FrancophonIA/ELRC3.0 huggingface dataset:
English: Methylphenidate should not be given to children under 6 years of age or the elderly as the safety and benefits of use in these age groups have not been established.
Slovenian: Metilfenidat se ne sme dajati otrokom, mlajšim od 6 let, ali starejšim osebam, saj varnost in koristi uporabe v teh starostnih skupinah nista bili dokazani.
English: ADHD is defined by ‘core' signs of lack of attention, hyperactivity and impulsiveness.
Slovenian: Motnja ADHD je opredeljena z „osnovnimi“ znaki, ki so pomanjkanje pozornosti, hiperaktivnost in impulzivnost.
English: In conclusion regarding the cardiovascular risks, it is accepted that there is a potential risk.
Slovenian: V zaključku obravnave tveganja srčno-žilnih obolenj se sprejme, da obstaja potencialno tveganje.
English: Forms of bipolar disorder
Slovenian: Oblike bipolarne motnje
English: Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient.
Slovenian: Diagnoza mora biti postavljena po kriterijih DSM-IV ali po smernicah ICD-10 in mora temeljiti na celotni anamnezi in pregledu bolnika.
English: The PL will be tested for User readability and the results will be submitted to the regulatory Authorities.
Slovenian: Navodila za uporabo bodo preskušena za berljivost z vidika uporabnika, rezultati pa bodo predloženi regulativnim organom.
English: Safety and efficacy in this age group has not been established.
Slovenian: Varnost in učinkovitost pri tej starostni skupini še ni bila ugotovljena.
English: The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data.
Slovenian: Kratkotrajne in dolgotrajne klinične posledice teh srčnožilnih učinkov pri otrocih in mladostnikih niso znane, vendar ni mogoče izključiti možnosti kliničnih zapletov, nastalih kot posledica učinkov, ki so jih opažali v kliničnih preskušanjih.
English: Study designed to: 1) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in children and youth, aged 2-24 years; 2) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in adults, aged 25-64 years; and, 3) perform additional analyses that are relevant to decision makers such as clinicians, state Medicaid programs, and parents/patients.
Slovenian: Študija, ki je zasnovana za: 1) vrednotenje povezave med uporabo zdravil za ADHD in tveganjem resnega srčno-žilnega obolenja pri otrocih in mladih ljudeh, starih od 2 do 24 let; 2) vrednotenje povezave med uporabo zdravil za ADHD in tveganjem resnega srčno-žilnega obolenja pri odraslih, starih od 25 do 64 let; in 3) dodatne analize, ki so pomembne za tiste, ki sprejemajo odločitve, kot so klinično osebje, državni programi Medicaid in starši/bolniki.
English: Frequency estimate: very common (≥ 1/10) common (≥ 1/100 to < 1/10) uncommon (≥ 1/1000 to <1/100) rare (≥ 1/10,000 to <1/1000) very rare (<1/10,000) not known (cannot be estimated from the available data).
Slovenian: Ocena pogostnosti: zelo pogosti (≥ 1/10) pogosti (≥ 1/100 do < 1/10) občasni (≥ 1/1000 do < 1/100) redki (≥ 1/10.000 do < 1/1000) zelo redki (< 1/10.000) ni znana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Because this is a noninterventional study, the MAH's will have no control over actual prescribing practices.
Slovenian: Ker je to študija brez intervencije, imetniki dovoljenj za promet z zdravilom ne bodo imeli nadzora nad dejansko prakso predpisovanja.
English: Though the diagnostic criteria for ADHD exclude children with developmental disorders, such as Asperger Syndrome, some clinicians argue that these conditions can coexist.
Slovenian: Čeprav diagnostična merila za ADHD izključujejo otroke z razvojnimi motnjami, kot je Aspergerjev sindrom, nekateri klinični strokovnjaki zatrjujejo, da ta stanja lahko soobstajajo.
English: If you <take> <use> more methylphenidate than you should If you or your child takes too many tablets, contact the doctor or nearest hospital casualty department immediately and tell them how many tablets have been taken.
Slovenian: Če ste <vzeli> <uporabili> večji odmerek metilfenidata, kot bi smeli Če vi ali vaš otrok vzamete preveč tablet, se takoj obrnite na zdravnika ali nezgodni oddelek najbližje bolnišnice in jih obvestite, koliko tablet ste vzeli.
English: MTA Study.
Slovenian: Sledenje študiji MTA.
English: WHAT METHYLPHENIDATE IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE METILFENIDAT IN ZA KAJ GA UPORABLJAMO
English: This product contains methylphenidate which may induce a false positive laboratory test for amphetamines, particularly with immunoassay screen test.
Slovenian: To zdravilo vsebuje metilfenidat, ki lahko povzroči lažno pozitiven izvid laboratorijskih preiskav na amfetamine, še posebej pri imunskem presejalnem testu.
English: The MAHs will also consider alternative methods for completing the review of usage (where possible) and off-label use in the Member States that are not currently covered by multinational (EU-wide) databases such as IMS.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo upoštevali tudi alternativne metode za pregled uporabe (kjer je možno) in uporabe izven obsega indikacij v državah članicah, ki trenutno niso zajete v meddržavnih zbirkah podatkov (na področju EU), kot je IMS.
English: <If you have any further questions on the use of this product, ask your <doctor> <or> <pharmacist>.>
Slovenian: <Če imate dodatna vprašanja o uporabi zdravila, se posvetujte <z zdravnikom> <ali> <s farmacevtom>.>
English: This scientific assessment on methylphenidate has reviewed the available safety data from clinical trials, preclinical studies, spontaneous reports and published literature.
Slovenian: V tem znanstvenem vrednotenju metilfenidata so bili pregledani razpoložljivi podatki o varnosti iz kliničnih preskušanj, predkliničnih študij, spontanih poročil in objavljene literature.
English: Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms.
Slovenian: Če se samo korektivni ukrepi izkažejo za nezadostne, mora odločitev o predpisovanju stimulanta temeljiti na strogi oceni jakosti otrokovih simptomov.
English: Some of these were conditions in which the use of methylphenidate is warned against or contra-indicated.
Slovenian: V nekaterih od teh primerov so bili prisotni pogoji, v katerih je uporaba metilfenidata odsvetovana ali kontraindicirana.
English: If the feasibility assessment shows that a scientifically valid, well-designed and suitably powered study is viable, then the MAHs commit to provide a detailed protocol.
Slovenian: Če vrednotenje izvedljivosti pokaže, da je znanstveno veljavna, dobro zasnovana in primerno močna študija možna, se imetniki dovoljenj za promet z zdravilom zavezujejo k predložitvi podrobnega protokola.
English: The regulatory status of the different Methylphenidate containing medicinal products is heterogeneous across EU Member States (MS).
Slovenian: Regulatorni status posameznih zdravil, ki vsebujejo metilfenidat, je v državah članicah EU heterogen.
English: A review of all available data found that the more specific terms “over-focussing” and “repetitive behaviours” reflect the observed effects of methylphenidate and should be added as possible adverse effects in the Product Information.
Slovenian: Pregled vseh razpoložljivih podatkov je pokazal, da bolj specifična izraza „čezmerno osredotočanje“ in „repetitivno vedenje“ odražata opažene učinke metilfenidata, zato ju je treba dodati možnim neželenim učinkom v podatkih o zdravilu.
English: Although most reports occurred in children and adolescents, there was a higher than expected number of reports in adults (where age was reported) for all of the key adverse event terms.
Slovenian: Čeprav se je večina poročil nanašala na otroke in mladostnike, je bilo za vse ključne neželene učinke poročil, ki so se nanašala na odrasle (od poročil z navedbo starosti), več kot je bilo pričakovano.
English: SE - Sweden Janssen-Cilag AB Box 7073
Slovenian: SE - Švedska Janssen-Cilag AB Box 7073
English: The MAHs agree to evaluate suitable comparator groups.
Slovenian: Imetniki dovoljenj za promet z zdravilom so se dogovorili, da bodo ovrednotili primerne primerjalne skupine.
English: • about any medications you or your child is taking
Slovenian: • o kakršnihkoli zdravilih, ki jih jemljete vi ali vaš otrok;
English: The proposed patient enrolment age will be as young as possible consistent with the age restrictions of the label (i.e. children aged 6 years or more).
Slovenian: Predlagana starost bolnikov ob vključitvi bo čim nižja in v skladu s starostnimi omejitvami na ovojnini (tj, otroci, stari 6 let ali več).
English: Treatment consists of appropriate supportive measures.
Slovenian: Zdravljenje prevelikega odmerjanja sestoji iz ustreznih podpornih ukrepov.
English: A currently ongoing cytogenicity study may give responses when finalised.
Slovenian: Tekoča študija citogenetike lahko po zaključku ponudi odzive.
English: Where indication was reported, this was most commonly ADHD, but there were also a significant proportion of reports with other indications reported.
Slovenian: V poročilih z navedbo indikacije je bila najpogostejša indikacija ADHD, vendar so bile v pomembnem deležu poročil tudi navedbe drugih indikacij.
English: Safety overview
Slovenian: Pregled varnosti
English: Tell the doctor before treatment if any of the above conditions or symptoms applies to you or your child.
Slovenian: Pred zdravljenjem obvestite zdravnika, če se katerokoli od zgoraj navedenih stanj nanaša na vas ali vašega otroka.
English: Appropriate educational placement is essential, and psychosocial intervention is generally necessary.
Slovenian: Nujen je ustrezen pristop k izobraževanju, pogosto je potrebno tudi psihosocialno ukrepanje.
English: If you or your child do not feel better with this medicine, your doctor may decide a different treatment is needed.
Slovenian: Če se vi ali vaš otrok ob jemanju tega zdravila ne počutite bolje, lahko zdravnik odloči, da potrebujete drugo zdravljenje.
English: The risk of carcinogenicity, effects on growth and the effects of long-term treatment were also evaluated.
Slovenian: Ovrednoteni so bili tudi tveganje kancerogenosti, učinki na rast ter učinki dolgoročnega zdravljenja;
English: In addition risk minimisation measures need to be in place in order to continuously identify and evaluate potential risks.
Slovenian: Dodatno je treba uvesti ukrepe za čim večje zmanjšanje tveganja, kar bo omogočilo neprekinjeno odkrivanje in vrednotenje možnih tveganj.
English: The signs of ADHD may persist into adolescence and adulthood, and may be associated with continuing emotional and social problems, unemployment, criminality and substance misuse.
Slovenian: Znaki motnje ADHD lahko vztrajajo še v mladostništvu in odraslosti ter so lahko povezani s trajnimi čustvenimi in socialnimi težavami, brezposelnostjo, kaznivimi dejanji ter zlorabo substanc.
English: Anxiety, agitation or tension
Slovenian: Tesnoba, razburjenost, napetost
English: For some of these children, methylphenidate treatment, along with other forms of non-medical treatment can reduce symptoms of hyperactivity and improve quality of life.
Slovenian: Pri nekaterih otrocih lahko sočasno zdravljenje z metilfenidatom in drugimi oblikami zdravljenja brez zdravil zmanjša simptome hiperaktivnosti ter izboljša kakovost življenja.
English: Rare: angina pectoris
Slovenian: Redki: angina pektoris (prsna stiska)
English: No events related to other cerebrovascular disorders were reported in children from clinical trials.
Slovenian: O drugih dogodkih, povezanih s cerebrovaskularnimi obolenji, pri otrocih v kliničnih preskušanjih niso poročali.
English: The most common side effects are nervousness, sleeplessness and headache.
Slovenian: Najpogostejši neželeni učinki so živčnost, nespečnost in glavobol.
English: Other strengths of this medicinal product and other methylphenidate-containing products may be available.
Slovenian: Na voljo so lahko tudi druge jakosti tega zdravila in druga zdravila, ki vsebujejo metilfenidat.
English: Children with severe ADHD can develop poor self-esteem, emotional and social problems.
Slovenian: Pri otrocih s hudo motnjo ADHD se lahko razvijejo slabo samospoštovanje, čustvene in socialne težave.
English: The literature also suggests that methylphenidate can exacerbate psychiatric disorders in patients with ADHD.
Slovenian: Literatura tudi nakazuje, da lahko metilfenidat poslabša psihiatrične motnje pri bolnikih z ADHD.
English: Dose titration should be started at the lowest possible dose.
Slovenian: Titriranje odmerka začnemo z najmanjšim možnim odmerkom.
English: Cerebral vasculitis appears to be a very rare idiosyncratic reaction to methylphenidate exposure.
Slovenian: Zdi se, da je vaskulitis možganskega žilja zelo redka idiosinkratična reakcija na izpostavljenost metilfenidatu.
English: Cumulative reviews showed that a large proportion of post-marketing cases analysed were used in indications not related to ADHD.
Slovenian: Kumulativni pregledi so pokazali, da se je v velikem deležu analiziranih primerov iz obdobja trženja zdravilo uporabilo za indikacije, ki niso povezane z motnjo ADHD.
English: If methylphenidate is taken for more than a year, your doctor should stop your treatment with methylphenidate for a short time once a year to see if the medicine is still needed.
Slovenian: Če jemljete metilfenidat več kot eno leto, mora zdravnik enkrat na leto za kratek čas prekiniti vaše zdravljenje z metilfenidatom, da preveri, ali zdravilo še potrebujete.
English: Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.
Slovenian: Napačna uporaba stimulantov osrednjega živčevja je lahko povezana z nenadno smrtjo in drugimi resnimi srčnožilnimi neželenimi dogodki.
English: - The Committee considered all the available data submitted on the safety of the methylphenidate containing products.
Slovenian: - Odbor je upošteval vse razpoložljive podatke, predložene v zvezi z varnostjo zdravil, ki vsebujejo metilfenidat;
English: FR - France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
Slovenian: FR - Francija JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
English: Common: hypertension
Slovenian: Pogosti: hipertenzija
English: The safety of the use of methylphenidate containing products during pregnancy and lactation has been assessed by the CHMP and further discussed in the Safety Working Party (SWP) in December 2008.
Slovenian: CHMP je ovrednotil varnost uporabe zdravil, ki vsebujejo metilfenidat, med nosečnostjo in dojenjem, dodatno pa je o tem razpravljala Delovna skupina za varnost decembra 2008.
English: Close ongoing monitoring is essential in these patients (see above ‘Psychiatric Disorders' and section 4.2) .
Slovenian: Natančno spremljanje je pri teh bolnikih zelo pomembno (glejte poglavje Psihiatrične motnje in poglavje 4.2).
English: Dose reduction and discontinuation
Slovenian: Zmanjšanje odmerka in ukinitev zdravila
English: Anti-hypertensive drugs Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Slovenian: Antihipertenzivi Metilfenidat lahko zmanjša učinkovitost zdravil, ki jih uporabljamo za zdravljenje hipertenzije.
English: Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
Slovenian: Bolnike je treba opozoriti na možnost pojava teh učinkov in jim svetovati naj se izogibajo potencialno nevarnim aktivnostim, kot sta vožnja in upravljanje z motornimi vozili, če se ti učinki pojavijo.
English: So, there is the need for this information to be clear to the prescribers and the public by strengthening the wording of the Product Information of the products.
Slovenian: Zato obstaja potreba po razjasnitvi teh podatkov za osebe, ki predpisujejo zdravila, in javnost, in sicer z razširitvijo besedila podatkov o zadevnih zdravilih.
English: SK - Slovakia Johnson & Johnson, s. r. o. Plynárenská 7/B
Slovenian: SK - Slovaška Johnson & Johnson, s. r. o. Plynárenská 7/B
English: Important information about some of the ingredients of methylphenidate {To be completed nationally, as appropriate]
Slovenian: Pomembne informacije o nekaterih sestavinah metilfenidata {izpolni država članica, če je to primerno]
English: Study on sexual maturation: a 2-year, long-term, open-label, prospective investigator initiated study in the US on 150 adolescents (12-17 years) with ADHD, to determine whether treatment with methylphenidate will prevent smoking in this population.
Slovenian: Študija spolnega zorenja: dveletna, dolgoročna, odprta, prospektivna študija 150 mladostnikov (12-17 let) z ADHD, ki so jo začeli raziskovalci v ZDA, da bi določili, ali zdravljenje z metilfenidatom prepreči kajenje v tej populaciji.
English: Study NCT 00341029 “Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall”, carried out by US National Institute of Environmental Health Sciences in collaboration with FDA.
Slovenian: Študija NCT 00341029 „Merjenje citogenskih končnih točk v limfocitih otrok z diagnozo motnje pomanjkanja pozornosti in hiperaktivnosti (ADHD), ki se zdravijo z metilfenidatom ali zdravilom Adderall“, ki jo je opravil ameriški inštitut National Institute of Environmental Health Sciences v sodelovanju z agencijo FDA.
English: ES - Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
Slovenian: ES - Španija JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
English: It is an amphetamine-like drug that has controlled drug status, which imposes restrictions on prescribing and handling.
Slovenian: Metilfenidat je amfetaminu podobno zdravilo, ki ima status nadzorovanega zdravila, ki zahteva omejitve pri predpisovanju in ravnanju z zdravilom.
English: A clear safety signal for Reynaud's phenomenon was detected and the CHMP's opinion is that there is sufficient evidence from the reviewed data to suspect a causal relationship between methylphenidate use and these reactions.
Slovenian: Zaznan je bil jasen varnostni signal za Raynaudov fenomen, zato CHMP meni, da v pregledanih podatkih obstaja dovolj dokazov za sum vzročne povezave med uporabo metilfenidata in navedenimi reakcijami.
English: The PL wording agreed by the CHMP should be revised to improve patient readability, and will then be user-tested.
Slovenian: Besedilo navodila za uporabo, o katerem soglaša CHMP, je treba popraviti, da bo za bolnika bolj berljivo, in nato preveriti na uporabnikih.
English: Attention-Deficit/Hyperactivity Disorder (ADHD)
Slovenian: Motnja pomanjkanja pozornosti s hiperaktivnostjo (Attention Deficit Hyperactivity DisorderADHD)
English: In terms of the suicidality the MAHs committed to make use of the current knowledge and to conduct a meta-analysis on the available results from different clinical studies.
Slovenian: V zvezi s samomorilnostjo so se imetniki dovoljenj za promet z zdravilom zavezali k uporabi trenutnega znanja in izvedbi meta-analize razpoložljivih rezultatov iz različnih kliničnih študij.
English: • Physicians guide to prescribing
Slovenian: • Priporočila zdravnikom za predpisovanje
English: It is widely accepted (from review of the literature) that long-term safety and effectiveness of methylphenidate has not been conclusively proven in suitably designed and conducted studies.
Slovenian: Splošno sprejeto je (iz pregleda literature), da dolgoročna varnost in učinkovitost metilfenidata ni prepričljivo dokazana v primerno zasnovanih in izvedenih študijah.
English: Worsening of Tourette's syndrome has also been reported.
Slovenian: Poročali so tudi o pojavu Tuorettovega sindroma.
English: Diagnosis cannot be made solely on the presence of one or more symptom.
Slovenian: Učenje je lahko prizadeto ali pa ne. Diagnoze ne moremo postaviti le na podlagi prisotnosti enega ali več simptomov.
English: Methylphenidate is not indicated for use in patients who may display some symptoms of ADHD but have not been formally diagnosed.
Slovenian: Metilfenidat ni indiciran za uporabo pri bolnikih, ki morda kažejo nekaj simptomov ADHD, vendar diagnoza uradno ni postavljena.
English: The MAHs will consider including predominantly EU-based data, and the feasibility assessment will also comment on what non-EU sources of data could be used as an alternative.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo upoštevali vključitev podatkov pretežno iz EU, v vrednotenju izvedljivosti pa bo tudi opisano, kateri viri podatkov izven EU se lahko uporabijo kot alternativni viri.
English: You should check with your <doctor> <or> <pharmacist> if you are not sure.> <The usual dose is...>
Slovenian: Če ste negotovi, se posvetujte <z zdravnikom> ali <s farmacevtom>.> <Običajen odmerek je ...>
English: The data submitted on the risk of cardiovascular disorders covered a range of reporting periods.
Slovenian: Predloženi podatki o tveganju srčno-žilnih obolenj so bili iz različnih obdobij poročanja.
English: The effects of methylphenidate on final height and final weight are currently unknown and being studied.
Slovenian: Učinki metilfenidata na končno telesno višino in maso še niso znani in jih trenutno preučujejo.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing methylphenidate initiated by the European Commission.
Slovenian: - Odbor je upošteval napotitev, ki jo je sprožila Evropska komisija v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo metilfenidat;
English: EL - Greece JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel: +30-210-6140061
Slovenian: EL - Grčija JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel.: +30-210-6140061
English: • about any other medical conditions (such as heart conditions) you, your child or you family may have.
Slovenian: • o kakršnihkoli drugih zdravstvenih stanjih (kot so obolenja srca), ki zadevajo vas, vašega otroka ali družino;
English: Although the data provided suggested that in most patients, these effects are reversible upon discontinuation, there is a lack of reliable data regarding the extent of the effect of methylphenidate on blood pressure and heart rate and also on the long-term effects or clinical consequences on the cardiovascular system of these effects.
Slovenian: Čeprav so predloženi podatki kazali, da so pri večini bolnikov ti učinki reverzibilni po prekinitvi jemanja, pa je premalo zanesljivih podatkov o obsegu učinka metilfenidata na krvni tlak in srčni utrip ter o dolgoročnih učinkih ali kliničnih posledicah teh učinkov na srčno-žilni sistem.
English: If the analysis on the basis of the currently available data is deemed feasible, the MAHs will make the resources available to support the analysis and update the RMP to reflect its findings.
Slovenian: Če se presodi, da je analiza na osnovi trenutno razpoložljivih podatkov izvedljiva, bodo imetniki dovoljenj za promet z zdravilom zagotovili vire za podporo analize in posodobili načrt obvladovanja tveganja tako, da bo odražal izsledke analize.
English: FI - Finland UCB Pharma Oy Finland Malminkaari 5 00700 Helsinki FINLAND
Slovenian: FI - Finska UCB Pharma Oy Finland Malminkaari 5 00700 Helsinki FINLAND
English: SE - Sweden Novartis Sverige AB Box 1150
Slovenian: SE - Švedska Novartis Sverige AB Box 1150
English: 2.1 Cardiovascular risk
Slovenian: 2.1 Tveganje srčno-žilnih obolenj
English: IE - Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24
Slovenian: UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24 Ireland