FrancophonIA/ELRC3.0 huggingface dataset:
English: For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used.
Croatian: Za lijekove s faktorom produljenog djelovanja poznato je da rezultati jednostupanjskog testa zgrušavanja krvi velikim dijelom ovise o primijenjenom aPTT reagensu i referentnom standardu.
English: If you forget to use Refixia
Croatian: Ako ste zaboravili primijeniti lijek Refixia
English: The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min.
Croatian: Brzina primjene treba se odrediti prema razini ugodnosti za bolesnika i ne smije biti veća od maksimalne brzine injekcije od 4 ml/min.
English: See “Instructions on how to use Refixia” for more information.
Croatian: Za više informacija pogledajte ‘Upute za uporabu lijeka Refixia'.
English: Histidine solution
Croatian: Otopina histidina
English: Refixia replaces this faulty or missing factor IX and helps blood to form clots at the site of bleeding.
Croatian: Refixia zamjenjuje taj faktor IX koji nedostaje ili ne djeluje pravilno te pomaže u stvaranju ugrušaka na mjestu krvarenja.
English: Factor IX is a single chain glycoprotein.
Croatian: Faktor IX jednolančani je glikoprotein.
English: In 29 adult and adolescent patients treated, 13 patients with 20 target joints were treated for one year with a weekly prophylactic dose of 40 IU/kg.
Croatian: U skupini od 29 odraslih i adolescentnih liječenih bolesnika, 13 bolesnika s 20 ciljnih zglobova liječeno je godinu dana tjednom dozom profilakse od 40 IU/kg.
English: Because of the risk of allergic reactions with factor IX, your initial treatment with Refixia should be given in a medical clinic or in the presence of health care professionals where proper medical care for allergic reactions can be provided if needed.
Croatian: Zbog rizika od alergijskih reakcija na lijekove koji sadrže faktor IX početno liječenje lijekom Refixia treba provesti u bolnici ili u prisutnosti zdravstvenog radnika na mjestu gdje se po potrebi može pružiti odgovarajuća medicinska pomoć u slučaju alergijskih reakcija.
English: If you stop using Refixia
Croatian: Ako prestanete primjenjivati lijek Refixia
English: Refixia is supplied as a powder.
Croatian: Refixia dolazi u obliku praška.
English: • Grasp the plunger rod by the wide top end and take it out of the carton.
Croatian: • Uhvatite potisni klip za široki kraj i izvadite ga iz kutije.
English: If it cannot be used immediately, use within 24 hours if stored in a refrigerator at 2°C - 8°C or within 4 hours if stored out of the refrigerator at a maximum temperature of 30°C.
Croatian: Ako se ne može primijeniti odmah, primijenite je u roku od 24 sata ako se čuva u hladnjaku na temperaturi od 2°C-8°C ili u roku od 4 sata ako se čuva izvan hladnjaka na maksimalnoj temperaturi od 30°C.
English: • shortness of breath or wheezing
Croatian: • nedostatak zraka ili piskanje pri disanju
English: The trough levels achieved with the weekly 40 IU/kg dosing regimen are summarised in section 5.2.
Croatian: Najniže koncentracije lijeka postignute uz režim doziranja od 40 IU/kg jednom tjedno prikazane su u dijelu 5.2.
English: In children aged 0-12 years, the median (IQR) annualised bleeding rate was 1.0 (0.00; 2.06) and the spontaneous bleeding rate was 0.00 (0.00; 0.00).
Croatian: U djece u dobi od 0-12 godina medijan (interkvartilni raspon) godišnje stope krvarenja iznosio je 1,00 (0,00; 2,06), a stopa spontanog krvarenja iznosila je 0,00 (0,00; 0,00).
English: The overall success rate (defined as excellent or good) for treatment of bleeds was 95% with 98% of the bleeds treated with one or two injections.
Croatian: Ukupna stopa uspjeha (definirana kao izvrsna ili dobra) liječenja krvarenja bila je 95% s 98% krvarenja liječenih jednom ili dvjema injekcijama.
English: • 1 vial with Refixia powder
Croatian: • 1 bočicu s praškom Refixia
English: The median (IQR) overall annual bleeding rate (ABR) in patients (13-65 years) treated with a prophylactic dose of 40 IU/kg once weekly was 1.04 (0.00; 4.01) whereas the traumatic ABR was 0.00 (0.00; 2.05), joint ABR was 0.97 (0.00; 2.07) and spontaneous ABR was 0.00 (0.00; 0.99).
Croatian: Medijan (interkvartilni raspon) godišnje stope krvarenja (GSK) u bolesnika (13-65 godina) liječenih dozom od 40 IU/kg jednom tjedno u svrhu profilakse bio je 1,04 (0,00; 4,01) dok je traumatski GSK bio 0,00 (0,00; 2,05), GSK za zglobove bio je 0,97 (0,00; 2,07) i spontani GSK 0,00 (0,00; 0,99).
English: Table 5 Single-dose pharmacokinetic parameters of Refixia (40 IU/kg) by age (geometric mean (CV%))
Croatian: Tablica 5 Farmakokinetički parametri jednokratne doze lijeka Refixia (40 IU/kg) po dobnim skupinama (geometrijska srednja vrijednost (CV%))
English: The analysis of plasma samples was conducted using the one-stage clotting assay.
Croatian: Analiza uzoraka plazme provedena je primjenom jednostupanjskog testa koagulacije.
English: • Push the plunger rod slowly until all air bubbles are gone.
Croatian: • Polako pritišćite potisni klip dok svi mjehurići zraka ne izađu.
English: A trial including 25 paediatric previously treated patients (ages 0-12 years) who received a prophylactic dose 40 IU/kg once weekly was performed.
Croatian: Provedeno je ispitivanje koje je uključivalo 25 prethodno liječenih pedijatrijskih bolesnika (u dobi od 0 do 12 godina) koji su jednom tjedno primali dozu profilakse od 40 IU/kg.
English: If a chromogenic assay is not available, it is recommended to use a one-stage clotting assay with an aPTT reagent (e.g. Cephascreen) qualified for use with Refixia.
Croatian: Ako kromogeni test nije dostupan, preporučuje se primijeniti jednostupanjski test zgrušavanja krvi s aPTT reagensom (npr. Cephascreen) koji je kvalificiran za upotrebu s lijekom Refixia.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Refixia Lijek čuvajte izvan pogleda i dohvata djece.
English: In the pivotal trial there was a non-randomised arm where 15 patients were treated in an on-demand regimen with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds.
Croatian: U pivotalnom ispitivanju sudjelovala je nerandomizirana skupina od 15 bolesnika liječenih po potrebi režimom od 40 IU/kg za blaga i umjerena krvarenja i 80 IU/kg za jaka krvarenja.
English: • Do not touch the syringe tip under the syringe cap.
Croatian: • Nemojte dodirnuti vrh štrcaljke ispod zatvarača štrcaljke.
English: Volume of distribution (Vss) (ml/kg) Factor IX activity 168 h post dosing (IU/ml)
Croatian: Volumen distribucije (Vss) (ml/kg) Aktivnost faktora IX 168 h nakon doziranja (IU/ml)
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike treba upoznati s ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: Leave the plunger rod untouched in the carton.
Croatian: Potisni klip ostavite u kutiji nedirnut.
English: Estimated mean factor IX trough levels IU/ml (95% CI)
Croatian: Procijenjena srednja vrijednost najnižih koncentracija faktora IX IU/ml (95% CI)
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Croatian: Broj primijenjenih jedinica faktora IX izražava se u internacionalnim jedinicama (IU), koje su u skladu s važećim standardom Svjetske zdravstvene organizacije (SZO) za lijekove koji sadrže faktor IX. Aktivnost faktora IX u plazmi izražava se ili postotkom (u odnosu na normalnu vrijednost u ljudskoj plazmi) ili u internacionalnim jedinicama (u odnosu na međunarodni standard za faktor IX u plazmi).
English: INFORMATION IN BRAILLE Refixia 500 IU
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Refixia 500 IU
English: INFORMATION IN BRAILLE Refixia 2000 IU
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Refixia 2000 IU
English: The trial included one open-label on-demand arm with treatment for approximately 28 weeks and two prophylaxis treatment arms with single-blind randomisation to either 10 IU/kg or 40 IU/kg once-weekly for approximately 52 weeks.
Croatian: Ispitivanje je uključivalo otvorenu skupinu s liječenjem po potrebi u trajanju od približno 28 tjedana i dvije profilaktički liječene skupine s jednostruko slijepom randomizacijom koje su dobivale 10 IU/kg ili 40 IU/kg jednom tjedno tijekom približno 52 tjedna.
English: The solvent is a histidine solution.
Croatian: Otapalo je otopina histidina.
English: Each vial of Refixia contains nominally 500 IU, 1000 IU or 2000 IU nonacog beta pegol corresponding to approximately 125 IU/ml, 250 IU/ml or 500 IU/ml respectively after reconstitution with histidine solvent.
Croatian: Jedna bočica lijeka Refixia nominalno sadrži 500 IU, 1000 IU ili 2000 IU nonakog beta pegola, što nakon pripreme s otopinom histidina približno odgovara 125 IU/ml, 250 IU/ml odnosno 500 IU/ml.
English: • Do not touch the syringe tip.
Croatian: • Nemojte dodirivati vrh štrcaljke.
English: Upon activation of Refixia, the activation peptide including the 40 kDa polyethylene-glycol moiety is cleaved off, leaving the native activated factor IX molecule.
Croatian: Nakon aktivacije lijeka Refixia, cijepa se aktivacijski peptid uključujući i polietilenglikolnu skupinu od 40 kDA, ostavljajući nativnu aktiviranu molekulu faktora IX.
English: • Use a clean and germ free (aseptic) technique.
Croatian: • Koristite tehniku koja osigurava čistu primjenu bez mikroorganizama (aseptička tehnika).
English: The mean trough levels at steady state are presented in Table 6; based on all pre-dose measurements taken every 8 weeks at steady state for all patients on once weekly dosing of 40 IU/kg.
Croatian: Srednje vrijednosti najniže koncentracije lijeka u stanju dinamičke ravnoteže navedene su u Tablici 6; na temelju svih mjerenja koja su provođena svakih 8 tjedana, a prije primjene doze i u stanju dinamičke ravnoteže, kod svih bolesnika s doziranjem 40 IU/kg jednom tjedno.
English: Pivotal trial
Croatian: Pivotalno ispitivanje
English: INFORMATION IN BRAILLE Refixia 1000 IU
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Refixia 1000 IU
English: Do not lift the vial adapter from the vial when removing the protective cap.
Croatian: Nemojte podići nastavak za bočicu s bočice kad skidate zaštitni pokrov.
English: Overdoses up to 169 IU/kg have been reported in clinical trials.
Croatian: U kliničkim ispitivanjima prijavljena su predoziranja u količini do 169 IU/kg.
English: These devices are not included in the Refixia package.
Croatian: Ovi medicinski proizvodi nisu uključeni u pakiranje lijeka Refixia.
English: • Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Croatian: • Prestanite pritiskati potisni klip i pustite ga da se samostalno pomiče unatrag dok pripremljena otopina puni štrcaljku.
English: Steady state pharmacokinetic parameters for adolescents and adults are shown in Table 4
Croatian: Farmakokinetički parametri u stanju dinamičke ravnoteže u adolescenata i odraslih prikazani su u
English: Rubber stopper (under plastic cap)
Croatian: Plastični zatvarač Gumeni graničnik (ispod plastičnog zatvarača)
English: Read these instructions carefully before using Refixia.
Croatian: Prije primjene lijeka Refixia pažljivo pročitajte ove upute.
English: Injecting Refixia via needleless connectors for intravenous (IV) catheters
Croatian: Injiciranje lijeka Refixia putem konektora za primjenu bez igle za intravenske (i.v.) katetere
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Croatian: Zbog rizika od alergijskih reakcija na lijekove koji sadrže faktor IX, a sukladno procjeni nadležnog liječnika, početne primjene faktora IX treba provesti pod medicinskim nadzorom na mjestu gdje se može pružiti odgovarajuća medicinska skrb u slučaju alergijskih reakcija.
English: In an ongoing trial in previously untreated patients, anaphylaxis has occurred in close temporal association with development of factor IX inhibitors following treatment with Refixia.
Croatian: U kliničkom ispitivanju u prethodno neliječenih bolesnika, koje je u tijeku, došlo je do anafilaksije čiji je nastanak bio vremenski usko povezan s razvojem inhibitora faktora IX nakon liječenja lijekom Refixia.
English: What Refixia is
Croatian: Što je Refixia
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide.
Croatian: Refixia je pročišćeni rekombinantni humani faktor IX (rFIX) s polietilenglikolom (PEG) od 40 kDa selektivno pričvršćenim na posebne N-vezane glikane aktivacijskog peptida u rFIX.
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds or 80 IU/kg for severe bleeds, where one bleed was evaluated as severe.
Croatian: Ukupna hemostatska djelotvornost Epizode krvarenja liječene su lijekom Refixia u dozi od 40 IU/kg za blaga ili umjerena krvarenja ili u dozi od 80 IU/kg za teška krvarenja, pri čemu je jedno krvarenje ocijenjeno kao teško.
English: Clearance (CL) (ml/hour/kg) Mean residence time (MRT) (hours)
Croatian: Klirens (CL) (ml/sat/kg) Srednja vrijednost vremena zadržavanja (MRT) (sati)
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Croatian: Nemojte bacati u otpad niti jedan predmet iz pribora dok ne injicirate pripremljenu otopinu.
English: 6.5 Nature and contents of container
Croatian: 6.5 Vrsta i sadržaj spremnika Svako pakiranje sadrži:
English: Recommended dose IU/kg of Refixia
Croatian: Preporučena doza Preporuke za doziranje u IU/kg lijeka Refixia
English: How Refixia is given
Croatian: Kako se Refixia primjenjuje
English: The reconstituted solution will be clear and colourless.
Croatian: Pripremljena otopina je bistra i bezbojna.
English: Refixia is recommended to be used immediately after it has been reconstituted.
Croatian: Preporučuje se primijeniti lijek Refixia odmah nakon pripreme za primjenu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Factor IX activity 168 h post dosing (IU/ml)
Croatian: Aktivnost faktora IX 168 h nakon doziranja (IU/ml)
English: The following side effects have been observed with Refixia:
Croatian: Pri primjeni lijeka Refixia primijećene su sljedeće nuspojave:
English: 7-12 years N=13
Croatian: 7-12 godina N=13
English: • Remove the protective paper from the vial adapter.
Croatian: • Uklonite zaštitni papir s nastavka za bočicu.
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Croatian: Refixia je pročišćeni rekombinantni humani faktor IX (rFIX) s polietilenglikolom (PEG) od 40 kDa konjugiranim na protein.
English: 13-17 years N=3
Croatian: 13-17 godina N=3
English: Do not use Refixia after the expiry date which is stated after “EXP” on the carton and on the vial and the pre-filled syringe labels.
Croatian: Refixia se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, te na naljepnicama na bočici i napunjenoj štrcaljki iza oznake ‘Rok valjanosti'.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: Otapalo histidin voda za injekcije natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: If you cannot use the reconstituted Refixia solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu lijeka Refixia, morate je upotrijebiti unutar 4 sata ako je čuvate na sobnoj temperaturi (do 30°C), odnosno unutar 24 sata ako je čuvate u hladnjaku (2°C-8°C).
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) • neutralising antibodies (inhibitors).
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
English: Refixia is used to treat and prevent bleeding in patients 12 years and above with haemophilia B (inborn factor IX deficiency).
Croatian: Refixia se koristi za liječenje i sprječavanje krvarenja u bolesnika s hemofilijom B (urođen nedostatak faktora IX) u dobi od 12 i više godina.
English: Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Croatian: Pakiranje sadrži: 1 bočicu s praškom, 4 ml otapala u napunjenoj štrcaljki, 1 potisni klip i 1 nastavak za bočicu
English: Table 3 Frequency of adverse reactions in clinical trials System Organ Class
Croatian: Tablica 3 Učestalost nuspojava u kliničkim ispitivanjima
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Croatian: Nakon primjene lijekova koji sadrže faktor IX postoji rizik od tromboembolijskih epizoda, s time da je taj rizik viši kod pripravaka niske čistoće.
English: Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid
Croatian: Otapalo: histidin, voda za injekcije, natrijev hidroksid, kloridna kiselina
English: Do not use the reconstituted solution if you notice any particles or discolouration.
Croatian: Nemojte upotrijebiti pripremljenu otopinu ako primijetite bilo kakve čestice ili ako je došlo do promjene boje.
English: *Pruritus includes the terms pruritus and ear pruritus **Injection site reactions include injection site pain, infusion site pain, injection site swelling, injection site erythema and injection site rash.
Croatian: **Reakcije na mjestu injiciranja uključuju bol na mjestu injiciranja, bol na mjestu infuzije, oticanje mjesta injiciranja, eritem na mjestu injiciranja i osip na mjestu injiciranja.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10);
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često
English: In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients.
Croatian: većih kirurških zahvata obavljenih na 13 prethodno liječenih odraslih i adolescentnih bolesnika.
English: Refixia may be taken out of the refrigerator for a maximum period of 6 months and stored at room temperature (up to 30°C).
Croatian: Refixia se može izvaditi iz hladnjaka i čuvati na sobnoj temperaturi (do 30°C) tijekom razdoblja od najviše 6 mjeseci.
English: Refixia is indicated for patients 12 years and above.
Croatian: Pedijatrijska populacija Refixia je indicirana za primjenu u bolesnika u dobi od 12 i više godina.
English: • The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid.
Croatian: • Sastojci u steriliziranom otapalu su histidin, voda za injekcije, natrijev hidroksid i kloridna kiselina.
English: • Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Croatian: • Odmah spojite potisni klip sa štrcaljkom tako da ga navijate u smjeru kazaljke na satu u klip koji se nalazi u napunjenoj štrcaljki, sve dok ne osjetite otpor.
English: Vial with Refixia powder
Croatian: Bočica s praškom Refixia
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Croatian: Može se čuvati na sobnoj temperaturi (do 30°C) tijekom jednokratnog razdoblja od najviše 6 mjeseci.
English: Each pack contains: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger
Croatian: - 1 staklenu bočicu (staklo tipa I) s praškom i čepom od klorobutilne gume - 1 sterilni nastavak za bočicu za rekonstituciju - 1 napunjenu štrcaljku s 4 ml otopine histidina s graničnikom (polipropilen), gumenim čepom klipa (bromobutil) i zatvaračem vrha štrcaljke s čepom (bromobutil)
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Croatian: Potrebno je naglasiti da u bolesnika s inhibitorima faktora IX kod sljedeće primjene faktora IX može postojati povećan rizik od anafilaksije.
English: Instructions on how to use Refixia
Croatian: Upute za uporabu lijeka Refixia
English: It is a vitamin-K dependent coagulation factor and it is synthesised in the liver.
Croatian: K i sintetizira se u jetri.
English: More extensive haemarthrosis, muscle bleeding or haematoma.
Croatian: krvarenje u mišiću ili hematom.
English: Wide top end
Croatian: Široki kraj
English: An infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters will also be needed.
Croatian: Potrebni su i infuzijski set (cjevčica i leptirasta igla), sterilni alkoholni tupferi, gaze i flasteri.
English: • The other ingredients in the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide and hydrochloric acid.
Croatian: • Drugi sastojci u prašku su natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid i kloridna kiselina.
English: Powder: sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid
Croatian: Prašak: natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid, kloridna kiselina
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place under controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene lijeka odgovornost su korisnika te se normalno ne preporučuje čuvanje dulje od 4 sata na sobnoj temperaturi (≤30°C) ili dulje od 24 sata u hladnjaku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Refixia
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Otapalo za lijek Refixia
English: Please record the beginning of storage at room temperature on the product carton.
Croatian: Na kutiji lijeka zabilježite datum početka čuvanja lijeka na sobnoj temperaturi.
English: Clearance CL (ml/hour/kg)
Croatian: Klirens CL (ml/sat/kg)
English: Do not take the vial adapter out of the protective cap with your fingers.
Croatian: Nemojte prstima vaditi nastavak za bočicu iz zaštitnog pokrova.
English: 2000 IU powder in a vial and 4 ml solvent in a pre-filled syringe, a plunger rod with a vial adapter - pack size of 1).
Croatian: praška u bočici i 4 ml otapala u napunjenoj štrcaljki, potisni klip i nastavak za bočicu - veličina pakiranja: 1).
English: In case of self-administration or administration by caregiver appropriate training is needed.
Croatian: U slučaju da bolesnik sam sebi daje lijek ili da mu ga daje njegovatelj, potrebna im je odgovarajuća obuka.
English: Before injection it must be reconstituted with the solvent supplied in the syringe.
Croatian: Prije injiciranja lijek mora biti pripremljen s otapalom koje dolazi u štrcaljki.
English: Do not freeze reconstituted Refixia solution or store it in syringes.
Croatian: Pripremljenu otopinu lijeka Refixia ne smijete zamrzavati niti čuvati u štrcaljkama.
English: For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti u uputi o lijeku.