FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme' (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Croatian: Nadalje, lijek ATryn primijenjen je u petero bolesnika koji su primili lijek tijekom operacije u okviru „programa milosrdnog davanja” (program u kojem liječnici mogu zatražiti lijek za neke bolesnike prije davanja odobrenja).
English: The company will also put in place, before launch in any European Union (EU) Member State, programmes to ensure that doctors can report information on the patients they treat and monitor the development of antibodies against ATryn.
Croatian: Prije stavljanja lijeka na tržište bilo koje države članice EU-a, tvrtka će također uspostaviti programe kojima će liječnicima omogućiti da evidentiraju informacije o bolesnicima koje liječe i prate razvoj protutijela koja djeluju na lijek ATryn.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atryn have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka ATryn nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment.
Croatian: Nakon toga se daje kontinuirana infuzija manje doze, tijekom koje je potreban stalan nadzor bolesnika i prilagodba brzine infuzije kako bi aktivnost antitrombina tijekom liječenja bila barem 80 % u odnosu na normalnu razinu.
English: This document is a summary of the European Public Assessment Report (EPAR) for ATryn.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek ATryn.
English: Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection.
Croatian: Budući da je ATryn protein koji se injicira, bolesnici mogu razviti protutijela (proteine koji se proizvode kao odgovor na lijek), uz rizik od alergijske reakcije za vrijeme injiciranja.
English: The doctor needs to calculate the doses to use, based both on the patient's weight and on the level of antithrombin activity.
Croatian: Liječnik mora izračunati doze za primjenu na temelju težine bolesnika i razine aktivnosti antitrombina.
English: ATryn must not be used in people who may be hypersensitive (allergic) to goat proteins or goat milk.
Croatian: ATryn se ne smije primjenjivati u osoba koje mogu biti preosjetljive (alergične) na proteine koze ili kozje mlijeko.
English: ATryn is used in adults who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Croatian: ATryn se upotrebljava u odraslih osoba s „urođenim nedostatkom antitrombina” (naslijeđenom niskom razinom proteina antitrombina).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ATryn.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka ATryn.
English: What is the risk associated with ATryn?
Croatian: Koji su rizici povezani s lijekom ATryn?
English: It is used when the patients are having surgery, to prevent problems due to the formation of blood clots.
Croatian: Primjenjuje se kada bolesnici imaju operaciju kako bi se spriječili problemi uzrokovani stvaranjem krvnih ugrušaka.
English: What information is still awaited for ATryn?
Croatian: Koje se još informacije očekuju o lijeku ATryn?
English: In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
Croatian: Najčešće nuspojave lijeka ATryn tijekom ispitivanjima (zabilježene u između 1 i 10 na 100 bolesnika) bile su vrtoglavica, glavobolja, krvarenje (na mjestu injiciranja ili nakon zahvata), mučnina (osjećaj slabosti) i iscjedak iz rane (iscjedak iz kirurške rane).
English: However, this has not yet been seen in patients treated with ATryn.
Croatian: Međutim, takvi slučajevi još nisu zabilježeni u bolesnika liječenih lijekom ATryn.
English: Why has ATryn been approved?
Croatian: Zašto je ATryn odobren?
English: The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment.
Croatian: U ispitivanju se mjerilo koliko je bolesnika oboljelo od tromboze dubokih vena (DVT, stvaranje krvnog ugruška u dubokoj veni, obično u nogama) tijekom 30 dana nakon liječenja.
English: Other information about ATryn:
Croatian: Ostale informacije o lijeku ATryn
English: What is ATryn?
Croatian: Što je ATryn?
English: One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients).
Croatian: Jedno ispitivanje lijeka ATryn provedeno je na 14 bolesnika s urođenim nedostatkom antitrombina u dobi između 21 i 74 godine koji su bili izloženi riziku od stvaranja krvnih ugrušaka tijekom operacije (pet bolesnika) ili tijekom poroda (devet bolesnica).
English: Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots.
Croatian: Bolesnici koji imaju urođeni nedostatak antitrombina imaju niske razine antitrombina u krvi i stoga su izloženi većem riziku od stvaranja krvnih ugrušaka.
English: ATryn is a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: ATryn je prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Croatian: Antitrombin u tijelu onemogućuje djelovanje trombina, tvari koja ima središnju ulogu u procesu zgrušavanja krvi.
English: The Committee decided that ATryn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka ATryn nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
English: Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery.
Croatian: Promatrani zajedno, ti rezultati potvrđuju učinkovitost lijeka ATryn u sprečavanju stvaranja krvnih ugrušaka u bolesnika podvrgnutih operaciji.
English: In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn.
Croatian: U programu milosrdnog davanja nisu primijećeni krvni ugrušci u bolesnika koji su primali lijek ATryn.
English: The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine's marketing authorisation.
Croatian: Tvrtka koja proizvodi lijek ATryn dostavila je Agenciji rezultate ispitivanja u kojem se istraživala primjena lijeka ATryn tijekom poroda u žena s urođenim nedostatkom antitrombina te će podnijeti zahtjev da se liječenje tijekom poroda pridoda odobrenju za stavljanje lijeka u promet.
English: See the package leaflet for full instructions.
Croatian: Cjelovite upute potražite u uputi o lijeku.
English: What benefit has ATryn shown during the studies?
Croatian: Koje su koristi lijeka ATryn dokazane u ispitivanjima?
English: ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Croatian: ATryn nadomješćuje nedostatak antitrombina i omogućuje privremenu kontrolu poremećaja zgrušavanja krvi.
English: The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery.
Croatian: CHMP je zaključio da informacije koje je tvrtka dostavila dokazuju da se pri primjeni odgovarajuće doze lijeka ATryn tijekom operacije može postići zadovoljavajuća razina aktivnosti antitrombina.
English: Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency.
Croatian: Liječenje lijekom ATryn mora započeti isključivo liječnik s iskustvom u liječenju bolesnika s urođenim nedostatkom antitrombina.
English: It contains the active substance antithrombin alfa.
Croatian: Lijek sadrži djelatnu tvar antitrombin alfa.
English: The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Croatian: Djelatna tvar u lijeku ATryn, antitrombin alfa, kopija je antitrombina, prirodnog proteina u krvi koji se proizvodi „tehnologijom rekombinantne DNK”.
English: What is ATryn used for?
Croatian: Za što se ATryn koristi?
English: For the full list of side effects and restrictions with ATryn, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka ATryn potražite u uputi o lijeku.
English: How is ATryn used?
Croatian: Kako se ATryn koristi?
English: How does ATryn work?
Croatian: Kako djeluje ATryn?
English: Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.
Croatian: Procjenjuje se da od te bolesti boluje samo jedna na 3 000 do 5 000 osoba.
English: How has ATryn been studied?
Croatian: Kako je ATryn ispitivan?
English: ATryn is an anticlotting agent.
Croatian: ATryn je sredstvo za sprečavanje zgrušavanja krvi.
English: * Statistical testing was not performed due to small numbers for individual mutations.
Croatian: * Statističko testiranje nije provedeno zbog malog broja pojedinačnih mutacija.
English: Lift here to open
Croatian: Podići ovdje za otvaranje.
English: It contains important information about how to take these two medicines.
Croatian: Uputa sadrži važne informacije o tome kako uzimati ova dva lijeka.
English: As such, a risk to the newborns/infants cannot be excluded.
Croatian: Prema tome, ne može se isključiti rizik za novorođenče/dojenče.
English: The potential relevance of these findings in humans is unknown.
Croatian: Moguća važnost ovih nalaza u ljudi nije poznata.
English: • Loss of appetite
Croatian: • gubitak apetita
English: Median (min, max)
Croatian: Medijan (min, maks)
English: Currently available data are described in sections 4.4, 4.8 and 5.1, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.4, 4.8 i 5.1, međutim, nije moguće dati preporuku o doziranju.
English: • Ringing in the ears
Croatian: • zvonjava u ušima
English: Food or liquid should be at room temperature or below.
Croatian: Hrana ili tekućina trebaju biti na sobnoj temperaturi ili nižoj.
English: It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Croatian: Bolje je izbjegavati primjenu lijeka Kalydeco tijekom trudnoće, ako je to moguće, a liječnik će Vam pomoći da odlučite što je najbolje za Vas i Vaše dijete.
English: Use all 7 days' doses before starting a new wallet.
Croatian: Primijenite doze za svih 7 dana prije nego što načnete novi pretinac.
English: Mutation (n)
Croatian: Mutacija (n)
English: Ivacaftor does not bind to human red blood cells.
Croatian: Ivakaftor se ne veže za ljudske crvene krvne stanice.
English: Kalydeco is available in the following pack sizes:
Croatian: Kalydeco je dostupan u sljedećim veličinama pakiranja:
English: Take the tablets approximately 12 hours apart.
Croatian: Uzmite te tablete u razmaku od približno 12 sati.
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to treatment cannot be excluded.
Croatian: Iako su u nekim slučajevima bili prisutni drugi čimbenici rizika (kao što su primjena kortikosteroida i izloženost zračenju), mogući rizik koji se može pripisati liječenju ne može se isključiti.
English: Absolute change at week 24
Croatian: Apsolutna promjena u 24. tjednu
English: Kalydeco with food and drink
Croatian: Kalydeco s hranom i pićem
English: * Values based on data from a single patient; standard deviation not reported.
Croatian: * Vrijednosti se temelje na podacima dobivenim za jednog bolesnika; standardna devijacija nije navedena.
English: Interim analysis 1: December 2017 Interim analysis 2: December 2019 Interim analysis 3: December 2021 Final report: December 2023
Croatian: 1. interim analiza: prosinac 2017. 2. interim analiza: prosinac 2019. 3. interim analiza: prosinac 2021.
English: 25 kg or more
Croatian: 25 kg ili više
English: See the end of section 2 - Important information about the contents of Kalydeco.
Croatian: Pogledajte na kraju dijela 2 - Važne informacije o sastojcima lijeka Kalydeco.
English: If your child feels dizzy, it is advised that your child does not ride his/her bike or do anything else that needs his/her full attention.
Croatian: Ako Vaše dijete osjeti omaglicu, savjetuje se da ne vozi bicikl ili radi nešto drugo što zahtijeva njegovu potpunu pozornost.
English: For patients who rolled over from study 2 the number of events was, overall, low.
Croatian: U bolesnika koji su prebačeni iz ispitivanja 2, broj događaja bio je, sveukupno gledano, mali.
English: Patients should be instructed to swallow the tablets whole.
Croatian: Bolesnicima treba dati uputu da tablete progutaju cijele.
English: Total daily dose
Croatian: Ukupna dnevna doza
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova, testove funkcije jetre i promatranje kliničkog stanja bolesnika.
English: In such cases, the starting dose should be as above recommended, but administered every other day.
Croatian: U takvim slučajevima treba primijeniti gore preporučenu početnu dozu, ali svaki drugi dan.
English: What Kalydeco is and what it is used for 2.
Croatian: Što je Kalydeco i za što se koristi 2.
English: Therefore, no dose adjustment of oral contraceptives is necessary.
Croatian: Stoga nije potrebna prilagodba doze oralnih kontraceptiva.
English: The effect of food on ivacaftor absorption is similar for both formulations, i.e., tablets and granules.
Croatian: Učinak hrane na apsorpciju ivakaftora sličan je za obje formulacije, tj. tablete i granule.
English: Your child's doctor will determine the correct dose for your child.
Croatian: Djetetov liječnik odredit će pravu dozu za Vaše dijete.
English: If not immediately consumed, the mixture has been shown to be stable for one hour and therefore should be ingested during this period.
Croatian: Ako se ne uzme odmah, pokazalo se da je mješavina stabilna jedan sat i stoga je treba uzeti u tom vremenu.
English: Check with your child's doctor if you are not sure.
Croatian: Provjerite s djetetovim liječnikom ako niste sigurni.
English: Effect on liver function tests
Croatian: Učinak na testove jetrene funkcije
English: See section 4.5 for interactions with ciclosporin or tacrolimus.
Croatian: Vidjeti dio 4.5 za interakcije s ciklosporinom ili takrolimusom.
English: • Once mixed, give the product to your child immediately.
Croatian: • Nakon miješanja, lijek odmah dajte djetetu.
English: 4 years.
Croatian: 4 godine
English: Relative risk of pulmonary exacerbation
Croatian: Relativni rizik pogoršanja plućnih simptoma
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Croatian: M1 i M6 dva su glavna metabolita ivakaftora u ljudi.
English: There were no additional improvements in study 4 (week 48 through week 144).
Croatian: U ispitivanju 4 nije bilo dodatnih poboljšanja (od 48. tjedna do 144. tjedna).
English: Peri- and post-natal development
Croatian: Perinatalni i postnatalni razvoj
English: The median (range) tmax is approximately 4.0 (3.0; 6.0) hours in the fed state.
Croatian: Medijan (raspon) tmax iznosi približno 4,0 (3,0; 6,0) sati u sitom stanju.
English: Therefore, liver function tests are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
Croatian: Stoga se u svih bolesnika preporučuju pretrage funkcije jetre prije početka liječenja ivakaftorom, svaka 3 mjeseca u prvoj godini liječenja i jedanput godišnje nakon toga.
English: Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Croatian: Obroci ili međuobroci koji sadrže masti uključuju one pripremljene s maslacem ili uljem ili one koji sadrže jaja.
English: Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Croatian: Liječnik će razmotriti korist dojenja za dijete i korist terapije za Vas.
English: The major metabolites M1 and M6 accounted for approximately 65% of the total dose eliminated with 22% as M1 and 43% as M6.
Croatian: Glavni metaboliti M1 i M6 činili su približno 65% ukupne doze, pri čemu se 22% eliminiralo u obliku M1 a 43% u obliku M6.
English: As a precautionary measure, it is preferable avoid the use of Kalydeco during pregnancy.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lijeka Kalydeco tijekom trudnoće.
English: What Kalydeco is and what it is used for
Croatian: Što je Kalydeco i za što se koristi
English: There are no data available on the effect of ivacaftor on fertility in humans.
Croatian: Nema dostupnih podataka o učinku ivakaftora na plodnost u ljudi.
English: • Inner ear disorder (feeling dizzy or spinning)
Croatian: • poremećaj unutarnjeg uha (osjećaj omaglice ili vrtnje)
English: Dosing intervals should be modified according to clinical response and tolerability.
Croatian: Intervale doziranja treba prilagoditi prema kliničkom odgovoru i podnošljivosti.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što uzmete ovaj lijek.
English: If you feel dizzy, do not drive, cycle or use machines.
Croatian: Ako osjetite omaglicu, nemojte upravljati vozilom, voziti bicikl ni raditi sa strojevima.
English: Digoxin and other P-gp substrates
Croatian: Digoksin i drugi supstrati P-gp-a
English: Infants aged at least 6 months, toddlers, children, adolescents and adults should be dosed according to Table 1.
Croatian: Dojenčad u dobi od najmanje 6 mjeseci, mala djeca, djeca, adolescenti i odrasli trebaju primati doze prema preporukama u tablici 1.
English: Do not break, chew or dissolve the tablets.
Croatian: Nemojte lomiti, žvakati ili otapati tablete.
English: Similar results to part 1 were seen in part 2 of the study.
Croatian: Rezultati slični onima dobivenim u 1. dijelu opaženi su i u 2. dijelu ispitivanja.
English: Vertex Pharmaceuticals (Ireland) Limited
Croatian: DRUGO Vertex Pharmaceuticals (Ireland) Limited
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1 or OATP1B3.
Croatian: In vitro ispitivanja pokazala su da ivakaftor nije supstrat OATP1B1 ili OATP1B3.
English: No statistical analysis was conducted for subjects 12 to 17 years of age because only 2 patients were enrolled in this study.
Croatian: Statistička analiza ispitanika u dobi od 12 do 17 godina nije provedena jer su u to ispitivanje bila uključena samo 2 bolesnika.
English: Study 4: open-label extension study
Croatian: Ispitivanje 4: otvoreni produžetak ispitivanja
English: Do not use this medicine after the expiry date which is stated on the package after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
English: • Pain or discomfort in the upper right stomach (abdominal) area
Croatian: • bol ili nelagoda u gornjem desnom području trbuha
English: • This medicine has been prescribed for your child only.
Croatian: • Ovaj je lijek propisan samo Vašem djetetu.
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Croatian: Drugi lijekovi kojima izloženost može biti povećana uključuju glimepirid i glipizid; te je lijekove potrebno primjenjivati uz oprez.
English: The phase of the poly-T variant identified with the R117H mutation should be determined in accordance with local clinical recommendations.
Croatian: Fazu varijante poli-T identificirane kod mutacije R117H treba utvrditi u skladu s lokalnim kliničkim preporukama.
English: Do not give your child a double dose to make up for a forgotten dose.
Croatian: Nemojte djetetu dati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Following oral administration in healthy volunteers, the majority of ivacaftor (87.8%) was eliminated in the faeces after metabolic conversion.
Croatian: Nakon peroralne primjene u zdravih dobrovoljaca, veći dio ivakaftora (87,8%) eliminirao se stolicom nakon metaboličke konverzije.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kalydeco therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Kalydecom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Use within one hour after mixing, just before or after a fat-containing meal or snack.
Croatian: Primijenite u roku od jednog sata nakon miješanja, i to neposredno prije ili poslije obroka ili međuobroka koji sadrži masti.
English: Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Croatian: Mjere tercijarnih ishoda uključivale su mjere djelotvornosti kao što su fekalna elastaza-1 i parametri rasta.
English: Ivacaftor was permanently discontinued in one patient.
Croatian: Primjena ivakaftora trajno je prekinuta u jednog bolesnika.
English: • Yellowing of the skin or the white part of the eyes
Croatian: • žuta boja kože ili bjeloočnica
English: Side effects seen in children and adolescents are similar to those observed in adults.
Croatian: Nuspojave primijećene u djece i adolescenata slične su onima opaženima u odraslih.
English: * Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Croatian: * Terapija se provodila tijekom slijepog, kontroliranog ispitivanja faze III u trajanju od 48 tjedana.