FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 130 patients were randomized to receive either a 30 mg dose of icatibant (63 patients) or comparator (either tranexamic acid, - 38 or placebo - 29 patients).
Croatian: Ukupno 130 bolesnika slučajnim je odabirom primilo dozu od 30 mg ikatibanta (63 bolesnika) ili komparator (traneksamsku kiselinu, - 38 ili placebo - 29 bolesnika).
English: All patients received at least one dose of icatibant (0.4mg/kg body weight up to a maximum dose of 30 mg) and the majority of patients were followed up for a minimum of 6 months.
Croatian: Svi su bolesnici dobili najmanje jednu dozu ikatibanta (0,4 mg/kg tjelesne težine do najviše doze od 30 mg) i većina bolesnika praćena je najmanje 6 mjeseci.
English: Carefully attach the needle to the syringe containing the colourless solution.
Croatian: Pažljivo pričvrstite iglu na štrcaljku s bezbojnom otopinom.
English: The pharmacokinetics of icatibant were characterized in paediatric HAE patients in study HGT-FIR086 (see section 5.1).
Croatian: Farmakokinetika ikatibanta bila je karakterizirana u pedijatrijskih bolesnika s nasljednim angioedema u ispitivanju HGT-FIR-086 (vidjeti dio 5.1).
English: 3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
Croatian: 3 ml otopine u napunjenoj štrcaljki od 3 ml (staklo tipa I) s čepom klipa (bromobutil obložen polimerom fluorougljika).
English: Median time to onset of symptom relief: all symptoms (hours): Abdominal pain Skin swelling Skin pain
Croatian: Medijan do početka ublažavanja simptoma: svi simptomi (sati): Bol u trbuhu Oticanje kože Bol na koži
English: These uterine effects also manifest in late stage pregnancy where icatibant exhibits a tocolytic effect resulting in delayed parturition in the rat, with increased fetal distress and perinatal death at high doses (10 mg/kg/day).
Croatian: Ti utjecaji na maternicu manifestiraju se i u kasnom stadiju trudnoće gdje ikatibant ima tokolitički učinak, što dovodi do odgođenog okota kod štakora uz povećani fetalni distres i perinatalnu smrt pri visokim dozama (10 mg/kg/dan).
English: Rash Erythema Pruritus
Croatian: Osip Eritem Pruritus
English: The primary endpoint was time to onset of symptom relief assessed using a 3-item composite visual analog score (VAS-3) consisting of assessments of skin swelling, skin pain, and abdominal pain.
Croatian: Primarni ishod bilo je vrijeme do početka ublažavanja simptoma procijenjeno pomoću kompozitne vizualne analogne skale s tri stavke (VAS-3) koja se sastoji od procjene oticanja kože, bolova na koži i bolova u trbuhu.
English: There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.
Croatian: Ograničeno je iskustvo s primjenom lijeka Firazyr u liječenju više od jednog napadaja nasljednog angioedema u pedijatrijskoj populaciji.
English: In these studies, patients on icatibant had a faster median time to onset of symptom relief (2.0, 2.5 and 2.0 hours, respectively) compared to tranexamic acid (12.0 hours) and placebo (4.6 and 19.8 hours).
Croatian: U ovim ispitivanjima kod bolesnika koji su primili ikatibant zabilježeno je prosječno brže vrijeme do početka ublažavanja simptoma (2,0, 2,5 i 2,0 sati, tim redoslijedom), u usporedbi s traneksamskom kiselinom (12,0 sati) i placebom (4,6 i 19,8 sati).
English: Adrenal gland hypertrophy was observed at all doses tested in rats.
Croatian: Hipertrofija nadbubrežnih žlijezdi primijećena je kod svih doza ispitanih na štakorima.
English: Patients with symptoms of laryngeal angioedema received open label treatment with icatibant.
Croatian: Bolesnici sa simptomima laringealnog angioedema primili su otvorenu terapiju ikatibantom.
English: Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke.
Croatian: Shodno tomu, potreban je oprez pri davanju ikatibanta bolesnicima u tjednima nakon moždanog udara.
English: The pharmacokinetic profile of icatibant in patients with HAE is similar to that in healthy volunteers.
Croatian: Farmakokinetički profil ikatibanta kod bolesnika s nasljednim angioedemom (HAE) sličan je onomu kod zdravih dobrovoljaca.
English: No clinical information on overdose is available.
Croatian: Nema dostupnih kliničkih podataka o predoziranju.
English: Common (may affect up to 1 in 10 people) : Feeling sick
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): Mučnina
English: In the clinical trials, not more than 8 injections of Firazyr per month have been administered.
Croatian: U kliničkim ispitivanjima nije dano više od 8 injekcija Firazyra u jednom mjesecu.
English: • Slowly push the plunger of the syringe with a steady hand until all the fluid is injected into the skin and no liquid remains in the syringe.
Croatian: • Mirnom rukom polako gurajte potisni klip štrcaljke sve dok sva tekućina ne bude ubrizgana pod kožu i štrcaljka ne ostane prazna
English: In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
Croatian: Kod nasljednog angioedema (HAE) u Vašem su krvotoku povećane razine tvari koja se naziva bradikinin, što dovodi do simptoma kao što su oticanje, bol, mučnina i proljev.
English: Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of Firazyr.
Croatian: Iscrpljenost, letargija, umor, pospanost i omaglica zabilježeni su nakon primjene Firazyra.
English: Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml.
Croatian: Firazyr se isporučuje kao bistra, bezbojna otopina za injekciju u napunjenoj staklenoj štrcaljki od 3 ml.
English: Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses).
Croatian: Trideset i jedan bolesnik dobio je jednu dozu ikatibanta i 1 bolesnik (adolescent) primio je ikatibant za dva napadaja nasljednog angioedema (ukupno dvije doze).
English: The efficacy population consisted of 22 patients who had been treated with icatibant (11 prepubertal and 11 pubertal/postpubertal) for HAE attack.
Croatian: Populacija u procijeni djelotvornosti sastojala se od 22 bolesnika liječena ikatibantom (11 u predpubertetu i 11 u pubertetu/postpubertetu) kod napadaja nasljednog angioedema.
English: 2) If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).
Croatian: 2) Ako otopina ikatibanta ne počinje prelaziti u graduiranu štrcaljku, nježno povucite klip graduirane štrcaljke dok otopina ikatibanta ne počne ulaziti u graduiranu štrcaljku (vidjeti sliku u nastavku).
English: Firazyr is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.
Croatian: Firazyr je dostupan kao jednostruko pakiranje koje sadržava jednu napunjenu štrcaljku s jednom iglom ili kao višestruko pakiranje koje sadržava tri napunjene štrcaljke s tri igle.
English: In HAE increased bradykinin concentrations are the key mediator in the development of the clinical symptoms.
Croatian: Kod HAE, povećane koncentracije bradikinina ključni su posrednik u razvoju kliničkih simptoma.
English: Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE.
Croatian: Zdravstveni radnik primijenio je Firazyr od 30 mg s.c. na 129 zdravih ispitanika i 236 bolesnika s nasljednim angioedemom (HAE).
English: Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2.
Croatian: Ishemijska bolest srca U ishemijskim uvjetima, propadanje srčane funkcije i smanjenje koronarnog protoka krvi mogli bi se teoretski javiti kao posljedica antagoniziranja bradikininskog receptora tipa
English: 2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less:
Croatian: 2a) Priprema štrcaljke za djecu i adolescente (2-17 godina) s tjelesnom težinom do 65 kg:
English: Icatibant had no effect on the fertility of male mice (top dose 80.8 mg/kg/day) and rats (top dose 10 mg/kg/day).
Croatian: Ikatibant nije imao nikakav učinak na plodnost mužjaka miševa (najveća doza 80,8 mg/dan) i štakora (najveća doza 10 mg/kg/dan).
English: Patients were randomized to receive either icatibant 30 mg or placebo by subcutaneous injection.
Croatian: Bolesnici su randomizirani za primanje 30 mg ikatibanta ili placebo supkutanom injekcijom.
English: Population pharmacokinetic modelling using both adult and paediatric data showed that clearance of icatibant is related to body weight with lower clearance values noted for lower body weights in the paediatric HAE population.
Croatian: Populacijsko farmakokinetičko modeliranje, koristeći podatke iz odrasle i pedijatrijske populacije, pokazalo je da je klirens ikatibanta povezan s tjelesnom težinom, a niže vrijednosti klirensa zabilježene su kod niže tjelesne težine u pedijatrijskoj populaciji s nasljednim angioedemom.
English: A subset of patients in this study experienced acute HAE attacks while receiving androgens, antifibrinolytic agents or Cl inhibitors.
Croatian: Podskupina bolesnika u ovom ispitivanju imala je akutne napadaje HAE dok je primala androgene, antifibrinolitička sredstva ili inhibitore C1.
English: Firazyr is intended for use under the guidance of a healthcare professional.
Croatian: Firazyr je namijenjen primjeni pod nadzorom zdravstvenog radnika.
English: 3) Preparing the injection site
Croatian: 3) Priprema mjesta primjene injekcije
English: The majority of paediatric patients who were treated with subcutaneous icatibant experienced injection site reactions such as erythema, swelling, burning sensation, skin pain and itching/pruritus; these were found to be mild to moderate in severity and consistent with reactions that have been reported in adults.
Croatian: Većina pedijatrijskih bolesnika liječenih supkutano primijenjenim ikatibantom imali su reakcije na mjestu injiciranja kao što su eritem, oticanje, osjećaj pečenja, bol na koži i svrbež/pruritus; ustanovilo se da su te reakcije bile blage do umjerene po težini i da su odgovarale reakcijama koje su prijavljivane u odraslih bolesnika.
English: • Release the skin fold and gently pull the needle out.
Croatian: • Otpustite nabor kože i lagano izvucite iglu
English: There are no observed differences in the exposure to icatibant between HAE patients with and without an attack.
Croatian: Nema zapaženih razlika u izloženosti ikatibantu između bolesnika s nasljednim angioedemom sa ili bez napadaja.
English: The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Croatian: Drugi sastojci su natrijev klorid, ledena acetatna kiselina, natrijev hidroksid i voda za injekciju.
English: Based on modelling for weight banded dosing, the predicted exposure to icatibant in the paediatric HAE population (see section 4.2) is lower than the observed exposure in studies conducted with adult HAE patients.
Croatian: Na temelju modeliranja za doziranje prema skupinama tjelesne težine, predviđena izloženost ikatibantu u pedijatrijskoj populaciji s nasljednim angioedemom (vidjeti dio 4.2) niža je od opažene izloženosti u ispitivanjima koja su provedena u odraslih bolesnika s nasljednim angioedemom.
English: Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
Croatian: Firazyr blokira djelovanje bradikinina i tako prekida daljnje napredovanje simptoma napadaja nasljednog angioedema.
English: Your healthcare provider will teach you and your caregiver how to safely inject Firazyr by following the instructions in the Package Leaflet.
Croatian: Liječnik će podučiti Vas ili Vašeg njegovatelja kako sigurno ubrizgati Firazyr pridržavajući se uputa o lijeku.
English: • Grip the syringe firmly.
Croatian: • Čvrsto držite štrcaljku.
English: 3) Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.
Croatian: 2) Zavijte adapter na napunjenu štrcaljku 3) Spojite graduiranu štrcaljku na drugi kraj adaptera pritom pazeći da su oba spoja dobro pričvršćena.
English: In addition: - You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with Firazyr.
Croatian: Osim toga: - Vi ili Vaš njegovatelj morate proći obuku iz tehnike davanja supkutane (potkožne) injekcije prije nego što samostalno ubrizgate ili primite od njegovatelja Firazyr.
English: A 2-week subcutaneous dose range finding study in juvenile rats identified 25 mg/kg/day as a maximally tolerated dose.
Croatian: U dvotjednom ispitivanju za utvrđivanje raspona supkutane doze u juvenilnih štakora, doza od 25 mg/kg/dan utvrđena je kao maksimalna podnošljiva doza.
English: HAE (an autosomal dominant disease) is caused by an absence or dysfunction of C1-esteraseinhibitor.
Croatian: Nasljedni (hereditarni) angioedem ili HAE je autosomno dominantna bolest koju uzrokuje nedostatak ili disfunkcija inhibitora C1-esteraze.
English: Solution for injection Multipack containing three pre-filled syringes and three 25G needles
Croatian: Otopina za injekciju Višestruko pakiranje koje sadržava tri napunjene štrcaljke i tri igle 25 G
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER TRAY LID}
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {POKLOPAC BLISTER PAKIRANJA}
English: If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse
Croatian: Ako niste sigurni koji volumen otopine izvući, pitajte svog liječnika, ljekarnika ili medicinsku sestru
English: Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy).
Croatian: Firazyr se ubrizgava kratkom iglom u potkožno masno tkivo abdomena (trbuha).
English: • 3 ml (recommended) graduated syringe
Croatian: • Graduirana štrcaljka od 3 ml (preporučena)
English: Do not use this medicine after the expiry date stated on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe.
Croatian: Bolesnike s laringealnim napadajima treba nakon davanja injekcije liječiti u odgovarajućoj zdravstvenoj ustanovi sve dok liječnik ne procijeni da ih je sigurno otpustiti.
English: Efficacy results for FAST-3 Efficacy Results: FAST-3; Controlled Phase -- ITT population
Croatian: Tablica 4. Rezultati djelotvornosti za FAST-3 Rezultati djelotvornosti: FAST-3; Kontrolirana fazaPopulacija s namjerom liječenja (ITT)
English: For adult patients, up to 2 additional injections may be given within 24 hours.
Croatian: U odraslih bolesnika, unutar 24 sata mogu se dati najviše 2 dodatne injekcije.
English: For adults, up to 2 additional injections may be given within 24 hours.
Croatian: U odraslih, unutar 24 sata mogu se dati najviše 2 dodatne injekcije.
English: Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).
Croatian: Dodatne reakcije na mjestu uboda injekcije (osjećaj pritiska, modrice, smanjeni osjet i/ili obamrlost, ispupčeni svrbljivi kožni osip i osjećaj topline).
English: Icatibant was not teratogenic when administered by SC injection during early embryonic and fetal development in rat (top dose 25 mg/kg/day) and rabbit (top dose 10 mg/kg/day).
Croatian: Ikatibant nije imao teratogeni učinak pri primjeni putem s.c. injekcije tijekom ranog embrionalnog i fetalnog razvoja kod štakora (najveća doza 25 mg/kg/dan) i kunića (najveća doza 10 mg/kg/dan).
English: Change from baseline to 12 hours
Croatian: Promjena od početne vrijednosti do 12 sati
English: Maximum daily exposures defined by area under the curve (AUC) at the No Observed Adverse Effect Levels (NOAEL) in the 9-month study in dog were 2.3 times the AUC in adult humans after a subcutaneous dose of 30 mg. A NOAEL was not measurable in the rat study, however, all of the findings from that study showed either completely or partially reversible effects in treated rats.
Croatian: Najveće dnevne izloženosti definirane područjem ispod krivulje (AUC) pri dozama bez uočenog štetnog učinka (NOAEL) u 9-mjesečnom ispitivanju na psima bile su 2,3 puta veće od područja ispod krivulje (AUC) kod odraslih osoba nakon supkutane primjene doze od 30 mg.
English: - If you are not sure which dose to inject, ask your doctor, pharmacist or nurse.
Croatian: - Ako niste sigurni koju dozu trebate ubrizgati, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: HAE attacks are accompanied by an increased release of bradykinin, which is the key mediator in the development of the clinical symptoms.
Croatian: Napadaji nasljednog angioedema (HAE) popraćeni su povećanim oslobađanjem bradikinina koji je ključni posrednik u razvoju kliničkih simptoma.
English: If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Firazyr can be administered after a further 6 hours.
Croatian: Ako nakon druge injekcije i dalje postoji nedovoljno povlačenje simptoma ili povratak simptoma, nakon još 6 sati može se dati treća injekcija Firazyra.
English: How should Firazyr be administered?
Croatian: Kako treba primjenjivati Firazyr?
English: Adrenal gland hypertrophy was seen to reverse after cessation of icatibant treatment.
Croatian: Uočeno je da je hipertrofija nadbubrežnih žlijezda reverzibilna nakon prekida terapije ikatibantom.
English: - The recommended dose of Firazyr is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
Croatian: Odrasle osobe - Preporučena doza Firazyra je jedna injekcija (3 ml, 30 mg) koja se ubrizgava supkutano (pod kožu) čim primijetite napadaj angioedema (na primjer, povećano oticanje kože, osobito na licu i vratu ili sve jača bol u trbuhu).
English: The primary efficacy endpoint was the time to onset of symptom relief using a visual analogue scale (VAS).
Croatian: Primarni ishod djelotvornosti bilo je vrijeme do početka ublažavanja simptoma uz korištenje vizualne analogne skale (VAS).
English: The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘sodium-free'.
Croatian: Otopina za injekciju sadržava manje od 1 mmol (23 miligrama) natrija pa se smatra da ne sadržava natrij.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTI-PACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Laryngeal attacks
Croatian: Laringealni napadaji
English: Controlled Clinical Study of FIRAZYR vs Tranexamic acid or Placebo: Efficacy Results FAST-2
Croatian: Kontrolirano kliničko ispitivanje FIRAZYRA nasuprot traneksamskoj kiselini ili placebu:
English: The pharmacokinetics of icatibant has been characterized by studies using both intravenous and subcutaneous administration to healthy volunteers and patients.
Croatian: Farmakokinetika ikatibanta opisana je u ispitivanjima u kojima je ikatibant primijenjen intravenski i supkutano na zdravim dobrovoljcima i bolesnicima.
English: Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles.
Croatian: Veličina pakiranja od jedne napunjene štrcaljke s jednom iglom ili višestruko pakiranje koje sadržava tri napunjene štrcaljke s tri igle.
English: Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections.
Croatian: POPIS POMOĆNIH TVARI Sadržava: ledenu acetatnu kiselinu, natrijev hidroksid, natrijev klorid, vodu za injekcije.
English: Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation).
Croatian: Gotovo svi ispitanici koji su supkutano primili ikatibant u kliničkim ispitivanjima razvili su reakcije na mjestu primjene injekcije (karakteriziraju ih iritacija kože, oticanje, bol, svrbež, eritem, osjećaj žarenja).
English: Firazyr is intended for subcutaneous administration preferably in the abdominal area.
Croatian: Firazyr je namijenjen supkutanoj primjeni, po mogućnosti u području abdomena.
English: No hypersensitivity or anaphylactic reactions were reported with Firazyr.
Croatian: Kod primjene Firazyra nisu zabilježene reakcije preosjetljivosti ili anafilaktičke reakcije.
English: -14.6 Change from baseline to 4 hours
Croatian: -14,6 Promjena od početne vrijednosti do 4 sata -44,8
English: 5) Disposal of the injection material
Croatian: 5) Zbrinjavanje otpadnog materijala nakon injekcije
English: Skin redness
Croatian: Crvenilo kože
English: The decision on initiating caregiver or self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4).
Croatian: Samostalna primjena lijeka od strane bolesnika/primjena od strane njegovatelja Odluku da bolesnik može samostalno početi primjenjivati lijek Firazyr ili da mu ga počne primjenjivati njegovatelj smije donijeti samo liječnik s iskustvom u dijagnosticiranju i liječenju nasljednog angioedema (vidjeti dio 4.4).
English: Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3).
Croatian: Stoga je potreban oprez pri davanju Firazyra bolesnicima s akutnom ishemijskom bolesti srca ili nestabilnom anginom pectoris
English: Change from baseline to 4 hours
Croatian: Promjena od početne vrijednosti do 4 sata
English: 4) Remove the pre-filled syringe and connector from the graduated syringe.
Croatian: 4) Odvojite napunjenu štrcaljku i adapter od graduirane štrcaljke.
English: 1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
Croatian: 1) Za početak prebacivanja otopine ikatibanta, gurnite klip napunjene štrcaljke (krajnje lijevo na slici u nastavku).
English: At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively.
Croatian: Početak ublažavanja simptoma nastupio je 1 i 2 sata nakon liječenja u približno 50%, odnosno 90% bolesnika.
English: Transferring the icatibant solution to the graduated syringe:
Croatian: Prebacivanje otopine ikatibanta u graduiranu štrcaljku:
English: ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels.
Croatian: ACE inhibitori su kontraindicirani kod bolesnika s nasljednim angioedemom (HAE) zbog povećanja razina bradikinina.
English: The primary efficacy endpoint was the time to onset of symptom relief (TOSR) measured using a composite investigator-reported symptom score.
Croatian: Primarna mjera ishoda bila je vrijeme do početka ublažavanja simptoma (engl. time to onset of symptom relief, TOSR) mjerena kompozitnim rezultatom simptoma koje je prijavljivao ispitivač.
English: Almost all patients receiving Firazyr will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation).
Croatian: Gotovo svi bolesnici koji prime Firazyr imat će reakcije na mjestu uboda injekcije (kao što je iritacija kože, oticanje, bol, svrbež, crvenilo kože i osjećaj žarenja).