FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Croatian: Provjerite da skidate samo blister pakiranje, a ne cijeli Mix2Vial set.
English: RODIN/Pednet study were excluded.
Croatian: PedNet and RODIN Study Group.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology, in vitro genotoxicity, and short term repeat-dose toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju sigurnosne farmakologije in vitro genotoksičnosti i kratkotrajnih ispitivanja toksičnosti ponovljenih doza.
English: Iblias is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Croatian: Iblias je pripremljen rekombinantnom tehnologijom bez dodavanja sastojaka ljudskog ili životinjskog porijekla tijekom proizvodnje.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period.
Croatian: U slučaju sljedećih događaja krvarenja aktivnost faktora VIII ne smije pasti ispod zadane razine (u % od normalne vrijednosti) tijekom odgovarajućeg razdoblja.
English: Iblias can be used in children of all ages.
Croatian: Iblias se može primjenjivati u djece bilo koje dobi.
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, injected two or three times per week.
Croatian: Doze su najčešće u rasponu od 20 do 40 IU oktokoga alfa po kilogramu tjelesne težine koje se injiciraju dva ili tri puta tjedno.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovisi o težini nedostatka faktora VIII, o mjestu i opsegu krvarenja te o kliničkom statusu bolesnika.
English: It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced.
Croatian: Proizvodi se tehnologijom rekombinantne DNK u stanicama bubrega mladog hrčka (eng. baby hamster kidney, BHK) u koju je uveden gen za ljudski faktor VIII.
English: Since Iblias is a replacement protein of endogenous factor VIII, no adverse effects on fertility are expected.
Croatian: Budući da je Iblias protein koji nadomješta endogeni faktor VIII, ne očekuju se štetni učinci na plodnost.
English: It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Croatian: Snažno se preporučuje provođenje laboratorijskih testova na plazmi u odgovarajućim vremenskim razmacima kako bi se osiguralo postizanje i održavanje odgovarajuće razine faktora VIII.
English: Dose/injection for bleed treatment Median (min; max)
Croatian: Doza/injekcija za liječenje krvarenja medijan (min; maks)
English: What Iblias contains
Croatian: Što Iblias sadrži
English: The amount to be administered and the frequency of administration should always be targeted to the clinical effectiveness required in the individual case.
Croatian: Količinu koju treba primijeniti i učestalost primjene uvijek treba prilagoditi postizanju ciljne kliničke učinkovitosti potrebne u pojedinom slučaju.
English: The excretion in animals has not been studied.
Croatian: Izlučivanje u životinja nije ispitivano.
English: Known allergic reactions to mouse or hamster proteins.
Croatian: Poznate alergijske reakcije na proteine miša ili hrčka.
English: Factor VIII 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 VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili kao postotak (u odnosu na normalnu ljudsku plazmu) ili u međunarodnim jedinicama (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: Each package of Iblias contains:
Croatian: Pakiranje lijeka Iblias sadrži:
English: These may be signs of a rare severe sudden allergic reaction (an anaphylactic reaction) to Iblias.
Croatian: To mogu biti znakovi rijetke, ali teške i iznenadne alergijske reakcije (anafilaktičke reakcije) na Iblias.
English: The most serious side effects are allergic reactions or anaphylactic shock (an uncommon, severe allergic reaction affecting blood pressure and breathing).
Croatian: Najozbiljnije nuspojave su alergijske reakcije ili anafilaktički šok ((manje često, teške alergijske reakcije koje utječu na krvni tlak i disanje).
English: If you stop using Iblias Do not stop using Iblias without checking with your doctor.
Croatian: Ako prestanete primjenjivati Iblias Nemojte prestati uzimati Iblias bez provjere s liječnikom.
English: Novimed Ltd. Teл.
Croatian: Novimed Ltd.
English: The recommended prophylaxis doses are 20-50 IU/kg twice weekly, three times weekly or every other day according to individual requirements.
Croatian: Preporučene doze za profilaksu su 20-50 IU/kg dva puta tjedno, tri puta tjedno ili svaki drugi dan prema potrebama bolesnika.
English: Animal reproduction studies have not been conducted with factor VIII.
Croatian: Ispitivanja reprodukcije na životinjama s faktorom VIII nisu provedena.
English: Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed recovery (i.e. 0.5 for recovery of 2.0%).
Croatian: Potreban broj jedinica = tjelesna težina (kg) x željeni porast faktora VIII (% ili IU/dl) x recipročna vrijednost vidljivog oporavka (npr. 0,5 za oporavak od 2,0%).
English: The reconstituted medicinal product is a clear and colourless solution.
Croatian: Rekostituirani lijek je bistra i bezbojna otopina.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Croatian: Ponoviti infuziju svakih 12 - 24 sata tijekom 3 - 4 dana ili dulje do prestanka boli i akutne onesposobljenosti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016
Croatian: Datum prvog odobrenja: 18. veljača 2016.
English: Follow the directions given by your doctor closely and use the detailed instructions for reconstitution and administration provided at the end of this leaflet.
Croatian: Strogo se pridržavajte uputa liječnika te slijedite detaljne upute za pripremu za primjenu i primjenu koje se nalaze na kraju ove upute o lijeku.
English: In completed clinical studies with 71 paediatric previously treated patients, the frequency, type and severity of adverse reactions in children were found to be similar to those in adults.
Croatian: U dovršenim kliničkim ispitivanjima sa 71 prethodno liječenim pedijatrijskim bolesnikom, utvrđeno je da su učestalost, vrsta i težina nuspojava u djece slične onima u odraslih.
English: What you need to know before you use Iblias
Croatian: Što morate znati prije nego počnete primjenjivati Iblias
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijekova s ljudskim koagulacijskim faktorom VIII (rDNA) s drugim lijekovima.
English: It is recommended that every time that you use Iblias, you note down name and batch number of the product.
Croatian: Dokumentiranje Preporučuje se da se svaki put kad primijenite Iblias zabilježe naziv i broj serije lijeka.
English: If you are using Iblias to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Croatian: Ako Iblias primijenjujete za prevenciju (profilaksu) krvarenja, liječnik će Vam izračunati potrebnu dozu.
English: Do not use this medicine after the expiry date which is stated on labels and cartons.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnicama i pakiranjima.
English: It is unknown whether Iblias is excreted in human milk.
Croatian: Nije poznato izlučuje li se Iblias u majčino mlijeko.
English: • dysgeusia (strange taste)
Croatian: • disgeuzija (poremećaj osjeta okusa)
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses for adolescents (≥ 12 years age) and adult patients are 20 to 40 IU of Iblias per kg body weight two to three times per week.
Croatian: Za dugotrajnu profilaksu krvarenja u bolesnika s teškom hemofilijom A uobičajene doze za adolescente (≥ 12 godina starosti) i odrasle bolesnike su 20 do 40 IU lijeka Iblias po kilogramu tjelesne težine dva do tri puta tjedno.
English: What is in this leaflet What Iblias is and what it is used for What you need to know before you use Iblias How to use Iblias
Croatian: Što je Iblias i za što se koristi Što morate znati prije nego počnete primjenjivati Iblias Kako primjenjivati Iblias
English: In children below the age of 12 higher doses or more frequent injections than in adults may be needed.
Croatian: U djece mlađe od 12 godina mogu biti potrebne veće doze ili češća primjena injekcija u odnosu na odrasle.
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII.
Croatian: Jedna bočica nominalno sadrži 250/500/1000/2000/3000 IU ljudskog koagulacijskog faktora VIII.
English: • Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Croatian: • Primijenite odmah uzmite sljedeću dozu te nastavite uzimati lijek u redovitim vremenskim razmacima koje Vam je odredio liječnik.
English: A population PK model was developed based on all available FVIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Croatian: Populacijski PK model razvijen je na temelju svih dostupnih mjerenja FVIII (iz učestalog uzorkovanja za PK analizu i svih uzoraka u kojih je došlo do prirasta (engl. recovery samples) ) tijekom 3 klinička ispitivanja što je omogućilo izračun PK parametara za ispitanike u različitim ispitivanjima.
English: Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids.
Croatian: Oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII pune duljine (rDNK)) je pročišćeni protein od 2332 aminokiseline.
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Croatian: Djeca i adolescenti Navedena upozorenja i mjere opreza odnose se na bolesnike bilo koje dobi, odrasle i djecu.
English: The FVIII:C of Iblias can be measured in plasma with a one-stage coagulation assay as well as with a chromogenic assay using the routine methods of the laboratory.
Croatian: FVIII:C za lijek Iblias može se mjeriti u plazmi jednostupanjskim testom koagulacije kao i kromogenim testom primjenom rutinskih metoda u laboratoriju.
English: Pyrexia, chest discomfort, injection site reactions **
Croatian: Pireksija, nelagoda u prsištu, reakcije na mjestu injekcije**
English: Consistent results were determined for both products.
Croatian: Dobiveni su dosljedni podaci za oba lijeka.
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Croatian: Tablica 1: Vodič za doziranje u epizodama krvarenja u kirurgiji Stupanj krvarenja / vrsta kirurškog zahvata
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
English: If these components cannot be used, please contact your doctor.
Croatian: Ako se ti dijelovi ne mogu uporabiti, obratite se svom liječniku.
English: If you experience dizziness or any other symptoms affecting your ability to concentrate and react, do not drive or use machines until the reaction subsides.
Croatian: Ako imate omaglicu ili druge simptome koji utječu na Vašu sposobnost koncentracije i reagiranja, nemojte upravljati vozilima ili raditi sa strojevima dok se reakcija ne povuče.
English: Minor surgery including tooth extraction
Croatian: Kirurški zahvat Manji kirurški zahvat uključujući vađenje zuba
English: Each vial of Iblias contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Croatian: Svaka bočica lijeka Iblias sadrži nominalno 250, 500, 1000, 2000 ili 3000 IU oktokoga alfa.
English: If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger dose of Iblias to control bleeding.
Croatian: Ako Vas je liječnik obavijestio da su se razvili inhibitori faktora VIII, možda će za kontrolu krvarenja biti potrebna veća doza lijeka Iblias.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU] 5 mL [for reconstitution of strengths 2000/3000 IU]
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2,5 ml [za pripremu za primjenu jačina od 250/500/1000 IU] 5,0 ml [za pripremu za primjenu jačina od 2000/3000 IU]
English: Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Croatian: Na ispruženoj ruci čvrsto držite jastučić na mjestu injiciranja tijekom otprilike 2 minute.
English: You are filtering by using the Mix2Vial adapter.
Croatian: Filtrirate tako da primjenjujete Mix2Vial nastavak.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min).
Croatian: Brzina primjene određuje se prema razini podnošljivosti bolesnika (maksimalna je brzina infuzije 2 ml/min).
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less risk of insufficient clinical response than high titre inhibitors.
Croatian: Klinički značaj razvoja inhibitora ovisit će o titru inhibitora, pri čemu inhibitori s niskim titrom koji su prolazno prisutni ili ostaju stalno niskog titra, predstavljaju manji rizik za pojavu nedovoljnog kliničkog odgovora u odnosu na inhibitore s visokim titrom.
English: • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
Croatian: • blaga hipotenzija (blago sniženje krvnog tlaka zbog čega prilikom ustajanja možete imati osjećaj da ćete se onesvijestiti)
English: Iblias is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Croatian: Utjecaj lijeka Iblias na mušku ili žensku plodnost nije vjerojatan, budući da se djelatna tvar prirodno nalazi u tijelu.
English: The Pharmacokinetic (PK) profile of Iblias was evaluated in PTPs with severe haemophilia A following 50 IU/kg in 21 subjects ≥ 18 years, 5 subjects ≥ 12 years and < 18 years and 19 subjects < 12 years of age.
Croatian: Farmakokinetički (PK) profil lijeka Iblias procijenjen je u prethodno liječenih bolesnika s teškom hemofilijom A nakon primjene 50 IU/kg u 21 ispitanika ≥ 18 godina, 5 ispitanika ≥ 12 godina i < 18 godina te 19 ispitanika < 12 godina.
English: It is strongly recommended that every time Iblias 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: Snažno se preporučuje da se pri svakoj primjeni lijeka Iblias zabilježi naziv i broj serije lijeka kako bi se održala veza između bolesnika i serije lijeka.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija A spolno je vezani nasljedni poremećaj koagulacije krvi zbog smanjene razine faktora VIII:C te uzrokuje obilno krvarenje u zglobovima, mišićima i unutrašnjim organima, bilo spontano ili uzrokovano slučajnom ili kirurškom traumom.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može poslužiti kao vodič za doziranje u epizodama krvarenja te kirurgiji:
English: 1 vial with powder.
Croatian: 1 bočica s praškom.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se nakon rekonstitucije treba odmah primijeniti.
English: Determine the point of injection and clean the skin with an alcohol swab.
Croatian: 14. Odredite mjesto injiciranja i očistite kožu kompresom natopljenom alkoholom.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Croatian: Ako se jave simptomi preosjetljivosti, bolesnike se treba savjetovati da odmah prekinu primjenu ovog lijeka i obrate se svom liječniku.
English: If you forget to use Iblias
Croatian: Ako ste zaboravili primijeniti Iblias
English: The active substance is human coagulation factor VIII (octocog alfa).
Croatian: Djelatna tvar je ljudski koagulacijski faktor VIII (oktokog alfa).
English: Experience with the use of factor VIII products during pregnancy and breast-feeding are not available since haemophilia A rarely occurs in women.
Croatian: Iskustva u primjeni lijekova s faktorom VIII tijekom trudnoće i dojenja nisu dostupna budući da se hemofilija A rijetko javlja u žena.
English: If patients experience dizziness or other symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the reaction subsides.
Croatian: Ako bolesnici imaju vrtoglavicu ili druge simptome koji utječu na njihovu sposobnost koncentracije i reagiranja, preporuča se da ne upravljaju vozilima niti ne rade sa strojevima dok se reakcija nepovuče.
English: After reconstitution, the solution is drawn through the vial filter transfer device into the sterile disposable syringe (both supplied).
Croatian: Otopina se nakon rekonstitucije uvlači kroz pribor za prijenos tekućine s filterom za bočicu u sterilnu jednokratnu štrcaljku (oboje isporučeno).
English: Two multi-center, open-label, cross-over, uncontrolled, randomized studies in previously treated adults/adolescents with severe haemophilia A (< 1%) and one multicenter, open label, uncontrolled study in previously treated children < 12 years with severe haemophilia A were conducted.
Croatian: Provedena su dva multicentrična, otvorena, ukrižena, nekontrolirana, randomizirana ispitivanja u prethodno liječenih odraslih osoba/adolescenata s teškom hemofilijom A (< 1%) i jedno multicentrično, otvoreno, nekontrolirano ispitivanje u prethodno liječene djece < 12 godina s teškom hemofilijom A.
English: Palpitation, sinus tachycardia common
Croatian: Palpitacije, sinusna tahikardija često
English: Iblias is used for treatment and prevention of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Croatian: Iblias se koristi za liječenje i prevenciju krvarenja u odraslih, adolescenata i djece bilo koje dobi s hemofilijom A (nasljedni nedostatak faktora VIII).
English: 1 vial with 2.5 mL water for injections.
Croatian: 1 bočica s 2,5 ml vode za injekcije.
English: In an international study involving 41 clinical laboratories, the performance of Iblias in FVIII:C assays was evaluated and compared to a marketed full length rFVIII product.
Croatian: U internacionalnom ispitivanju u kojem je sudjelovao 41 klinički laboratorij procijenjena je učinkovitost lijeka Iblias pri korištenju FVIII:C testova te je uspoređena s lijekom na tržištu koji sadrži rFVIII pune duljine.
English: • you have previously developed factor VIII inhibitors to a different product.
Croatian: • ste prethodno već razvili inhibitore faktora VIII na drugi lijek.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje se treba provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: Iblias is a medicine that contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Croatian: Iblias je lijek koji kao djelatnu tvar sadrži rekombinantni ljudski koagulacijski faktor VIII, također zvan oktokog alfa.
English: Therefore, factor VIII should be used during pregnancy only if clearly indicated.
Croatian: Stoga se faktor VIII tijekom dojenja smije koristiti samo ako za to postoje jasne indikacije.
English: This medicine may be stored at ambient room temperature (up to 25 °C) for a limited period of 12 months when you keep it in its outer carton.
Croatian: Ovaj se lijek može držati na sobnoj temperaturi (do 25 °C) tijekom ograničenog razdoblja od 12 mjeseci ako ga držite u vanjskom pakiranju.
English: Iblias is provided as a powder and solvent for solution for injection and is a dry, white to slightly yellow powder or cake.
Croatian: Iblias se sastoji od praška i otapala za otopinu za injekciju, a dostupan je u obliku suhog bijelog do žućkastog praška ili kolačića.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Croatian: Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6 i upute o lijeku.
English: After reconstitution the solution is clear.
Croatian: Nakon rekonstitucije otopina je bistra.
English: The speed of injection should be based on your comfort, but should not be faster than 2.0 mL per minute.
Croatian: Vaše podnošljivosti, ali ne bi trebala biti veća od 2 ml po minuti.
English: Do not use Iblias if you notice visible particulate matter or turbidity.
Croatian: Iblias nemojte koristiti ako zamijetite vidljive čestice ili zamućenje.
English: If no further dose is required, remove the venipuncture set and syringe.
Croatian: Ako nije potrebna druga doza, uklonite set za venepunkciju i štrcaljku.
English: Haemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-haemophilic patients when clotting has been normalised by treatment with FVIII.
Croatian: Bolesnici s hemofilijom i kardiovaskularnim faktorima rizika ili bolestima mogu imati isti rizik od razvoja kardiovaskularnih događaja kao i bolesnici koji nemaju hemofiliju kad se koagulacija krvi normalizira liječenjem s FVIII.
English: This result is similar to the reported values for factor VIII derived from human plasma.
Croatian: Ti su rezultati slični zabilježenim vrijednostima prilikom primjene faktora VIII dobivenog iz ljudske plazme.
English: If this dose does not control your bleeding your doctor may consider giving you another product.
Croatian: Ako se krvarenje ne uspije kontrolirati ni većom dozom, liječnik će Vam možda dati drugi lijek.
English: A safety and efficacy study has been performed in children of 0-12 years (see section 5.1); limited data are available for children below 1 year.
Croatian: Ispitivanje sigurnosti i djelotvornosti provedeno je u djece u dobi 0-12 godina (vidjeti dio 5.1).
English: Uncommon (may affect up to 1 in 100 users):
Croatian: Manje često /mogu se javiti u do 1 na 100 korisnika):
English: 1 vial with 5 mL water for injections.
Croatian: 1 bočica s 5 ml vode za injekcije.
English: Do not use Iblias
Croatian: Nemojte primjenjivati Iblias
English: The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Iblias.
Croatian: Analiza svih zabilježenih prirasta po jedinici doze u prethodno liječenih bolesnika pokazala je da prilikom korištenja lijeka Iblias dolazi do medijana porasta od > 2% (> 2 IU/dl) po IU/kg tjelesne težine.
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Croatian: Držite štrcaljku usmjerenu prema gore i potiskujte klip dok sav zrak ne izađe iz štrcaljke.