FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the newly identified risks of psychiatric and skin reactions in conjunction with cardiovascular risks, but also evidence of significant off label use and concerns about potential abuse, misuse or diversion, a formal review of the full benefit-risk balance of modafinil was initiated by the CHMP through an article 31 referral procedure.
Maltese: Minħabba rriskji li għadhom kif ġew identifikati ta' reazzjonijiet psikjatriċi u tal-ġilda flimkien ma' riskji kardjovaskulari, iżda wkoll evidenza ta' użu sinifikanti mhux ittikkettat u tħassib dwar abbuż potenzjali, użu ħażin jew diverżjoni, inbdiet reviżjoni formali tal-bilanċ sħiħ tal-benefiċċju-riskju misCHMP permezz ta' proċedura ta' riferiment skont l-Artikolu 31.
English: Modafinil should be discontinued at the first sign of rash and not restarted (see section 4.8).
Maltese: Modafinil għandu jitwaqqaf mal-ewwel sinjal ta' raxx u ma jerġax jinbeda (ara sezzjoni 4.8).
English: Modafinil tablets are not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale and in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants.
Maltese: Il-pilloli modafinil mhumiex rakkomandati f'pazjenti bi storja medika ta' ipertrofija ventrikulari taxxellug jew cor pulmonale u f'pazjenti b'mitral valve prolapse li kellhom is-sindrome ta' mitral valve prolapse meta kienu qed jirċievu stimulanti tas-CNS fil-passat.
English: Uncommon: minor allergic reaction (e.g., hayfever symptoms) Unknown: Angioedema, urticaria (hives).Hypersensitivity reactions (characterised by features such as fever, rash, lymphadenopathy and evidence of other concurrent organ involvement)
Maltese: Mhux komuni: reazzjoni allerġika żgħira (eż., sintomi ta' hayfever) Mhux magħrufa: Anġjoedema, urtikarja ((ħorriqija), Reazzjonijiet ta' sensittività eċċessiva (ikkaratterizzati minn sintomi bħal deni, raxx, limfadenopatija u evidenza ta' involviment oħra fl-istess ħin ta' organi)
English: Maintenance of sleep hygiene
Maltese: Ipersomnja Idjopatika
English: This included serious cases of moderate chest pain linked to symptomatic mitral valve prolapse, increased heart rate, congestive heart failure, cardiomegaly, palpitations, syncope and bradycardia.
Maltese: Dan inkluda każijiet serji ta' uġigħ moderat fis-sider relatat ma' prolass sintomatiku tal-valv mitrali tal-qalb, żieda fir-rata tat-taħbit tal-qalb, insuffiċjenza konġestiva tal-qalb, kardjomegalija, palpitazzjonijiet, sinkope u bradikardja.
English: Modafinil is associated with the onset or worsening of psychotic symptoms or manic symptoms (including hallucinations, delusions, agitation or mania).
Maltese: Modafinil hu assoċjati mal-bidu jew l-aggravament ta' sintomi psikotiċi jew sintomi maniċi (li jinkludu alluċinazzjonijiet, delużjonijiet, aġitazzjoni jew manija).
English: Common: abdominal pain, nausea, dry mouth, diarrhoea, dyspepsia, constipation Uncommon: flatulence, reflux, vomiting, dysphagia, glossitis, mouth ulcers
Maltese: Komuni: uġigħ addominali, nawsja, ħalq xott, dijarea, dispepsja, stitikezza Mhux komuni: gass, rifluss, rimettar, disfaġja, glossite, ulċeri tal-ħalq
English: The MAHs will conduct a retrospective drug utilisation study of the use of modafinil in the primary care setting, with data retrieved and analysed at least from the UK General Practice Research Database (GPRD).
Maltese: Il-MAHs sejrin jagħmlu studji dwar l-użu retrospettiv tal-mediċina tal-użu ta' modafinil f'ambjent ta' kura primarja, b'dejta miksuba u analizzata tal-inqas mill-UK General Practice Research Database (GPRD).
English: In the placebo controlled studies, various cardiovascular events occurred almost exclusively in the modafinil treated group.
Maltese: Fl-istudji kkontrollati bi plaċebo, diversi avvenimenti kardjovaskulari seħħew kważi b'mod esklussiv fil-grupp trattat b'modafinil.
English: The active ingredient in the tablets is modafinil.
Maltese: Is-sustanza attiva fil-pilloli hi modafinil.
English: Modafinil Generis 100 mg tablets
Maltese: Modafinil Generis 100 mg pilloli
English: Due to a possible inhibition of CYP2C19 by modafinil and suppression of CYP2C9 the clearance of phenytoin may be decreased when modafinil is administered concomitantly.
Maltese: Minħabba inibizzjoni possibbli ta' CYP2C19 minn modafinil u t-trażżin ta' CYP2C9, it-tneħħija ta' phenytoin tista' titnaqqas meta modafinil jingħata fl-istess ħin.
English: • Omeprazole (for acid reflux, indigestion or ulcers).
Maltese: - Omeprazole (għal rifluss tal-aċidu, indiġestjoni jew ulċeri).
English: In a case report, a 50% reduction in ciclosporin concentration was observed in a patient receiving ciclosporin in whom concurrent treatment with modafinil was initiated.
Maltese: F'rapport dwar każ partikulari, kien osservat tnaqqis ta' 50% fil-konċentrazzjoni ta' ciclosporin f'pazjent li kien qed jirċievi ciclosporin, li fih kienet inbdiet kura fl-istess ħin b'modafinil.
English: The CHMP Scientific Advisory Group (SAG) was also consulted.
Maltese: Il-Grupp ta' Konsulenza Xjentifika tas-CHMP (SAG) ġie kkonsultat ukoll.
English: It is however noted that the dose-response profile does not seem to be linear.
Maltese: Madankollu, huwa nnotat li l-profil doża-rispons ma jidhirx li huwa wieħed lineari.
English: Infections and infestations Uncommon: pharyngitis, sinusitis
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni: farinġite, sinusite
English: Data will be presented in future modafinil PSURs.
Maltese: Id-dejta sejra tkun ippreżentata f'PSURs futuri ta' modafinil.
English: Results from clinical interaction studies suggest that the largest effects may be on substrates of CYP3A4/5 that undergo significant presystemic elimination, particularly via CYP3A enzymes in the gastrointestinal tract.
Maltese: Riżultati minn studji dwar interazzjoni klinika jissuġġerixxu li l-ikbar effetti jistgħu jkunu fuq substrati ta' CYP3A4/5 li jgħaddu minn eliminazzjoni presistemika sinifikanti, partikularment permezz ta' enzimi ta' CYP3A fl-apparat gastrointestinali.
English: Systemic exposure increases in a dose proportional manner over the range of 200-600 mg.
Maltese: L-espożizzjoni sistemika tiżdied b'mod li hu proporzjonali għad-doża fuq il-medda ta' 200-600 mg.
English: Reproductive system and breast disorders Uncommon: menstrual disorder
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni: disturbi fil-mestrwazzjoni
English: Rare cases of serious or life-threatening rash, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.
Maltese: Każijiet rari ta' raxx serju jew ta' periklu għall-ħajja, li jinkludu s-Sindrome ta' Stevens-Johnson (SJS), Nekrolisi Epidermali Tossika (TEN), u Raxx Minħabba l-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS) kienu rrappurtati f'persuni adulti u tfal fl-esperjenza ta' wara t-tqegħid fis-suq madwar id-dinja.
English: In clinical trials, all the hypersensitivity related terms were reported more commonly in association to modafinil than to placebo.
Maltese: Fil-provi kliniċi, it-termini relatati mas-sensittività eċċessiva ġew irrapportati b'mod aktar komuni f'assoċjazzjoni ma' modafinil milli ma' plaċebo.
English: If psychotic or manic symptoms occur, discontinuation of modafinil may be required.
Maltese: Jekk iseħħu sintomi psikotiċi jew maniċi, jista' jkun hemm bżonn li modafinil jitwaqqaf.
English: • Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modafinil containing medicinal products contains').
Maltese: • Allerġiku/a (tbati minn sensittività eċċessiva) għal modafinil jew għal xi sustanzi oħra ta' dawn il pilloli (ara sezzjoni 6 ‘X'fihom prodotti mediċinali li fihom Modafinil').
English: Uncommon side effects (affecting fewer than 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (li jaffettwaw inqas minn persuna 1 minn kull 100 persuna):
English: MODAFINIL 200 mg tablets
Maltese: MODAFINIL 200 mg pilloli
English: CEPHALON SRL Piazza G. Marconi, 25 00144 ROMA Italia
Maltese: Marconi, 25 00144
English: Other medicinal products: Substances that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol and omeprazole may have reduced clearance upon co-administration of modafinil and may thus require dosage reduction.
Maltese: Prodotti mediċinali oħrajn: Sustanzi li fil-biċċa l-kbira tagħhom jiġu eliminati permezz talmetaboliżmu ta' CYP2C19, bħal diazepam, propranolol u omeprazole, jista' jkollhom tneħħija mnaqqsa meta modafinil jingħata magħhom, u għaldaqstant jista' jkun hemm bżonn ta' tnaqqis fid dożaġġ.
English: The 400 mg dose in study 303 did not lead to higher MWT differences or improved ESS score than the 200 mg dose.
Maltese: Id-doża ta' 400 mg fl-istudju 303 ma wasslitx għal differenzi ogħla fl-MWT jew punteġġ tal-ESS imtejjeb aktar mid-doża ta' 200 mg.
English: However, modafinil binds to the norepinephrine transporter and inhibits norepinephrine uptake, but these interactions are weaker than those observed with the dopamine transporter.
Maltese: Ma jidhirx li modafinil hu agonist dirett ta' 1-adrenoceptor Madankollu, modafinil jeħel mattrasportatur norepinephrine u jinibixxi l-assorbiment ta' norepinephrine, iżda dawn l-interazzjonijiet huma iktar dgħajfa minn dawk osservati mat-trasportatur ta' dopamine.
English: While some of the pre-clinical studies have shown reproductive toxicity, the available human data are insufficient to establish whether toxicity occurs in humans during pregnancy and lactation.
Maltese: Waqt li wħud mill-istudji pre-kliniċi urew tossiċità riproduttiva, id-dejta umana disponibbli m'hijiex biżżejjed biex jiġi stabbilit jekk isseħħx tossiċità fil-bnedmin waqt it-tqala u t-treddigħ.
English: • Antiviral medicines to treat HIV infection (protease inhibitors e.g. indinavir or ritonavir).
Maltese: - Mediċini antivirali għal kura ta' infezzjoni bl-HIV (inibituri tal-protease (eż. indinavir jew ritonavir). - Ciclosporin (jintuża biex jiġi evitat it-tiċħid ta' organu tat-trapjant, jew għal artrite jew psorjasi).
English: Serious nervous system and psychiatric related events such as suicidal ideation, psychotic episodes, and depression have also been identified in association to modafinil.
Maltese: Avvenimenti serji fis-sistema nervuża u psikjatriċi bħal pereżempju ħsibijiet ta' suwiċidju, episodji psikotiċi u depressjoni ġew ukoll identifikati f'assojazzjoni ma' modafinil.
English: Cephalon France, 20, rue Charles Matigny, 94700 Maisons-Alfort, France
Maltese: Id-Danimarka Cephalon France, 20, rue Charles Matigny, 94700 Maisons-Alfort, France
English: General disorders and administration site conditions Common: asthenia, chest pain Uncommon: peripheral oedema, thirst
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni: astenja, uġigħ fis-sider Mhux komuni: edema periferali, għatx
English: Posology
Maltese: IPPREŻENTATI
English: Caution should be exercised in giving modafinil to patients with a history of psychiatric disorders including psychosis, depression , mania, major anxiety, agitation, insomnia or substance abuse (see below).
Maltese: Għandu jkun hemm kawtela meta modafinil jingħata lil pazjenti bi storja medika ta' disturbi psikjatriċi li jinkludu psikosi, dipressjoni, manija, ansjetà maġġuri, aġitazzjoni, nuqqas ta' rqad jew abbuż mid-drogi (ara hawn taħt).
English: Modiodal® 100 mg tablets
Maltese: Modiodal® 100 mg pilloli
English: Uncommon: hypercholesterolaemia, hyperglycaemia, diabetes mellitus, increased appetite,
Maltese: Mhux komuni: iperkolesterolemija, ipergliċemija, dijabete mellitus, żieda fl-aptit
English: Anticoagulants: Due to possible suppression of CYP2C9 by modafinil the clearance of warfarin may be decreased when modafinil is administered concomitantly.
Maltese: Mediċini kontra l-koagulazzjoni tad-demm: Minħabba trażżin possibbli ta' CYP2C9 minn modafinil, it-tneħħija ta' warfarin tista' titnaqqas meta modafinil jingħata fl-istess ħin.
English: The MAHs will provide, within 3 months of the Commission Decision, a feasibility analysis of an epidemiological cardiovascular safety study.
Maltese: Fi żmien 3 xhur mid-Deċiżjoni tal-Kummissjoni, il-MAHs sejrin jipprovdu analiżi dwar il-fattibilità ta' studju dwar is-sigurtà kardjovaskulari epidemjoloġika.
English: The MAHs should inform healthcare professionals on the outcome of this review on modafinil via a Direct Healthcare Professional Communication (DHPC) to be distributed the Monday after 5 days have passed from the adoption of the European Commission Decision.
Maltese: Il-MAHs għandhom jinformaw lill-professjonisti fil-kura tas-saħħa dwar ir-riżultat ta' din ir-reviżjoni fuq modafinil permezz ta' Komunikazzjoni Diretta għall-Professjonisti fil-Kura tas-Saħħa (Direct Healthcare Professional Communication - DHPC) li sejra titqassam it-Tnejn wara li jkunu għaddew 5 ijiem mill-adozzjoni tad-Deċiżjoni tal-Kummissjoni Ewropea.
English: What Modafinil containing medicinal products contains Each tablet contains modafinil (either 100 mg or 200 mg) as the active ingredient.
Maltese: X'fihom prodotti mediċinali li fihom Modafinil Kull kapsula fiha modafinil (jew 100 mg jew 200 mg bħala s-sustanza attiva.
English: Breastfeeding
Maltese: MODAFINIL
English: Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhoea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.
Maltese: Is-sintomi li l-biċċa l-kbira akkompanjaw doża eċċessiva b'modafinil, waħdu jew flimkien ma' mediċini oħrajn, kienu jinkludu: nuqqas ta' rqad, sintomi tas-sistema nervuża ċentrali bħal nuqqas ta' kwiet fil-ġisem, diżorjentazzjoni, konfużjoni, tqanqil u alluċinazzjonijiet; tibdil diġestiv bħal nawseja u dijarea; u tibdil kardjovaskulari bħal takikardija, bradikardija, pressjoni għolja u uġigħ fis-sider.
English: • The Committee considered that the evidence for clinically significant efficacy of modafinilcontaining products in excessive sleepiness associated with obstructive sleep disorder, shift work sleep disorder and idiopathic hypersomnia is very limited, and therefore any potential benefit for patients is outweighed by the identified risks.
Maltese: • Il-Kumitat ikkunsidra li l-evidenza għal effikaċja klinikament sinifikanti ta' prodotti li fihom modafinil f'ħedla eċċessiva assoċjata ma' disturb li jtellef l-irqad, disturb fl-irqad minħabba xxogħol bix-xift u insomnja idjopatika, hija limitata ħafna u għalhekk kull benefiċċju potenzjali għall-pazjenti huwa misbuq mir-riskji identifikati.
English: Anticonvulsants: Co-administration of potent inducers of CYP activity, such as carbamazepine and phenobarbital, could reduce the plasma levels of modafinil.
Maltese: L-għoti flimkien ta' inducers qawwija ta' attività ta' CYP, bħal carbamazepine u phenobarbital, jista' jnaqqas il-livelli ta' modafinil fil-plażma.
English: MODIODAL 100MG tablets
Maltese: MODIODAL 100MG pilloli
English: Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1).
Maltese: Il-kura għandha tinbeda minn, jew taħt is-superviżjoni ta' tabib b'għarfien adattat ta' disturbi indikati (ara sezzjoni 4.1).
English: It is noted during the discussion with the MAH that, in the clinical trials, there was an average blood pressure increase of 2-3 mmHg of systolic blood pressure during the long term extension of pivotal studies.
Maltese: Waqt id-diskussjoni mal-MAH ġie nnotat, li fil-provi kliniċi, kien hemm żieda medja fil-pressjoni taddemm ta' 2-3 mmHg ta' pressjoni tad-demm sistolika matul l-estensjoni għal terminu twil tal-istudji pivotali.
English: Modafinil containing medicinal products can cause blurred vision or dizziness in up to 1 in 10 people.
Maltese: Prodotti mediċinali li fihom Modafinil jistgħu jikkawżaw vista mċajpra jew sturdament f'sa minn persuna 1 minn kull 10.
English: While modafinil is not a directacting dopamine receptor agonist, in vitro and in vivo data indicate that modafinil binds to the dopamine transporter and inhibits dopamine reuptake.
Maltese: Filwaqt li modafinil mhuwiex agonist ta' riċettur ta' dopamine li jaġġixxi b'mod dirett, dejta in vitro u in vivo tindika li modafinil jeħel mat-trasportatur ta' dopamine u jinibixxi l-assorbiment mill-ġdid ta' dopamine.
English: Patients using steroidal contraceptives
Maltese: Pazjenti li jużaw kontraċettivi sterojdjali
English: Significant safety issues identified during this review (skin and hypersensitivity reactions, cardiovascular events) require further study.
Maltese: Kwistjonijiet ta' sigurtà sinifikanti identifikati waqt din ir-reviżjoni (reazzjonijiet tal-ġilda u ta' sensittività eċċessiva, avvenimenti kardjovaskulari) jeħtieġu aktar studju.
English: MODAFINIL 100 mg tablets
Maltese: MODAFINIL 100 mg pilloli
English: Narcolepsy
Maltese: Ċipru
English: Since the effectiveness of steroidal contraceptives may be reduced when used with modafinil, alternative or concomitant methods of contraception are recommended, and for two months after discontinuation of modafinil (also see 4.5 with respect to potential interaction with steroidal contraceptives).
Maltese: Billi l-effettività ta' kontraċettivi sterojdjali tista' titnaqqas meta jintużaw ma' modafinil, metodi alternattivi ta' kontraċezzjoni jew li jintużaw fl-istess ħin huma rakkomandati, u għal xahrejn wara t-twaqqif ta' modafinil (ara wkoll 4.5 fir-rigward ta' interazzjoni potenzjali ma' kontraċettivi sterojdjali).
English: The mechanism of action is not entirely understood, but the most consistent findings of the various studies performed are the inhibitory effects on the dopamine and norepinephrine transporters.
Maltese: Il-mekkaniżmu ta' azzjoni mhuwiex mifhum kompletament, iżda l-aktar sejbiet kostanti tad-diversi studji li saru huma l-effetti inibitorji fuq it-trasportaturi ta' dopamine u norepinephrine.
English: MODIODAL 100 mg tablets
Maltese: MODIODAL 100 mg pilloli
English: Updates on data from the registry will be presented in future modafinil PSURs.
Maltese: L-aġġornamenti dwar id-dejta mill-istudju għandhom jiġu ppreżentati f'PSURs futuri ta' modafinil.
English: Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, haematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia.
Maltese: Sinjali u sintomi ta' dan id-disturb kienu differenti; madankollu, il-pazjenti tipikament, għalkemm mhux esklussivament, kellhom deni u raxx assoċjati ma' involviment ta' sistemi ta' organi oħrajn. Manifestazzjonijiet assoċjati oħrajn kienu jinkludu mijokardite, epatite, testijiet tal-funzjoni tal-fwied b'riżultati mhux normali, abnormalitajiet ematoloġiċi (eż., eosinofilija, lewkopenija, tromboċitopenija), ħakk, u astenja.
English: • Being sick (vomiting)
Maltese: • Tkun imdardar (tirremetti)
English: Modafinil Teva 100 mg tablets
Maltese: Modafinil Teva 100 mg pilloli
English: In clinical trials, the most commonly reported events leading to study discontinuation were insomnia, anxiety, depression and agitation.
Maltese: Fil-provi kliniċi, l-aktar avvenimenti irrapportati b'mod komuni li jwasslu għal twaqqif tal-istudju kienu insomnja, ansjetà, depressjoni u aġitazzjoni.
English: In the two phase 3 randomised, double blind, placebo-controlled, multicenter studies presented, results obtained with both objective efficacy measures used were consistent and demonstrated statistically significant benefits of modafinil when compared to placebo.
Maltese: Fiż-żewġ studji b'aktar minn ċentru wieħed, randomizzati tal-fażi 3, double-blind, ikkontrollati bi plaċebo ppreżentati, ir-riżultati miksubin bl-użu taż-żewġ miżuri għall-effikaċja tal-objettiv kienu konsistenti u urew benefiċċji statistikament sinifikanti ta' modafinil meta mqabbel ma' plaċebo.
English: Because this type of event is considered to be rare, to have observed cases in a clinical trial setting is unexpected and considered indicative of an incidence higher than previously thought.
Maltese: Minħabba li dan it-tip ta' avveniment huwa meqjus bħala rari, li jiġu osservati każijiet f'ambjent ta' prova klinika mhuwiex mistenni u dan huwa meqjus indikattiv ta' inċidenza ogħla minn kemm maħsub qabel.
English: Reproductive toxicity studies conducted in rats and rabbits showed an increased incidence in skeletal variations (changes in the numbers of ribs and delayed ossification), embryo-fetal lethality (periimplantation loss and resorptions) and some evidence of an increase in stillbirths (rats only), in the absence of maternal toxicity, at clinically relevant exposures.
Maltese: Studji dwar it-tossiċità fir-riproduzzjoni li saru fil-firien u l-fniek wrew żieda fl-inċidenza ta' varjazzjonijiet skeletriċi (tibdil fin-numri ta' kustilji u dewmien fl-ossifikazzjoni), letalità embrijufetali (telf ta' qabel l-impjantazzjoni u assorbimenti mill-ġdid) u xi evidenza ta' żieda fi frieħ li jitwieldu mejtin (fil-firien biss), fl-assenza ta' tossiċità materna, f'espożizzjonijiet klinikament rilevanti.
English: 100mg tablets
Maltese: 100mg pilloli
English: In clinical trials, another 3 cases of Serious Cutaneous Adverse Reactions (SCARs) have been observed, which is of particular concern given the rare background incidence rate of such events.
Maltese: Serji fuq il-Ġilda (SCARs), li huwa ta' tħassib partikolari meta wieħed iqis irrata ta' inċidenza fl-isfond rari ta' tali avvenimenti.
English: There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment (see section 5.2).
Maltese: Hemm informazzjoni inadegwata biex jiġu stabbiliti s-sigurtà u l-effikaċja tad-dożaġġ f'pazjenti b'indeboliment renali (ara sezzjoni 5.2).
English: The cardiovascular profile of modafinil remains the most relevant concern in the OSA population given the already elevated baseline risk.
Maltese: Il-profil kardjovaskulari ta' modafinil jibqa' l-aktar tħassib relevanti fil-popolazzjoni OSA meta wieħed iqis ir-riskju diġà elevat tal-linja bażi.
English: Cardiovascular adverse events such as hypertension and arrhytmias are documented in association with modafinil.
Maltese: Avvenimenti avversi kardjovaskulari bħal pereżempju l-pressjoni għolja u l-arritmiji huma ddokumentati f'assoċjazzjoni ma' modafinil.
English: • The opinion adopted a Product Information which did not fully reflect the safety information for modafinil
Maltese: • L-opinjoni adottat Informazzjoni dwar il-Prodott li ma rriflettietx b'mod sħiħ l-informazzjoni dwar is-sigurtà għal modafinil
English: Updates on data from the study should be presented in future modafinil PSURs.
Maltese: L-aġġornamenti dwar id-dejta mill-istudju għandhom ikunu ppreżentati f'PSURs futuri ta' modafinil.
English: Method of administration For oral use.
Maltese: Metodu ta' kif għandu jingħata Għal użu orali.
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: There are limited data available on the use of modafinil in elderly patients.
Maltese: Hemm dejta limitata disponibbli dwar l-użu ta' modafinil f'pazjenti anzjani.
English: Modafinil is a wakefulness promoting agent.
Maltese: Modafinil hu assoċjat mal-bidu jew aggravament ta' ansjetà.
English: 100 mg tablets
Maltese: 100 mg pilloli
English: Common: blurred vision Uncommon: abnormal vision, dry eye
Maltese: Mhux komuni: vista mhux normali, għajnejn xotti
English: In the two phase 3 randomised, double blind, placebo-controlled, multicenter studies presented, modest improvement was seen in the objective parameters measured.
Maltese: Fiż-żewġ studji b'aktar minn ċentru wieħed, randomizzati tal-fażi 3, double-blind, ikkontrollati bi plaċebo ppreżentati, ġie nnotat titjib modest fil-parametri oġġettivi mkejla.
English: Modafinil was first authorized in the EU in France, in June 1992.
Maltese: Modafinil ġie awtorizzat għall-ewwel darba fi Franza, f'Ġunju 1992.