FrancophonIA/ELRC3.0 huggingface dataset:
English: What Modafinil containing medicinal products contains Each tablet contains modafinil (either 100 mg or 200 mg) as the active ingredient.
Slovenian: Kaj vsebujejo zdravila, ki vsebujejo modafinil Vsaka tableta vsebuje modafinil (100 ali 200 mg) kot zdravilno učinkovino.
English: Alternative or concomitant methods of contraception are recommended for patients treated with modafinil.
Slovenian: Za bolnice, ki se zdravijo z modafinilom, se priporočajo alternativne ali sočasne metode kontracepcije.
English: Caution should be exercised in administering modafinil to patients with history of alcohol, drug or illicit substance abuse.
Slovenian: Pri dajanju modafinila bolnikom, ki so zlorabljali alkohol, zdravila ali prepovedane snovi, je potrebna previdnost.
English: Detailed grounds for re-examination submitted by the Marketing Authorisation Holder One MAH expressed its disagreement with the CHMP opinion, focusing its grounds for reexamination on the following points:
Slovenian: En imetnik dovoljenja za promet z zdravilom je izrazil nestrinjanje z mnenjem CHMP in se v utemeljitvi zahtevka za ponovni pregled osredotočil na naslednje točke:
English: Abuse, misuse, diversion
Slovenian: Zloraba, napačna uporaba, odstopanje
English: Blood and lymphatic system disorders Uncommon: eosinophilia, leucopenia
Slovenian: Bolezni krvi in limfatičnega sistema Občasni: eozinofilija, levkopenija
English: Common: tachycardia, palpitation Uncommon: extrasystoles, arrhythmia, bradycardia
Slovenian: Pogosti: tahikardija, palpitacije Občasni: ekstrasistole, aritmija, bradikardija
English: Insomnia Because modafinil promotes wakefulness, caution should be paid to signs of insomnia.
Slovenian: Nespečnost Ker modafinil spodbuja budnost, bodite pozorni na znake nespečnosti.
English: Therefore, this SPC and package leaflet may not necessarily represent the current text.
Slovenian: Torej ta povzetek glavnih značilnosti zdravila in navodilo za uporabo morda ne predstavljajo trenutnih besedil.
English: In clinical trials, the most commonly reported events leading to study discontinuation were insomnia, anxiety, depression and agitation.
Slovenian: Od dogodkov, ki so povzročili prekinitev sodelovanja v študiji, so v kliničnih preskušanjih najpogosteje poročali o nespečnosti, tesnobi, depresiji in razdraženosti.
English: Care should be taken in using modafinil in patients with co-morbid bipolar disorder because of concern for possible precipitation of a mixed/manic episode in such patients.
Slovenian: Pri bolnikih s komorbidnimi bipolarnimi motnjami je potrebna previdnost zaradi možnosti morebitnega pojava mešane/manične epizode pri teh bolnikih.
English: Updates on data from the registry will be presented in future modafinil PSURs.
Slovenian: Posodobljeni podatki iz registra bodo predloženi v prihodnjih PSUR za modafinil.
English: Common: vasodilatation Uncommon: hypertension, hypotension
Slovenian: Pogosti: vazodilatacija Občasni: hipertenzija, hipotenzija
English: The dose of modafinil should be reduced by half in patients with severe hepatic impairment (see section 5.2).
Slovenian: Bolniki z jetrno okvaro Pri bolnikih s hudo jetrno okvaro je treba odmerek modafinila prepoloviti (glejte poglavje 5.2).
English: Belgium N.V. Organon Kloosterstraat 6, 5349 AB Oss
Slovenian: Kloosterstraat 6, 5349 AB Oss The Netherlands
English: In the two phase 3 randomised, double blind, placebo-controlled, multicenter studies presented, modest improvement was seen in the objective parameters measured.
Slovenian: V dveh predloženih randomiziranih, dvojno zaslepljenih, s placebom nadzorovanih, multicentričnih študijah 3. faze so ugotovili skromno izboljšanje izmerjenih objektivnih parametrov.
English: How to store Modafinil containing medicinal products Further information
Slovenian: Shranjevanje zdravil, ki vsebujejo modafinil Dodatne informacije
English: Patients should be monitored for signs of phenytoin toxicity, and repeated measurements of phenytoin plasma levels may be appropriate upon initiation or discontinuation of treatment with modafinil.
Slovenian: Bolnik naj se nadzoruje za znake toksičnosti fenitoina, po začetku in koncu zdravljenja z modafinilom pa so primerne ponovljene meritve ravni fenitoina v plazmi.
English: Updates on data from the study should be presented in future modafinil PSURs.
Slovenian: Posodobljene podatke iz študije je treba predložiti v prihodnjih PSUR za modafinil.
English: Skin and hypersensitivity reactions
Slovenian: Kožne in preobčutljivostne reakcije
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.
Slovenian: Simptomi, ki najpogosteje spremljajo preveliko odmerjanje samega modafinila ali kombinacije z drugimi zdravili, so vključevali insomnijo, simptome osrednjega živčevja, kot so nemir, motnje orientacije, zmedenost, razdraženost in halucinacije, spremembe prebavnega trakta, kot sta navzea in diareja, in srčno-žilne spremembe, kot so tahikardija, bradikardija, hipertenzija in bolečina v prsnem košu.
English: If suicide-related symptoms develop in association with modafinil, treatment should be discontinued.
Slovenian: Če se razvijejo simptomi, povezani s samomorom, v povezavi z modafinilom, je treba zdravljenje prekiniti.
English: Positive re-challenge or de-challenge is also reported on a number of cases.
Slovenian: Pri številnih primerih so poročali tudi o pozitivnih rezultatih ponovnega izziva ali odtegnitve.
English: Common: dizziness, somnolence, paraesthesia
Slovenian: Pogosti: omotičnost, zaspanost, parestezija
English: Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively,
Slovenian: Znaki in simptomi te motnje so bili različni, vendar pa so bolniki navadno, čeprav ne izključno, imeli zvišano telesno temperaturo in izpuščaj, povezan z vpletenostjo drugih organskih sistemov.
English: The development of skin and hypersensitivity reactions, as well as neuropsychiatric reactions seems to be closely correlated to the modafinil dose.
Slovenian: Zdi se, da je pojav kožnih in preobčutljivostnih reakcij ter nevropsihiatričnih reakcij v tesni soodvisnosti od odmerka modafinila.
English: If a multi-organ hypersensitivity reaction is suspected, modafinil should be discontinued.
Slovenian: Če obstaja sum multiorganske preobčutljivostne reakcije, je treba zdravljenje z modafinilom prekiniti.
English: Isolated cases have also been reported after prolonged treatment (e.g., 3 months).
Slovenian: Po dolgotrajnem zdravljenju (npr. treh mesecih) so poročali tudi o posameznih primerih izpuščaja.
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.
Slovenian: Zaradi morebitne inhibicije CYP2C19 z modafinilom in supresije CYP2C9 je lahko očistek fenitoina zmanjšan, kadar se sočasno daje modafinil.
English: Reproductive system and breast disorders Uncommon: menstrual disorder
Slovenian: Motnje reprodukcije in dojk Občasno: menstrualne motnje
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.
Slovenian: V študiji 303 je odmerek 200 mg modafinila povzročil povečanje rezultatov testa vzdrževanja budnosti (MWT) za 1,6 minute v primerjavi z izhodiščno vrednostjo, odmerek 400 mg pa za 1,4 minute.
English: Uncommon: abnormal ECG, weight increase, weight decrease
Slovenian: Občasni: nenormalen EKG, povečanje telesne mase, zmanjšanje telesne mase
English: Office Park da Beloura, Edifício 4, Quinta da Beloura
Slovenian: Generis Farmacêutica, S.A. Office Park da Beloura, Edifício 4, Quinta da Beloura 2710-444 Sintra Portugal
English: However, there have been reports of modafinil being used as a performance enhancer.
Slovenian: Odkrili pa so tudi poročila o uporabi modafinila za izboljšanje zmogljivosti.
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.
Slovenian: Druga zdravila: Učinkovine, ki se večinoma izločajo prek presnove s CYP2C19, kot so diazepam, propranolol in omeprazol, imajo lahko zmanjšane očistke ob sočasnem dajanju modafinila, zato bo morda potrebno zmanjšanje odmerka.
English: Modafinil is a wakefulness promoting agent.
Slovenian: Modafinil je sredstvo za spodbujanje budnosti.
English: If psychotic or manic symptoms occur, discontinuation of modafinil may be required.
Slovenian: Če se pojavijo psihotični ali manični simptomi, bo morda treba zdravljenje prekiniti.
English: Gonzagagasse 16/16, A-1010 Vienna, Austria
Slovenian: Torrex Chiesi Pharma GmbH, Gonzagagasse 16/16, A-1010 Vienna, Austria
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.
Slovenian: Študije reproduktivne toksičnosti, izvedene pri podganah in kuncih, so pokazale povečano pogostost skeletnih sprememb (spremembe v številu reber in zakasnela osifikacija), embrio-fetalno smrtnost
English: Modafinil is metabolized by the liver.
Slovenian: Modafinil se presnavlja v jetrih.
English: Anticoagulants: Due to possible suppression of CYP2C9 by modafinil the clearance of warfarin may be decreased when modafinil is administered concomitantly.
Slovenian: Antikoagulansi: Zaradi možne supresije CYP2C9 z modafinilom je očistek varfarina lahko zmanjšan, če se hkrati jemlje tudi modafinil.
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)
Slovenian: Občasni: manjše alergijske reakcije (npr. simptomi senenega nahoda) Neznana: angioedem, urtikarija (koprivnica), preobčutljivostne reakcije (za katere so značilni povišana telesna temperatura, izpuščaj, limfadenopatija in dokazi sočasne vključenosti drugih organov)
English: Unknown: serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Slovenian: Neznana: resne kožne reakcije, vključno z multiformnim eritemom, Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in izpuščajem zaradi zdravila z eozinofilijo ter sistemskimi simptomi (DRESS - Drug Rash with Eosinophilia and Systemic Symptoms)
English: Positive de-challenge and/or re-challenge was reported in some cases.
Slovenian: Pri številnih primerih so poročali o pozitivnih rezultatih odtegnitve in/ali ponovnega izziva.
English: Obstructive Sleep Apnoea
Slovenian: Obstruktivna apneja med spanjem
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of psychotic or manic symptoms.
Slovenian: Bolniki, ki so zdravljeni z modafinilom, naj se skrbno nadzorujejo za pojav ali poslabšanje psihotičnih ali maničnih simptomov.
English: Other associated manifestations included myocarditis, hepatitis, liver function test abnormalities, haematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia.
Slovenian: Druge povezane manifestacije so vključevale miokarditis, hepatitis, nenormalnosti pri testiranju delovanja jeter, hematološke nenormalnosti (npr. eozinofilijo, levkopenijo, trombocitopenijo), pruritus in astenijo.
English: The Committee considered that the evidence for clinically significant efficacy of modafinil-containing 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.
Slovenian: Odbor je menil, da so dokazi za klinično pomembno učinkovitost zdravil, ki vsebujejo modafinil, za indikacijo čezmerne zaspanosti v povezavi z obstruktivno apnejo med spanjem, motnjo spanja zaradi izmenskega dela in idiopatsko hipersomnijo zelo omejeni, zato znana tveganja odtehtajo vse možne koristi.
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of aggressive or hostile behaviour.
Slovenian: Bolniki, ki so zdravljeni z modafinilom, naj bodo skrbno nadzorovani za pojav ali poslabšanje agresivnega ali sovražnega vedenja.
English: Potential risk of abuse, misuse and diversion
Slovenian: Možno tveganje zlorabe, napačne uporabe in rekreativne uporabe
English: Uncommon: dyskinesia, hypertonia, hyperkinesia, amnesia, migraine, tremor, vertigo, CNS stimulation, hypoaesthesia, incoordination, movement disorder, speech disorder, taste perversion
Slovenian: Občasni: diskinezija, hipertonija, hiperkinezija, amnezija, migrena, tremor, vrtoglavica, stimulacija osrednjega živčevja, hipestezija, nekoordiniranost, motnje gibanja, motnje govora, sprememba okusa
English: If symptoms occur, discontinuation of modafinil may be required.
Slovenian: Če se simptomi pojavijo, bo morda treba prekiniti zdravljenje z modafinilom.
English: In clinical trials, with the exception of headache, dizziness and cataplexy, all other nervous system related terms occurred almost exclusively in the modafinil treated patients.
Slovenian: V kliničnih preskušanjih so se izrazi v zvezi z živčevjem (z izjemo glavobola, omotice in katapleksije) pojavljali skoraj izključno pri bolnikih, zdravljenih z modafinilom.
English: Induced emesis or gastric lavage should be considered.
Slovenian: Razmisli naj se o inducirani emezi ali izpiranju želodca.
English: Do not take Modafinil containing medicinal products if you:
Slovenian: Ne jemljite zdravil, ki vsebujejo modafinil:
English: Marketing Authorisation Holder and manufacturers [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalci [Glejte Dodatek I - Izpolni država članica]
English: Narcolepsy
Slovenian: Narkolepsija
English: You will need to consider other birth control methods while taking Modafinil containing medicinal products, and for two months after stopping treatment, because Modafinil containing medicinal products reduces their effectiveness.
Slovenian: Razmisliti boste morali o drugih metodah kontracepcije medtem ko jemljete zdravila, ki vsebujejo modafinil, in dva meseca po prenehanju zdravljenja,
English: Off label use
Slovenian: Uporaba zunaj obsega indikacij
English: The cardiovascular profile of modafinil remains the most relevant concern in the OSA population given the already elevated baseline risk.
Slovenian: Srčno-žilni profil modafinila ostaja najpomembnejši problem v populaciji bolnikov z OSA, ki imajo večje izhodiščno tveganje.
English: It is especially important if you are taking any of the following medicines as well as Modafinil containing medicinal products:
Slovenian: To je še posebej pomembno, če jemljete katerakoli od naslednjih zdravil skupaj z zdravili, ki vsebujejo modafinil: - hormonska kontracepcijska sredstva (vključno s kontracepcijskimi tabletami, vsadki,
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.
Slovenian: • Odbor je menil, da so dokazi za klinično pomembno učinkovitost zdravil, ki vsebujejo modafinil, za indikacijo čezmerne zaspanosti v povezavi z obstruktivno apnejo med spanjem, motnjo spanja zaradi izmenskega dela in idiopatsko hipersomnijo zelo omejeni, zato znana tveganja odtehtajo vse možne koristi.
English: Appropriate data on the cardiovascular safety of modafinil in OSA patients continues to be considered necessary to assess the magnitude of the concern.
Slovenian: Za oceno obsega problema so še vedno potrebni primerni podatki o srčnožilni varnosti modafinila pri bolnikih z OSA.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Modafinil containing medicinal products 100 mg Tablets Modafinil containing medicinal products 200 mg Tablets Modafinil
Slovenian: Zdravila, ki vsebujejo modafinil, 100 mg tablete Zdravila, ki vsebujejo modafinil, 200 mg tablete modafinil
English: Higher concentrations of one of the circulating metabolites, modafinil sulfone, are present in children and adolescents as compared to adults.
Slovenian: Otroci in mladostniki imajo večje koncentracije enega od presnovkov, modafinilijevega sulfona, v krvnem obtoku kot odrasli.
English: Patients treated with modafinil should be carefully monitored for the appearance or worsening of suicide-related behaviour.
Slovenian: Bolnike, ki so zdravljeni z modafinilom, je treba skrbno nadzorovati za pojav ali poslabšanje vedenja, povezanega s samomori.
English: Renal and urinary disorders Uncommon: abnormal urine, urinary frequency
Slovenian: Bolezni sečil Občasni: nenormalen urin, pogostost uriniranja
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, increased cough, asthma, epistaxis, rhinitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni: dispneja, povečano kašljanje, astma, epistaksa, rinitis
English: The cardiovascular profile of modafinil is of particular concern in the OSA population given the already elevated baseline risk.
Slovenian: Srčno-žilni profil modafinila zlasti vzbuja skrb v populaciji bolnikov z OSA, ki imajo večje izhodiščno tveganje.
English: Member State
Slovenian: ČLANICAH
English: Furthermore, it was noted that differences likely to be clinically significant in objective measures of sleepiness between modafinil and placebo were limited to a very small percentage of the patient population in the modafinil clinical trials.
Slovenian: Poleg tega so ugotovili, da so bile v kliničnih preskušanjih modafinila razlike med modafinilom in placebom, ki so bile verjetno klinično pomembne glede na objektivna merila zaspanosti, omejene na zelo majhen odstotek populacije bolnikov.
English: Common: abdominal pain, nausea, dry mouth, diarrhoea, dyspepsia, constipation Uncommon: flatulence, reflux, vomiting, dysphagia, glossitis, mouth ulcers
Slovenian: Pogosti: abdominalne bolečine, navzea, suha usta, diareja, dispepsija, zaprtje Občasni: flatulenca, refluks, bruhanje, disfagija, glositis, ustne razjede
English: Serious adverse reactions affecting the nervous system have been reported spontaneously in association with modafinil, including cerebrovascular disorders, convulsions and extrapyramidal symptoms.
Slovenian: V spontanih poročilih so bili v zvezi z modafinilom navedeni resni neželeni učinki, ki vplivajo na živčevje, vključno s cerebrovaskularnimi boleznimi, konvulzijami in ekstrapiramidalnimi simptomi.
English: Anxiety
Slovenian: Anksioznost
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: [Glejte Dodatek I - podatke je treba dopolniti v posameznih državah.]
English: The signs may include: o mood swings or abnormal thinking, o aggression or hostility, o forgetfulness or confusion, o feeling of extreme happiness, o over-excitement or hyperactivity, o anxiety or nervousness, o depression, suicidal thoughts or behaviour, o agitation or psychosis (a loss of contact with reality which may include delusions or sensing things that are not real), feeling detached or numb, or personality disorder.
Slovenian: Ti znaki lahko vključujejo: o nihanje razpoloženja ali nenormalno razmišljanje; o agresijo ali sovražnost; o pozabljivost ali zmedenost; o občutek ekstremne sreče; o pretirano vzburjenost ali hiperaktivnost; o tesnobnost ali nervoznost; o depresijo, samomorilne misli ali vedenje;
English: Blood pressure and heart rate should be regularly monitored in patients receiving modafinil.
Slovenian: Pri bolnikih, ki jemljejo modafinil, naj se redno nadzorujeta krvni tlak in utrip.
English: Suicide-related behaviour (including suicide attempts and suicidal ideation) has been reported in patients treated with modafinil.
Slovenian: Pri bolnikih, zdravljenih z modafinilom, so poročali o s samomorom povezanem vedenju (vključno s poskusi samomora in samomorilnimi mislimi).
English: Important information about some of the ingredients of Modafinil containing medicinal products [To be completed nationally].
Slovenian: Pomembne informacije o nekaterih sestavinah zdravil, ki vsebujejo modafinil [Izpolni država članica]
English: Following a request from the MAH, the CHMP convened a Scientific Advisory Group (SAG) CNS during the re-examination procedure.
Slovenian: CHMP je v postopku ponovnega pregleda po zahtevku imetnika dovoljenja za promet z zdravilom sklical znanstveno svetovalno skupino (SAG) za klinično nevrologijo.
English: • Have an irregular heartbeat.
Slovenian: • če imate nereden srčni utrip;
English: The following adverse reactions have been reported in clinical trials and/or post-marketing experience.
Slovenian: V kliničnih preskušanjih in/ali izkušnjah po dajanju zdravila v promet so poročali o naslednjih neželenih učinkih.
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.
Slovenian: Poročali so o redkih primerih smrtno nevarnega izpuščaja, vključno s Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo ter o izpuščaju zaradi zdravil z eozinofilijo in sistemskimi simptomi pri otrocih in odraslih po postmarketinških izkušnjah z vsega sveta.
English: A total of 16 cases of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis/Erythema Multiforme have been reported in a post-marketing setting.
Slovenian: V obdobju trženja zdravila so poročali o 16 primerih Stevens-Johnsonovega sindroma ali toksične epidermalne nekrolize ali mutiformnega eritema.
English: General disorders and administration site conditions Common: asthenia, chest pain Uncommon: peripheral oedema, thirst
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti: astenija, bolečina v prsnem košu Občasni: periferni edem, žeja
English: Musculoskeletal and connective tissue disorders Uncommon: back pain, neck pain, myalgia, myasthenia, leg cramps, arthralgia, twitch
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni: bolečine v hrbtu, bolečine v vratu, mialgija, miastenija, krči v nogah, artralgija, trzanje
English: Uncommon: sleep disorder, emotional lability, decreased libido, hostility, depersonalisation, personality disorder, abnormal dreams, agitation, aggression, suicidal ideation.
Slovenian: Pogosti: nervoza, insomnija, anksioznost, depresija, nenormalno mišljenje, zmedenost Občasni: motnje spanja, čustvena labilnost, zmanjšan libido, sovražnost, depersonalizacija, osebnostna motnja, nenormalne sanje, agitacija, agresija, samomorilne misli Redki: halucinacije, manija, psihoza
English: • Calcium channel blockers or beta-blockers for high blood pressure or heart problems (e.g. amlodipine, verapamil or propranalol).
Slovenian: Med zdravljenjem bo vaš zdravnik nadzoroval čas strjevanja krvi; - zaviralce kalcijevih kanalčkov ali zaviralce receptorjev beta za visok krvni tlak ali težave s srcem (npr. amlodipin, verapamil ali propranalol); - statine za zniževanje ravni holesterola (npr. atorvastatin ali simvastatin).
English: Abuse, misuse and diversion
Slovenian: Zloraba, napačna uporaba in rekreativna uporaba
English: Particularly for serious skin disorders, data is indicative of a higher incidence in the paediatric population.
Slovenian: Podatki kažejo večjo pojavnost v pediatrični populaciji, zlasti resnih kožnih bolezni.