FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic or hypersensitivity reactions are rare but may be very serious.
Croatian: Alergijske reakcije ili reakcije preosjetljivosti su rijetke, ali mogu biti vrlo ozbiljne.
English: Do not take Skilarence if you are pregnant or trying to become pregnant, as Skilarence may harm your baby.
Croatian: Nemojte uzimati Skilarence ako ste trudni ili pokušavate zatrudnjeti jer Skilarence može naškoditi Vašem djetetu.
English: Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects.
Croatian: Vaš će liječnik provjeriti koliko Vam se stanje poboljšalo nakon što počnete uzimati Skilarence i provjerit će imate li nuspojave.
English: България/ Česká republika/ Eesti/ Ελλάδα/ España/ Hrvatska/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ România/ Slovenija/ Slovenská republika Almirall, S.A., Teл./ Tel/ Τηλ: +34 93 291 30 00
Croatian: България/Českárepublika/Eesti/Ελλάδα/España/Hrvatska/Κύπρος/Latvija/Lietuva/Magyarorsz ág/Malta/România/Slovenija/Slovenská republika Almirall, S.A., Teл./Tel/Τηλ: +34 93 291 30 00
English: Clinical studies of Skilarence did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently compared to patients under 65 years (see section 5.2).
Croatian: Klinička ispitivanja lijeka Skilarence nisu uključila dovoljan broj bolesnika u dobi od 65 i više godina da bi se odredilo imaju li oni različiti odgovor u usporedbi s bolesnicima mlađima od 65 godina (vidjeti dio 5.2).
English: In any case blood counts should be monitored until values have returned to the normal range.
Croatian: U svakom slučaju krvnu sliku treba pratiti sve dok se vrijednosti ne vrate u normalan raspon.
English: The kidney was identified as a major target organ of toxicity in non-clinical studies.
Croatian: Bubreg je identificiran kao glavni ciljni organ toksičnosti u nekliničkim ispitivanjima.
English: Depending on the results of these blood and urine tests, your doctor may reduce your dose of Skilarence or stop treatment.
Croatian: Ovisno o rezultatima pretraga krvi i urina Vaš Vam liječnik može smanjiti dozu lijeka Skilarence ili prekinuti liječenje.
English: Do not take Skilarence - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6) - if you have severe problems with your stomach or intestines - if you have severe liver or kidney problems - if you are pregnant or breast-feeding
Croatian: Nemojte uzimati Skilarence - ako ste alergični na dimetilfumarat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako imate ozbiljne probleme sa želucem ili crijevima - ako imate ozbiljnih problema s jetrom ili bubrezima - ako ste trudni ili dojite
English: Evening of dimethyl fumarate
Croatian: Večer dimetilfumarata
English: Therefore, the tablets should not be crushed, divided, dissolved or chewed.
Croatian: Stoga se tablete ne smiju drobiti, dijeliti, otapati ili žvakati.
English: What Skilarence is and what it is used for 2.
Croatian: Što je Skilarence i za što se koristi 2.
English: If PML is suspected, treatment with Skilarence should be stopped immediately and further appropriate neurological and radiological examinations performed.
Croatian: Ako se sumnja na PML, liječenje lijekom Skilarence treba odmah prekinuti te provesti daljnje odgovarajuće neurološke i radiološke pretrage.
English: Certain types of vaccines (live vaccines) may cause infection if used during treatment with Skilarence.
Croatian: Određene vrste cjepiva (živa cjepiva) mogu uzrokovati infekciju ako se primijene tijekom liječenja lijekom Skilarence.
English: Talk to your doctor if you have bad diarrhoea and are concerned that other medicines you are taking might not work.
Croatian: Obratite se svom liječniku ako imate jak proljev i zabrinuti ste da drugi lijekovi koje uzimate možda ne djeluju.
English: 9/L, blood monitoring should be performed monthly until levels return to 1.0x10
Croatian: 9L, treba obavljati mjesečno praćenje krvi dok se vrijednosti ne vrate na 1,0x10
English: Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years.
Croatian: Od 699 bolesnika, većina su bili bijelci (99 %) i muškarci (65 %), a srednja dob bila je 44 godine.
English: Persistent moderate or severe lymphopenia during treatment with dimethyl fumarate is also considered a risk factor for PML.
Croatian: Perzistentna umjerena ili teška limfopenija tijekom liječenja dimetilfumaratom također se smatra rizičnim čimbenikom za PML.
English: If treatment success is observed before the maximum dose is reached, no further increase of dose is necessary.
Croatian: Ako se zapazi uspjeh liječenja prije nego se dostigne maksimalna doza, nije potrebno daljnje povećanje doze.
English: Skilarence may cause problems with your blood, liver or kidneys.
Croatian: Skilarence može uzrokovati probleme s krvi, jetrom ili bubrezima.
English: If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose.
Croatian: Ako se pojedino povećanje doze ne podnosi, može se privremeno smanjiti na zadnju podnošljivu dozu.
English: What you need to know before you take Skilarence
Croatian: Što morate znati prije nego počnete uzimati Skilarence
English: Dosage modifications may also be necessary if abnormalities in laboratory parameters are observed (see section 4.4).
Croatian: Modifikacije doziranja mogu također biti potrebne ako se uoče abnormalnosti laboratorijskih parametara (vidjeti dio 4.4).
English: In case of individual intolerability of the increased dosage during weeks 4 to 16, the patient was to return to the last tolerated dose taken since the start of week 4, which was to be maintained until end of the treatment period (week 16).
Croatian: U slučaju pojedinačne nepodnošljivosti povećane doze tijekom 4. i 16. tjedna, bolesnik se vraćao na posljednju podnošljivu dozu uzetu od početka 4. tjedna, koju je bilo potrebno održavati sve do kraja razdoblja liječenja (16. tjedan).
English: During treatment with Skilarence, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
Croatian: Tijekom liječenja lijekom Skilarence, potrebno je izbjegavati istodobnu primjenu drugih derivata fumaratne kiseline (topikalnu ili sistemsku).
English: You must avoid using other products that contain fumarates to prevent taking too much.
Croatian: Morate izbjegavati primjenu drugih lijekova koji mogu sadržavati fumarate kako bi se spriječilo uzimanje prevelike količine.
English: The tablets are packed in PVC/PVDC-aluminium blisters.
Croatian: Tablete su pakirane u PVC/PVDC aluminijskim blisterima.
English: Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine.
Croatian: Izbjegavajte jaka alkoholna pića (više od 50 mL žestokog pića koje sadrži više od 30 % volumnog udjela alkohola) tijekom liječenja lijekom Skilarence jer alkohol može ući u interakciju s lijekom.
English: Skilarence tablets must be swallowed whole with fluid during or immediately after a meal.
Croatian: Skilarence tablete moraju se progutati cijele s tekućinom tijekom ili neposredno nakon obroka.
English: At week 16 (end of treatment), there was no further decline in lymphocyte counts.
Croatian: U 16. tjednu (kraj liječenja) nije bilo daljnjeg opadanja broja limfocita.
English: This helps to reduce stomach problems and other side effects.
Croatian: To pomaže smanjiti želučane tegobe i druge nuspojave.
English: Allergic skin reaction*
Croatian: Alergijska reakcija na koži*
English: Before treatment
Croatian: Prije liječenja
English: Immunosuppression is a risk factor for the use of live vaccines.
Croatian: Imunosupresija je čimbenik rizika pri primjeni živih vakcina.
English: The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive).
Croatian: Djelotvornost oralnih kontraceptiva može biti smanjena te se preporučuje korištenje alternativnih mehaničkih metoda kontracepcije kako bi se spriječila mogućnost neuspjeha kontracepcije (vidjeti informacije o lijeku za oralni kontraceptiv).
English: Taking Skilarence with food delayed the tmax of monomethyl fumarate from 3.5 to 9.0 hours.
Croatian: Uzimanje lijeka Skilarence s hranom produžilo je tmax monometilfumarata sa 3,5 na 9,0 sati.
English: This interaction with glutathione leads to the inhibition of translocation into the nucleus and the transcriptional activity of the nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB).
Croatian: Ova interakcija s glutationom dovodi do inhibicije translokacije u jezgru i transkripcijske aktivnosti nuklearnog faktora pojačivača kappa lakog lanca aktiviranih B-stanica (NF-κB).
English: The MAH shall ensure that in each Member State where Skilarence is marketed, healthcare professionals who are expected to prescribe and dispense Skilarence have access to the following educational package.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da u svakoj državi članici u kojoj je Skilarence stavljen u promet, svi zdravstveni djelatnici od kojih se očekuje da propisuju Skilarence imaju pristup sljedećem edukacijskom paketu.
English: It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
Croatian: On mijenja aktivnost imunosnog sustava i smanjuje stvaranje tvari uključenih u nastanak psorijaze.
English: During treatment a complete blood count with differential should be performed every 3 months.
Croatian: Tijekom liječenja treba provjeriti kompletnu i diferencijalnu krvnu sliku svaka 3 mjeseca.
English: Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Croatian: Daljnji se metabolizam odvija oksidacijom kroz ciklus trikarboksilne kiseline, stvarajući ugljikov dioksid i vodu.
English: The apparent terminal elimination half-life of monomethyl fumarate is about 2 hours.
Croatian: Prividni terminalni poluvijek eliminacije monometilfumarata je otprilike 2 sata.
English: Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that can lead to severe disability or death.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) je rijetka, ali ozbiljna infekcija mozga koja može dovesti do teške onesposobljenosti ili smrti.
English: If you are affected, be careful when driving or using machines.
Croatian: Ako Vam se to dogodi, pažljivo upravljajte vozilima i radite sa strojevima.
English: In case of unclear symptoms Fanconi syndrome should be considered and appropriate examinations should be performed.
Croatian: U slučaju nejasnih simptoma treba imati na umu Fanconijev sindrom te provesti odgovarajuće pretrage.
English: 9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Croatian: 9/L kod 1/29 (3,5 %) bolesnika 6 mjeseci i kod 0/28 (0 %) 12 mjeseci nakon prekida terapije.
English: The maximum daily dose allowed is 720 mg (3 x 2 tablets of Skilarence 120 mg).
Croatian: Maksimalna dopuštena dnevna doza je 720 mg (3 x 2 tablete lijeka Skilarence 120 mg).
English: There are limited data from the use of dimethyl fumarate in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni dimetilfumarata u trudnica.
English: Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Croatian: Skilarence je namijenjen za primjenu pod vodstvom i nadzorom liječnika iskusnog u dijagnosticiranju i liječenju psorijaze.
English: In particular, if you are taking a contraceptive medicine (the pill), the effect may be reduced and you may need to use other barrier methods to prevent pregnancy.
Croatian: Osobito ako uzimate oralne kontraceptive (pilule) djelotvornost može biti smanjena i možda trebate koristiti druge, mehaničke metode za sprječavanje trudnoće.
English: The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths.
Croatian: Aktivni sastojak u lijeku Skilarence, dimetilfumarat, primjenjuje se također i u drugim lijekovima kao što su tablete, masti i kupke.
English: Uncommon Not known Not known
Croatian: Manje često Nepoznato Nepoznato
English: Typical symptoms associated with PML are diverse, become worse over days to weeks and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision and changes in thinking, memory and orientation leading to confusion and personality changes.
Croatian: Karakteristični simptomi povezani s PML-om su različiti, pogoršavaju se tijekom dana i tjedana te uključuju progresivno slabljenje jedne strane tijela ili nespretnost udova, smetnje vida i promjene mišljenja, pamćenja i orijentacije koje dovode do zbunjenosti i promjena osobnosti.
English: The benefits of treatment with Skilarence were also supported by patient self-perceived improvements in their quality of life.
Croatian: Koristi liječenja lijekom Skilarence također su potvrđene samoprocijenjenim poboljšanjem kvalitete života od strane bolesnika.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Skilarence.
English: Patients received treatment for up to 16 weeks and follow-up visits were planned for up to 12 months after treatment was stopped.
Croatian: Bolesnici su primili liječenje do 16 tjedana, a posjeti praćenja su planirani do 12 mjeseci nakon prekida liječenja.
English: If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved.
Croatian: Ako imate ozbiljnu infekciju, bilo prije početka liječenja lijekom Skilarence, bilo tijekom liječenja, liječnik Vam može savjetovati da ne uzimate Skilarence dok infekcija ne prođe.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
English: Based on the pharmacology of dimethyl fumarate, a need for dose adjustment in the elderly is not expected.
Croatian: Na temelju farmakologije dimetilfumarata, ne očekuje se potreba za prilagodbom doze u starijih osoba.
English: Most adverse reactions were considered mild and did not lead to discontinuation of study treatment.
Croatian: Većina nuspojava smatrale su se blagima i nisu dovele do prekida ispitivanog liječenja.
English: From the fourth week, treatment is switched to only 1 tablet of Skilarence 120 mg in the evening.
Croatian: Od četvrtog tjedna, u liječenju se prelazi na samo 1 tabletu lijeka Skilarence 120 mg uvečer.
English: E-08740 Sant Andreu de la Barca, Barcelona Spain
Croatian: E-08740 Sant Andreu de la Barca, Barcelona Španjolska
English: Dimethyl fumarate does not show any binding affinity to serum proteins which may further contribute to its rapid elimination from the circulation.
Croatian: Dimetilfumarat ne pokazuje nikakav afinitet za vezanje za proteine u serumu što možda dodatno doprinosi njegovoj brzoj eliminaciji iz cirkulacije.
English: There are no data available with Skilarence in paediatric patients.
Croatian: Nema dostupnih podataka za Skilarence u pedijatrijskih bolesnika.
English: Gastrointestinal tolerability can be improved by following the dose titration schedule on initiating Skilarence treatment and by taking Skilarence with food (see sections 4.2 and 4.8).
Croatian: Gastrointestinalna podnošljivost može se poboljšati pridržavanjem rasporeda za titraciju doze na početku liječenja lijekom Skilarence i uzimanjem lijeka Skilarence s hranom (vidjeti dijelove 4.2 i 4.8).
English: If treatment success was observed before the maximum dose of 720 mg/day of dimethyl fumarate was reached, no further increase of dosage was necessary and the dosage was to be steadily reduced to an individual maintenance dose.
Croatian: Ako je zapažen uspjeh liječenja prije nego je dostignuta maksimalna doza dimetilfumarata od 720 mg/dan, nije bilo potrebno daljnje povećanje doze i doziranje je trebalo postupno smanjiti na individualnu dozu održavanja.
English: Do not crush, break, dissolve or chew the tablet.
Croatian: Nemojte drobiti, lomiti, otapati ili žvakati tabletu.
English: A previous infection with JCV is considered a prerequisite for the development of PML.
Croatian: Prethodna infekcija JC virusom smatra se preduvjetom za razvoj PML-a.
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Croatian: Progresija može uključivati simptome kao što su poliurija, polidipsija i slabost proksimalnih mišića.
English: It is recommended to monitor hepatic function (SGOT, SGPT, gamma-GT, AP) prior to initiation of treatment and every 3 months thereafter, since elevation of hepatic enzymes has been observed in some patients in the Phase III study.
Croatian: Preporučuje se nadzirati jetrenu funkciju (AST, ALT, GGT, ALP) prije uvođenja liječenja i svaka 3 mjeseca nakon toga, budući da je uočen porast jetrenih enzima u nekih bolesnika u ispitivanju faze III.
English: During the Phase III placebo-controlled clinical trial, renal function was not seen to deteriorate during therapy across treatment groups.
Croatian: Tijekom placebom kontroliranog kliničkog ispitivanja faze III, nije zapaženo pogoršanje bubrežne funkcije u skupinama liječenja za vrijeme terapije.
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Croatian: Najvažniji znakovi su: proteinurija, glikozurija (uz normalne razine šećera u krvi), hiperaminoacidurija i fosfaturija (moguće istodobno s hipofosfatemijom).
English: Early diagnosis of Fanconi syndrome and discontinuation of Skilarence treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Croatian: Rano postavljanje dijagnoze Fanconijeva sindroma i prekid liječenja lijekom Skilarence važno je za sprječavanje nastanka oštećenja bubrega i osteomalacije, budući da je sindrom obično reverzibilan.
English: Patients receiving Skilarence should be instructed to report symptoms of infection to a physician.
Croatian: Bolesnike koji primaju Skilarence treba uputiti da simptome infekcije prijave liječniku.
English: No carcinogenicity studies have been performed for Skilarence.
Croatian: Nisu provedena ispitivanja karcinogenosti za Skilarence.
English: During treatment
Croatian: Tijekom liječenja
English: Maintenance of long term efficacy has been well described for other dimethyl fumarate-containing products, and therefore the treatment benefits seen with Skilarence at 16 weeks can be expected to be maintained in patients treated over the long term for at least 24 months.
Croatian: Zadržavanje dugoročne djelotvornosti dobro je opisano za druge lijekove koji sadrže dimetilfumarat te se stoga može očekivati da će se koristi liječenja postignute lijekom Skilarence u 16 tjedana zadržati u bolesnika koji se dugoročno liječe tijekom najmanje 24 mjeseca.
English: If a patient develops an infection during treatment with Skilarence, suspension of treatment should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Croatian: Ako bolesnik razvije infekciju tijekom liječenja lijekom Skilarence, potrebno je razmotriti prekid liječenja i ponovno procijeniti koristi i rizike prije ponovnog uvođenja liječenja.
English: Prior to initiating treatment with Skilarence, a current complete blood count (including differential blood count and platelet count) should be available.
Croatian: Prije uvođenja liječenja lijekom Skilarence, mora biti dostupna trenutna kompletna krvna slika (uključujući diferencijalnu krvnu sliku i broj trombocita).
English: Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): - alergijske reakcije na koži
English: If the side effects are not troublesome, your dose will be increased until your condition is well controlled.
Croatian: Ako nuspojave nisu zabrinjavajuće doza će Vam se povećavati do postizanja dobre kontrole Vašeg stanja.
English: Blood sampling for safety clinical laboratory tests at follow-up visits was only performed in case of abnormalities at the preceeding visit.
Croatian: Uzorci krvi uzeti su za sigurnosne kliničke laboratorijske pretrage kod posjeta tijekom praćenja, samo u slučaju vrijednosti izvan raspona kod prethodnog posjeta.
English: Hence it is reasonable to expect the long-term efficacy of Skilarence to also be comparable to dimethyl fumarate-containing products.
Croatian: Stoga je opravdano očekivati da će dugoročna djelotvornost lijeka Skilarence također biti usporediva s onom za lijekove koji sadrže dimetilfumarat.
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided because it may lead to increased dissolution rates of Skilarence and, therefore, may increase the frequency of gastrointestinal adverse reactions.
Croatian: Treba se izbjegavati konzumacija velikih količina jakih alkoholnih pića (više od 30 % volumnog udjela alkohola) jer može dovesti do povećanja brzine rastvaranja lijeka Skilarence i tako povećati učestalost gastrointestinalnih nuspojava.
English: After your condition has improved sufficiently, your doctor will consider how to gradually reduce the daily dose of Skilarence to what you need to maintain your improvement.
Croatian: Nakon što Vam se stanje dovoljno poboljša, liječnik će razmotriti kako postupno smanjiti dnevnu dozu lijeka Skilarence na onu koja je dovoljna za održavanje poboljšanja.
English: Hepatic enzymes increased Serum creatinine increased*
Croatian: Povećani jetreni enzimi Povišena razina kreatinina u serumu*
English: If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose.
Croatian: Ako imate teške nuspojave nakon povećanja doze, liječnik Vam može preporučiti da se privremeno vratite na prethodnu dozu.
English: Haematological changes
Croatian: Hematološke promjene
English: In cases of severe or prolonged diarrhoea during treatment with Skilarence, absorption of other medicinal products may be affected.
Croatian: U slučajevima teške ili prolongirane dijareje tijekom liječenja lijekom Skilarence, može biti utjecaja na apsorpciju drugih lijekova.
English: See the instructions in the patient leaflet of the contraceptive you are taking.
Croatian: Pogledajte uputu o lijeku za oralne kontraceptive koje uzimate.
English: Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Croatian: Značajno je da se Fanconijev sindrom može pojaviti i bez povišenih razina kreatinina ili smanjenja brzine glomerularne filtracije.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Skilarence in all subsets of the paediatric population in this indication (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Skilarence u svim podskupinama pedijatrijske populacije za odobrenu indikaciju (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: 9/L but is ≥0.7 x10
Croatian: 9/L, ali je ≥0,7x10
English: The mean and median values of lymphocytes remained within the normal range during the clinical study.
Croatian: Srednje vrijednosti i medijan broja limfocita ostale su unutar normalnog raspona tijekom kliničkog ispitivanja.
English: More than 90% of these diarrhoea events were of mild to moderate severity (see section 4.4).
Croatian: Više od 90 % ovih događaja proljeva bilo je blage do umjerene težine (vidjeti dio 4.4).