FrancophonIA/ELRC3.0 huggingface dataset:
English: Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
Maltese: Studji epidemjoloġiċi jipprovdu riżultati konfliġġenti rigward ir-riskju ta' malformazzjonijiet konġenitali.
English: Adopted at the 11-14 June 2019 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-11 u l-14 ta' Ġunju 2019
English: Patients with prosthetic valves
Maltese: Effetti mhux mixtieqa
English: Propylthiouracil is able to cross the human placenta.
Maltese: Propylthiouracil jista' jgħaddi mill-plaċenta tal-bniedem.
English: Rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement (TAVR).
Maltese: Rivaroxaban m'għandux jintuża għat-tromboprofilassi f'pazjenti li reċentement ikunu għamlu bdil transkateter tal-valv aortiku (TAVR).
English: Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy.
Maltese: Hija meħtieġa valutazzjoni individwali tal-benefiċċju/riskju qabel it-trattament bi propylthiouracil waqt it-tqala.
English: Rivaroxaban - Premature ending of the GALILEO study in patients who have received an artificial heart valve through a transcatheter aortic valve replacement (TAVR) (EPITT no
Maltese: 3. Rivaroxaban - Tmiem qabel iż-żmien tal-istudju GALILEO f'pazjenti li rċevew valv tal-qalb artifiċjali permezz ta' bdil transkateter tal-valv aortiku (TAVR) (EPITT nru 19294)
English: Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome.
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu […] Doża eċċessiva tista' tikxef is-sindromu eżistenti Brugada.
English: 2.5 ml (suspension) 2.5 ml (emulsion)
Maltese: 2.5 ml (suspensjoni) 2.5 ml (emulsjoni)
English: 3.75 micrograms propagated in eggs ** haemagglutinin
Maltese: *imnissla fil-bajd **emagglutinina
English: After mixing, 1 dose (0.5 ml) contains: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Maltese: Razza tixbaħ A/Indonesia/05/2005 (H5N1) użat (PR8-IBCDC-RG2)
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Maltese: Jingħata filmuskolu suspensjoni (H5N1): kunjett (ħġieġ) emulsjoni (suppliment): kunjett (ħġieġ)
English: 50 vials (suspension) 2 x 25 vials (emulsion)
Maltese: 2 x 25 kunjett (emulsjoni)
English: Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection
Maltese: Prepandrix 3.75 µg HA
English: Strength Pharmaceutical form
Maltese: KG Arzneimittel
English: 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member
Maltese: Prodotti mediċinali għal użu topiku li fihom 0.005 % w/w estradiol/0.4 % w/w prednisolone Stat
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn għandu jingħata, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Vaginal cream Vaginal use, topical use
Maltese: Użu vaġinali, użu topiku
English: 0.01 % w/w estradiol containing medicinal products for topical use Member
Maltese: Prodotti mediċinali għal użu topiku li fihom 0.01 % w/w estradiol Stat Membru (fiż-ŻEE)
English: Vaginal emulsion Cutaneous use, vaginal use
Maltese: Emulsjoni vaġinali
English: Invented name
Maltese: Anness I
English: Further information on Tafinlar 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: Tafinlar is available as capsules (50 and 75 mg).
Maltese: Tafinlar huwa disponibbli bħala kapsuli (50 u 75 mg).
English: Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013.
Maltese: Tafinlar irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-26 ta' Awwissu 2013.
English: Tafinlar contains the active substance dabrafenib.
Maltese: Tafinlar fih is-sustanza attiva dabrafenib.
English: Other information about Tafinlar
Maltese: Informazzjoni oħra dwar Tafinlar
English: Patients given the combination lived 25.6 months on average, versus 18 months with vemurafenib.
Maltese: Il-pazjenti li ngħataw il-kombinazzjoni għexu bħala medja ta' 25.6 xahar, imqabbla ma' 18-il xahar b'vemurafenib.
English: What are the risks associated with Tafinlar?
Maltese: X'inhuma r-riskji assoċjati ma' Tafinlar?
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Maltese: Madwar 40% tal-pazjenti kkurati bil-kombinazzjoni jew mietu jew il-marda reġgħet tfaċċat wara medja ta' madwar 3 snin u nofs meta mqabbla ma' 59% tal-pazjenti li rċevew il-plaċebo.
English: The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division.
Maltese: Is-sustanza attiva f‘Tafinlar, dabrafenib, taħdem billi tinblokka l-BRAF, proteina involuta fl-istimolar tad-diviżjoni taċ-ċelloli.
English: The most common side effects with Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Tafinlar (li jistgħu jaffetwaw iktar minn persuna 1 minn 10) huma papilloma (felul), uġigħ ta' ras, dardir, remettar, iperkeratożi (meta l-ġilda teħxien u tiħrax), telf taxxagħar, raxx, uġigħ fil-ġogi, deni u għeja.
English: Patients given the combination lived for 11 months without their disease worsening, compared with 8.8 months for those given Tafinlar alone.
Maltese: Il-pazjenti li ġew ikkurati bil-kombinazzjoni għexu għal 11-il xahar mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 8.8 xhur għallpazjenti li ngħataw Tafinlar waħdu.
English: Patients taking Tafinlar lived on average 6.9 months before the disease got worse, compared with 2.7 months in patients given dacarbazine.
Maltese: Il-pazjenti li ħadu Tafinlar għexu bħala medja għal 6.9 xhur mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 2.7 xhur għal pazjenti li ngħataw dacarbazine.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Tafinlar and trametinib given for 1 year was compared with placebo (a dummy treatment).
Maltese: Fi studju li involva 870 pazjent b'melanoma fi stadju III li kienet tneħħiet b'kirurġija, il-kombinazzjoni ta' Tafinlar u trametinib mogħtija għal sena tqabblet ma' plaċebo (kura finta).
English: The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.
Maltese: L-użu ta' Tafinlar u trametinib wassal għal rispons f'aktar minn 60% tal-pazjenti, meta mqabbel ma' 23 % tal-pazjenti li użaw Tafinlar waħdu.
English: Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600'.
Maltese: Tafinlar huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti li ċ-ċelloli tal-kanċer tagħhom għandhom mutazzjoni ġenetika speċifika (bidla) msejħa ‘BRAF V600'.
English: It is used in combination with trametinib.
Maltese: Jintuża flimkien ma' trametinib.
English: How is Tafinlar used?
Maltese: Kif jaħdem Tafinlar?
English: When Tafinlar is taken in combination with trametinib, the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Maltese: Meta Tafinlar jittieħed flimkien ma' trametinib, l-effetti sekondarji l-aktar komuni (li jistgħu jaffetwaw iktar minn persuna 1 minn kull 5) huma deni, għeja, dardir, tertir, uġigħ ta' ras, dijarea, remettar, uġigħ fil-ġogi u raxx.
English: As for all medicines, data on the use of Tafinlar are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Tafinlar hija ssorveljata kontinwament.
English: • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
Maltese: • melanoma avvanzata (stadju III) wara kirurġija għaliha.
English: What measures are being taken to ensure the safe and effective use of Tafinlar?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Tafinlar?
English: In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib.
Maltese: Fit-tieni studju li involva 704 pazjenti, Tafinlar ma' trametinib tqabbel ma' mediċina oħra għall-melanoma, vemurafenib.
English: In one study 423 patients were given either the combination or Tafinlar alone.
Maltese: Fi studju wieħed 423 pazjent ingħataw jew il-kombinazzjoni jew Tafinlar waħdu.
English: Tafinlar was more effective than the cancer medicine dacarbazine at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Maltese: Tafinlar kien aktar effettiv mill-mediċina kontra l-kanċer dacarbazine fil-kontroll tal-melanoma li nfirxet f'partijiet oħra tal-ġisem jew li ma setgħetx titneħħa b'kirurġija.
English: For the full list of side effects and restrictions with Tafinlar, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Tafinlar, ara l-fuljett ta' tagħrif.
English: The European Medicines Agency decided that Tafinlar's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Tafinlar fil-kanċers bil-mutazzjoni BRAF V600 huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal).
Maltese: Id-doża ta' Tafinlar użata kemm waħedha jew flimkien ma' trametinib hija ta' 150 mg darbtejn kuljum u tittieħed fuq stonku vojt (mill-inqas siegħa qabel jew sagħtejn wara l-ikel).
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Maltese: Fil-melanoma u fil-kanċer tal-pulmun mhux b'ċelloli żgħar bil-mutazzjoni BRAF V600, il-forma anomala ta' BRAF għandha rwol fl-iżvilupp tal-kanċer billi tippermetti d-diviżjoni mhux ikkontrollata taċ-ċelloli tat-tumuri.
English: Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
Maltese: Tafinlar jintuża flimkien ma' trametinib;
English: Store below 30 °C.
Maltese: Aħżen f'temperatura taħt it-30 °C.
English: CNS effects and mental disturbances
Maltese: Effetti CNS u disturbi mentali
English: Dark urine, urinary incontinence
Maltese: Awrina skura, inkontinenza urinarja
English: Cellulose, microcrystalline
Maltese: Ċellulose, microcrystalline
English: Phenytoin and papaverine
Maltese: Phenytoin u papaverine
English: Dose (mg), median (range)
Maltese: Doża (mg), medjan (medda)
English: Amneal Pharma logo
Maltese: Logo Amneal Pharma
English: UPDRSII-III score
Maltese: Punteġġ UPDRSII-III
English: Mean UPDRS (Part II and Part III) Score a)
Maltese: UPDRS Medja (Parti II u Parti III) Riżultat a)
English: Placebo Numient 145 mg d)
Maltese: Plaċebo Numient 145 mg d)
English: A total of 393 patients (mean age 63.2 years; 65% male patients) were randomized.
Maltese: Total ta' 393 pazjent (età medja ta' 63.2 sena, 65 % tal-pazjenti rġiel) kienu rrandomizzati.
English: System organ class Very Common
Maltese: Sistema talklassifika talorgani
English: Psychotic episode, agitation
Maltese: Episodju psikotiku, aġitazzjoni
English: b) Combined term that includes atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia
Maltese: b) Terminu kombinat li jinkludi fibrillazzjoni atrijali, palpitazzjoni atrijali, blokk atrijoventrikulari, bundle branch block, sindromu tas-sinus marid, bradikardija, u takikardija
English: “Off” time (hrs)*
Maltese: Ħin “off” (sigħat)*
English: Carbidopa is metabolized to two main metabolites: α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3, 4-dihydroxy-phenylpropionic acid.
Maltese: Carbidopa huwa metabolizzat f'żewġ metaboliti prinċipali: aċidu α-methyl-3-methoxy-4hydroxyphenylpropionic u aċidu α-methyl-3, 4-dihydroxy-phenylpropionic.
English: Date of first authorisation: 19 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Id-data tal-ewwel awtorizzazzjoni: 19 Novembru 2015
English: Monoamine oxidase inhibitors
Maltese: Inibituri ta' monoamine oxidase
English: Indigo carmine (E132), lake Yellow iron oxide (E172) Titanium dioxide (E171) Gelatine
Maltese: Indigo carmine (E132), lake Iron oxide isfar (E172) Titanium dioxide (E171) Ġelatina
English: Methacrylic acid - methyl methacrylate copolymers (1:1) Methacrylic acid - methyl methacrylate copolymers (1:2) Triethyl citrate
Maltese: Aċidu metakrilliku - kopolimeri tal-metil metakrilat (1:1) Acidu metakrilliku - kopolimeri tal-metil metakrilat (1:2) Triethyl citrate
English: Table 3.
Maltese: Tabella 5:
English: Levodopa is bound to plasma protein only to a small extent (10-30%).
Maltese: Levodopa huwa marbut mal-proteini fil-plażma sa ċertu punt (10-30 %) biss.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettiv
English: 400 to 549
Maltese: Minn 400 sa 549
English: False negative results might be obtained upon application of glucose-oxidase methods for glucosuria.
Maltese: Riżultati negattivi foloż jistgħu jinkisbu meta jintużaw metodi ta' glucose-oxidase għal glukosurja.
English: Dopamine D2 receptor antagonists, benzodiazepines and isoniazid
Maltese: Antagonisti tar-riċettur D2 tad-dopamina, benzodiazepines u isoniazid
English: CGI-C much improved (95% CI)
Maltese: valur p CGI-C imtejjeb ħafna (95 % CI)
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA02
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-Parkinson, aġenti dopaminerġiċi, kodiċi ATC:
English: Gastrointestinal hemorrhage, peptic ulcer disease (see section 4.4), dysphagia, dyspepsia, dysgeusia, glossodynia, flatulence
Maltese: Emorraġija gastrointestinali, mard tal-ulċera peptika (ara sezzjoni 4.4), disfaġja, dispepsja, disgewżja, glossodynia, gass fl-istonku
English: Syncope, thrombophlebitis
Maltese: Sinkope, tromboflebite
English: Carbidopa is a peripheral aromatic amino acid decarboxylase inhibitor.
Maltese: Carbidopa huwa inibitur decarboxylase amino aċidu aromatiku periferali.
English: Other medicines and Numient
Maltese: Mediċini oħra u Numient
English: Data in the ASCEND-PD study were analysed using a standard mixed-model analysis of variance.
Maltese: Dejta fl-istudju ASCEND-PD ġiet analizzata permezz ta' analiżi tal-mudelli mħalltin standard tal-varjanza.
English: Unknown a)
Maltese: Mhux magħruf a)
English: In healthy adults, oral administration of Numient after a high-fat, high-calorie meal reduced levodopa Cmax 21% while the overall extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state (see section 5.2).
Maltese: F'adulti b'saħħithom, l-amministrazzjoni orali ta' Numient wara ikla li fiha ħafna xaham u ħafna kaloriji, is-C mass ta' levodopa tnaqqas b'21 % filwaqt li l-limitu ġenerali ta' assorbiment ta' levodopa (AUC inf ) kien simili (żieda ta' 13 %) għal dak osservat fl-istat sajjem (ara sezzjoni 5.2).
English: The efficacy and safety of Numient in patients with advanced stage Parkinson's disease have been evaluated in 2 double-blind, active-controlled studies: parallel study ADVANCE-PD (study IPX066-B09-02; 22 weeks) and cross-over study ASCEND-PD (study IPX066-B-09-06 Part 1; 11 weeks).
Maltese: L-effikaċja u s-sigurtà ta' Numient f'pazjenti bil-marda tal-Parkinson fi stadju avvanzat ġew evalwati f'żewġ studji b'kontroll attiv, double blind: l-istudju parallel ADVANCE-PD (l-istudju IPX066-B0902; 22 ġimgħa) u l-istudju cross-over ASCEND-PD (l-istudju IPX066-B-09-06 Parti 1; 11-il ġimgħa).
English: The ingredients in the ink are SB-6018 blue ink, shellac (E904), propylene glycol, and indigo carmine (E132) lake
Maltese: L-ingredjenti tal-linka huma SB-6018 linka blu, shellac (E904), propylene glycol, u indigo carmine (E132) lake
English: Levodopa-naïve patients with Parkinson's disease APEX-PD
Maltese: Pazjenti li huma “levodopa-naïve” bil-marda tal-Parkinsons APEX-PD
English: Alcohol interaction
Maltese: Interazzjoni tal-alkoħol
English: Neuroleptic malignant syndrome (NMS)
Maltese: Sindromu newroleptiku malinn (SNM).
English: The most frequently recorded concomitant medicinal products for Parkinson's disease in randomized patients were dopamine agonists (64%), and MAO inhibitors (37%).
Maltese: L-aktar prodotti mediċinali konkomitanti rreġistrati b'mod frekwenti għall-marda ta' Parkinson f'pazjenti randomizzati kienu l-agonisti tad-dopamina (64 %), u l-inibituri MAO (37 %).
English: Agranulocytosis, thrombocytopenia, leucopenia
Maltese: Agranuloċitosi, tromboċitopenija, lewkopenija
English: Eligible patients were randomized (1:1:1:1) to placebo or one of three fixed levodopa/carbidopa doses of 145 mg/36.25 mg, 245 mg/61.25 mg, or 390 mg/97.5 mg, three times a day.
Maltese: Pazjenti eligibbli kienu randomizzati (1:1:1:1) għal plaċebo jew wieħed minn tlett dożi fissi ta' levodopa/carbidopa tal-145 mg/36.25 mg, 245 mg/61,25 mg, jew 390 mg/97.5 mg, tliet darbiet kuljum.
English: Capsule contents
Maltese: Kontenuti tal-kapsula
English: 3 hard capsules 145 mg/36.25 mg TID
Maltese: 3 kapsuli ibsin 145 mg/36.25 mg TID
English: Psychotic episode, impulse control disorder (see section 4.4), agitation
Maltese: Episodju psikotiku, disturb fil-kontroll tal-impuls (ara sezzjoni 4.4), aġitazzjoni
English: 550 to 749
Maltese: Minn 550 sa 749
English: COMT inhibitors
Maltese: Inibituri COMT
English: Blurred vision, diplopia, mydriasis,
Maltese: Vista mċajpra, diplopja, midrijasi,
English: Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone), benzodiazepines and isoniazid may reduce the therapeutic effects of levodopa.
Maltese: Antagonisti tar-riċettur D2 tad-dopamina (per eżempju phenothiazines, butyrophenones, risperidone), benzodiazepines u isoniazid: jistgħu jnaqqsu l-effetti terapewtiċi ta' levodopa.
English: Baselineb)
Maltese: Linja bażib)
English: Modified-release hard capsule
Maltese: Qoxra tal-kapsula
English: 750 to 949
Maltese: Minn 750 sa 949
English: Initial total daily dose of Numient (levodopa in mg)
Maltese: Doża totali inizjali ta' kuljum ta' Numient (levodopa f'mg)
English: Neuroleptic malignant syndrome (see sections 4.3 and 4.4), ataxia
Maltese: Sindromu newroleptiku malinn (ara sezzjonijiet 4.3 u 4.4), atassja
English: Melanoma (see section
Maltese: Melanoma (ara sezzjoni 4.4)
English: Levodopa is extensively metabolized to various metabolites.
Maltese: Levodopa huwa metabolizzat b'mod estensiv f'bosta metaboliti.
English: Co-administration with non-selective monoamine oxidase (MAO) inhibitors.
Maltese: L-għoti flimkien ma' inibituri monoamine oxidase (MAO) mhux selettivi.
English: 2 hard capsules 245 mg/61.25 mg TID
Maltese: 2 kapsuli ibsin 245 mg/61.25 mg TID
English: Cognitive impairment, confusional state, hallucination, depression (see section 4.5), anxiety, abnormal dreams, insomnia
Maltese: Indeboliment konjittiv, stat konfużjonali, alluċinazzjoni, dipressjoni (ara sezzjoni 4.5), ansjetà, ħolm anormali, nuqqas ta' rqad
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: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi (SKO) u frekwenza (Tabella 3). 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 disponibblii).
English: 3 hard capsules 245 mg/61.25 mg TID 4 hard capsules 245 mg/61.25 mg TID
Maltese: 3 kapsuli ibsin 245 mg/61.25 mg TID 4 kapsuli ibsin 245 mg/61.25 mg TID
English: Carbidopa is approximately 36% bound to plasma proteins.
Maltese: Carbidopa huwa marbut mal-proteini tal-plażma b'madwar 36 %.
English: 3 hard capsules 195 mg/48.75 mg TID
Maltese: 3 kapsuli ibsin 195 mg/48.75 mg TID
English: Fall, peripheral oedema, non-cardiac chest pain, asthenia, fatigue
Maltese: Fall, edema periferali, uġigħ fis-sider mhux kardijaku, astenja, għejja
English: Numient capsules are supplied in plastic bottles with a dessicant and a plastic cap, available in bottles of 25, 100 or 240 hard capsules.
Maltese: Kapsuli Numient huma fornuti fi fliexken tal-plastik b'dessikant u għatu tal-plastik, disponibbli fi fliexken tal-25, 100 jew 240 kapsuli ibsin.
English: Percentage “off” time*
Maltese: Perċentwal ta' ħin “off”*
English: a) For the UPDRS, higher scores indicate greater severity of impairment b) All values based on 361 patients from the Intent to Treat population who had valid End of Study values c) Negative numbers indicate improvement as compared with the baseline value d) Three times per day e) P-value is less than 0.05 versus placebo
Maltese: a) Għall-UPDRS, punteġġi ogħla jindikaw severità akbar ta' indeboliment b) Valuri kollha bbażati fuq 361 pazjent tal-popolazzjoni mill-intenzjoni għat-Trattament li kellhom valuri ta' Tmiem ta' Studju validi c) Numri negattivi jindikaw titjib meta mqabbla mal-valur tal-linja bażi d) Tliet darbiet kuljum e) Valur-P huwa inqas minn 0.05 kontra plaċebo
English: Elevated urea nitrogen, alkaline phosphatases; positive Coomb's test; leucocytes, and bacteria in the urine a) Adverse reactions not observed in the clinical development of Numient, but reported for other levodopa/carbidopa medicinal products.
Maltese: Livell għoljin ta' nitroġenu tal-urea, alkaline phosphatases; test pożittiv ta' Coomb; lewkoċiti, u batterji fl-awrina a) Reazzjonijiet avversi li ma ġewx osservati fl-iżvilupp kliniku ta' Numient, iżda li ġew irrapportati għal prodotti mediċinali oħra ta' levodopa/carbidopa .
English: Numient shows dose proportional pharmacokinetics for both carbidopa and levodopa over the levodopa dose strength range of 95 mg to 245 mg.
Maltese: Numient juri doża farmakokinetika proporzjonali kemm għal carbidopa u levadopa fuq il-firxa tassaħħa tad-doża ta' levodopa minn 95 mg għal 245 mg.
English: Phaeochromocytoma.
Maltese: Fejokromoċitoma.
English: The main secondary endpoints included “off” time, “on” time without troublesome dyskinesia, and UPDRS Parts II+III score.
Maltese: Il-punti ta' tmiem sekondarji ewlenin kienu jinkludu l-ħin“off”, l-ħin “on” mingħajr diskinesija problematika, u punteġġ tal-Partijiet II+III tal-UPDRS.
English: Impact of renal function on levodopa/carbidopa clearance is limited (see section 5.2).
Maltese: Impatt tal-funzjoni tal-kliewi fuq it-tneħħija ta' levodopa/carbidopa hija limitata (ara sezzjoni 5.2).
English: There have been rare reports that the beneficial effects of levodopa in Parkinson's disease are reversed by phenytoin and papaverine.
Maltese: Kien hemm rapporti rari li l-effetti benefiċi ta' levodopa fil-marda ta' Parkinsons huma mreġġa' lura bil-phenytoin u papaverine.
English: A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Maltese: Passat preċedenti ta' sindromu newroleptiku malinn (SNM) u/jew rabdomilożi mhux trawmatika.
English: Symptomatic treatment of adult patients with Parkinson's disease.
Maltese: Trattament sintomatiku ta' pazjenti adulti bil-marda tal-Parkinson.