese: Preparazzjonijiet levodopa/carbidopa jistgħu jipprovdu riżultat ta' test falz-pożittiv għall-korpi talketone, jekk strixxa tat-test hija użata biex ikun stabbilit xi ketonuria.
English: Levodopa/carbidopa should be administered cautiously to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage) and a history of convulsions.
Maltese: Preparazzjonijiet ta' Levodopa/carbidopa għandhom ikunu amministrati b'mod kawt lill-pazjenti b'mard tal-qalb iskemiku, mard serju kardjovaskulari jew pulmonari, ażma tal-bronki, mard tal-kliewi, fwied jew endokrinali, jew passat ta' mard ta' ulċera peptika (minħabba l-possibiltà ta' emorraġija gastro-intestinali fin-naħa ta' fuq) u passat ta' konvulżjonijiet.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: In particular, tell your doctor or pharmacist if you are taking the following medicines: Other medicines for Parkinson's disease, such as ‘anticholinergics' (e.g. orphenadrine and trihexyphenidyl), ‘selective MAO-B inhibitors' (e.g. selegiline and rasagiline), and a ‘COMT inhibitor' (e.g. entacapone)
Maltese: Mediċini oħra għal marda tal-Parkinsons, bħal ‘anticholinergics' (eż. orphenadrine u trihexyphenidyl), ‘inibituri selettivi
English: Narrow-angle glaucoma.
Maltese: - Żomm dan il-fuljett.
English: Decreased haemoglobin and haematocrit have been observed on long-term levodopa/carbidopa treatment.
Maltese: Tnaqqis fl-emoglobina u fl-ematokrit ġie osservat f'kura fit-tul b'levodopa/carbidopa.
English: 145 mg/36.25 mg modified-release hard capsule Light blue body and a blue cap of 19 x 7 mm imprinted with “IPX066” and “145” in blue ink.
Maltese: 145 mg/36.25 mg kapsula iebsa li terħi l-mediċina b'mod modifikat Parti blu ċara u b'għatu blu ta' 19 × 7 mm stampati b' “IPX066” u “145” b'linka blu.
English: The ASCEND-PD study was a randomized, double-blind, 2-treatment, 2-period crossover study in which 110 patients on a stable regimen of levodopa/carbidopa/entacapone (LCE) containing at least 400 mg per day of levodopa were included.
Maltese: L-istudju ASCEND-PD kien studju crossover, b'żewġ perjodi, b'żewġ kuri, double-blind, randomizzat li fih 110 pazjent fuq reġim stabbli ta' levodopa/carbidopa/entacapone (LCE) li fih kienu inklużi talanqas 400 mg kuljum ta' levodopa.
English: 95 mg/23.75 mg modified-release hard capsule White body and a blue cap of 18 x 6 mm imprinted with “IPX066” and “95” in blue ink.
Maltese: 95 mg/23.75 mg kapsula iebsa li terħi l-mediċina b'mod modifikat Parti bajda u b'għatu blu ta' 18 × 6 mm stampati b' “IPX066” u “95” b'linka blu.
English: Laboratory testing
Maltese: Ittestjar fil-laboratorju
English: Dose linearity
Maltese: Linearità tad-Doża
English: 245 mg/61.25 mg modified-release hard capsules Each capsule contains 245 mg levodopa and 61.25 mg carbidopa (as monohydrate)
Maltese: Kull 245 mg/61.25 mg kapsula iebsa li terħi mediċina b'mod modifikat t fiha 245 mg levodopa u 61.25 mg carbidopa (bħala monohydrate)
English: Patients continued on stable concomitant anti-Parkinson medicinal product.
Maltese: Pazjenti komplew fuq prodott mediċinali konkomitanti stabbli kontra l-Parkinsons.
English: Do not take Numient if you have taken a medicine called a ‘non-selective monoamine oxidase (MAO) inhibitor' for treating depression in the last 14 days.
Maltese: Tiħux Numient jekk ħadt il-mediċina li tissejjaħ ‘inibitur monoamine oxidase mhux selettiv' (MAO) għat-trattament tad-dipressjoni fl-aħħar 14-il jum.
English: Sudden sleep onset
Maltese: Doża inizjali ssuġġerita ta' Numient
English: Benzodiazepines such as alprazolam, diazepam, and lorazepam used to treat anxiety Tricyclic antidepressants (TCAs; used to treat depression) Papaverine (used to improve blood flow around the body) Treatment for high blood pressure (hypertension)
Maltese: Benzodiazepines bħal alprazolam, diazepam, u lorazepam użati biex jittrattaw l-ansjetà Antidipressanti triċikliċi (TCAs; użati biex jikkuraw id-dipressjoni) Papaverine (użat biex itejjeb il-fluss tad-demm madwar il-ġisem) Trattament għall-pressjoni għolja tad-demm (pressjoni għolja) Phenytoin li jintuża biex jikkura aċċessjonijiet (konvulżjonijiet) Isoniazid li jintuża biex jikkura t-tuberkolożi
English: Increased levels of sugar, uric acid and/or liver enzymes in the blood Abnormal kidney function tests and/or blood in the urine
Maltese: Żieda fil-livelli ta' zokkor, uric acid u/jew enzimi tal-fwied fid-demm Testijiet għal funzjoni anormali tal-kliewi u/jew id-demm fl-awrina
English: Skin and
Maltese: U LUŻU