FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 97-patient randomised placebo-controlled study, the data collected during specific ophthalmologic investigations, aiming at documenting the function of the cone and rod systems and the ascending visual pathway (i.e. electroretinogram, static and kinetic visual fields, colour vision, visual acuity), in patients treated with ivabradine for chronic stable angina pectoris over 3 years, did not show any retinal toxicity.
Maltese: F'studju b'97 pazjent ikkontrollat bil-plaċebo u magħmul b'mod arbitrarju, it-tagħrif miġbur waqt investigazzjonijiet speċifiċi oftalmoloġiċi, bl-għan li jiddokumentaw il-funzjoni tassistemi tal-kon u r-rod u l-passaġġi viżwali li jitikgħu għall-moħħ (i.e. elettroretinogramm, kamp viżiv statiku u kinetiku, viżjoni bil-kulur, akutezza fil-viżta), f'pazjenti ttrattati b'ivabridine għal anġina pectoris stabbli kronika fuq medda ta' 3 snin, ma wera ebda tossiċità retinali.
English: Do not take Ivabradine Zentiva if you are breast-feeding (see “Do not take Ivabradine Zentiva”).
Maltese: Tiħux Ivabradine Zentiva jekk qed tredda' (ara taħt “Tiħux Ivabradine Zentiva ”).
English: Oblong, one side and both edges scored white tablets with dimensions 4.8×8.8 mm.
Maltese: Pilloli bojod b'daqsijiet ta' 4.8×8.8 mm.
English: Symptoms Overdose may lead to severe and prolonged bradycardia (see section 4.8).
Maltese: Sintomi Doża eċċessiva tista' twassal għal bradikardija severa u fit-tul (ara sezzjoni 4.8).
English: One film-coated tablet contains 7.5 mg ivabradine (hydrochloride).
Maltese: Pillola waħda miksija b'rita fiha 7.5 mg ivabradine ( bħala hydrochloride)
English: Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers or - in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Maltese: Ivabradine huwa indikat: - f'adulti li ma jistgħux jittolleraw jew li għandhom kontraindikazzjoni għall-użu ta' betablokkers jew - f'kombinazzjoni ma' beta-blokkers f'pazjenti li mhumiex ikkontrollati adegwatament b'doża ottimali ta' beta-blokkers
English: - Phenytoin (for epilepsy).
Maltese: TWISSIJA(IET) SPEĊJALI
English: Therefore, ivabradine is contra-indicated during breast-feeding (see section 4.3).
Maltese: Għalhekk ivabradine huwa kontra- indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: The study showed no difference in the rate of the primary composite outcome in the ivabradine group by comparison to the placebo group (relative risk ivabradine:placebo: 1.00, p = 0.945).
Maltese: L-istudju ma wera ebda differenza fir-rata tar-riżultat kompost primarju fil- grupp tal-ivabradine meta mqabbel malgrupp tal-plaċebo (riskju relattiv ivabradine:plaċebo 1.00, p=0.945).
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine
Maltese: Ivabradine Zentiva 5 mg pilloli miksijin b'rita Ivabradine
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Maltese: Ivabradine Zentiva 5 mg pilloli miksija b'rita Ivabradine Zentiva 7.5 mg pilloli miksija b'rita ivabradine
English: In patients with mild hepatic impairment (Child Pugh score up to 7) unbound AUC of ivabradine and the main active metabolite were about 20% higher than in subjects with normal hepatic function.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh sa 7 punti) l-AUC ta' ivabradine maħlul u l-prodott attiv tal-metaboliżmu prinċipali kienu madwar 20% ogħla milli f'pazjenti fejn il-fwied kien jaħdem normali.
English: One film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Maltese: Pillola waħda miksija b'rita fiha 5 mg ivabradine (bħala hydrochloride)
English: The intake of St. John's Wort should be restricted during the treatment with ivabradine.
Maltese: John's Wort waqt il-kura b'ivabradine.
English: Ivabradine Zentiva 7.5 mg film-coated tablets:
Maltese: Ivabradine Zentiva 7.5 mg pilloli miksijin b‘rita:
English: Ivabradine Zentiva 7.5 mg film-coated tablets Ivabradine
Maltese: Ivabradine Zentiva 7.5 mg pilloli miksijin b'rita Ivabradine
English: Ivabradine Zentiva 5 mg film-coated tablets:
Maltese: Ivabradine Zentiva 5 mg pilloli miksija b'rita:
English: EU/1/16/1144/003 EU/1/16/1144/004 EU/1/16/1144/005 EU/1/16/1144/006 EU/1/16/1144/007
Maltese: EU/1/16/1144/001 EU/1/16/1144/002 EU/1/16/1144/003
English: In patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.
Maltese: F'pazjenti ta' età 'l fuq minn 75 sena, doża mnaqqsa għandha tiġi kkunsidrata fil-bidu talkura (2.5 mg darbtejn kuljum i.e. nofs pillola ta' 5 mg darbtejn kuljum) qabel ma d-doża tiżdied bil-qies jekk ikun hemm bżonn.
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir)
Maltese: (clarithromycin, erythromycin per os, josamycin, telithromycin), inibituri HIV protease
English: (5 mg b.i.d., if age ≥ 75 years) and titration up to 10 mg b.i.d.).
Maltese: Intużat skema terapewtika ogħla mill-pożoloġija approvata (doża tal-bidu ta' 7.5 mg b.i.d (5 mg b.i.d, jekk l-età kienet ≥ 75 sena) u titrazzjoni sa 10 mg b.i.d).
English: Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Maltese: Ivabradine ma jinfluwenzax il-metaboliżmu u l-konċentrazzjoni fil-plażma ta' sustanzi oħra li fuqhom jaħdem CYP3A4 (inibituri dgħajfa, moderati u qawwija).
English: Treatment with ivabradine was associated with an average reduction in heart rate of 15 bpm from a baseline value of 80 bpm.
Maltese: Il-kura b'ivabradine kienet assoċjata ma' tnaqqis medju fir-rata tal- qalb ta' 15 bpm mill-valur tal-linja bażi ta' 80 bpm.
English: No influence on glucose or lipid metabolism was observed.
Maltese: Ma ġie osservat ebda effett fuq il-metaboliżmu tal-glucose jew tallipidi.
English: - Sino-atrial block.
Maltese: - Żomm dan il-fuljett.
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Zentiva 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs id- doża, jiġifieri nofs pillola ta' 5 mg ta' Ivabradine Zentiva 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta' 5 mg filgħaxija.
English: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (e.g. ventricular or supraventricular tachycardia).
Maltese: Ivabradine m'huwiex effikaċi fil-kura jew prevenzjoni ta' arritmiji kardijaċi u bl-istess mod jitlef l- effikaċja tiegħu meta sseħħ taki-arritmija (eż. takikardija ventrikulari jew supraventrikulari).
English: Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarisation in the sinus node and regulates heart rate.
Maltese: Ivabradine hu prodott mediċinali li jnaqqas ir-rata tat-taħbit tal-qalb b'mod pur billi jimpedixxi b'mod selettiv u speċifiku l-pace maker b'kurrent If kardijaku li jikkontrolla ddepolorazzjoni dijastolika spontanja fis-sinus node u jirregola r-rata tat-taħbit tal-qalb.
English: The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and bradycardia, are dose dependent and related to the pharmacological effect of the medicinal product.
Maltese: L-aktar reazzjonijiet avversi komuni b'ivabradine, fenomeni mudwali (ċrieki ta' dawl) u bradikardja huma dawk li jiddependu mid-doża u relatati mal-effett farmakoloġiku talprodott mediċinali.
English: The antianginal and anti-ischaemic efficacy of ivabradine was studied in five double-blind randomised trials (three versus placebo, and one each versus atenolol and amlodipine).
Maltese: Effikaċja klinika u sigurtà L-effikaċja kontra l-anġina u kontra l-iskemija ta' ivabradine ġiet studjata f'ħames provi randomised għamja doppji (tlieta versus plaċebo, wieħed versus atenolol u wieħed versus amlodipine).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer.
English: Potassium-depleting diuretics (thiazide diuretics and loop diuretics) Hypokalaemia can increase the risk of arrhythmia.
Maltese: Dijuretiċi li jnaqqsu l-potassju (dijuretiċi thiazide u dijuretiċi loop) L-ipokalemija tista' żżid ir-riskju ta' arritmija.
English: The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Maltese: Idderivattiv N-desmethylated ta' ivabradine ġie identifikat bħala s-sustanza attiva maġġura ffurmata fil- metaboliżmu fil-bniedem.
English: Abdominal pain
Maltese: Popolazzjoni pedjatrika
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TALPRODOTT MEDIĊINALI
English: The PK/PD relationship of ivabradine in paediatric chronic heart failure patients aged 6 months to less than 18 years is similar to the PK/PD relationship described in adults.
Maltese: Ir-relazzjoni PK/PD ta' ivabradine f'pazjenti b'insuffiċjenza kardijaka kronika pedjatrika li għandhom bejn 6 xhur u inqas minn 18-il sena hija simili għar-relazzjoni PK/PD deskritta fladulti.
English: There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Maltese: M'hemmx evidenza ta' riskju ta' bradikardija (eċċessiva) mar-ritorn għal sinus rhythm meta l- kardjoverżjoni farmakoloġika tinbeda f'pazjenti li qed jieħdu ivabradine.
English: in age-subset [6 - 12] months, 0.05 mg/kg b.i.d.
Maltese: Id-doża tal-bidu kienet 0.02 mg/kg b.i.d fis-sottogrupp bejn [6-12[-il xahar, 0.05 mg/kg b.i.d f'età bejn [1-3[ snin u f'età bejn [3-18[-il sena <40 kg, u 2.5 mg b.i.d f'età bejn [3-18[-il sena u ≥40 kg.
English: These data are consistent with the pharmacological effect of ivabradine related to its interaction with hyperpolarisationactivated Ih currents in the retina, which share extensive homology with the cardiac pacemaker If current.
Maltese: Din l- informazzjoni hija konsistenti mal-effett farmakoloġiku ta' ivabradine relatat ma' l-interazzjoni tiegħu ma' iperpolarizzazzjoni-attivata tal-kurrenti Ih fir-retina, li jaqsmu omoloġija estensiva ma' kurrent If tal-pacemaker tal-qalb.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għatTqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Blood and lymphatic system disorders Uncommon Eosinophilia Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: Hypotension, possibly related to bradycardia
Maltese: Sturdament, possibbilment relatata ma' bradikardija
English: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute (see section 4.3).
Maltese: Ivabradine m'għandux jinbeda f'pazjenti li qabel il-kura jkollhom rata tat-taħbit tal-qalb waqt il- mistrieħ ta' inqas minn 70 taħbita fil-minuta (ara sezzjoni 4.3).
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Maltese: Wara ġimagħtejn ta' kura, id-doża tista' tiżdied għal 7.5 mg darbtejn kuljum jekk ir-rata talqalb waqt il- mistrieħ tkun persistentement ogħla minn 60 bpm jew titnaqqas għal 2.5 mg darbtejn kuljum (nofs pillola waħda ta' 5 mg darbtejn kuljum) jekk ir-rata tal-qalb waqt ilmistrieħ tkun persistentement inqas minn 50 bpm jew fil-każ ta' sintomi relatati ma' bradikardija bħal sturdament, għeja jew pressjoni baxxa.
English: Ivabradine Zentiva is not intended for use in children and adolescents younger than 18 years.
Maltese: Ivabradine Zentiva mhuwiex intenzjonat sabiex jintuża fi tfal u adoloxxenti ta' inqas minn 18-il sena.
English: If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Maltese: Jekk waqt il-kura ir-rata tat-taħbit tal-qalb mistrieħa tonqos b'mod persistenti għal inqas minn 50 bpm jew jekk il-pazjent iħoss xi sintomi relatati ma' bradikardija bħal sturdament, għeja kbira jew ipotensjoni, id-doża għandha titnaqqas jew il-kura għandha titwaqqaf jekk ir-rata tat-taħbit tal-qalb tkun inqas minn 50 bpm jew sintomi ta' bradikardija jippersistu (ara sezzjoni 4.2).
English: Pregnancy
Maltese: AWTORIZZAZZJONI
English: No data are available in patients with creatinine clearance below 15 mL/min.
Maltese: Mhemmx informazzjoni dwar pazjenti li għandhom tneħħija tal-krejatinina ta' inqas minn 15 mL/min.
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section
Maltese: L-użu flimkien ta' ivabradine ma' dawn il-prodotti mediċinali huwa kontraindikat (ara sezzjoni
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn ilbenefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Common (may affect up to 1 in 10 people) - Modification in the heart functioning (the symptoms are a slowing down of the heart rate).
Maltese: Komuni: (tista' taffettwa sa persuna 1 minn kull 10) Modifikazzjoni fil-funzjoni tal-qalb (is-sintomi huma tnaqqis fir-rata tat-taħbit tal-qalb).
English: It usually appears between 40 and 50 years of age.
Maltese: Dan jiġri l-aktar fl-età ta' bejn l-40 u l-50 sena.
English: When treatment modifications are made in chronic heart failure patients treated with ivabradine blood pressure should be monitored at an appropriate interval (see section 4.8).
Maltese: Meta jsiru modifiki tal-kura f'pazjenti b'insuffiċjenza kronika tal-qalb ikkurati b'ivabradine, il- pressjoni tad-demm tagħhom għandha tiġi mmonitorjata f'intervall xieraq (ara sezzjoni 4.8).
English: Ivabradine Zentiva (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Maltese: Anġina pectoris sintomatika stabbli (li tikkaġuna uġigħ fis-sider) f'adulti li r-rata tat-taħbit tal- qalb tagħhom hija 70 taħbita jew aktar fil-minuta.
English: The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Maltese: L-użu ta' ivabradine f'pazjenti li jbatu minn sindromu QT konġenitali jew li qegħdin jieħdu kura bi prodotti mediċinali li jtawwlu l-QT għandu jiġi evitat (ara sezzjoni 4.5).
English: Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Maltese: Ivabradine jiġi metabollizzat b'CYP3A4 biss u hu impeditur dgħajjef ħafna ta' dan iċċitokromu.
English: - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Maltese: L-użu ta' ivabradine flimkien ma' inibituri ta' CYP3A4 moderati (eż.fluconazole) jista' jiġi kkunsidrat b'doża tal-bidu ta' 2.5 mg darbtejn kuljum u jekk ir-rata tat-taħbit tal-qalb mistrieħa hija ogħla minn 70 bpm, hemm bżonn li l-pazjent ikun taħt monitoraġġ minħabba ir-rata tat-taħbit tal-qalb.
English: Uncommon Dyspnoea
Maltese: Mhux komuni Eosinofilja
English: Risk for abuse and dependence
Maltese: Riskju għal abbuż u dipendenza
English: Dexamfetamine, (2S)-1-phenylpropan-2-amine, is the dextrorotatory, stereoisomer of amfetamine.
Maltese: Dexamfetamine, (2S)-1-phenylpropan-2-aminehuwa d-dextrorotatory, stereoisomer ta' amfetamine.
English: • Introduction of a statement in section 4.8 on reporting of suspected adverse reactions.
Maltese: • Introduzzjoni ta' dikjarazzjoni fis-sezzjoni 4.8 dwar rapportar ta' reazzjonijiet avversi suspettati.
English: More importantly, the Arnold LE (2000) comparative review analysed six non-duplicative studies, from which a response rate of 66% was calculated for dexamfetamine sulphate, 56% for methylphenidate and 85% stimulant response if both are tried.
Maltese: Fuq kollox, ir-reviżjoni komparattiva Arnold LE (2000) analizzat sitt studji mhux duplikattivi, li minnhom ġiet ikkalkolata rata ta' rispons ta' 66% għal dexamfetamine sulphate, 56% għal methylphenidate u 85% rispons għallistimulant jekk jiġu ppruvati t-tnejn.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-referenza mibdija mir-Renju Unit taħt l-Artikolu 29(4) tadDirettiva 2001/83/KE.
English: Methylphenidate reversibly binds to the presynaptic transporter protein with resultant inhibition of catecholamines re-uptake into the presynaptic neuron (Volkow et al., 2002), increases the release of dopamine from presynaptic cytoplasmic storage vesicles and blocks the uptake of dopamine into neuronal cytoplasmic storage vesicles, making dopamine more available in the presynaptic cytoplasm for release into the synaptic cleft (Sulzer et al., 2005).
Maltese: Ir-raġuni għar-risponsi differenti tista' tkun mekkaniżmi ta' azzjoni farmakoloġika differenti. Methylphenidate jeħel b'mod riversibbli mal-proteina trasportatur presinattika b'inibizzjoni riżultanti ta' riassorbiment mill-ġdid tal-katekolamini fin-newrun presinattiku (Volkow et al., 2002), iżid ir-rilaxx ta' dopamina mill-infafet ta' ħżin ċitoplasmatiċi presinattiċi u jimblokka l-assorbiment ta' dopamina fl-infafet ta' ħażna ċitoplasmatika newronali, u b'hekk jagħmel dopamina aktar disponibbli fi-ċitoplasma presinattika għar-rilaxx filmixquq sinattiku (Sulzer et al., 2005).
English: In the Elia et al. study, approximately 30% of participants did not respond to one treatment but only 4% were non-responders to both.
Maltese: Fl-istudju Elia et al., madwar 30% tal-parteċipanti ma rrispondewx għal kura waħda iżda 4% biss ma rrispondewx għaż-żewġ kuri.
English: Overall summary of the scientific evaluation of Dexamed (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Dexamed (ara l-Anness I)
English: Ramtvedt et al. (2013) have reported that in a cross-over clinical study including 36 children with a diagnostic of ADHD (as per Norwegian diagnostic guidelines), who received, in sequence, 2 weeks each of methylphenidate, dexamfetamine and placebo, dexamfetamine and methylphenidate each produced a favourable response in 26 children (72%), but not always the same child.
Maltese: (2013) irrapportaw li fi studju kliniku inkroċjat li jinkludi 36 tifel u tifla djanjostiċi b'ADHD (skont il-linji gwida djanjositiċi Norveġiżi), li rċevew, f'sekwenza, ġimagħtejn kull wieħed ta' methylphenidate, dexamfetamine u plaċebo, dexamfetamine u methylphenidate kull wieħed ipproduċa rispons favorevoli f'26 tifel u tifla (72%), iżda mhux dejjem l-istess tifel/tifla.
English: The present application for Dexamed as second-line treatment of ADHD is a bibliographic (wellestablished use) application.
Maltese: Din l-applikazzjoni għal Dexamed bħala kura ta' linja sekondarja ta' ADHD hija applikazzjoni biblijografika (użu stabbilit sew).
English: These data are further supported by the Arnold et al. (1978) study.
Maltese: Wilens et al. 2003).
English: The proposed risk minimisation measures are a combination of routine activities (inclusion of warnings in the product information) and the following educational materials and tools:
Maltese: Il-miżuri ta' minimizzazzjoni tar-riskju proposti huma kombinazzjoni ta' attivitajiet ta' rutina (inklużjoni ta' twissijiet fl-informazzjoni dwar il-prodott) u l-materjali u l-għodod edukattivi li ġejjin:
English: Amfetamines increase levels of catecholamine in the synaptic cleft by blocking reuptake of noradrenaline and dopamine by presynaptic neurons, by releasing dopamine and noradrenaline from dopaminergic neurons, and possibly by inhibiting monoamine oxidase.
Maltese: L-amfetamini jżidu llivelli ta' catecholamine fil-mixquq sinattiku billi jimblokkaw ir-riassorbiment ta' noradrenalina u dopamina min-newroni presinattiċi, bir-rilaxx ta' dopamina u noradrenalina minn newroni dopaminerġiċi, u possibbilment billi jinibixxu monoamine oxidase.
English: However, a more recent meta-analysis by Humphreys et al. (2013) investigated both published and unpublished reports on a total of 15 different studies and concluded that effective treatment of ADHD, typically using methylphenidate, does not seem to have impact of substance abuse later in life.
Maltese: (2013) investigat kemm ir-rapporti ppubblikati kif ukoll dawk mhux ippubblikati minn total ta' 15-il studju differenti u kkonkludiet li kura effikaċi ta' ADHD, ġeneralment permezz ta' methylphenidate, ma jidhirx li għandha impatt fuq l-abbuż ta' sustanzi aktar tard fil-ħajja.
English: Efficacy in second line treatment of ADHD
Maltese: Effikaċja fil-kura ta' linja sekondarja ta' ADHD
English: It is noted that age can be a dominant factor in substance use disorder.
Maltese: Huwa nnotat li l-età tista' tkun fattur dominanti fid-disturb tal-użu ta' sustanzi.
English: • Introduction of a statement in section 4.4 on “Abuse, misuse, and diversion” reporting that the risk is generally greater for short acting stimulants than for corresponding long-acting products.
Maltese: • Introduzzjoni ta' dikjarazzjoni fis-sezzjoni 4.4 dwar "Abbuż, użu ħażin, u devjazzjoni" li tirrapporta li r-riskju huwa ġeneralment akbar għal stimulanti b'azzjoni qasira milli għal prodotti b'azzjoni fit-tul korrispondenti.
English: Dexamfetamine is currently used for treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD) in several EU countries including the reference Member State (RMS) in this procedure.
Maltese: Dexamfetamine bħalissa jintuża għall-kura ta' narkolessija u disturb ta' iperattività fin-nuqqas ta' attenzjoni (ADHD) f'bosta pajjiżi tal-UE inkluż l-Istat Membru ta' referenza (RMS) f'din il-proċedura.