FrancophonIA/ELRC3.0 huggingface dataset:
English: Given this and the negligible systemic exposure following topical use, the PRAC considered that no further risk minimization activities are deemed necessary.
Croatian: S obzirom na to, kao i na zanemarivu sistemsku izloženost nakon topikalne primjene, PRAC je zaključio da nisu potrebne dodatne aktivnosti u pogledu minimizacije rizika.
English: • A direct healthcare professional communication (DHPC) was also considered appropriate for all oral and topical retinoids.
Croatian: • Također je zaključeno da se neposredna komunikacija sa zdravstvenim radnicima putem pisma zdravstvenim radnicima za sve oralne i topikalne retinoide smatra primjerenom.
English: In this respect, the PRAC recommended amendments to the product information, including harmonising the warnings and precautions of use for the oral retinoids acitretin, alitretinoin and isotretinoin to reflect the teratogenic risk associated with their use and communication to healthcare professionals through a direct healthcare professional communication.
Croatian: U tom je pogledu PRAC preporučio izmjene informacija o lijeku, uključujući usklađivanje upozorenja i mjera opreza pri uporabi oralnih retinoida acitretina, alitretinoina i izotretinoina, kako bi uključivale rizik od teratogenosti povezan s njihovom primjenom te komunikaciju sa zdravstvenim radnicima putem pisma zdravstvenim radnicima.
English: After reviewing all the available data to address the concerns discussed, the PRAC adopted a recommendation on 8 February 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Croatian: Nakon što je pregledao sve dostupne podatke o navedenim zabrinutostima, PRAC je 8. veljače 2018.
English: The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU.
Croatian: PRAC je primijetio da se slučajevi trudnoće za vrijeme liječenja oralnim retinoidima i dalje prijavljuju u EU-u unatoč uvođenju mjera za sprječavanje trudnoće, uključujući programe prevencije trudnoće.
English: The PRAC thereby concludes that the benefit-risk balance of topical retinoids in pregnancy is not favourable, and therefore recommends that use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy.
Croatian: Stoga je zaključak PRAC-a da omjer koristi i rizika topikalnih retinoida tijekom trudnoće nije povoljan te preporučuje da bi primjena topikalnih retinoida trebala biti kontraindicirana tijekom trudnoće i u žena koje planiraju trudnoću.
English: Given this and the negligible systemic exposure following topical no further risk minimization activities are deemed necessary.
Croatian: S obzirom na to, kao i na zanemarivu sistemsku izloženost nakon topikalne primjene, smatra se da daljnje aktivnosti u pogledu minimizacije rizika nisu potrebne.
English: The PRAC therefore recommended that the use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy given the non-life threatening nature of the indications.
Croatian: preporučio kontraindikaciju primjene topikalnih retinoida tijekom trudnoće i u žena koje planiraju trudnoću, s obzirom na to da u indikacije za primjenu ovih lijekova ne spadaju stanja opasna po život.
English: However, given that humans are the most sensitive species to retinoid embryopathy and that several other factors may contribute to an increased systemic exposure, such as excessive use and damaged skin barrier, the PRAC agreed that the teratogenic risk cannot be completely excluded.
Croatian: Međutim, s obzirom na činjenicu da su ljudi vrsta koja je najosjetljivija na retinoidnu embriopatiju te da nekoliko drugih čimbenika može pridonijeti povećanoj sistemskoj izloženosti, kao što su pretjerana primjena lijeka i oštećenje kožne barijere,
English: The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for retinoid-containing medicinal products.
Croatian: Slijedom toga, PRAC preporučuje izmjenu uvjeta odobrenja za stavljanje u promet lijekova koji sadrže retinoide.
English: • Furthermore, the PRAC noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids.
Croatian: • Nadalje, PRAC je primijetio da su podatci koji se odnose na neuropsihijatrijske reakcije nakon topikalne primjene retinoida krajnje ograničeni.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for retinoidcontaining medicinal products.
Croatian: CHMP stoga preporučuje izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijekove koji sadrže retinoide.
English: • The PRAC considered the totality of the data submitted, including responses from the marketing authorisation holders with regard to the consistency and effectiveness of existing routine and additional risk minimisation measures for oral and topical retinoids-containing medicinal products in relation to teratogenic effects and neuropsychiatric disorders.
Croatian: • PRAC je razmotrio sve dostavljene podatke vezane uz teratogene učinke i neuropsihijatrijske poremećaje u pogledu dosljednosti i učinkovitosti postojećih rutinskih i dodatnih mjera minimizacije rizika za lijekove koji sadrže oralne i topikalne retinoide, uključujući odgovore nositelja odobrenja za stavljanje lijeka u promet.
English: The human data on congenital malformations after oral retinoid exposure show a significant risk of retinoid embryopathy (of up to 30% of fetuses exposed); furthermore it is known that approximately one-third of pregnant patients exposed to oral retinoids during pregnancy will have spontaneous abortions.
Croatian: Podatci o urođenim malformacijama u ljudi nakon izloženosti oralnim retinoidima pokazuju značajan rizik od retinoidne embriopatije (u do 30 % izloženih fetusa).
English: Overall, the PRAC concludes that the benefit-risk balance of medicinal products containing retinoids remains favourable, but that marketing authorisation(s) should be varied for both the oral and topical retinoids to ensure risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed, as appropriate.
Croatian: Sveukupno gledajući, PRAC zaključuje da je omjer koristi i rizika za lijekove koji sadrže retinoide i dalje povoljan, ali da je potrebna izmjena odobrenja za stavljanje lijeka u promet i za oralne i za topikalne retinoide kako bi se osiguralo da su rizici povezani s teratogenim učincima i neuropsihijatrijskim poremećajima točno i dosljedno navedeni gdje je to potrebno.
English: The PRAC acknowledged that the implementation of the following elements of the PPP need to be considered and agreed at national level to account for the different healthcare systems in the EU:
Croatian: S obzirom na različite zdravstvene sustave u EU-u, PRAC je potvrdio da provedbu sljedećih elemenata programa prevencije trudnoće treba razmotriti i dogovoriti na nacionalnoj razini:
English: The CHMP, as a consequence, considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication.
Croatian: CHMP smatra da je omjer koristi i rizika za lijekove koji sadržavaju retinoide i dalje povoljan pod uvjetom da se provedu dogovorene izmjene informacija o lijeku i plana upravljanja rizikom, uvjeta odobrenja za stavljanje lijekova u promet i s time povezane komunikacije.
English: For tretinoin and bexarotene, it was considered that in light of the oncological indications, specialist management in a hospital setting and population at risk that existing risk minimisation was appropriate and proportionate.
Croatian: U slučaju tretinoina i beksarotena, zaključeno je da je postojeća minimizacija rizika primjerena i razmjerna s obzirom na onkološke indikacije, specijalističko liječenje u bolničkom okruženju i populaciju bolesnika koja je izložena riziku.
English: In view of the above, the PRAC considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication.
Croatian: S obzirom na sve prethodno navedeno, PRAC smatra da omjer koristi i rizika za lijekove koji sadrže retinoide ostaje povoljan pod uvjetom da se provedu dogovorene izmjene informacija o lijeku i plana upravljanja rizikom, uvjeta odobrenja za stavljanje lijekova u promet i s time povezane komunikacije.
English: The PRAC further noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids.
Croatian: Nadalje, PRAC je napomenuo da su podatci koji se odnose na neuropsihijatrijske reakcije nakon topikalne primjene retinoida krajnje ograničeni.
English: • The option of a pictogram/symbol to accompany the box warning wording and to be included in the visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product.
Croatian: kao i njihovog uvrštavanja u vizualni podsjetnik na vanjskom pakiranju kako bi se bolesnice upozorilo na rizik od oštećenja ploda te na potrebu uporabe učinkovite kontracepcije prilikom primjene lijeka.
English: • Dissemination of the patient reminder card;
Croatian: • distribucija kartice s podsjetnikom za bolesnika; • kontrolni popis za ljekarnika;
English: Furthermore, specific studies to measure effectiveness of the agreed changes to the PPP have been imposed on the marketing authorisation holders as an outcome of the referral.
Croatian: Nadalje, kao rezultat ovog arbitražnog postupka, od nositelja odobrenja za stavljanje lijeka u promet zahtijeva se provedba posebnih ispitivanja za mjerenje učinkovitost dogovorenih izmjena programa prevencije trudnoće.
English: • The PRAC also concluded that there was a need to further harmonise and streamline the measures in the PPP including associated educational materials for the oral retinoids acitretin, alitretinoin and isotretinoin to ensure these are optimal to support discussions between patients and healthcare professionals on the risks and the associated risk minimisation measures.
Croatian: • PRAC je također zaključio da je potrebno dodatno uskladiti i pojednostaviti mjere programa prevencije trudnoće, uključujući edukacijske materijale o oralnim retinoidima acitretinu,
English: • With regards to the teratogenic risk of topical retinoids (adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene), the PRAC concluded that the data available show that after topical application, systemic exposure is expected to be negligible and unlikely to result in adverse fetal outcomes.
Croatian: tretinoina i tazarotena), PRAC je zaključio da dostupni podatci pokazuju da bi sistemska izloženost nakon topikalne primjene trebala biti zanemariva te kako nije vjerojatno da će rezultirati štetnim ishodom za fetus.
English: Inovelon (rufinamide)
Croatian: Inovelon (rufinamid)
English: Inovelon should be taken with water and food.
Croatian: Lijek Inovelon treba uzimati s vodom i hranom.
English: The dose is then adjusted every other day according to the patient's response to treatment.
Croatian: Doza se zatim prilagođava svakog drugog dana prema bolesnikovu odgovoru na liječenje.
English: The medicine should not be used in patients who have severe problems with their liver.
Croatian: Lijek ne smiju uzimati bolesnici koji imaju ozbiljne probleme s jetrom.
English: The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets.
Croatian: Tvrtka je također predstavila rezultate ispitivanja koji pokazuju da je peroralna suspenzija proizvela jednake razine djelatne tvari u krvi kao i tablete.
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Croatian: Lennox-Gastautov sindrom jedan je od najozbiljnijih oblika epilepsije u djece.
English: What measures are being taken to ensure the safe and effective use of Inovelon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Inovelon?
English: Further information on Inovelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Inovelon nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment in children less than 4 years of age generally starts with a daily dose of 10 mg per kilogram body weight.
Croatian: Liječenje djece mlađe od četiri godine općenito započinje dnevnom dozom od 10 mg po kilogramu tjelesne težine.
English: All of the patients had Lennox-Gastaut syndrome that was not controlled despite continuous treatment for at least four weeks with up to three other anti-epileptic medicines.
Croatian: Svi su bolesnici imali Lennox-Gastautov sindrom koji nije bio pod kontrolom, unatoč neprekidnom liječenju tijekom najmanje četiri tjedna s pomoću do tri druga antiepileptička lijeka.
English: In older patients, treatment usually starts with a dose of 200 or 400 mg daily.
Croatian: U stariji bolesnika liječenje obično započinje dozom od 200 do 400 mg dnevno.
English: Inovelon received a marketing authorisation valid throughout the EU on 16 January 2007.
Croatian: Lijek Inovelon dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. siječnja 2007.
English: Side effects reported with Inovelon are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Inovelon pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: By attaching to the channels, rufinamide prevents them switching from an inactive state to an active state.
Croatian: Vezivanjem na te kanale rufinamid sprječava njihov prijelaz iz neaktivnog u aktivno stanje.
English: Given that the disease behaves the same way in both age groups, Inovelon could therefore be expected to act similarly in children aged 1 to 4 years.
Croatian: Budući da se bolest ponaša na isti način u objema dobnim skupinama, može se očekivati da će lijek Inovelon djelovati slično u djece u dobi od jedne do četiri godine.
English: However, other analyses showed that doses based on body weight in children aged 1 to 4 years produced similar levels of the medicine in the body to those seen with standard doses in older patients.
Croatian: Međutim, druge analize pokazale su da su doze na temelju tjelesne težine u djece u dobi od jedne do četiri godine proizvele razine lijeka u organizmu slične onima koje su opažene u starijih bolesnika koji su primali standardnu dozu.
English: In a main study involving 139 patients aged between 4 and 30 years (three quarters of them below 17 years old) Inovelon caused a reduction in the number and severity of seizures.
Croatian: U glavnom ispitivanju u kojem je sudjelovalo 139 bolesnika u dobi od četiri do 30 godina (tri četvrtine bolesnika mlađih od 17 godina) lijek Inovelon prouzročio je smanjenje broja i ozbiljnosti napadaja.
English: This dampens down the activity of the brain cells and prevents abnormal electrical activity from spreading through the brain.
Croatian: Time se smanjuje aktivnost stanica mozga i sprječava širenje abnormalne električne aktivnosti mozgom.
English: What is Inovelon and what is it used for?
Croatian: Što je Inovelon i za što se primjenjuje?
English: Other information about Inovelon
Croatian: Ostale informacije o lijeku Inovelon
English: The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, vomiting, and tiredness.
Croatian: Najčešće nuspojave pri primjeni lijeka Inovelon (koje su se pojavile u više od 1 od 10 bolesnika) bile su pospanost, glavobolja, omaglica, povraćanje i umor.
English: The European Medicines Agency decided that Inovelon's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Inovelon nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Croatian: Njegovi simptomi obuhvaćaju nekoliko vrsta napadaja, abnormalnu električnu aktivnost u mozgu, poteškoće pri učenju i probleme u ponašanju.
English: Inovelon is used as an add-on to other anti-epileptic medicines.
Croatian: Inovelon se primjenjuje kao dodatna terapija uz druge antiepileptičke lijekove.
English: A study involving 37 children aged 1 to 4 years was inconclusive because of its small size and because it was not designed to show benefit.
Croatian: Ispitivanje u kojem je sudjelovalo 37-ero djece u dobi od jedne do četiri godine nije dalo jasne rezultate zbog malog broja ispitanika te zbog toga što nije bilo ustrojeno za utvrđivanje koristi.
English: Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Croatian: Lennox-Gastautov sindrom rijetka je bolest, a lijek Inovelon je dobio status „lijeka za rijetku bolest” 20. listopada 2004.
English: The daily dose is divided into two halves, taken morning and evening about 12 hours apart.
Croatian: Jedna polovica uzima se ujutro, a druga uvečer s razmakom od 12 sati.
English: The main measures of effectiveness were the change in the number of seizures in the four weeks after Inovelon or placebo was added, compared with the four weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient's parent or guardian.
Croatian: Glavna mjerila djelotvornosti bile su promjene učestalosti napadaja u četiri tjedna nakon dodavanja lijeka Inovelon ili placeba u usporedbi s četiri tjedna prije dodavanja, te promjene jačine napadaja koju su procijenili roditelji ili skrbnici bolesnika na temelju ljestvice od sedam točaka.
English: The active substance in Inovelon, rufinamide, acts by attaching to special channels (sodium channels) on brain cells that control their electrical activity.
Croatian: Djelatna tvar u lijeku Inovelon, rufinamid, djeluje vezivanjem na posebne kanale u stanicama mozga (natrijevi kanali) koji upravljaju njihovom električnom aktivnošću.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inovelon have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Inovelon nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Inovelon and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Inovelon i zašto je odobren u EU-u
English: Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic' seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo.
Croatian: U bolesnika kojima je dodan lijek Inovelon također je smanjen broj „toničkih-atoničkih” napadaja za 42,5 % (uobičajena vrsta napadaja u bolesnika s Lennox-Gastautovim sindromom koja često uključuje i pad bolesnika na pod) u usporedbi s povećanjem od 1,9 % u bolesnika kojima je dodan placebo.
English: As for all medicines, data on the use of Inovelon are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Inovelon kontinuirano se prate.
English: Inovelon is an epilepsy medicine used to treat patients aged one year or older who have LennoxGastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood.
Croatian: Inovelon je lijek protiv epilepsije koji se primjenjuje za liječenje bolesnika u dobi od jedne godine ili starijih s Lennox-Gastautovim sindromom, rijetkom vrstom epilepsije koja se obično pojavljuje u djece, no može se nastaviti do odrasle dobi.
English: Why is Inovelon authorised in the EU?
Croatian: Zašto je lijek Inovelon odobren u EU-u?
English: An improvement in the severity of seizures was reported for about half of the patients adding Inovelon, compared with a third of those adding placebo.
Croatian: Prijavljeno je poboljšanje u pogledu ozbiljnosti napadaja za približno polovicu bolesnika kojima je dodan lijek Inovelon u usporedbi s trećinom bolesnika kojima je dodan placebo.
English: Inovelon must not be used in patients who are hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients.
Croatian: Lijek Inovelon ne smije se primjenjivati u bolesnika preosjetljivih (alergičnih) na rufinamid, derivate triazola (kao što su neki lijekovi koji se primjenjuju za liječenje gljivičnih infekcija) ili bilo koji drugi sastojak.
English: The dose of Inovelon depends on the patient's age and weight and whether the patient is also taking valproate (another anti-epileptic medicine).
Croatian: Doza lijeka Inovelon ovisi o dobi i tjelesnoj težini bolesnika te o tome uzimali li bolesnik također valproat (drugi antiepileptički lijek).
English: Inovelon contains the active substance rufinamide.
Croatian: Inovelon sadržava djelatnu tvar rufinamid.
English: What are the risks associated with Inovelon?
Croatian: Koji su rizici povezani s lijekom Inovelon?
English: How does Inovelon work?
Croatian: Kako djeluje Inovelon?
English: The study compared the effects of adding Inovelon tablets or adding placebo (a dummy treatment) to the other medicines the patients were taking.
Croatian: U ispitivanju su uspoređeni učinci dodavanja tableta lijeka Inovelon ili dodavanja placeba (prividnog liječenja) drugim lijekovima koje su bolesnici uzimali.
English: For more information about using Inovelon, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Inovelon pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the four-week period before Inovelon was started.
Croatian: Kod bolesnika koji su uzimali lijek Inovelon smanjen je ukupni broj napadaja za 35,8 %, koji je četiri tjedna prije početka liječenja lijekom Inovelon iznosio prosječno 290 napadaja.
English: What benefits of Inovelon have been shown in studies?
Croatian: Koje su koristi od lijeka Inovelon utvrđene u ispitivanjima?
English: Inovelon can only be obtained with a prescription and treatment should be started by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders) experienced in the treatment of epilepsy.
Croatian: Liječenje treba započeti pedijatar (liječnik specijaliziran za liječenje djece) ili neurolog (liječnik za poremećaje mozga) koji ima iskustva u liječenju epilepsije.
English: There was a 1.6% reduction in the patients who added placebo to their existing treatment.
Croatian: U bolesnika kojima je postojećem liječenju dodan placebo broj napadaja smanjen je za 1,6 %.
English: For the full list of side effects of Inovelon, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Inovelon potražite u uputi o lijeku.
English: Just take your next dose at the usual time.
Croatian: Jednostavno uzmite sljedeću dozu u uobičajeno vrijeme.
English: Resolor was generally well tolerated.
Croatian: Resolor se općenito dobro podnosio.
English: The mechanism for this interaction is not clear.
Croatian: Mehanizam ove interakcije nije jasan.
English: Its terminal half-life is about one day.
Croatian: Terminalni poluvijek mu je oko jedan dan.
English: B-2300 Turnhout Belgium
Croatian: B-2300 Turnhout Belgija