FrancophonIA/ELRC3.0 huggingface dataset:
English: Remsima injection to be given under the skin was shown to be as effective as Remsima given by infusion into a vein in a study involving 343 patients with rheumatoid arthritis.
Croatian: U ispitivanju provedenom u 343 bolesnika s reumatoidnim artritisom, pokazalo se da je ubrizgavanje lijeka Remsima pod kožu jednako učinkovito kao i primjena lijeka Remsima infuzijom u venu.
English: This usually takes between 15 and 30 minutes.
Croatian: Za to je obično potrebno između 15 i 30 minuta.
English: Make the next injection as soon as you remember.
Croatian: Primijenite sljedeću injekciju čim se sjetite.
English: Adults donating their own blood
Croatian: Odrasli koji daju svoju krv
English: At the final analysis, 1 653 deaths were reported.
Croatian: U vrijeme završne analize bilo je zabilježeno 1653 smrtnih slučajeva.
English: This requires urgent treatment.
Croatian: To zahtijeva hitno liječenje.
English: Weight (kg)
Croatian: Težina (kg)
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: Administer over at least one to five minutes, depending on the total dose.
Croatian: Primjenjivati tijekom najmanje jedne do pet minuta, ovisno o ukupnoj dozi.
English: • anaemia from other causes
Croatian: • anemiju zbog drugih uzroka
English: • if you know, or think that it may have been accidentally frozen, or
Croatian: • ako znate ili mislite da je možda bio slučajno zamrznut ili
English: Retacrit may not be suitable for you.
Croatian: Retacrit možda nije prikladan za Vas.
English: Uncontrolled hypertension.
Croatian: Nekontrolirana hipertenzija.
English: • porphyria (a rare blood disorder)
Croatian: • porfiriju (rijetki poremećaj krvi)
English: Vary the site from day to day.
Croatian: Svaki dan izmijenjujte mjesto.
English: • Or under the skin (subcutaneously).
Croatian: • ili pod kožu (supkutano).
English: Treatment with Retacrit is divided into two stages - correction and maintenance phase.
Croatian: Liječenje Retacritom podijeljeno je u dvije faze - fazu korekcije i fazu održavanja.
English: • If you have high blood pressure not properly controlled with medicines.
Croatian: • ako imate visoki krvni tlak koji nije pravilno kontroliran lijekovima
English: 1316 BN Almere The Netherlands
Croatian: 1316 BN Almere Nizozemska
English: No unexpected adverse events were reported (see section 4.2).
Croatian: Nisu zabilježeni nikakvi neočekivani štetni događaji (vidjeti dio 4.2).
English: Push it slowly and evenly, keeping the skin fold pinched.
Croatian: Potisnite polako i jednolično, i dalje držeći nabor kože.
English: • have recently had a heart attack or stroke
Croatian: • nedavno ste imali srčani udar ili moždani udar
English: • Skin rashes, which may result from an allergic reaction.
Croatian: • kožni osipi, koji mogu biti posljedica alergijske reakcije
English: This regresses during the course of continued therapy.
Croatian: To se povlači tijekom daljnje terapije.
English: Thus, the volume of distribution is slightly greater than the plasma space.
Croatian: Prema tome, volumen distribucije nešto je veći od volumena plazme.
English: Do not try to replace the needle cover.
Croatian: Ne pokušavajte zamijeniti pokrov igle.
English: If you use more Retacrit than you should
Croatian: Ako primijenite više Retacrita nego što ste trebali
English: The pharmacokinetic profile of erythropoietins in children and adolescents appears to be similar to that of adults.
Croatian: Farmakokinetički profil eritropoetina u djece i adolescenata čini se sličan onom u odraslih.
English: Together, these two components comprise the needle-trap (safety) feature.
Croatian: Zajedno, ove dvije komponente čine (sigurnosnu) klopku za iglu.
English: Usual maintenance dose
Croatian: Uobičajena doza održavanja
English: • Take a syringe out of the refrigerator.
Croatian: • Izvadite štrcaljku iz hladnjaka.
English: • For patients on peritoneal dialysis Retacrit may be given twice a week.
Croatian: • Bolesnicima na peritonejskoj dijalizi Retacrit se može davati dva puta tjedno.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012
Croatian: Datum posljednje obnove odobrenja: 15. studenog 2012.
English: Other medicines and Retacrit
Croatian: Drugi lijekovi i Retacrit
English: 17.UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: If you are a patient with hepatitis C and you receive interferon and ribavirin
Croatian: Ako ste bolesnik s hepatitisom C i primate interferon i ribavirin
English: Your healthcare professional will always record the exact product you are using.
Croatian: Zdravstveni radnik će uvijek zabilježiti točan lijek koji primjenjujete.
English: Overall, these studies have methodological limitations but treatment was associated with positive trends towards higher haemoglobin levels.
Croatian: Ukupno gledano, ova su ispitivanja imala metodološka ograničenja, ali liječenje je bilo povezano s pozitivnim trendovima prema višim razinama hemoglobina.
English: • Push the needle in fully.
Croatian: • Uvedite iglu u potpunosti.
English: In case of larger volumes, more than one site should be chosen for the injection.
Croatian: U slučaju većeg volumena potrebno je izabrati više od jednog mjesta za injiciranje.
English: Depending on your individual situation a blood transfusion may be preferable.
Croatian: Ovisno o Vašoj situaciji, transfuzija krvi može biti pogodniji izbor.
English: After approximately two months of therapy, virtually all patients were transfusion-independent.
Croatian: Nakon približno dva mjeseca terapije gotovo svi bolesnici bili su neovisni o transfuziji.
English: • Do not pull back on the plunger at any time.
Croatian: • Nemojte povlačiti klip u bilo kojem trenutku.
English: • Only use Retacrit if it has been stored correctly - see section 5, How to Store Retacrit.
Croatian: • Retacrit smijete upotrijebiti samo ako je bio pravilno čuvan - pogledajte dio 5, „Kako čuvati Retacrit“.
English: Influenza-like illness may occur especially at the start of treatment.
Croatian: Bolest nalik gripi može se pojaviti osobito na početku liječenja.
English: Consequently, epoetin zeta should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Posljedično, epoetin zeta bi trebalo koristiti tijekom trudnoće samo ako je potencijalna dobrobit veća od potencijalnog rizika za fetus.
English: If Retacrit is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 ml) in a single injection.
Croatian: Ako se Retacrit ubrizgava pod kožu (supkutano), ubrizgana količina obično nije veća od jednog mililitra (1 ml) u jednoj injekciji.
English: Your doctor will decide this.
Croatian: O tome će odlučiti liječnik.
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Croatian: U pravilu, djeci tjelesne težine manje od 30 kg potrebne su više doze održavanja nego djeci tjelesne težine veće od 30 kg i odraslima.
English: • Choose an injection site.
Croatian: • Odaberite mjesto injiciranja.
English: Do not double up the injections to make up for a forgotten dose.
Croatian: Nemojte primijeniti dvostruku dozu lijeka kako biste nadoknadili zaboravljenu dozu.
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Croatian: Potrebno je praćenje krvnog tlaka, osobito na početku terapije (vidjeti dio 4.4).
English: Frequency estimate: 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: Učestalost nuspojava: 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 učestalost iz dostupnih podataka).
English: If it occurs, appropriate dose adjustment should be made as provided.
Croatian: Ako se to dogodi, potrebna je odgovarajuća prilagodba doze, kako je navedeno.
English: The needle guard will NOT activate unless the ENTIRE dose has been given.
Croatian: Štitnik za iglu NEĆE se aktivirati dok se ne ubrizga CIJELA doza.
English: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
Croatian: • problemi s krvlju koji mogu uzrokovati bol, tamno obojenje mokraće ili povećanu osjetljivost kože na sunčevu svjetlost (porfirija).
English: Your doctor has carried out blood tests and decided you need Retacrit.
Croatian: Liječnik Vam je proveo krvne pretrage i odlučio da Vam je potreban Retacrit.
English: Currently available data for subcutaneous use of epoetin alfa in these populations are described in section 5.1 but no recommendation on posology can be made.
Croatian: Trenutno dostupni podaci za supkutanu primjenu epoetina alfa u tim populacijama opisani su u dijelu 5.1, međutim, nije moguće dati preporuku o doziranju.
English: • If blood tests show your haemoglobin is too high before the operation, the treatment will be stopped.
Croatian: • Ako krvne pretrage pokažu da Vam je razina hemoglobina prije operacije previsoka, liječenje će se prekinuti.
English: • have severe heart disease
Croatian: • imate tešku bolest srca
English: These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Croatian: Tim ozbiljnim kožnim osipima često prethodi vrućica i/ili simptomi nalik gripi.
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Croatian: Medijan dobi bolesnika uključenih u ispitivanje bio je 11,6 godina (raspon od 0,5 do 20,1 godina).
English: The liquid needs to come to room temperature.
Croatian: Tekućina mora postići sobnu temperaturu.
English: • When the plunger is pushed as far as it will go, take out the needle and let go of the skin.
Croatian: • Kada je klip potisnut koliko god ide, izvadite iglu i pustite kožu.
English: What Retacrit is and what it is used for
Croatian: Što je Retacrit i za što se koristi
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107c. stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Do not freeze or shake.
Croatian: Ne zamrzavati ili protresati.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Croatian: Osipi mogu napredovati u široko rasprostranjeno ljuštenje kože i komplikacije opasne za život.
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: • prilikom 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 ta izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Additional supportive care should be provided as necessary.
Croatian: Ako je neophodno, treba osigurati dodatnu potpornu njegu.
English: What Retacrit is and what it is used for What you need to know before you use Retacrit How to use Retacrit
Croatian: Što je Retacrit i za što se koristi Što morate znati prije nego počnete uzimati Retacrit Kako uzimati Retacrit
English: Retacrit is a biosimilar medicinal product.
Croatian: Retacrit je biosličan lijek.
English: Continue bending the needle until the syringe exceeds a 45 degree angle with the flat surface to render it permanently unusable.
Croatian: Nastavite savijati iglu sve dok štrcaljka nije prešla kut od 45 stupnjeva u odnosu na ravnu površinu te postala trajno neupotrebljiva.
English: The product is for single use only.
Croatian: Ovaj lijek namijenjen je samo za jednokratnu uporabu.
English: • When the needle is pulled out of your skin, there may be a little bleeding at the injection site.
Croatian: • Kada izvadite iglu iz kože, na mjestu injiciranja može biti malo krvarenja.
English: In general, all pharmacodynamic markers increased in a linear manner with dose reaching a maximum response at the highest dose levels.
Croatian: Općenito, svi farmakodinamički biljezi rasli su linearno s porastom doze, s tim da je maksimalan odgovor dosegnut pri najvišim dozama.
English: • If you are allergic to epoetin zeta or any of the other ingredients of this medicine (listed in section
Croatian: • ako ste alergični na epoetin zeta ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The dose of Retacrit you receive is based on your bodyweight in kilograms.
Croatian: Doza Retacrita koju primate ovisi o Vašoj tjelesnoj težini izraženoj u kilogramima.
English: Eighty-one percent of patients achieved the haemoglobin concentration level.
Croatian: Osamdeset i jedan posto bolesnika postigao je tu razinu koncentracije hemoglobina.
English: Haemoglobin levels should be monitored regularly.
Croatian: Razine hemoglobina treba redovito nadzirati.
English: All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Croatian: Treba se pridržavati svih posebnih upozorenja i posebnih mjera opreza koje se odnose na program autologne predonacije, osobito rutinsku nadoknadu volumena.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Retacrit therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Retacrit uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: What Retacrit looks like and contents of the pack
Croatian: Kako Retacrit izgleda i sadržaj pakiranja
English: Contains phenylalanine, see leaflet for further information.
Croatian: Sadrži fenilalanin, za dodatne informacije pogledajte uputu o lijeku.
English: • Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Croatian: • Nemojte pokušavati injekciju primijeniti sami ukoliko Vas tome nisu posebno podučili liječnik ili medicinska sestra.
English: The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton.
Croatian: Prividna molekularna masa eritropoetina iznosi od 32 000 do 40 000 daltona.
English: • Check the syringe, to make sure it is the right dose, has not passed its expiry date, is not damaged, and the liquid is clear and not frozen.
Croatian: • Provjerite štrcaljku kako biste bili sigurni da je doza ispravna, da nije prošao rok valjanosti, da nije oštećena te da je tekućina bistra i nije smrznuta.
English: It consists of a plastic needle “catcher” which is firmly attached to the syringe label.
Croatian: Sastoji se od plastičnog "hvatača" igle koji je čvrsto vezan za naljepnicu štrcaljke.
English: Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Croatian: Bolesnici predviđeni za kirurški zahvat koji iz bilo kojeg razloga ne mogu primiti adekvatnu antitrombotičku profilaksu.
English: Retacrit is given alone and not mixed with other liquids for injection.
Croatian: Retacrit se daje sam i ne smije se miješati s drugim tekućinama za injekciju.
English: Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Croatian: Druga dva manja, randomizirana, placebom kontrolirana ispitivanja nisu uspjela pokazati značajno poboljšanje parametara kvalitete života na ljestvici EORTC-QLQ-C30 ili ljestvici CLAS.
English: ESAs are not indicated for use in this patient population,
Croatian: ESA lijekovi nisu indicirani za primjenu u toj populaciji bolesnika.
English: The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Croatian: Uzrok anemije koju imate također je čimbenik na temelju kojega liječnik određuje točnu dozu.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Croatian: Kao i za sve čimbenike rasta, postoji bojazan da bi epoetini mogli poticati rast tumora.
English: Talk to your doctor if any of the following apply to you.
Croatian: Obratite se svom liječniku ako se nešto od sljedećeg odnosi na Vas.
English: During the maintenance phase, Retacrit can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Croatian: Tijekom faze održavanja Retacrit se može primjenjivati ili 3 puta tjedno ili, u slučaju supkutane primjene, jednom tjedno ili jednom u svaka 2 tjedna.
English: Talk to your doctor, pharmacist or nurse before using Retacrit.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Retacrit.
English: No evidence exists that indicates that treatment with epoetin zeta alters the metabolism of other medicinal products.
Croatian: Nema dokaza koji bi upućivali na to da liječenje epoetinom zeta mijenja metabolizam drugih lijekova.
English: Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Croatian: Glavobolje, a osobito iznenadne, probadajuće glavobolje nalik migreni, osjećaj smetenosti ili napadaji mogu biti znak naglog porasta krvnog tlaka.
English: Dose increases and decreases should be done one dosing step at a time (see diagram below).
Croatian: Povećanja i smanjenja doze treba provoditi postepeno, po jedan dozni korak (vidjeti dijagram u nastavku).
English: What you need to know before you use Retacrit
Croatian: Što morate znati prije nego počnete uzimati Retacrit
English: Retacrit should be administered by the intravenous route.
Croatian: Retacrit treba primjenjivati intravenskim putem.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Croatian: Čimbenici koje valja uzeti u obzir pri toj procjeni trebaju uključivati vrstu tumora i njegov stadij, stupanj anemije, očekivano preživljenje, okolinu u kojoj se bolesnik liječi i želje bolesnika (vidjeti dio 5.1).
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Croatian: U četiri placebom kontrolirana ispitivanja, omjeri hazarda za ukupno preživljenje bili su u rasponu od 1,25 do 2,47 u korist kontrolnih ispitanika.
English: Retacrit may be given by injection:
Croatian: Retacrit se može dati injekcijom:
English: Your doctor will help you to decide if Retacrit is suitable for you.
Croatian: Liječnik će Vam pomoći da odlučite je li Retacrit za Vas prikladan.
English: Medicinal products that decrease erythropoiesis may decrease the response to epoetin zeta.
Croatian: Lijekovi koji smanjuju eritropoezu mogu smanjiti odgovor na epoetin zeta.
English: Retacrit can reduce the need for a blood transfusion.
Croatian: Retacrit može smanjiti potrebu za transfuzijom krvi.
English: This risk may be higher if you have other risk factors for developing blood clots (for example, if you have had a blood clot in the past or are overweight, have diabetes, have heart disease or you are off your feet for a long time because of surgery or illness).
Croatian: Taj rizik može biti veći ako imate druge čimbenike rizika za razvoj krvnih ugrušaka (primjerice, ako ste prije imali krvni ugrušak ili imate prekomjernu tjelesnu težinu, šećernu bolest, bolest srca ili dugo mirujete zbog operacije ili bolesti).
English: • can't take medicines to thin the blood
Croatian: • ne smijete uzimati lijekove za razrjeđivanje krvi.
English: Retacrit should be administered after the completion of the blood donation procedure.
Croatian: Retacrit treba primijeniti nakon završetka postupka donacije krvi.
English: Please discuss this with your doctor.
Croatian: Razgovarajte o tome sa svojim liječnikom.
English: The recommended dosing regimen is described in the following diagram*:
Croatian: Preporučeni režim doziranja prikazan je u dijagramu kako slijedi*:
English: Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01
Croatian: Farmakoterapijska skupina: drugi antianemici, eritropoetin, ATK oznaka: B03XA01
English: As with any other injectable product, check that there are no particles in the solution or change in colour.
Croatian: Kao i kod svih drugih lijekova koji se primjenjuju injiciranjem, provjerite da otopina ne sadrži čestice i da nije promijenila boju.
English: Do not use this medicine after the expiry date which is stated on the box and on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „EXP“.
English: Do not administer Retacrit by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Croatian: Nemojte primijeniti Retacrit putem intravenske infuzije ili zajedno s otopinom drugog lijeka (vidjeti dio 6.6 za dodatne informacije).
English: • Place the plastic catcher of the needle-trap against a hard, stable surface and with one hand pivot the syringe barrel upward against the needle forcing the needle into the catcher where it locks in place (an audible 'click” is heard when the needle is locked in the catcher).
Croatian: • Postavite plastični ''hvatač'' klopke za iglu na tvrdu, stabilnu podlogu i s jednom rukom okrenite štrcaljku prema gore u odnosu na iglu, prisiljavajući iglu u ''hvatač'' gdje se zaključava (kada je igla zaključana u ''hvatač'' čuje se ''klik'').
English: Do not use this medicine if you notice that the seal is broken or if the liquid is coloured or you can see particles floating in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je nepropusno pakiranje oštećeno, ako je tekućina obojena ili u njoj možete opaziti plutajuće čestice.
English: Your doctor or nurse may have shown you how to do this.
Croatian: Vam je možda već pokazala kako to napraviti.
English: Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Croatian: Jednom kad je štrcaljka izvađena iz hladnjaka i dosegne sobnu temperaturu (do 25°C), mora biti ili upotrijebljena u roku od 3 dana ili bačena.
English: The haemoglobin response varies between patients and may be impacted by iron stores and the presence of concurrent medical problems.
Croatian: Odgovor hemoglobina razlikuje se među bolesnicima i može biti pod utjecajem zaliha željeza i istovremeno prisutnih zdravstvenih problema.
English: After 52 weeks, 57% of patients remained in the study, receiving a median dose of 200 IU/kg/week.
Croatian: Nakon 52 tjedna, 57% bolesnika nastavilo je ispitivanje, primajući medijan doze od 200 IU/kg tjedno.
English: • Do not remove the needle cover from the pre-filled syringe until you are ready to inject your medicine.
Croatian: • Ne uklanjajte pokrov igle s napunjene štrcaljke sve dok niste spremni injicirati lijek.
English: This medicinal product contains phenylalanine which may be harmful for people with phenylketonuria.
Croatian: Ovaj lijek sadrži fenilalanin koji može biti štetan osobama s fenilketonurijom.
English: • if the liquid is coloured or you can see particles floating in it,
Croatian: • ako je tekućina obojena ili se u njoj vide plutajuće čestice