FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will decide if it is necessary to treat you with another medicine for an early reduction of your blood cell number to prevent blood clots and bleeding.
Croatian: Vaš liječnik će odlučiti je li Vas potrebno liječiti drugim lijekom za postizanje ranog smanjena broja Vaših krvnih stanica kako bi se spriječili ugrušci i krvarenje.
English: • Your doctor will tell you if you may use the pen for a second injection.
Croatian: • Vaš liječnik će Vam reći kada možete koristiti brizgalicu za drugu injekciju.
English: Your doctor will reduce your starting dose to 50 microgram if you have severe kidney problems.
Croatian: Vaš liječnik će smanjiti Vašu početnu dozu na 50 mikrograma ako imate teške probleme s bubrezima.
English: • History or presence of autoimmune disease
Croatian: • Anamneza ili prisutnost autoimune bolesti
English: Do not give this medicine to children and adolescents because no information is available on the use of Besremi in this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima, jer nema dostupnih podataka o primjeni lijeka Besremi u ovoj dobnoj skupini.
English: In this case, place the pen back into the outer carton and store it in the refrigerator for the next use.
Croatian: U tom slučaju, vratite brizgalicu natrag u vanjsku kutiju i spremite je u hladnjak za sljedeću uporabu.
English: This medicine is for subcutaneous use which means that it is injected in the tissue under your skin.
Croatian: Ovaj lijek je za supkutanu primjenu što znači da se injekcija primjenjuje u tkivo pod kožu.
English: If you use more Besremi than you should
Croatian: Ako primijenite više lijeka Besremi nego što ste trebali
English: • Combination with telbivudine (see section 4.5)
Croatian: • Kombinacija s telbivudinom (vidjeti dio 4.5)
English: The clicking sounds will stop when the injection is complete.
Croatian: Klikanje prestaje kada je primjena injekcije dovršena.
English: Characteristics of the study population are presented in Table 2.
Croatian: Karakteristike populacije iz ispitivanja prikazane su u Tablici 2.
English: Other medicines and Besremi
Croatian: Drugi lijekovi i Besremi
English: • If you do not see the droplet after the seventh time, ask your doctor or pharmacist for advice.
Croatian: • Ako ne vidite kapljicu nakon 7. puta, upitajte svog liječnika ili ljekarnika za savjet.
English: Influenza like illness
Croatian: Bolest nalik influenci
English: - if you have changes in your vision − you must tell your doctor and have an immediate eye examination.
Croatian: - ako imate promjene vida - morate se obratiti svom liječniku i odmah obaviti pregled očiju.
English: • Do not put the outer needle cap back on the needle until after you have injected the medicine.
Croatian: • Nemojte stavljati vanjsku kapicu igle natrag na iglu sve dok niste injicirali lijek.
English: In case of appearance or worsening of this skin disorders, the stop of the treatment must be envisaged.
Croatian: U slučaju pojave ili pogoršanja kožnih poremećaja potrebno je razmotriti prekid liječenja.
English: Get a new pen and start afresh.
Croatian: Uzmite novu brizgalicu i počnite ispočetka.
English: Your doctor will tell you the dose you need.
Croatian: Vaš liječnik će Vam reći koju dozu lijeka morate uzimati.
English: • Keep the injection site clean until the small injection wound has closed.
Croatian: • Održavajte mjesto injiciranja čistim dok se ne zatvori mala rana od injekcije.
English: Endocrine system
Croatian: Endokrini sustav
English: • Immunosuppressed transplant recipients
Croatian: • Imunosuprimirani bolesnici s transplantatom
English: The safety and efficacy of Besremi in children and adolescents has not been established.
Croatian: Sigurnost i djelotvornost lijeka Besremi u djece i adolescenata nije ustanovljena.
English: After 36 months of treatment, the complete haematological response was 70.5%.
Croatian: Nakon 36 mjeseci liječenja, udio bolesnika s potpunim hematološkim odgovorom iznosio je 70,5%.
English: Do not use Besremi if you are taking telbivudine (for treating hepatitis B) since the combination of these medicines increases the risk of peripheral neuropathy (numbness, tingling, or burning sensations in the arms and legs).
Croatian: Nemojte primjenjivati Besremi ako uzimate telbivudin (za liječenje hepatitisa B), jer kombinacija tih lijekova povećava rizik od periferne neuropatije (utrnulosti, trnaca ili osjećaja pečenja u rukama i nogama).
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Croatian: Veliki volumeni trebaju se primjenjivati s oprezom i samo ako je neophodno, osobito u osoba s oštećenjem funkcije jetre ili bubrega zbog rizika od akumulacje i toksičnosti (metabolička acidoza).
English: You have to use a different injection site for each of the two pens.
Croatian: Morate koristiti različito mjesto primjene injekcije za svaku od dvije brizgalice.
English: • If you need two pens, use a different injection site for each pen (e. g., right and left side of belly or right and left thigh).
Croatian: • Ako su Vam potrebne dvije brizgalice, koristite različito mjesto primjene injekcije za svaku brizgalicu (npr. desna i lijeva strana trbuha ili desno i lijevo bedro).
English: • If you do not see a droplet at the needle tip, repeat steps 5 and 6 up to six times until a droplet emerges.
Croatian: • Ako ne vidite kapljicu na vrhu igle, ponovite korake 5. i 6. do šest puta, sve dok se kapljica ne pojavi.
English: The average molecular mass is approximately 60 kDa, of which the PEG moiety constitutes approximately 40 kDa .
Croatian: Prosječna molekularna masa je približno 60 kDa, od čega na PEG-a dio otpada približno 40 kDa.
English: The patient received a 10-time higher starting dose as recommended and developed flu-like symptoms for three days which were rated as non-serious.
Croatian: Bolesnik je primio 10 puta veću početnu dozu od preporučene i razvio simptome nalik gripi tijekom tri dana, a za koje je ocijenjeno da nisu ozbiljni.
English: The potency of this medicinal product should not be compared to that of another pegylated or nonpegylated protein of the same therapeutic class (see section 5.1).
Croatian: Potentnost ovog lijeka ne smije se uspoređivati s drugim pegiliranim ili nepegiliranim proteinom iste terapijske skupine (vidjeti dio 5.1).
English: Vogt-Koyanagi-Harada disease#, acute hypersensitivity reactions#**
Croatian: Vogt-Koyanagi-Harada bolest#, reakcije akutne preosjetljivosti#**
English: You will need the following supplies for your injection:
Croatian: Za primjenu svoje injekcije trebat ćete sljedeće:
English: There is no antidote for the medicinal product available.
Croatian: Nije dostupan antidot za ovaj lijek.
English: Interferons are produced by your immune system to block the growth of cancer cells.
Croatian: Interferone proizvodi Vaš imunološki sustav kako bi se zaustavio rast stanica raka.
English: If the increase in liver enzymes is progressive and clinically significant despite dose reduction, or if there is evidence of hepatic decompensation, therapy should be discontinued (see section 4.4).
Croatian: Ako je porast u razinama jetrenih enzima progresivan i klinički značajan unatoč redukciji doze ili ako postoji dokaz jetrene dekompenzacije, terapiju treba prekinuti (vidjeti dio 4.4).
English: very rare myocardial ischemia#
Croatian: vrlo rijetko ishemija miokarda#
English: • Decompensated cirrhosis of the liver (Child-Pugh B or C)
Croatian: • Dekompenzirana ciroza jetre (Child-Pugh stadij B ili C)
English: Any patient reporting a decrease or loss of vision or reporting other eye symptoms should have an immediate eye examination.
Croatian: U bilo kojeg bolesnik koji prijavi slabljenje ili gubitak vida ili druge simptome povezane s okom mora se odmah napraviti liječnički pregled očiju.
English: Ask your doctor or pharmacist for advice: - if you are pregnant or breast-feeding.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet: - ako ste trudni ili dojite.
English: Respiratory system
Croatian: Respiratorni sustav
English: Please note down your injection dates and dose as instructed by your doctor.
Croatian: Zabilježite datume primjene Vaše injekcije i dozu prema uputama Vašeg liječnika.
English: Besremi has minor influence on the ability to drive and use machines.
Croatian: Besremi malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Events were reported at various time points typically several months after starting treatment with interferon alfa.
Croatian: Događaji su bili zabilježeni u različitim vremenskim točkama, obično nekoliko mjeseci nakon početka liječenja interferonom alfa.
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC code: L03AB15
Croatian: Farmakoterapijska skupina: Imunostimulatori, interferoni, ATK oznaka: L03AB15
English: Once you have started Besremi treatment, talk to your doctor: - if you develop symptoms of depression (such as feelings of sadness, dejection, and suicidal thoughts).
Croatian: Nakon što ste započeli liječenje lijekom Besremi, razgovarajte sa svojim liječnikom: - ako razvijete simptome depresije (poput osjećaja tuge, utučenosti i misli o samoubojstvu).
English: Any medicine remaining in the pre-filled pen after the second use and/or after 30 days must be discarded.
Croatian: Sav lijek preostao u brizgalici nakon nakon druge uporabe i/ili nakon 30 dana mora se baciti.
English: This medicine contains 5 mg benzyl alcohol in each 0.5 mL.
Croatian: Ovaj lijek sadrži 5 mg benzilnog alkohola u svakih 0,5 ml.
English: Your doctor will help you decide if you have to stop breast-feeding when you are using this medicine.
Croatian: Vaš liječnik će odlučiti morate li prestati dojiti kada koristite ovaj lijek.
English: • If you are using this pen for the first time, continue with preparation of the pen in step 5.
Croatian: • Ako koristite ovu brizgalicu po prvi put, nastavite s pripremom brizgalice u koraku 5.
English: To prevent passing on infectious diseases, you should never share Besremi pre-filled pen with anyone else, even when the needle is changed.
Croatian: Za sprječavanje prenošenja zarazne bolesti ne smijete nikada dijeliti napunjenu brizgalicu Besremi ni s kim, čak niti ako promijenite iglu.
English: - if you have psoriasis or other skin problems because they may get worse during treatment with Besremi.
Croatian: - ako imate psorijazu ili druge probleme s kožom koji bi se mogli pogoršati tijekom liječenja lijekom Besremi.
English: The medicinal product is intended for long-term treatment and can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections with the pre-filled pen.
Croatian: Lijek je namijenjen za dugotrajno liječenje i može ga primjenjivati liječnik, medicinska sestra, član obitelji ili bolesnik kada je obučen u primjeni supkutanih injekcija napunjenom brizgalicom.
English: Your doctor or pharmacist will show you how to use the pen.
Croatian: Vaš liječnik ili ljekarnik će Vam pokazati kako upotrebljavati brizgalicu.
English: b defined as the improvement of disease-related signs (clinically significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
Croatian: b definirano kao poboljšanje znakova povezanih s bolesti (klinički značajna splenomegalija) te simptoma povezanih s bolesti (mikrovaskularni poremećaji, pruritus, glavobolja).
English: • Disinfect your skin in the injection area using an alcohol swab before the injection.
Croatian: • Dezinficirajte kožu u području davanja injekcije uporabom alkoholne maramice a prije davanja injekcije.
English: Patients should be closely monitored, in particular during the titration phase; complete blood counts including determination of haematocrit level, leukocyte and platelet counts should be performed regularly also after the individual optimal dose has been established.
Croatian: Bolesnike treba pomno nadzirati, posebice tijekom faze titracije; pregled kompletne krvne slike, uključujući određivanje razine hematokrita, leukocita i trombocita treba provoditi redovito također nakon utvrđivanja individualne optimalne doze.
English: Do not use this medicine after the expiry date which is stated on the label and the outer carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i vanjskoj kutiji iza oznake „EXP“.
English: The pre-filled pen may not be used more than twice, and must be discarded 30 days after the first use, regardless of any medicinal product remaining in the pre-filled pen.
Croatian: Napunjena brizgalica ne smije se upotrebljavati više od dva puta i mora se baciti 30 dana nakon prve uporabe, neovisno o količini preostalog lijeka u napunjenoj brizgalici.
English: For benzyl alcohol and sodium, see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”.
Croatian: Za benzilni alkohol i natrij, vidjeti dio 2 „Bersemi sadrži benzilni alkohol“ i „Besremi sadrži natrij“.
English: In case of an overdose, close monitoring of the patient and symptomatic treatment, if necessary, are recommended.
Croatian: U slučaju predoziranja preporučuje se pomno praćenje bolesnika i simptomatsko liječenje prema potrebi.
English: • End stage renal disease (GFR <15 mL/min)
Croatian: • Završni stadij bubrežne bolesti (GFR <15 ml/min)
English: Contact your doctor immediately if you notice any of the following serious side effects during your treatment with Besremi:
Croatian: Odmah se obratite svom liječniku ako uočite bilo koju od sljedećih ozbiljnih nuspojava tijekom liječenja lijekom Besremi:
English: Patients should be closely monitored for any symptoms of psychiatric disorders and therapeutic management should be considered by the treating physician if such symptoms emerge.
Croatian: Bolesnike treba pomno nadzirati kako bi se uočila svaka pojava simptoma psihijatrijskih poremećaja te je potrebno da nadležni liječnik razmotri terapijsko liječenje ako se pojave takvi simptomi.
English: Do not drive or use machines if you feel dizzy, sleepy or confused while using Besremi.
Croatian: Nemojte voziti ili upravljati strojevima ako se osjećate omamljeno, pospano ili smeteno dok se liječite lijekom Besremi.
English: When the increase in liver enzyme levels is progressive and persistent, the dose should be reduced.
Croatian: Kada je porast u razinama jetrenih enzima progresivan i perzistentan, dozu treba smanjiti.
English: The usual starting dose of Besremi is 100 microgram every 2 weeks.
Croatian: Uobičajena početna doza lijeka Besremi je 100 mikrograma svaka 2 tjedna.
English: very rare blindness#
Croatian: vrlo rijetko sljepoća#
English: To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed.
Croatian: Za sprječavanje mogućeg prijenosa bolesti ili bilo koje kontaminacije, uporaba napunjene brizgalice lijeka Besremi mora biti strogo ograničena na jednog bolesniku, čak i kada se igla promjeni.
English: Talk to your doctor before using Besremi: - if you have thyroid disease.
Croatian: Razgovarajte sa svojim liječnikom prije nego počnete primjenjivati Besremi: - ako imate bolest štitnjače.
English: The effect of Besremi during pregnancy is not known.
Croatian: Učinak lijeka Besremi tijekom trudnoće nije poznat.
English: Before use, the pre-filled pen should be brought to room temperature (15 °C - 25 °C) for up to 15 minutes.
Croatian: Prije uporabe napunjenu brizgalicu treba pustiti da tijekom 15 minuta postigne sobnu temperaturu (15°C - 25°C).
English: As ropeginterferon alfa-2b may have the same effect, this medicinal product is not recommended during pregnancy.
Croatian: S obzirom da ropeginterferon alfa-2b može imati isti učinak, ovaj lijek se ne preporučuje tijekom trudnoće.
English: • If you are unable to reach the required dose setting by turning the dose knob, your pen may not have sufficient medicine left.
Croatian: • Ako ne možete dosegnuti potrebnu dozu okretanjem kotačića za odabir doze, u Vašoj brizgalici možda nije ostalo dovoljno lijeka.
English: • Hold the pen so that the display window and the label are visible during the injection.
Croatian: • Držite brizgalicu tako da su prozorčić za prikaz doze i naljepnica vidljivi tijekom primjene injekcije.
English: The maximum recommended single dose is 500 micrograms injected every two weeks.
Croatian: Maksimalna preporučena pojedinačna doza je 500 mikrograma injicirati svaka 2 tjedna.
English: If you have health problems which may lead to eye problems such as diabetes or high blood pressure, you doctor should check your vision also during treatment.
Croatian: Ako imate problema sa zdravljem koji mogu uzrokovati probleme s očima, poput šećerne bolesti ili visokog krvnog tlaka, Vaš liječnik treba provjeravati Vaš vid i tijekom liječenja.
English: You should brush your teeth thoroughly twice daily and have regular dental checks.
Croatian: Morate četkati zube temeljito dva puta na dan te redovito odlaziti na stomatološke preglede.
English: However, if more than 2 days have passed since you missed the dose, leave out the dose and inject the next dose when it is due.
Croatian: Međutim, ako je prošlo više od 2 dana od propuštene doze, preskočite tu dozu i injicirajte sljedeću dozu kada za nju dođe vrijeme, prema uobičajenom rasporedu.
English: - periodontal (affecting gums) and dental disorders, change in colour of the tongue
Croatian: - parodontalni (koji zahvaćaju desni) i dentalni poremećaji, promjena boje jezika
English: - if you have diabetes or high blood pressure − your doctor may ask you to have an eye examination.
Croatian: - ako imate šećernu bolest ili visoki krvni tlak − Vaš liječnik Vas može poslati na pregled očiju.
English: Responder % (n/N)
Croatian: Ispitanici s odgovorom % (n/N)
English: Dose titration phase
Croatian: Doziranje Faza titracije
English: If you stop using Besremi
Croatian: Ako prestanete primjenjivati Besremi
English: What Besremi looks like and contents of the pack
Croatian: Kako Besremi izgleda i sadržaj pakiranja
English: • Hold the push button down and wait for at least 10 seconds before removing the needle.
Croatian: • Držite gumb pritisnutim nadolje i pričekajte barem 10 sekundi prije vađenja igle.
English: 3F, No. 28, Keya West Road
Croatian: 28, Keya West Road Daya District
English: Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet AOP Orphan Pharmaceuticals AG
English: Your doctor or pharmacist will explain to you how to use the two pens.
Croatian: Vaš liječnik ili ljekarnik će Vam objasniti kako primijeniti dvije brizgalice.
English: Polycythaemia vera is a type of cancer in which the bone marrow produces too many red blood cells, white blood cells and platelets (cells that help the blood to clot).
Croatian: Policitemija vera je vrsta raka krvi u kojem koštana srža proizvodi previše crvenih krvnih stanica, bijelih krvnih stanica i trombocita (stanica koje pomažu zgrušavanju krvi).
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Croatian: Bolesnici moraju četkati zube temeljito dva puta na dan te redovito odlaziti na stomatološke preglede.
English: Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.
Croatian: Vezivanje na IFNAR pokreće silaznu signalnu kaskadu kroz aktivaciju kinaza, posebice Janus kinaze 1 (JAK1) i tirozin kinaze 2 (TYK2) te aktivator transkripcije proteina (engl. signal transducer and activator of transcription, STAT).
English: The push button should be pressed in completely and held down for at least 10 seconds before removing the needle.
Croatian: Potisni gumb treba pritisnuti do kraja i držati tako pritisnutim barem 10 sekundi prije izvlačenja igle.
English: not known pulmonary fibrosis#, pneumonia#, pulmonary arterial hypertension#*
Croatian: nepoznato plućna fibroza#, pneumonija#, plućna arterijska hipertenzija#*
English: Contents of the pack and other information What Besremi contains
Croatian: Sadržaj pakiranja i druge informacije Što Besremi sadrži
English: - if you have or had severe mental disorders (such as depression or suicidal thoughts or if you tried to kill yourself).
Croatian: - ako imate ili ste imali teži psihički poremećaj (poput depresije ili misli o samoubojstvu ili ako ste se pokušali ubiti).
English: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Vienna
Croatian: AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/II f 1160 Beč
English: Then press the push button until the display window shows “0”.
Croatian: Potom pritisnite potisni gumb dok prozorčić ne prikaže „0“.
English: Apply an adhesive plaster if needed.
Croatian: Prema potrebi primijenite flaster.
English: - if you have or had an autoimmune disease (such as rheumatoid arthritis, psoriasis or inflammatory bowel disease).
Croatian: - ako imate ili ste imali autoimunu bolest (poput reumatoidnog artritisa, psorijaze ili upalne bolesti crijeva).
English: The most common adverse reactions are leukopenia (19.1%), thrombocytopenia (18.5%), arthralgia (12.9%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza like illness (10.7%), myalgia (10.7%), pyrexia (8.4%), pruritus (8.4%), increased alanine aminotransferase (8.4%), anaemia (7.9%), pain in extremity (6.7%), alopecia (6.7%), neutropenia (6.7%), increased aspartate aminotransferase (6.2%), headache (6.2%), diarrhoea (5.6%), chills (5.1%), dizziness (5.1%) and injection site reaction (5.1%).
Croatian: Najčešće nuspojave su leukopenija (19,1%), trombocitopenija (18,5%), artralgija (12,9%), umor (12,4%), povećana razina gama-glutamiltransferaze (11,2%), bolest nalik influenci (10,7%), mijalgija (10,7%), pireksija (8,4%), pruritus (8,4%), povišena razina alanin aminotrasnferaze (8,4%), anemija (7,9%), bol u ekstremitetima (6,7%), alopecija (6,7%), neutropenija (6,7%), povišena razina aspartat aminotransferaze (6,2%), glavobolja (6,2%), proljev (5,6%), neutropenija (5,1%), zimica (5,1%), omaglica (5,1%) te reakcija na mjestu primjene injekcije (5,1%).
English: Interferon alfa therapy has been associated with hepatotoxicity characterized by potentially significant increases in liver enzymes.
Croatian: Terapija interferonom alfa povezana je s hepatotoksičnošću koja je karakterizirana potencijalno značajnim porastima razina jetrenih enzima.
English: Obese or underweighted patients
Croatian: Pretili ili pothranjeni bolesnici
English: Serious adverse reactions are depression (1.1%), atrial fibrillation (1.1%) and acute stress disorder
Croatian: Ozbiljne nuspojave su depresija (1,1%), fibrilacija atrija (1,1%) te akutni stresni poremećaj (0,6%).
English: Cardiovascular system
Croatian: Kardiovaskularni sustav
English: - if you have or had severe heart problems (such as heart attack or stroke).
Croatian: - ako imate ili ste imali teške probleme sa srcem (poput srčanog udara ili moždanog udara).
English: The dose is titrated individually with a recommended starting dose of 100 micrograms (or 50 micrograms in patients under another cytoreductive therapy).
Croatian: Doza se titrira individualno za svakog bolesnika s preporučenom početnom dozom od 100 mikrograma (ili 50 mikrograma u bolesnika koji su podvrgnuti drugoj citoreduktivnoj terapiji).
English: If you are a woman of childbearing potential, your doctor will discuss with you if effective birth control should be used during your treatment with Besremi.
Croatian: Ako ste žena u reproduktivnoj dobi, Vaš liječnik će raspraviti s Vama trebate li primjenjivati učinkovitu metodu kontracepcije tijekom liječenja lijekom Besremi.
English: Phlebotomy as rescue treatment to normalise blood hyperviscosity may be necessary.
Croatian: Može biti potrebna felbotomija kao metoda „rescue“ liječenja kako bi se postigla normalizaciju hiperviskoznosti krvi.
English: If you forget to use Besremi
Croatian: Ako ste zaboravili primijeniti Besremi