FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje treba provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom trajanja liječenja, odgovarajuće određivanje razina faktora VIII savjetuje se kao vodič u određivanje doze koju treba primijeniti i učestalost ponavljanja infuzija.
English: Perioperative management (surgical prophylaxis)
Croatian: Perioperativno liječenje (kirurška profilaksa)
English: The median dosing interval was 3.6 days and the mean dose (SD) was 48.7 (4.4) IU/kg.
Croatian: Medijan intervala doziranja bio je 3,6 dana i srednja doza (SD) bila je 48,7 (4,4) IU/kg.
English: o The appearance of the reconstituted solution is clear and colourless.
Croatian: o Izgled rekonstituirane otopine bistar je i bezbojan.
English: Table 3: Pharmacokinetic parameters using the chromogenic assay (Arithmetic mean ± SD)
Croatian: Tablica 3: Farmakokinetički parametri pomoću kromogenog testa (Aritmetička sredina ± SD)
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: * Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Croatian: *Ljudski faktor VII proizveden tehnologijom rekombinantne DNK u staničnoj liniji jajnika kineskog hrčka (engl.
English: The median joint ABR (Q1 ; Q3) in the on-demand arm was 38.1 (24.5 ; 44.6) compared to 0.0 (0.0 ; 2.0) while on prophylaxis, and the median spontaneous ABR was 21.6 (11.2 ; 33.2) on the on-demand arm compared to 0.0 (0.0 ; 2.2) while on prophylaxis.
Croatian: Medijan ASK-a za zglobove (Q1, Q3) u skupini liječenoj kod krvarenja bio je 38,1 (24,5; 44,6) u usporedbi sa 0,0 (0,0; 2,0) kod režima profilakse, a medijan ASK-a za spontano krvarenje bio je 21,6 (11,2; 33,2) u skupini liječenoj kod krvarenja u usporedbi sa 0,0 (0,0; 2,2) kod profilakse.
English: Open the ADYNOVI blister by peeling away the lid.
Croatian: Otvorite blister lijeka ADYNOVI tako da odlijepite pokrov.
English: The observed event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year-old patient who had developed a previous rash while on ADYNOVI.
Croatian: Zabilježeni događaj preosjetljivosti bio je blagi prolazni osip koji nije bio ozbiljan, koji se pojavio u jednog dvogodišnjeg bolesnika koji je i prethodno bio razvio osip dok je uzimao ADYNOVI.
English: Each powder vial contains nominally 250, 500,
Croatian: Jedna bočica s praškom nominalno sadrži 250, 500
English: Instructions for injection Antiseptic technique (clean and low-germ conditions) is required during administration.
Croatian: Upute za injekciju Tijekom pripreme mora se koristiti antiseptička tehnika (čisti uvjeti s malim brojem mikroorganizma).
English: Before opening the product may be stored at room temperature (up to 30° C) for a period of up to 3 months.
Croatian: Prije otvaranja, lijek se može čuvati na sobnoj temperaturi (do 30 °C) tijekom razdoblja od najviše 3 mjeseca.
English: ADYNOVI has an extended half-life of 1.4 to 1.5-fold compared to recombinant human coagulation factor VIII (octocog alfa) in the adolescent and adult population, as determined based on one stage clotting and chromogenic assays, respectively.
Croatian: ADYNOVI ima prošireni poluvijek od 1,4 do 1,5-puta usporedbi s rekombinantnim ljudskim faktorom koagulacije VIII pune duljine (oktokog alfa) u populaciji adolescenata i odraslih, kako je određeno na temelju jednostupanjskog testa koagulacije odnosno kromogenog testa.
English: Prophylactic treatment for patients from 12 to <18 years is the same as for adult patients.
Croatian: Profilaktičko liječenje bolesnika koji imaju 12 do <18 godina isto je kao i kod liječenja odraslih bolesnika.
English: The median dose per infusion to treat all bleeding episodes in the per-protocol population was 32.0 (Interquartile Range (IQR): 21.5) IU per kg.
Croatian: Medijan doze po infuziji za liječenje epizoda krvarenja u populaciji liječenoj po protokolu bio je 32,0 (interkvartilni raspon: 21,5) IU po kg.
English: Swirl gently until the powder is completely dissolved.
Croatian: Nježno kružeći bočicom miješajte dok se prašak potpuno ne otopi.
English: NA, Not applicable, as Incremental Recovery and Cmax in children were determined by individual PK.
Croatian: NP, Nije primjenjivo, kako je prirast po jedinici doze i Cmax u djece određivan je putem pojedinačne farmakokinetike.
English: Subjects received either prophylactic treatment (n = 120) with ADYNOVI at a dose of 40-50 IU per kg twice weekly or on-demand treatment (n = 17) with ADYNOVI at a dose of 10-60 IU per kg for a 6-month period.
Croatian: Ispitanici koju su primili profilaksu lijekom (n= 120) ADYNOVI uz dozu od 40-50 IU po kg dvaput tjedno ili liječenje kod krvarenja (n= 17) lijekom ADYNOVI uz dozu od 10-60 IU po kg tijekom šestomjesečnog razdoblja.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Croatian: Jača hemartroza, krvarenje u mišiću ili hematom
English: The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Croatian: Potrebno je odrediti brzinu primjene koja će biti ugodna za bolesnika, a do najviše 10 ml/min.
English: ADYNOVI is for intravenous use.
Croatian: ADYNOVI se primjenjuje intravenski.
English: Disconnect the syringe; attach a butterfly needle to the syringe and inject the reconstituted solution into a vein.
Croatian: Odvojite štrcaljku; pričvrstite leptir-iglu na štrcaljku i injicirajte pripremljenu otopinu u venu.
English: The solution should be clear or slightly opalescent.
Croatian: Otopina bi trebala biti bistra ili blago opalescentna.
English: Do not use ADYNOVI if the solution is not fully clear or not completely dissolved.
Croatian: ADYNOVI se ne smije upotrijebiti ako otopina nije potpuno bistra ili potpuno otopljena.
English: or 1000 IU rurioctocog alfa pegol.
Croatian: ili 1000 IU rurioktokog alfa pegola.
English: In the per-protocol population, i.e. dosed according to the protocol specific dosing requirements, a total of 101 subjects received a twice a week regimen in the prophylaxis arm, and 17 subjects were treated episodically in the on-demand arm.
Croatian: U populaciji liječenoj prema planu ispitivanja, odnosno kod koje je doziranje bilo prema specifičnim zahtjevima u planu ispitivanja, ukupno 101 ispitanik bio je na režimu doziranja dvaput tjedno u skupini koja je primala profilaksu, a 17 ispitanika liječeno je po epizodi u skupini liječenoj kod krvarenja.
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Croatian: Ako trebate centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, prisutnost bakterija u krvi i tromboza na mjestu postavljenog katetera.
English: The half-life extension in the paediatric population was 1.3 to 1.5 fold using both the one stage clotting and chromogenic assays.
Croatian: Produljenje poluvijeka u pedijatrijskoj populaciji bilo je 1,3- do 1,5-struko koristeći jednostupanjski test koagulacije i kromogeni test.
English: Please record the end of the 3-month storage at room temperature on the product carton.
Croatian: Zabilježite datum završetka tromjesečnog čuvanja lijeka na sobnoj temperaturi na kutiji lijeka.
English: Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C).
Croatian: Uhvatite pakiranje BAXJECT II Hi-Flow za rub i skinite pakiranje s uređaja (slika C).
English: A total of 66 PTPs with severe haemophilia A were dosed (32 subjects aged < 6 years and 34 subjects aged 6 to < 12 years) in the paediatric study.
Croatian: Ukupno 66 prethodno liječenih bolesnika s teškom hemofilijom A (32 ispitanika u dobi <6 godina i 34 ispitanika u dobi od 6 do <12) dobivalo je dozu u pedijatrijskom ispitivanju.
English: The prophylactic regimen was 40 to 60 IU/kg of ADYNOVI twice a week.
Croatian: Režim profilakse bio je 40 do 60 IU/kg lijeka ADYNOVI dvaput tjedno.
English: Turn the system upside down (powder vial now on top).
Croatian: Preokrenite sustav naopako (bočica s otopljenim praškom sada na vrhu).
English: ADYNOVI is used for the treatment and prevention of bleeding in patients from 12 years of age with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: ADYNOVI se koristi za liječenje i prevenciju krvarenja kod bolesnika s hemofilijom A (nasljednim poremećajem krvarenja uzrokovanim manjkom faktora VIII) koji imaju 12 i više godina.
English: Forty out of 101 subjects (40%) experienced no bleeding episodes, 58 out of 101 subjects (57%) experienced no joint bleeding episodes, and 58 out of 101 subjects (57%) experienced no spontaneous bleeding episodes in the prophylaxis arm. All subjects in the on-demand arm experienced a bleeding episode, including a joint or spontaneous bleeding episode.
Croatian: Od 101 ispitanika 40 (40%) ih nije iskusilo epizode krvarenja, 58 od 101 ispitanika (57%) nije iskusilo epizode krvarenja u zglobovima i 58 od 101 ispitanika (57%) nije iskusilo spontane epizode krvarenja u skupini na profilaksi.
English: The powder is a white to off-white crumbly powder.
Croatian: Prašak je bijeli do bjelkasti mrvljivi prašak.
English: Do not use ADYNOVI: - if you are allergic to rurioctocog alfa pegol, octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Croatian: Nemojte primjenjivati ADYNOVI: - ako ste alergični na rurioktokog alfa pegol, oktokog alfa ili neki drugi sastojak ovog lijeka
English: It is strongly recommended that every time that ADYNOVI is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Strogo se preporučuje kod svake primjene lijeka ADYNOVI bolesniku, evidentirati naziv i broj serije lijeka kako bi se zadržala poveznica između bolesnika i serije lijeka.
English: During the shelf life the powder vial may be kept at room temperature (up to 30 °C) for a single period not exceeding 3 months.
Croatian: Unutar roka valjanosti, bočica s praškom se može čuvati na sobnoj temperaturi (do 30 °C) u jednokratnom razdoblju ne dužem od 3 mjeseca.
English: Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside (Figure A).
Croatian: Otvorite pakiranje uređaja BAXJECT II Hi-Flow tako da odlijepite pokrov ne dirajući unutrašnjost (slika A).
English: Catheter-related complications
Croatian: Komplikacije vezane za kateter
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Figure F).
Croatian: Uvucite rekonstituiranu otopinu u štrcaljku povlačeći potisnik polako unatrag (slika F).
English: Peel-off labels are provided on the blister.
Croatian: Odvojive naljepnice nalaze se na blisteru.
English: Skin and subcutaneous tissue disorders Rash
Croatian: Poremećaji kože i potkožnog tkiva
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Croatian: Otopinu treba primijeniti polako, pri brzini koja treba biti ugodna za bolesnika, ne brže od 10 ml po minuti. (Vidjeti dio 4 „Moguće nuspojave”).
English: ADYNOVI in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Croatian: ADYNOVI u sustavu BAXJECT III: hermetički zatvoreni blister čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: If you stop using ADYNOVI Do not stop using ADYNOVI without consulting your doctor.
Croatian: Ne prekidajte primjenu lijeka ADYNOVI bez savjetovanja sa svojim liječnikom.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, 1000 IU or 2000 IU of powder.
Croatian: Staklena bočica tipa I, zatvorena gumenim čepom od klorobutila sadrži 250 IU, 500 IU, 1000 IU ili 2000 IU praška.
English: Solvent: Clear and colourless solution.
Croatian: Otapalo: bistra i bezbojna otopina.
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Croatian: Ovaj lijek sadrži 0,45 mmol (10 mg) natrija po bočici.
English: Place the powder vial on a flat surface with the solvent vial on top (Figure 1).
Croatian: Postavite bočicu s praškom na ravnu površinu s bočicom otapala na vrhu (slika 1).
English: - ADYNOVI with BAXJECT II Hi-Flow device: Each pack contains a powder vial, a solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Croatian: - ADYNOVI s uređajem BAXJECT II Hi-Flow: Jedno pakiranje sadrži bočicu s praškom, bočicu s otapalom i uređaj za rekonstituciju (BAXJECT II Hi-Flow).
English: When infused into a haemophilic patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Croatian: Kada se lijek primjeni u bolesnika s hemofilijom, faktor VIII veže se za endogeni von Willebrandov faktor u bolesnikovu krvotoku.
English: Remove the BAXJECT III system from the blister.
Croatian: Uklonite sustav BAXJECT III iz blistera.
English: A total of 518 bleeding episodes were treated with ADYNOVI in the per-protocol population.
Croatian: U populaciji liječenoj prema planu ispitivanja, lijekom ADYNOVI liječeno je ukupno 518 epizoda krvarenja.
English: Population PK with sparse sampling b
Croatian: Populacijska farmakokinetika s djelomičnim uzorkovanjem b
English: Instructions for reconstitution
Croatian: Upute za pripremu
English: ADYNOVI with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light.
Croatian: ADYNOVI s uređajem BAXJECT II Hi-Flow: bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Peel-off labels are provided on the powder vial.
Croatian: Odvojive naljepnice nalaze se na bočici s praškom.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet>
English: Disconnect the syringe; attach a suitable needle and inject intravenously.
Croatian: Odvojite štrcaljku, pričvrstite odgovarajuću iglu i injicirajte intravenski.
English: - ADYNOVI in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister, withthe powder vial and the solvent vial preassembled for reconstitution.
Croatian: - ADYNOVI u sustavu BAXJECT III: Jedno pakiranje sadrži u hermetički zatvorenom blisteru sustav BAXJECT III spreman za korištenje, s bočicom s praškom i bočicom s otapalom već pričvršćenim za rekonstituciju).
English: Prevention of bleeding The usual dose of ADYNOVI is 40 to 50 IU per kg body weight, administered 2 times per week.
Croatian: Uobičajena doza lijeka ADYNOVi je 40 do 50 IU po kg tjelesne težine, primijenjena 2 puta tjedno.
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 67
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Baxalta Innovations GmbH Industriestrasse 67
English: Do not use if the solution is not fully clear or not completely dissolved.
Croatian: Ne smije se upotrijebiti ako otopina nije potpuno bistra ili potpuno otopljena.
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: Bolesnici trebaju biti informirani o ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje u plućima, hipotenziju i anafilaksiju.
English: • Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from particles).
Croatian: • Pripremljenu otopinu pregledajte kako biste bili sigurni da ne sadrži vidljive čestice ili da nije promijenila boje (otopina treba biti bistra, bezbojna i bez vidljivih čestica).
English: Treatment of bleeding episodes
Croatian: Liječenje epizoda krvarenja:
English: How to use ADYNOVI
Croatian: Kako primjenjivati ADYNOVI
English: Results for Incremental Recovery and Cmax determined by individual PK in parenthesis.
Croatian: Rezultati za prirast po jedinici doze i Cmax određen pojedinačnom farmakokinetikom su u zagradi.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, or 1000 IU of powder.
Croatian: Staklena bočica tipa I, zatvorena gumenim čepom od klorobutila sadrži 250 IU, 500 IU ili 1000 IU praška.
English: ADYNOVI is for intravenous use
Croatian: ADYNOVI se primjenjuje intravenski
English: Allow the vials of powder and solvent to reach room temperature (between 15 °C and 25 °C) before use.
Croatian: Prije uporabe pustite da bočice s praškom i otapalom dosegnu sobnu temperaturu (između 15 °C i 25 °C).
English: o Do not use if particulate matter or discoloration is observed.
Croatian: o Ne koristiti ako primijetite vidljive čestice ili promjenu boje.
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Croatian: Početna hemartroza, krvarenje u mišiću ili usnoj šupljini.
English: For long term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg bodyweight twice weekly in 3 to 4 day intervals.
Croatian: Za dugotrajnu profilaksu preporučuje se doza od 40 do 50 IU lijeka ADYNOVI po kg tjelesne težine dvaput tjedno u razmacima od 3 do 4 dana.
English: Excipient(s) with known effect Each powder vial contains 0.45 mmol (10 mg) sodium, see section 4.4.
Croatian: Jedna bočica s praškom sadrži 0,45 mmol (10 mg) natrija, vidjeti dio 4.4.
English: - The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 and sterilised water for injections.
Croatian: Drugi sastojci su manitol, trehaloza dihidrat, histidin, glutation, natrijev klorid, kalcijev klorid dihidrat, tris(hidroksimetil)aminometan, polisorbat 80 i sterilizirana voda za injekciju.
English: The product may not be returned to refrigerated storage after storage at room temperature.
Croatian: Nakon čuvanja na sobnoj temperaturi lijek se ne smije vratiti na čuvanje u hladnjaku.
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika 12 godina s hemofilijom A (urođeni nedostatak faktora VIII) koji imaju 12 i više godina.
English: Always use ADYNOVI exactly as your doctor has told you.
Croatian: Ako primijenite više lijeka ADYNOVI nego što ste trebali Uvijek primijenite ADYNOVI točno onako kako Vam je rekao liječnik.
English: If you or your child´s bleeding is not being controlled with ADYNOVI, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka ADYNOVI, odmah se obratite liječniku.
English: ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII.
Croatian: ADYNOVI sadrži djelatnu tvar rurioktokog alfa pegol, pegilirani ljudski faktor koagulacije VIII.
English: ADYNOVI contains sodium
Croatian: ADYNOVI sadrži natrij
English: Plasma factor VIII activity was measured by the one stage clotting assay and chromogenic assay.
Croatian: Aktivnost faktora VIII u plazmi izmjerena je jednostupanjskim testom koagulacije i kromogenim testom.
English: Turn the system over so that the solvent vial is on top.
Croatian: Okrenite sustav naopako tako da je bočica s otapalom na vrhu.
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products.
Croatian: International Units, IU), koje su povezane s trenutačnim WHO standardom za koncentrat za lijekove s faktorom VIII.
English: Control of bleeding was rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in 63 out of 70 (90.0%) bleeding episodes.
Croatian: U 63 od 70 (90%) epizoda krvarenja kontrola krvarenja bila je ocijenjena odlično (potpuno olakšanje bolova i prestanak objektivnih znakova krvarenja nakon pojedinačne infuzije) ili dobro (definitivno olakšanje boli i/ili poboljšanje znakova krvarenja nakon jedne infuzije).
English: You should be aware of the early signs of allergic reactions such as rash,
Croatian: Morate znati da su rani znakovi alergijskih reakcija: osip, koprivnjača,
English: ADYNOVI Adults (18 years and older) N = 18 Dose: 45 ± 5 IU/kg
Croatian: ADYNOVI Odrasli (18 godina i stariji) N= 18 Doza: 45 ± 5 IU/kg
English: Do not refrigerate after reconstitution.
Croatian: Nemojte odlagati u hladnjak nakon rekonstitucije.
English: Press straight down to fully insert the clear plastic spike through the solvent vial stopper (Figure B).
Croatian: Pritisnite prema dolje kako biste ubacili prozirni plastični šiljak uređaja u pakiranju kroz čep bočice otapala (slika B).
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised water for injections.
Croatian: Staklena bočica tipa I, zatvorena gumenim čepom od klorobutila sadrži 5 ml sterilizirane vode za injekcije.
English: • Do not use if the lid is not completely sealed on the blister
Croatian: • Ne koristiti ako pokrov na blisteru nije u potpunosti zalijepljen.
English: Quickly insert the purple plastic spike fully into the powder vial stopper by pushing straight down (Figure D).
Croatian: Brzo umetnite ljubičasti plastični šiljak do kraja u čep bočice s praškom tako da ga pogurnete prema dolje (slika D).
English: ADYNOVI Adolescents (12-<18 years) N = 8 Dose: 45 ± 5 IU/kg
Croatian: ADYNOVI Adolescenti (12-<18 godina) N= 8 Doza: 45 ± 5 IU/kg
English: Paediatric Pharmacokinetics
Croatian: Pedijatrijska farmakokinetika
English: How to store ADYNOVI
Croatian: Kako čuvati ADYNOVI
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 2 ml of sterilised water for injections.
Croatian: Staklena bočica tipa I, zatvorena gumenim čepom od klorobutila sadrži 2 ml sterilizirane vode za injekcije.
English: Incremental recovery [(IU/dL)/(IU/kg)]
Croatian: Prirast po jedinici doze [(IU/dL)/(IU/kg)]
English: What ADYNOVI looks like and contents of the pack ADYNOVI is provided as a powder and solvent for solution for injection.
Croatian: ADYNOVI dolazi kao prašak i otapalo za otopinu za injekciju.
English: OUTER CARTON (BAXJECT III SYSTEM)
Croatian: VANJSKO PAKIRANJE (SUSTAV BAXJECT III)
English: Excipients: mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80
Croatian: Pomoćne tvari: manitol, trehaloza dihidrat, histidin, glutation, natrijev klorid, kalcijev klorid dihidrat, tris(hidroksimetil)aminometan, polisorbat 80
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Croatian: Uvucite rekonstituiranu otopinu u štrcaljku povlačeći potisnik polako unatrag.
English: The solvent is a clear, colourless solution.
Croatian: Otapalo je bistra, bezbojna otopina.
English: Do not remove the blue cap from the BAXJECT II Hi-Flow device.
Croatian: Nemojte skidati plavi zatvarač s uređaja BAXJECT II Hi-Flow.
English: OUTER CARTON (BAXJECT II HI-FLOW DEVICE)
Croatian: VANJSKO PAKIRANJE (UREĐAJ BAXJECT II HI-FLOW)
English: The human relevance of kidney vacuolation observed in the preclinical study is unknown.
Croatian: Nije poznata relevantnost za ljude u pogledu vakuolizacije bubrega u pretkliničkim ispitivanjima.