FrancophonIA/ELRC3.0 huggingface dataset:
English: The grounds for the referral were concerns expressed by the German medicines regulatory agency regarding the bioequivalence study comparing Pantoprazole Olinka and Pantecta.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib imfisser mill-aġenzija regolatorja tal-mediċini Ġermaniża dwar l-istudju ta' bijoekwivalenza li jqabbel Pantoprazole Olinka u Pantecta.
English: Pharmaceutical form Route of administration Packaging Content
Maltese: Kontenut(konċentrazzjoni) Daqs tal-pakkett
English: • Abnormal periods.
Maltese: • Periods mhux normali.
English: ORCHID EUROPE LTD Building 3, Chiswick park
Maltese: Il-Finlandja ORCHID EUROPE LTD Building 3, Chiswick park
English: Off-label use
Maltese: Użu off-label
English: NL-5349 AB Oss
Maltese: NL-5349 AB
English: Cephalon Pharma GmbH Fraunhoferstr.
Maltese: Il-Ġermanja Cephalon Pharma GmbH Fraunhoferstr.
English: GENESIS PHARMA (CYPRUS) LTD, 2 Amfipoleos, 1st floor, P.O.Box 23638, 2025 Strovolos, Lefkosia, Cyprus
Maltese: GENESIS PHARMA (CYPRUS) LTD, 2 Amfipoleos, 1st floor, P.O.Box 23638, 2025
English: 9a D-82152 Martinsried Germany
Maltese: D-82152 Martinsried
English: Gonzagagasse 16/16, 1010, Vienna, Austria
Maltese: Gonzagagasse 16/16, 1010, Vienna,
English: Belgium N.V. Organon Kloosterstraat 6, 5349 AB Oss
Maltese: N.V. Organon Kloosterstraat 6, 5349 AB
English: III/1-3.
Maltese: III/1-3. Hungary
English: In study 402, MSLT increased from 7.6 minutes at baseline to 8.6 minutes.
Maltese: Fi studju 402, MSLT żdiedet minn 7.6 minuti fil-linja bażi għal 8.6 minuti.
English: Rare: hallucinations, mania, psychosis
Maltese: Rari: alluċinazzjonijiet, manija, psikożi.
English: In study 303, 200 mg and 400 mg of Modafinil resulted in increases of MWT of 1.6 and 1.4 minutes, respectively, when compared to baseline.
Maltese: Fi studju 303, 200 mg u 400 mg ta' Modafinil irriżultaw f'żidiet ta' MWT ta' 1.6 u 1.4 minuti, rispettivament, meta mqabbla mal-linja bażi.
English: Psychotic or manic symptoms
Maltese: Sintomi psikotiċi jew maniċi
English: TEVA ITALIA S.R.L.
Maltese: S.R.L.
English: Statistically significant differences were seen in the subjective parameters (ESS and CGI-C).
Maltese: Intwerew differenzi statistikament sinifikanti fil-parametri suġġettivi (ESS u CGI-C).
English: Radlická 3185/1c 150 00, Prague, Czech Republic
Maltese: Radlická 3185/1c
English: There are 517 cases of hostility/aggression (4 of which with a fatal outcome), 331 cases of psychosis/psychotic disorders (of which 1 had a fatal outcome), 330 cases of depression and 118 cases of suicide/self-injury (15 with a fatal outcome).
Maltese: Hemm 517-il każ ta' ostilità/aggressjoni (4 minnhom b'riżultat fatali), 331 każ ta' disturb ta' psikożi/psikotiċi (li wieħed minnhom kellu riżultat fatali), 330 każ ta' depressjoni u 118-il każ ta' suwiċidju/awto-leżjoni (15 minnhom b'riżultat fatali).
English: - Obstructive Sleep Apnoea (OSA), approved in 11 Member States;
Maltese: - Apnea li Ttellef l-Irqad (OSA), approvata fi 11-il Stat Membru;
English: Aggressive or hostile behaviour
Maltese: Imġiba aggressiva jew ostili
English: Cardiovascular risks
Maltese: Riskji kardjovaskulari
English: The chief metabolite (40 - 50% of the dose), modafinil acid, has no pharmacological activity.
Maltese: Il-metabolit prinċipali (40 - 50% tad-doża), modafinil acid, m'għandu l-ebda attività farmakoloġika.
English: This includes 69 events of torsades de pointes/QT prolongation, 405 of cardiac arrhythmia, 74 of cardiac failure, 205 of hypertension, 462 of cardiomyopathy and 57 of ischemic heart disease.
Maltese: Dan jinkludi 69 avveniment ta' torsades de pointes/titwil tal-QT, 405 ta' arritmija kardijaka, 74 ta' insuffiċjenza kardijaka, 205 ta' pressjoni għolja, 462 ta' kardjomijopatija u 57 ta' mard iskemiku tal-qalb.
English: • Have had alcohol or drug problems in the past.
Maltese: • Kellek problemi bl-alkoħol jew drogi fil-passat.
English: • Flushing.
Maltese: • Fwawar.
English: In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash.
Maltese: Fi provi kliniċi ta' modafinil, l-inċidenza ta' raxx li rriżulta fit-twaqqif tal-mediċina kienet ta' madwar 0.8% (13 minn kull 1,585 persuna) f'pazjenti pedjatriċi (età ta' <17-il sena); dan jinkludi raxx serju.
English: Abuse, misuse, diversion
Maltese: Abbuż, użu ħażin, diverżjoni
English: • Medicines for epilepsy (e.g. carbamazepine, phenobarbital or phenytoin).
Maltese: - Mediċini għal epilessija (eż. carbamazepine, phenobarbital jew phenytoin).
English: Modafinil also does not inhibit the activities of adenylyl cyclase, catechol-O-methyltransferase, glutamic acid decarboxylase MAO-A or B, nitric oxide synthetase, phosphodiesterases II-VI, or tyrosine hydroxylase.
Maltese: Modafinil ukoll ma jinibixxix l-attivitajiet ta' adenylyl cyclase, catechol-O-methyltransferase, glutamic acid decarboxylase MAO-A jew B, nitric oxide synthetase, phosphodiesterases
English: Common: tachycardia, palpitation Uncommon: extrasystoles, arrhythmia, bradycardia
Maltese: Komuni: palpitazzjonijiet,takikardija, palpitazzjoni Mhux komuni: extrasystoles, arritmija, bradikardija
English: Overall benefit/risk assessment
Maltese: Valutazzjoni globali tal-benefiċċju/riskju
English: • Misinterpretation of the risks associated to modafinil
Maltese: • Il-misinterpretazzjoni tar-riskji assoċjati ma' modafinil
English: The frequency of adverse reactions considered at least possibly related to treatment, in clinical trials involving 1561 patients taking modafinil were as follows: very common (≥1/10), common (≥1/100 to ≤1/10), uncommon (≥1/1000 to ≤1/100), unknown (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' reazzjonijiet avversi kkunsidrati li huma mill-inqas possibbilment marbuta mal-kura, fi provi kliniċi li kienu jinvolvu 1,561 pazjent li kienu qed jieħdu modafinil kienu kif ġej: komuni ħafna (≥1/10), komuni ( ≥1/100 sa ≤1/10), mhux komuni (≥1/1000 sa ≤1/100), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: A review of the MAH's pharmacovigilance database identified 873 spontaneous reports of cardiovascular disorders, of which 171 were serious and 17 had a fatal outcome.
Maltese: Reviżjoni tad-database ta' farmakoviġilanza tal-MAH identifikat 873 rapport spontanju ta' disturbi kardjovaskulari, li minnhom 171 kienu serji u 17 kellhom riżultat fatali.
English: In non-clinical models, modafinil has weak to negligible interactions with receptors involved in the regulation of sleep/wake states (e.g., adenosine, benzodiazepine, dopamine, GABA, histamine, melatonin, norepinephrine, orexin, and serotonin).
Maltese: F'mudelli mhux kliniċi, modafinil għandu interazzjonijiet bejn dgħajfa u negliġibbli ma' riċetturi involuti fir-kontroll tal-istati ta' rqad/qawmien (eż., adenosine, benzodiazepine, dopamine, GABA, istamina, melatonin, norepinephrine, orexin, u serotonin).
English: Modafinil is moderately bound to plasma protein (approximately 60%), primarily to albumin, which indicates that there is a low risk of interaction with strongly bound drugs.
Maltese: Modafinil jeħel b'mod moderat mal-proteini fil-plażma (madwar 60%), primarjament mal-albumina, li jindika li hemm riskju baxx ta' interazzjoni ma' mediċini li jeħlu bil-qawwa.
English: Czech Republic Teva Pharmaceuticals CR, s.r.o.
Maltese: Is-Slovakkja Teva Pharmaceuticals CR, s.r.o.,
English: In study 305 (a phase 3 randomised, double-blind, placebo-controlled study), a modest but statistically significant improvement was observed in the MSLT score.
Maltese: Fi studju 305 (studju tal-fażi 3 randomizzat, double-blind u kkontrollat bi plaċebo), ġie osservat titjib modest iżda statistikament sinifikanti fil-punteġġ MSLT.
English: Further consideration will be given to the use of databases in other EU countries, such as the Institute for Drug Outcomes Research (PHARMO) in the Netherlands and Cegedim in France.
Maltese: Sejra tingħata aktar kuonsiderazzjoni għall-użu ta' databases f'pajjiżi oħrajn tal-UE bħallInstitute for Drug Outcomes Research (PHARMO) fl-Olanda u Cegedim fi Franza.
English: After 4 weeks of treatment, subjects in study 402 still presented with MSLT values below the normal (i.e. 10 minutes).
Maltese: Wara 4 ġimgħat ta' trattament, is-suġġetti fi studju 402 xorta ppreżentaw valuri MSLT taħt in-normal (jiġifieri 10 minuti).
English: - Idiopathic hypersomnia (IH), approved in 4 Member States;
Maltese: - Ipersomnja idjopatika (IH), approvata f'4
English: Bipolar disorders
Maltese: Disturbi bipolari
English: GENESIS PHARMA Kiffissias Avenue 274 Halandri Athens 152 32 Greece
Maltese: GENESIS PHARMA Kiffissias Avenue 274
English: Luxembourg ORGANON N.V Kloosterstraat 6
Maltese: .V Kloosterstraat 6
English: A fatal outcome was reported in 3 cases (cardiomyopathy, cardiac failure and syncope).
Maltese: Ġie rrapportat riżultat fatali fi tliet każijiet (kardjomijopatija, insuffiċjenza kardijaka u sinkope).
English: Renal and urinary disorders Uncommon: abnormal urine, urinary frequency
Maltese: Mhux komuni: awrina mhux normali, frekwenza urinarja
English: In addition, there were reports of suicidal ideation, hostility/aggression and psychotic episodes.
Maltese: Ma' dawn kien hemm rapporti ta' ħsibijiet ta' suwiċidju, ostilità/aggressjoni u episodji psikotiċi.
English: No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil.
Maltese: L-ebda raxxijiet serji tal-ġilda ma kienu rrappurtati fi provi kliniċi ta' modafinil fuq persuni adulti (0 minn 4,264 persuna).
English: In 2007, concerns relating to serious psychiatric disorders (suicidal thoughts/behaviour, symptoms of psychosis and mania) and serious skin and subcutaneous tissue disorders (including erythema multiforme and Stevens-Johnson syndrome) prompted a review of the available data from clinical trials and spontaneous adverse reaction reports by the Pharmacovigilance Working Party (PhVWP).
Maltese: Fl-2007, tħassib relatat ma' disturbi psikjatriċi serji (ħsibijiet/imġiba ta' suwiċidju, sintomi ta' psikożi u manija) u disturbi serji fil-ġilda u fit-tessut ta' taħt il-ġilda (inkluż eritema multiforme u s-sindromu ta' Stevens-Johnson) xprunaw reviżjoni tad-dejta disponibbli minn provi kliniċi u rapporti ta' reazzjoni avversa mill-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP).
English: A search of the MAH's pharmacovigilance database revealed a total of 485 reports related to abuse, misuse, dependency and tolerance associated to modafinil use.
Maltese: Tfittxija fid-database tal-farmakoviġilanza tal-MAH uriet total ta' 485 rapport relatat ma' abbuż, użu ħażin, dipendenza u tolleranza assoċjata mal-użu ta' modafinil.
English: • Difficulty moving muscles smoothly or other movement problems, muscle tension, coordination problems.
Maltese: • Diffikultà biex iċċaqlaq il-muskoli b'mod normali jew problemi oħrajn tal-moviment, tensjoni fil muskoli, problemi fil-koordinazzjoni.
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see section 4.5).
Maltese: Billi modafinil jista' jnaqqas l-effettività ta' kontraċezzjoni orali, metodi addizzjonali alternattivi ta' kontraċezzjoni huma meħtieġa (ara sezzjoni 4.5)
English: Czech Republic Torrex Chiesi CZ, s.r.o.
Maltese: Torrex Chiesi CZ, s.r.o. Na Květnici 33
English: Modafinil is metabolized by the liver.
Maltese: Modafinil hu metabolizzat mill-fwied.
English: A total of 16 cases of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis/Erythema Multiforme have been reported in a post-marketing setting.
Maltese: Total ta' 16-il każ tas-Sindromu Stevens Johnson/Nekroliżi Epidermika Tossika/Eritema Multiforme ġew irrapportati f'ambjent wara t-tqegħid fis-suq.
English: Modafinil is a racemic compound, and the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans.
Maltese: Modafinil hu kompost raċemiku, u l-enantiomers għandhom farmakokinetika differenti fejn it- t1/2 taleliminazzjoni tal-R-isomer hi tliet darbiet iktar minn dik tal-S-isomer f'persuni adulti.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing modafinil.
Maltese: • Il-Kumitat ikkunsidra r-riferiment magħmul skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom modafinil.
English: Examples include ciclosporin, HIV-protease inhibitors, buspirone, triazolam, midazolam and most of the calcium channel blockers and statins.
Maltese: Eżempji jinkludu ciclosporin, inibituri tal-protease tal-HIV, buspirone, triazolam, midazolam u l-biċċa l-kbira talimblokkaturi tal-kanal tal-calcium u statins.
English: Communication
Maltese: Kommunikazzjoni
English: In addition, in vitro induction of CYP1A2, CYP2B6 and CYP3A4/5 activities has been observed in human hepatocytes, which were it to occur in vivo, could decrease the blood levels of drugs metabolised by these enzymes, thereby possibly decreasing their therapeutic effectiveness.
Maltese: Flimkien ma' dan, induzzjoni in vitro ta' attivitajiet ta' CYP1A2, CYP2B6 u CYP3A4/5kienet osservata f'epatoċiti tal-bniedem, u li din kellha sseħħ in vivo, kieku kienet tnaqqas il-livelli fiddemm ta' mediċini metabolizzati minn dawn l-enzimi, u b'hekk possibbilment tnaqqas l-effettività terapewtika tagħhom.
English: A significant number of adverse reactions relating to psychiatric disorders have been reported spontaneously.
Maltese: Numru sinifikanti ta' reazzjonijiet avversi relatati ma' disturbi psikjatriċi ġew irrapportati b'mod spontanju.
English: Antidepressants: A number of tricyclic antidepressants and selective serotonin reuptake inhibitors are largely metabolised by CYP2D6.
Maltese: Numru ta' antidipressanti triċikliċi u inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin huma fil-biċċa l-kbira tagħhom metabolizzati minn CYP2D6.
English: Uncommon: sweating, rash, acne, pruritis
Maltese: Mhux komuni: għaraq, raxx, akne, ħakk tal-ġilda
English: • Migraine.
Maltese: • Emigranja.
English: • Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranalol).
Maltese: - Imblokkaturi tal-kanal tal-calcium jew imblokkaturi beta għal pressjoni tad-demm għolja jew problemi tal-qalb (eż. amlodipine, verapamil jew propranalol).
English: The MAHs will access and submit data on the study on recreational use and diversion among university students in the UK, being developed by the Centre for Public Health, School of Pharmacy and Biomolecular Sciences - Liverpool John Moores University.
Maltese: Il-MAHs sejrin jaċċessaw u jissottomettu dejta dwar l-istudju fuq l-użu rikreattiv u d-diverżjoni fost listudenti tal-università fir-Renju Unit, li qiegħed jiġi żviluppat mis-Centre for Public Health, School of Pharmacy and Biomolecular Sciences - Liverpool John Moores University.
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: Unknown: serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Maltese: Mhux magħrufa: reazzjonijiet serji tal-ġilda, li jinkludu eritema multiforme, is-Sindrome ta' StevensJohnson, Nekrolisi Epidermali Tossika, u Raxx Minħabba l-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS).
English: Common: decreased appetite
Maltese: Komuni: nuqqas ta' aptit
English: This risk appears to be higher in children.
Maltese: Ir-riskju jidher li huwa ogħla fit-tfal.
English: • Have uncontrolled, moderate to severe high blood pressure (hypertension).
Maltese: • Għandek pressjoni tad-demm għolja moderata sa severa u mhux ikkontrollata (ipertensjoni).
English: Serious adverse reactions affecting the nervous system have been reported spontaneously in association with modafinil, including cerebrovascular disorders, convulsions and extrapyramidal symptoms.
Maltese: Reazzjonijiet avversi serji li jaffettwaw is-sistema nervuża ġew irrapportati spontanjament f'assoċjazzjoni ma' modafinil, inkluż disturbi ċerebrovaskulari, konvulżjonijiet u sintomi ekstrapiramidali.
English: Potential risk of abuse, misuse and diversion
Maltese: Riskju potenzjali ta' abbuż, użu ħażin u diverżjoni
English: Teva Denmark A/S, Parallelvej 10, 2800 Kongens Lyngby, Denmark
Maltese: Id-Danimarka Teva Denmark A/S, Parallelvej 10,
English: The wake-promoting effects of modafinil are antagonised by D1/D2 receptor antagonists suggesting that it has indirect agonist activity.
Maltese: L-effetti ta' modafinil li jippromwovu l-qawmien huma antagonizzati minn antagonisti ta' riċetturi ta' D1/D2, u dan jissuġġerixxi li għandu attività agonista indiretta.
English: Fertility No data on fertility are available.
Maltese: Fertilità L-ebda dejta mhi disponibbli dwar il-fertilità.
English: - Moderate to severe chronic shift work sleep disorder (SWSD), approved in 10 Member States.
Maltese: - Disturb kroniku moderat għal sever fl-irqad minħabba x-xogħol bix-xift (SWSD), approvat f'10 Stati Membri.
English: Common: abnormal liver function tests, dose related increases in alkaline phosphatase and gamma glutamyl transferase have been observed.
Maltese: Komuni: testijiet tal-funzjoni tal-fwied b'riżultat anormali, kienu osservati żidiet fil-livell ta' alkaline phosphatase u gamma glutamyl transferase marbuta mad-doża.
English: However the effect size is small and does not necessarily reflect a clinically significant benefit.
Maltese: Madankollu, d-daqs tal-effett huwa żgħir u mhux neċessarjament jirrifletti benefiċċju klinikament sinifikanti.
English: Uncommon: dyskinesia, hypertonia, hyperkinesia, amnesia, migraine, tremor, vertigo, CNS stimulation, hypoaesthesia, incoordination, movement disorder, speech disorder, taste perversion
Maltese: Mhux komuni: diskinesija, ipertonija, iperkinesija, amnesija, emigranja, rogħda, sturdament, stimulazzjoni tas-CNS, ipoestesija, nuqqas ta' koordinazzjoni, disturbi fil-moviment, disturbi fiddiskors, tibdil fit-togħma
English: Modafinil "Teva" 100 mg tablets
Maltese: Modafinil "Teva" 100 mg pilloli
English: Even though the prevalence of idiopathic hypersomnia is thought to be very low (between 1/10 000 and 1/25 000 for IH with long sleep time and between 1/11 000 and 1/100 000 for IH without long sleep time) and the difficulties in conducting large scale trials are acknowledged, no conclusions can be drawn to support the efficacy of the product with such a limited dataset.
Maltese: Anki jekk il-prevalenza ta' ipersomnja idjopatika hija maħsuba li hija baxxa ħafna (bejn 1/10 000 u 1/25 000 għal IH b'ħin ta' rqad twil u bejn 1/11 000 u 1/100 000 għal IH mingħajr ħin ta' rqad twil) u d-diffikultajiet biex isiru provi fuq skala kbira huma rikonoxxuti, ebda konklużjoni ma tista' tinstilet biex tkun appoġġjata leffikaċja tal-prodott b'sett ta' dejta daqshekk limitat.
English: Common: nervousness, insomnia, anxiety, depression, abnormal thinking, confusion.
Maltese: Komuni: nervożità, nuqqas ta' rqad, ansjetà, dipressjoni, ħsibijiet mhux normali, konfużjoni.
English: Severe chronic renal failure (creatinine clearance up to 20 mL/min) did not significantly affect the pharmacokinetics of modafinil administered at 200 mg, but exposure to modafinil acid was increased 9-fold.
Maltese: Insuffiċjenza severa kronika renali (tneħħija tal-krejatinina sa 20 mL/min) ma affettwatx b'mod sinifikanti l-farmakokinetika ta' modafinil li jingħata f'doża ta' 200 mg, iżda l-espożizzjoni għal aċidu ta' modafinil żdiedet b'9 darbiet.
English: NAME OF THE MEDICINAL PRODUCT Modafinil - containing medicinal products (see Annex I) products 100 mg tablets Modafinil - containing medicinal products (see Annex I) products 200 mg tablets See Annex I - To be completed nationally.
Maltese: Prodotti mediċinali li fihom modafinil (ara Anness I) prodotti 100 mg pilloli Prodotti mediċinali li fihom modafinil (ara Anness I) prodotti 200 mg pilloli Ara Anness I - Biex jimtela mill-pajjiż partikolari.
English: The MAHs will conduct a pharmacoepidemiological study using large-linked claims databases in the United States to further assess the incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Maltese: Il-MAHs sejrin jagħmlu studju farmakoepidemjoloġiku bl-użu ta' databases ta' klejms relatati kbar flIstati Uniti biex jevalwaw aktar l-inċidenza tas-sindromu Stevens-Johnson u nekroliżi tossiċi epidermali.
English: Steroidal contraceptives: The effectiveness of steroidal contraceptives may be impaired due to induction of CYP3A4/5 by modafinil.
Maltese: L-effettività ta' kontraċettivi sterojdali tista' tiġi indebolita minħabba linduzzjoni ta' CYP3A4/5 minn modafinil.
English: Uncommon: sleep disorder, emotional lability, decreased libido, hostility, depersonalisation, personality disorder, abnormal dreams, agitation, aggression, suicidal ideation.
Maltese: Mhux komuni: problemi biex torqod, nuqqas ta' stabbilità emozzjonali, tnaqqis fil-libido, ostilità, dipersonalizzazzjoni, disturbi fil-personalità, ħolm mhux normali, aġitazzjoni, aggressjoni, formazzjoni ta' ħsieb biex jitwettaq suwiċidju
English: Pharmacotherapeutic group: Psychoanaleptic, centrally acting sympathomimetic, ATC code: N06BA
Maltese: Psikoanalettiċi, simpatomimetiċi li jaġixxu b'mod ċentrali, Kodiċi ATC:
English: 200mg tablets
Maltese: 200mg pilloli
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Modafinil containing medicinal products 100 mg Tablets Modafinil containing medicinal products 200 mg Tablets Modafinil
Maltese: Prodotti mediċinali li fihom Modafinil 100 mg Pilloli Prodotti mediċinali li fihom Modafinil 200 mg Pilloli
English: Modafinil may increase its own metabolism via induction of CYP3A4/5 activity but the effect is modest and unlikely to have significant clinical consequences.
Maltese: Modafinil jista' jżid il-metaboliżmu tiegħu stess permezz ta' induzzjoni ta' attività ta' CYP3A4/5, iżda l-effett hu modest u mhux mistenni li jkollu konsegwenzi kliniċi sinifikanti.
English: Adults with severe kidney and liver problems The usual dose is 100 mg a day.
Maltese: Persuni adulti bi problemi severi tal-kliewi u tal-fwied Id-doża tas-soltu hi ta' 100 mg kuljum.
English: Although modafinil-induced wakefulness can be attenuated by the 1-adrenoceptor antagonist, prazosin, in other assay systems (e.g. vas deferens) responsive to -adrenoceptor agonists, modafinil is inactive.
Maltese: Għalkemm qawmien ikkaġunat minn modafinil jista' jittaffa mill-antagonist ta' 1-adrenoceptor, prazosin, f'sistemi oħrajn ta' assaġġ (eż. vas deferens) li jirrispondu għal agonisti ta' -adrenoceptor, modafinil hu inattiv.
English: Blood and lymphatic system disorders Uncommon: eosinophilia, leucopenia
Maltese: Mhux komuni: eosinofilja, lewkopenija
English: In patients deficient in CYP2D6 (approximately 10% of a Caucasian population) a normally ancillary metabolic pathway involving CYP2C19 becomes more important.
Maltese: F'pazjenti b'defiċjenza ta' CYP2D6 (madwar 10% tal-popolazzjoni Kawkasa) passaġġ metaboliku li hu normalment anċillari li jinvolvi CYP2C19 isir aktar importanti.
English: A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Maltese: Dijanjosi ta' narkolepsija għandha ssir skont il-linja gwida tal-Klassifikazzjoni Internazzjonali ta' Disturbi fl-Irqad (ICSD2).
English: In this assessment of the benefit-risk profile of modafinil in its different indications, the CHMP reviewed available data from pre-clinical and clinical studies, spontaneous reports, published literature and other data submitted by the MAHs as relevant.
Maltese: F'din il-valutazzjoni tal-profil tal-benefiċċju-riskju ta' modafinil fl-indikazzjonijiet differenti tiegħu, is-CHMP irreveda dejta disponibbli minn studji pre-kliniċi u kliniċi, rapporti spontanji, letteratura ippubblikata u dejta oħra sottomessa mill-MAHs bħala relevanti.