FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Nenad, lisuride, is a dopamine agonist.
Maltese: Is-sustanza attiva f'Nenad, lisuride, hija agonista tad-dopamina.
English: On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
Maltese: Fit-30 ta' Novembru 2009, Axxonis Pharma AG għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li jixtieq li jirtira l-applikazzjoni tiegħu għal awtorizzazzjoni għattqegħid fis-suq għal Nenad, għat-trattament tas-sinjali u s-sintomi tas-sindromu idjopatiku tar-riġlejn irrekwieti moderat sa sever fl-adulti.
English: The patients were given Nenad, ropinirole (another medicine for restless legs syndrome) or placebo (a dummy medicine).
Maltese: sindromu tar-riġlejn irrekwieti) jew plaċebo (mediċina finta).
English: The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome.
Maltese: Il-kumpanija ppreżentat riżultati minn studju ewlieni wieħed ta' 309 pazjenti bis-sindromu tar-riġlejn irrekwieti moderat sa sever.
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni kienet waslet fi tmiemha u s-CHMP kien ħareġ opinjoni negattiva.
English: Nenad is a transdermal patch (patch that delivers a medicine across the skin) that contains the active substance lisuride.
Maltese: Nenad huwa roqgħa transdermali (roqgħa li tagħti mediċina minn ġol-ġilda) li fiha s-sustanza attiva lisuride.
English: What was Nenad expected to be used for?
Maltese: Kif kien mistenni li jaħdem Nenad?
English: Nenad was expected to be used in adults with moderate-to-severe idiopathic restless legs syndrome.
Maltese: Nenad kien mistenni li jintuża fl-adulti bis-sindromu idjopatiku tar-riġlejn irrekwieti moderat sa sever.
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: Is-sindromu tar-riġlejn irrekwieti huwa disturb li bih il-pazjent ikollu urġenza inkontrollabbli biex iċaqlaq riġlejh biex iwaqqaf sensazzjonijiet skomdi, ta' uġigħ jew strambi fil-ġisem, normalment bil-lejl.
English: patients' symptoms after 12 weeks using the International Restless Legs Syndrome rating scale (IRLS) score.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla filkalkolu tas-sintomi tal-pazjenti wara 12-il ġimgħa bl-użu tal-punteġġ tal-iskala Internazzjonali talKalkolu tas-Sindromu tar-riġlejn irrekwieti (International Restless Legs Syndrome rating scale - IRLS).
English: The effects of Nenad were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Nenad għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: However, the syndrome is thought to be caused by problems in the way dopamine works in the brain, which was expected to be corrected by lisuride.
Maltese: Madankollu, huwa maħsub li s-sindromu huwa kkawżat minn problemi fil-mod kif taħdem iddopamina fil-moħħ, li kien mistenni jiġi korrett permezz ta' lisuride.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Nenad be refused.
Maltese: Abbażi tal-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fi żmien l-irtar, is-CHMP kien ta opinjoni negattiva, u rrakkomanda li l-awtorizzazzjoni għat-tqegħid fissuq għal Nenad tiġi rrifjutata.
English: This means that it imitates the action of dopamine, a messenger substance in the parts of the brain that control movement and co ordination.
Maltese: Dan ifisser li timita l-azzjoni ta' dopamina, sustanza messaġġiera fil-partijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni.
English: The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study.
Maltese: Il-210 pazjenti li lestew l-ewwel 12-il ġimgħa ġew offruti wkoll l-opportunità li jkomplu t-trattament fi studju ta' estensjoni.
English: EU/1/08/486/001 7 tablets EU/1/08/486/002 14 tablets EU/1/08/486/003 28 tablets EU/1/08/486/004 30 tablets EU/1/08/486/005 56 tablets EU/1/08/486/006 60 tablets EU/1/08/486/007 90 tablets EU/1/08/486/008 112 tablets EU/1/08/486/009 180 tablets EU/1/08/486/010 336 tablets
Maltese: EU/1/08/486/001 7 pilloli EU/1/08/486/002 14-il pillola EU/1/08/486/003 28 pillola EU/1/08/486/004 30 pillola EU/1/08/486/005 56 pillola EU/1/08/486/006 60 pillola EU/1/08/486/007 90 pillola EU/1/08/486/008 112-il pillola EU/1/08/486/009 180 pillola EU/1/08/486/010
English: Do not take Xiliarx:
Maltese: Tiħux Xiliarx:
English: Xiliarx 50 mg tablets
Maltese: Xiliarx 50 mg pilloli
English: EU/1/08/486/011 336 tablets (3 packs of 112)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/486/011 336 pillola (3 pakketti ta' 112)
English: • Uncommon: Diarrhoea, flatulence
Maltese: • Mhux komuni: Dijarea, gass
English: • The active substance is vildagliptin.
Maltese: • Is-sustanza attiva hi vldagliptin.
English: Xiliarx 50 mg tablets vildagliptin
Maltese: Xiliarx 50 mg pilloli vildagliptin
English: EU/1/08/486/001-011
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/486/001-011
English: Xiliarx 50 mg tablets are available in packs containing 7, 14, 28, 30, 56, 60, 90, 112, 180 or 336 tablets and in multipacks comprising 3 cartons, each containing 112 tablets.
Maltese: Xiliarx 50 mg pilloli jiġu f'pakketti li jkun fihom 7, 14, 28, 30, 56, 60, 90, 112, 180 jew 336 pillola u f'pakketti b'ħafna li fihom 3 kartuni, li kull waħda minnhom fiha 112-il pilloli.
English: The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanza attiva ta' Xiliarx, vildagliptin, tagħmel parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: Xiliarx contains lactose
Maltese: Xiliarx fih lactose
English: The safety and efficacy of Xiliarx in children and adolescents (< 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Xiliarx fi tfal u adolexxenti (< 18-il sena) ma ġewx determinati s'issa.
English: Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Maltese: Xiliarx mgħandux jintuża f'pazjenti b'indeboliment tal-fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il-kura > 3 darbiet il-limitu ta' fuq tan-normal (ULN) (ara wkoll sezzjonijiet 4.4 u 5.2).
English: Xiliarx is not a substitute for insulin in insulin-requiring patients.
Maltese: Xiliarx mhux sostitut ta' l-insulina f'pazjenti li jeħtieġu l-insulina.
English: • Uncommon: Constipation
Maltese: • Komuni: Sturdament
English: Other medicines and Xiliarx
Maltese: Mediċini oħra u Xiliarx
English: In the pioglitazone add-on study, the absolute weight increases with placebo, Xiliarx 100 mg daily were 1.4 and 2.7 kg, respectively.
Maltese: Fl-istudju biż-żieda ta' pioglitazone, il-piż assolut jiżdied bil-plaċebo u b'Xiliarx 100 mg kuljum kienu 1.4 u 2.7 kg rispettivament.
English: Table 5 Adverse reactions reported in patients who received Xiliarx 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Maltese: Reazzjonijiet avversi rapportati f'pazjenti li ħadu Xiliarx 50 mg darbtejn kuljum ma' metformin u xi sulphonylurea (N=157)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Table 4 Adverse reactions reported in patients who received Xiliarx 100 mg daily as monotherapy in double-blind studies (N=1,855)
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Xiliarx 100 mg kuljum bħala monoterapija fi studji double-blind (N=1,855)
English: Xiliarx contains lactose (milk sugar).
Maltese: 82 mg lactose (anidru).
English: A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
Maltese: Waqt prova klinika b'vildagliptin fost pazjenti bi klassi I-III funzjonali New York Heart Association (NYHA) intwera li trattament b'vildagliptin ma wassalx għal bidla fil-funzjoni tal-ventrikolu taxxellug jew biex tiggrava l-insuffiċjenza konġestiva tal-qalb eżistenti diġà (CHF) meta mqabbel malplaċebo.
English: Xiliarx is not recommended for use in children and adolescents under (< 18 years).
Maltese: Xiliarx mhux irrakkomandat għall-użu fi tfal u adolexxenti (< 18-il sena).
English: Adverse reactions reported in patients who received Xiliarx in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Xiliarx fi studji double blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt għall-kull indikazzjoni bil-klassi ta' l-organi tas-sistema u frekwenza assoluta.
English: Table 1 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with metformin in double-blind studies (N=208)
Maltese: Tabella 1 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Xiliarx 100 mg kuljum ma' metformin fi studji double-blind (N=208)
English: Some patients have had the following side effects while taking Xiliarx, metformin and a sulphonylurea:
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Xiliarx, metformin u sulphonylurea:
English: Table 2 Adverse reactions reported in patients who received Xiliarx 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Maltese: Tabella 2 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Xiliarx 100 mg kuljum ma' sulphonylurea fi studji double-blind (N=170)
English: Table 3 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Xiliarx 100 mg flimkien ma' thiazolidinedione fi studji double-blind (N=158)
English: Table 6 Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Maltese: Tabella 6 Reazzjonijiet avversi rapportati f'pazjenti li rċevew Xiliarx 100 mg kuljum f'kombinazzjoni mal-insuluna (bi jew mingħajr metformin) fi studji double blind (N=371)
English: What Xiliarx looks like and contents of the pack Xiliarx 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Maltese: Xiliarx 50 mg pilloli huma tondi, bojod jagħtu fl-isfar ċar u ċatti, b'“NVR” fuq naħa u “FB” fuq loħra.
English: • 100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx alone, with another medicine called metformin or a glitazone, with a combination of metformin and a sulphonylurea, or with insulin.
Maltese: • 100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Xiliarx waħdu, ma' mediċina oħra li tissejjaħ metformin jew xi glitazone, flimkien ma' metformin u xi sulphonylurea, jew mal-insulina.
English: How to store Xiliarx
Maltese: X'fih Xiliarx
English: • Uncommon: Headache, constipation, swollen hands, ankle or feet (oedema), joint pain, low blood glucose • Very rare: Sore throat, runny nose, fever
Maltese: • Mhux komuni: Uġigħ ta' ras, stitikezza, idejn, għaksa jew saqajn minfuħin (edema), uġigħ fil ġogi, zokkor fid-demm baxx
English: In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of Xiliarx is 50 mg once daily (see also sections 4.4, 5.1 and 5.2).
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat jew qawwi jew b'mard talkliewi fl-aħħar stadju (ESRD), id-doża rrakkomandata ta' Xiliarx hija ta' 50 mg darba kuljum (ara wkoll sezzjonijiet 4.4, 5.1 u 5.2).
English: Xiliarx is used to treat adult patients with type 2 diabetes.
Maltese: Xiliarx jintuża biex jikkura pazjenti adulti b'dijabete tat-tip 2.
English: Tel: +34 900 102 712
Maltese: Mylan Pharmaceuticals, S.L. Tel: +34 900 102 712
English: Some patients have had the following side effects while taking Xiliarx and insulin (with or without metformin):
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Xiliarx u l-insulina (flimkien ma' metformin jew mingħajru):
English: • Do not use any Xiliarx pack that is damaged or shows signs of tampering.
Maltese: • Tuża l-ebda pakkett ta' Xiliarx li jkun danneġġjat jew li juri sinjali ta' tbabis.
English: Xiliarx works by making the pancreas produce more insulin and less glucagon.
Maltese: Xiliarx sabiex jiġi evitat livell baxx ta' glukosju fid-demm [ipogliċemija]).
English: Therefore Xiliarx should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Maltese: M'hemmx bżonn ta' aġġustar tad-doża f'pazjenti anzjani (ara wkoll sezzjonijiet 5.1 u 5.2).
English: In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of
Maltese: F'pazjenti b'indeboliment qawwi tal-kliewi, vildagliptin naqqas l-HbA1c b'mod sinifikanti meta tqabbel mal-plaċebo (differenza ta' -0.56%) mill-medja tal-linja bażi ta' 7.7%.
English: Other side effects Some patients have had the following side effects while taking Xiliarx and metformin:
Maltese: Xi pazjenti kellhom dawn l-effetti sekondarji waqt li kienu qed jieħdu Xiliarx u metformin:
English: 23 June 2014 EMA/427574/2014
Maltese: EMA/427574/2014
English: The review of zolpidem-containing medicines was initiated on 4 July 2013 at the request of the Italian Medicines Agency (AIFA) under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini li fihom zolpidem inbdiet fl-4 ta' Lulju 2013 fuq talba tal-Aġenzija tal-Mediċini Taljana (AIFA) skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE)
English: It acts by attaching to and stimulating a particular type of receptor on nerve cells called the alpha-1 GABA-A receptor (also called the omega-1 receptor).
Maltese: Jaġixxi billi jeħel ma' u jistimula tip partikulari ta' riċettur fuq iċ-ċelloli tan-nervituri msejjaħ ir-riċettur GABA-A alpha-1 (imsejjaħ ukoll ir-riċettur omega-1).
English: As zolpidem-containing medicines are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 24 April 2014.
Maltese: Peress li l-mediċini li fihom zolpidem huma kollha awtorizzati nazzjonalment, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adotta pożizzjoni finali fl24 ta' April 2014.
English: On 24 April 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficulty sleeping).
Maltese: Fl-24 ta' April 2014, il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u lProċedura Deċentralizzata - Bnedmin (CMDh)1 approva b'maġġoranza rakkomandazzjonijiet ġodda għal mediċini li fihom zolpidem, li jintużaw għall-kura fuq żmien qasir ta' insomnja (diffikultà biex torqod).
English: The normal recommended daily dose in adults, which must not be exceeded, remains at 10 mg, and for older patients and patients with reduced liver function it remains at 5 mg.
Maltese: Id-doża normali rakkomandata ta' kuljum fl-adulti, li m'għandhiex tinqabeż, tibqa' ta' 10 mg, u għal pazjenti akbar fl-età u pazjenti bi tnaqqis fil-funzjoni tal-fwied tibqa' ta' 5 mg.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati ta' sigurtà għal mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar lUE.
English: • It is important that patients do not exceed the recommended dose of zolpidem, which is 10 mg by mouth once a day; a lower dose may be prescribed to some adults.
Maltese: • Huwa importanti li l-pazjenti ma jaqbżux id-doża rakkomandata ta' zolpidem, li hija ta' 10 mg millħalq darba kuljum; xi adulti jistgħu jiġu preskritti doża aktar baxxa.
English: A neurotransmitter is a chemical that carries signals between nerve cells.
Maltese: Newrotrasmettitur huwa kimika li ġġorr is-sinjali bejn iċċelloli tan-nervituri.
English: The data analysed during the review showed that, while most cases of impaired driving were linked to the intake of a 10 mg daily dose of zolpidem, lower doses were not shown to significantly reduce the risk of impaired driving and were not consistently shown to be effective at population level.
Maltese: Id-dejta analizzata matul irreviżjoni wriet li, filwaqt li ħafna mill-każijiet ta' tnaqqis fil-ħila ta' sewqan kienu marbuta mat-teħid ta' doża ta' kuljum ta' 10 mg ta' zolpidem, dożi aktar baxxi ma ntwerewx li jnaqqsu b'mod sinifikanti r-riskju ta' tnaqqis fil-ħila ta' sewqan u ma ntwerewx b'mod konsistenti li kienu effettivi fil-livell talpopolazzjoni.
English: These recommendations followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety of zolpidem with regards to the risk of impaired driving, somnambulism, and reduced mental alertness (such as drowsiness and slower reactions) after taking the medicine, and information on its effectiveness at lower doses.
Maltese: Dawn ir-rakkomandazzjonijiet saru wara reviżjoni mill-Kumitat dwar il-Valutazzjoni tar-Riskji ta' Farmakoviġilanza (PRAC) tal-EMA tad-dejta disponibbli dwar is-sigurtà ta' zolpidem fir-rigward tarriskju ta' tnaqqis fil-ħila ta' sewqan, sonnambulanza, u tnaqqis fil-viġilanza mentali (bħal ħedla u reazzjonijiet aktar bil-mod) wara t-teħid tal-mediċina, u informazzjoni dwar l-effikaċja tiegħu f'dożi aktar baxxi.
English: Zolpidem has been authorised via national procedures in all Member States of the EU.
Maltese: Zolpidem ġie awtorizzat permezz ta' proċeduri nazzjonali fl-Istati Membri kollha tal-UE.
English: • The daily dose of zolpidem remains 10 mg a day in adults and 5 mg a day in the elderly and in patients with hepatic impairment; this dose must not be exceeded.
Maltese: • Id-doża ta' kuljum ta' zolpidem tibqa' ta' 10 mg kuljum fl-adulti u ta' 5 mg kuljum fl-anzjani u f'pazjenti b'indeboliment epatiku; din id-doża m'għandhiex tinqabeż.
English: In older patients and patients with reduced liver function a lower dose of 5 mg is recommended.
Maltese: F'pazjenti akbar fl-età u f'pazjenti bi tnaqqis fil-funzjoni tal-fwied hija rakkomandata doża aktar baxxa ta' 5 mg.
English: Since the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the central nervous system (brain and spinal cord), or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Maltese: Peress li r-riskju ta' tnaqqis fil-ħila ta' sewqan jidher li jiżdied jekk zolpidem jittieħed flimkien ma' mediċini oħra li għandhom effett fuq is-sistema nervuża ċentrali (il-moħħ u l-korda spinali), jew mal-alkoħol jew drogi illeċiti, dawn is-sustanzi m'għandhomx jintużaw waqt it-teħid ta' zolpidem.
English: • The risk of impaired mental alertness is higher if zolpidem is taken with less than a full night of sleep remaining; therefore, a period of at least 8 hours is recommended between taking zolpidem and performing activities such as driving or operating other machinery.
Maltese: • Ir-riskju ta' tnaqqis fil-viġilanza mentali huwa ogħla jekk zolpidem jittieħed meta jkun għad fadal anqas minn nofs lejl ta' rqad; għalhekk, huwa rakkomandat li jkun hemm perjodu ta' mill-inqas 8 siegħat bejn it-teħid ta' zolpidem u t-twettiq ta' attivitajiet bħal sewqan u tħaddim ta' magni oħra.
English: As the CMDh position on zolpidem was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Maltese: Peress li l-pożizzjoni tas-CMDh dwar zolpidem ġiet adottata b'vot ta' maġġoranza, intbagħtet lillKummissjoni Ewropea, li approvatha u fit-23 ta' Ġunju 2014 adottat deċiżjoni vinkolanti legalment madwar l-UE kollha.
English: This receptor is part of a system in the brain that normally responds to a neurotransmitter called gamma-aminobutyric acid (GABA) and which reduces the activity of the brain, causing relaxation and sleepiness.
Maltese: Dan ir-riċettur huwa parti minn sistema fil-moħħ li normalment tirrispondi għal newrotrasmettitur imsejjaħ aċidu gamma-aminobutirriku (GABA) u li jnaqqas l-attività tal-moħħ, li jikkawża rilassament u ngħas.
English: Furthermore, patients should not drive or perform activities that require mental alertness for at least 8 hours after taking zolpidem.
Maltese: Barra minn hekk, il-pazjenti m'għandhomx isuqu jew iwettqu attivitajiet li jeħtieġu viġilanza mentali għal mill-inqas 8 sigħat wara li jieħdu zolpidem.
English: • A review of the available data confirmed that the benefit-risk balance of zolpidem-containing medicines remains positive but changes have been introduced to the product information of these medicines, aimed at further minimising the known risks of next-morning reduced mental alertness and impaired driving ability.
Maltese: • Reviżjoni tad-dejta disponibbli kkonfermat li l-bilanċ tal-benefiċċju-riskju ta' mediċini li fihom zolpidem jibqa' pożittiv iżda ġew introdotti bidliet lill-informazzjoni dwar il-prodott ta' dawn ilmediċini, bil-għan li jkomplu jiġu minimizzati r-riskji magħrufa ta' tnaqqis fil-viġilanza mentali u tnaqqis fil-ħila ta' sewqan l-għada filgħodu.
English: • Zolpidem-containing medicines are used for the short-term treatment of insomnia (difficulty sleeping).
Maltese: • Mediċini li fihom zolpidem jintużaw għall-kura fuq żmien qasir ta' insomnja (diffikultà biex torqod).
English: • Patients taking zolpidem should make sure there is a period of at least 8 hours between taking the medicine and driving or operating other machinery.
Maltese: • Pazjenti li jkunu qed jieħdu zolpidem għandhom ikunu ċerti li jkun hemm perjodu ta' mill-inqas 8 sigħat bejn it-teħid tal-mediċina u sewqan jew tħaddim ta' magni oħra.
English: Zolpidem may cause drowsiness and slower reactions the day after taking the medicine, which could cause impaired driving ability and increase the risk of road accidents; a warning of these risks is included in the package leaflet.
Maltese: Zolpidem jista' jikkawża ħedla u reazzjonijiet aktar bil-mod il-jum wara li tieħu l-mediċina, li jistgħu jikkawżaw tnaqqis fil-ħila ta' sewqan u jżid ir-riskju ta' inċidenti fit-toroq; twissija ta' dawn ir-riskju hija inkluża fil-fuljett ta' tagħrif.