FrancophonIA/ELRC3.0 huggingface dataset:
English: The text differed among MAHs, but the recommendation of baseline assessment and monitoring of growth was common to most products.
Slovenian: Besedila se razlikujejo med imetniki dovoljenj za promet z zdravilom, vendar je pri večini zdravil prisotno priporočilo o izhodiščnem vrednotenju ter spremljanju rasti.
English: Dose titration
Slovenian: Titracija odmerka
English: Long-term use (more than 12 months) in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Slovenian: Dolgotrajna uporaba (več kot 12 mesecev) pri otrocih in mladostnikih Varnosti in učinkovitosti dolgotrajne uporabe metilfenidata niso sistematično ovrednotili v nadzorovanih preskušanjih.
English: 5, 10, 20 mg - tablet 10, 20, 30, 40 - prolongedrelease capsule, hard
Slovenian: 5, 10, 20 mg - tableta 10, 20, 30, 40 - kapsula s prirejenim sproščanjem, trda
English: 11.56 mg Tablet
Slovenian: 11,56 mg Tableta
English: The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate.
Slovenian: Učinkovina se nahaja v ovojnici, ki se ne absorbira in je namenjena zagotavljanju nadzorovane hitrosti sproščanja učinkovine.
English: Caution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure (see also sections on cardiovascular and cerebrovascular conditions in Section 4.4 Warnings and Precautions for use)
Slovenian: Uporaba metilfenidata z zdravili, ki zvišajo krvni tlak Pri bolnikih, ki se zdravijo z metilfenidatom in katerimkoli zdravilom, ki lahko tudi zviša krvni tlak, je potrebna previdnost (glejte tudi poglavja o srčnožilnih in možganskožilnih boleznih v poglavju 4.4).
English: Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.
Slovenian: Pri tistih, ki imajo dodatne dejavnike tveganja (kot so srčnožilne bolezni v pretekli anamnezi ali sočasno jemanje drugih zdravil, ki zvišajo krvni tlak), pa je treba pri vsakem obisku po uvedbi zdravljenja z metilfenidatom opraviti pregled, da ugotovite morebitne nevrološke znake ali simptome.
English: Most frequently reported psychiatric adverse events of interest from spontaneous reports were abnormal behaviour, abnormal thinking, anger, hostility, aggression, agitation, tic, irritability, anxiety, crying, depression, somnolence, aggravated ADHD, psychomotor hyperactivity, emotional disorder, anger, nervousness, psychotic disorder, mood swings, morbid thoughts, obsessive-compulsive disorder, personality change/disorder, restlessness, confusional state, hallucinations, lethargy, paranoia and suicidality.
Slovenian: Najpogosteje poročani zanimivi psihiatrični neželeni učinki v spontanih poročilih so bili nenormalno vedenje, nenormalne misli, jeza, sovražnost, nasilje, agitiranost, tik, razdražljivost, anksioznost, jok, depresija, nespečnost, poslabšanje motnje ADHD, psihomotorična hiperaktivnost, čustvena motnja, jeza, živčnost, psihotična motnja, spremembe razpoloženja, morbidne misli, obsesivno-kompulzivna motnja, sprememba/motnja osebnosti, nemirnost, zmedenost, halucinacije, letargija, paranoja in samomorilnost.
English: Patients on long-term therapy (i.e. over 12 months) must have careful ongoing monitoring according to the guidance in sections 4.2 and 4.4. for cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric disorders.
Slovenian: Bolnike na dolgoročni terapiji (tj. več kot 12 mesecev) je treba skrbno neprekinjeno spremljati, zlasti srčnožilno stanje, rast, tek, razvoj de novo ali poslabšanje predhodno obstoječih psihiatričnih simptomov.
English: On going studies on sex maturation will also provide new data in this aspect.
Slovenian: Nove podatke s tega področja bodo dale tudi tekoče raziskave o spolnem zorenju.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS
Slovenian: POGOJI DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: {The MA Holder should describe the dose conversion (between formulations) and the dose titration steps that are relevant to the formulation and strength of their own methylphenidate product, in each methylphenidate SPC in the EU}
Slovenian: [Imetnik dovoljenja za promet mora opisati postopke zamenjave (med farmacevtskimi oblikami ) in titracije odmerkov, ki so pomembni pri farmacevtskih oblikah in jakostih njegovega zdravila z metilfenidatom, v vsakem SmPC z metilfenidatom v EU]
English: Methylphenidate may lower the convulsive threshold in patient with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities.
Slovenian: Metilfenidat je treba uporabljati previdno pri bolnikih z epilepsijo, saj bi lahko znižal prag za nastanek konvulzij pri bolnikih, ki imajo epileptične napade v anamnezi, pri tistih s predhodnimi motnjami EEG brez epileptičnih napadov, in redko tudi pri tistih, ki v anamnezi nimajo konvulzij ali motenj v EEG.
English: Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period.
Slovenian: Če se v času enega meseca po ustrezni prilagoditvi odmerka simptomi ne izboljšajo, je treba zdravljenje s tem zdravilom ukiniti.
English: A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with ADHD with symptoms that may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal electoencephalograpy (EEG).
Slovenian: Program celovitega zdravljenja navadno vključuje psihološke, izobraževalne in socialne ukrepe ter tudi zdravljenje z zdravili in je usmerjen k uravnoteženju otrok, ki imajo motnje pozornosti s hiperaktivnostjo in simptome, ki lahko vključujejo kronično anamnezo kratkotrajne pozornosti, raztresenosti, čustvene labilnosti, impulzivnosti, zmerne do hude hiperaktivnosti, blagih nevroloških znakov in neobičajne elektroencefalografije (EEG).
English: DE - Germany Alfred E.Tiefenbacher GmbH & Co.KG Van-der-Smissen-Str. 1
Slovenian: DE - Nemčija Alfred E.Tiefenbacher GmbH & Co.KG
English: Methylphenidate is not licensed for use in adults in ADHD.
Slovenian: Metilfenidat ni indiciran za uporabo pri odraslih z ADHD.
English: Methylphenidate treatment does not need to be indefinite.
Slovenian: Ni potrebe, da je zdravljenje z metilfenidatom neomejeno.
English: DE - Germany Novartis Pharma GmbH D-90327 Nuernberg
Slovenian: DE - Nemčija Novartis Pharma GmbH D-90327 Nuernberg
English: There is little evidence to suggest that patients at higher risk can be identified and the initial onset of symptoms may be the first indication of an underlying clinical problem.
Slovenian: Pogosto je lahko šele začetni pojav simptomov prvi znak obstoječih kliničnih težav.
English: Pharmacokinetic interaction
Slovenian: Farmakokinetične interakcije
English: This medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine
Slovenian: To zdravilo vsebuje saharozo in ga ne smejo jemati bolniki z redkimi dednimi motnjami fruktozne intolerance, malabsorpcije glukoze in galaktoze ter pomanjkanja saharaze oz. izomaltaze.
English: Signs of overdose may include: vomiting, agitation, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling of extreme happiness, confusion (severe confusion), hallucinations (seeing, feeling or hearing things that are not real), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or irregular), high blood pressure, dilated pupils and dry nose and mouth.
Slovenian: Znaki prevelikega odmerjanja so lahko: bruhanje, vznemirjenost, tresavica, povečani neobvladljivi gibi, trzanje mišic, napadi (lahko jim sledi koma), občutek pretirane sreče, zmedenost (huda zmedenost), halucinacije (videti, čutiti ali slišati stvari, ki niso resnične), znojenje, rdečica, glavobol, povišana telesna temperatura, spremembe v bitju srca (počasno, hitro ali neredno), visok krvni tlak, razširjene zenice, suha usta in nos.
English: Renal or hepatic insufficiency There is no experience with the use of methylphenidate in patients with renal or hepatic insufficiency.
Slovenian: Ledvična ali jetrna insuficienca Pri bolnikih z ledvično ali jetrno insuficienco ni izkušenj z uporabo metilfenidata.
English: Psychiatric disorders to monitor for are described below, and include (but are not limited to) motor or vocal tics, aggressive or hostile behaviour, agitation, anxiety, depression, psychosis, mania, delusions, irritability, lack of spontaneity, withdrawal and excessive perseveration.
Slovenian: Psihiatrične motnje, na katere je treba biti pozoren, so navedene spodaj in vključujejo na primer motorične ali govorne tike, nasilno ali sovražno vedenje, razdražljivost, tesnobo, depresijo, psihozo, manijo, privide, pomanjkanje spontanosti, umik vase in pretirano perseveracijo.
English: Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity.
Slovenian: Ob odtegnitvi zdravila je potreben skrben nadzor, saj se ob tem lahko razkrijeta depresija in tudi dolgotrajna prevelika aktivnost.
English: DK - Denmark UCB Nordic A/S Arne Jacobsen Allé 15, DK-2300 Kobenhavn S Denmark
Slovenian: DK - Danska UCB Nordic A/S Arne Jacobsen Allé 15, DK-2300 Kobenhavn S Denmark
English: In addition the MAHs have committed to perform drug utilisation studies (DUS) in all EU MS to investigate the level of misuse, as requested by the CHMP.
Slovenian: Poleg tega je CHMP od imetnikov dovoljenj za promet z zdravilom zahteval, da so se zavezali k izvedbi študij rabe zdravila v vseh državah članicah EU, da se ugotovi raven zlorabe.
English: Johnson & Johnson d.o.o.
Slovenian: SI - Slovenija Johnson & Johnson d.o.o.
English: DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
Slovenian: DE - Nemčija UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
English: Methylphenidate treatment should not and need not, be indefinite.
Slovenian: Zdravljenje z metilfenidatom ne sme biti pretirano dolgo in tudi ni potrebe, da bi bilo.
English: IS
Slovenian: NL
English: Peripheral coldness and Raynaud's phenomenon are also listed as possible reactions in section 4.8 of some of the SPCs for methylphenidate.
Slovenian: V poglavju 4.8 nekaterih povzetkov glavnih značilnosti zdravila sta za metilfenidat kot možni reakciji navedena tudi periferna hladnost in Raynaudov fenomen.
English: DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
Slovenian: DE - Nemčija UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim Germany
English: Furthermore, the results of the ongoing studies focusing on this issue, once available, will be submitted for assessment as requested by the CHMP (see Annex IV).
Slovenian: Poleg tega je CHMP zahteval, da se rezultati tekočih študij, ki se osredotočajo na to vprašanje, predložijo v vrednotenje, ko bodo na voljo (glejte Dodatek IV).
English: If surgery is planned, methylphenidate treatment should not be used on the day of surgery.
Slovenian: Če je načrtovan kirurški poseg, naj bolnik na dan posega ne vzame metilfenidata.
English: Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy, repetitive behaviours, over-focussing, Not known: delusions*, thought disturbances*, confusional state
Slovenian: Zelo redki: poskus samomora (vključno z izvedenim samomorom)*, prehodno depresivno razpoloženje*, neobičajno mišljenje, apatija, ponavljajoče vedenje, pretirano osredotočanje Neznani: blodnje*, motnje mišljenja*, stanje zmedenosti
English: Janssen-Pharmaceutica N.V. Tumhoutseweg 30
Slovenian: Janssen-Pharmaceutica N.V.
English: • Assessing psychiatric symptoms, each time your dose in changed and then at least every six months or at every visit.
Slovenian: • ocena psihiatričnih simptomov ob vsaki spremembi odmerka in nato vsaj vsakih šest mesecev ali ob vsakem obisku.
English: • Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
Slovenian: • diagnoza ali anamneza hude depresije, nervozne anoreksije/motenj prehranjevanja, samomorilnih nagnjenj, psihotičnih simptomov, resnih vedenjskih motenj, manije, shizofrenije, psihopatske oz. mejne (čustveno neuravnovešene) osebnostne motnje,
English: If such sideeffects occur it may be dangerous to perform any hazardous activities, such as driving, operating machinery, riding a bike or climbing trees until you are certain that you or your child will not be affected.
Slovenian: Dokler niste prepričani, da vas ali vašega otroka ti neželeni učinki ne bodo prizadeli, je lahko izvajanje dejavnosti, kot so vožnja, upravljanje strojev, vožnja kolesa ali plezanje na drevesa, nevarno.
English: The MAHs undertook the commitment to investigate the feasibility of a long term study on the children development and to provide a study protocol, as requested by the CHMP.
Slovenian: CHMP je od imetnikov dovoljenj za promet z zdravilom zahteval, da so se zavezali k ugotovitvi izvedljivosti dolgoročne študije o razvoju otrok ter predložitvi protokola študije.
English: The MAHs should closely monitor reports of cyanosis in future PSURs, including them as terms for targeted follow-up.
Slovenian: V prihodnjih rednih poročilih o varnosti zdravila morajo imetniki dovoljenj za promet z zdravilom natančno spremljati poročilo o cianozi ter ta izraz vključiti v ciljano sledenje.
English: ET - Estonia Johnson & Johnson UAB, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Slovenian: ET - Estonija Johnson & Johnson UAB, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: ANEKS III SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritis, rashes and eruptions
Slovenian: Občasni: preobčutljivostne reakcije, kot so angionevrotski edem, anafilaktične reakcije, zatekanje ušes, bulozna stanja, eksfoliativne bolezni, urtikarije, pruritus, izpuščaji in erupcije
English: If manic or psychotic symptoms occur, consideration should be given to a possible causal role for methylphenidate, and discontinuation of treatment may be appropriate.
Slovenian: Če se pri bolniku pojavijo manični ali psihotični simptomi, je treba upoštevati možnost vzročne povezanosti njihovega pojava z jemanjem metilfenidata in po potrebi prekiniti zdravljenje z njim.
English: Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate.
Slovenian: Zaradi možnosti pojava ali poslabšanja tikov, je treba bolnike, med zdravljenjem z metilfenidatom, redno spremljati.
English: During the procedure the MAHs have been requested to submit data from spontaneous reports.
Slovenian: 2.1.b Podatki iz spontanih poročil Med postopkom so bili imetniki dovoljenj za promet z zdravilom naprošeni, da predložijo podatke iz spontanih poročil.
English: Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
Slovenian: Zdravljenje je treba uvesti pod nadzorom zdravnika specialista s področja zdravljenja vedenjskih motenj pri otrocih in/ali mladostnikih.
English: AT - Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
Slovenian: AT - Avstrija Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
English: LT - Lithuania UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Slovenian: LT - Litva UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania
English: FR - France Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal
Slovenian: FR - Francija Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal
English: Pre-treatment screening:
Slovenian: Presejalno testiranje pred zdravljenjem
English: Growth
Slovenian: Rast
English: The MAHs should harmonise the relevant wording of the Package Leaflet by reflecting the changes proposed in the SPC.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo uskladiti zadevno besedilo navodila za uporabo tako, da odraža spremembe, ki so predlagane v povzetku glavnih značilnosti zdravila.
English: Foetal toxicity (i.e. total litter loss) and maternal toxicity was noted in rats at maternally toxic doses.
Slovenian: Pri odmerkih, ki so toksični za mater, so pri podganah opazili toksičnost za plod (to je popolna izguba ploda) in toksičnost za mater.
English: LV - Latvia UAB Johnson & Johnson, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Slovenian: LV - Latvija UAB Johnson & Johnson, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania
English: The PI for all methylphenidate-containing products have warnings related to this point in section 4.4 of the SPC.
Slovenian: Navodila za uporabo vseh zdravil, ki vsebujejo metilfenidat, imajo opozorila v zvezi s tem področjem v poglavju 4.4 povzetkov glavnih značilnosti zdravila.
English: Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months.
Slovenian: Krvni tlak in frekvenco pulza je treba zabeležiti v kartoteko ob vsaki prilagoditvi odmerka ter nato najmanj vsakih 6 mesecev.
English: HOW TO <TAKE> <USE> methylphenidate
Slovenian: KAKO <JEMATI> <UPORABLJATI> metilfenidat
English: Infections and infestations Common: Nasopharyngitis
Slovenian: Infekcijske in parazitske bolezni Pogosti: nazofaringitis
English: <Always <take> <use> methylphenidate exactly as your doctor has told you.
Slovenian: <Pri <jemanju> <uporabi> metilfenidata natančno upoštevajte zdravnikova navodila.
English: Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible discontinuation of methylphenidate.
Slovenian: Lahko bo potrebno zdravljenje osnovne psihiatrične motnje in morda tudi prekinitev zdravljenja z metilfenidatom.
English: (10 mg - tablet) mg, 30 mg, 40 mg - modifiedrelease capsule, hard)
Slovenian: (10 mg - tableta) (20 mg, 30 mg, 40 mg - kapsula s prirejenim sproščanjem, trda)
English: BE - Belgium JANSSEN CILAG N.V. Roderveldlaan, 1
Slovenian: BE - Belgija JANSSEN CILAG N.V.
English: Choice of methylphenidate formulation
Slovenian: Izbira farmacevtske oblike metilfenidata
English: Treatment There is no specific antidote to methylphenidate overdosage.
Slovenian: Zdravljenje Za preveliko odmerjanje metilfenidata ni specifičnega antidota.
English: In addition the results of the ongoing studies focusing on this issue, once available, will be submitted for assessment as requested by the CHMP (see Annex IV).
Slovenian: Ravno tako je CHMP zahteval, da se rezultati tekočih študij, ki se osredotočajo na to vprašanje, predložijo v vrednotenje, ko bodo na voljo (glejte Dodatek IV).
English: Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes.
Slovenian: Pri bolnikih s spremembami vedenja naj zdravnik oceni potrebo po prilagoditvi sheme zdravljenja.
English: AT - Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
Slovenian: AT - Avstrija Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
English: Uncommon: psychotic disorders*, auditory, visual, and tactile hallucinations*, anger, suicidal ideation*, mood altered, mood swings, restlessness, tearfulness, tics*, worsening of pre-existing tics or Tourette's syndrome*, hypervigilance, sleep disorder Rare: mania*, disorientation, libido disorder
Slovenian: Občasni: psihotične motnje*, slušne, vidne in tipne halucinacije*, jeza, samomorilni naklepi*, sprememba razpoloženja, nihanje razpoloženja, nemir, jokavost, tiki*, poslabšanje predhodno obstoječih tikov ali Tourettovega sindroma*, hipervigilnost, motnja spanja Redki: manija*, zmedenost, motnja libida
English: Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Slovenian: Na voljo mora biti intenzivna nega za ohranjanje zadostne prekrvavitve in izmenjave plinov v dihalih.
English: Skin and subcutaneous tissue disorders Common: alopecia, pruritus, rash, urticaria Uncommon: angioneurotic oedema, bullous conditions, exfoliative conditions Rare: hyperhidrosis, macular rash, erythema Very rare: erythema multiforme, exfoliative dermatitis, fixed drug eruption
Slovenian: Občasni: angionevrotski edem, bulozna stanja, eksfoliativne bolezni Redki: hiperhidroza, makularni izpuščaj, eritem Zelo redki: multiformni eritem, eksfoliativni dermatitis, z jemanjem zdravil povezana erupcija
English: Patient age, the presence of risk factors for substance use disorder (such as co-morbid oppositionaldefiant or conduct disorder and bipolar disorder), previous or current substance abuse should all be taken into account when deciding on a course of treatment for ADHD.
Slovenian: Pri odločitvi glede poteka zdravljenja ADHD je torej treba upoštevati starost bolnika, prisotnost dejavnikov tveganja za jemanje drog (na primer sočasnega nasprotovalnega in kljubujočega vedenja, drugih vedenjskih motenj in bipolarne motnje) ter predhodno ali sedanjo zlorabo drog.
English: Sandoz A/S C.F. Tietgens Boulevard 40
Slovenian: DK - Danska Sandoz A/S C.F. Tietgens
English: Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Slovenian: Bolnike je treba spremljati tudi glede tveganja za ne-jemanje zdravila, za napačno uporabo ali zlorabo metilfenidata.
English: MT - Malta Janssen-Cilag International N.V. Turnhoutseweg 30
Slovenian: MT - Malta Janssen-Cilag International N.V.
English: EL - Greece LABORATORIOS RUBIO S.A. C/Industria 29 Pol. Compte de Sert 08755-Castellbisbal (Barcelona) SPAIN
Slovenian: EL - Grčija LABORATORIOS RUBIO S.A. C/Industria 29 Pol. Compte de Sert 08755-Castellbisbal (Barcelona) SPAIN
English: Consideration should be given to the exacerbation of an underlying psychiatric condition and to a possible causal role of methylphenidate treatment.
Slovenian: Pri tem mora upoštevati možnost, da je prišlo do poslabšanja osnovne psihiatrične motnje in morebitno vzročno povezanost tega pojava z jemanjem metilfenidata.
English: When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from methylphenidate.
Slovenian: Pri zdravljenju bolnikov, ki so zaužili prevelik odmerek te farmacevtske oblike, je treba upoštevati zapoznelo sproščanje metilfenidata iz nje.
English: Patients should be monitored for symptoms at every adjustment of dose, then at least every 6 months and at every visit.
Slovenian: Bolnike morate spremljati ob vsaki prilagoditvi odmerka, in nato najmanj vsakih šest mesecev ali ob vsakem obisku.
English: Cerebrovascular disorders
Slovenian: Možganskožilne bolezni
English: Known sensitivity to methylphenidate or any of the excipients
Slovenian: • Preobčutljivost za metilfenidat ali katerokoli pomožno snov,
English: Very rare: cardiac arrest, myocardial infarction Not known: supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles
Slovenian: Neznani: supraventrikularna tahikardija, bradikardija, ventrikularne ekstrasistole, ekstrasistole
English: The emergence or worsening of aggression or hostility can be caused by treatment with stimulants.
Slovenian: Zdravljenje s psihostimulanti lahko povzroči pojav ali poslabšanje agresivnega vedenja ali sovražnosti.