natgillin/translations-raw huggingface dataset:
No therapeutic intervention was necessary. 
Terapevtski ukrepi niso bili potrebni.
All patients maintained efficacy. 
Pri vseh bolnikih se je učinkovitost vzdrževala.
System Organ Class (incidence category) 
Organski sistem (kategorija incidence)
1) General Information 
1) Splošne informacije
The terminal plasma half-life is about 1-2 hours. 
Končna razpolovna doba v plazmi je približno 1-2 uri.
Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013 
Datum zadnjega podaljšanja: 13. marec 2013
Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used. 
Vaš zdravnik je določil natančen odmerek zdravila Firazyr in vam bo povedal, kako pogosto ga smete uporabljati.
38 Number of subjects in ITT Population 27 
38 Število oseb v ITT
Each syringe should only be used once. 
Vsaka brizga se lahko uporabi samo enkrat.
Information on individual race effect is limited. 
Informacije o učinku pri posameznih rasah so omejene.
Efficacy data were obtained from an initial open-label Phase II study and from three controlled Phase III studies. 
Podatki o učinkovitosti so bili pridobljeni iz začetne odprte študije faze II in iz treh kontroliranih študij faze III.
Patients should be advised not to drive and use machines if they feel tired or dizzy. 
Bolnike je treba opozoriti, da ne vozijo in upravljajo s stroji, če so utrujeni ali omotični.
It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids. 
To je sintetični dekapeptid s podobno strukturo kot bradikinin, vendar s 5 neproteionogenimi aminokislinami.
Clearance is about 15-20 l/h and independent of dose. 
Očistek je približno 15-20 l/h in je neodvisen od odmerka.
Table 3 shows the efficacy results for these studies. 
Tabela 3 vsebuje rezultate teh študij za učinkovitost.
The frequency of adverse reactions listed in Table 1 is defined using the following convention: 
Pogostnost neželenih učinkov, ki so navedeni v Preglednici 1, je opredeljena v skladu z naslednjim dogovorom:
- You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice. 
- V 24-urnem obdobju smete prejeti največ 3 injekcije, če potrebujete več kot 8 injekcij v enem mesecu, pa se morate posvetovati z zdravnikom.
Limited information is available on patients older than 65 years of age. 
O uporabi pri bolnikih, starejših od 65 let, ni na voljo zadostnih informacij.
92.4% of these attacks of HAE were treated with a single dose of Firazyr. 
92,4 % napadov HAE so zdravili z enkratnim odmerkom zdravila Firazyr.
Do not throw away any medicines via waste water or household waste. 
Zdravila ne odvrzite v odpadne vode ali med gospodinjske odpadke.
Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor. 
Ikatibant je selektivni kompetitivni antagonist na receptorju za bradikinin tipa 2 (B2).
- If you are allergic to icatibant, or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na ikatibant ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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). 
Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
Placebo p-value 
Placebo vrednost p
Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours. 
Pri dveh pediatričnih bolnikih so se pojavile reakcije na mestu injiciranja, ki so jih ocenili kot hude, ki pa se popolnoma izginile v 6 urah.
• Adapter (proximal and/or distal female luer lock connector/coupler) 
• vmesnik (proksimalni in/ali distalni ženski priključek/spoj Luer lock);
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed. 
Ne uporabljajte tega zdravila, če opazite da je ovojnina brizge ali igle poškodovana ali če so vidni znaki kvarjenja, na primer, če je raztopina motna, če v njej plavajo delci ali če se je spremenila barva raztopine.
(Very Common, ≥1/10) 
(zelo pogosti, ≥1/10)
• Press slowly so that this takes approximately 30 seconds. 
• Bat potiskajte počasi, tako da injiciranje traja približno 30 sekund.
Available exposure data suggest no difference in the clearance between non-White (n=40) and White (n=132) subjects. 
Razpoložljivi podatki o izpostavljenosti kažejo, da razlik v očistku med preskušanci bele rase (n = 132) in pripadniki drugih ras (n = 40) ni.
It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment. 
Ni znano, ali se ikatibant pri ljudeh izloča v materino mleko, vendar je priporočljivo, da doječe matere, ki želijo uporabiti zdravilo Firazyr, 12 ur po uporabi zdravila ne dojijo.
For adults, subsequent doses that may be required for the same attack should be administered within a medical institution (see section 4.2). 
Pri odraslih je treba nadaljnje odmerke, ki so morda potrebni pri istem napadu, dajati v zdravstveni ustanovi (glejte poglavje 4.2).
Results do not indicate a carcinogenic potential for icatibant. 
Rezultati ne nakazujejo karcinogenega potenciala ikatibanta.
In vitro studies have confirmed that icatibant is not degraded by oxidative metabolic pathways and is not an inhibitor of major cytochrome P450 (CYP) isoenzymes (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) and is not an inducer of CYP 1A2 and 3A4. 
Študije in vitro so potrdile, da se ikatibant ne razgrajuje po oksidacijskih presnovnih poteh ter da ni zaviralec glavnih izoencimov citokroma P450 (CYP) (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4) in ni induktor CYP 1A2 in 3A4.
Do not choose an area that is bruised, swollen, or painful. 
Ne izberite mesta s podplutbami, oteklino ali bolečino.
No clinically significant changes in reproductive hormones were observed during clinical studies. 
V kliničnih študijah niso opazili klinično pomembnih sprememb reproduktivnih hormonov.
Icatibant volume of distribution (Vss) is about 20-25 L. Plasma protein binding is 44%. 
Volumen porazdelitve (Vss) ikatibanta je približno 20-25 l. Vezava na plazemske proteine je 44 %.
Subsequent episodes of HAE were treated in an open label extension. 
Nadaljnje epizode HAE so zdravili v odprti razširjeni študiji.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown. 
Študije na živalih so pokazale učinke na ugnezdenje v maternico in kotenje (glejte poglavje 5.3), vendar pa možno tveganje za ljudi ni znano.
• The syringe is now ready for injection. 
• Brizga je pripravljena za injiciranje.
In a standard battery of in vitro and in vivo tests icatibant was not genotoxic. 
V standardnem nizu in vitro in in vivo preizkusov ikatibant ni bil genotoksičen.
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less: 
2a) Priprava brizge za otroke in mladostnike (2-17 let), ki tehtajo 65 kg ali manj
The relevance of this to the safety of Firazyr is unknown (see section 5.2). 
Pomen tega dejstva za varnost zdravila Firazyr ni znan (glejte poglavje 5.2).
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. 
Pri ishemičnih stanjih je poslabšanje srčne funkcije in zmanjšanja koronarnega pretoka teoretično lahko posledica antagonizma na receptorju za bradikinin tipa 2.
These tissue findings were consistent with reported effects on gonadotrophins and during the subsequent treatment-free period appear to be reversible. 
Te ugotovitve na tkivu so bile skladne s poročanimi učinki na gonadotropine in so bile reverzibilne v poznejšem obdobju brez zdravljenja.
Data suggest that there is no difference in the clearance between females and males after correcting for body weight. 
Spol Podatki kažejo, da ni bilo razlik pri očistku pri ženskah in moških po popravku za telesno maso.
Similar effects of icatibant on reproductive tissue were seen in sexually mature rats and dogs. 
Podobne učinke ikabitanta na reproduktivno tkivo so opazili pri spolno zrelih podganah in psih.
No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established. 
Pri otrocih, mlajših od 2 let ali s telesno maso 12 kg ali manj, ni mogoče priporočiti režima odmerjanja, saj niso ugotovili varnosti in učinkovitosti v tej pediatrični skupini.
Avoid touching the ends of the connector and syringe tips, to prevent contamination 
Ne dotikajte se koncev vmesnika in konic brizg, da preprečite kontaminacijo.
• 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. 
• Prepričajte se, da v brizgi ni nobenih zračnih mehurčkov, tako da potiskate bat, dokler se na konici igle ne pojavi prva kapljica.
A total of 237 patients were treated with 1,386 doses of 30 mg icatibant for 1,278 attacks of acute HAE. 
Skupno 237 bolnikov so zdravili z 1386 odmerki 30 mg ikatibanta zaradi 1278 napadov akutnega HAE.
Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in older people (75-80 years) compared to patients aged 40 years. 
Podatki nakazujejo, da se očistek s starostjo zmanjšuje, kar pomeni, da je pri starejših (75-80 let) izpostavljenost za 50-60 % večja kot pri bolnikih, starih 40 let.
Eleven patients were of prepubertal status and 21 patients were either pubertal or postpubertal. 
Enajst bolnikov je bilo v predpuberteti, 21 bolnikov pa je bilo v puberteti ali postpuberteti.
The dosing regimen used for this study is unlikely to be sustained in the clinical setting. 
Režim odmerjanja, ki je bil uporabljen v tej študiji, bi bilo težko izvajati v kliničnem okolju.
These effects are usually mild and clear up without the need for any additional treatment. 
Ti učinki so navadno blagi in izginejo brez dodatnega zdravljenja.
Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml). 
Bolniki, ki tehtajo več kot 65 kg, morajo prejeti celotno vsebino napolnjene injekcijske brizge (3 ml).
This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies. 
Pri tem bolniku so 5 mesecev opravljali sledenje, pri čemer so bili nadaljnji vzorci negativni za protitelesa proti ikatibantu.
• Push the plunger of the graduated syringe so that any air is transferred back into the pre-filled syringe (this step may need to be repeated several times). 
• Potisnite bat brizge z oznakami za prostornino, tako da se ves zrak potisne nazaj v napolnjeno injekcijsko brizgo (ta korak boste morda morali ponoviti večkrat).
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. 
Izkazalo se je, da je ikatibant poslabšal inducirano ishemično bolezen srca pri mnogih nekliničnih modelih, čeprav se škodljiv učinek ni vedno kazal v akutni ishemiji.
Some of the side effects connected with Firazyr are similar to the symptoms of your disease. 
Nekateri neželeni učinki, povezani z uporabo zdravila Firazyr, so podobni simptomom vaše bolezni.
This area should be at least 5 cm (2 inches) away from any scars. 
To mesto mora biti vsaj 5 cm oddaljeno od kakršnih koli brazgotin.
Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life threatening laryngeal attacks). 
Zdravilo Firazyr se sme uporabljati med nosečnostjo samo, če možna korist odtehta možno tveganje za plod (npr. pri zdravljenju morebitnih življenjsko ogrožajočih laringealnih napadov).
Each Firazyr syringe is intended for single use only. 
Vsaka brizga zdravila Firazyr je namenjena le enkratni uporabi.
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). 
Pri prvih 15 napadih, ki so jih zdravili z zdravilom Firazyr (1114 odmerkov za 1030 napadov), je bila mediana časa do pojava olajšanja simptomov podobna pri vseh napadih (od 2,0 do 2,5 ure).
A hypodermic needle (25 G; 16 mm) is included in the pack. 
Igla za subkutano aplikacijo (25 G; 16 mm) je priložena pakiranju.
• Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger. 
• Brizgo držite med dvema prstoma ene roke, pri čemer je palec na spodnjem delu bata.
The results were similar to patients with non-laryngeal attacks of HAE with respect to time to onset of symptom relief. 
Rezultati so bili podobni kot pri bolnikih z nelaringealnimi napadi HAE glede na čas do pojava lajšanja simptomov.
The pharmacokinetic profile of icatibant in patients with HAE is similar to that in healthy volunteers. 
Farmakokinetični profil ikatibanta pri bolnikih s HAE je podoben kot pri zdravih prostovoljcih.
These reactions were erythema, swelling, burning and warm sensation. 
Te reakcije so bile eritem, otekanje, pekoč občutek in občutek toplote.
Do not pull up on the plunger. 
Ne vlecite za bat.
Icatibant had no effect on the fertility of male mice and rats (see section 5.3). 
Ikatibant ni imel nobenega učinka na plodnost mišjih in podganjih samcev (glejte poglavje 5.3).
HAE (an autosomal dominant disease) is caused by an absence or dysfunction of C1-esteraseinhibitor. 
Hereditarni angioedem (HAE) (avtosomna dominantna bolezen) se pojavi zaradi odsotnosti ali disfunkcije zaviralca C1-esteraze.
* 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. 
* Podplutba na mestu injiciranja, hematom na mestu injiciranja, pekoč občutek na mestu injiciranja, eritem na mestu injiciranja, hipoestezija na mestu injiciranja, draženje na mestu injiciranja, otopelost na mestu injiciranja, edem na mestu injiciranja, bolečina na mestu injiciranja, občutek pritiska na mestu injiciranja, pruritus na mestu injiciranja, otekanje na mestu injiciranja, urtikarija na mestu injiciranja in občutek toplote na mestu injiciranja.
- If your symptoms get worse or do not improve, you must seek immediate medical help. 
- Če se vaši simptomi poslabšajo, ali če se ne izboljšajo, se takoj posvetujte z zdravnikom.
What you need to know before you use Firazyr Do not use Firazyr 
Kaj morate vedeti, preden boste uporabili zdravilo Firazyr Ne uporabljajte zdravila Firazyr
In the majority of cases a single injection of Firazyr is sufficient to treat an attack. 
V večini primerov zadošča za zdravljenje napada ena injekcija zdravila Firazyr.
• Hold syringe between 45-90 degrees angle to skin with needle facing the skin. 
• Brizgo držite pod kotom med 45 in 90 stopinjami glede na kožo, igla pa naj bo obrnjena proti koži.
Contents of the pack and other information What Firazyr contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Firazyr
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. 
Ikatibant ni izzval sprememb srčne prevodnosti in vitro (kanal hERG) ali in vivo pri normalnih psih ali pri različnih modelih psov (prekatno spodbujanje, telesni napor in koronarna ligacija), kjer niso bile opažene nobene s tem povezane hemodinamske spremembe.
Following subcutaneous administration, the absolute bioavailability of icatibant is 97%. 
Absorpcija Po subkutani aplikaciji je absolutna biološka uporabnost ikatibanta 97 %.
If you have never received Firazyr previously, your first dose of Firazyr will always be injected by your doctor or nurse. 
Če niste še nikoli prejeli zdravila Firazyr, vam bo prvi odmerek injiciral vaš zdravnik ali medicinska sestra.
Not known (frequency cannot be estimated from the available data) : Hives (urticaria) 
Neznanao (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood. 
Ikatibant se pri podganah izloča v mleko v koncentracijah, ki so podobne koncentracijam v krvi samic.
Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe. 
Bolnike z laringealnimi napadi je treba po injiciranju obravnavati v ustrezni zdravstveni ustanovi, dokler zdravnik ne presodi, da je odpust varen.
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. 
V študiji pri 39 zdravih odraslih moških in ženskah, ki so jih zdravili s 30 mg vsakih 6 ur v 3 odmerkih vsake 3 dni, kar je pomenilo skupno 9 odmerkov, niso ugotovili nobenih klinično pomembnih sprememb od izhodiščnih vrednosti pri bazalni in z GnRH stimulirani koncentraciji reproduktivnih hormonov pri nobenem od spolov.
Icatibant is extensively metabolized by proteolytic enzymes to inactive metabolites that are primarily excreted in the urine. 
Biotransformacija Ikatibant obsežno presnavljajo proteolitični encimi v neaktivne presnovke, ki se primarno izločajo z urinom.
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. 
Po subkutanem injiciranju posameznega odmerka (0,4 mg/kg do največ 30 mg) je čas do doseganja največje koncentracije približno 30 minut, končni razpolovni čas pa je približno 2 uri.
The treatment effect of icatibant was confirmed by secondary efficacy endpoints. 
Učinek zdravljenja z ikatibantom so potrdili sekundarni pokazatelji učinkovitosti.
• Grip the syringe firmly. 
• Trdno primite brizgo.
Firazyr has minor influence on the ability to drive and use machines. 
Zdravilo Firazyr ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
Difference between treatments (95% CI, p-value) 
Razlika med zdravljenji (95 %
Median time to onset of symptom relief: all symptoms (hours): Abdominal pain Skin swelling Skin pain 
Mediana časa do nastopa olajšanja simptomov: vsi simptomi (v urah): bolečina v trebuhu oteklina na koži bolečine v koži
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. 
Ikatibant je močan antagonist bradikinina, zato lahko zdravljenje z visokimi odmerki vpliva na proces ugnezdenja v maternico in nadaljnjo stabilnost v maternici v zgodnji nosečnosti.
What Firazyr is and what it is used for 
Kaj je zdravilo Firazyr in za kaj ga uporabljamo
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before starting to use Firazyr. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se pred začetkom zdravljenja z zdravilom Firazyr posvetujte s svojim zdravnikom.
2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children) 
Priprava brizge in igle za injiciranje: Vsi bolniki (odrasli, mladostniki in otroci)
The appropriate dose to be administered is based on body weight (see section 4.2). 
Ustrezen odmerek temelji na telesni masi (glejte poglavje 4.2).
• Discard the syringe, needle and needle cap into the sharp container for throwing away waste that might hurt others if not handled properly. 
• Brizgo, iglo in pokrovček za iglo odvrzite v vsebnik za odstranjevanje ostrih predmetov, ki lahko povzročijo poškodbo, če se ne uporabljajo pravilno.
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. 
V 2-letni študiji za ugotovitev karcinogenega potenciala ikatibanta pri podganah dnevni odmerki z do približno 2-kratno stopnjo izpostavljenosti v primerjavi s stopnjo, doseženo pri terapevtskem odmerku pri ljudeh, niso imeli vpliva na pojavnost ali morfologijo tumorjev.
Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin. 
Kljub dokazanemu ugodnemu učinku blokade receptorja B2 neposredno po možganski kapi je teoretično mogoče, da ikatibant oslabi pozitivne zaščitne učinke bradikinina na živčne celice v pozni fazi.
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. 
Opazili niso nobenega pomembnega učinka ikatibanta na koncentracijo progesterona v luteinski fazi in luteinsko delovanje ali na dolžino menstruacijskega cikla pri ženskah, prav tako pa ni bilo nobenih pomembnih učinkov ikatibanta na število, gibljivost in morfologijo semenčic pri moških.
Adults The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg. 
Priporočeni odmerek pri odraslih je eno subkutano injiciranje 30 mg zdravila Firazyr.
It is important that Firazyr is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema. 
Pomembno je, da si zdravilo subkutano (podkožno) injicirate, takoj ko opazite napad angioedema.
Shire Pharmaceuticals Ireland Limited 
DRUGI PODATKI Shire Pharmaceuticals Ireland Limited
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. 
V kliničnih študijah za registracijo zdravila so skupno 999 napadov HAE zdravili s 30 mg zdravila Firazyr, ki so ga subkutano dajali zdravstveni delavci.
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. 
Pri zdravih mladih osebah so ikatibant dajali v odmerkih 0,8 mg/kg v 4 urah; 1,5 mg/kg/dan ali 0,15 mg/kg/dan 3 dni; pojav hipotenzije, vazodilatacije in refleksne tahikardije zaradi bradikinina je bil preprečen.
(Common, ≥1/100 to <1/10) 
(pogosti, ≥ 1/100 do < 1/10)
Icatibant is mainly eliminated by metabolism with less than 10% of the dose eliminated in the urine as unchanged drug. 
Ikatibant se izloča pretežno presnovljen, manj kot 10 % odmerka pa se izloči z urinom v nespremenjeni obliki.
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). 
Klinične študije 3. faze (FAST-1 in FAST-2) so bila randomizirana, dvojno slepa, nadzorovana preskušanja in so imele enake načrte, razen za primerjalno zdravilo (v eni je bilo zdravilo primerjano s peroralno traneksaminsko kislino in v drugi s placebom).