FrancophonIA/ELRC3.0 huggingface dataset:
English: A number of plausible molecular mechanism exists that may contribute to vascular occlusive events.
Croatian: Postoji niz plauzibilnih molekularnih mehanizama koji mogu doprinijeti vaskularnim okluzijama.
English: The MAH shall provide relevant healthcare professionals with educational material highlighting important medical risks for which monitoring and/or dose adjustment are recommended, instructions on management of adverse events based on monitoring and dose modifications or treatment withdrawal and available data on the relationship between dose and risk of vascular occlusive events.
Croatian: Nositelj odobrenja dostavit će relevantnim zdravstvenim djelatnicima edukacijske materijale u kojima se navode važni zdravstveni rizici za koje se preporuča praćenje i/ili prilagodba doze, upute za upravljanje nuspojavama na temelju praćenja kao i modifikacije doze ili ustezanje liječenja i dostupni podaci o odnosu između doze i rizika od vaskularne okluzije.
English: This raises the question of whether similar outcomes in terms of efficacy could be achieved with lower (starting and/or maintenance) doses, which are expected to reduce the risk of vascular occlusive events.
Croatian: Ovo otvara pitanje mogu li se slični ishodi u smislu djelotvornosti postići s manjim dozama (početnim dozama i/ili dozama održavanja), za koje se očekuje da će smanjiti rizik od vaskularne okluzije.
English: • Inclusion of safety and efficacy data following dose reduction in CP-CML patients who have achieved MCyR to inform physicians of the currently available data on dose reduction.
Croatian: • uključivanje podataka o sigurnosti i učinkovitosti po smanjivanju doze u bolesnika sa CPCML-om koji su postigli MCyR kako bi se obavijestilo liječnike o trenutno dostupnim podacima za smanjivanje doze.
English: Efficacy data in relation to dose reduction indicates that patients who have been dose reduced maintained response (MCyR and MMR) for the duration of the currently available follow-up.
Croatian: Podaci o djelotvornosti u odnosu na smanjivanje doze ukazuju na to da su bolesnici, kojima je smanjena doza, zadržali odgovor (MCyR i MMR) tijekom trajanja trenutno dostupnih kontrola.
English: The majority of cases of cardiac failure occurred in patients at known risk from underlying disease, cardiovascular risk factors and prior treatment with cardiotoxic medications including other TKIs.
Croatian: Većina slučajeva zatajenja srca nastupila je u bolesnika s poznatim rizikom od bolesti koja se nalazi u podlozi, čimbenicima kardiovaskularnog rizika i prethodnom terapijom kardiotoksičnih lijekova koji su uključivali druge TKI-ove.
English: The overall safety profile for ponatinib is generally consistent with that considered at the time of marketing authorisation, with the notable addition of the risk of vascular occlusive events.
Croatian: Cjelokupan sigurnosni profil za ponatinib načelno je konzistentan s profilom koji je razmatran u trenutku izdavanja odobrenja za stavljanje lijeka u promet, uz istaknuti dodatak rizika od vaskularne okluzije.
English: Further non-clinical studies will be conducted with the aim to further characterise the potential mechanisms for vascular occlusive events with ponatinib treatment.
Croatian: Provest će se daljnja neklinička ispitivanja sa ciljem daljnjeg karakteriziranja potencijalnih mehanizama za vaskularne okluzije s terapijom ponatinibom.
English: The PRAC considered whether a recommendation for dose reduction (in the absence of an adverse event) in patients with chronic phase CML who have achieved major cytogenetic response was appropriate.
Croatian: PRAC je razmotrio je li primjerena preporuka za smanjivanje doze (u slučaju odsutnosti nuspojava) u bolesnika s kroničnom fazom CML-a koji su postigli značajan citiogenetski odgovor.
English: As part of the assessment of potential causes that may lead to an increased occurrence of vascular occlusive events in ponatinib treated patients, molecular mechanisms based on on-target and offtarget effects were discussed.
Croatian: Kao sastavni dio ocjene potencijalnih uzroka koji mogu rezultirati učestalijim nastupanjem okluzivnih događaja u bolesnika liječenih ponatinibom razmatrani su molekularni mehanizmi temeljeni na ciljanom i neciljanom djelovanju.
English: These included further consideration of the PK-PD profile of ponatinib to determine the optimal dosing in all patient populations and indications (including recommendations for initial dose and dose reductions), further assessment of the nature, severity and frequency of all treatment-emergent vascular occlusive adverse events (and possible sequelae), and heart failure, exploration of the potential mechanisms of action leading to vascular occlusive events and consideration of the possibilities for further risk minimisation measures.
Croatian: Ovo je uključivalo daljnje razmatranje FK-FD profila ponatiniba kako bi se utvrdilo optimalno doziranje u svih populacija bolesnika i indikacija (uključujući preporuke za početnu dozu i redukcije doza), daljnja ocjena prirode, ozbiljnosti i učestalosti svih nuspojava vaskularne okluzije koje se pojavljuju kao posljedica liječenja (kao i mogući naknadni događaji), te zatajenje srca, istraživanje potencijalnih mehanizama djelovanja koji rezultiraju vaskularnom okluzijom kao i razmatranja mogućnosti za daljnje mjere smanjivanja rizika.
English: However, there were a number of outstanding issues which could not be resolved within the expedited variation procedure and which required a further review of the benefit-risk balance of Iclusig.
Croatian: No, bio je prisutan niz neriješenih problema koji se nisu mogli ukloniti pokrenutim postupkom varijacije, te koji su zahtijevali daljnji pregled omjera koristi i rizika lijeka Iclusig.
English: • The PRAC also noted that, although limited, the data in chronic phase CML is indicative of maintenance of response in patients who are dose reduced and therefore it was considered important to generate further data on the dose-efficacy relationship to potentially inform future risk minimisation measures.
Croatian: • PRAC je također napomenuo da, iako ograničeni, podaci u kroničnoj fazi CML-a su indikativni za održavanje odgovora u bolesnika čija je doza smanjena i stoga se smatra važnim generiranje daljnjih podataka o odnosu doze i učinkovitosti kako bi se potencijalno informiralo o budućim mjerama za smanjivanje rizika.
English: Therefore no formal recommendation can be issued regarding concomitant the use of these agents and the potential risks of haemorrhage with anti-platelet and anticoagulant agents in ponatinib treated patients need to be considered.
Croatian: Stoga se ne može izdati službena preporuka u vezi s istovremenom primjenom ovih lijekova, te je potrebno razmotriti potencijalne rizike od krvarenja s antitrombocitnim i antikoagulatnim lijekovima u bolesnika liječenih ponatinibom.
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation and
Croatian: • kroničnom mijeloičnom leukemijom (KML) u kroničnoj, ubrzanoj ili blastičnoj fazi bolesti koji su rezistentni na liječenje dasatinibom ili nilotinibom; koji ne podnose dasatinib ili nilotinib i za koje naknadno liječenje imatinibom nije klinički opravdano; ili koji imaju T315I mutaciju i
English: Grounds for the recommendation
Croatian: Razlozi za preporuku Budući da je
English: This study is considered key to the benefit-risk of ponatinib and has been imposed as a condition to the marketing authorisation.
Croatian: Ovo se ispitivanje smatra ključnim za omjer koristi i rizika ponatiniba, te je postavljeno kao uvjet za izdavanje odobrenja za stavljanje lijeka u promet.
English: • The PRAC also considered the currently available data on dose-efficacy and dose-toxicity relationship, and concluded that it was too limited to allow for a formal recommendation for dose reduction as a risk minimisation measure in patients who have not experienced toxicity.
Croatian: • PRAC također razmotrio trenutno dostupne podatke o odnosima doze i djelotvornosti te doze i toksičnosti, i zaključio da su isti preograničeni za donošenje službenih preporuka za smanjivanje doze kao mjere za smanjivanje rizika u bolesnika koji nisu imali naznake toksičnosti.
English: The risk of vascular occlusive events is likely to be dose related and therefore a dose reduction would be expected to reduce the risk of vascular occlusive events.
Croatian: Izgledno je da je rizik od vaskularne okluzije povezan s dozom, te se stoga očekuje da bi smanjenje doze smanjilo rizik od vaskularne okluzije.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisation for Iclusig should be varied.
Croatian: Nakon što je razmotrio preporuku PRAC-a, CHMP je suglasan sa cjelokupnim znanstvenim zaključcima koje je donio PRAC te je mišljenja kako je potrebno izmijeniti odobrenja za stavljanje lijeka u promet za lijek Iclusig.
English: Conducting further studies aimed at clarifying the dose-efficacy relationship of ponatinib is considered key to allow exploration of dose reduction in the context of risk minimisation, which could ultimately lead to improving the benefit-risk balance of the product.
Croatian: Ključnim se smatra provođenje daljnjih ispitivanja usmjerenih na pojašnjavanje odnosa doze i djelotvornosti ponatiniba kako bi se omogućilo istraživanje smanjenje doze u kontekstu smanjivanja rizika, što bi na posljetku moglo rezultirati poboljšanjem omjera koristi i rizika za proizvod.
English: Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group for oncology, the PRAC concluded that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Croatian: Na temelju ukupnosti svih podataka ocjenjenih tijekom postupka i savjeta znanstvene savjetodavne skupine za onkologiju, PRAC je zaključio da omjer koristi i rizika za lijek Iclusig ostaje povoljan uzimajući u obzir dopune informacija o proizvodu te je predmetom usuglašenih mjera za smanjivanje rizika i dodatnih aktivnosti na području farmakovigilancije.
English: The PRAC also recommended that a dose-ranging study be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving major cytogenetic response.
Croatian: PRAC je također preporučio provođenje ispitivanja raspona doze u bolesnika sa CP-CML kako bi se utvrdila optimalna početna doza za lijek Iclusig i okarakterizirale sigurnost i učinkovitost lijeka Iclusig po smanjivanju doze nakon postizanja značajnog citogenetskog odgovora.
English: The PRAC has therefore recommended the variation to the terms of the marketing authorisation for Iclusig.
Croatian: Stoga je PRAC preporučio izmjenu uvjeta odobrenja za stavljanje u promet lijeka za lijek Iclusig.
English: A dose-ranging study will be conducted in patients with CP-CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR.
Croatian: Ispitivanje raspona doze provest će se u bolesnika sa CP-CML-om sa ciljem utvrđivanja optimalne početne doze lijeka Iclusig i okarakteriziranja sigurnosti i djelotvornosti lijeka Iclusig po smanjivanju doza nakon postizanja MCyR-a.
English: The possible role of anti-platelet, anti-coagulant or lipid lowering drugs in reducing the risk of vascular occlusive events remains uncertain.
Croatian: I dalje se ne može reći sa sigurnošću koja je moguća uloga antitrombocitnih i antikoagulantnih lijekova, kao i lijekova za snižavanje lipida u postupku smanjivanja rizika vaskularne okluzije.
English: The PRAC is therefore of the opinion that the benefit-risk balance of Iclusig remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Croatian: PRAC je stoga mišljenja da omjer koristi i rizika za lijek Iclusig ostaje povoljan uzimajući u obzir dopune informacija o proizvodu, te da je predmetom usuglašenih mjera za smanjivanje rizika i dodatnih aktivnosti na području farmakovigilancije.
English: No special treatment is required.
Croatian: Nije potrebno nikakvo posebno liječenje.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Ovaj lijek uvijek uzimajte točno onako kako vam je rekao liječnik.
English: These medicines should be taken in the morning.
Croatian: Te je lijekove potrebno uzimati ujutro.
English: The combination should be avoided.
Croatian: Tu kombinaciju je potrebno izbjegavati.
English: Terminal half life (t½) is 3.5-4 hours.
Croatian: Terminalni poluvijek (t½) iznosi 3,5 do 4 sata.
English: - This medicine has been prescribed for you or your child only.
Croatian: - Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: Clinical efficacy and safety in the paediatric population
Croatian: Klinička djelotvornost i sigurnost u pedijatrijskoj populaciji
English: The treatment effects on sleep variables were associated with improved parents' well-being.
Croatian: Učinci liječenja na varijable spavanja bili su povezani s poboljšanom dobrobiti roditelja.
English: These medicines should be avoided, especially in the evening.
Croatian: Te je lijekove potrebno izbjegavati, posebice uvečer.
English: -3.64,3.89 ns
Croatian: -3,64, 3,89 nz
English: Tablets should be swallowed whole.
Croatian: Tablete se trebaju progutati cijele.
English: This leaflet was last revised in { month/YYYY}.
Croatian: Ova uputa je zadnji put revidirana u { mjesec/GGGG}.
English: For children and adolescents aged 2-18
Croatian: Za djecu i adolescente u dobi od 2 do 18 godina
English: If this change in behaviour occurs, you must tell your doctor.
Croatian: Ako se pojavi ova promjena u ponašanju, morate obavijestiti svojeg liječnika.
English: 5- or 8-methoxypsoralen
Croatian: 5- ili 8-metoksipsoralen
English: The tablets should be taken after the evening meal, i.e. on a full stomach.
Croatian: Tablete je potrebno uzeti nakon večernjeg obroka, tj. na pun želudac.
English: - suffers from an autoimmune disease (where the body's own immune (defence) system attacks parts of the body).
Croatian: - patite od autoimune bolesti (kada imunosni (obrambeni) sustav organizma napada vlastite dijelove organizma).
English: Common: may affect between 1 in 100 to 1 in 10 people
Croatian: Često: mogu se javiti u od 1 na 100 osoba do 1 u 10 osoba
English: Beta-blockers
Croatian: Beta-blokatori
English: Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 to 1 in 10 people).
Croatian: Neočekivane promjene u ponašanju, kao što je agresivnost, mogu se često pojaviti (između 1 na 100 do 1 na 10 ljudi).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODATCI ČITLJIVI LJUDSKIM OKOM PC:
English: Do not give this medicine to children below the age of 2 years as it has not been tested and its effects are unknown.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 2 godine jer još nije ispitan u toj populaciji i njegovi učinci nisu poznati.
English: DO NOT take Slenyto if you or your child: - is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Croatian: NEMOJTE uzimati Slenyto ako ste Vi ili Vaše dijete: - alergični na melatonin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: After taking this medicine, you or your child should not drive a vehicle, ride a bicycle, or use machinery until completely recovered.
Croatian: Nakon što uzmete ovaj lijek, Vi ili Vaše dijete ne smijete upravljati vozilom, voziti bicikl ili upravljati strojevima dok se potpuno ne oporavite.
English: • is pregnant or might be pregnant.
Croatian: • trudni ili mislite da biste mogli biti trudni.
English: Interactions with other medicines
Croatian: Interakcije s drugim lijekovima
English: It is important to continue taking this medicine to treat the condition.
Croatian: Važno je da nastavite uzimati ovaj lijek za liječenje Vašeg stanja.
English: DATE OF REVISION OF THE TEXT {DD month YYYY}
Croatian: DATUM REVIZIJE TEKSTA {DD mjesec GGGG}
English: When
Croatian: Kada
English: Data are available for up to 2 years' treatment.
Croatian: Dostupni su podatci za liječenje u trajanju do 2 godine.
English: Melatonin is a hormone produced naturally by the body.
Croatian: Melatonin je hormon koji se prirodno stvara u tijelu.
English: If there is no improvement in your/your child's symptoms, your doctor may increase the dose of Slenyto to find the most suitable dose for you/your child.
Croatian: Ako ne dođe do poboljšanja Vaših/djetetovih simptoma, Vaš liječnik može povećati dozu lijeka Slenyto kako bi pronašao najprikladniju dozu za Vas/Vaše dijete.
English: How long
Croatian: Koliko dugo
English: You should speak to your doctor before taking/giving Slenyto as its use is not recommended in such cases.
Croatian: Trebate razgovarati sa svojim liječnikom prije uzimanja/davanja lijeka Slenyto jer se njegova primjena u takvim slučajevima ne preporučuje.
English: A five-fold variability in Cmax between different members of the same sex has also been observed.
Croatian: Opažena je i peterostruka varijabilnost u vrijednostima Cmax između osoba istog spola.
English: Other medicines and Slenyto
Croatian: Drugi lijekovi i Slenyto
English: • Changes in mood
Croatian: • promjene raspoloženja
English: 6.5 Nature and contents of container
Croatian: 6.5 Vrsta i sadržaji spremnika
English: The maximum daily dose that you/your child will receive is 10 mg (two 5-mg tablets).
Croatian: Najveća dnevna doza koju ćete Vi/Vaše dijete primiti je 10 mg (dvije tablete od 5 mg).
English: Slenyto is available in two strengths: 1 mg and 5 mg.
Croatian: Slenyto je dostupan u dvije jačine: 1 mg i 5 mg.
English: Bioavailability is in the order of 15%.
Croatian: Bioraspoloživost iznosi 15%.
English: • Low levels of white blood cells (neutropenia)
Croatian: • niska razina bijelih krvnih stanica (neutropenija)
English: The medicine can help you or your child fall asleep and may help you or your child sleep for longer during the night.
Croatian: Lijek može pomoći Vama ili Vašem djetetu da zaspete i da dulje spavate tijekom noći.
English: Treatment difference (SE)
Croatian: Razlika između liječenja (SE)
English: It is for the treatment of insomnia (sleeplessness) when a healthy sleeping routine (such as a regular bedtime and soothing sleeping environment) has not worked well enough.
Croatian: Primjenjuje se za liječenje nesanice kada zdrava rutina spavanja (kao što je redoviti odlazak na spavanje i umirujuća okolina) nije dovoljna.
English: Concomitant use of the following medicinal products should be considered with caution:
Croatian: Kod istodobne primjene sljedećih lijekova treba primijeniti oprez:
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podatci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg.
Croatian: Ako se opazi neadekvatan odgovor, dozu treba povećati na 5 mg.
English: Smoking can increase the breakdown of melatonin by the liver, which may make this medicine less effective.
Croatian: Pušenje može povećati razgradnju melatonina u jetri, što ovaj lijek može učiniti manje učinkovitim.
English: Alcohol should not be taken with melatonin, because it reduces the effectiveness of melatonin on sleep.
Croatian: Alkohol Alkohol se ne smije uzimati s melatoninom jer smanjuje učinkovitost melatonina na san.
English: Do not drink alcohol before, during or after taking Slenyto, because alcohol weakens the effect of the medicine.
Croatian: Slenyto s alkoholom Nemojte piti alkohol prije, tijekom ni nakon uzimanja lijeka Slenyto, jer alkohol slabi učinak lijeka.
English: The doctor may want you/your child to stop taking this medicine.
Croatian: Liječnik će možda zatražiti da Vi/Vaše dijete prestanete uzimati ovaj lijek.
English: Treatment was administered for up to two years.
Croatian: Liječenje je trajalo do dvije godine.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30 °C.
English: Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Croatian: Istodobna primjena rezultirala je povećanim poremećajem pažnje, pamćenja i koordinacije u usporedbi sa samim zolpidemom.
English: What Slenyto is and what it is used for
Croatian: Što je Slenyto i za što se primjenjuje
English: After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.
Croatian: Nakon najmanje 3 mjeseca liječenja liječnik treba procijeniti učinak liječenja i razmotriti prekid liječenja ako ne primjećuje klinički značajan učinak liječenja.
English: France e-mail: regulatory@neurim.com
Croatian: Francuska e-pošta: regulatory@neurim.com
English: Concomitant use of the following medicinal products is not recommended (see section 4.4):
Croatian: Ne preporučuje se istodobna primjena sljedećih lijekova (vidjeti dio 4.4.):
English: A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent to approximately 2000 mg/day in humans.
Croatian: Blagi učinak na postnatalni rast i vijabilnost primijećen je u štakora samo pri vrlo visokim dozama, koje odgovaraju otprilike 2000 mg/dan u ljudi.
English: Composite Sleep Disturbance Index; SE = standard error
Croatian: Composite Sleep Disturbance Index - Kompozitni indeks poremećaja spavanja; SE = standardna pogreška
English: • beta-blockers (used to control blood pressure).
Croatian: • beta-blokatori (koriste se za kontrolu krvnog tlaka).
English: Open label treatment period results (91weeks)
Croatian: Rezultati razdoblja otvorenog liječenja (91 tjedan)
English: Slenyto should be taken in the evening, 30 to 60 minutes before bedtime.
Croatian: Lijek Slenyto treba uzeti uvečer, 30 do 60 minuta prije spavanja.
English: It is possible that melatonin is passed into human breast milk, therefore your doctor will decide whether you or your daughter should breastfeed whilst taking melatonin.
Croatian: Postoji mogućnost da melatonin prelazi u mlijeko ljudi, stoga će Vaš liječnik odlučiti smijete li Vi ili Vaša kći dojiti dok uzimate melatonin.
English: The effect of melatonin on newborns/infants is unknown.
Croatian: Učinak melatonina na novorođenčad/dojenčad nije poznat.
English: Frequency not known (reported from use in adults)
Croatian: Nepoznata učestalost (prijavljena kod primjene u odraslih)
English: Please tell your doctor if you or your child starts or stops smoking during treatment.
Croatian: Obavijestite svojeg liječnika ako Vi ili Vaše dijete počnete ili prestanete pušiti tijekom liječenja.
English: Slenyto shortens the time it takes to fall asleep and lengthens the duration of sleep.
Croatian: Slenyto skraćuje vrijeme potrebno da bolesnik zaspe i produljuje trajanje sna.
English: The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Croatian: Apsorpcija peroralno unesenog melatonina potpuna je u odraslih, a u starijih osoba može se smanjiti do 50%.
English: This finding is compatible with the short half-life of melatonin in humans.
Croatian: Taj nalaz u skladu je s kratkim poluvijekom melatonina u ljudi.