FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single subcutaneous administration (0.4 mg/kg up to a maximum of 30 mg), the time to maximum concentration is approximately 30 minutes and the terminal half-life is about 2 hours.
Croatian: Nakon jedne supkutane primjene (0,4 mg/kg do najviše 30 mg), vrijeme do maksimalne koncentracije približno je 30 minuta, a terminalni poluvijek je približno 2 sata.
English: For patients who have never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician.
Croatian: Za bolesnike koji nikad prije nisu primali Firazyr, prvo liječenje treba provesti u zdravstvenoj ustanovi ili pod nadzorom liječnika.
English: Icatibant had no effect on the fertility of male mice and rats (see section 5.3).
Croatian: Ikatibant nije imao nikakav učinak na plodnost mužjaka miševa i štakora (vidjeti dio 5.3).
English: Icatibant did not elicit any cardiac conduction change in vitro (hERG channel) or in vivo in normal dogs or in various dog models (ventricular pacing, physical exertion and coronary ligation) where no associated hemodynamic changes were observed.
Croatian: Ikatibant nije izazvao promjene srčanog provođenja in vitro (hERG kanal) ili in vivo kod normalnih pasa ili kod različitih modela pasa (ventrikularni ritam, fizički napor i koronarna ligacija) ondje gdje nisu primijećene nikakve povezane hemodinamičke promjene.
English: This area should be at least 5 cm (2 inches) away from any scars.
Croatian: To bi područje trebalo biti najmanje 5 cm udaljeno od bilo kakvog ožiljka.
English: (Common, ≥1/100 to <1/10)
Croatian: (Često, ≥1/100 do <1/10)
English: No clinically significant changes in reproductive hormones were observed during clinical studies.
Croatian: Tijekom kliničkih ispitivanja nisu zapažene klinički značajne promjene u reproduktivnim hormonima.
English: Each Firazyr syringe is intended for single use only.
Croatian: Svaka štrcaljka lijeka Firazyr namijenjena je samo za jednokratnu uporabu.
English: • Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site.
Croatian: • Držeći štrcaljku u jednoj ruci, upotrijebite drugu ruku kako biste lagano primili nabor kože između palca i prstiju na prethodno dezinficiranom mjestu primjene injekcije
English: Some of the side effects connected with Firazyr are similar to the symptoms of your disease.
Croatian: Neke nuspojave povezane s Firazyrom slične su simptomima
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Učestalost nuspojava navedenih u tablici 1 definirana je pomoću sljedećih razreda: Vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000).
English: Icatibant is extensively metabolized by proteolytic enzymes to inactive metabolites that are primarily excreted in the urine.
Croatian: Ikatibant se u velikoj mjeri metabolizira pomoću proteolitičkih enzima u neaktivne metabolite koji se prvenstveno izlučuju putem urina.
English: The relevance of this to the safety of Firazyr is unknown (see section 5.2).
Croatian: Nije poznato koliko je to značajno za sigurnost primjene Firazyra (vidjeti dio 5.2).
English: • Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
Croatian: • Držite štrcaljku u jednoj ruci između dva prsta, a palac postavite na donji dio potisnog klipa
English: There were no significant effects of icatibant on the concentration of luteal phase progesterone and luteal function, or on menstrual cycle length in females and there were no significant effects of icatibant on sperm count, motility and morphology in males.
Croatian: Nije bilo značajnih učinaka ikatibanta na koncentraciju progesterona lutealne faze i lutealnu funkciju, ili na duljinu menstrualnog ciklusa kod žena, a nije bilo ni značajnih učinaka ikatibanta na broj, motilitet i morfologiju spermija kod muškaraca.
English: Table 1: Dosage regimen for children and adolescents Body Weight
Croatian: Tablica 1: Shema doziranja za djecu i adolescente Tjelesna težina
English: Similar effects of icatibant on reproductive tissue were seen in sexually mature rats and dogs.
Croatian: Slični učinci ikatibanta na reproduktivno tkivo uočeni su kod spolno zrelih štakora i pasa.
English: Firazyr is intended for subcutaneous injection (under the skin).
Croatian: Firazyr je namijenjen za supkutanu injekciju (pod kožu).
English: It is important that Firazyr is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema.
Croatian: Važno je da Firazyr ubrizgate supkutano (pod kožu) čim primijetite napadaj angioedema.
English: No effects were detected in the post-natal development of rat pups.
Croatian: Nisu uočeni nikakvi učinci na postnatalni razvoj mladunaca štakora.
English: A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies.
Croatian: Ukupno 32 pedijatrijska bolesnika (8 djece u dobi od 2 do 11 godina i 24 adolescenata u dobi od 12 do 17 godina) s nasljednim angioedemom izloženo je liječenju s ikatibantom tijekom kliničkih ispitivanja.
English: Subsequent episodes of HAE were treated in an open label extension.
Croatian: Kasnije epizode HAE liječene su u otvorenom produžetku ispitivanja.
English: In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional.
Croatian: U kliničkim ispitivanjima korištenim za registraciju, ukupno 999 napadaja nasljednog angioedema (HAE) liječeno je s 30 mg Firazyra koji je potkožno primijenio zdravstveni radnik.
English: Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
Croatian: Odmah obavijestite liječnika ako primijetite da se simptomi napadaja bolesti pogoršavaju nakon primanja Firazyra.
English: • Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop appears on the tip of the needle.
Croatian: • Pobrinite se da u štrcaljki ne bude mjehurića zraka tako što ćete pritiskati potisni klip sve dok se na vrhu igle ne pojavi prva kap.
English: The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below).
Croatian: Potreban volumen za injekciju, u ml, treba uvući u praznu graduiranu štrcaljku od 3 ml (vidjeti tablicu u nastavku).
English: These effects are usually mild and clear up without the need for any additional treatment.
Croatian: Te nuspojave obično su blage i nestaju bez potrebe za dodatnim liječenjem.
English: Adults The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg.
Croatian: Preporučena doza u odraslih je jedna supkutana injekcija Firazyra od 30 mg.
English: What you need to know before you use Firazyr 3.
Croatian: Što morate znati prije nego počnete primjenjivati Firazyr
English: Firazyr contains a small amount of sodium
Croatian: Firazyr sadržava malu količinu natrija
English: • Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin fold.
Croatian: • Držite nabor kože, prinesite štrcaljku koži i brzo uvedite iglu u nabor kože
English: Abnormal liver function test
Croatian: Abnormalni nalazi testova procjene funkcije jetre
English: Firazyr is not known to interact with other medicines.
Croatian: Nisu poznate interakcije Firazyra s drugim lijekovima.
English: In a 2 year study to evaluate the carcinogenic potential of icatibant in rats, daily doses giving exposure levels up to approximately 2-fold that achieved after a therapeutic dose in humans had no effect on the incidence or morphology of tumours.
Croatian: U dvogodišnjem ispitivanju procjene kancerogenog potencijala ikatibanta u štakora, dnevne doze s približno dvostrukim razinama izloženosti koje su postignute nakon terapijske doze u ljudi nisu utjecale na incidenciju ili morfologiju tumora.
English: In the first 15 Firazyr treated attacks (1,114 doses for 1,030 attacks), the median times to onset of symptom relief were similar across attacks (2.0 to 2.5 hours).
Croatian: U prvih 15 napadaja liječenih lijekom Firazyr (1114 doza za 1030 napadaja), medijan vremena do početka ublažavanja simptoma bio je sličan u svim napadajima (2,0 do 2,5 sata).
English: - See section on instructions for use for the dose to inject.
Croatian: - Vidjeti dio o uputama za uporabu za informacije o dozi koju je potrebno ubrizgati.
English: These tissue findings were consistent with reported effects on gonadotrophins and during the subsequent treatment-free period appear to be reversible.
Croatian: Ti tkivni nalazi bili su u skladu s prijavljenim učincima gonadotropina, a tijekom kasnijeg razdoblja bez terapije pokazali su se reverzibilnima.
English: Table 4 shows the efficacy results for FAST-3.
Croatian: U tablici 4 prikazani su rezultati djelotvornosti za FAST-3.
English: If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr.
Croatian: Ako dojite, ne biste trebali dojiti 12 sati nakon posljednjeg primanja Firazyra.
English: Icatibant has been shown to aggravate induced cardiac ischemia in several non-clinical models, although a detrimental effect has not consistently been shown in acute ischemia.
Croatian: Pokazalo se da ikatibant pogoršava induciranu ishemiju srca u nekoliko nekliničkih modela, iako nije uvijek uočen štetan utjecaj kod akutne ishemije.
English: Eleven patients were of prepubertal status and 21 patients were either pubertal or postpubertal.
Croatian: Jedanaest bolesnika bilo je u predpubertetu, a 21 bolesnik bio je u pubertetu ili u postpubertetu.
English: The pre-filled icatibant syringe and all other components are for single use only.
Croatian: Napunjena štrcaljka ikatibanta i sve druge komponente namijenjene su samo za jednokratnu uporabu.
English: The following step-by step instructions are intended for: - self-administration (adults) - administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg).
Croatian: Sljedeće upute po koracima namijenjene su: - Samostalnoj primjeni lijeka (odrasli) - Primjeni od strane njegovatelja ili zdravstvenog radnika u odraslih, adolescenata ili djece od navršene 2. godine nadalje (s tjelesnom težinom od najmanje 12 kg).
English: Remove the needle cap from the blister.
Croatian: Izvadite kapicu igle iz blistera.
English: The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.
Croatian: Preporučena doza lijeka Firazyr na temelju tjelesne težine u djece i adolescenata (u dobi od 2 do 17 godina) navedena je u tablici 1 u nastavku.
English: In case of insufficient relief or recurrence of symptoms after self-treatment or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice.
Croatian: U slučaju nedovoljnog povlačenja simptoma ili povratka simptoma nakon samostalne primjene lijeka od strane bolesnika ili primjene od strane njegovatelja, preporučuje se da bolesnik ili njegovatelj potraži liječnički savjet.
English: Overall, the median time to minimal symptoms (earliest time post treatment when all symptoms were either mild or absent) was 1.1 hours (95% confidence interval, 1.0-2.0 hours).
Croatian: Ukupno, medijan vremena do minimalnih simptoma (najranije vrijeme nakon liječenja kada su svi simptomi bili blagi ili odsutni) bio je 1,1 sat (95%-tni interval pouzdanosti, 1,0-2,0 sata).
English: Remove the seal from the needle cap (the needle should be still in the needle cap).
Croatian: Uklonite zaštitnu foliju s kapice igle (igla i dalje treba biti u kapici igle).
English: All needles and syringes should be disposed of in a sharps container.
Croatian: Sve igle i štrcaljke trebaju biti odložene u spremnik za oštre predmete.
English: Firazyr is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Croatian: Djeca i adolescenti Firazyr se ne preporučuje za primjenu u djece mlađe od 2 godine ili tjelesne težine manje od 12 kg jer nije ispitan u tih bolesnika.
English: The instructions include the following main steps:
Croatian: Upute uključuju sljedeće glavne korake: 1) Opće informacije
English: Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Croatian: 50 - 58 Baggot Street Lower Dublin 2
English: One Firazyr-treated patient tested positive for anti-icatibant antibodies before and after treatment with Firazyr.
Croatian: Jedan bolesnik liječen Firazyrom na testu je bio pozitivan na antiikatibant protutijela prije i nakon liječenja Firazyrom.
English: 3) Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe.
Croatian: 3) Nastavite gurati klip napunjene štrcaljke dok potreban volumen injekcije (doza) nije prešao u graduiranu štrcaljku.
English: Phase III clinical studies (FAST-1 and FAST-2) were randomized, double-blind, controlled trials and had identical designs except for the comparator (one with oral tranexamic acid as the comparator and one placebo controlled).
Croatian: Klinička ispitivanja faze III (FAST-1 i FAST-2) bila su randomizirana, dvostruko slijepa, kontrolirana ispitivanja s identičnim dizajnom, osim u slučaju komparatora (jedno je kao komparator imalo peroralno primijenjenu traneksamsku kiselinu, a drugo je bilo kontrolirano placebom).
English: Number of subjects in ITT Population 36
Croatian: Broj ispitanika u ITT populaciji
English: Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home.
Croatian: Bolesnici koji dožive laringealni napadaj trebaju uvijek potražiti liječnički savjet i otići na promatranje u zdravstvenu ustanovu i nakon primjene injekcije kod kuće.
English: • Discard the syringe, needle and needle cap into the sharp container for throwing away waste that might hurt others if not handled properly.
Croatian: • Bacite štrcaljku, iglu i kapicu igle u posudu za oštre predmete predviđenu za otpadni materijal koji bi mogao ozlijediti druge ako se ne zbrine na odgovarajući način.
English: Efficacy results for FAST-1 and FAST-2
Croatian: Tablica 3. Rezultati djelotvornosti za FAST-1 i FAST-2
English: A total of 66 patients with attacks of HAE affecting the larynx were treated in these controlled Phase III clinical trials.
Croatian: Ukupno 66 bolesnika s napadajima nasljednog angioedema (HAE) koji je zahvatio grkljan liječeno je u ovim kontroliranim kliničkim ispitivanjima faze III.
English: - If you experience no relief of symptoms after 6 hours, you should seek medical advice regarding additional injections of Firazyr.
Croatian: - Ako ne dođe do ublažavanja simptoma nakon 6 sati, trebate potražiti liječnički savjet u vezi s dodatnim injekcijama Firazyra.
English: In a study of 39 healthy adult men and women treated with 30 mg every 6 hours for 3 doses every 3 days for a total of 9 doses, there were no clinically significant changes from baseline in basal and GnRH-stimulated concentration of reproductive hormones in either females or males.
Croatian: U ispitivanju provedenom na 39 zdravih odraslih muškaraca i žena koji su dobivali 30 mg lijeka svakih 6 sati, i to 3 doze svaka 3 dana, što je ukupno 9 doza, nije bilo klinički značajnih promjena u odnosu na početnu vrijednost bazalne i GnRh-om stimulirane koncentracije reproduktivnih hormona ni kod žena ni kod muškaraca.
English: - Immediately after you self-inject Firazyr or your caregiver injects you with Firazyr while you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution.
Croatian: - Odmah nakon što samostalno ubrizgate Firazyr ili Vam njegovatelj da injekciju Firazyra u trenutku kad imate laringealni napadaj (opstrukciju gornjih dišnih puteva), morate potražiti liječničku pomoć u zdravstvenoj ustanovi.
English: Where the required dose is less than 30 mg (3 ml), the following equipment is required to extract and administer the appropriate dose:
Croatian: Kada je potrebna doza niža od 30 mg (3 ml), potrebna je sljedeća oprema za uzimanje i primjenu odgovarajuće doze:
English: A total of 237 patients were treated with 1,386 doses of 30 mg icatibant for 1,278 attacks of acute HAE.
Croatian: Ukupno 237 bolesnika primilo je 1386 doza od 30 mg ikatibanta u slučaju 1278 napadaja akutnog HAE.
English: Transaminases increased
Croatian: Povećane transaminaze
English: * Injection site bruising, Injection site hematoma, Injection site burning, Injection site erythema, Injection site hypoesthesia, Injection site irritation, Injection site numbness, Injection site edema, Injection site pain, Injection site pressure sensation, Injection site pruritus, Injection site swelling, Injection site urticaria, and Injection site warmth.
Croatian: * Modrice na mjestu injiciranja, hematom na mjestu injiciranja, osjećaj žarenja na mjestu injiciranja, eritem na mjestu injiciranja, hipoestezija na mjestu injiciranja, iritacija na mjestu injiciranja, obamrlost na mjestu injiciranja, edem na mjestu injiciranja, bol na mjestu injiciranja, osjećaj pritiska na mjestu injiciranja, pruritus na mjestu injiciranja, oticanje na mjestu injiciranja, urtikarija na mjestu injiciranja i osjećaj topline na mjestu injiciranja.
English: Injection Volume
Croatian: Volumen injekcije
English: These symptoms may occur as a result of an attack of HAE.
Croatian: Ovi simptomi mogu se pojaviti kao posljedica napadaja nasljednog angioedema.
English: Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using Firazyr.
Croatian: Nemojte upravljati vozilima ili raditi na strojevima ako osjećate umor ili omaglicu kao posljedicu napadaja nasljednog angioedema (HAE) ili nakon primjene Firazyra.
English: The treatment effect of icatibant was confirmed by secondary efficacy endpoints.
Croatian: Terapijski učinak ikatibanta potvrđen je sekundarnim ishodima djelotvornosti.
English: Icatibant is a potent antagonist of bradykinin and therefore, at high dose levels, treatment can have effects on the uterine implantation process and subsequent uterine stability in early pregnancy.
Croatian: Ikatibant je učinkovit antagonist bradikinina i zbog toga, visoke doze lijeka mogu utjecati na proces implantacije u maternici i kasniju stabilnost maternice u ranoj trudnoći.
English: In healthy young subjects, icatibant administered in doses of 0.8 mg/kg over 4 hours; 1.5 mg/kg/day or 0.15 mg/kg/day for 3 days, development of bradykinin-induced hypotension, vasodilatation and reflex tachycardia was prevented.
Croatian: Kod zdravih mladih ispitanika, u slučaju primjene ikatibanta u dozama od 0,8 mg/kg kroz 4 sata, 1,5 mg/kg/dan ili 0,15 mg/kg/dan u razdoblju od 3 dana, spriječen je razvoj hipotenzije inducirane bradikininom, vazodilatacije i refleksne tahikardije.
English: These reactions were erythema, swelling, burning and warm sensation.
Croatian: Te su reakcije bile eritem, oticanje, osjećaj pečenja i topline.
English: In the majority of cases a single injection of Firazyr is sufficient to treat an attack.
Croatian: U većini slučajeva za liječenje napadaja dovoljna je jedna injekcija Firazyra.
English: The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side.
Croatian: Mjesto primjene injekcije treba biti nabor kože na trbuhu otprilike 5-10 cm ispod pupka na bilo kojoj strani.
English: A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects.
Croatian: Doza od 3,2 mg/kg primijenjena intravenski (otprilike 8 puta terapijska doza) uzrokovala je prolazni eritem, svrbež, navale crvenila ili hipotenziju kod zdravih ispitanika.
English: • Choose the injection site.
Croatian: • Odaberite mjesto primjene injekcije.
English: In an integrated analysis of these controlled Phase III studies, the time to onset of symptom relief and time to onset of primary symptom relief were similar regardless of age group, sex, race, weight or whether or not the patient used androgens or antifibrinolytic agents.
Croatian: U integriranoj analizi ovih kontroliranih ispitivanja faze III vrijeme do početka ublažavanja simptoma i vrijeme do početka ublažavanja primarnog simptoma bilo je slično neovisno o dobnoj skupini, spolu, rasi, tjelesnoj težini ili tome je li bolesnik koristio androgene ili antifibrinolitička sredstva.
English: Firazyr was administered by subcutaneous injection at a dose of 0.4 mg/kg based on body weight to a maximum dose of 30 mg.
Croatian: Firazyr je primijenjen supkutanom injekcijom pri dozi od 0,4 mg/kg na temelju tjelesne težine do maksimalne doze od 30 mg.
English: Refer to table 1 for dosage information.
Croatian: Vidjeti tablicu 1 za informacije o doziranju.
English: Across repeated treatment in adults in the controlled phase III trials, transient positivity to antiicatibant antibodies was observed in rare cases.
Croatian: Tijekom opetovanog liječenja odraslih osoba u kontroliranim ispitivanjima faze III u rijetkim je slučajevima primijećena prolazna pozitivnost na anti-ikatibant protutijela.
English: • Screw the syringe on the needle still fixed in the needle cap.
Croatian: • Zavrnite štrcaljku na iglu koja je i dalje fiksirana u kapici igle.
English: An open label, non-randomised single-arm study (HGT-FIR-086) was performed with a total of 32 patients.
Croatian: Nerandomizirano, otvoreno ispitivanje jedne skupine (HGT-FIR-086) provedeno je s ukupno 32 bolesnika.
English: Injection site reactions*
Croatian: Reakcije na mjestu injiciranja*
English: Icatibant was shown to be a competitive antagonist when the bradykinin challenge dose was increased 4-fold.
Croatian: Pokazalo se da je ikatibant kompetitivni antagonist kad je testna doza bradikinina četverostruko povećana.
English: Elderly people have been shown to have increased systemic exposure to icatibant.
Croatian: Pokazalo se da je kod starijih osoba povećana sistemska izloženost ikatibantu.
English: The results were similar to patients with non-laryngeal attacks of HAE with respect to time to onset of symptom relief.
Croatian: Rezultati su bili slični onima kod bolesnika s nelaringealnim napadajima HAE kad je riječ o vremenu do početka ublažavanja simptoma.
English: • Withdraw the required volume of icatibant solution.
Croatian: • Izvucite potreban volumen otopine ikatibanta.
English: Overall the median time to onset of symptom relief was 1.0 hour (95% confidence interval, 1.0-1.1 hours).
Croatian: Ukupno medijan vremena do početka ublažavanja simptoma bio je 1,0 sati (95%-tni interval pouzdanosti, 1,0-1,1 sat).
English: In both rats and dogs, there was a dose-related reduction in circulating sex hormone levels and the repeated use of icatibant reversibly delayed sexual maturation.
Croatian: I kod štakora i kod pasa došlo je do smanjenja razina spolnih hormona u cirkulaciji povezanog s dozom, a ponavljana primjena ikatibanta reverzibilno je odgodila spolno sazrijevanje.
English: Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
Croatian: Firazyr je indiciran za simptomatsko liječenje akutnih napadaja nasljednog (hereditarnog) angioedema (HAE) kod odraslih osoba, adolescenata i djece od navršene 2. godine, koji imaju nedostatak inhibitora C1-esteraze.
English: Do not pull up on the plunger.
Croatian: Nemojte povlačiti potisni klip.
English: Table 1: Dosage regimen for paediatric patients Body Weight
Croatian: Tablica 1: Shema doziranja za pedijatrijske bolesnike Tjelesna težina