FrancophonIA/ELRC3.0 huggingface dataset:
English: Those parts currently not needed can be stored in the reservoir of the tablet box (under the slide of the closure), until the next administration.
Slovenian: Deli, ki trenutno niso potrebni, se lahko do naslednjega dajanja shranijo v predalčku škatle za tablete (pod drsnim delom zaporke).
English: The tablets should be swallowed with water independent of meals.>
Slovenian: Tablete je treba pogoltniti z vodo, ne glede na obroke hrane.> Prenehanje zdravljenja
English: • tramadol (painkiller)
Slovenian: • tramadol (zdravilo za lajšanje bolečin)
English: Stopping treatment with Saroten solution for injection Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache, feeling unwell, sleeplessness and irritability).
Slovenian: Zdravnik se bo odločil, kdaj in kako boste prenehali zdravljenje, da se prepreči pojav morebitnih neprijetnih simptomov, ki se lahko pojavijo pri nenadnem prenehanju (npr. glavobol, slabo počutje,
English: How to store Saroten solution for injection Keep this medicine out of the sight and reach of children.
Slovenian: Shranjevanje zdravila Saroten raztopina za injiciranje Zdravilo shranjujte nedosegljivo otrokom!
English: <[Saroten and associated names 75 mg, modified release tablets] Due to the two score lines the Saroten and associated names 75 mg can be divided into three parts.
Slovenian: <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem] Zaradi dveh razdelilnih zarez je možno tableto zdravila Saroten in povezana imena 75 mg razdeliti na tri dele.
English: Uncommon (> 1/1,000, < 1/100);
Slovenian: Občasni (> 1/1.000, < 1/100);
English: Saroten and associated names 10 mg film-coated tablets Saroten and associated names 25 mg film-coated tablets Saroten and associated names 50 mg film-coated tablets
Slovenian: Saroten in povezana imena 10 mg filmsko obložene tablete Saroten in povezana imena 25 mg filmsko obložene tablete Saroten in povezana imena 50 mg filmsko obložene tablete
English: <[Saroten and associated names 50 mg film-coated tablets] X are dividable tablets with three score lines.
Slovenian: <[Saroten in povezana imena 50 mg filmsko obložene tablete] Zdravilo X so deljive tablete s tremi razdelilnimi zarezami.
English: NAME OF THE MEDICINAL PRODUCT Saroten and associated names 25 mg prolonged-release capsules, hard Saroten and associated names 50 mg prolonged-release capsules, hard Saroten and associated names 75 mg, modified release tablets
Slovenian: Saroten in povezana imena 25 mg trde kapsule s podaljšanim sproščanjem Saroten in povezana imena 50 mg trde kapsule s podaljšanim sproščanjem Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem
English: Reduced hepatic function
Slovenian: Zmanjšano delovanje ledvic
English: This medicine is taken every evening as a single daily dose.
Slovenian: Kdaj in kako jemati zdravilo X To zdravilo se jemlje enkrat na dan vsak večer.
English: <[Saroten and associated names 75 mg, modified release tablets] Saroten retard Tabs 75 mg are dividable retard tablets with two score lines.
Slovenian: <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem] Zdravilo Saroten retard tablete 75 mg so deljive tablete s prirejenim sproščanjem z dvema razdelilnima zarezama.
English: <[Saroten and associated names prolonged-release capsules, hard] The capsules should be swallowed with water.
Slovenian: <[Saroten in povezana imena trde kapsule s podaljšanim sproščanjem] Kapsule pogoltnite z vodo.
English: INFORMATION IN BRAILLE [To be completed nationally] UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Navedba smiselno ni potrebna.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities Not applicable.
Slovenian: 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
English: Saroten and associated names (see Annex I) 10 mg film-coated tablets Saroten and associated names (see Annex I) 25 mg film-coated tablets Saroten and associated names (see Annex I) 50 mg film-coated tablets
Slovenian: Saroten in povezana imena (glejte Prilogo I) 10 mg filmsko obložene tablete Saroten in povezana imena (glejte Prilogo I) 25 mg filmsko obložene tablete Saroten in povezana imena (glejte Prilogo I) 50 mg filmsko obložene tablete amitriptilin
English: If necessary the dose can be increased by 25 mg or 50 mg after 1 week up to 150 mg daily.
Slovenian: Po potrebi se lahko odmerek po 1 tednu poveča po 25 mg ali
English: If you receive doses above 100 mg daily, your doctor may need to do more frequent follow-up with you.
Slovenian: Če prejemate odmerke večje od 100 mg na dan, bodo morda potrebni pogostejši zdravniški pregledi.
English: The initial dose should be 10 mg - 25 mg in the evening.
Slovenian: Začetni odmerek mora biti 10 mg - 25 mg zvečer.
English: Saroten and associated names is indicated for in-hospital treatment of major depressive disorders in adults.
Slovenian: 4.1 Terapevtske indikacije Zdravilo X je indicirano za bolnišnično zdravljenje hudih depresij pri odraslih.
English: Antidepressants - Non-selective monoamine reuptake inhibitor (tricyclic antidepressant) ATC code: N 06 AA 09
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Antidepresivi - neselektivni zaviralci privzema monoaminov (triciklični antidepresivi), Oznaka ATC: N06AA09 Mehanizem delovanja
English: Rare side effect, may affect up to 1 in 1,000 people.
Slovenian: Redek neželeni učinek; pojavi se lahko pri največ 1 od 1.000 bolnikov.
English: Major depressive disorder
Slovenian: Huda depresija
English: You should immediately have an eye examination before the treatment with this medicine can be continued.
Slovenian: Pred nadaljevanjem zdravljenja s tem zdravilom vam morajo takoj opraviti pregled oči, ker so to lahko znaki akutnega glavkoma.
English: • Major Depressive Disorder
Slovenian: • huda depresija
English: Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting).
Slovenian: • modrice, krvavitev, bledica ali persistentno vneto žrelo in zvišana telesna temperatura Ti simptomi so lahko prvi znak krvne bolezni ali prizadetosti kostnega mozga, kot so lahko zmanjšanje števila rdečih krvnih celic (ki po telesu prenašajo kisik), belih krvnih celic (ki pomagajo v boju proti okužbam) in krvnih ploščic (ki pomagajo pri strjevanju krvi).
English: <[Saroten and associated names 10 mg film-coated tablets; Saroten and associated names 25 mg filmcoated tablets; Saroten and associated names 25 mg prolonged-release capsules, hard; Saroten and associated names 50 mg prolonged-release capsules, hard; Saroten and associated names 50 mg filmcoated tablets]
Slovenian: <[Saroten in povezana imena 10 mg filmsko obložene tablete; Saroten in povezana imena 25 mg filmsko obložene tablete; Saroten in povezana imena 25 mg trde kapsule s podaljšanim sproščanjem;
English: • thyroid disease
Slovenian: • hudo bolezen jeter
English: • drowsiness
Slovenian: • omotičnost
English: <[Saroten and associated names 75 mg, modified release tablets] The score line facilitates breaking of the retard tablet into 3 equal doses.
Slovenian: <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem] Razdelilna zareza olajša lomljenje tablete s prirejenim sproščanjem na 3 enake dele.
English: Initially 50 mg daily in the evening.
Slovenian: Začetni odmerek je 50 mg na dan zvečer.
English: The active substance is amitriptyline.
Slovenian: Učinkovina je amitriptilinijev klorid.
English: • congested nose.
Slovenian: • agresivnost • zamašen nos
English: Very common Orthostatic hypotension.
Slovenian: Žilne bolezni zelo pogosti ortostatska hipotenzija občasni hipertenzija neznana pogostnost hipertermija
English: Further treatment with oral formulation:
Slovenian: Nadaljevanje zdravljenja s peroralno obliko
English: Allergic inflammation of the pulmonary alveoli and of the lung tissue, respectively (alveolitis, Löffler's syndrome).
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti zamašen nos zelo redki alergijsko vnetje pljučnih alveolov ali pljučnega tkiva (alveolitis, Loefflerjev sindrom)
English: What you need to know before you are given X
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo X Zdravila X ne boste prejeli:
English: Weight decreased.
Slovenian: Zmanjšano delovanje jeter
English: Patency of the airway is maintained by intubation, where required.
Slovenian: Če je potrebno, je treba vzdrževati prehodnost dihal z intubacijo.
English: The recommended dose is:
Slovenian: Priporočeni odmerki za otroke:
English: • tinnitus
Slovenian: • navzea
English: Sympathomimetic agents: Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants).
Slovenian: izoprenalina, noradrenalina, fenilefrina in fenilpropanolamina (npr. vsebovanih v lokalnih in splošnih anestetikih in nosnih dekongestivih).
English: • Chronic tension type headache prophylaxis
Slovenian: • preprečevanje kroničnega glavobola tenzijskega tipa
English: Rare (> 1/10,000, < 1/1,000);
Slovenian: Redki (≥ 1/10.000, < 1/1.000);
English: • decreased heart rate
Slovenian: • poslabšanje srčnega popuščanja
English: • Depression in adults (major depressive episodes)
Slovenian: To zdravilo se uporablja za zdravljenje: • depresije pri odraslih (hude depresivne epizode)
English: Recommended doses are 25 mg - 75 mg in the evening.
Slovenian: Priporočeni odmerki so 25 mg - 75 mg zvečer.
English: Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility.
Slovenian: Antiholinergični simptomi: midriaza, tahikardija, zastajanje urina, suhe sluznice, upočasnjeno gibanje črevesja, konvulzije, zvišana telesna temperatura, nenadni pojav depresije osrednjega živčevja,
English: PHARMACEUTICAL FORM [To be completed nationally] <[Saroten and associated names 50 mg film-coated tablets] The tablet can be divided into 4 equal doses.>
Slovenian: <[Saroten in povezana imena 50 mg filmsko obložene tablete] Tableta se lahko deli na 4 enake odmerke.>
English: • medicine to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
Slovenian: diltiazem in verapamil), gvanetidin, betanidin, klonidin, reserpin in metildopa
English: Your doctor will advise you whether to start/continue/stop breast-feeding, or stop using this medicine taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Slovenian: Glede na razmerje med koristmi dojenja za vašega otroka in koristmi zdravljenja za vas vam bo zdravnik svetoval, ali naj začnete/nadaljujete/prenehate z dojenjem ali pa prenehate uporabljati to zdravilo.
English: Neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine prophylaxis
Slovenian: Nevropatska bolečina, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene
English: Potential for amitriptyline to affect other medicinal products Contraindicated combinations
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možnost vpliva amitriptilina na delovanje drugih zdravil Kontraindicirane kombinacije
English: The duration of treatment is decided by your doctor.
Slovenian: Zdravnik se bo odločil, kako dolgo bo trajalo zdravljenje.
English: The dose may be increased depending on individual patient response and tolerability.
Slovenian: Glede na odziv posameznega bolnika in prenašanje zdravila, se odmerek lahko povečuje.
English: • shakiness of hands or other body parts
Slovenian: • zaspanost/dremavost • tresenje rok ali drugih delov telesa
English: Dose increase
Slovenian: Priporočeni odmerek
English: • fatigue
Slovenian: • omotico
English: Elderly (above 65 years of age) and patients with cardiovascular disease The recommended initial dose is 25 mg in the evening.
Slovenian: Starejši (stari več kot 65 let) in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 25 mg zvečer.
English: Elderly patients over 65 years of age and patients with cardiovascular disease Initially 25 mg in the evening.
Slovenian: Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Začetni odmerek je 25 mg zvečer.
English: Recommended doses are 25 mg - 75 mg daily in the evening.
Slovenian: Priporočeni odmerki so 25 mg - 75 mg na dan zvečer.
English: Elderly patients over 65 years of age and patients with cardiovascular disease Initially 10 mg - 25 mg daily.
Slovenian: Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Začetni odmerek je10 mg - 25 mg.
English: <[Saroten and associated names prolonged-release capsules, hard ] Excipients
Slovenian: <[Saroten in povezana imena trde kapsule s podaljšanim sproščanjem]
English: • thyroid medication.
Slovenian: • zdravila za zdravljenje bolezni ščitnice.
English: Very common Weight increased.
Slovenian: a so dosti bolj šibki.
English: • Chronic tension type headache prophylaxis in adults
Slovenian: • nevropatske bolečine pri odraslih • preprečevanje kroničnega glavobola tenzijskega tipa pri odraslih
English: If a dose of X is missed Make a new appointment for an injection with your physician.
Slovenian: metabolna acidoza, hipokaliemija Če je bil odmerek zdravila X izpuščen Z zdravnikom se dogovorite za nov datum za injiciranje zdravila.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN [izpolni država članica]
English: Adults The recommended initial dose is 10 mg - 25 mg in the evening.
Slovenian: Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
English: • Migraine prophylaxis
Slovenian: • preprečevanje migrene
English: Elderly patients over 65 years of age and patients with cardiovascular disease A starting dose of 10 mg - 25 mg in the evening is recommended.
Slovenian: Starejši bolniki, stari več kot 65 let in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
English: e.g.:
Slovenian: EKG).
English: What X contains
Slovenian: Zdravilo X vsebuje natrij
English: Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation).
Slovenian: Srčni simptomi: aritmije (ventrikularne tahiaritmije, torsade de pointes, ventrikularna fibrilacija), na EKG se vidi značilno podaljšanje intervala PR, razširitev kompleksa QRS, podaljšanje intervala QT,
English: Elderly (above 65 years of age) and patients with cardiovascular disease The recommended initial dose is 10 mg - 25 mg in the evening.
Slovenian: Starejši (stari več kot 65 let) in bolniki s srčno-žilno boleznijo Priporočeni začetni odmerek je 10 mg - 25 mg zvečer.
English: Depending on your response to the medicine, your doctor may increase the dose to 100 mg.
Slovenian: Glede na vaš odziv na zdravilo lahko zdravnik odmerek postopno poveča do 100 mg zvečer.
English: Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability.
Slovenian: Pri tem je treba skrbno spremljati klinični odziv in znake morebitnega neprenašanja zdravila.
English: Amitriptyline
Slovenian: OVOJNINAH AMPULA
English: The effects in overdose will be potentiated by simultaneous ingestion of alcohol and other psychotropic.
Slovenian: Sočasno uživanje alkohola in drugih psihotropnih snovi okrepi učinke prevelikega odmerka.
English: Reproductive system and breast disorders
Slovenian: Organski sistemi po MedDRA
English: Carton/Label
Slovenian: PODATKI V BRAILLOVI PISAVI
English: • the prophylactic treatment of chronic tension type headache (CTTH) in adults
Slovenian: • preprečevanje kroničnega glavobola tenzijskega tipa pri odraslih • preprečevanje migrene pri odraslih
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Te spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so izid postopka arbitraže.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla/nalepka
English: Micturition disorders.
Slovenian: - Navodilo shranite.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] BATCH NUMBER
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: PHARMACEUTICAL FORM [To be completed nationally] <[Saroten and associated names 75 mg, modified release tablets] The tablet can be divided into 3 equal doses .>
Slovenian: <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem] Tableta se lahko deli na 3 enake odmerke.>
English: Weakened patients with cerebral or cardiac impairment, as well as patients with poor circulation, breathing problems, impaired liver function or advanced renal impairment a dose reduction is recommended.
Slovenian: težavami z dihanjem, okvaro jeter ali napredovalo okvaro ledvic se priporoča zmanjšanje odmerka.
English: • antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), and bupropion)
Slovenian: • antidepresivi (npr. selektivni zaviralci ponovnega privzema serotonina (SSRI) (fluoksetin,
English: Common side effect, may affect up to 1 in 10 people.
Slovenian: Pogost neželeni učinek; pojavi se lahko pri največ 1 od 10 bolnikov.
English: Cardiomyopathies, torsades de pointes.
Slovenian: NMDA v osrednjem živčevju in hrbtenjači.
English: What X contains <[Saroten and associated names prolonged-release capsules, hard ] The active substance is amitriptyline.>
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X <[Saroten in povezana imena trde kapsule s podaljšanim sproščanjem] Učinkovina je amitriptilin.> <[Saroten in povezana imena 75 mg tablete s prirejenim sproščanjem]
English: Antifungals such as fluconazole (CYP2C9 inhibitor) and terbinafine (CYP2D6 inhibitor) have been observed to increase serum levels of amitriptyline and nortriptyline.
Slovenian: (zaviralec CYP2D6), povečajo ravni amitriptilina in nortriptilina v serumu.
English: Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline.
Slovenian: Če ste prejeli velike odmerke amitriptilina, se lahko pojavijo motnje srčnega ritma in hipotenzija.
English: Tricyclic antidepressants (TCA) including amitriptyline are primarily metabolised by the hepatic cytochrome P450 isozymes CYP2D6 and CYP2C19, which are polymorphic in the population.
Slovenian: CYP2D6 in CYP2C19 jetrnega citokroma P450, ki sta v populaciji polimorfna.
English: • the prophylactic treatment of migraine in adults
Slovenian: • zdravljenje hude depresije pri odraslih
English: Symptoms of overdose include: dilated pupils fast or irregular heartbeats difficulties passing water dry mouth and tongue intestinal blockage fits fever agitation confusion hallucinations uncontrolled movements low blood pressure, weak pulse, pallor difficulty breathing blue discolouration of the skin decreased heart rate drowsiness loss of consciousness coma various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.
Slovenian: Srčne bolezni zelo pogosti palpitacije, tahikardija pogosti atrioventrikularni blok, kračni blok občasni kolaps, poslabšanje srčnega popuščanja redki aritmija zelo redki kardiomiopatije, torsade de pointes neznana pogostnost preobčutljivostni miokarditis
English: • liver function impairment (e.g. cholestatic liver disease).
Slovenian: • okvara jeter (npr. holestaza jeter)
English: • nausea
Slovenian: • kolaps
English: What X looks like and contents of the pack [To be completed nationally].
Slovenian: Izgled zdravila X in vsebina pakiranja
English: Saroten and associated names is indicated for: • the treatment of major depressive disorder in adults
Slovenian: Učinkovitost in varnost amitriptilina je bila dokazana pri zdravljenju naslednjih indikacij pri odraslih: • huda depresija
English: Uncommon Hepatic impairment (e.g. cholestatic liver disease).
Slovenian: Bolezni jeter, žolčnika in žolčevodov občasni okvara jeter (npr. holestaza jeter)
English: The CYP3A4 and CYP1A2 isozymes metabolise amitriptyline to a lesser extent.
Slovenian: Amitriptilin se v manjši meri presnavlja z izoencimoma CYP3A4 in CYP1A2.
English: This medicine is used to treat:
Slovenian: Zdravljenje naslednjih stanj se razlikuje od primera do primera:
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni tinitus
English: excitement, anxiety, difficulties sleeping, nightmares convulsions tinnitus increased blood pressure diarrhoea, vomiting skin rash, nettle rash (urticarial), swelling of the face and tongue difficulties passing urine increased production of breast milk or breast milk outflow without breast feeding increased pressure in the eye ball collapse conditions worsening of cardiac failure liver function impairment (e.g. cholestatic liver disease)
Slovenian: Psihiatrične motnje zelo pogosti agresivnost pogosti stanje zmedenosti, zmanjšan libido, agitacija občasni hipomanija, manija, anksioznost, nespečnost, nočne more redki delirij (pri starejših bolnikih), halucinacije (pri bolnikih s shizofrenijo), samomorilne misli ali vedenje*
English: Rare: may affect up to 1 in 1,000 people decreased appetite delirium (especially in elderly patients), hallucinations (especially in patients with schizophrenia), abnormality in the heart's rhythm, or heartbeat pattern swelling of the salivary glands hair loss increased sensitivity to sunlight breast enlargement in men fever weight loss abnormal results of liver function tests
Slovenian: Psihiatrične motnje zelo pogosti agresivnost pogosti stanje zmedenosti, zmanjšan libido občasni hipomanija, manija, anksioznost, nespečnost, nočne more redki delirij (pri starejših bolnikih), halucinacije (pri bolnikih s shizofrenijo), samomorilne misli ali vedenje*
English: Give 50 g of charcoal if within one hour of ingestion.
Slovenian: V prvi uri po zaužitju se da 50 g aktivnega oglja.
English: • absent sensation of appetite
Slovenian: • zmanjšanje apetita
English: What you need to know before you take X
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo X Kako jemati zdravilo X
English: Uncommon Collapse conditions, worsening of cardiac failure.
Slovenian: Samomorilne misli in poslabšanje depresije
English: Treatment 1.
Slovenian: dostopa.
English: Neuropathic pain, chronic tension type headache and migraine prophylaxis It might take a few weeks before your feel any improvement of your pain.
Slovenian: Nevropatska bolečina, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene pri odraslih Pri vsakem posameznem bolniku je treba odmerek titrirati do odmerka, ki zagotavlja ustrezno analgezijo z neželenimi učinki na zdravilo, ki jih še lahko prenaša.
English: • methylphenidate (used to treat ADHD)
Slovenian: • metilfenidat (uporablja se za zdravljenje motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD))
English: • children aged 6 to 10 years: 10 mg - 20 mg. A suitable dosage form should be used for this age group.
Slovenian: • otroci, stari od 6 do 10 let: 10 mg - 20 mg.
English: It is important that you read this card carefully.
Slovenian: Pomembno je, da kartico natančno preberete.
English: 1 PRAC recommendations issued on 11 February 2016
Slovenian: 1 Priporočila odbora PRAC, izdana 11. februarja 2016
English: Tysabri was authorised in the European Union in June 2006.
Slovenian: Zdravilo Tysabri je bilo v Evropski uniji odobreno junija 2006.
English: Healthcare professionals should follow these recommendations:
Slovenian: Zdravstveni delavci naj sledijo naslednjim priporočilom:
English: • If you have any questions or concerns, speak to your doctor, nurse or pharmacist.
Slovenian: • Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.