natgillin/translations-raw huggingface dataset:
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Firazyr Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Table 1: Dosage regimen for paediatric patients Body Weight 
Preglednica 1: Režim odmerjanja pri pediatričnih bolnikih
Your healthcare provider will teach you and your caregiver how to safely inject Firazyr by following the instructions in the Package Leaflet. 
Zdravstveno osebje bo vas in vašega negovalca poučilo, kako varno injicirati zdravilo Firazyr, pri čemer je treba upoštevati navodilo za uporabo.
In the pivotal juvenile toxicity study in which sexually immature rats were treated daily with 3 mg/kg/day for 7 weeks, atrophy of testes and epididymides were observed; the observed microscopic findings were partially reversible. 
V ključni študiji toksičnosti za razvoj mladičev, v kateri so spolno nezrele podgane zdravili s 3 mg/kg na dan 7 tednov, so opazili atrofijo testisov in epididimisa; opažene mikroskopske ugotovitve so bile delno reverzibilne.
Where the required dose is less than 30 mg (3 ml), the following equipment is required to extract and administer the appropriate dose: 
Kadar je potreben odmerek manjši od 30 mg (3 ml), je za odmerjanje in dajanje ustreznega odmerka potrebna naslednja oprema:
ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels. 
Zaviralci ACE so kontraindicirani pri bolnikih s hereditarnim angioedemom zaradi možnega povišanja ravni bradikinina.
Firazyr is intended for subcutaneous injection (under the skin). 
Zdravilo Firazyr je namenjeno za subkutano injekcijo (pod kožo).
Injection site reactions* 
reakcije na mestu injiciranja*
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. 
Na podlagi modeliranja za odmerjanje glede na telesno maso je predvidena izpostavljenost ikatibantu pri pediatrični populaciji z napadi HAE (glejte poglavje 4.2) nižja od opažene izpostavljenosti v študijah, opravljenih pri odraslih bolnikih z napadi HAE.
Controlled Clinical Study of FIRAZYR vs Tranexamic acid or Placebo: Efficacy Results FAST-2 
Kontrolirana klinična študija zdravila FIRAZYR v primerjavi s traneksamično kislino/placebom: rezultati učinkovitosti
• 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. 
• Z mirno roko počasi potiskajte bat brizge, dokler se pod kožo ne injicira celotna tekočina in v brizgi ni več tekočine.
For adult patients, up to 2 additional injections may be given within 24 hours. 
Pri odraslih bolnikih se lahko v roku 24 ur dasta 2 dodatni injekciji.
Firazyr solution for injection should be injected slowly due to the volume to be administered. 
Raztopino za injiciranje Firazyr je treba injicirati počasi zaradi prostornine, ki jo je treba injicirati.
The pharmacokinetics of icatibant has been characterized by studies using both intravenous and subcutaneous administration to healthy volunteers and patients. 
Farmakokinetične lastnosti ikatibanta so bile preučene v študijah, ki so vključevale intravensko in subkutano dajanje ikatibanta zdravim prostovoljcem in bolnikom.
Overall the median time to onset of symptom relief was 1.0 hour (95% confidence interval, 1.0-1.1 hours). 
Skupno je bila mediana časa do nastopa izboljšanja simptomov 1,0 ure (95-odstotni interval zaupanja; 1,0-1,1 ure).
Preferred Term 
Priporočeni izraz
HAE attacks are accompanied by an increased release of bradykinin, which is the key mediator in the development of the clinical symptoms. 
Napade HAE spremlja povečano sproščanje bradikinina, ki je ključni posrednik pri pojavu kliničnih simptomov.
3) Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely. 
3) Pritrdite brizgo z oznakami prostornine na drugi konec vmesnika in poskrbite, da bo vse trdno pritrjeno.
Pharmacotherapeutic group: Other haematological agents, drugs used to treat hereditary angioedema; 
Farmakoterapevtska skupina: druga krvna zdravila, zdravila za zdravljenje hereditarnega angioedema,
Change from baseline to 12 hours 
Sprememba izhodiščne vrednosti na 12 ur
In both rats and dogs, repeated use of icatibant resulted in effects on reproductive organs. 
Pri podganah in psih je ponavljajoča se uporaba ikatibanta povzročila učinke na spolne organe.
• Choose the injection site. 
• Izberite mesto injiciranja.
Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using Firazyr. 
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite in ne upravljajte s stroji, če ste utrujeni ali omotični zaradi napada HAE ali po uporabi zdravila Firazyr.
Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 
Zdravilo Firazyr zavira aktivnost bradikinina ter tako ustavi nadaljnje napredovanje simptomov napada HAE.
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). 
Skupno je mediana časa do minimalnih simptomov (najzgodnejši čas po odmerjanju zdravila, ko so bili vsi simptomi blagi, ali pa jih ni bilo) bila 1,1 ure (95-odstotni interval zaupanja; 1,0-2,0 ur).
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). 
Ti učinki na maternico se kažejo tudi v poznem stadiju nosečnosti, ko ikatibant izkazuje tokolitičen učinek, kar se kaže v zakasneli kotitvi pri podganah, s povečanjem fetalnega distresa in perinatalne smrti pri visokih odmerkih (10 mg/kg/dan).
For adults, up to 2 additional injections may be given within 24 hours. 
Pri odraslih se lahko v roku 24 ur dasta 2 dodatni injekciji.
Across repeated treatment in adults in the controlled phase III trials, transient positivity to antiicatibant antibodies was observed in rare cases. 
V nadzorovanih preskušanjih 3. faze s ponavljajočimi se zdravljenji pri odraslih so v redkih primerih opazili prehodno pozitivnost za protitelesa proti ikatibantu.
Elderly people have been shown to have increased systemic exposure to icatibant. 
Pri starejših bolnikih je bila dokazana večja sistemska izpostavljenost ikatibantu.
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). 
V teh študijah so imeli bolniki, ki so prejemali ikatibant, krajšo mediano časa do nastopa olajšanja simptomov (2,0, 2,5 oziroma 2,0 ure) kot bolniki, ki so prejemali traneksamično kislino (12,0 ure) ali tisti, ki so prejemali placebo (4,6 oziroma 19,8 ure).
A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects. 
Odmerek 3,2 mg/kg intravensko (približno 8-kratni terapevtski odmerek) je pri zdravih osebah povzročil prehodne eriteme, srbečico, vročinske oblive ali hipotenzijo.
One Firazyr-treated patient tested positive for anti-icatibant antibodies before and after treatment with Firazyr. 
En bolnik, ki se je zdravil z zdravilom Firazyr, je bil pozitiven za protitelesa proti ikatibantu pred zdravljenjem z zdravilom Firazyr in po njem.
A subset of patients in this study experienced acute HAE attacks while receiving androgens, antifibrinolytic agents or Cl inhibitors. 
Podskupina bolnikov v tej študiji je imela akutne napade HAE med jemanjem androgenov, antifibrinolitičnih učinkovin ali zaviralcev CI.
Icatibant was shown to be a competitive antagonist when the bradykinin challenge dose was increased 4-fold. 
Ikatibant je izkazal lastnosti kompetitivnega antagonista, ko je bil provokacijski odmerek bradikinina povečan 4-kratno.
In HAE increased bradykinin concentrations are the key mediator in the development of the clinical symptoms. 
Pri HAE so povečane koncentracije bradikinina ključni posrednik pri pojavu kliničnih simptomov.
Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE. 
Zdravstveni delavci so zdravilo Firazyr 30 mg subkutano dali 129 zdravim preskušancem in 236 bolnikom s HAE.
If there is air in the graduated syringe: 
Če je v brizgi z oznakami za prostornino zrak:
These symptoms may occur as a result of an attack of HAE. 
Ti simptomi se lahko pojavijo kot posledica napada hereditarnega angioedema.
How should Firazyr be administered? 
Kako je treba dati zdravilo Firazyr?
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). 
Zaradi tega je pri dajanju zdravila Firazyr bolnikom z akutno ishemično boleznijo srca ali nestabilno angino pektoris potrebna previdnost (glejte poglavje 5.3).
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. 
Pri večini pediatričnih bolnikov, ki so prejeli ikatibant s subkutanim injiciranjem so se pojavile reakcije na mestu injiciranja, kot so eritem, otekanje, pekoč občutek, bolečine in srbenje/pruritus na koži; ugotovili so, da so te reakcije blage do zmerne in da so skladne z reakcijami, o katerih so poročali pri odraslih.
In the clinical trials, not more than 8 injections of Firazyr per month have been administered. 
V kliničnih preskušanjih so v enem mesecu aplicirali največ 8 injekcij zdravila Firazyr.
Table 1: Dosage regimen for children and adolescents Body Weight 
Preglednica 1: Režim odmerjanja za otroke in mladostnike
Change from baseline to 4 hours 
Sprememba izhodiščne vrednosti na 4 ure
Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2). 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Farmakokinetične interakcije, povezane s CYP450, niso pričakovane (glejte poglavje 5.2).
The efficacy population consisted of 22 patients who had been treated with icatibant (11 prepubertal and 11 pubertal/postpubertal) for HAE attack. 
Populacija za ugotavljanje učinkovitosti je vključevala 22 bolnikov, pri katerih so napad HAE zdravili z ikatibantom (11 v predpuberteti in 11 v puberteti/postpuberteti).
• Release the skin fold and gently pull the needle out. 
• Spustite kožno gubo in nežno izvlecite iglo.
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. 
Zdravilo Firazyr je indicirano za simptomatsko zdravljenje akutnih napadov hereditarnega (prirojenega) angioedema (HAE) pri odraslih, mladostnikih in otrocih, starih 2 leti ali več, s pomanjkanjem zaviralca C1-esteraze.
The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below). 
Potrebno prostornino odmerka za injiciranje v ml je treba izvleči v prazno brizgo z oznakami prostornine velikosti 3 ml (glejte spodnjo preglednico).
• Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin fold. 
• Držite kožno gubo, brizgo približajte koži in iglo hitro vstavite v kožno gubo.
Firazyr is not known to interact with other medicines. 
Ni znano, da bi zdravilo Firazyr medsebojno delovalo z drugimi zdravili.
In the clinical trial, not more than 1 injection of Firazyr per HAE attack has been administered. 
V kliničnem preskušanju niso dajali več kot 1 injekcije zdravila Firazyr na napad HAE.
Laryngeal attacks 
Laringealni napadi
These reactions were generally mild to moderate in severity, transient, and resolved without further intervention. 
Te reakcije so bile navadno blage do zmerne, prehodne in so samodejno prenehale.
The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side. 
Mesto injiciranja mora biti kožna guba na kateri koli strani trebuha, približno 5-10 cm pod popkom.
Time to symptom relief was defined as the duration of time (in hours) taken for improvement of symptoms to occur by a magnitude of 20%. 
Čas do izboljšanja simptomov je bil opredeljen kot čas (v urah), potreben za 20
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). 
Prejemali so ikatibant v odmerku 30 mg (63 bolnikov) ali komparator (38 bolnikov je prejemalo traneksamično kislino, 29 pa placebo).
Efficacy Results: FAST-3; Controlled Phase -- ITT population 
Rezultati za učinkovitost: FAST-3; nadzorovana faza - populacija, ki so jo nameravali zdraviti (ITT)
Carefully attach the needle to the syringe containing the colourless solution. 
Iglo previdno pritrdite na napolnjeno injekcijsko brizgo, ki vsebuje brezbarvno raztopino.
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). 
Ikatibant ni imel nobenega vpliva na plodnost mišjih (največji odmerek 80,8 mg/kg/dan) in podganjih (največji odmerek 10 mg/kg/dan) samcev.
- 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). 
- Priporočeni odmerek zdravila Firazyr je ena injekcija (3 ml, 30 mg), injicirana subkutano (pod kožo), kakor hitro opazite napad angioedema (na primer povečano otekanje kože, zlasti na obrazu in vratu, ali močnejše bolečine v trebuhu)
Response rate (%, CI) at 4 hours after start of treatment 
CI) po 4 urah po začetku zdravljenja
The primary efficacy endpoint was the time to onset of symptom relief (TOSR) measured using a composite investigator-reported symptom score. 
Primarni cilj študije pri ugotavljanju učinkovitosti je bil čas do nastopa izboljšanja simptomov (TOSR - time to onset of symptom relief), ki so ga izmerili s sestavljenim rezultatom simptomov, ki jih poročajo raziskovalci.
Patients with symptoms of laryngeal angioedema received open label treatment with icatibant. 
Bolniki s simptomi laringealnega angioedema so prejemali zdravljenje z ikatibantom v odprti fazi.
Table 4 shows the efficacy results for FAST-3. 
Tabela 4 vsebuje rezultate študije FAST-3 za učinkovitost.
No effects were detected in the post-natal development of rat pups. 
Učinkov na postnatalni razvoj podganjih mladičev niso ugotovili.
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. 
Zdravilo Firazyr so injicirali subkutano pri odmerku 0,4 mg/kg na podlagi telesne mase do največjega odmerka 30 mg.
The pharmacokinetics of icatibant were characterized in paediatric HAE patients in study HGT-FIR086 (see section 5.1). 
V študiji HGT-FIR-086 so raziskovali farmakokinetiko ikatibanta pri pediatričnih bolnikih s HAE (glejte poglavje 5.1).
The clinical relevance of the adrenal gland findings is unknown. 
Klinična pomembnost ugotovitev pri nadledvični žlezi ni znana.
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). 
Ikatibant ni bil teratogen, ko so ga dajali s subkutano injekcijo med zgodnjim embrionalnim in fetalnim razvojem pri podganah (maksimalni odmerek 25 mg/kg/dan) in zajcih (maksimalni odmerek 10 mg/kg/dan).
Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied. 
Sočasno dajanje zdravila Firazyr in zaviralcev angiotenzinske konvertaze (ACE) ni bilo raziskano.
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. 
V integrirani analizi teh nadzorovanih študij 3. faze sta bila čas do pojava lajšanja simptomov in čas do pojava lajšanja primarnega simptoma podobna ne glede na starostno skupino, spol, raso, telesno maso in ne glede na to, ali je bolnik uporabljal androgene ali antifibrinolitične učinkovine ali ne. Tudi odziv v nadzorovanih preskušanjih 3. faze je bil podoben pri vseh ponavljajočih se napadih.
No clinical information on overdose is available. 
Na voljo ni kliničnih poročil o primerih prevelikega odmerjanja.
All needles and syringes should be disposed of in a sharps container. 
Vse igle in brizge morate zavreči v zbiralnik za ostre predmete.
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘sodium-free'. 
Firazyr vsebuje majhno količino natrija Raztopina za injiciranje vsebuje manj kot 1 mmol (23 miligramov) natrija, zato je pravzaprav »brez natrija«.
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). 
Injiciranje, ki ga izvede negovalec/samoinjiciranje Odločitev o tem, ali bo injiciranje zdravila Firazyr izvedel negovalec ali bolnik lahko sprejme samo zdravnik z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema (glejte poglavje 4.4).
A 2-week subcutaneous dose range finding study in juvenile rats identified 25 mg/kg/day as a maximally tolerated dose. 
V 2-tedenski študiji za ugotavljanje razpona subkutanega odmerka pri mladičih podgan so ugotovili, da je 25 mg/kg/dan največji odmerek, ki ga živali še prenašajo.
Median time to overall patient improvement, by physician (hours) 
Mediana časa do celokupnega izboljšanja stanja bolnika, po oceni zdravnika (v urah)
Table 2: Adverse reactions reported with icatibant 
Preglednica 2: Neželeni učinki, o katerih so poročali pri uporabi ikatibanta
Talk to your doctor before taking Firazyr: - if you are suffering from angina (reduced blood flow to the heart muscle) - if you have recently suffered a stroke 
Pred začetkom jemanja zdravila Firazyr se posvetujte s svojim zdravnikom: - če imate angino pektoris (zmanjšan dovod krvi v srčno mišico)
3) Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe. 
3) Še naprej potiskajte bat napolnjene injekcijske brizge, dokler se potrebna prostornina za injiciranje (odmerek) ne prenese v brizgo z oznakami za prostornino.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea. 
Pri HAE je v krvnem obtoku povečana raven snovi, imenovane bradikinin, ki povzroča simptome, kot so oteklina, bolečina, navzea (slabost) in driska.
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. 
Pri podganah in psih so pokazali znižanje ravni cirkulirajočih spolnih hormonov, ki je bilo odvisno od odmerka, pri ponavljajoči se uporabi ikatibanta pa reverzibilno upočasnjeno spolno zorenje.
The pre-filled icatibant syringe and all other components are for single use only. 
Napolnjena injekcijska brizga z ikatibantom in vsi drugi deli so namenjeni enkratni uporabi.
Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older. 
Zdravilo Firazyr je namenjeno za zdravljenje simptomov hereditarnega (prirojenega) angioedema (HAE) pri odraslih, mladostnikih in otrocih, starih 2 leti ali več.
No hypersensitivity or anaphylactic reactions were reported with Firazyr. 
Pri zdravilu Firazyr niso poročali o nobenih preobčutljivostnih ali anafilaktičnih reakcijah.
What Firazyr looks like and contents of the pack 
Izgled zdravila Firazyr in vsebina pakiranja
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. 
Če po drugi injekciji ni zadostnega olajšanja ali se simptomi ponovijo, se lahko bolniku po nadaljnjih 6 urah aplicira še tretja injekcija zdravila Firazyr.
Patients were randomized to receive either icatibant 30 mg or placebo by subcutaneous injection. 
Bolnike so naključno razporedili tako, da so s subkutanim injiciranjem prejeli ikatibant 30 mg ali placebo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTI-PACK (WITHOUT BLUE BOX) 
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA PRI SKUPNEM PAKIRANJU (BREZ »BLUE BOX« PODATKOV)
Solution for injection Multipack containing three pre-filled syringes and three 25G needles 
Skupno pakiranje, ki vsebuje tri napolnjene injekcijske brizge in tri igle 25G
Efficacy results for FAST-1 and FAST-2 
Tabela 3: Rezultati študij FAST-1 in FAST-2 za učinkovitost
- If you experience no relief of symptoms after 6 hours, you should seek medical advice regarding additional injections of Firazyr. 
- Če po 6 urah ne občutite olajšanja simptomov, se morate posvetovati z zdravnikom o dodatnih injekcijah zdravila Firazyr.
Change in Composite VAS Score at 2 hrs after treatment 
Sprememba rezultata sestavljenega VAS 2 uri po zdravljenju
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. 
V kliničnih študijah so zdravljenju z ikatibantom izpostavili skupno 32 pediatričnih bolnikov (8 otrok, starih od 2 do 11 let in 24 mladostnikov, starih od 12 do 17 let) s HAE.
For icatibant, no clinical data on exposed pregnancies are available. 
Kliničnih podatkov za nosečnice, ki so bile izpostavljene ikatibantu, ni na voljo .
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). 
2) Če se raztopina ikatibanta ne začne prenašati v brizgo z oznakami prostornine, rahlo povlecite bat brizge z oznakami prostornine, da začne raztopina ikatibanta pritekati vanjo (glejte spodnjo sliko).
Dizziness Headache 
omotica glavobol
Repeated-dose studies of up to 6-months duration in rats and 9-months duration in dogs have been conducted. 
Opravili so študije ponavljajočih se odmerkov, ki so trajale do 6 mesecev pri podganah in do
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. 
Maksimalna dnevna izpostavljenost, opredeljena kot območje pod krivuljo (AUC) pri stopnji brez opaženih neželenih učinkov (NOAEL), je bila v 9-mesečni študiji na psih 2,3-krat večja od AUC pri odraslih ljudeh po subkutanem odmerku 30 mg.
The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection. 
Pomožne snovi so natrijev klorid, koncentrirana ocetna kislina, natrijev hidroksid in voda za injekcije.
The primary efficacy endpoint was the time to onset of symptom relief using a visual analogue scale (VAS). 
V študijah faze III je bil primarni pokazatelj učinkovitosti čas do nastopa olajšanja simptomov, določen z uporabo vizualne analogne lestvice (VAS - visual analogue scale).
HAE manifests as intermittent attacks of subcutaneous and/or sub mucosal oedema involving the upper respiratory tract, the skin and the gastrointestinal tract. 
HAE se kaže v obliki občasnih napadov subkutanih in/ali submukoznih edemov, ki prizadenejo zgornja dihala, kožo in prebavila.