FrancophonIA/ELRC3.0 huggingface dataset:
English: For 3 minor surgeries during the study, Coagadex was rated as excellent in preventing bleeding episodes.
Croatian: U tri manja operativna zahvata obavljena tijekom ispitivanja lijek Coagadex ocijenjen je kao izvrstan u sprječavanju epizoda krvarenja.
English: Factor X deficiency is a bleeding disorder caused by lack of factor X, a protein needed for normal clotting of the blood.
Croatian: Nedostatak faktora X poremećaj je krvarenja prouzročen nedostatkom faktora X, proteina potrebnog za normalno zgrušavanje krvi.
English: Patients with hereditary factor X deficiency lack factor X, a protein needed to form the blood clot that stops wounds from bleeding.
Croatian: Bolesnicima s nasljednim nedostatkom faktora X nedostaje faktor X, protein potreban za stvaranje krvnog ugruška koji sprečava krvarenje iz rane.
English: Patients received Coagadex either to treat any spontaneous bleeding during the treatment period or to prevent bleeding during surgery.
Croatian: Bolesnici su primali Coagadex za liječenje svake epizode spontanog krvarenja koje se pojavilo tijekom razdoblja liječenja ili za sprječavanje krvarenja tijekom operativnog zahvata.
English: How does Coagadex work?
Croatian: Kako djeluje Coagadex?
English: The side effects of Coagadex were considered manageable and of mild or moderate intensity.
Croatian: Smatra se da je nuspojavama lijeka Coagadex moguće upravljati i da su blagog do umjerenog intenziteta.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Coagadex contains the active substance human coagulation factor X.
Croatian: Više informacija o statusu lijeka za liječenje rijetkih bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: How is Coagadex used?
Croatian: Kako se Coagadex koristi?
English: In these patients, blood clots do not form properly, resulting in bleeding that does not stop easily and poor wound healing.
Croatian: U tih bolesnika ne dolazi do normalnog zgrušavanja krvi, što dovodi do duljeg vremena krvarenja i slabog cijeljenja rane.
English: What benefits of Coagadex have been shown in studies?
Croatian: Koje su koristi lijeka Coagadex utvrđene u ispitivanjima?
English: By replacing the missing factor X, Coagadex helps the blood to clot and gives temporary control of bleeding.
Croatian: On nadomješta faktor X koji nedostaje i time potpomaže zgrušavanje krvi i omogućuje privremenu kontrolu krvarenja.
English: For the full list of side effects and restrictions with Coagadex, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Coagadex potražite u uputi o lijeku.
English: Patients may inject Coagadex themselves at home once they have been trained appropriately.
Croatian: Nakon odgovarajuće obuke bolesnici si mogu samostalno injicirati lijek Coagadex.
English: Symptoms you should be aware of
Croatian: Simptomi na koje trebate pripaziti
English: *At least one of these adverse reactions was reported as serious
Croatian: *Barem jedna od ovih nuspojava zabilježena je kao ozbiljna.
English: In some cases, patients were hospitalised.
Croatian: U nekim su slučajevima bolesnici bili hospitalizirani.
English: • if you are pregnant or think you may be pregnant.
Croatian: • ako ste trudni ili mislite da biste mogli biti trudni.
English: Date of latest renewal: 23 August 2019
Croatian: Datum posljednje obnove odobrenja: 23. kolovoza 2019.
English: This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
Croatian: To znači da bi utjecaj Vašeg stanja na svakodnevne aktivnosti, odnose s drugima i druge čimbenike trebao biti manji nego prije.
English: Do not take a dose
Croatian: Nemojte uzeti dozu
English: Apremilast is not genotoxic.
Croatian: Apremilast nije genotoksičan.
English: The safety and efficacy of apremilast in children aged 0 to 17 years have not been established.
Croatian: Sigurnost i djelotvornost apremilasta u djece u dobi od 0 do 17 godina nisu ustanovljene.
English: Physical function and health-related quality of life
Croatian: Fizičko funkcioniranje i kvaliteta života povezana sa zdravljem
English: Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment.
Croatian: Molimo da pogledate dodatno upozorenje u dijelu 4.4. za bolesnike koji su pothranjeni na početku liječenja.
English: • Do not take a double dose to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvije doze kako biste nadoknadili zaboravljenu dozu.
English: • difficulty sleeping (insomnia)
Croatian: • teškoće sa spavanjem (nesanica)
English: Apremilast was studied in young and elderly healthy subjects.
Croatian: Apremilast je ispitivan u mladih i starijih zdravih ispitanika.
English: *NRI: None responder imputation.
Croatian: *NRI: Imputacija bolesnika bez odgovora.
English: These studies had a similar design through week 32.
Croatian: Ta su ispitivanja imala sličan dizajn do 32. tjedna.
English: • The ‘treatment initiation pack' is clearly labelled to make sure you take the correct tablet at the correct time.
Croatian: • Pakiranje za početak liječenja jasno je označeno kako biste bili sigurni da ste u pravo vrijeme uzeli pravu tabletu.
English: Take the next dose at your regular time.
Croatian: Tu sljedeću dozu uzmite u uobičajeno vrijeme.
English: If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered.
Croatian: Ako bolesnik ne pokazuje znakove terapijske koristi nakon 24 tjedna, treba ponovno razmotriti liječenje.
English: • rifampicin - an antibiotic used for tuberculosis
Croatian: • rifampicin - antibiotik koji se koristi za liječenje tuberkuloze
English: • Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.
Croatian: • Lijek Otezla uzmite otprilike u isto vrijeme svaki dan, jednu tabletu ujutro i jednu tabletu navečer.
English: Total Daily Dose
Croatian: Ukupna dnevna doza
English: If your condition has not improved after six months of treatment, you should talk to your doctor.
Croatian: Ako Vam se stanje nije poboljšalo nakon šest mjeseci liječenja, trebali biste se obratiti svom liječniku.
English: • suicidal ideation or behaviour
Croatian: • suicidalne ideje ili ponašanje
English: • The ‘treatment initiation pack' will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
Croatian: • Pakiranje za početak liječenja sadrži također dovoljno tableta za još 8 dana pri preporučenoj dozi (od 7. do 14. dana).
English: • You can take the tablets either with or without food.
Croatian: • Tablete možete uzimati s hranom ili bez hrane.
English: The mean apparent volume of distribution (Vd) is 87 L, indicative of extravascular distribution.
Croatian: Srednji prividni volumen distribucije (Vd) iznosi 87 l, što pokazuje ekstravaskularnu distribuciju.
English: These improvements were maintained at week 24.
Croatian: Ta poboljšanja održala su se do 24. tjedna.
English: You may also experience sleeplessness, or depressive mood.
Croatian: Također možete patiti od nesanice ili depresivnog raspoloženja.
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: To uključuje lijekove koji se nabavljaju bez recepta i biljne lijekove.
English: • Your treatment will start at a lower dose and will gradually be increased over the first 6 days of treatment.
Croatian: • Vaše liječenje započet će pri nižoj dozi, a zatim će se doza postupno povećavati tijekom prvih 6 dana liječenja.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Croatian: • teška alergijska reakcija (koja može uključivati oticanje lica, usana, usta, jezika ili grla, što može dovesti do otežanog disanja ili gutanja)
English: What Otezla is and what it is used for
Croatian: Što je Otezla i za što se koristi
English: Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8).
Croatian: Slučajevi suicidalnih ideja i ponašanja, uključujući samoubojstvo, zabilježeni su u bolesnika sa ili bez depresije u anamnezi (vidjeti dio 4.8).
English: • if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na apremilast ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression.
Croatian: Apremilast je povezan s povećanim rizikom od psihijatrijskih poremećaja kao što su nesanica i depresija.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In general, PASI responses were achieved by week 16 and were maintained through week 32.
Croatian: Općenito, PASI odgovori su postignuti do 16. tjedna i održali su se do 32. tjedna.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: Human plasma protein binding of apremilast is approximately 68%.
Croatian: Vezanje apremilasta na proteine u ljudskoj plazmi približno je 68%.
English: An initial titration schedule is required as shown below in Table 1.
Croatian: Potrebna je početna titracija kao što je prikazano u tablici 1.
English: Take the medicine pack and this leaflet with you.
Croatian: Sa sobom ponesite pakiranje lijeka i ovu Uputu.
English: If patients miss a dose, the next dose should be taken as soon as possible.
Croatian: Ako bolesnici propuste dozu, sljedeću dozu treba uzeti što prije.
English: Concomitant treatment with biologic DMARDs, including TNF blockers, was not allowed.
Croatian: Istodobno liječenje biološkim DMARD lijekovima, uključujući blokatore TNF-a nije bilo dopušteno.
English: Response Rate +/- SE (%)
Croatian: Stopa odgovora +/- SE (%)
English: No re-titration is required after initial titration.
Croatian: Nakon početne titracije, ponovno titriranje nije potrebno.
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: None of these patients had overt clinical consequences resulting from weight loss.
Croatian: Nijedan od tih bolesnika nije imao očite kliničke posljedice kao rezultat gubitka tjelesne težine.
English: Table 1: Dose titration schedule
Croatian: Tablica 1: Raspored titracije doze
English: • Do not stop taking Otezla without talking to your doctor first.
Croatian: • Nemojte prestati uzimati lijek Otezla, a da prije toga niste razgovarali sa svojim liječnikom.
English: The film-coated tablets should be swallowed whole, and can be taken either with or without food.
Croatian: Filmom obložene tablete treba progutati cijele, a mogu se uzimati s hranom ili bez nje.
English: What Otezla is and what it is used for What you need to know before you take Otezla How to take Otezla
Croatian: Što je Otezla i za što se koristi Što morate znati prije nego počnete uzimati lijek Otezla
English: The patient's response to treatment should be evaluated on a regular basis.
Croatian: Bolesnikov odgovor na liječenje treba redovito procjenjivati.
English: Placebo 30 mg twice daily APR*
Croatian: Placebo 30 mg dvaput na dan APR*
English: Approximately one-third of patients had not received prior phototherapy, conventional systemic or biologic therapy.
Croatian: Približno jedna trećina bolesnika nije prethodno primala fototerapiju, konvencionalnu sistemsku ili biološku terapiju.
English: In the event of overdose, symptomatic and supportive care is advised.
Croatian: U slučaju predoziranja savjetuje se simptomatska i potporna skrb.
English: No fertility data is available in humans.
Croatian: Nema podataka za plodnost u ljudi.
English: • You should continue taking Otezla until your doctor tells you to stop.
Croatian: • Lijek Otezla morate uzimati sve dok Vam liječnik ne kaže da ga prestanete uzimati.
English: Due to the study design the duration of re-treatment was variable, and ranged from 2.6 to 22.1 weeks.
Croatian: Zbog ustroja ispitivanja, trajanje ponovnog liječenja je bilo varijabilno i u rasponu od 2,6 do 22,1 tjedna.
English: It is not known if this medicine passes into human milk.
Croatian: Nije poznato prelazi li ovaj lijek u majčino mlijeko.
English: Not known side effects (frequency cannot be estimated from the available data):
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
English: Otezla has not been studied in children and adolescents, therefore it is not recommended for use in children and adolescents aged 17 years and under.
Croatian: Lijek Otezla nije ispitan u djece i adolescenata pa se stoga ne preporučuje za primjenu u djece i adolescenata mlađih od 17 godina.
English: The number of patients with arthritis mutilans and predominant spondylitis subtypes was too small to allow meaningful assessment.
Croatian: Broj bolesnika s podtipovima mutilirajućim artritisom i predominantnim spondilitisom bio je premali da bi omogućio jasnu procjenu.
English: If you take more Otezla than you should
Croatian: Ako uzmete više lijeka Otezla nego što ste trebali
English: During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment.
Croatian: Tijekom ključnih ispitivanja najveće poboljšanje opaženo je unutar prva 24 tjedna liječenja.
English: • The active substance is apremilast.
Croatian: • Djelatna tvar je apremilast.
English: Similar response rates were observed across all weight ranges.
Croatian: Slične stope odgovora opažene su za sve raspone tjelesne težine.
English: • Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging.
Croatian: • Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakvo oštećenje ili znakove promjene na pakiranju lijeka.
English: • Swallow the tablets whole, preferably with water.
Croatian: • Tablete progutajte cijele, poželjno s vodom.
English: Patients 65 years of age or older may be at a higher risk of complications.
Croatian: Bolesnici u dobi od 65 godina i više mogu biti pod povećanim rizikom od komplikacija.
English: Decreased appetite*
Croatian: Često oslabljen apetit*
English: Most events occurred within the first few weeks of treatment.
Croatian: Većina slučajeva javila se unutar prvih nekoliko tjedana liječenja.
English: You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.
Croatian: Kroz ovaj postupak postupnog povećavanja doze prolazit ćete samo jedanput čak i ako ponovno započinjete liječenje.
English: • When you first start taking Otezla, you will receive a ‘treatment initiation pack' which contains all the doses as listed in the table below.
Croatian: • Kada počnete uzimati lijek Otezla, dobit ćete pakiranje za početak liječenja koje sadrži sve doze kako je navedeno u tablici ispod.
English: Uncommon instances of suicidal thinking and behaviour (including suicide) were reported.
Croatian: Zabilježene su manje česte pojave suicidalnog razmišljanja i ponašanja (uključujući samoubojstvo).
English: Apremilast was detected in milk of lactating mice (see section 5.3).
Croatian: Apremilast je nađen u mlijeku ženki miševa u laktaciji (vidjeti dio 5.3).
English: • upper respiratory tract infections such as cold, runny nose, sinus infection
Croatian: • infekcije gornjih dišnih puteva kao što su prehlada, curenje nosa, infekcija sinusa
English: Please notify your doctor immediately of any feelings of depression, suicidal thoughts or suicidal behaviour you may have.
Croatian: Odmah obavijestite svog liječnika o svakom osjećaju depresije, suicidalnim mislima ili suicidalnom ponašanju koje bi mogli imati.
English: If you take more Otezla than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više lijeka Otezla nego što ste trebali, obratite se liječniku ili odmah otiđite u bolnicu.
English: Patients who are underweight at the start of treatment should have their body weight monitored regularly.
Croatian: Bolesnicima koji su pothranjeni na početku liječenja potrebno je redovito nadzirati tjelesnu težinu.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Otezla.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Otezla.
English: QR code to be included www.otezla-eu-pil.com
Croatian: Unijeti QR kod www.otezla-eu-pil.com
English: Your doctor will talk to you about how to increase your dose when you first start taking Otezla.
Croatian: Liječnik će Vam objasniti kako povećavati dozu kada započnete uzimati lijek Otezla.
English: Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants, ATC code: L04AA32
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA32
English: Apremilast is contraindicated during pregnancy (see section 4.3).
Croatian: Apremilast je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Sun as symbol for morning dose Moon as symbol for evening dose Refer to the wallet card for daily dose
Croatian: Simbol sunca za jutarnju dozu Simbol mjeseca za večernju dozu
English: These GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks.
Croatian: Te nuspojave probavnog sustava najčešće se pojave unutar prva 2 tjedna liječenja i obično nestaju unutar 4 tjedna.
English: ACR responses were maintained in the long-term open label extension studies for up to 5 years.
Croatian: Odgovori ACR održali su se u dugoročnim otvorenim produžecima ispitivanja do 5 godina.
English: Apremilast pharmacokinetics are linear, with a dose-proportional increase in systemic exposure in the dose range of 10 to 100 mg daily.
Croatian: Farmakokinetika apremilasta je linearna, s porastom sistemske izloženosti proporcionalnim dozi u rasponu od 10 do 100 mg na dan.
English: Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu metodu kontracepcije kako bi tijekom liječenja spriječile trudnoću.
English: Before starting treatment with Otezla, inform your doctor if you are suffering from symptoms of worsening depression with suicidal thinking or behaviour, especially if you take any additional medicines since some of those could increase the probability of these side effects.
Croatian: Prije početka liječenja lijekom Otezla, obavijestite svog liječnika ako uočite simptome pogoršanja depresije sa suicidalnim razmišljanjem ili ponašanjem, a osobito ako uzimate bilo kakve dodatne lijekove obzirom da neki lijekovi mogu povećati vjerojatnost pojave ovih nuspojava.
English: No such effects were observed when exposure in animals was at 1.3-fold the clinical exposure (see section 5.3).
Croatian: Takvi učinci nisu opaženi kada je izloženost u životinja bila 1,3 puta veća od kliničke izloženosti (vidjeti dio 5.3).
English: • phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
Croatian: • fenitoin, fenobarbital i karbamazepin - lijekove koji se koriste u liječenju napadaja ili epilepsije
English: The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Croatian: Rizike i koristi započinjanja ili nastavljanja liječenja apremilastom potrebno je pažljivo ocijeniti u bolesnika koji su prijavili prijašnje ili postojeće psihijatrijske simptome ili ako je namijenjeno istodobno liječenje s drugim lijekovima koji bi mogli izazvati psihijatrijske događaje.
English: The plasma clearance of apremilast is on average about 10 L/hr in healthy subjects, with a terminal elimination half-life of approximately 9 hours.
Croatian: Klirens apremilasta u plazmi u prosjeku je oko 10 l/h u zdravih ispitanika, s terminalnim poluvijekom eliminacije od približno 9 sati.
English: In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
Croatian: U slučaju neobjašnjenog i klinički značajnog gubitka težine, potrebno je da te bolesnike procijeni liječnik te je potrebno razmotriti i prekid liječenja.
English: Psoriatic arthritis and psoriasis are usually lifelong conditions and there is currently no cure.
Croatian: Psorijatični artritis i psorijaza obično su stanja koja traju cijeli život i za njih zasad nema izlječenja.
English: Subjects who discontinued early prior to the time point and subjects who did not have sufficient data for a definitive determination of response status at the time point are counted as non-responders.
Croatian: Ispitanici koji su prekinuli liječenje prije vremenske točke procjene i oni za koje nije bilo dovoljno podataka da se definitivno odredi status njihovog odgovora u toj vremenskoj točki, ubrojeni su među ispitanike bez odgovora.
English: Apremilast was used as a monotherapy (34.8%) or in combination with stable doses of small molecule DMARDs (65.2%).
Croatian: Apremilast se primjenjivao kao monoterapija (34,8%) ili u kombinaciji sa stabilnim dozama malomolekulskih DMARD lijekova (65,2%).
English: It is likely that pup developmental effects observed during the first week of the postnatal period were related to the apremilast-related pup toxicity (decreased pup weight and viability) and/or lack of maternal care (higher incidence of no milk in the stomach of pups).
Croatian: Vjerojatno je da su razvojni učinci opaženi u mladunčadi tijekom prvog tjedna postnatalnog razdoblja bili povezani s toksičnošću izazvanom apremilastom (smanjena težina mladunčadi i sposobnost preživljenja) i/ili nedostatkom maternalne skrbi (veća incidencija nepostojanja mlijeka u želucu mladunčadi).
English: Carcinogenicity studies in mice and rats showed no evidence of carcinogenicity related to treatment with apremilast.
Croatian: Ispitivanja kancerogenosti u miševa i štakora nisu dala dokaze za kancerogenost povezanu s terapijom apremilastom.
English: This is because Otezla can affect the way some other medicines work.
Croatian: To je potrebno zbog toga što Otezla može utjecati na način na koji djeluju drugi lijekovi.
English: This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Croatian: Pripada skupini lijekova pod nazivom 'inhibitori fosfodiesteraze 4', koji pomažu smanjiti upalu.
English: • Active psoriatic arthritis - if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs' (DMARDs) or when you have tried one of these medicines and it did not work.
Croatian: • aktivni psorijatični artritis - ako ne možete uzimati drugu vrstu lijekova koja se naziva ‘antireumatski lijekovi koji mijenjaju tijek bolesti' (DMARD) ili kada ste uzimali neki od tih lijekova ali nije djelovao
English: PVC/ aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Croatian: Blisteri od PVC/aluminijske folije sadrže 14 filmom obloženih tableta u pakiranjima od 56 tableta i 168 tableta.