FrancophonIA/ELRC3.0 huggingface dataset:
English: Grasp the packaged needle firmly in both hands.
Croatian: Čvrsto uhvatite zapakiranu iglu objema rukama.
English: Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled syringe.
Croatian: Nemojte si pokušavati dati injekciju dok ne budete sigurni da razumijete kako koristiti napunjenu štrcaljku.
English: MIRCERA pre-filled syringe Instructions For Use
Croatian: MIRCERA napunjena štrcaljka Upute za uporabu
English: Disinfect your hands well with soap and warm water or hands sanitizer.
Croatian: Temeljito dezinficirajte ruke sapunom i toplom vodom ili sredstvom za dezinfekciju ruku.
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA03
Croatian: Farmakoterapijska skupina: Ostali pripravci za liječenje anemije; ATK oznaka: B03XA03
English: Dose changes will not be made more often than once a month.
Croatian: Doza neće biti mijenjana češće od jedanput mjesečno.
English: • If your doctor suspects or confirms that you have these antibodies in your blood, you must not be treated with MIRCERA.
Croatian: • Ako Vaš liječnik sumnja ili je potvrdio da u krvi imate ta protutijela, ne smijete se liječiti lijekom MIRCERA.
English: HOW TO GIVE THE INJECTION Step 1: Allow the syringe to adjust to room temperature
Croatian: KAKO PRIMIJENITI INJEKCIJU Korak 1: Pričekajte da se štrcaljka ugrije na sobnu temperaturu
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2007
Croatian: Datum prvog odobrenja: 20. srpnja 2007.
English: Clean the chosen injection site area using an alcohol pad to reduce the risk of infection; carefully follow the instructions of the alcohol pad.
Croatian: Očistite odabrano mjesto za injekciju jastučićem natopljenim alkoholom kako biste smanjili rizik od infekcije; pažljivo slijedite upute priložene uz jastučić natopljen alkoholom.
English: Stevens-Johnson syndrome / toxic epidermal necrolysis*
Croatian: Stevens Johnsonov sindrom/toksična epidermalna nekroliza *
English: Store the syringe in its original box until ready to use.
Croatian: Štrcaljku čuvajte u originalnoj kutiji sve dok je ne budete spremni upotrijebiti.
English: Once removed from the refrigerator the medicinal product must be used within this period.
Croatian: Jednom kada ga se izvadi iz hladnjaka, lijek se mora iskoristiti unutar ovog razdoblja.
English: Other medicines and MIRCERA
Croatian: Drugi lijekovi i MIRCERA
English: · You should use a different injection site each time you administer an injection, at least three centimeters from the area you used for the previous injection.
Croatian: • Lijek trebate injicirati svaki puta na drugo mjesto, koje mora biti najmanje tri centimetara udaljeno od mjesta na kojem ste prethodno injicirali lijek.
English: · Read the packaging and ensure you have the dose prescribed by your healthcare professional.
Croatian: • Pročitajte tekst na pakiranju i provjerite imate li dozu koju Vam je propisao zdravstveni radnik.
English: Studies in animals have shown no evidence of impaired fertility (see section 5.3).
Croatian: Istraživanja na životinjama nisu pokazala štetno djelovanje na plodnost (vidjeti dio 5.3).
English: Examine the syringe and check the expiration date on the syringe and box.
Croatian: Pregledajte štrcaljku i provjerite rok valjanosti na štrcaljki i kutiji.
English: In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were aged 75 years and over.
Croatian: U kliničkim je ispitivanjima 24% bolesnika koji su primali lijek MIRCERA imalo između 65 i 74 godine, a 20% ih je imalo 75 i više godina.
English: If you do not respond adequately to MIRCERA, your doctor will check your dose and will inform you if you need to change doses of MIRCERA.
Croatian: Ako ne budete odgovarali na lijek MIRCERA na odgovarajući način, Vaš liječnik će provjeriti Vašu dozu i obavijestiti Vas ako morate promijeniti doze lijeka MIRCERA.
English: · Do not inject through clothing.
Croatian: • Nemojte injicirati lijek kroz odjeću.
English: The pre-filled syringe is ready for use.
Croatian: Napunjena štrcaljka spremna je za korištenje.
English: Further injections can be given by a healthcare professional or, after you have been trained, you can inject MIRCERA yourself (see instructions at the end of this leaflet.)
Croatian: Daljnje injekcije lijeka MIRCERA može Vam davati zdravstveni radnik ili si ih možete sami ubrizgavati nakon edukacije (vidjeti upute na kraju).
English: To be sure the needle can be inserted correctly under the skin, use your free hand to pinch a fold of loose skin at the clean injection site.
Croatian: Kako biste bili sigurni da iglu možete pravilno ubosti pod kožu, slobodnom rukom uhvatite nabor kože na očišćenom mjestu za injekciju.
English: Your doctor will decide to treat you with MIRCERA administered as a single injection once a month.
Croatian: Liječnik će odlučiti hoće li Vas liječiti lijekom MIRCERA primijenjenom kao jedna injekcija jedanput mjesečno.
English: Pure red cell aplasia*
Croatian: Pure Red Cell Aplasia, PRCA).
English: Your doctor will calculate your MIRCERA starting dose based on the last dose of your previous medicine.
Croatian: Liječnik će izračunati početnu dozu lijeka MIRCERA na temelju posljednje doze Vašeg prethodnog lijeka.
English: Treatment interruption
Croatian: Prekid liječenja
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 1214 g/dl.
Croatian: Ciljna koncentracija hemoglobina u dva je ispitivanja bila >13 g/dl, a u preostala tri ispitivanja bila je između 12-14 g/dl.
English: Individual responsiveness must be considered when treatment is initiated.
Croatian: Na početku liječenja treba uzeti u obzir individualni odgovor.
English: • hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).
Croatian: • hipertenzivna encefalopatija (vrlo visok krvni tlak koji može uzrokovati glavobolju, pogotovo naglu, pulsirajuću glavobolju nalik migreni, smetenost, poremećaje govora, napadaje ili konvulzije).
English: No patients treated with MIRCERA were included in this data analysis.
Croatian: Bolesnici liječeni lijekom MIRCERA nisu bili uključeni u ovu analizu podataka.
English: A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure).
Croatian: Česta nuspojava (može se javiti u do 1 na 10 osoba) je hipertenzija (visok krvni tlak).
English: What MIRCERA contains
Croatian: Što MIRCERA sadrži
English: Once you have removed your medicine from the refrigerator you must use it within this period of one month.
Croatian: Jednom kada ste lijek izvadili iz hladnjaka, morate ga upotrijebiti unutar ovog razdoblja od jednog mjeseca.
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Croatian: Lijek nemojte injicirati u madeže, ožiljke, modrice niti područja na kojima je koža bolna na dodir, crvena, tvrda ili oštećena.
English: Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.
Croatian: Liječnik će Vas savjetovati o tome trebate li prekinuti ili nastaviti s dojenjem te prekinuti ili nastaviti liječenje.
English: A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with MIRCERA should be made taking into account the benefit of breast-feeding to the child and the benefit of MIRCERA therapy to the woman.
Croatian: Odluku o tome treba li nastaviti ili prekinuti dojenje odnosno treba li nastaviti ili prekinuti terapiju lijekom MIRCERA treba donijeti uzimajući u obzir korist dojenja za dijete i korist terapije lijekom MIRCERA za majku.
English: · Only handle the syringe by the body, because any contact with the release clips could cause premature release of the safety device.
Croatian: • Štrcaljkom rukujte držeći je isključivo za tijelo jer bilo kakav doticaj s otpusnim kvačicama može uzrokovati prerano otpuštanje sigurnosne naprave.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Croatian: Nedostatak željeza, folne kiseline ili vitamina B12 smanjuju učinkovitost lijekova za stimulaciju eritropoeze pa ih stoga treba nadomjestiti.
English: Dose adjustments should not be made more frequently than once a month.
Croatian: Doza se ne smije prilagođavati češće od jedanput mjesečno.
English: A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radia-, chemoradia-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Croatian: Provedena je i analiza podataka na razini pojedinog bolesnika u više od 13 900 bolesnika sa zloćudnom bolesti (na kemoterapiji, radioterapiji, kemo-radioterapiji ili bez terapije) koji su sudjelovali u 53 kontrolirana klinička ispitivanja koja su uključivala nekoliko epoetina.
English: MIRCERA has not shown evidence of impaired fertility in animals.
Croatian: MIRCERA nije pokazala štetno djelovanje na plodnost kod životinja.
English: The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Croatian: Potentnost metoksi polietilenglikol epoetina beta se ne smije uspoređivati s potentnosti drugih pegiliranih ili nepegiliranih proteina iste terapijske skupine.
English: Treatment with MIRCERA must be started under the supervision of a healthcare professional.
Croatian: Liječenje lijekom MIRCERA mora započeti pod nadzorom zdravstvenog radnika.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/l or with transferrin saturation below 20%.
Croatian: Nadomjesna terapija željezom preporučuje se svim bolesnicima s vrijednošću feritina u serumu manjom od 100 mikrograma/l ili zasićenjem transferina manjim od 20%.
English: Rare side effects (may affect up to 1 in 1000 people) are:
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) su:
English: · Never attempt to take the syringe apart.
Croatian: • Nikada nemojte pokušavati rastaviti štrcaljku.
English: · Do not touch the needle or let it touch any surface, as the needle may become contaminated and may cause injury and pain if touched.
Croatian: • Nemojte dirati iglu i ne dopustite da dotakne bilo kakvu površinu jer se može onečistiti te uzrokovati ozljedu i bol ako je dotaknete.
English: Overdose can result in manifestations of an exaggerated pharmacodynamic effect, e.g. excessive erythropoiesis.
Croatian: Predoziranje se može očitovati pretjeranim farmakodinamičkim učinkom, npr. pretjeranom eritropoezom.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na neposredne štetne učinke na trudnoću, embrio/fetalni razvoj, porod ili postporođajni razvoj, ali upućuju na reverzibilno smanjenje težine fetusa karakteristično za ovu skupinu lijekova (vidjeti dio 5.3).
English: What MIRCERA is and what it is used for What you need to know before you use MIRCERA How to use MIRCERA
Croatian: Što je MIRCERA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek MIRCERA
English: Approximately 6% of patients treated with MIRCERA are expected to experience adverse reactions.
Croatian: Očekuje se da će otprilike 6% bolesnika liječenih lijekom MIRCERA imati nuspojave.
English: The following instructions explain how to use the MIRCERA pre-filled syringe to give yourself an injection.
Croatian: Upute u nastavku opisuju kako koristiti MIRCERA napunjenu štrcaljku da biste sami sebi dali injekciju.
English: · Do not remove the needle shield until you are ready to perform an injection.
Croatian: • Nemojte ukloniti zaštitni pokrov igle dok ne budete spremni dati si injekciju.
English: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).
Croatian: Liječenje simptomatske anemije povezane s kroničnom bolesti bubrega u odraslih bolesnika (vidjeti dio 5.1).
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Croatian: Eritropoetinski receptori mogu biti eksprimirani na površini različitih tumorskih stanica.
English: Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Croatian: Dva kontrolirana klinička ispitivanja u kojima su epoetini davani bolesnicima s različitim vrstama karcinoma, uključujući karcinome glave i vrate te karcinom dojke, pokazala su neobjašnjeno povećanje smrtnosti.
English: Treatment with MIRCERA is not recommended in children and adolescents, because it has not been studied in these patients.
Croatian: Liječenje lijekom MIRCERA se ne preporučuje u djece i adolescenata jer u tim skupinama bolesnika lijek nije ispitan.
English: · Do not touch the release clips (see diagram below) as this may damage the syringe and make it unusable.
Croatian: • Nemojte dirati otpusne kvačice (vidjeti dijagram u nastavku) jer možete oštetiti štrcaljku i učiniti je neupotrebljivom.
English: When MIRCERA was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Croatian: Kada je MIRCERA davana supkutano mužjacima i ženkama štakora prije i tijekom parenja, nije bilo utjecaja na reproduktivnu sposobnost, plodnost i parametre nalaza sperme.
English: During this period when you have stored MIRCERA at a room temperature not above 30 °C you may not put MIRCERA back in the refrigerator before use.
Croatian: Tijekom tog razdoblja, dok lijek MIRCERA čuvate na sobnoj temperaturu do 30°C, ne smijete ju vraćati u hladnjak prije upotrebe.
English: This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated whith typical symptoms, such as tiredness, weakness and shortness of breath.
Croatian: Ovaj Vam je lijek propisan jer imate anemiju uzrokovanu kroničnom bolesti bubrega i praćenu tipičnim simptomima kao što su umor, slabost i nedostatak zraka.
English: What MIRCERA looks like and contents of the pack MIRCERA is a solution for injection in pre-filled syringe.
Croatian: Kako MIRCERA izgleda i sadržaj pakiranja MIRCERA je otopina za injekciju u napunjenoj štrcaljki.
English: MIRCERA should be administered either subcutaneously or intravenously.
Croatian: MIRCERA se primjenjuje ili supkutano ili intravenski.
English: If your blood pressure is high and cannot be controlled, either by appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
Croatian: Ako Vam je krvni tlak previsok i ne može se kontrolirati odgovarajućim lijekovima ili posebnom prehranom, liječnik će privremeno prekinuti liječenje lijekom MIRCERA ili smanjiti dozu.
English: · Do not touch the release clips of the safety device.
Croatian: • Nemojte dirati otpusne kvačice sigurnosne naprave.
English: At the evaluation period (week 29-36), the mean and median level of haemoglobin in patients treated with MIRCERA was virtually identical to their baseline haemoglobin level.
Croatian: U periodu evaluacije (29. - 36. tjedan praćenja) srednja vrijednost i medijan vrijednosti hemoglobina u bolesnika liječenih lijekom MIRCERA bili su gotovo identični njihovim početnim vrijednostima.
English: For instructions on the administration of the medicinal product, see section 6.6.
Croatian: Za upute o primjeni lijeka vidjeti dio 6.6.
English: • Your doctor will check the amount of iron in your blood before and during MIRCERA treatment.
Croatian: • Liječnik će provjeravati količinu željeza u krvi prije i tijekom liječenja lijekom MIRCERA.
English: Caution should be exercised when prescribing to pregnant women.
Croatian: Potreban je oprez ako se MIRCERA propisuje trudnicama.
English: The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/l.
Croatian: Sigurnost i djelotvornost terapije lijekom MIRCERA nije utvrđena u bolesnika s hemoglobinopatijama, neurološkim napadajima, krvarenjem ili nedavnim krvarenjem koja su zahtijevala transfuziju ili uz razinu trombocita veću od 500 x 109/l.
English: *Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
Croatian: *Protein proizveden na stanicama ovarija kineskog hrčka (CHO) tehnologijom rekombinantne DNK i kovalentno konjugiranog na linearni metoksi polietilenglikol (PEG).
English: In a six-month rat toxicity study no tumorigenic or unexpected mitogenic responses were observed in non-haematological tissues.
Croatian: Tijekom šestomjesečnog ispitivanja toksičnosti u štakora, u nehematološkim tkivima nisu uočeni tumorogeni ni neočekivani mitogeni odgovori.
English: Remove the box containing the MIRCERA pre-filled syringe from the refrigerator.
Croatian: Izvadite kutiju s MIRCERA napunjenom štrcaljkom iz hladnjaka.
English: · Do not swallow the medicine in the syringe.
Croatian: • Nemojte progutati lijek u štrcaljki.
English: There are two different ways (routes) to inject MIRCERA into your body.
Croatian: Postoje dva različita načina (puta) za injiciranje lijeka MIRCERA.
English: Data from correction studies with patients treated once every two weeks and once every four weeks show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high and comparable to comparators.
Croatian: Podaci iz studija korekcije anemije u kojima su bolesnici liječeni jednom svaka dva tjedna i jednom svaka četiri tjedna pokazuju da su stope hemoglobinskog odgovora u skupini liječenoj lijekom MIRCERA na kraju perioda korekcije bile visoke i usporedive s usporednim lijekom.
English: • Contact your doctor if you feel tired, weak or have shortness of breath, because this could mean that your MIRCERA treatment is not effective.
Croatian: • Obratite se liječniku ako osjećate umor, slabost ili nedostatak zraka jer to može značiti da liječenje lijekom MIRCERA nije učinkovito.
English: If high blood pressure is difficult to control by medical treatment or dietary measures, the dose must be reduced or administration discontinued (see section 4.2).
Croatian: Ukoliko se visoki krvni tlak teško kontrolira lijekovima ili dijetom, doza se mora smanjiti ili prekinuti primjenu (vidjeti dio 4.2).
English: If you have these symptoms please contact your doctor immediately to receive treatment.
Croatian: Ako se pojave ovi simptomi, odmah se obratite liječniku radi liječenja.
English: The starting dose of MIRCERA is based on the calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1.
Croatian: Početna doza lijeka MIRCERA izračunava se na temelju prethodne tjedne doze darbepoetina alfa ili epoetina u trenutku zamjene, kako je prikazano u Tablici 1.
English: An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis and patients not on dialysis.
Croatian: Analiza 126 bolesnika s kroničnom bolesti bubrega pokazala je da nema razlike u farmakokinetici između bolesnika na dijalizi i bolesnika koji nisu na dijalizi.
English: No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Croatian: U štakora nije uočen značajan prijenos metoksi polietilenglikol-epoetina beta putem posteljice, a ispitivanja na životinjama ne ukazuju na štetan učinak na trudnoću, embrio/fetalni razvoj, porod ili postporođajni razvoj.
English: Hold the syringe firmly with one hand and pull off the needle shield with the other hand.
Croatian: Jednom rukom čvrsto uhvatite štrcaljku, a drugom skinite zaštitni pokrov igle.
English: Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Croatian: Zbog intraindividualne varijabilnosti, u pojedinih bolesnika povremeno mogu biti primijećene vrijednosti hemoglobina koje su iznad ili ispod poželjne razine.
English: It is unknown whether MIRCERA is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se MIRCERA u majčino mlijeko u ljudi.
English: (c) Description of selected adverse reactions
Croatian: (c) Opis odabranih nuspojava
English: · Not allowing the medicine to come to room temperature could result in an uncomfortable injection, and it may be difficult to depress the plunger.
Croatian: • Ako ne pričekate da se lijek ugrije na sobnu temperaturu, injekcija bi mogla biti neugodna i možda će biti teško pritisnuti klip do kraja.
English: As primary growth factor for erythroid development, the natural hormone erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia.
Croatian: Kao primarni faktor rasta za razvoj eritrocita, prirodni hormon eritropoetin stvara se u bubrezima i otpušta u krvotok kao odgovor na hipoksiju.
English: The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Croatian: Karcinogeni potencijal metoksi polietilenglikol-epoetina beta nije procjenjivan u dugoročnim ispitivanjima na životinjama.
English: Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance are recommended in these patients.
Croatian: Kako je iskustvo u liječenju bolesnika na peritonealnoj dijalizi ograničeno, za te se bolesnike preporučuje redovita kontrola hemoglobina i strogo pridržavanje smjernica za prilagodbu doze.
English: There is no evidence that MIRCERA alters the metabolism of other medicinal products.
Croatian: Ne postoje dokazi da MIRCERA mijenja metabolizam drugih lijekova.
English: · Be sure not to touch the cleaned area prior to the injection and do not fan or blow on the clean area.
Croatian: • Nikako nemojte dodirivati očišćeno područje prije injekcije i nemojte sušiti očišćeno područje mahanjem ili puhanjem.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Croatian: Takvi slučajevi su zabilježeni u bolesnika s hepatitisom C, liječenih interferonom i ribavirinom, pri istovremenoj uporabi epoetina.
English: Adverse reactions in Table 2 are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave u Tablici 2 popisane su prema MedDRA klasifikaciji organskih sustava i kategorijama učestalosti.
English: Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
Croatian: Liječnik će provjeriti postoje li drugi uzroci anemije i poslati Vas na krvne pretrage ili pregled koštane srži.
English: A reticulocyte count should be considered as part of the evaluation.
Croatian: U sklopu evaluacije također treba razmotriti broj retikulocita.
English: MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data.
Croatian: Ne preporučuje se primjena lijeka MIRCERA u djece i adolescenata mlađih od 18 godina jer nema podataka o sigurnosti i djelotvornosti u toj dobnoj skupini.
English: Keep the syringe in the box to protect it from light and allow it to reach room temperature for at least 30 minutes.
Croatian: Štrcaljku ostavite u kutiji radi zaštite od svjetlosti i pričekajte najmanje 30 minuta da se ugrije na sobnu temperaturu.