FrancophonIA/ELRC3.0 huggingface dataset:
English: On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Croatian: Dana 13. studenoga 2017. tvrtka Medday Pharmaceuticals službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Qizenday za liječenje progresivne multiple skleroze.
English: Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Croatian: Qizenday je lijek koji se trebao koristiti za liječenje odraslih osoba s progresivnim oblikom multiple skleroze, bolesti u kojoj je zaštitna ovojnica oko živčanih stanica u mozgu i leđnoj moždini oštećena, a živci progresivno degeneriraju.
English: How does Qizenday work?
Croatian: Kako djeluje Qizenday?
English: The first study involved 154 patients with spinal progressive multiple sclerosis.
Croatian: Prvim ispitivanjem obuhvaćeno je 154 bolesnika sa spinalnom
English: Withdrawal of the marketing authorisation application for Qizenday (biotin)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Qizenday (biotin)
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova u kojima se koristi lijek Qizenday.
English: What was Qizenday expected to be used for?
Croatian: Za što se Qizenday trebao koristiti?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Croatian: Na temelju pregleda podataka i odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Qizenday za liječenje progresivne multiple skleroze.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog mišljenja CHMP-a da izneseni klinički podatci ne omogućuju Odboru da zaključi da je omjer koristi i rizika za Qizenday pozitivan.
English: Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Croatian: (biotin) EMA/821654/2017
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks.
Croatian: Sukladno navedenome CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Qizenday ne nadmašuju s njim povezane rizike.
English: • concentrate.
Croatian: • koncentrirati se.
English: Adults and elderly
Croatian: Odrasli i stariji
English: Adolescent subjects must weigh at least 34 kg.
Croatian: Adolescentni ispitanici moraju imati težinu od najmanje 34 kg.
English: Take the medicine pack with you and tell them how much you have taken.
Croatian: Ponesite sa sobom pakiranje lijeka i recite im koliko ste ga uzeli.
English: They can find it hard to behave well at home, at school or in other places.
Croatian: Teško im je pristojno se ponašati kod kuće, u školi i na drugim mjestima.
English: Children under 6 years
Croatian: Djeca mlađa od 6 godina
English: • you have fainted recently
Croatian: • ako ste se nedavno onesvijestili
English: Date of first authorisation: 17/09/2015
Croatian: Datum prvog odobrenja: 17. rujna 2015.
English: • seeing or hearing things that are not there (hallucination).
Croatian: • vide se ili čuju stvari koje ne postoje (halucinacija)
English: These checks may include:
Croatian: Te pretrage mogu uključivati:
English: It is recommended clinical judgement be exercised during this period.
Croatian: Preporučuje se klinička prosudba tijekom tog razdoblja.
English: Lactose is a type of sugar.
Croatian: Laktoza je vrsta šećera.
English: If you forget a dose, wait until the next day and take your usual dose.
Croatian: Ako zaboravite uzeti dozu, pričekajte do sljedećeg dana i uzmite svoju uobičajenu dozu.
English: This will show if you still need to take the medicine.
Croatian: Tako će se pokazati trebate li i dalje uzimati ovaj lijek.
English: These small changes are not expected to be clinically meaningful.
Croatian: Ne očekuje se da će ove male promjene biti klinički značajne.
English: ADHD does not affect the intelligence of a child or young person.
Croatian: ADHD ne utječe na inteligenciju djeteta ili mlade osobe.
English: This is because this medicine can make these problems worse.
Croatian: Razlog je taj što ovaj lijek može pogoršati te tegobe.
English: Week 5 Week 6 Week 7
Croatian: 5. tjedan 6. tjedan 7. tjedan
English: ADHD can cause problems with everyday life.
Croatian: ADHD može uzrokovati tegobe u svakodnevnom životu.
English: Patients should be advised to drink plenty of fluid.
Croatian: Bolesnicima treba savjetovati da piju puno tekućine.
English: Tel + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com
Croatian: + 44 (0) 1256 894 959 e-mail: medinfoEMEA@shire.com
English: Activated charcoal may be useful in limiting the absorption.
Croatian: Aktivni ugljen može biti koristan u ograničavanju apsorpcije.
English: Intuniv with food, drinks and alcohol
Croatian: Intuniv s hranom, pićem i alkoholom
English: • sit still
Croatian: • mirno sjediti
English: This medicine belongs to a group of medicines which affects brain activity.
Croatian: Ovaj lijek pripada skupini lijekova koji utječu na moždanu aktivnost.
English: The medicine is given as part of a treatment programme, which usually includes the following:
Croatian: Lijek se daje u sklopu programa liječenja, koje obično uključuje sljedeće:
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzimite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
English: Intuniv is taken once daily either morning or evening.
Croatian: Intuniv se uzima jedanput na dan, bilo ujutro ili navečer.
English: • This leaflet has been written as though the person taking the medicine is reading it.
Croatian: • Ova je uputa pisana kao da je čita osoba koja uzima lijek.
English: However, individuals may have larger increases than reflected by the mean changes.
Croatian: No kod pojedinih osoba može doći do većeg porasta od onog koji odražavaju srednje vrijednosti promjene.
English: Your doctor will routinely monitor you to see how this medicine affects you.
Croatian: Liječnik će Vas rutinski pratiti da vidi kako ovaj lijek djeluje na Vas.
English: Syncope has also been observed.
Croatian: Opažena je i sinkopa.
English: The elimination half-life of guanfacine is approximately 18 hours.
Croatian: Poluvijek eliminacije gvanfacina iznosi približno 18 sati.
English: • You may not notice an immediate effect upon starting treatment, some patients may notice an improvement after the first week but it could take longer.
Croatian: • Možda nećete primijetiti učinak odmah na početku liječenja; neki bolesnici mogu primijetiti poboljšanje nakon prvog tjedna, ali možda bude potrebno i dulje.
English: The Educational material and Prescriber checklist shall contain the following key messages:
Croatian: Edukacijski materijal i kontrolna lista za propisivača sadržavat će sljedeće ključne poruke:
English: Children (under 6 years old) and adults (18 years and over)
Croatian: Djeca (mlađa od 6 godina) i odrasli (u dobi od 18 godina i više)
English: Fainting has also been reported but is not a common effect.
Croatian: Također je zabilježena i nesvjestica, ali to nije uobičajeni učinak.
English: • This medicine should be taken once a day either in the morning or evening.
Croatian: • Ovaj lijek treba uzimati jedanput na dan, bilo ujutro bilo navečer.
English: Depending on how you respond to treatment your doctor may increase your dose more slowly.
Croatian: Ovisno o tome kako odgovorite na liječenje, liječnik Vam može sporije povisivati dozu.
English: The blisters are contained in cardboard cartons.
Croatian: Blisteri se nalaze u kartonskim kutijama.
English: If you are worried, speak to your doctor.
Croatian: Ako ste zabrinuti, obratite se svom liječniku.
English: Monitoring during titration
Croatian: Praćenje tijekom titracije
English: • you suffer from any other psychiatric conditions
Croatian: • ako bolujete od bilo koje druge psihijatrijske bolesti.
English: Treatment is recommended only for children who are able to swallow the tablet whole without problems.
Croatian: Liječenje se preporučuje samo za djecu koja mogu bez teškoća progutati cijelu tabletu.
English: • Do not take this medicine if you are pregnant or you are not using contraception.
Croatian: • Nemojte uzimati ovaj lijek ako ste trudni ili ne koristite kontracepciju.
English: Children and young people with ADHD may have difficulty learning and doing homework.
Croatian: Djeca i mlade osobe s ADHD-om mogu imati poteškoće s učenjem i pisanjem zadaće.
English: • Educational material (including prescriber checklist) for the healthcare professionals
Croatian: • Edukacijski materijal (uključujući kontrolnu listu za propisivača) za zdravstvene radnike.
English: Your doctor may want to review your treatment.
Croatian: Liječnik će Vam možda željeti provjeriti terapiju.
English: Before you start taking this medicine your doctor will check to make sure this medicine is safe for you and that it will help you.
Croatian: Prije nego što počnete uzimati ovaj lijek liječnik će provjeriti je li ovaj lijek za Vas siguran i hoće li Vam pomoći.
English: Patients should not drink alcohol whilst taking Intuniv.
Croatian: Bolesnici ne smiju piti alkohol dok uzimaju Intuniv.
English: The safety and efficacy of guanfacine in adult and the elderly with ADHD has not been established and therefore should not be used in this group.
Croatian: Sigurnost i djelotvornost gvanfacina u odraslih i starijih osoba s ADHD-om nije ustanovljena pa se stoga ne smije primjenjivati u ovoj skupini.
English: • Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice).
Croatian: • Tabletu progutajte cijelu, s vodom ili drugom tekućinom (ali ne sa sokom od grejpfruta).
English: • difficulty to get or keep an erection (erectile dysfunction).
Croatian: • poteškoće s postizanjem ili održavanjem erekcije (erektilna disfunkcija).
English: People with ADHD find it hard to:
Croatian: Osobama s ADHD-om teško je:
English: Therefore, a risk on the breast-fed infant cannot be excluded.
Croatian: Stoga se ne može isključiti rizik za dojenče.
English: If you take more Intuniv than you should
Croatian: Ako uzmete više Intuniva nego što ste trebali
English: Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Croatian: Intuniv se mora primjenjivati kao dio sveobuhvatnog programa liječenja ADHD-a, koji obično uključuje psihološke, edukacijske i socijalne mjere.
English: Guanfacine is a non-stimulant.
Croatian: Gvanfacin nije stimulans.
English: If you need to take Intuniv for more than a year your doctor will monitor your response to treatment and your doctor may stop the medicine for a short time; this may happen during a school holiday.
Croatian: Ako trebate uzimati Intuniv dulje od godinu dana, liječnik će pratiti Vaš odgovor na liječenje i može Vam prekinuti davati lijek neko kraće vrijeme; to može biti tijekom školskih praznika.
English: If you feel unwell in any way while you are taking your medicine please tell an adult straight away.
Croatian: Ako se na bilo koji način osjećate loše dok uzimate svoj lijek, molimo da o tome odmah obavijestite odraslu osobu.
English: • Your doctor will start you on 1 mg per day.
Croatian: • Liječnik će započeti Vaše liječenje dozom od 1 mg na dan.
English: Intuniv may affect your weight and height if taking for long periods, your doctor will therefore monitor your growth.
Croatian: Intuniv Vam može utjecati na težinu i visinu ako se uzima tijekom duljih razdoblja pa će stoga liječnik pratiti Vaš rast.
English: • changes in liver blood test results (increased alanine aminotransferase)
Croatian: • promjene u rezultatima krvnih pretraga jetre (povišena alanin aminotransferaza)
English: Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible change in the ADHD treatment programme.
Croatian: Možda bude potrebno liječiti podležeće psihijatrijsko stanje i razmotriti mogućnost promjene u programu liječenja ADHD-a.
English: The recommended dose titration for children and adolescents is provided below (see tables 1 and 2).
Croatian: Preporučena titracija doze za djecu i adolescente prikazana je niže u tekstu (vidjeti tablice 1 i 2).
English: An apparent increase in mean QTc was observed for both doses.
Croatian: Vidljivo povećanje srednje vrijednosti QTc intervala bilo je opaženo za obje doze.
English: The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: Management of Intuniv overdose should include monitoring for and treatment of these signs and symptoms.
Croatian: Zbrinjavanje predoziranja Intunivom treba uključivati praćenje i liječenje ovih znakova i simptoma.
English: See section 4.2 for further dosing recommendations
Croatian: Vidjeti dio 4.2 za dodatne preporuke za doziranje
English: • medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
Croatian: • lijekove za tegobe s mentalnim zdravljem (benzodiazepine, barbiturate i antipsihotike)
English: The following table presents all adverse reactions based on clinical trials and spontaneous reporting.
Croatian: U sljedećoj su tablici prikazane sve nuspojave na temelju kliničkih ispitivanja i spontanih prijava.
English: • you are allergic to guanfacine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na gvanfacin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The mode of action of guanfacine in ADHD is not fully established.
Croatian: Način djelovanja gvanfacina u ADHD-u nije u potpunosti ustanovljen.
English: • It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast).
Croatian: • Može se uzimati s hranom ili bez nje, ali nemojte ga uzimati s masnom hranom (npr. doručak s visokim udjelom masti).
English: In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines:
Croatian: Osobito obavijestite liječnika ili ljekarnika ako uzimate neku od sljedećih vrsti lijekova:
English: Studies SPD503-301 and SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States.
Croatian: Ispitivanja SPD503-301 i SPD503-304 trajala su 8 odnosno 9 tjedana i oba su provedena u Sjedinjenim Američkim Državama.
English: Other medicines and Intuniv
Croatian: Drugi lijekovi i Intuniv
English: • medicines for epilepsy such as valproic acid
Croatian: • lijekove za epilepsiju, kao što je valproatna kiselina
English: Patients should be warned of these possible effects and be advised that if affected, they should avoid these activities (see section 4.4).
Croatian: Bolesnike treba upozoriti na ove moguće učinke i savjetovati im da izbjegavaju navedene aktivnosti ako osjete takve učinke (vidjeti dio 4.4).
English: This medicine should not be used in children under 6 years of age and adults 18 years and over because it is not known if it works or is safe.
Croatian: Ovaj lijek ne smiju uzimati djeca mlađa od 6 godina i odrasli u dobi od 18 godina i više jer nije poznato djeluje li i je li siguran.
English: Due to variability in interaction effect, further dose titration may be needed (see above).
Croatian: Zbog promjenjivog interakcijskog učinka može biti potrebno dodatno titriranje doze (vidjeti gore).
English: If you take more Intuniv than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako ste uzeli više Intuniva nego što ste trebali, odmah se obratite liječniku ili otiđite u bolnicu.
English: If this happens do not drive, cycle, use any tools or machines or participate in activities that could cause injury until you know how this medicine affects you.
Croatian: Ako se to dogodi, nemojte upravljati vozilima, biciklom, rukovati alatima i strojevima ili sudjelovati u aktivnostima u kojima biste se mogli ozlijediti prije nego što saznate kako na Vas utječe ovaj lijek.
English: • medicines that can affect the way Intuniv is eliminated by the liver (please see table below)
Croatian: • lijekove koji mogu utjecati na uklanjanje Intuniva putem jetre (molimo, pogledajte tablicu niže).
English: Shire Pharmaceuticals Ireland Limited (as MA Logo)
Croatian: Shire Pharmaceuticals Ireland Limited (kao logo nositelja odobrenja)
English: • Do not drink alcohol when taking this medicine as it may make you sleepy or drowsy.
Croatian: • Nemojte piti alkohol kad uzimate ovaj lijek, jer od toga možete postati pospani i omamljeni.
English: Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician.
Croatian: Bolesnike u kojih se tijekom liječenja ADHD-a pojavi suicidalna ideacija ili suicidalno ponašanje treba odmah procijeniti njihov liječnik.
English: Do not use this medicine if the tablets or blister pack look damaged.
Croatian: Ovaj lijek se ne smije upotrijebiti ako tablete ili blister pakiranje izgledaju oštećeno.
English: The results with respect to the primary endpoint study are presented in Table 5.
Croatian: Rezultati u pogledu primarnog ishoda ispitivanja prikazani su u tablici 5.
English: If two or more consecutive doses are missed, re-titration is recommended based on the patient's tolerability to guanfacine.
Croatian: Ako se propuste dvije ili više uzastopnih doza, preporučuje se ponovna titracija na temelju bolesnikove podnošljivosti gvanfacina.
English: These patients should receive further cardiac evaluation based on clinical judgement (see section 4.8).
Croatian: U tih bolesnika treba provesti daljnju srčanu procjenu na temelju kliničke prosudbe (vidjeti dio 4.8).
English: It may have a moderate to severe influence on the ability to drive, use machines or cycling.
Croatian: To može imati umjereni do jaki utjecaj na sposobnost upravljanja vozilima, rada sa strojevima ili vožnje biciklom.
English: Systemic exposure to guanfacine is similar for men and women given the same mg/kg dose.
Croatian: Sistemska izloženost gvanfacinu slična je u muškaraca i žena koji prime istu dozu u mg/kg.
English: Guanfacine is not dialysable in clinically significant amounts (2.4%).
Croatian: Gvanfacin se ne može ukloniti dijalizom u klinički značajnim količinama (2,4%).
English: Intuniv should not be used in children under the age of 6 years because efficacy and safety in this patient population has not been studied.
Croatian: Intuniv se ne smije primjenjivati u djece mlađe od 6 godina zato što njegova djelotvornost i sigurnost u ove populacije bolesnika nije ispitana.
English: • Your daily dose will be between 1 and 7 mg depending on your age and how you respond to Intuniv, but not more that 7 mg.
Croatian: • Vaša dnevna doza iznosit će između 1 i 7 mg ovisno o Vašoj dobi i odgovoru na Intuniv, ali doza neće biti viša od 7 mg.
English: All drug-drug interaction studies have been performed in adults, however, the outcome is expected to be similar in the indicated paediatric age range.
Croatian: Sva ispitivanja interakcija lijekova provedena su u odraslih; međutim, očekuje se sličan ishod u indiciranom pedijatrijskom dobnom rasponu.
English: Summary of primary efficacy for study SPD503-316: ADHD-RS-IV
Croatian: Tablica 5. Sažetak primarne djelotvornosti u ispitivanju SPD503-316: ADHD-RS-IV
English: The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10)
Croatian: Terminologija za učestalost koja se koristi u daljnjem tekstu definira se na sljedeći način: Vrlo često (≥1/10)
English: • trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares
Croatian: • poteškoće sa spavanjem (nesanica) ili isprekidan san (otežano održavanje sna) ili noćne more
English: Active renal secretion is mediated via OCT2 transporter.
Croatian: Aktivna sekrecija u bubrezima posredovana je transporterom OCT2.
English: Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7).
Croatian: Sinkopa može uključivati rizik od padova ili nezgoda, koji mogu rezultirati ozbiljnim ozljedama (vidjeti dijelove 4.8 i 4.7).
English: Difference from placebo (95%CI)
Croatian: Razlika u odnosu na placebo (95% CI)
English: Results of the secondary endpoints were consistent with that of the primary endpoint.
Croatian: Rezultati sekundarnih ishoda bili su sukladni onima za primarni ishod.
English: Prior to launch of Intuniv in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije puštanja Intuniva u promet, nositelj odobrenja u svakoj državi članici mora usuglasiti s nacionalnim nadležnim tijelom sadržaj i oblik edukacijskog programa, uključujući medije komunikacije, načine distribucije i sve druge aspekte programa.
English: During the first year of treatment, the patient should be assessed at least every 3 months for:
Croatian: Trajno praćenje Tijekom prve godine liječenja, bolesnika treba procijeniti najmanje svaka 3 mjeseca zbog:
English: As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial dosing and/or dose adjustments.
Croatian: U sklopu liječenja, liječnik će pažljivo nadzirati kako Intuniv djeluje na Vas tijekom početne primjene i/ili prilagodbe doze.
English: What Intuniv is and what it is used for What you need to know before you take Intuniv How to take Intuniv
Croatian: Što je Intuniv i za što se koristi Što morate znati prije nego počnete uzimati Intuniv Kako uzimati Intuniv
English: Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro chromosomal aberration test.
Croatian: Gvanfacin nije bio genotoksičan u raznim testiranim modelima, uključujući Amesov test i in vitro test kromosomske aberacije.
English: Intuniv should not be crushed, chewed or broken before swallowing because this increases the rate of guanfacine release.
Croatian: Intuniv se ne smije drobiti, žvakati niti lomiti prije gutanja jer to povećava brzinu oslobađanja gvanfacina.
English: The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment and diminished gradually thereafter.
Croatian: Pojava somnolencije/sedacije i hipotenzije bila je najizraženija u prvih nekoliko tjedana liječenja i nakon toga se postupno smanjivala.
English: • unusual heart rhythm (sinus arrhythmia and first-degree arterioventricular block)
Croatian: • neobičan srčani ritam (sinusna aritmija i atrioventrikularni blok prvog stupnja)
English: Do not chew, divide or crush.
Croatian: Nemojte je žvakati, lomiti ni drobiti.
English: If you are giving this medicine to your child, please replace “you” with “your child” throughout.
Croatian: molimo da umjesto „Vi“ čitate „Vaše dijete“ kroz cijeli tekst.