FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common [≥ 1/100 to < 1/10]).
Croatian: Najčešće prijavljene nuspojave bile su bol u kostima (vrlo često [≥1/10]) i mišićno-koštana bol (često
English: The syringes are provided with an automatic needle guard.
Croatian: Štrcaljka ima automatski štitnik za iglu.
English: Never leave the pre-filled syringe unattended where others might tamper with it. Do not shake the pre-filled syringe.
Croatian: Nikada ne ostavljajte napunjenu štrcaljku bez nadzora na mjestu gdje bi je drugi mogli dirati.
English: Pre-filled syringe (Type I glass), with a rubber plunger stopper, a plunger rod, a stainless steel needle and a rubber needle cap with an automatic needle guard.
Croatian: Napunjena štrcaljka (staklo tipa I), s gumenim čepom klipa, klipom, iglom od nehrđajućeg čelika te gumenom kapicom za iglu i s automatskim štitnikom za iglu.
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Croatian: Uz iznimku najmlađe dobne skupine (0-5 godina), srednji AUC pedijatrijskih bolesnika bio je sličan onom odraslih bolesnika s visokorizičnim rakom dojke stadij II-IV, koji su primali 100 μg/kg pegfilgrastima nakon završetka terapije doksorubicinom/docetakselom (vidjeti dio 4.8 i 5.1).
English: Ziextenzo contains the active substance pegfilgrastim.
Croatian: Ziextenzo sadrži djelatnu tvar pegfilgrastim.
English: The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Croatian: Uobičajena doza je jedna napunjena štrcaljka od 6 mg primijenjena supkutano (injekcija pod kožu), koja se mora dati najmanje 24 sata nakon posljednje doze kemoterapije na kraju svakog kemoterapijskog ciklusa.
English: (acute febrile dermatosis)1,2;
Croatian: Sweetov sindrom (akutna febrilna dermatoza)1,2;
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Croatian: Sigurnost i djelotvornost pegfilgrastima nisu ispitivane u bolesnika koji primaju kemoterapiju povezanu s odgođenom mijelosupresijom, npr. nitrozoureju.
English: Ziextenzo is for subcutaneous use.
Croatian: Ziextenzo je namijenjen supkutanoj primjeni.
English: Ziextenzo is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
Croatian: Ziextenzo se primjenjuje za smanjenje trajanja neutropenije (smanjenog broja bijelih krvnih stanica) i pojave febrilne neutropenije (smanjeni broj bijelih krvnih stanica praćen vrućicom), koji se mogu javiti uslijed primjene citotoksične kemoterapije (lijekova koji uništavaju brzorastuće stanice).
English: • Choose a different site each time you give yourself an injection.
Croatian: • Pri svakoj primjeni injekcije odaberite drugo mjesto injiciranja.
English: • Cotton ball or gauze.
Croatian: • Kuglica vate ili gaza.
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Croatian: Opća upozorenja i mjere opreza Ograničeni klinički podaci upućuju na usporediv učinak pegfilgrastima i filgrastima na vrijeme potrebno za oporavak od teške neutropenije u bolesnika s de novo akutnom mijeloičnom leukemijom (AML) (vidjeti dio 5.1).
English: Do not use the pre-filled syringe after the expiry date which is stated on the carton or syringe label.
Croatian: Ne upotrebljavajte napunjenu štrcaljku nakon isteka roka valjanosti navedenog na pakiranju ili naljepnici na štrcaljki.
English: Common (≥ 1/100 to < 1/10)
Croatian: [≥ 1/100 i < 1/10]).
English: - The other ingredients are glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide and water for injections.
Croatian: - Ostali su sastojci ledena acetatna kiselina, sorbitol (E 420), polisorbat 20, natrijev hidroksid i voda za injekcije.
English: Do not use the pre-filled syringe if any other particulates and/or discolouration are observed.
Croatian: Ne upotrebljavajte napunjenu štrcaljku ako primijetite bilo kakve čestice i/ili promjenu boje.
English: You may take Ziextenzo out of the refrigerator and keep it at room temperature (not above 35 °C) for no longer than 120 hours.
Croatian: Lijek Ziextenzo možete izvaditi iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 35 °C), ali ne dulje od 120 sata.
English: The injection site
Croatian: Mjesto injiciranja
English: Uncommonly, cases have resulted in respiratory failure or ARDS, which may be fatal (see section 4.4).
Croatian: Manje često su ovi slučajevi rezultirali respiratornim zatajenjem ili ARDS-om koji mogu imati smrtni ishod (vidjeti dio 4.4).
English: Remove the pre-filled syringe from the blister.
Croatian: Izvadite napunjenu štrcaljku iz blistera.
English: The trade name of the administered product should be clearly recorded in the patient file.
Croatian: Zaštićeni naziv primijenjenog lijeka mora se jasno navesti u bolesnikovoj medicinskoj dokumentaciji.
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1%
Croatian: Incidencija febrilne neutropenije bila je niža u bolesnica randomiziranih u grupu koja je dobivala pegfilgrastima u usporedbi s bolesnicama koje su dobivale placebo (1% prema 17%,
English: • if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin that itch.
Croatian: • ako imate alergijsku reakciju koja uključuje slabost, pad krvnog tlaka, otežano disanje, oticanje lica (anafilaksa), crvenilo i navale crvenila, osip na koži ili područja kože koja svrbe.
English: Dispose of the used pre-filled syringe immediately after use in a sharps container.
Croatian: Odložite napunjenu štrcaljku neposredno nakon uporabe u spremnik za oštre predmete.
English: In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Croatian: U dva randomizirana, dvostruko slijepa, pivotalna ispitivanja u bolesnica s rakom dojke visokog rizika, stadij II-IV, podvrgnutih mijelosupresivnoj kemoterapiji koja se sastojala od doksorubicina i docetaksela, primjena pegfilgrastima, u pojedinačnoj dozi jednom po ciklusu, smanjila je trajanje neutropenije i učestalost pojave febrilne neutropenije slično kao dnevna primjena filgrastima (medijan od 11 dnevnih primjena).
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for 4 cycles).
Croatian: ispitivan je učinak pegfilgrastima na incidenciju pojave febrilne neutropenije nakon primjene kemoterapijskog režima povezanog s razvojem febrilne neutropenije sa stopom od 10-20% (docetaksel 100 mg/m2 svaka 3 tjedna tijekom 4 ciklusa).
English: One 6 mg dose (a single pre-filled syringe) of Ziextenzo is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
Croatian: Jednokratna doza lijeka Ziextenzo od 6 mg (jedna napunjena štrcaljka) preporučuje se uz svaki kemoterapijski ciklus, najmanje 24 sata nakon primjene citotoksične kemoterapije.
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95% CI -0.15, 0.63).
Croatian: U jednom ispitivanju (n = 157), u kojemu je primjenjivana fiksna doza pegfilgrastima od 6 mg, srednje vrijeme trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosilo je 1,8 dana, a 1,6 dana u skupini koja je primala filgrastim (razlika od 0,23 dana, 95% CI -0,15, 0,63).
English: Store the blistered pre-filled syringe in its carton to protect it from light.
Croatian: Čuvati blister s napunjenom štrcaljkom u kutiji radi zaštite od svjetlosti.
English: If a caregiver is giving you the injection, the outer upper arms may also be used.
Croatian: Ako Vam injekciju daje njegovatelj, može je primijeniti i u nadlakticu.
English: Read ALL the way through these instructions before injecting.
Croatian: Prije injiciranja pročitajte ove upute U CIJELOSTI.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Excipients with known effect Each pre-filled syringe contains 30 mg sorbitol (E420).
Croatian: Jedna napunjena štrcaljka sadrži 30 mg sorbitola (E 420).
English: Instructions for use of Ziextenzo pre-filled syringe
Croatian: Upute za uporabu napunjene štrcaljke lijeka Ziextenzo
English: The pre-filled syringe cannot be re-used.
Croatian: Ova napunjena štrcaljka ne može se rabiti višekratno.
English: Your Ziextenzo pre-filled syringe with needle guard
Croatian: Ziextenzo napunjena štrcaljka sa štitnikom za iglu
English: • swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Croatian: oticanje ili podbuhlost, što može biti povezano s rjeđom učestalošću mokrenja, otežano disanje, oticanje trbuha i osjećaj punoće, te opći osjećaj umora
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Croatian: Gurnite iglu do kraja kako biste bili sigurni da ćete ubrizgati cjelokupnu količinu lijeka.
English: Excipients: glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: ledena acetatna kiselina, sorbitol (E 420), polisorbat 20, natrijev hidroksid, voda za injekcije.
English: Ziextenzo 6 mg injection pegfilgrastim
Croatian: Ziextenzo 6 mg injekcija pegfilgrastim
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Croatian: Mišićno koštana bol (mijalgija, artralgija, bol u udovima,
English: Each pack contains 1 glass pre-filled syringe with a rubber plunger stopper, a plunger rod, an attached stainless steel needle and needle cap.
Croatian: U svakom pakiranju nalazi se 1 napunjena staklena štrcaljka s gumenim čepom klipa, klipom,
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Croatian: Nakon primjene pegfilgrastima prijavljeni su obično asimptomatski slučajevi splenomegalije i slučajevi rupture slezene, uključujući neke slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: In this configuration the needle guard is ACTIVATED - DO NOT USE the pre-filled syringe
Croatian: Ako je štitnik za iglu u ovom položaju znači da je AKTIVIRAN - NE SMIJETE UPOTREBLJAVATI napunjenu štrcaljku
English: Ziextenzo contains sorbitol (E420) and sodium
Croatian: Ziextenzo sadrži sorbitol (E 420) i natrij.
English: Its colour may vary from colourless to slightly yellowish.
Croatian: Boja tekućine može biti bezbojna do blago žućkasta.
English: Before use, Ziextenzo solution should be inspected visually for particulate matter.
Croatian: Prije uporabe, potrebno je provjeriti sadrži li otopina lijeka Ziextenzo vidljive čestice.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Ziextenzo Lijek čuvajte izvan pogleda i dohvata djece.
English: Solution for injection 1 pre-filled syringe with automatic needle guard containing 0.6 mL solution for injection.
Croatian: Jedna napunjena štrcaljka s automatskim štitnikom za iglu koja sadrži 0,6 ml otopine za injekciju.
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 mcg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 mcg hr/ml and 29.3 ± 23.2 mcg·hr/ml, respectively) (see section 5.1).
Croatian: Djeca u najmlađoj dobnoj skupini (0-5 godina) imala su veću srednju ekspoziciju pegfilgrastimu (AUC) (± standardno odstupanje) (47,9 ± 22,5 μg·hr/ml) u odnosu na stariju djecu u dobi od 6-11, odnosno 12-21 godine
English: Important safety information Caution: Keep the pre-filled syringe out of the sight and reach of children.
Croatian: Oprez: čuvajte napunjenu štrcaljku izvan pogleda i dohvata djece.
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults.
Croatian: 0-5 godina (92%) u odnosu na stariju djecu, u dobi 6-11 godina (80%) i 12-21 godina (67%), odnosno odrasle.
English: Ziextenzo 6 mg injection pegfilgrastim SC
Croatian: Ziextenzo 6 mg injekcija pegfilgrastim s.c.
English: Solution for injection (injection) Clear, colourless to slightly yellowish solution for injection.
Croatian: Bistra, bezbojna do blago žućkasta otopina za injekciju.
English: How to use Ziextenzo
Croatian: Kako primjenjivati lijek Ziextenzo
English: If you use more Ziextenzo than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Ziextenzo nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Preparing the Ziextenzo pre-filled syringe ready for use
Croatian: Ziextenzo napunjene štrcaljke za uporabu
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Croatian: Povišena razina laktatdehidrogenaze i alkalne fosfataze1; Prolazno povišenje vrijednosti testova jetrene funkcije za ALT ili AST1
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rukovanju s lijekom prije primjene vidjeti dio 6.6.
English: Carefully pull the needle cap straight off. You may see a drop of liquid at the end of the needle.
Croatian: Na vrhu igle ćete možda primijetiti kap tekućine.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers (e.g. C-reactive protein and white blood cell count) were raised.
Croatian: Aortitis U zdravih ispitanika i bolesnika oboljelih od raka nakon primjene G-CSF-a zabilježen je aortitis, čiji su simptomi uključivali vrućicu, bol u abdomenu, malaksalost, bol u leđima i povišene upalne markere (npr. C-reaktivni protein i broj leukocita).
English: Injection site pain1 Non-cardiac chest
Croatian: Ne-kardijalna bol u prsištu
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Croatian: Dan ispitivanja sposobnosti, plodnost, ciklus estrusa, dane između parenja i koitusa i intrauterino preživljavanje.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): • upala aorte (velika krvna žila koja prenosi krv iz srca u tijelo), vidjeti dio 2.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Ziextenzo.
Croatian: Ako primjenjujete lijek Ziextenzo, morate prekinuti s dojenjem, osim ako Vaš liječnik ne savjetuje drugačije.
English: Cases of capillary leak syndrome have been reported in the post-marketing setting with granulocyte colony-stimulating factor use.
Croatian: Slučajevi sindroma povećane propusnosti kapilara uz primjenu faktora stimulacije rasta granulocita prijavljeni su nakon stavljanja lijeka na tržište.
English: Package leaflet: Information for the user Ziextenzo 6 mg solution for injection in pre-filled syringe pegfilgrastim ▼This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Ziextenzo 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: How to use the Ziextenzo pre-filled syringe
Croatian: Kako primijeniti napunjenu štrcaljku lijeka Ziextenzio
English: Ziextenzo 6 mg solution for injection in pre-filled syringe
Croatian: Ziextenzo 6 mg otopina za injekciju u napunjenoj štrcaljki
English: In a second study (n = 310), which used a weight-adjusted dose (100 µg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI-0.36, 0.30).
Croatian: U drugom ispitivanju (n = 310), u kojemu je primjenjivana doza prilagođena tjelesnoj težini (100 μg/kg), srednje trajanje neutropenije 4. stupnja u skupini liječenoj pegfilgrastimom iznosilo je 1,7 dana, u usporedbi s
English: The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary AML; therefore, it should not be used in such patients.
Croatian: kroničnom mijeloičnom leukemijom te u bolesnika sa sekundarnom AML, stoga se lijek ne smije primjenjivati u tih bolesnika.
English: How to store Ziextenzo
Croatian: Kako čuvati lijek Ziextenzo
English: Sandoz GmbH Schaftenau Biochemiestr.
Croatian: Sandoz GmbH Schaftenau Biochemiestr. 10 6336 Langkampfen Austrija
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment has been reported in patients treated with pegfilgrastim.
Croatian: Kod bolesnika liječenih pegfilgrastimom prijavljena je preosjetljivost, uključujući anafilaktičke reakcije, koja se može javiti kod prvog ili sljedećeg liječenja.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Croatian: U potomstvu skotnih ženki štakora kojima je supkutano primijenjen pegfilgrastim nisu primijećene nuspojave, ali se pokazalo da je pegfilgrastim u zečeva uzrokovao embrionalnu/fetalnu toksičnost
English: The figure below shows a ready to use syringe.
Croatian: Druga slika prikazuje štrcaljku spremnu za uporabu.
English: Acute respiratory distress syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Croatian: (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza)
English: • if you get left upper abdominal pain or pain at the tip of your shoulder.
Croatian: Pogledajte dio 4. • ako osjetite bol u gornjem lijevom dijelu trbuha ili u vrhu ramena.
English: Thrombocytopenia1 Leukocytosis1
Croatian: Leukocitoza1
English: INSTRUCTIONS ON USE
Croatian: UPOTREBLJAVATI
English: Ziextenzo 6 mg solution for injection in pre-filled syringe pegfilgrastim
Croatian: Ziextenzo 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: Ziextenzo is a clear, colourless to slightly yellowish solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Croatian: Ziextenzo je bistra, bezbojna do blago žućkasta otopina za injekciju u napunjenoj štrcaljki
English: Only a solution that is clear and colourless to slightly yellowish should be injected.
Croatian: Injicirati se smije samo bistra, bezbojna do blago žućkasta otopina.
English: Injecting Ziextenzo yourself
Croatian: Samostalno davanje lijeka Ziextenzo
English: • if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Croatian: Recite odmah svom liječniku ako imate neku od navedenih nuspojava ili kombinaciju navedenih nuspojava: • oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, teškoće disanja, oticanje trbuha i osjećaj punoće te opći osjećaj umora.
English: • Periodic safety update reports
Croatian: Važne sigurnosne informacije
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Croatian: U bolesnika oboljelih od raka i zdravih darivatelja rijetko je zabilježena upala aorte (velike krvne žile koja prenosi krv iz srca u tijelo), čiji simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
English: Storage of the Ziextenzo pre-filled syringe
Croatian: Čuvanje Ziextenzo napunjene štrcaljke
English: Gastrointestinal disorders
Croatian: Sažeti tablični prikaz nuspojava
English: Bone pain
Croatian: Čep klipa
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari ledena acetatna kiselina sorbitol (E 420) polisorbat 20 natrijev hidroksid (za prilagodbu ph) voda za injekcije
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size bottle (HDPE)
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: EU/1/98/081/006 EU/1/98/081/007
Croatian: Broj (EU) odobrenja
English: Film-coated tablet Film-coated tablet
Croatian: Veličina pakovanja
English: Comtan Comtan
Croatian: (Zaštićeno) ime
English: The maximum dose is 500 micrograms every two weeks.
Croatian: Najveća doza je 500 mikrograma svaka dva tjedna.
English: The usual starting dose is 100 micrograms every two weeks, which can be increased gradually until the levels of red blood cells are sufficiently low and stable.
Croatian: Uobičajena početna doza je 100 mikrograma svaka dva tjedna, što se može postupno povećavati dok razina crvenih krvnih stanica ne budu dovoljno niska i stabilna.
English: What measures are being taken to ensure the safe and effective use of Besremi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Besremi?
English: If side effects occur, the doctor can reduce the dose or stop treatment temporarily.
Croatian: U slučaju pojave nuspojava liječnik može smanjiti dozu ili privremeno prekinuti liječenje.
English: What is Besremi and what is it used for?
Croatian: Što je Besremi i za što se primjenjuje?
English: Besremi must not be used together with telbivudine (a medicine for treating hepatitis B).
Croatian: Besremi se ne smije primjenjivati zajedno s telbivudinom (lijekom koji se koristi za liječenje hepatitisa B).
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU311932.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/EU311932.