FrancophonIA/ELRC3.0 huggingface dataset:
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišično-koštanog sustava i vezivnog tkiva manje često grčevi u mišićima
English: Children
Croatian: FARMACEUTSKI
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja manje često dispneja
English: Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers or - in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Croatian: − u kombinaciji s beta-blokatorima u bolesnika u kojih bolest nije dovoljno dobro kontrolirana optimalnom dozom beta-blokatora.
English: Contra-indication of concomitant use
Croatian: Istodobna primjena koja je kontraindicirana
English: Package leaflet: Information for the patient Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Croatian: Ivabradine Zentiva 5 mg filmom obložene tablete Ivabradine Zentiva 7,5 mg filmom obložene tablete ivabradin
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: U podskupini bolesnika kojima je srčana frekvencija bila ≥ 75/min i koji su primali preporučenu ciljnu dozu beta blokatora nije primijećena statistički značajna korist za primarnu kompozitnu mjeru ishoda (omjer hazarda: 0,97, 95% CI [0,74; 1,28]) niti ostale sekundarne mjere ishoda, uključujući hospitalizaciju zbog pogoršanja zatajivanja srca (omjer hazarda: 0,79, 95% CI [0,56; 1,10]) ili smrt zbog zatajenja srca (omjer hazarda: 0,69, 95% CI [0,31; 1,53]).
English: Risks associated with long term use
Croatian: Rizici povezani s dugoročnom uporabom
English: Risk management plan
Croatian: Plan upravljanja rizicima
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Croatian: • Povjerenstvo je razmatralo notifikaciju o procjeni koju je zatražilo Ujedinjeno Kraljevstvo u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: The CHMP was therefore asked to consider:
Croatian: Od CHMP-a se stoga tražilo da razmotri:
English: There are, however, methodological problems with this study.
Croatian: Međutim, postoje metodološki problemi s ovim ispitivanjem.
English: However, the number of responders increased to 33 (92%) after both stimulants were tried.
Croatian: Međutim broj osoba koje su odgovorile na liječenje porastao je na 33 (92 %) nakon što su isprobana oba stimulansa.
English: The reason for the different responses could be different pharmacological mechanisms of action.
Croatian: Razlog za različite odgovore mogao bi biti različiti farmakološki mehanizam djelovanja.
English: In addition, this was an independent study published in 1991 which precludes the assessment of the original data.
Croatian: Osim toga to je bilo nezavisno ispitivanje objavljeno 1991. koje je isključilo procjenu originalnih podataka.
English: At the final CMDh discussion, there were two major issues where agreement could not be reached by Member States.
Croatian: Nakon završne rasprave s CMDh-om, ostala su dva glavna pitanja oko kojih države članice nisu mogle postići dogovor.
English: The number of patients was small and the statistical significance of the findings is uncertain.
Croatian: Broj bolesnika bio je mali, a statistički značaj nalaza nesiguran.
English: Risk for abuse and dependence
Croatian: Rizik od zloporabe i ovisnosti
English: However it is noted that overall very few data is available in clinical practice to support this.
Croatian: Međutim, zabilježeno je da je ukupno gledano dostupno vrlo malo podataka u kliničkoj praksi kako bi se poduprla ova tvrdnja.
English: Therefore, the assessment of efficacy is based on an intensive literature search as well as on current European treatment guidelines.
Croatian: Stoga se procjena djelotvornosti temelji na intenzivnom pretraživanju literature kao i na trenutnim Europskim smjernicama o liječenju.
English: • Introduction of a statement in section 4.8 on reporting of suspected adverse reactions.
Croatian: • Uvođenje izjave u dio 4.8 o prijavljivanju sumnji na nuspojave.
English: The CHMP therefore considered that this publication can be regarded as supportive of efficacy but does not provide conclusive evidence.
Croatian: CHMP je stoga smatrao da se ova publikacija može smatrati kao potpora djelotvornosti, ali da ne osigurava konkluzivni zaključak.
English: The experts' panel recognises this risk but considers its frequency to be low.
Croatian: Panel stručnjaka prepoznaje taj rizik, ali smatra da je njezina učestalost niska.
English: While the review has methodological limitations, the conclusions reached are based on relevant evidence.
Croatian: Iako ocjena ima metodološka ograničenja, postignuti zaključci temelje se na relevantnim dokazima.
English: The Netherlands considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Croatian: Nizozemska je smatrala da izdavanje odobrenja za lijek sadrži potencijalni ozbiljan rizik za javno zdravlje.
English: The study by Elia et al. (1991) concluded that there is a need to try both stimulants because there is individual variability in response.
Croatian: Ispitivanje od strane Elia i suradnika (1991.) zaključilo je da nema potrebe ispitati oba stimulansa jer postoji individualna varijabilnost u odgovoru.
English: The identified risk of cardiomyopathy is mainly associated with chronic use, especially with high dose use.
Croatian: Identificirani rizik od kardiomiopatije uglavnom je povezan s kroničnom uporabom, posebice kod uporabe visokih doza.
English: The two substances have similar efficacy in ADHD but different mechanisms of action.
Croatian: Dvije tvari imaju sličnu djelotvornost u ADHD-u, ali različite mehanizme djelovanja.
English: During the assessment of the application at Member State level, advice from the PRAC on the risk management plan was sought and the applicant agreed with the recommendation to:
Croatian: Tijekom procjene zahtjeva na razini države članice, zatražen je savjet PRAC-a o planu upravljanja rizicima i podnositelj zahtjeva složio se s preporukama za:
English: In addition to specific measures in the risk management plan, the committee recommended the monitoring of blood pressure and pulse rate in order to minimise these risks.
Croatian: Pored specifičnih mjera u planu upravljanja rizicima, Povjerenstvo je preporučilo nadzor tlaka krvi i brzine pulsa kako bi se smanjili ovi rizici.
English: However there are perceived risks of diversion and abuse associated with this medication.
Croatian: Međutim, postoji prepoznati rizik od diverzije i zloporabe povezanih s ovim lijekom.
English: Treatment optimisation may be also easier to achieve with immediate-release forms when an initial titration phase is needed to determine the correct dosing levels.
Croatian: Optimizaciju liječenja može biti lakše postići s oblicima lijeka s neposrednim oslobađanjem kada je potrebna početna faza titracije za određivanje točne razine doziranja.
English: It is a Central Nervous System stimulant, more potent than the racemic mixture.
Croatian: Stimulans je središnjeg živčanog sustava, snažniji od racemične smjese.
English: From the publication alone it is difficult to assess the meaningfulness of the suggested effect sizes based on which the level of response was assessed, but despite some lack of clarity regarding methodology it is noted that the conclusions are in line with those of the Elia et al. study.
Croatian: Iz same publikacije teško je procijeniti smislenost predloženog učinka veličina na temelju koja je razina odgovora procijenjena, ali unatoč određenom nedostatku jasnoće u vezi metodologije uočeno je da su zaključci u skladu s onima iz ispitivanja Elia i suradnika.
English: Experimentation with recreational drugs generally starts during adolescence, whereas treatment of ADHD can begin at an earlier age.
Croatian: Eskperimentiranja s rekreacijskim drogama općenito počinju tijekom adolescencije dok liječenje ADHDa može započeti u ranijoj dobi.
English: In addition, at least seven evidence-based guidelines for the pharmacological treatment of ADHD recommend dexamfetamine as first-line therapy; others give an explicit favourable recommendation for use as a therapeutic option in ADHD (Seixas et al., 2012).
Croatian: Osim toga, najmanje sedam smjernica potkrijepljenih dokazima za farmakološko liječenje ADHD-a preporučuje deksamfetamin kao terapiju prve linije; drugi daju izrazito povoljne preporuke za uporabu kao terapeutsku opciju u ADHD-u (Seixas et al., 2012.).
English: In addition, the CHMP recommended that the risk management plan should be further updated (see annex IV).
Croatian: Pored toga, CHMP je preporučio daljnja ažuriranja plana upravljanja rizicima(vidjeti Dodatak IV.).
English: In the Elia et al. study, approximately 30% of participants did not respond to one treatment but only 4% were non-responders to both.
Croatian: U ispitivanju Elia i suradnika, približno 30 % sudionika nije reagiralo na liječenje ali samo 4 % bolesnika nije reagiralo niti na jednu terapiju.
English: In other publications, authors seem to have further concluded that ADHD treatment with stimulants during childhood is associated with a reduction in the risk of substance use disorder later in life (Biederman et al. 1999; Wilens et al. 2003).
Croatian: U drugim publikacijama čini se da su autori nadalje zaključili da je liječenje stimulansima ADHD-a tijekom djetinjstva povezano sa smanjenjem rizika od poremećaja uporabe tvari kasnije u životu (Biederman i sur. 1999.; Wilens i sur. 2003.).
English: Moreover short acting treatments are expected to have some advantages compared to long-acting treatments.
Croatian: Štoviše, očekuje se da će kratkoročna liječenja imati neke prednosti u usporedbi s dugoročnim liječenjima.
English: The CHMP, having considered the data submitted in the application is of the opinion that the above risk management activities are necessary for the safe and effective use of the medicinal product.
Croatian: CHMP je uzimajući u obzir podatke predane u zahtjevu smatrao da su prethodno navedene aktivnosti upravljanja rizikom potrebne za sigurnu i djelotvornu uporabu lijeka.
English: Dexamfetamine is currently used for treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD) in several EU countries including the reference Member State (RMS) in this procedure.
Croatian: Deksamfetamin se trenutno koristi za liječenje narkolepsije i poremećaja hiperaktivnosti i deficita pozornosti (ADHD) u nekoliko država EU-a uključujući i referentnu državu članicu (RMS) u postupku.
English: Efficacy in second line treatment of ADHD
Croatian: Djelotvornost u drugoj liniji liječenja ADHD-a
English: The proposed risk minimisation measures are a combination of routine activities (inclusion of warnings in the product information) and the following educational materials and tools:
Croatian: Predložene mjere upravljanja rizikom kombinacija su rutinskih aktivnosti (uključivanje upozorenja u informacije o proizvodu) te sljedećih edukativnih materijala i alata:
English: It is acknowledged that abuse and dependence may occur, however there appears to be a difference between the population that abuses stimulants and the general ADHD population.
Croatian: Potvrđeno je da se mogu javiti zloporaba i ovisnost, međutim čini se da postoji razlika između populacija koje zloupotrebljavaju stimulanse i opće populacije s ADHD-om.
English: During the referral procedure, the CHMP recommended safety related changes to the product information:
Croatian: Tijekom postupka arbitraže CHMP je preporučio sigurnosne promjene u informacijama o lijeku:
English: It is noted that age can be a dominant factor in substance use disorder.
Croatian: Zabilježeno je da dob može biti dominantan čimbenik u poremećajima uporabe tvari.
English: During treatments regular evaluations should be performed regarding treatment necessity (see below) and possible occurrence of overuse, dependence or diversion.
Croatian: Tijekom liječenja potrebno je provoditi redovite procjene u vezi potrebe liječenja (vidjeti u nastavku) te moguće pojave prekomjerne uporabe, ovisnosti ili diverzije.
English: It is noted that all the guidelines mentioned in this article are from countries where dexamfetamine is already marketed for ADHD.
Croatian: Uočeno je da su sve smjernice spomenute u ovom članku iz država u kojima je deksamfetamin već stavljen na tržište zbog ADHD-a.
English: The author concludes that the individual patient response profiles are non-congruent, and that non-response or intolerable side effects with one stimulant do not preclude a good response to the other.
Croatian: Autor zaključuje da profili odgovora pojedinih bolesnika nisu sukladni te da izostanak reakcije ili nepodnošljive nuspojave jednog stimulansa ne isključuju dobru reakciju na drugi stimulans.
English: There is also evidence that amfetamines increase release and turnover of serotonin.
Croatian: Također postoji dokaz da amfetamini povećavaju otpuštanje i povrat serotonina u stanice.
English: Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Croatian: Znanstveni zaključci i razlozi za pozitivno mišljenje koje je prikazala
English: It was noted that increased blood pressure may occur as well as tachycardia.
Croatian: Zabilježeno je da se može javiti povišeni tlak krvi kao i tahikardija.
English: • Introduction of a statement in section 4.4 on “Abuse, misuse, and diversion” reporting that the risk is generally greater for short acting stimulants than for corresponding long-acting products.
Croatian: • Uvođenje izjave u dio 4.4. o „zloporabi, pogrešnoj uporabi i diverziji” koji prijavljuje da je rizik općenito veći za stimulanse kratkoročnog djelovanja nego za odgovarajuće lijekove dugoročnog djelovanja.
English: • Checklists for pre-screening and on-going monitoring of patients' blood pressure, heart rate, growth (weight, height, appetite) and emergence of psychoses.
Croatian: • popisi provjere za predprobir i tekući nadzor bolesnikova tlaka krvi, srčane frekvencije, rasta (težina, visina, apetit) i hitnosti psihoze.
English: This publication also includes a comprehensive review of the preclinical pharmacodynamics of the two compounds, which may help explain the observed variability in response.
Croatian: Ova publikacija također je uključivalo iscrpan pregled nekliničke farmakodinamike dvije komponente što može pomoći u objašnjenju uočene varijabilnosti u odgovoru.
English: More importantly, the Arnold LE (2000) comparative review analysed six non-duplicative studies, from which a response rate of 66% was calculated for dexamfetamine sulphate, 56% for methylphenidate and 85% stimulant response if both are tried.
Croatian: Još važnije, usporedna procjena Arnold LE (2000.) analizirala je 6 neduplikativnih ispitivanja iz kojih je izračunata stopa odgovora od 66 % za deksamfetamin sulfat, 56 % za metilfenidat i 85 % odgovora na stimulans ako su ispitana oba lijeka.
English: With regards to other potential risks associated with long-term use of dexamfetamine such as possible impairment of neuro-cognitive development and risk of cardiomyopathy, there is no clinical evidence to support that long-term treatment has any negative influence on neuro-cognitive development.
Croatian: S obzirom na druge potencijalne rizike povezane s dugoročnom uporabom deksamfetamina poput mogućeg oštećenja neurokognitivnog razvoja i rizika od kardiomiopatije, nema kliničkog dokaza koji bi podržao tezu da dugoročno liječenja ima negativan utjecaj na neurokognitivni razvoj.
English: During the procedure the MAH conducted further research in the literature, online, in databases from European Health Authorities and WHO and its own safety database.
Croatian: Tijekom postupka nositelj odobrenja je proveo daljnja istraživanja u literaturi, na mreži, u bazama podataka europskih zdravstvenih tijela i Svjetske zdravstvene organizacije i svojoj vlastitoj bazi podataka.
English: Lastly, it is noted that lisdexamfetamine is an inactive prodrug which is absorbed to the bloodstream where it is gradually converted to dexamfetamine.
Croatian: Konačno, uočeno je da je lizdeksamfetamin inaktivni prolijek koji se apsorbira u krvotok gdje se postupno pretvara u deksamfetamin.
English: Dexamfetamine, (2S)-1-phenylpropan-2-amine, is the dextrorotatory, stereoisomer of amfetamine.
Croatian: Deksamfetamin, (2S)-1-fenilpropan-2-amin je desnozakrećući steroizomer amfetamina.
English: Overall summary of the scientific evaluation of Dexamed (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijeka Dexamed (vidjeti Dodatak I.)
English: Although it is acknowledged that misuse, abuse, dependence and diversion are events that will not always be reported to the prescribers, the search retrieved a very low event rate in the countries where dexamfetamine is available on the market for ADHD.
Croatian: Iako je potvrđeno da su pogrešna uporaba, zloporaba, ovisnost i diverzija događaji koji se neće uvijek prijavljivati propisivačima, pretraživanje je pronašlo vrlo nisku stopu u državama u kojima je deksamfetamin dostupan na tržištu za liječenje ADHD-a.
English: Lisdexamfetamine was recently approved in some Member States as part of a comprehensive treatment programme for ADHD in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Croatian: Lizdeksamfetamin nedavno je odobren u nekim državama članicama kao dio iscrpnog programa liječenja za ADHD u djece u dobi od 6 godina i starijih kada se odgovor na prethodno liječenje metilfenidatom nije smatrao odgovarajućim.
English: • Amendment to the section 4.1 to advise that “Treatment should be under the supervision of a specialist in childhood and/or adolescent behavioural disorders.” and that “Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine 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 and potential for abuse, misuse or diversion.”
Croatian: • Promjena dijela 4.1. koja savjetuje da „Liječenje mora biti pod nadzorom specijaliste za poremećaje ponašanja u djece i/ili adolescenata.” i da „Deksamfetamin nije indiciran u sve djece s ADHD-om te se odluka o uporabi deksamfetamina mora temeljiti na vrlo temeljitoj procijeni težine i kroničnosti simptoma u djece koji su povezani s dječjom dobi i potencijalom za zloporabu, pogrešnu uporabu i diverziju.”
English: This meta-analysis identified a number of key issues that may explain the differences in outcome of the studies, and the authors noted that, while building on that of Wilens et al. (2003), is still relatively modest in terms of number of studies included.
Croatian: Ova meta analiza identificirala je brojna ključna pitanja koja mogu objasniti razlike u ishodu ispitivanja i autori su zabilježili, na temelju rezultata ispitivanja Wilensa i sur. (2003.) da je još uvijek relativno skromna u smislu broja uključenih ispitivanja.
English: Therefore the introduction of a dexamfetamine product with a risk management plan is expected to provide significant improvement by collecting information about use of the product in real life setting, as well as introducing risk minimisation measures that are currently not in place.
Croatian: Stoga se očekuje da će uvođenje lijeka deksamfetamina uz plan upravljanja rizicima pružiti značajno poboljšanje prikupljanjem informacija o uporabi lijeka u stvarnom okruženju kao i uvođenje mjera minimizacije rizika koje nisu trenutno aktualne.
English: The Committee also noted that dexamfetamine-containing products have been available in the EU for several years without a risk management plan and therefore the introduction of a dexamfetamine product with a risk management plan is expected to represent a significant improvement for patients.
Croatian: Povjerenstvo je također uočilo da su lijekovi koji sadrže deksamfetamin dostupni u EU-u tijekom nekoliko godina bez plana upravljanja rizicima i stoga se očekuje da će uvođenje deksamfetamina uz plan upravljanja rizicima biti znatno poboljšanje za bolesnike.
English: While there is no information about the sequence of treatments, mainly due to its cross-over design the results are convincing.
Croatian: Dok s jedne strane nema informacija o slijedu terapija, rezultati su uvjerljivi uglavnom zbog njegovog unakrsnog dizajna.
English: In addition, the DUS should be expanded to actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Croatian: Pored toga, ispitivanje iskorištenja lijeka treba proširiti kako bi se aktivno dobila izvješća o zloporabi, pogrešnoj uporabi, diverziji i ovisnosti u djece s ADHD-om iz centara za kontrolu otrova, centara za praćenje lijekova, drugih baza podataka, javno dostupnih informacije u literaturi i na mreži,
English: Therefore as a measure to mitigate this risk, the applicant proposed to downgrade dexamfetamine to second line use in ADHD and for children and adolescents of 6 to 17 years of age, if other medicinal and nonmedical treatment options have not achieved adequate results.
Croatian: Stoga, kao mjera smanjenja ovog rizika podnositelj zahtjeva predložio je da smanji uporabu deksamfetamina na drugu liniju uporabe u ADHD-u i za djecu i adolescente u dobi od 6 do 17 godina ako drugi lijekovi i nemedicinske terapije nisu postigli odgovarajuće rezultate.
English: This is acceptable as in well-established use applications it is not required that applicants provide results of pre-clinical tests and clinical trials, these are to be replaced by appropriate scientific literature.
Croatian: To je prihvatljivo jer u zahtjevima za odobravanje lijekova prema dobro utvrđenoj primjeni nije potrebno da podnositelj zahtjeva podnese rezultate nekliničkih i kliničkih ispitivanja, već ih zamjenjuje odgovarajućom znanstvenom literaturom.
English: This retrospective (new users) study will also compare the relative risk between dexamfetamine and other stimulants in the patient population.
Croatian: Ovo petogodišnje retrospektivno ispitivanje (za nove korisnike) također će usporediti deksamfetamin i druge stimulanse u populaciji bolesnika.
English: These data are further supported by the Arnold et al. (1978) study.
Croatian: Te je podatke nadalje podupro Arnold sa suradnicima. u svom ispitivanju (1978.).
English: The experts consulted expressed the fact that ADHD is less likely to produce euphoria in children when the products are used as intended.
Croatian: Konzultirani stručnjaci izrazili su činjenicu da je manje vjerojatno da će ADHD izazvati euforiju u djece kad se lijek koristi u skladu s indikacijama.
English: However, a more recent meta-analysis by Humphreys et al. (2013) investigated both published and unpublished reports on a total of 15 different studies and concluded that effective treatment of ADHD, typically using methylphenidate, does not seem to have impact of substance abuse later in life.
Croatian: Međutim, novije meta analize od strane Humphreys i sur. (2013.) ispitivale su i objavljena i neobjavljena izvješća o ukupno 15 različitih ispitivanja i zaključili su da se čini da djelotvorno liječenje ADHD-a tipičnom uporabom metilfenidata nema utjecaja na kasniju zloporabu tvari.
English: Even though no single study can be taken as pivotal evidence, the publications submitted within the application, which include not just published studies but also therapeutic guidelines and textbooks, are supportive of the efficacy in second line treatment of ADHD.
Croatian: Iako se nijedno pojedinačno ispitivanje ne može uzeti kao glavni dokaz, publikacija predana uz zahtjev koji uključuje ne samo objavljena ispitivanja nego i terapijske smjernice i udžbenike podržavaju djelotvornost druge linije liječenja ADHD-a.
English: Its use as second line treatment only, despite its proven efficacy, is a measure introduced in order to mitigate this concern.
Croatian: Njegova uporaba samo u drugoj liniji liječenja, unatoč svojoj dokazanoj djelotvornosti je mjera uvedena kako bi se smanjila ova bojazan.