FrancophonIA/ELRC3.0 huggingface dataset:
English: Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age.
Slovenian: Zdravljenje z metilfenidatom ni indicirano pri vseh otrocih z ADHD in odločitev o uporabi tega zdravila mora temeljiti na zelo natančni oceni jakosti in kroničnosti otrokovih simptomov glede na otrokovo starost.
English: 2.8 Pregancy and lactation
Slovenian: 2.8 Nosečnost in dojenje
English: Pharma B.V.; Lage Mosten 33 ; 4822 NK BREDA/NL
Slovenian: ; Lage Mosten 33 ; 4822 NK BREDA/NL
English: General disorders and administration site conditions Common: pyrexia, growth retardation during prolonged use in children* Uncommon: chest pain, fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti: pireksija, zastoj v rasti pri daljši uporabi pri otrocih* Občasni: bolečina v prsih, utrujenost
English: There is a risk of sudden blood pressure increase during surgery.
Slovenian: Med kirurškim posegom bi lahko prišlo do nenadnega zvišanja krvnega tlaka.
English: Heterogeneity exists in both the availability of the different products across MS and among the product information between products.
Slovenian: Ugotovljena je heterogenost pri dostopnosti posameznih zdravil v državah članicah ter med podatki o posameznih zdravilih.
English: Methylphenidate treatment is usually discontinued during or after puberty.
Slovenian: Zdravljenje z metilfenidatom običajno ukinemo v času pubertete ali po njej.
English: Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.
Slovenian: Kronična zloraba metilfenidata lahko vodi do razvoja izrazite tolerance za zdravilo in psihološke odvisnosti, z različnimi stopnjami nenormalnega vedenja.
English: The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with {invented name} and those, which have been reported with other methylphenidate hydrochloride formulations.
Slovenian: Spodnja preglednica prikazuje vse neželene učinke (NUZ), ki so jih opazili med kliničnimi preskušanji, in spontana poročila iz postmarketinških izkušenj {lastniško ime zdravila}, vključno s tistimi, ki so bili poročani z drugimi farmacevtskimi oblikami, ki vsebujejo metilfenidatijev klorid.
English: Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.
Slovenian: Pri zdravljenju bolnikov, katerih osnovna bolezen se lahko poslabša zaradi povečanja krvnega tlaka ali srčne frekvence, je potrebna previdnost.
English: In addition the CHMP also requested that a consistent and structured approach is taken in the future for the assessment of the safety information in the Period Safety Assessment Reports (PSURs) and the Risk Management Plans.
Slovenian: Poleg tega je CHMP zahteval, da se v prihodnje izvaja dosleden in strukturiran pristop pri vrednotenju varnostnih podatkov v rednih poročilih o varnosti zdravila ter načrtih obvladovanja tveganja.
English: There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate.
Slovenian: Obstaja eno poročilo o dojencu, pri katerem je v obdobju izpostavljenosti metilfenidatu, prišlo do nespecifičnega zmanjšanja telesne mase, vendar si je, potem ko je mati prekinila zdravljenje z metilfenidatom, opomogel in pridobil na masi.
English: In the case of emergent psychiatric symptoms or exacerbation of preexisting psychiatric disorders, methylphenidate should not be given unless the benefits outweigh the risks to the patient.
Slovenian: V primeru pojavljanja psihiatričnih simptomov ali poslabšanja obstoječih psihiatričnih motenj smete zdravljenje z metilfenidatom nadaljevati le, če njegove koristi odtehtajo potencialno tveganje za bolnika.
English: Other measures to detoxify the gut include administration of activated charcoal and a cathartic.
Slovenian: Med druge ukrepe za detoksifikacijo črevesja sodi tudi uporaba aktivnega oglja in odvajala.
English: However, there are reports indicating that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g. phenobarbitol, phenytoin, primodone) and some antidepressants (tricyclics and selective serotonin reuptake inhibitors).
Slovenian: Vendar obstajajo poročila, ki kažejo, da lahko metilfenidat zavira presnovo kumarinskih antikoagulantov, antikonvulzivov (npr. fenobarbitol, fenitoin, primidon) in nekaterih antidepresivov
English: ADHD often occurs along with other (co-morbid) disorders such as oppositional defiant and conduct disorders, learning disorders, anxiety, depression, tic disorders and Tourette's syndrome.
Slovenian: ADHD se pogosto pojavlja skupaj z drugimi (komorbidnimi) motnjami, kot so motnje kljubovanja in obnašanja, motnje učenja, anksioznost, depresija, motnje s tiki in Tourettov sindrom.
English: For some high-risk substance abuse patients, methylphenidate or other stimulants may not be suitable and non-stimulant treatment should be considered.
Slovenian: Pri nekaterih bolnikih z velikim tveganjem za zlorabo drog metilfenidat in drugi stimulanti morda ne bodo primerni in boste morali uporabiti zdravljenje brez stimulantov.
English: A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4)
Slovenian: Celovita anamneza naj vključuje podatke o drugih zdravilih, ki jih bolnik sočasno jemlje, drugih sedanjih in preteklih boleznih in psihiatričnih motnjah ali simptomih ter družinski anamnezi nenadnih srčnih/nepričakovanih smrtih in natančnih vrednostih telesne višine in mase pred začetkom zdravljenja na diagramu rasti (glejte poglavji 4.3 in 4.4).
English: The analysis of the data provided by MAHs showed a highly variable effect of methylphenidate on blood pressure and heart rate.
Slovenian: Analiza podatkov, ki so jih predložili imetniki dovoljenj za promet z zdravilom, je pokazala zelo variabilen učinek metilfenidata na krvni tlak in srčni utrip.
English: Methylphenidate should not be used in children under the age of 6 years.
Slovenian: Metilfenidata ne smete uporabljati pri otrocih mlajših od 6 let.
English: The literature is conflicting with regards to the effects of methylphenidate on growth and sexual maturation.
Slovenian: Literatura vsebuje nasprotujoče si podatke o učinkih metilfenidata na rast in spolno zorenje.
English: Therefore strengthening the Product Information and giving guidance to prescribers on the correct use is necessary.
Slovenian: Zato so nujna razširitev podatkov o zdravilu in priporočila o pravilni uporabi za osebe, ki predpisujejo zdravila.
English: The CHMP therefore agreed that in order to ensure any effect on growth is minimised, improved and harmonised warnings, guidelines on monitoring (frequency of monitoring, method of measurement) and actions to take, should be implemented in the SPC and the PL.
Slovenian: CHMP se je zato strinjal, da je treba za zagotovitev čim večjega zmanjšanja učinka na rast v povzetke glavnih značilnosti zdravila in navodila za uporabo uvesti usklajena opozorila, priporočila o spremljanju (pogostost spremljanja, metoda merjenja) in ukrepe.
English: BE - Belgium NOVARTIS PHARMA N.V. Medialaan, 40
Slovenian: BE - Belgija NOVARTIS PHARMA N.V.
English: There were un-confounded cases with no underlying history of cerebrovascular disorders, reporting cerebral infarction and cerebral artery occlusion; right cerebral occlusion and cerebral ischaemic event.
Slovenian: Obstajali so primeri brez vpliva begavih spremenljivk, ki so bili brez anamneze obstoječega cerebrovaskularnega obolenja ter z navedbami cerebralnega infarkta in okluzije cerebralne arterije; desne cerebralne okluzije in cerebralnega ishemijskega dogodka.
English: Methylphenidate is associated with the onset or exacerbation of motor and verbal tics.
Slovenian: Metilfenidat so povezovali z nastankom ali poslabšanjem motoričnih in verbalnih tikov.
English: Overall, the data relating to cardiovascular risks from all clinical trials of methylphenidate-containing products showed that the events of hypertension, heart rate increases or arrhythmias (mainly tachycardia) and QT prolongation were the main cardiovascular events reported.
Slovenian: Na splošno so podatki o tveganju srčno-žilnih obolenj iz vseh kliničnih preskušanj zdravil, ki vsebujejo metilfenidat, pokazali, da so najpogosteje poročani poglavitni srčno-žilni dogodki hipertenzija, pospešen srčni utrip ali aritmije (v glavnem tahikardija) ter podaljšanje QT.
English: Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac evaluation.
Slovenian: Pri bolnikih, ki med zdravljenjem z metilfenidatom dobijo simptome, kot so palpitacije, bolečine v prsih ob naporu, nepojasnjeno sinkopo, dispnejo ali kakšne druge simptome, ki kažejo na srčno bolezen, pa morate takoj opraviti specialistični pregled srca.
English: Longstanding abuse of methylphenidate can lead to marked tolerance, psychological dependence, abnormal behaviour, psychotic episodes.
Slovenian: Dolgotrajna zloraba metilfenidata lahko vodi v izrazito odpornost, psihološko odvisnost, neobičajno vedenje, psihotične epizode.
English: The MAHs should evaluate newly identified or potential risks, or new new/important information on existing identified or potential risks, in the RMP on an ongoing basis
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo v načrtih obvladovanja tveganja redno vrednotiti novo ugotovljena ali možna tveganja ali nove/pomembne podatke o obstoječih ugotovljenih ali možnih tveganjih.
English: Furthermore, the MAHs committed to investigate the long term effect on children's development.
Slovenian: Ravno tako so se imetniki dovoljenj za promet z zdravilom zavezali k raziskovanju dolgoročnega učinka na razvoj otrok.
English: Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
Slovenian: Učinkovitost peritonealne dialize ali zunajtelesne hemodialize pri prevelikem odmerjanju metilfenidata še ni bila ugotovljena.
English: The MAHs should include, in the core safety specification, the final core table of identified and potential risks as requested by the CHMP.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo na zahtevo CHMP v osrednjo specifikacijo varnosti vključiti končno osrednjo preglednico ugotovljenih in možnih tveganj.
English: The synchronisation of the PSUR submission will facilitate a common assessment and harmonised response by the National Competent Authorities on updates of the SPC / PL and RMP.
Slovenian: Sinhronizacija predložitve rednih poročil o varnosti zdravila bo olajšala skupno vrednotenje in usklajen odziv nacionalnih pristojnih organov na posodobitve povzetka glavnih značilnosti zdravila / navodila za uporabo in načrta obvladovanja tveganja.
English: Not known: cerebrovascular disorders* (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsions*, migraine
Slovenian: Neznani: cerebrovaskularne motnje* (vključno z vaskulitisom, možganskimi krvavitvami, cerebrovaskularnimi poškodbami, možganskim arteritisom, zaporo možganske žile), generalizirani tonično-klonični krči*, migrena
English: Use with centrally acting alpha-2 agonists (e.g. clonidine) Serious, adverse events, including sudden death, have been reported in concomitant use with clonidine.
Slovenian: Uporaba s centralno delujočimi agonisti adrenergičnih receptorjev alfa-2 (npr. klonidin) Pri sočasni uporabi metilfenidata s klonidinom so poročali o resnih neželenih učinkih, vključno z nenadno smrtjo.
English: DE - Germany TAD Pharma GmbH Postfach 720
Slovenian: DE - Nemčija TAD Pharma GmbH Postfach 720
English: AT - Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75
Slovenian: AT - Avstrija Janssen-Cilag Pharma GmbH Pfarrgasse 75
English: • Phaeochromocytoma
Slovenian: • feokromocitom,
English: DK-Denmark Janssen-Cilag A/S Hammerbakken 19
Slovenian: DK - Danska Janssen-Cilag A/S Hammerbakken 19
English: Before performing gastric lavage, control agitation and seizures if present and protect the airway.
Slovenian: Preden opravite izpiranje želodca, nadzorujte bolnikovo vznemirjenost in epileptične napade, če so prisotni, in zavarujte dihalne poti.
English: Novartis Pharma B.V.; Raapopseweg 1; 6824 DP ARNHEM/NL
Slovenian: ; Raapopseweg 1; 6824 DP ARNHEM/NL
English: Overall, cardiovascular events reported were mainly of cardiac arrhythmias (including tachycardia), hypertension, cardiac arrests, ischemia, QT prolongation, with some reports of sudden death.
Slovenian: Na splošno so bili poročani srčno-žilni dogodki v glavnem srčne aritmije (vključno s tahikardijo), hipertenzija, srčni zastoji, ishemija, podaljšanje QT ter nekaj poročil nenadne smrti.
English: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products.
Slovenian: Bolniki z ADHD imajo pogosto sočasno tudi druge psihiatrične motnje, kar je treba upoštevati pri predpisovanju stimulantov.
English: DE - Germany ratiopharm GmbH D-89070 Ulm
Slovenian: DE - Nemčija ratiopharm GmbH D-89070 Ulm
English: Like all medicines, methylphenidate can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi metilfenidat neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
Slovenian: • obstoječe srčnožilne bolezni vključno s hudo hipertenzijo, srčnim popuščanjem, arterijsko okluzivno boleznijo, angino pektoris, hemodinamsko pomembno prirojeno srčno napako, kardiomiopatijami, miokardnim infarktom, potencialno življenje ogrožujočimi aritmijami in motnjami v delovanju ionskih kanalčkov,
English: Where analyses of medical history or concurrent medications were provided, these did not provide conclusive evidence of predictive risk factors for cardiovascular effects of methylphenidate.
Slovenian: Kadar so podatki vsebovali analize zdravstvene anamneze ali sočasno jemanih zdravil, ni bilo možno najti prepričljivih dokazov napovednih dejavnikov tveganja srčno-žilnih učinkov metilfenidata.
English: AT - Austria UCB Pharma GmbH Jaquingasse 16-18/3 A-1030 Wien
Slovenian: AT - Avstrija UCB Pharma GmbH Jaquingasse A-1030 Wien
English: The MAHs have committed to it.
Slovenian: Imetniki dovoljenj za promet z zdravilom so se zavezali k temu.
English: Methylphenidate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision.
Slovenian: Metilfenidat lahko povzroči omotico, zaspanost in motnje vida, vključno s težavami z akomodacijo očesa, dvojnim in zameglenim vidom.
English: Your child should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Slovenian: Vašega otroka je treba spremljati za tveganje rekreativne uporabe, napačne uporabe in zlorabe metilfenidata.
English: Drug treatment is usually discontinued during or after puberty.
Slovenian: Zdravljenje z zdravili se običajno prekine med puberteto ali po njej.
English: Recent findings from a case-control study have indicated a potentially increased risk of lymphocytic leukaemia with methylphenidate, which the MAHs were required to further evaluate.
Slovenian: Nedavna odkritja v študiji primerov in kontrol so pokazala potencialno povečano tveganje limfocitne levkemije zaradi metilfenidata, zato je bilo od imetnikov dovoljenj za promet z zdravilom zahtevano dodatno vrednotenje.
English: The MAH review of post-marketing spontaneous data found that cerebrovascular events from spontaneous reports consisted mainly of the reported terms: cerebrovascular accident, stroke, cerebral infarction and cerebral ischemia as well as a few reports of other events.
Slovenian: Imetniki dovoljenj za promet z zdravilom so pregledali podatke iz spontanih poročil v času trženja zdravil ter ugotovili, da cerebrovaskularni dogodki v teh poročilih obsegajo zlasti izraze: cerebrovaskularni insult, možganska kap, cerebralni infarkt in cerebralna ishemija ter nekaj poročil o drugih dogodkih.
English: Treatment must be under the supervision of a specialist in childhood behavioural disorders.
Slovenian: Zdravljenje mora potekati pod nadzorom specialista za motnje vedenja v otroštvu.
English: • pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Slovenian: • obstoječe cerebrovaskularne motnje, možganska anevrizma, žilne bolezni, vključno z vaskulitisom ali kapjo.
English: Common: anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children*
Slovenian: Pogosti: anoreksija, zmanjšan tek, zmerno zmanjšano pridobivanje telesne mase in višine pri daljši uporabi pri otrocih*
English: Pregnancy-embryonal/foetal development
Slovenian: Nosečnost- razvoj embria/ploda
English: Common: arrhythmia, tachycardia palpitations
Slovenian: Pogosti: aritmija, tahikardija, palpitacije
English: The MAHs submitted data supporting the position that there is no preclinical or clinical evidence for a significant carcinogenic risk associated with methylphenidate.
Slovenian: Imetniki dovoljenj za promet z zdravilom so predložili podatke, ki podpirajo stališče, da ni predkliničnih ali kliničnih dokazov za zadostno tveganje kancerogenosti, povezane z metilfenidatom.
English: Novartis s.r.o.
Slovenian: CS - Češka Novartis s.r.o.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III
Slovenian: Posledično je CHMP priporočil ohranitev dovoljenj za promet z zdravili iz Dodatka I, katerih dopolnila zadevnih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedena v Dodatku III.
English: Your doctor will decide whether you or your daughter should use methylphenidate.
Slovenian: Zato bo zdravnik odločil, ali naj vi ali vaša hči med jemanjem metilfenidata dojita.
English: Methylphenidate is indicated as a part of a comprehensive treatment programme for ADHD in children over 6 years of age where remedial measures alone prove insufficient.
Slovenian: Metilfenidat je indiciran kot del celovitega programa zdravljenja motnje ADHD pri otrocih, starejših od 6 let, kjer so zgolj ukrepi za odpravo stanja nezadostni.
English: There was no evidence from pre-clinical or clinical trial data of an increased risk of cyanosis with methylphenidate.
Slovenian: V predkliničnih podatkih in podatkih kliničnih preskušanj ni bilo dokazov o zvišanem tveganju cianoze zaradi metilfenidata.
English: Metabolism and nutritional disorders*
Slovenian: Presnovne in prehranske motnje*
English: Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD) in adolescents and children 6 years of age and over when other non pharmaceutical measures alone have proven insufficient.
Slovenian: Metilfenidat se uporablja za zdravljenje motnje pozornosti s hiperaktivnostjo (ADHD) pri mladostnikih in otrocih, starejših od 6 let, ko so se drugi nefarmacevtski ukrepi sami izkazali za nezadostne.
English: Reproductive system and breast disorders Rare: Gynaecomastia
Slovenian: Motnje reprodukcije in dojk Redki: ginekomastija
English: Careful supervision is required during withdrawal from abusive use since severe depression may occur.
Slovenian: Tudi med ukinitvijo zdravila zaradi njegove zlorabe je potreben skrben nadzor, ker lahko nastopi huda depresija.
English: Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Slovenian: Pogosti: anoreksija, čustvena labilnost, napadalnost*, vznemirjenje*, anksioznost*, depresija*, razdražljivost, neobičajno vedenje
English: If seizure frequency increases or new-onset seizures occur, methylphenidate should be discontinued.
Slovenian: Če se poveča pogostnost epileptičnih napadov ali se pojavijo novi napadi, je treba metilfenidat ukiniti.
English: • Hyperthyroidism or Thyrotoxicosis
Slovenian: • hipertireoza ali tirotoksikoza,
English: Common: abdominal pain, diarrhoea, nausea, stomach discomfort, and vomiting - {for inclusion in PL for non-modified release formulations :} “these usually occur at the beginning of treatment and may be alleviated by concomitant food intake”, Dry mouth.
Slovenian: Pogosti: bolečine v trebuhu, driska, navzeja, nelagodje v želodcu in bruhanje {vključiti v navodilo za uporabo nespremenjenih formulacij za sproščanje :} „ti se najpogosteje pojavijo na začetku zdravljenja in jih lahko olajšamo s sočasnim zaužitjem hrane“, suha usta.
English: Because the {Invented name} tablet is nondeformable and does not appreciably change in shape in the gastrointestinal (GI) tract, it should not ordinarily be administered to patients with pre-existing severe GI narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets.
Slovenian: Potencialna verjetnost zapore prebavnega trakta [izpolni država članica kot je primerno] Ker se tableta {zaščiteno ime zdravila} ne spremeni in v prebavilih bistveno ne spremeni svoje oblike, je običajno ne smemo predpisovati bolnikom z obstoječimi hudimi zožitvami v prebavilih (patološkimi ali iatrogenimi) ali bolnikom z disfagijo ali večjimi težavami pri požiranju tablet.
English: Uncommon: myalgia, muscle twitching Very rare: muscle cramps
Slovenian: Občasni: mialgija, trzanje mišic Zelo redki: mišični krči
English: ES - Spain Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
Slovenian: ES - Španija Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
English: Musculoskeletal, connective tissue and bone disorders Common: arthralgia
Slovenian: Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti Pogosti: artralgija
English: The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy.
Slovenian: Zdravnik, ki se odloči za dolgotrajno zdravljenje (dlje kot 12 mesecev) z metilfenidatom pri otroku ali mladostniku z ADHD, mora periodično s poskusnimi obdobji, ko bolnik ne jemlje zdravila, ocenjevati korist dolgotrajne uporabe zdravila za posameznega bolnika da oceni stanje bolnika, kadar ne jemlje farmakoterapije.
English: Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3 Contraindications).
Slovenian: Zaradi nevarnosti nastanka hipertenzivne krize je metilfenidat kontraindiciran pri bolnikih, ki se sočasno zdravijo z neselektivnimi, ireverzibilnimi zaviralci MAO oziroma so se z njimi zdravili 2 tedna pred tem (glejte poglavje 4.3).
English: Very rare: Anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura Unknown: Pancytopenia
Slovenian: Zelo redki: anemija, levkopenija, trombocitopenija, trombocitopenična purpura Neznani: pancitopenija