FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available (see section 5.1).
Maltese: M'hemmx dejta disponibbli (ara sezzjoni 5.1).
English: Disturbance in attention Paraesthesia Hypoaesthesia
Maltese: Disturbi fl-attenzjoni Parasteżija Ipoesteżija
English: The film-coating of the tablet contains: hypromellose, macrogol 400, titanium dioxide (E171).
Maltese: Il-kisja b'rita tal-pillola fiha: hypromellose, macrogol 400, titanium dioxide (E171).
English: The tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.
Maltese: Il-qalba tal-pillola: microcrystalline cellulose, anhydrous lactose, crospovidone (tip A), magnesium stearate.
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), or not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa <1/10), mhux komuni (≥ 1/1000 sa <1/100), rari (≥ 1/10,000 sa <1/1000), rari ħafna (<1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Selincro contains the active substance nalmefene.
Maltese: Selincro fih is-sustanza attiva nalmefene.
English: Les Bouillides Sophia Antipolis 06560 Valbonne France
Maltese: Elaiapharm2881, Route des Crêtes Z.I. Les Bouillides Sophia Antipolis 06560 Valbonne Franza
English: Elderly patients (≥65 years of age)
Maltese: Pazjenti anzjani ((≥65 sena)
English: Selincro is available in packs of 7, 14, 28, 42, 49 or 98 tablets in blister cards.
Maltese: Selincro huwa disponibbli f'pakketti li fihom 7, 14, 28, 42, 49 jew 98 pillola f'kards ta' folji.
English: Blister: Clear PVC/PVdC-aluminium blisters in cardboard boxes Pack sizes of 7, 14, 28, 42, 49 and 98 film-coated tablets
Maltese: Folji ċari tal-aluminju-PVC/PVdC f'kaxxi tal-kartun Daqsijiet ta' pakketti ta' 7, 14, 28, 42, 49, u 98 pillola miksijin b'rita
English: Selincro 18 mg tablet nalmefene
Maltese: Selincro 18 mg pillola nalmefene
English: Patients with severe hepatic impairment (Child-Pugh classification).
Maltese: Pazjenti b'indeboliment epatiku sever (klassifikazzjoni Child-Pugh).
English: Nalmefene was shown to have skin sensitisation potential in the Local Lymph Node Assay in mice after topical application.
Maltese: Intwera li nalmefene għandu potenzjal ta' sensitizzazzjoni tal-ġilda fil-Local Lymph Node Assay filġrieden wara l-applikazzjoni topikali.
English: Nalmefene exhibits a dose-independent linear pharmacokinetic profile in the dose interval of 18.06 mg to 72.24 mg, with a 4.4 times increase in Cmax and a 4.3 times increase in AUC0-tau (at or near steady state).
Maltese: Nalmefene juri profil farmakokinetiku lineari indipendenti mid-doża fil-medda tad-doża bejn 18.06 mg sa 72.24 mg, b'żieda ta' 4.4 darbiet fis-Cmax u żieda ta' 4.3 darbiet fl-AUC0-tau (fi jew qrib stat fiss).
English: Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies.
Maltese: Stat ta' konfużjoni u rarament, alluċinazzjonijiet u dissoċjazzjoni kienu rrappurtati fl-istudji kliniċi.
English: For example, a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Maltese: Per eżempju, flixkun inbid (750 ml; 12% alkoħol fil-volum) fih madwar 70 g alkoħol u flixkun birra (330 ml; 5% alcohol fil-volum) fih madwar 13 g alkoħol.
English: Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate).
Maltese: Kull pillola miksija b'rita fiha 18.06 mg nalmefene (bħala hydrochloride dihydrate).
English: Selincro does not prevent the intoxicating effects of alcohol.
Maltese: Selincro ma jilqax kontra l-effetti intossikanti tal-alkoħol.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Do not take Selincro:
Maltese: Tiħux Selincro:
English: In Studies 1 (n=579), and 2 (n=655), 18%, and 33%, of the total population, respectively, considerably reduced their alcohol consumption in the period between screening and randomisation.
Maltese: Fl-istudji 1 (n=579) u 2 (n=655), 18% u 33% tal-popolazzjoni totali, rispettivament, naqsu b'mod sinifikanti l-konsum tal-alkoħol tagħhom fil-perijodu bejn l-ewwel eżaminazzjoni u l-għażla b'mod arbitrarju.
English: Psychiatric effects were reported in clinical studies (see section 4.8).
Maltese: Effetti psikjatriċi kienu rrappurtati fi studji kliniċi (ara sezzjoni 4.8).
English: Selincro is a white, oval, biconvex, film-coated tablet of 6.0 x 8.75 mm.
Maltese: Selincro hu pillola miksija b'rita, ta' kulur abjad, ovali, konvessa miż-żewġ naħat ta' 6.0 x 8.75 mm.
English: Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine)) (see section 4.4).
Maltese: Pazjenti li jieħdu agonisti tal-opjojdi (bħal analġeżiċi li fihom l-opjojdi, opjojdi għal terapija ta' sostituzzjoni b'agonisti (eż. methadone) jew agonisti parzjali (eż. buprenorphine) tal-opjojdi (ara sezzjoni 4.4).
English: Following oral administration, nalmefene undergoes extensive, rapid metabolism to the major metabolite nalmefene 3-O-glucuronide, with the UGT2B7 enzyme being primarily responsible for the conversion, and with the UGT1A3 and UGT1A8 enzymes as minor contributors.
Maltese: Wara l-għoti orali, nalmefene jgħaddi minn metaboliżmu estensiv u rapidu għall-metabolit prinċipali nalmefene 3-O-glucuronide, liema konverżjoni sseħħ bl-attivita prinċipali tal-enzima UGT2B7, u lenżimi UGT1A3 u UGT1A8 bħala kontributuri minuri.
English: However, nalmefene 3-O-sulphate is present in concentrations less than 10% of that of nalmefene and thus considered highly unlikely to be a major contributor to the pharmacological effect of nalmefene.
Maltese: Madankollu, nalmefene 3-O-sulphate huwa preżenti f'konċentrazzjonijiet anqas minn 10% ta' dak ta' nalmefene u għalhekk meqjus improbabbli ħafna li jkun kontributur ewlieni għall-effett farmakoloġiku ta' nalmefene.
English: Co-administration with medicinal products that are potent inhibitors of the UGT2B7 enzyme (for example, diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid) may significantly increase the exposure to nalmefene.
Maltese: It-teħid flimkien ma' prodotti mediċinali li huma inibituri qawwijin tal-enzima UGT2B7 (per eżempju, diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid) jistgħu jżidu b'mod sinifikanti l-espożizzjoni għal nalmefene.
English: Administration of high-fat food increases the total exposure (AUC) by 30% and the peak concentration (Cmax) by 50%; the time to peak concentration (tmax) is delayed by 30 min (tmax is 1.5 hours).
Maltese: Amministrazzjoni ta' ikel li għandu ammont għoli ta' xaħam iżid l-espożizzjoni totali (AUC) bi 30% u l-konċentrazzjoni massima (Cmax) b'50%; ilħin biex tintlaħaq il-konċentrazzjoni massima (tmax) jiżdied bi 30 min (tmax hija 1.5 sigħat).
English: An HDD was defined as a day with a consumption ≥60 g of pure alcohol for men and ≥40 g for women.
Maltese: L-HDD kien definit bħala ġurnata ta' konsum ta' ≥60g ta' alkoħol pur għall-irġiel u ≥40g għan-nisa.
English: Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination)
Maltese: Alluċinazzjoni ( inkluż lalluċinazzjoni tas-smigħ, lalluċinazzjoni tas-sens tal-mess, lalluċinazzjoni viżwali u lalluċinazzjoni somatika,)
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 49 film-coated tablets 98 film-coated tablets
Maltese: 7 pilloli miksijin b'rita 14-il pillola miksijin b'rita 28 pillola miksijin b'rita 42 pillola miksijin b'rita 49 pillola miksijin b'rita 98 pillola miksijin b'rita
English: Somnolence Tremor
Maltese: Tqala u treddigħ
English: Nalmefene is rapidly absorbed after a single oral administration of 18.06 mg, with a peak concentration (Cmax) of 16.5 ng/ml after approximately 1.5 hours and an exposure (AUC) of 131 ng*h/ml.
Maltese: Nalmefene huwa assorbit malajr wara l-għoti orali ta' pillola waħda ta' 18.06 mg, bil-konċentrazzjoni massima (Cmax) ta' 16.5 ng/ml wara madwar 1.5 sigħat u l-espożizzjoni (AUC) ta' 131 ng*h/ml.
English: Overall, the studies included 1,941 patients, 1,144 of whom were treated with Selincro 18 mg as-needed.
Maltese: In ġenerali, l-istudji inkludew 1,941 pazjent, li minnhom 1,144 kienu kkurati b'Selincro 18 mg skont kif meħtieġ.
English: Selincro contains lactose
Maltese: Selincro fih lactose
English: The estimated volume of distribution (Vd/F) is approximately 3200 l.
Maltese: Il-volum ta' distribuzzjoni (Vd/F) huwa stmat li hu madwar 3200 l.
English: A small proportion of nalmefene is converted to nalmefene 3-O-sulphate by sulphation and to nornalmefene by CYP3A4/5.
Maltese: Proporzjon żgħir ta' nalmefene huwa konvertit għal nalmefene 3-O-sulphate b'sulfazzjoni u għal nornalmefene permezz ta' CYP3A4/5.
English: Film-coated tablet (tablet) White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with “S” on one side
Maltese: Pillola bajda, ovali, ibbuzzata fuq iż-żewġ naħat, 6.0 x 8.75 mm u mnaqqxa bl-ittra “S” fuq naħa waħda.
English: The nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, or carcinogenic potential.
Maltese: L-informazzjoni mhux klinika ma turi l-ebda periklu speċjali għall-bnedmin ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, tossiċità minħabba doża ripetuta, ġenotossiċità, u potenzjal karċinoġeniku.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glukosju-galactose m'għandhomx jieħdu din il-mediċina.
English: Other medicines and Selincro
Maltese: Mediċini oħra u Selincro
English: Based on in vitro studies, no clinically relevant interactions between nalmefene, or its metabolites, and concomitantly administered medicinal products metabolised by the most common CYP450 and UGT enzymes or membrane transporters are anticipated.
Maltese: Studji in vitro wrew li ma kienx hemm interazzjonijiet klinikament rilevanti antiċipati bejn nalmefene, jew il-metaboliti tiegħu, u prodotti mediċinali oħra metabolizzati mill-enżimi CYP450 u UGT l-aktar komuni jew trasportaturi membraniċi meta ngħataw flimkien.
English: Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8).
Maltese: Reazzjonijiet avversi bħal disturbi fl-attenzjoni, li wieħed iħossu anormali, dardir, sturdament, sonnolenza, nuqqas ta' rqad u uġigħ ta' ras jistgħu iseħħu wara l-għoti ta' nalmefene (ara sezzjoni 4.8).
English: For the inactive major metabolite nalmefene 3-O-glucuronide, the AUC and Cmax were up to 5.1 times and 1.8 times higher in patients with severe renal impairment, respectively (see sections 4.3 and 4.4).
Maltese: Għall-metabolit maġġuri inattiv nalmefene 3-Oglucuronide, l-AUC u s-Cmax kienu sa 5.1 drabi u 1.8 drabi ogħla f'pazjenti b'indeboliment renali sever, rispettivament (ara sezzjonijiet 4.3 u 4.4).
English: In Study 2, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (30% versus 28%, respectively).
Maltese: Fl-iStudju 2, in-numru ta' pazjenti li ħarġu mill-istudju kien ogħla fil-grupp ta' Selincro milli fil-grupp tal-plaċebo (30% kontra 28%, rispettivament).
English: Caution should be excercised when taking medicines such as diclofenac (antiinflammatory medicine used to treat, for example, muscle pain), fluconazole (antibiotic used to treat diseases caused by some types of fungus), omeprazole (medicine used to block the production of acid in the stomach), or rifampicin (antibiotic used to treat diseases caused by some types of bacteria) together with Selincro.
Maltese: Wieħed għandu joqgħod attent meta jittieħdu mediċini bħal diclofenac (mediċina kontra linfjammazzjoni użata biex tikkura ,per eżempju, uġigħ fil-muskoli), fluconazole (antibijotiku użat filkura ta' mard ikkawżat minn xi tipi ta' fungus), omeprazole (mediċina użata biex twaqqaf ilproduzzjoni ta' aċtu fl-istonku), jew rifampicin (antibijotiku użat fil-kura ta' mard ikkawżat minn xi tipi ta' batterji) flimkien ma' Selincro.
English: Name and address of the manufacturers responsible for batch release H. Lundbeck A/S
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) H. Lundbeck A/S
English: The TAC was 102 g/day at baseline in the Selincro group (n=171) and 99 g/day at baseline in the placebo group (n=167).
Maltese: It-TAC kien ta' 102 g/ġurnata bħala linja bażi fil-grupp ta' Selincro (n=171) u ta' 99 g/ġurnata bħala linja bażi fil-grupp tal-plaċebo (n=167).
English: Pharmacokinetic data after oral administration of nalmefene to patients with severe hepatic impairment are not available (see sections 4.3 and 4.4).
Maltese: M'hemmx dejta farmakokinetika disponibbli wara l-għoti orali ta' nalmefene lill-pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3 u 4.4).
English: For patients with mild, moderate or severe renal impairment the AUC for nalmefene was 1.1 times, 1.4 times and 2.4 times higher, respectively.
Maltese: Għal pazjenti b'indeboliment renali ħafif, moderat jew sever, l-AUC għal nalmefene kienet 1.1 drabi, 1.4 drabi u 2.4 drabi ogħla rispettivament.
English: A study with IV administration suggested that there were no relevant changes in the pharmacokinetics in the elderly as compared to non-elderly adults (see sections 4.2 and 4.4).
Maltese: Studju b'amministrazzjoni IV ssuġġerixxa li ma kienx hemm tibdil relevanti fil-farmakokinetika fl-anzjani meta mqabbel ma' adulti li mhumiex anzjani (ara sezzjonijiet 4.2 u 4.4).
English: Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.
Maltese: L-informazzjoni klinika disponibbli hija limitata dwar l-użu ta' Selincro f'pazjenti ≥65 sena u li għandhom dipendenza fuq l-alkoħol.
English: The oral clearance of nalmefene (CL/F) was estimated as 169 l/h and the terminal half-life was estimated as 12.5 hours.
Maltese: It-tneħħija orali ta' nalmefene (CL/F) kienet stmata bħala 169 l/siegħa u l-half-life terminali kienet stmata bħala 12.5 sigħat.
English: Conversely, concomitant administration with a UGT inducer (for example, dexamethasone, phenobarbital, rifampicin, omeprazole) may potentially lead to subtherapeutic nalmefene plasma concentrations.
Maltese: Mill-banda l-oħra, it-teħid flimkien ma' stimulatur ta' UGT (per eżempju, dexamethasone, phenobarbital, rifampicin, omeprazole) jista' possibbilment iwassal għal konċentrazzjonijiet fil-plażma ta' nalmefene li jkunu taħt il-livell terapewtiku.
English: The TAC was 113 g/day at baseline in the Selincro group (n=148) and 108 g/day at baseline in the placebo group (n=155).
Maltese: It-TAC kien ta' 113 g/ġurnata bħala linja bażi fil-grupp ta' Selincro (n=148) u ta' 108 g/ġurnata bħala linja bażi fil-grupp tal-plaċebo (n=155).
English: Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [see section 5.1], without physical withdrawal symptoms and who do not require immediate detoxification.
Maltese: Selincro huwa indikat biex inaqqas il-konsum ta' alkoħol f'pazjenti adulti li għandhom dipendenza fuq l-alkoħol u li għandhom livell għoli ta' riskju għax-xorb (DRL) [ara sezzjoni 5.1] mingħajr sintomi fiżiċi fin-nuqqas tal- alkoħol u li ma jeħtiġux ditossifikazzjoni immedjata.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The TAC was 100 g/day at baseline in the Selincro group (n=141) and 101 g/day at baseline in the placebo group (n=42).
Maltese: It-TAC kien ta' 100 g/ġurnata bħala linja bażi fil-grupp ta' Selincro (n=141) u ta' 101 g/ġurnata bħala linja bażi fil-grupp tal-plaċebo (n=42).
English: Occupancy data obtained in a PET study after single and repeated daily dosing with 18.06 mg nalmefene show 94% to 100% receptor occupancy within 3 hours after dosing, which suggests that nalmefene readily crosses the blood-brain barrier.
Maltese: Dejta tal-okkupanza miksuba b'studju PET wara għoti ta' doża waħda u dożaġġ ripetut kuljum bi 18.06 mg nalmefene turi 94% sa 100% okkupanza fir-riċettur fi żmien 3 sigħat wara d-dożaġġ, li jissuġġerixxi li nalmefene jaqsam malajr il-barriera tad-demm fil-moħħ.
English: The majority of the patients had low (55% had a score of 0-13) or intermediate (36% had a score of 14-21) alcohol dependence according to the Alcohol Dependence Scale.
Maltese: Il-parti l-kbira tal-pazjenti kellhom dipendenza fuq l-alkoħol baxxa (55% kellhom punteġġ ta' 0-13) jew intermedja (36% kellhom punteġġ ta' 14-21) skont l-iSkala ta' Dipendenza mill-Alkoħol.
English: In this post-hoc target population, more patients receiving nalmefene discontinued (45%) as compared to those receiving placebo (31%).
Maltese: F'din il-popolazzjoni ta' mira post-hoc, aktar pazjenti li kienu qed jirċievi nalmefene ħarġu mill-istudju (45%) meta mqabbla ma' dawk li kienu qed jirċievu l-plaċebo (31%).
English: Post-hoc efficacy analysis in patients who maintained a high or very high DRL at randomisation In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
Maltese: Fl-iStudju 1, in-numru ta' pazjenti li ħarġu mill-istudju kien ogħla fil-grupp ta' Selincro milli fil-grupp ta' plaċebo (50% kontra 32%, rispettivament).
English: The metabolites are not considered to contribute with significant pharmacological effect on the opioid receptors in humans, except for nalmefene 3-O-sulphate, which has a potency comparable to that of nalmefene.
Maltese: Il-metaboliti mhumiex ikkunsidrati li jikkontribwixxu b'effett farmakoloġiku sinifikanti fuq ir-riċetturi opjojdi fil-bnedmin, ħlief għal nalmefene 3-O-sulphate li għandha potenza komparabbli ma' dik ta' nalmefene.
English: - Each film-coated tablet contains 18.06 milligram nalmefene (as hydrochloride dihydrate) - The other ingredients are:
Maltese: - Kull pillola miksija b'rita fiha 18.06 milligrammi nalmefene (bħal hydrochloride dihydrate) - Is-sustanzi l-oħra huma:
English: Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).
Maltese: Pazjenti b'passat reċenti ta' sindromu akut ta' rtirar mill-alkoħol (li jinkludi alluċinazzjonijiet, aċċessjonijiet u tremens delirium),
English: reduced sense of touch - racing heart, a sensation of a rapid, forceful, or irregular beating of the heart - vomiting, dry mouth, diarrhoea - excessive sweating - muscle spasms - feeling of exhaustion, weakness, discomfort or uneasiness, feeling strange - weight loss
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - nuqqas ta' aptit - diffikultà biex torqod, konfużjoni, tkun bla sabar, tnaqqis fil-ħajra għas-sess - tħeddil, kontrazzjonijiet involontarji tal-ġisem, ma tħossokx daqshekk fuq tiegħek, sensazzjoni stramba fil-ġilda bħal tniggiż, tnaqqis fis-sens tal-mess - tħoss qalbek qiegħda tiġri, sensazzjoni ta' tħabbit tal-qalb b'ritmu mgħaġġel, b'qawwa kbira jew irregolari. - rimettar, ħalq xott, dijarea - tegħreq iżżejjed - spażmi fil-muskoli - tħossok bla saħħa,debboli, ma tħossokx komdu/a jew disturbat/a, tħossok stramb - tnaqqis fil-piż
English: Selincro with food and alcohol
Maltese: Selincro ma' ikel u alkoħol
English: Selincro is for oral use.
Maltese: Selincro huwa għal użu orali.
English: Nalmefene does not exhibit any substantial pharmacokinetic differences between sexes, between young and elderly, or between ethnic groups.
Maltese: Nalmefene ma juri ebda differenzi farmakokinetiċi sostanzjali bejn is-sessi, bejn żgħażagħ u anzjani, jew bejn il-gruppi etniċi.
English: From distribution, metabolism, and excretion data, it appears that nalmefene has a high hepatic extraction ratio.
Maltese: Minn dejta tad-distribuzzjoni, metaboliżmu u eliminazzjoni, jidher li nalmefene għandu proporzjon għoli ta' estrazzjoni epatika.
English: In a study in patients with interstitial cystitis, 20 patients received 108 mg/day of nalmefene for more than 2 years.
Maltese: Fi studju f'pazjenti b'ċistite interstizjali, 20 pazjent irċevew 108 mg/jum ta' nalmefene għal aktar minn sentejn.
English: No specific study with oral dosing has been conducted in patients ≥65 years of age.
Maltese: Ma sar ebda studju speċifiku b' dożaġġ orali f'pazjenti ≥65 sena.
English: The average protein-bound fraction of nalmefene in plasma is approximately 30%.
Maltese: Il-medja tal-frazzjoni ta' nalmafene magħqud mal-proteini fil-plażma hija madwar 30%.
English: For HDDs there were 23 days/month at baseline in the Selincro group (n=148) and 22 days/month at baseline in the placebo group (n=155).
Maltese: Għall-HDDs kien hemm 23 ġurnata/xahar bħala linja bażi fil-grupp ta' Selincro (n=148) u 22 ġurnata/xahar bħala linja bażi fil-grupp tal-plaċebo (n=155).
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in alcohol dependence; ATC code: N07BB05
Maltese: Mediċini oħra li jaħdmu fuq is-sistema nervuża, mediċini li jintużaw f'każijiet ta' dipendenza fuq l-alkoħol, Kodiċi ATC:
English: There is no clinically relevant pharmacokinetic drug-drug interaction between nalmefene and alcohol.
Maltese: M'hemm l-ebda interazzjoni farmakokinetika li hija klinikament rilevanti bejn nalmefene u l-alkoħol.
English: Both studies were randomised, double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Maltese: Iż-żewġ studji kienu magħmula b'mod arbitrarju, double blind, b'grupp-parallel u kkontrollati bi plaċebo, u wara 6 xhur ta' kura, il-pazjenti li rċevew Selincro reġgħu ntgħażlu b'mod arbitrarju biex jirċievu jew plaċebo jew Selincro fuq perjodu ta' xahar.
English: The majority (80%) of the patients included had a high or very high DRL (alcohol consumption >60 g/day for men and >40 g/day for women according to the WHO DRLs of alcohol consumption) at screening, of these 65% maintained a high or very high DRL between screening and randomisation.
Maltese: DRL għoli jew għoli ħafna (konsum tal-alkoħol >60 g/jum għall-irġiel u >40 g/jum għan-nisa skont id-DRLs tad-WHO għall-konsum tal-alkoħol) waqt l-ewwel eżaminazzjoni, minn dawn (65%) baqgħu b'DRL għoli jew għoli ħafna bejn l-ewwel eżaminazzjoni u l-għażla b'mod arbitrarju.
English: The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi f'Tabella 1 kienu kkalkulati abbażi ta' tliet studji double-blind, randomised u kkontrollati bi plaċebo f'pazjenti li kellhom dipendenza fuq l-alkoħol.
English: Restlessness
Maltese: Irrekwitezza
English: The following side effects have been reported with Selincro:
Maltese: L-effetti sekondarji li ġejjin ġew irrapportati b'Selincro:
English: For the patients who continued in the study and provided efficacy data at 1 year, the TAC was 24 g/day in the Selincro group (n=78) and 47 g/day in the placebo group (n=29).
Maltese: Għall-pazjenti li baqgħu fl-istudju u pprovdew tagħrif dwar leffikaċja wara sena, it-TAC kien ta' 24 g/ġurnata fil-grupp ta' Selincro (n=78) u ta' 47 g/ġurnata filgrupp tal-plaċebo (n=29).
English: Libido decreased (including loss of libido)
Maltese: Tnaqqis fil-libido (inkluż it-telf tallibido)