FrancophonIA/ELRC3.0 huggingface dataset:
English: These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory..
Slovenian: Med takšne simptome lahko na primer sodijo hudi glavoboli, občutek odrevenelosti, šibkost, paraliza in motnje koordinacije, vida, govora, jezika ali spomina.
English: Cardiovascular and Cerebrovascular effects
Slovenian: Učinki na srčno-žilni sistem in cerebrovaskularni sistem
English: Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.
Slovenian: Čeprav lahko nekatere resne srčne težave že same po sebi pomenijo povečano tveganje za nenadno smrt, pa uporaba stimulantnih zdravil ni priporočljiva pri otrocih ali mladostnikih z znanimi strukturnimi anomalijami srca, kardiomiopatijo, resnimi motnjami srčnega ritma ali drugimi resnimi srčnimi težavami, zaradi katerih bi bili lahko ti otroci bolj občutljivi za simpatikomimetične učinke stimulantnega zdravila.
English: 2.2 Cerebrovascular risk There was no evidence reported from pre-clinical studies in relation to this risk.
Slovenian: 2.2 Tveganje cerebrovaskularnih obolenj V zvezi s tem tveganjem v predkliničnih študijah ni bilo poročanih dokazov.
English: FI - Finland Janssen-Cilag Oy Metsänneidonkuja 8 02130 Espoo FINLAND
Slovenian: FI - Finska Janssen-Cilag Oy Metsänneidonkuja 8 02130 Espoo FINLAND
English: Methylphenidate is not considered to be teratogenic in rats and rabbits.
Slovenian: Metilfenidat ni teratogen pri podganah in kuncih.
English: Janssen-Cilag B.V.; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
Slovenian: ; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
English: In the event of Leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders, discontinuation of treatment should be considered.
Slovenian: V primeru levkopenije, trombocitopenije, anemije ali drugih sprememb, vključno z resnimi ledvičnimi in jetrnimi motnjami, po potrebi ukinite zdravljenje.
English: Methylphenidate has a well-documented effect on blood pressure and heart rate (increased pulse rate, increased blood pressure and tachycardia are recognised adverse events of methylphenidate and are listed in the product information).
Slovenian: Metilfenidat ima dobro opisan učinek na krvni tlak in srčni utrip (pospešen srčni utrip, zvišan krvni tlak in tahikardija so dokazani neželeni učinki metilfenidata in so navedeni v podatkih o zdravilu).
English: You or your child must not drink alcohol while taking this medicine as alcohol may make this medicine's side effects worse.
Slovenian: Ob jemanju tega zdravila vi ali vaš otrok ne smete piti alkohola, saj lahko alkohol poslabša neželene učinke tega zdravila.
English: This included assessment on the impact of risks of cardiovascular, cerebrovascular and psychiatric disorders on the benefit/risk balance.
Slovenian: To je obsegalo vrednotenje vpliva tveganja srčno-žilnih obolenj, cerebrovaskularnih obolenj in psihiatričnih motenj na razmerje med koristnimi učinki in tveganji.
English: The MAHs will investigate the feasibility of carrying out a meta-analysis of the risk of suicidality associated with the use of methylphenidate in children and adolescents with ADHD on the basis of the clinical trial data of methylphenidate that is currently available to the MAHs.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo raziskali izvedljivost meta-analize tveganja samomorilnosti, ki je povezana z uporabo metilfenidata pri otrocih in mladostnikih z ADHD na osnovi podatkov kliničnih preskušanj metilfenidata, s katerimi trenutno razpolagajo imetniki dovoljenj za promet z zdravilom.
English: Where possible, measures of usage including variables such as information on total amount used, patient age, gender, indication dose, duration of use, treatment continuity, comorbidities, concomitant medications, data on patterns of use, physician specialty will be used.
Slovenian: Po možnosti se uporabljajo merila uporabe, vključno s spremenljivkami, kot so podatki o skupni porabljeni količini, starosti bolnika, spolu, odmerku glede na indikacijo, trajanju uporabe, stalnosti zdravljenja, sočasnih boleznih, sočasno uporabljenih zdravilih, vzorcu uporabe ter specializaciji zdravnika.
English: There was no consistent pattern of dosage or time-to-onset from the submitted data.
Slovenian: V predloženih podatkih ni bilo opaziti doslednega vzorca odmerjanja ali časa do pojava dogodka.
English: DE - Germany HEXAL AG Postfach 1263
Slovenian: DE - Nemčija HEXAL AG Postfach 1263
English: If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage.
Slovenian: Če znaki in simptomi niso prehudi in je bolnik pri zavesti, mu lahko izpraznimo želodec s sprožanjem bruhanja ali izpiranjem želodca.
English: • mania
Slovenian: • manija;
English: The MAHs will produce fully harmonised Risk Minimisation tools that contain all of the important information from the Clinical Particulars section of the Core SPC.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo pripravili popolnoma usklajena orodja za čim večje zmanjšanje tveganja, ki bodo vsebovala vse pomembne podatke iz poglavja Klinični podatki osrednjega povzetka glavnih značilnosti zdravila.
English: DE - Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstr.8
Slovenian: DE - Nemčija Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstr.8
English: Psychiatric effects
Slovenian: Psihiatrični učinki
English: If you suffer from or have any worries about any of the the side effects below, tell your doctor or pharmacist:
Slovenian: Če trpite za katerimkoli od spodaj navedenih neželenih učinkov ali vas skrbi glede kateregakoli od le-teh, obvestite svojega zdravnika ali farmacevta:
English: Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Slovenian: Izboljšanje se namreč lahko ohrani tudi po začasni ali popolni ukinitvi zdravila.
English: In the Member States that are covered by the IMS database, the MAHs will also evaluate off-label use of methylphenidate.
Slovenian: V državah članicah, zajetih v zbirki podatkov IMS, bodo imetniki dovoljenj za promet z zdravilom ovrednotili tudi uporabo metilfenidata izven obsega indikacij.
English: The EC considered that some safety concerns, including cardiovascular and cerebrovascular disorders, potentially associated with methylphenidate treatment should be evaluated.
Slovenian: Evropska komisija je menila, da je treba ovrednotiti nekaj varnostnih zadržkov, vključno z obolenji srca in ožilja ter cerebrovaskularnimi obolenji, ki so morda povezana z zdravljenjem z metilfenidatom.
English: The conclusions of this assessment led to a CHMP proposal on strengthening and harmonising the respective Product Information of the products with the inclusion of pre- and post-treatment monitoring, updating the sections of the SPC related to the contraindications and warnings, harmonising the information on adverse reactions, checking of the posology and use, updating the information on use in pregnancy and lactation.
Slovenian: CHMP na osnovi zaključkov tega vrednotenja predlaga razširitev in uskladitev podatkov o posameznih zdravilih z vključitvijo spremljanja pred zdravljenjem in po njem, posodobitvijo poglavij povzetkov glavnih značilnosti zdravila, ki se nanašajo na kontraindikacije in opozorila, uskladitvijo podatkov o neželenih učinkih, preverjanjem odmerjanja ter uporabe, posodobitvijo podatkov o uporabi med nosečnostjo in dojenjem.
English: Due to the prolonged-release design of the tablet, {Invented name} should only be used in patients who are able to swallow the tablet whole.
Slovenian: Ker gre za obliko tablete s podaljšanim sproščanjem, smete {zaščiteno ime zdravila} uporabljati le pri bolnikih, ki lahko pogoltnejo celo tableto.
English: This only study raises a potential signal of risk of leukaemia with methylphenidate use, despite the limitations of the findings, as discussed by the authors and the MAHs.
Slovenian: Ta edina študija kaže na potencialni signal tveganja levkemije zaradi uporabe metilfenidata, vendar z omejitvami odkritij, o čemer so razpravljali avtorji in imetniki dovoljenj za promet z zdravilom.
English: In order for your doctor to decide if methylphenidate is the correct medicine for you or your child, your doctor will discuss the following with you:
Slovenian: Da se bo lahko zdravnik odločil, ali je metilfenidat pravo zdravilo za vas ali vašega otroka, se boste z njim posvetovali o sledečem:
English: • paralysis or impairment of movement and vision, difficulties in speech (could be symptoms of cerebral vasculitis).
Slovenian: • paraliza ali ovirano gibanje in oslabljen vid, motnje govora (to so lahko znaki možganskega vaskulitisa).
English: Exacerbation of pre-existing Psychotic or manic symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.
Slovenian: Poslabšanje obstoječih psihotičnih ali maničnih simptomov Pri psihotičnih bolnikih lahko uporaba metilfenidata poslabša simptome vedenjskih motenj in motenj mišljenja.
English: Methylphenidate has been available in Europe for decades for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 years and older.
Slovenian: Metilfenidat je že desetletja na voljo v Evropi za zdravljenje motnje pomanjkanja pozornosti in hiperaktivnosti (ADHD) pri otrocih, starih 6 let in več.
English: Most cerebrovascular events from clinical trials were of migraine, with a higher incidence rate in methylphenidate-treated group compared with placebo group.
Slovenian: Večino cerebrovaskularnih dogodkov v kliničnih preskušanjih je predstavljala migrena z višjo stopnjo pojavnosti v skupini, ki se je zdravila z metilfenidatom, kot v skupini, ki je prejemala placebo.
English: 2.1.a Data from clinical trials
Slovenian: 2.1.a Podatki iz kliničnih preskušanj
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The proposed follow-up duration of at least 5 years for individual subjects will be considered.
Slovenian: Pri tem bodo upoštevali predlog, da sledenje posameznemu preiskovancu traja najmanj 5 let.
English: AT - Austria Novartis Pharma GmbH Brunner Straße 59
Slovenian: AT - Avstrija Novartis Pharma GmbH Brunner Straße 59
English: The completed clinical studies presented a range of conclusions on the effects of methylphenidate on growth and sexual maturation.
Slovenian: Predložene opravljene klinične študije vsebujejo vrsto zaključkov o učinkih metilfenidata na rast in spolno zorenje.
English: Ongoing monitoring: Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
Slovenian: Ves čas je treba spremljati bolnikovo rast ter psihiatrični status in stanje srčnožilnega sistema (glejte tudi poglavje 4.4).
English: Your doctor will therefore carefully be watching you or your child's height and weight.
Slovenian: Zato bo zdravnik skrbno opazoval telesno višino in maso vas ali vašega otroka kot tudi, kako dobro se vi ali vaš otrok prehranjujete.
English: Use in children under 6 years of age
Slovenian: Uporaba zdravila pri otrocih, mlajših od 6 let
English: Analyses of data from clinical trials of methylphenidate in children and adolescents with ADHD showed that patients using methylphenidate may commonly experience changes in diastolic and systolic blood pressure of over 10 mmHg relative to controls.
Slovenian: Analiza podatkov iz kliničnih preskušanj metilfenidata pri otrocih in mladostnikih z ADHD je pokazala, da se pri bolnikih, ki uporabljajo metilfenidat, lahko pojavijo spremembe v sistoličnem ali diastoličnem krvnem tlaku glede na začetne vrednosti za več kot 10 mmHg v primerjavi s kontrolno skupino.
English: The main objective was the cardiovascular risk of the product to children but additionally other risks were also evaluated; cerebrovascular, effect on growth and long term treatment, the psychiatric risk and a potential risk of leukaemia.
Slovenian: Glavni cilj je bilo tveganje srčno-žilnih obolenj zaradi zdravila pri otrocih, vendar so bila dodatno vrednotena tudi druga tveganja: tveganje cerebrovaskularnih obolenj, vpliv na rast, vpliv dolgoročnega zdravljenja, tveganje psihiatričnih motenj ter možno tveganje levkemije.
English: Very rare: convulsions, choreo-athetoid movements, reversible ischaemic neurological deficit Neuroleptic malignant syndrome (NMS; Reports were poorly documents and in most of cases, patients were also receiving other drugs, so the role of methylphenidate is unclear).
Slovenian: Zelo redki: konvulzije (krči), horeoatetoidni gibi, reverzibilni ishemični nevrološki primanjkljaj, nevroleptični maligni sindrom (ker so v večini primerov bolniki prejemali tudi druga zdravila in ker so bila poročila slabo dokumentirana, vloga metilfenidata ni jasna).
English: Particular care should be taken in using methylphenidate to treat ADHD in patients with comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in such patients.
Slovenian: Posebna previdnost je potrebna pri uporabi metilfenidata za zdravljenje ADHD pri bolnikih s sočasno bipolarno motnjo (vključno z nezdravljeno bipolarno motnjo tipa I ali drugimi oblikami bipolarne motnje), zaradi možnosti pojava mešane ali manične epizode.
English: There was some evidence from pre-clinical studies showing an effect of methylphenidate on some growth parameters, sexual maturation and related hormones as well as on developmental toxicity.
Slovenian: Obstaja nekaj dokazov iz predkliničnih študij, ki kažejo učinek metilfenidata na nekatere rastne parametre, spolno zorenje in s tem povezane hormone ter razvojno toksičnost.
English: For that reason the CHMP requested strengthening of the Product Information giving advice on pre-treatment evaluation of the patients and on going screening and monitoring during the treatment with these products (see Annex III).
Slovenian: Zaradi tega je CHMP zahteval, da se v podatke o zdravilu dodajo priporočila za obravnavo bolnikov pred zdravljenjem ter za neprekinjeno presejanje in spremljanje med zdravljenjem s temi zdravili (glejte Dodatek III).
English: If the ADRs with {invented name} and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
Slovenian: Če so bile pogostnosti NUZ z {lastniško ime zdravila} in drugimi farmacevtskimi oblikami metilfenidata različne, je bila uporabljena višja pogostnost od obeh.
English: Psychiatric adverse events of particular interest with methylphenidate reported from clinical trials included aggression, violent behaviour, psychosis, mania, irritability and suicidality.
Slovenian: Psihiatrični neželeni učinki, ki so posebej zanimivi v zvezi z metilfenidatom in so bili poročani v kliničnih preskušanjih, so bili agresivnost, nasilno vedenje, psihoza, manija, razdražljivost in samomorilnost.
English: There is limited information that suggests that methylphenidate is passed into human breast milk.
Slovenian: Le malo podatkov nakazuje na to, da se metilfenidat prenaša v materino mleko.
English: The recently published retrospective case control review of prescription records for more than 35,000 patients did not indicate either a moderate or a strong association between methylphenidate use and cancer risk in children for any of 18 defined cancer sites.
Slovenian: Nedavno objavljen retrospektivni pregled primerov in kontrol na osnovi evidence predpisovanja metilfenidata 35 000 bolnikom v 18 opredeljenih onkoloških ustanovah ne kaže bodisi zmerne bodisi močne povezave med uporabo metilfenidata in tveganjem raka pri otrocih.
English: 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: CHMP je zahteval tudi, da se v prihodnje izvaja dosleden in strukturiran pristop pri vrednotenju podatkov o varnosti v rednih poročilih o varnosti zdravila ter načrtih obvladovanja tveganja.
English: If you stop <taking> <using> methylphenidate
Slovenian: Če ste prenehali <jemati> <uporabljati> methylphenidate
English: The safety evaluation of this procedure is mainly focussed on the following concerns potentially associated with methylphenidate treatment: cardiovascular risks, cerebrovascular risks, psychiatric disorders, carcinogenicity, effect on growth and effects of long term treatment.
Slovenian: Vrednotenje varnosti je bilo v tem postopku v glavnem osredotočeno na naslednje zadržke, ki so potencialno povezani z zdravljenjem z metilfenidatom: tveganje srčno-žilnih obolenj, tveganje cerebrovaskularnih obolenj, psihiatrične motnje, kancerogenost, učinek na rast ter učinki dolgoročnega zdravljenja.
English: In the presence of severe intoxication, a carefully titrated dose of a benzodiazepine be given before performing gastric lavage.
Slovenian: V primeru hude zastrupitve pa morate bolniku najprej dati skrbno titriran odmerek benzodiazepina, preden opravite izpiranje želodca.
English: The pre-clinical data on the risk of cardiovascular disorders submitted suggested that methylphenidate does not have an effect on rapidly activating inward rectifying potassium channels (which play a role in neuronal excitability and heart rate) or on action potential duration.
Slovenian: Predloženi predklinični podatki o tveganju srčno-žilnih obolenj kažejo, da metilfenidat nima učinka na hitro aktivirane navznoter uravnane kalijeve kanalčke (ki sodelujejo pri vzdražljivosti živčevja in srčnem utripu) ali na trajanje akcijskega potenciala.
English: Fax: +34-93-772 25 01
Slovenian: Telefaks: +34-93-772 25 01
English: All MAHs are therefore required to add Raynaud's phenomenon to their Product Information (PI) for all methylphenidate-containing products.
Slovenian: Od vseh imetnikov dovoljenj za promet z zdravilom je bilo zato zahtevano, da dodajo Raynaudov fenomen v podatke o zdravilu za vsa zdravila, ki vsebujejo metilfenidat.
English: • psychotic disorders, including visual, tactile or auditory hallucinations or delusions
Slovenian: • psihotične motnje, vključno z vidnimi, tipnimi ali slušnimi halucinacijami ali blodnjami;
English: DE - Germany Medice Postfach 2063
Slovenian: DE - Nemčija Medice Postfach 2063
English: Where provided, the information on drug dechallenge suggested that methylphenidate may play a causative role in the development of serious psychiatric disorders.
Slovenian: Podatki o odtegnitvi zdravila so, kjer so bili predloženi, nakazovali, da je metilfenidat morda vzrok razvoja resnih psihiatričnih motenj.
English: Your doctor will specifically discuss wether you or your child is at risk for bipolar (affective) disorder, which will involve checking psychiatric history, inlcuding a family history of suicide, bipolar disorder and depression.
Slovenian: Zdravnik se bo posebej posvetoval glede tveganja, da se pri vas ali vašem otroku razvije bipolarna (afektivna) motnja, in bo zato pregledal psihiatrično anamnezo, vključno z družinsko anamnezo samomora, bipolarne motnje in depresije;
English: Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate.
Slovenian: Preden predpišete to zdravilo, opravite začetni pregled bolnikovega srčnožilnega sistema, vključno s krvnim tlakom in srčno frekvenco.
English: Patients should be informed that {Invented name} must be swallowed whole with the aid of liquids.
Slovenian: Bolniku povejte, da mora tableto {zaščiteno ime zdravila} pogoltniti celo, s pomočjo tekočine.
English: Patients who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant arrhythmia,) and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.
Slovenian: Pri bolnikih, pri katerih razmišljate o zdravljenju s psihostimulansi, morate pridobiti skrbno anamnezo (vključno s podatki o nenadni srčni ali nepojasnjeni smrti ali pojavu maligne aritmije v družinski anamnezi) ter pri njih opraviti fizikalni pregled za oceno morebitnega obstoja srčne bolezni z nadaljnjimi specialističnimi srčnimi preiskavami, če začetni izvidi nakazujejo tovrstno bolezen v anamnezi.
English: The MAHs will harmonise the PSUR reporting schedule for methylphenidate-containing products and submit once yearly PSURs for their respective products for the next 3 years, after which the reporting frequency will be reviewed.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo uskladili urnik rednega poročanja o varnosti zdravila za zdravila, ki vsebujejo metilfenidat, ter vsako leto v naslednjih treh letih predložili redno poročilo o varnosti zdravila za posamezna zdravila, po teh treh letih pa se bo pogostnost poročanja pregledala.
English: When used for a long period of time, methylphenidate may cause reduced growth (weight gain and/or height) in some children.
Slovenian: Če se metilfenidat uporablja daljši čas, lahko pri nekaterih otrocih zavira rast (zaviranje pridobivanja telesne mase in/ali višine).
English: Lactation Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate
Slovenian: Dojenje Metilfenidat so našli v mleku ženske, ki se je zdravila z njim.
English: Finally as requested by the CHMP the relevant sections of the Product Information are amended to harmonise the safety information on the cerebrovascular risk.
Slovenian: CHMP je zahteval, da se ustrezna poglavja podatkov o zdravilu spremenijo tako, da se uskladijo varnostni podatki o tveganju cerebrovaskularnih obolenj.
English: Taking methylphenidate with alcohol
Slovenian: Jemanje metilfenidata z alkoholom
English: Because a predominant action of methylphenidate is to increase extracelluar dopamine levels, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists including antipsychotics.
Slovenian: Ker metilfenidat deluje predvsem tako, da poveča zunajcelično koncentracijo dopamina, je lahko njegova sočasna uporaba z neposrednimi in posrednimi agonisti dopamina (vključno z DOPA in tricikličnimi antidepresivi), ali z antagonisti dopamina, vključno z antipsihotiki, povezana s pojavom farmakodinamičnih interakcij.
English: Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for methylphenidate containing products in the treatment of ADHD in children aged six and above, is considered favourable and recommended the maintenance of the Marketing Authorisation in accordance to the amendments of the Summary of Product Characteristics, and Package Leaflet (set out in Annex III) for the medicinal products referred to in Annex I.
Slovenian: CHMP je ob upoštevanju vseh naštetih elementov zaključil, da je za zdravila, ki vsebujejo metilfenidat, za zdravljenje motnje ADHD pri otrocih, starih šest let in več, razmerje med koristnimi učinki in tveganji ugodno in za zdravila iz Dodatka I priporoča ohranitev dovoljenj za promet z zdravilom, skladno z dopolnili povzetkov glavnih značilnosti zdravila in navodil za uporabo (opisanimi v Dodatku III).