FrancophonIA/ELRC3.0 huggingface dataset:
English: A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a.
Croatian: Kod bolesnika koji su uzimali Aubagio došlo je do stope od 13,5% trajnog prekida, u usporedbi sa stopom od 24% trajnog prekida kod bolesnika koji su uzimali interferon beta-1a.
English: What benefits of Aubagio have been shown in studies?
Croatian: Koje su koristi lijeka Aubagio utvrđene u ispitivanjima?
English: For practical information about using Aubagio, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Aubagio pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Aubagio used?
Croatian: Kako se Aubagio koristi?
English: For the full list of all side effects reported with Aubagio, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Aubagio potražite u uputi o lijeku.
English: You may watch television.
Croatian: Možete gledati televiziju.
English: Your doctor will also tell you what to do.
Croatian: Liječnik će Vam također dati savjet što učiniti.
English: You can then repeat the test.
Croatian: Potom možete ponoviti test.
English: The type of clothes you must wear are:
Croatian: Vrsta odjeće koju morate nositi uključuje:
English: •At the request of the European Medicines Agency;
Croatian: Na zahtjev Europske agencije za lijekove;
English: Talk to your doctor for more information.
Croatian: Obratite se svom liječniku za više informacija.
English: You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Croatian: Svaki dan možete produljiti izlaganje za još 15 minuta, tj. drugog dana 30 minuta, trećeg dana 45 minuta, četvrtog dana 60 minuta i tako dalje.
English: Plasma protein binding is at 85-87 %.
Croatian: Vezanje za proteine plazme iznosi 85-87%.
English: The use of headlamps is recommended instead.
Croatian: Umjesto toga preporučuje se uporaba naglavnih svjetiljki.
English: These effects may make it difficult to eat and drink.
Croatian: Ovi učinci mogu otežati uzimanje hrane i pića.
English: No other interactions have been observed.
Croatian: Nisu opažene druge interakcije.
English: Day 1 (0-24 hours)
Croatian: 1. dan (0-24 sata)
English: • Do not wear very thin clothing because it will not protect you from strong light.
Croatian: • Nemojte nositi jako tanku odjeću, zato što Vas neće zaštititi od jake svjetlosti.
English: You must follow these instructions carefully.
Croatian: Morate se pažljivo pridržavati ovih uputa.
English: After 2 to 4 days, the treated area will turn black.
Croatian: Nakon 2 do 4 dana, liječeno područje postaje crno.
English: Of these, 6 had a complete local response according to WHO criteria.
Croatian: Od njih, 6 je imalo potpuni lokalni odgovor prema kriterijima SZO-a.
English: Treatment should be supportive.
Croatian: Liječenje treba biti potporno.
English: You must get out of the light immediately.
Croatian: Odmah se morate skloniti sa svjetla.
English: Stay in shaded areas or go out when it is cloudy.
Croatian: Zadržavajte se u sjeni ili izlazite van kad je oblačno.
English: For treatment of other types of pain listed in this section, please see section 4.4.
Croatian: Za liječenje drugih vrsta bola navedenih u ovom dijelu, molimo vidjeti dio 4.4.
English: Start on Day 8 with 10-15 minutes outdoors.
Croatian: Započnite 8. dana s 10-15 minuta boravka na otvorenom.
English: Unknown:
Croatian: Nepoznato:
English: • A planned surgical procedure within the next 30 days.
Croatian: • Kirurški postupak planiran u sljedećih 30 dana.
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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Porphyria or other diseases exacerbated by light.
Croatian: • Porfirija ili druge bolesti koje pogoršava svjetlost.
English: Wait 24 hours to see if there is any redness.
Croatian: Pričekajte 24 sata da vidite pojavljuje li se crvenilo.
English: What should I do to prevent burns?
Croatian: Što moram učiniti da spriječim opekotine?
English: • You will gradually become less sensitive to light.
Croatian: • Postupno ćete postati manje osjetljivi na svjetlost.
English: Furthermore you will probably notice swelling and reddening around the area that has been treated.
Croatian: Nadalje, vjerojatno ćete opaziti oticanje i crvenilo oko područja koje je liječeno.
English: Your eyes may be very sensitive to bright lights during this week.
Croatian: Oči Vam mogu biti jako osjetljive na jaku svjetlost tijekom ovog tjedna.
English: • Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.
Croatian: • Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek ako ste trudni.
English: Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Croatian: Oksimetrima se mora mijenjati položaj najmanje svakih 10-15 minuta da bi se izbjegao rizik od lokalnih opekotina kože.
English: Single dose.
Croatian: Jednokratna doza.
English: Do not stay in the sunlight for more than 15 minutes the first time.
Croatian: Nemojte se prvi put zadržati na sunčevoj svjetlosti dulje od 15 minuta.
English: Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011
Croatian: Datum posljednje obnove: 22. rujna 2011.
English: Proactively managing the local effects and diminishing photoactivation in non-tumour areas is important to manage the risks.
Croatian: Proaktivno upravljanje lokalnim učincima i smanjenje fotoaktivacije u netumorskim područjima važno je za upravljanje rizicima.
English: If you are given more Foscan than you should
Croatian: Ako dobijete više Foscana nego što ste trebali
English: If you have this problem, wear dark glasses.
Croatian: Ako imate takav problem, nosite naočale s tamnim staklima.
English: Pain occurs the day after illumination and usually lasts 2 to 4 weeks.
Croatian: Bol se javlja dan nakon obasjavanja i obično traje 2 do 4 tjedna.
English: Foscan will be stored at the hospital pharmacy.
Croatian: Foscan će se čuvati u bolničkoj ljekarni.
English: The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Croatian: Medijan opaženog trajanja odgovora tumora u svih bolesnika iznosio je 57 dana za ukupni odgovor i 84 dana za potpuni odgovor.
English: Women of childbearing potential have to use effective contraception during and up 3 months after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom i do 3 mjeseca nakon liječenja.
English: Prophylactic treatment with corticosteroids should be considered.
Croatian: Treba razmotriti profilaktičko liječenje kortikosteroidima.
English: SAFETY INFORMATION
Croatian: SIGURNOSNE INFORMACIJE
English: The laser light is not hot and will not burn.
Croatian: Laserska svjetlost nije vruća i ne žari.
English: You may be given some medicine to reduce the swelling.
Croatian: Možda ćete dobiti neke lijekove za smanjenje oticanja.
English: On the first day after the skin test, you can stay in direct sunlight for 15 minutes.
Croatian: Prvog dana nakon kožnog testa možete ostati na izravnoj sunčevoj svjetlosti 15 minuta.
English: • Sunscreen creams will not prevent this sensitivity.
Croatian: • Kreme za sunčanje sa zaštitnim faktorima neće spriječiti tu osjetljivost.
English: Please ask your doctor or nurse if you are not sure about anything.
Croatian: Molimo da upitate svog liječnika ili medicinsku sestru ako u nešto niste sigurni.
English: If extravasation occurs, protect the area from light for at least 3 months.
Croatian: U slučaju ekstravazacije, zaštitite to područje od svjetlosti najmanje 3 mjeseca.
English: It is important that patients are re-introduced to normal light gradually (see the light protection guidelines for patients at the end of this section).
Croatian: Važno je da se bolesnici počnu postupno ponovno izlagati normalnoj svjetlosti (vidjeti smjernice za bolesnike za zaštitu od svjetlosti na kraju ovog dijela).
English: You can now begin to go outside during daylight hours.
Croatian: Sada možete početi izlaziti za vrijeme dnevnog svjetla.
English: Remove the intravenous cannula immediately following the injection.
Croatian: Uklonite intravensku kanilu odmah nakon injekcije.
English: Stay in the shade.
Croatian: Zadržavajte se u sjeni.
English: This blackness is caused by dead cancer cells (necrosis).
Croatian: To crnilo uzrokovano je mrtvim stanicama karcinoma (nekroza).
English: Keep the curtains drawn and use light bulbs of 60 W or less.
Croatian: Neka zastori budu navučeni i koristite žarulje snage 60 W ili manje.
English: High rates of administration caused death in dogs and rabbits.
Croatian: Velike brzine primjene izazvale su smrt u pasa i kunića.
English: Increased damage to tissue was noted.
Croatian: Zabilježeno je povećano oštećenje tkiva.
English: You may get eye pain or headache when lights are switched on.
Croatian: Može Vam se pojaviti bol u oku ili glavobolja kad se upale svjetla.
English: Each field is to be illuminated once only at each treatment.
Croatian: Svako područje obasjava se samo jedanput po jednom liječenju.
English: Do not use Foscan - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent.
Croatian: Nemojte primjenjivati Foscan - ako ste alergični na temoporfin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako ste preosjetljivi (alergični) na porfirine, - ako imate porfiriju ili neku drugu bolest koju pogoršava svjetlost, - ako tumor koji se liječi zahvaća veliku krvnu žilu, - ako idete na operaciju u sljedećih 30 dana, - ako imate bolest očiju, zbog koje ih je potrebno pregledati jakim svjetlom u sljedećih 30 dana, - ako se već liječite fotosenzibilizirajućim sredstvom.
English: The dose is 0.15 mg/kg body weight.
Croatian: Doza iznosi 0,15 mg/kg tjelesne težine.
English: Foscan may also damage the tissue that is surrounding the tumour.
Croatian: Foscan može također oštetiti tkivo koje okružuje tumor.
English: Appropriate precaution must be taken when handling this medicinal product.
Croatian: Moraju se poduzeti odgovarajuće mjere opreza kad se rukuje ovim lijekom.
English: Foscan contains ethanol (alcohol):
Croatian: Foscan sadrži etanol (alkohol)
English: Foscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with temoporfin.
Croatian: Foscan se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje temoporfinom.
English: • You may be sensitive to light for more than 15 days.
Croatian: • Možete biti osjetljivi na svjetlost dulje od 15 dana.
English: Most people will be able to go back to their normal routine by Day 22.
Croatian: Većina osoba može se vratiti svojim uobičajenim navikama izlaženja 22. dana.
English: Do not store above 25
Croatian: Ne čuvati na temperaturi iznad 25
English: Foscan is photosensitive.
Croatian: Foscan je fotoosjetljiv.
English: As a consequence of local infection In the photoactivated area As a consequence of local oedema
Croatian: Kao posljedica lokalne infekcije U fotoaktiviranom području Kao posljedica lokalnog edema
English: Temoporfin is bound to plasma lipoproteins and high density proteins such as albumin in the blood.
Croatian: Temoporfin se veže za lipoproteine plazme i proteine visoke gustoće, kao što je albumin u krvi.
English: Normally, people are able to begin to return to normal outdoor lighting after 15 days.
Croatian: Obično se osobe mogu početi vraćati uobičajenom vanjskom osvjetljenju nakon 15 dana.
English: The amount of alcohol in this product may alter the effects of other medicines.
Croatian: Količina alkohola u ovom lijeku može promijeniti učinke drugih lijekova.
English: Press the syringe plunger to fill all dead space within the filter.
Croatian: Pritisnite klip štrcaljke tako da se ispuni sav mrtvi prostor unutar filtra.
English: Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg.
Croatian: Objavljena klinička istraživanja pokazala su da su trajanje i jačina fotoosjetljivosti kod preporučene doze od 0,15 mg/kg bili smanjeni za trećinu u odnosu na dozu od 0,3 mg/kg.
English: This pain will be controlled with painkillers.
Croatian: Ovu ćete bol kontrolirati analgeticima.
English: Do not sunbathe.
Croatian: Nemojte se sunčati.
English: Unplanned or emergency surgical procedures where Foscan has been administered within the previous 30 days must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient.
Croatian: Neplanirani ili hitni kirurški postupci kad se Foscan primijenio u prethodnih 30 dana smiju se provesti samo ako je to apsolutno neophodno i ako su moguće koristi veće od rizika za bolesnika.
English: Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis.
Croatian: Obasjavanje tumora smije se provesti samo ako moguća korist opravdava mogući rizik od pretjerane nekroze.
English: Events occurring at a frequency not known (frequency cannot be estimated from the available data):
Croatian: Događaji koji se javljaju nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka)
English: What Foscan looks like and contents of the pack
Croatian: Kako Foscan izgleda i sadržaj pakiranja
English: Strict observance of the reduced light regime is required.
Croatian: Zahtijeva se strogo pridržavanje režima malog izlaganja svjetlosti.
English: •Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Such a reaction has been reported with topical 5-fluorouracil.
Croatian: Takva je reakcija zabilježena s lokalno primijenjenim 5-fluorouracilom.
English: If it is absolutely necessary to go outdoors during the hours of daylight, you must be careful to cover up all your skin including your face and hands and wear dark glasses.
Croatian: Ako svakako morate izaći za vrijeme dnevnog svjetla, pazite da Vam sva koža bude pokrivena, uključujući lice i šake, i da nosite naočale s tamnim staklima.
English: • Hypersensitivity to porphyrins.
Croatian: • Preosjetljivost na porfirine.
English: What you need to know before you use Foscan
Croatian: Što morate znati prije nego počnete primati Foscan
English: On the basis of the pharmacodynamic profile, temoporfin is presumed to be safe or unlikely to produce an effect.
Croatian: Na temelju farmakodinamičkog profila, temoporfin se smatra sigurnim i nije vjerojatno da će izazvati neki učinak.
English: There is no enterohepatic recirculation of these metabolites.
Croatian: Nema enterohepatičke recirkulacije tih metabolita.
English: • Closed shoes: for feet.
Croatian: • Zatvorene cipele: za stopala.
English: This product is also harmful for those suffering from alcoholism.
Croatian: Ovaj je lijek također štetan za osobe koje boluju od alkoholizma.
English: Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).
Croatian: Ispitivanja na životinjama pokazala su neke hematološke promjene i promjene u biokemijskom sastavu krvi (sniženje trombocita, eritrocita i hemoglobina, povišenje neutrofila, fibrinogena, bilirubina, triglicerida i kolesterola).
English: • You may not be given the laser treatment.
Croatian: • Možda nećete biti liječeni laserom.
English: If you do not see any skin redness in the next 24 hours, you can gradually increase your time outdoors during the week.
Croatian: Ako ne primijetite nikakvo crvenilo kože u sljedeća 24 sata, tijekom ovog tjedna možete postupno produljiti vrijeme boravka na otvorenom.
English: If there is no redness, you can gradually increase your exposure to sunlight day by day.
Croatian: Ako nema crvenila, možete postupno, iz dana u dan, povećavati svoje izlaganje sunčevoj svjetlosti.
English: Do not use this medicine after the expiry date which is stated on the label and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: No specific systemic symptoms are known to be associated with overdose.
Croatian: Nisu poznati posebni sistemski simptomi povezani s predoziranjem.
English: Your doctor will cover the normal tissue surrounding your cancer and then shine the laser light directly at the cancer for about 5 minutes.
Croatian: Liječnik će pokriti normalno tkivo koje okružuje karcinom i potom usmjeriti lasersku svjetlost izravno na karcinom na otprilike 5 minuta.
English: • Four days after your injection, your doctor will treat your cancer with laser light.
Croatian: • Četiri dana nakon injekcije, liječnik će Vam obasjati karcinom laserskom svjetlošću.
English: If at any time you notice a prickly or burning feeling or see skin reddening after exposure to sun, wait until this disappears before exposing your skin to light for this length of time again.
Croatian: Ako u bilo kojem trenutku primijetite bockanje ili žarenje ili opazite crvenilo na koži nakon izlaganja suncu, pričekajte da nestane prije nego što ponovno izložite kožu svjetlosti tijekom vremenskog razdoblja u tom trajanju.
English: A skin photosensitivity test must be carried out before the patient returns to normal light conditions.
Croatian: Test fotoosjetljivosti kože mora se provesti prije nego što se bolesnik vrati u uvjete uobičajenog osvjetljenja.
English: Limited data are available on the elimination of temoporfin in humans.
Croatian: Dostupni su ograničeni podaci o eliminaciji temoporfina u ljudi.
English: An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Croatian: Opažen je veliki volumen distribucije koji je na sredini između ukupne i izvanstanične tjelesne tekućine.
English: A WHO local complete response was observed in 14 % of patients.
Croatian: Potpuni lokalni odgovor prema kriterijima Svjetske zdravstvene organizacije (SZO) bio je opažen u 14% bolesnika.
English: Driving and use of machines may resume under normal lighting or daylight conditions once photosensitivity has been shown to have subsided.
Croatian: Upravljanje vozilima i rad na strojevima mogu se nastaviti pod uobičajenim osvjetljenjem ili uvjetima dnevnog svjetla nakon što se pokaže da se fotoosjetljivost povukla.
English: Photoactivation induces local tissue damage resulting in acute inflammatory response.
Croatian: Fotoaktivacija inducira oštećenje lokalnog tkiva što uzrokuje akutni upalni odgovor.
English: Both these metabolites show conjugated character.
Croatian: Oba metabolita imaju značajke konjugiranih spojeva.
English: In a clinical trial of 147 patients with advanced head and neck squamous cell carcinoma, tumour response, defined as a reduction of a minimum of 50 % of the tumour mass for a minimum of four weeks, was observed in 25 % after a single treatment.
Croatian: U kliničkom ispitivanju na 147 bolesnika s uznapredovalim karcinomom skvamoznih stanica glave i vrata, odgovor tumora definiran kao smanjenje tumorske mase za najmanje 50% u roku od najmanje četiri tjedna bio je opažen u 25% bolesnika nakon jednog liječenja.
English: Although no other developmental effects were observed, the applied doses were not sufficiently in excess of the human therapeutic dose to provide an adequate margin of safety.
Croatian: Iako nisu opaženi drugi učinci na razvoj, primijenjene doze nisu bile dovoljno više od terapijske doze za ljude da bi omogućile odgovarajući raspon sigurnosti.
English: • Fistula in the treated area
Croatian: • Fistula u liječenom području.
English: • The amount of alcohol in this medicine may impair your ability to drive or use machines for a few hours after injection.
Croatian: • Količina alkohola u ovom lijeku može narušiti Vašu sposobnost da upravljate vozilima ili rukujete strojevima nekoliko sati nakon injekcije.
English: Do NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) solution for injection or water for injections.
Croatian: NEMOJTE je ispirati vodenim otopinama kao što je otopina za injekciju natrijevog klorida od 9 mg/ml (0,9%) ili voda za injekcije.
English: The genotoxicity of temoporfin has been investigated to a limited extent.
Croatian: Genotoksičnost temoporfina ispitana je u ograničenom opsegu.
English: Continue pressing the plunger to expel excess Foscan until the required volume is left in the syringe, allowing sufficient to cover the dead space in the intravenous cannula (Figure 3).
Croatian: Nastavite pritiskati klip kako biste istisnuli suvišni Foscan sve dok u štrcaljki ne ostane potreban volumen, ostavljajući dovoljnu količinu da pokrije mrtvi prostor u intravenskoj kanili (slika 3).
English: Calculate the required dose of Foscan according to the bodyweight of the patient.
Croatian: Izračunajte potrebnu dozu Foscana prema tjelesnoj težini bolesnika.
English: • Sunglasses with side panels: for eyes and skin around eyes.
Croatian: • Sunčane naočale sa štitnicima sa strane: za oči i kožu oko očiju.
English: Limited information is available on the effects of overexposure to laser light during treatment.
Croatian: Dostupne su ograničene informacije o učincima prevelikog izlaganja laserskoj svjetlosti tijekom liječenja.
English: Days 2-7
Croatian: 2.-7. dan
English: This response is commonly associated with oedema and pain, followed by necrosis.
Croatian: Ovaj je odgovor često povezan s edemom i boli, nakon koje slijedi nekroza.
English: In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose.
Croatian: U slučaju predoziranja, liječenje laserom dovelo bi do značajnije nekroze tumora nego što bi se očekivalo uz preporučenu dozu.
English: There is a risk of damage of the surrounding area following photoactivation.
Croatian: Postoji rizik od oštećenja okolnog tkiva nakon fotoaktivacije.
English: A second course of treatment may be given at the discretion of the treating physician in patients where additional tumour necrosis and removal is deemed appropriate, with a recommended minimum interval of 4 weeks between treatments.
Croatian: Drugi ciklus liječenja može se provesti prema prosudbi nadležnog liječnika u bolesnika u kojih se smatra da je prikladna dodatna nekroza tumora i njegovo uklanjanje, uz preporučeni minimalni vremenski razmak između liječenja od 4 tjedna.
English: By 15 days post-infusion, temoporfin plasma concentration has declined to background such that patients are generally able to begin a gradual return to normal outdoor lighting conditions.
Croatian: Do 15. dana nakon infuzije, koncentracije temoporfina u plazmi snizile su se na osnovne, tako da su se bolesnici općenito mogli početi postupno vraćati uobičajenim uvjetima vanjskog osvjetljenja.