FrancophonIA/ELRC3.0 huggingface dataset:
English: Growth factor treatment such as G-CSF must not be given to patients for 3 weeks prior to Zevalin administration as well as for 2 weeks following completion of the treatment (see also section 4.4).
Croatian: Bolesnicima se 3 tjedna prije primjene te 2 tjedna nakon dovršetka terapije Zevalinom ne smije davati terapija čimbenikom rasta, kao što je G-CSF (vidjeti također dio 4.4).
English: Deaths due to MDS/AML included five (2.5%) patients in the Zevalin arm compared to no patients in the control arm.
Croatian: Zbog mijelodisplastičnog sindroma/akutne mijeloične leukemije, u skupini koja je primala Zevalin umrlo je 5 bolesnika (2,5%), dok u kontrolnoj skupini nije bilo smrtnih slučajeva.
English: The use of Zevalin is therefore not recommended in NHL patients with CNS involvement.
Croatian: Primjena Zevalina stoga se ne preporučuje u bolesnika kojim je NHL zahvatio središnji živčani sustav.
English: In patients given intravenous infusions of 250 mg/m rituximab followed by intravenous injections of
Croatian: U bolesnika kojima se davala intravenska infuzija rituksimaba u dozi od 250 mg/m praćena intravenskim injekcijama od 15 MBq/kg Zevalina radioaktivno označenog izotopom
English: Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Croatian: Da bi se izbjegla oštećenja tkiva povezana sa zračenjem, potrebno je podrobno pratiti eventualne znakove ekstravazacije tijekom injekcije Zevalina.
English: One vial contains 3.2 mg ibritumomab tiuxetan* to be diluted in 2 ml solution (1.6 mg per ml).
Croatian: Jedna bočica sadrži 3,2 mg ibritumomab tiuksetana* koji treba razrijediti u 2 ml otopine (1,6 mg po ml).
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. adrenaline, antihistamines and corticosteroids, must be available for immediate use in the event of an allergic reaction during administration of rituximab or Zevalin.
Croatian: Zbog potencijalnih alergijskih reakcija tijekom primjene rituksimaba ili Zevalina, lijekovi za njihovo zbrinjavanje (npr. adrenalin, antihistaminici i kortikostereoidi) moraju biti odmah dostupni.
English: From the final analysis at around 7.5 years of a study investigating the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy (Study 4, Section 5.1) of the 204 patients receiving Y-90 Zevalin following first line chemotherapy, 26 (12.7%) patients in the Zevalin arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm.
Croatian: U konačnoj analizi, provedenoj nakon otprilike 7,5 godina ispitivanja u kojem su ispitivane djelotvornost i sigurnost konsolidacijske terapije Zevalinom u bolesnika s uznapredovalim folikularnim limfomom koji su odgovorili na prvu liniju kemoterapije (ispitivanje 4, dio 5.1), od 204 bolesnika koji su nakon prve linije kemoterapije primali Zevalin radioaktivno označen izotopom
English: The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Croatian: Zevalin je primijenjen po prethodno navedenom protokolu (vidjeti dio 4.2).
English: One ibritumomab tiuxetan vial contains 3.2 mg ibritumomab tiuxetan* in 2 ml solution (1.6 mg per ml).
Croatian: Jedna bočica ibritumomab tiuksetana sadrži 3,2 mg ibritumomab tiuksetana* u 2 ml otopine (1,6 mg po ml).
English: Stomach Thymus
Croatian: Stopa CRu-a
English: Hypersensitivity reactions following Zevalin administration are commonly observed.
Croatian: Nakon primjene Zevalina često se primjećuju reakcije preosjetljivosti.
English: Ibritumomab tiuxetan vial: Clear colourless solution.
Croatian: Bočica ibritumomab tiuksetana: bistra, bezbojna otopina.
English: Characteristics of yttrium-90
Croatian: Svojstva izotopa itrij-90
English: Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [
Croatian: Analize procijenjene apsorbirane doze zračenja provedene su pomoću kvantitativnog snimanja Zevalina radioaktivno označenog izotopom
English: Please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use.
Croatian: Detaljne smjernice za korištenje rituksimaba molimo potražite u Sažetku opisa svojstava tog lijeka.
English: Data from 349 patients with relapsed or refractory low-grade, follicular lymphoma, or transformed non-Hodgkin's lymphoma studied in five trials:
Croatian: Podaci dobiveni na 349 bolesnika s recidivirajućim ili refraktornim, folikularnim limfomom ili transformiranim ne-Hodgkinovim limfomom niskog stupnja ispitivanih u pet studija.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Croatian: Upotreba, rukovanje i zbrinjavanje radiofarmaceutskih lijekova podliježe strogim zakonima.
English: - patients with ≥ 150,000 platelets/mm 3: 15 MBq/kg body weight.
Croatian: - za bolesnike s ≥ 150 000 trombocita/mm
English: Nervous system disorders
Croatian: • NHL koji zahvaća središnji živčani sustav
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 12. Između Zevalina i setova za infuziju nisu primijećene nikakve inkompatibilnosti.
English: HOW TO USE ZEVALIN
Croatian: KAKO PRIMJENJIVATI ZEVALIN
English: These adverse drug reactions are based upon 349 patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma studied in 5 clinical trials.
Croatian: Te se nuspojave lijeka temelje na podacima prikupljenim na 349 pacijenata s recidivirajućim ili refraktornim folikularnim ili transformiranim B-staničnim ne-Hodgkinovim limfomom niskog stupnja ispitivanih u 5 kliničkih ispitivanja.
English: - neutrophil counts < 1,500/mm - prior bone marrow transplant or stem cell support
Croatian: (konsolidacijska terapija) - bolesnicima s brojem neutrofila < 1500/mm - bolesnicima podvrgnutim prethodnom presađivanju koštane srži ili potpornom liječenju matičnim stanicama.
English: intravenous infusion of 250 mg/m rituximab shortly (within 4 hours) before administration of [
Croatian: - intravenska infuzija rituksimaba u dozi od 250 mg/m neposredno (unutar 4 sata) prije primjene otopine Zevalina radioaktivno označenog izotopom
English: Extravasation with subsequent infusion site reactions, Damage to lymphomasurrounding tissue and complications due to lymphoma swelling
Croatian: bol, simptomi nalik gripi, malaksalost, periferni edem, pojačano znojenje ekstravazacija s posljedičnom reakcijom na mjestu infuzije, oštećenje tkiva oko limfoma i komplikacije zbog oticanja limfoma
English: As
Croatian: I
English: Marketing Authorisation Holder Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Croatian: Nositelj odobrenja Spectrum Pharmaceuticals B.V.
English: Radiopharmaceuticals must be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Korisnik radiofarmaceutike mora pripremati sukladno propisima o zaštiti od radioaktivnosti i propisima o farmaceutskoj kakvoći.
English: • Intracranial haemorrhage while thrombocytopenic
Croatian: • intrakranijalno krvarenje tijekom trombocitopenije
English: Small Intestine Red Marrow
Croatian: Crvena koštana srž Stijenka mokraćnog mjehura Površine kosti
English: Disodium phosphate dodecahydrate Human albumin solution Hydrochloric acid, diluted (for pH adjustment) Pentetic acid
Croatian: Bočica pufera za pripremu formulacije: natrijev hidrogenfosfat dodekahidrat otopina humanog albumina kloridna kiselina, razrijeđena (za podešavanje pH) pentetična kiselina kalijev klorid kalijev dihidrogenfosfat natrijev klorid natrijev hidroksid voda za injekcije
English: Women of childbearing potential as well as males must use effective contraceptive methods during and up to 12 months after treatment with Zevalin.
Croatian: Žene i muškarci u reproduktivnoj dobi tijekom i u razdoblju od 12 mjeseci nakon terapije Zevalinom moraju primjenjivati učinkovite metode kontracepcije.
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads (see sections ‘4.4 and 5.2).
Croatian: Y] na muške i ženske spolne žlijezde (vidjeti također dio 4.4 i 5.2).
English: Y]-radiolabelled Zevalin, the median serum effective half-life of ibritumomab tiuxetan [
Croatian: Y] medijan efektivnog poluvijeka ibritumomab tiuksetana [
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion
Croatian: Zevalin 1,6 mg/ml set za pripravu radiofarmaceutika za infuziju
English: Y]-radiolabelled Zevalin solution.
Croatian: Y]-radioaktivno označenog Zevalina
English: • Treatment with growth factors
Croatian: • Liječenje čimbenicima rasta
English: - platelet counts <100,000/mm
Croatian: - bolesnicima s brojem trombocita < 100 000/mm
English: Vascular disorders Petechiae**
Croatian: Krvožilni poremećaji petehije**
English: Patients with hepatic impairment The safety and efficacy have not been studied in patients with hepatic impairment.
Croatian: Sigurnost i djelotvornost u bolesnika s oštećenjem funkcije bubrega nisu ispitane.
English: If you have received more Zevalin than you should Your doctor will treat you, as appropriate, if you have any particular ill effects.
Croatian: Ako se pojave neki konkretni negativni učinci, liječnik će Vas prema potrebi liječiti.
English: Consolidation therapy after remission induction in previously untreated patients with follicular lymphoma patients with ≥ 150,000 platelets/mm³: 15 MBq/kg up to a maximum of 1200 MBq for patients with less than 150,000 platelets per mm³ see section ‘4.4' Repeated use: Data on the re-treatment of patients with [90Y]-radiolabelled Zevalin are not available.
Croatian: 3: 15 MBq/kg do najviše 1200 MBq - za bolesnike s manje od 150 000 trombocita po mm³ vidjeti dio 4.4.
English: In]-radiolabelled Zevalin, the estimated radiation dosimetry for individual organs following administration of [
Croatian: In] procijenjena dozimetrija zračenja za pojedinačne organe nakon primjene Zevalina radioaktivno označenog izotopom
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Sodium acetate solution
Croatian: Zevalin 1,6 mg/ml set za pripravu radiofarmaceutika Otopina natrijevog acetata
English: It may be necessary to perform a dilution (1:100) before application of the [
Croatian: na trakice za ITLC možda će ga biti potrebno razrijediti (u omjeru 1:100).
English: Infusion reactions may occur during or following Zevalin administration after pretreatment with Rituximab.
Croatian: Tijekom ili nakon primjene Zevalina nakon prethodnog liječenja rituksimabom mogu se pojaviti infuzijske reakcije.
English: Meningioma
Croatian: meningeom
English: Formulation buffer vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 10 ml solution.
Croatian: I s gumenim čepom (od bromobutila obloženog teflonom) koja sadrži 10 ml otopine.
English: fungal infections in the mouth such as oral thrush (oral candidiasis) - other blood related cancers (myelodysplastic syndrome (MDS) / acute myeloid leukaemia
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - trovanje krvi (sepsa)*, infekcija pluća (upala pluća)*, infekcije mokraćnog sustava, gljivične infekcije usta, kao što je soor (oralna kandidijaza) - druge maligne bolesti vezane uz krv (mijelodisplastični sindrom (MDS) / akutna mijeloična leukemija (AML))*
English: One ibritumomab tiuxetan vial.
Croatian: Jedna bočica ibritumomab tiuksetana.
English: Y]-radiolabelled Zevalin solution contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Croatian: Konačna otopina Zevalina radioaktivno označenog izotopom [90Y], ovisno o koncentraciji radioaktivnosti, sadrži do 28 mg natrija po dozi.
English: Disodium phosphate dodecahydrate Sodium hydroxide Potassium dihydrogen phosphate Potassium chloride Pentetic acid
Croatian: Bočica pufera za pripremu formulacije: otopina humanog albumina natrijev klorid natrijev hidrogenfosfat dodekahidrat natrijev hidroksid kalijev dihidrogenfosfat kalijev klorid pentetična kiselina kloridna kiselina, razrijeđena voda za injekcije
English: Yttrium identification
Croatian: Prijavljivanje nuspojava
English: Using a 2-3 ml sterile syringe, transfer 1.3 ml ibritumomab tiuxetan solution to the reaction vial.
Croatian: 3. korak: prenesite otopinu ibritumomab tiuksetana u bočicu za reakciju Pomoću sterilne štrcaljke volumena od 2 do 3 ml prenesite 1,3 ml otopine ibritumomab tiuksetana u bočicu za reakciju.
English: • The following minimum yttrium-90 characteristics are recommended: Radioactivity concentration at time of use
Croatian: • Preporučuju se sljedeća minimalna svojstva izotopa itrij-90:
English: Repeated use: Data on the re-treatment of patients with [90Y]-radiolabeled Zevalin are not available.
Croatian: Ponovljena primjena: podaci o ponovljenom liječenju bolesnika Zevalinom radioaktivno označenim izotopom
English: - patients with 100,000-150,000 platelets/mm 3: 11 MBq/kg
Croatian: 3: 15 MBq/kg tjelesne težine - za bolesnike sa 100 000-150 000 trombocita/mm
English: • Infections and infestations - Data from 349 patients with relapsed or refractory low-grade, follicular lymphoma, or transformed non-Hodgkin's lymphoma studied in five trials:
Croatian: • Infekcije i infestacije - Podaci dobiveni na 349 bolesnika s recidivirajućim ili refraktornim, folikularnim limfomom ili transformiranim ne-Hodgkinovim limfomom niskog stupnja ispitivanih u pet studija: Tijekom prvih 13 tjedana nakon liječenja Zevalinom bolesnici su infekcije razvijali vrlo često. a infekcije 3. i 4. stupnja prijavljivane su često.
English: Treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL):
Croatian: Liječenje recidivirajućeg ili refraktornog CD20+ folikularnog B-staničnog ne-Hodgkinovog limfoma (NHL-a) nakon prethodnog liječenja rituksimabom - za bolesnike s ≥ 150 000 trombocita/mm
English: How to store Zevalin
Croatian: Kako čuvati Zevalin
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Formulation buffer solution
Croatian: Zevalin 1,6 mg/ml set za pripravu radiofarmaceutika Bočica za reakciju
English: Respiratory, thoracic, and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj, rinitis
English: After you are given Zevalin
Croatian: Nakon primanja Zevalina
English: 15 MBq/kg of [
Croatian: 3: 11 MBq/kg
English: Please tell your doctor that you were given Zevalin if you are due for vaccination after using it.
Croatian: Ako se morate cijepiti nakon završetka liječenja, molimo obavijestite liječnika da ste primali Zevalin.
English: Urinary Bladder Wall3
Croatian: Medijan TTP-a3,6
English: Y]-radiolabelled Zevalin overdosage.
Croatian: Doza Zevalina radioaktivno označenog izotopom
English: Sterile, pyrogen-free yttrium-90 chloride of the above specified quality must be used for the preparation of [
Croatian: Y] mora se koristiti sterilan, apirogeni itrij-90 klorid gore navedene kakvoće.
English: • The active substance is ibritumomab tiuxetan.
Croatian: BOČICA OTOPINE IBRITUMOMAB TIUKSETANA
English: Reaction vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl)
Croatian: Bočica za reakciju: staklena bočica tipa
English: • Severe mucocutaneous reactions
Croatian: • Teške reakcije na koži i sluznici
English: Breasts
Croatian: Raspon
English: Y]- or
Croatian: Y],
English: Pancreas Skin
Croatian: Tanko crijevo
English: Lower Large Intestinal Wall Upper Large Intestinal Wall Heart Wall
Croatian: Stijenka donjeg dijela debelog crijeva
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads.
Croatian: Budući da je omaglica prijavljivana kao česta nuspojava, Zevalin može negativno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Sodium acetate vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl) containing 2 ml solution.
Croatian: I s gumenim čepom (od bromobutila obloženog teflonom) koja sadrži 2 ml otopine.
English: Using a 1-ml sterile syringe, transfer sodium acetate solution to reaction vial.
Croatian: 1. korak: prenesite otopinu natrijevog acetata u bočicu za reakciju Pomoću sterilne štrcaljke volumena 1 ml prenesite otopinu natrijevog acetata u bočicu za reakciju.
English: Step 2: Clean your hands
Croatian: Korak 2: Operite ruke
English: Your doctor will decide which is best for you.
Croatian: Liječnik će odlučiti što je za Vas najbolje.
English: All three injection sites are equally suitable.
Croatian: Sva tri mjesta primjene jednako su pogodna.
English: Date of latest renewal: 15 May 2012
Croatian: Datum posljednje obnove odobrenja: 15. svibnja 2012.
English: • if you have high blood pressure that cannot be controlled
Croatian: • ako imate visok krvni tlak koji se ne može kontrolirati.
English: Therefore, caution should be used in these patients.
Croatian: Stoga je u tih bolesnika potreban oprez.
English: After preparation of the syringe as described in steps 1 to 5:
Croatian: Nakon pripreme štrcaljke kako je opisano u koracima 1-5:
English: Not included in the pack:
Croatian: Nije uključeno u pakiranje:
English: · Let the skin dry for approximately 10 seconds.
Croatian: • Pričekajte približno 10 sekundi da se koža osuši.
English: EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 EU/1/07/400/024
Croatian: EU/1/07/400/008 EU/1/07/400/009 EU/1/07/400/010 EU/1/07/400/011 EU/1/07/400/012 EU/1/07/400/013 EU/1/07/400/017 EU/1/07/400/018 EU/1/07/400/019 EU/1/07/400/020 EU/1/07/400/021 EU/1/07/400/022 EU/1/07/400/023 EU/1/07/400/024
English: · You may see a drop of liquid at the end of the needle.
Croatian: • Možda ćete vidjeti kap tekućine na kraju igle.
English: · Any part of the syringe appears to be damaged.
Croatian: • ako bilo koji dio štrcaljke izgleda oštećeno
English: Now, the tear-off label can be removed, if necessary.
Croatian: Sada možete odlijepiti naljepnicu, ako je potrebno.
English: No interaction studies have been performed.
Croatian: Nisu provedena ispitivanja interakcije.
English: Its use is limited to adult patients (aged 18 years or older).
Croatian: Primjena ovog lijeka ograničena je samo na odrasle bolesnike (u dobi od 18 ili više godina).
English: The most frequent reported adverse reaction was hypertension (common).
Croatian: Najčešće prijavljivana nuspojava bila je hipertenzija (često).
English: · If needed, you may cover the injection site with a small bandage.
Croatian: • Ako je potrebno, mjesto primjene možete prekriti malim flasterom.
English: (a) Summary of the safety profile
Croatian: (a) Sažetak sigurnosnog profila
English: What MIRCERA is and what it is used for
Croatian: Što je MIRCERA i za što se koristi
English: Your healthcare professional will always record the exact product you are using.
Croatian: Zdravstveni radnik će uvijek zabilježiti koji točno lijek uzimate.
English: Adverse reactions observed only during post-marketing are marked (*).
Croatian: Nuspojave zabilježene samo nakon stavljanja lijeka u promet su označene (*).
English: Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni, mislite da ste trudni ili planirate zatrudnjeti.
English: MIRCERA is a medicine produced by gene-technology.
Croatian: MIRCERA je lijek proizveden genskom tehnologijom.
English: Your doctor will consider what is the best treatment for you during pregnancy.
Croatian: Vaš će liječnik odlučiti koje je liječenje tijekom trudnoće za Vas najbolje.
English: Choose one of the recommended injection sites as shown.
Croatian: Odaberite jedno od preporučenih mjesta za injekciju prikazanih na slici.
English: Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, repeat dose toxicity and reproductive toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja kardiovaskularne sigurnosne farmakologije, toksičnosti ponovljenih doza i reproduktivne toksičnosti.
English: It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically thereafter.
Croatian: Preporučuje se kontrola hemoglobina svaka dva tjedna do stabilizacije te periodički nakon toga.
English: Assemble all of the supplies you will need for an injection on a clean, well-lit flat surface such as a table.
Croatian: Pripremite sav pribor potreban za primjenu injekcije na čistoj i dobro osvijetljenoj ravnoj površini poput stola.
English: It is important to read and follow these instructions carefully so that you are able to use the pre-filled syringe correctly and safely.
Croatian: Važno je da navedene upute pročitate i pažljivo slijedite kako biste napunjenu štrcaljku mogli upotrijebiti na ispravan i siguran način.
English: This is important to ensure that the syringe and medicine are safe to use.
Croatian: To je važno kako biste bili sigurni da su štrcaljka i lijek sigurni za uporabu.
English: If clinically indicated, phlebotomy may be performed.
Croatian: Ako je klinički indicirano, može se izvesti flebotomija.
English: Do not allow the medicine to freeze, and protect the medicine from light.
Croatian: Nemojte dopustiti da se lijek smrzne i zaštitite ga od svjetlosti.
English: The frequency of possible side effects listed below:
Croatian: Učestalost mogućih nuspojava navedena je niže:
English: Treatment with MIRCERA is normally long-term.
Croatian: Liječenje lijekom MIRCERA obično je dugoročno.
English: This means that you have too few red blood cells and your haemoglobin level is too low (your body's tissues might not receive enough oxygen).
Croatian: To znači da imate premalo eritrocita i prenisku razinu hemoglobina (tkiva u Vašem tijelu možda ne dobivaju dovoljno kisika).
English: • maculo-papular rash (red skin reaction that can include pimples or spots)
Croatian: • makulo-papularni osip (crvenilo kože koje može uključivati prištiće ili mrlje)
English: As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy.
Croatian: Kao što je slučaj kod svih ostalih faktora rasta, postoji određena bojazan da bi LSE mogli stimulirati rast svih vrsta zloćudnih novotvorina.
English: Do not move the needle while it is inserted in the skin
Croatian: Nemojte pomicati iglu dok se nalazi u koži.
English: The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
Croatian: Prosječna molekularna masa iznosi otprilike 60 kDa, od čega proteinski dio zajedno s ugljikohidratima čini otprilike 30 kDa.
English: If you have any of these conditions, your doctor will discuss it with you and must treat you with caution.
Croatian: Bolujete li od bilo kojeg od navedenih stanja, liječnik će s Vama o tome porazgovarati i mora Vašem liječenju pristupiti s oprezom.
English: Frequency categories are defined using the following convention: very common (³1/10); common (³1/100 to <1/10); uncommon (³1/1,000 to <1/100); rare (³1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The sterile pre-filled syringe does not contain any preservative and is to be used for a single injection only.
Croatian: Sterilna napunjena štrcaljka ne sadrži konzervanse i smije se koristiti samo za jedno injiciranje.
English: If you use more MIRCERA than you should
Croatian: Ako primite više lijeka MIRCERA nego što ste trebali
English: Injection into muscle could result in an uncomfortable injection.
Croatian: Injekcija u mišić mogla bi uzrokovati nelagodu pri injiciranju.
English: Push the plunger up slowly to the remove all air,, as shown to you by a healthcare professional.
Croatian: Polako pritisnite klip da biste uklonili sav zrak, onako kako Vam je pokazao zdravstveni radnik.