FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 22 November 2018
Croatian: Datum prvog odobrenja: 22. studenog 2018
English: This leaflet was last revised in .
Croatian: Ova uputa je zadnji puta revidirana u.
English: All antibody titres were low.
Croatian: Titri svih protutijela bili su niski.
English: Results of the subgroup analysis were consistent with overall study results for all subjects.
Croatian: Rezultati analize podskupine bili su u skladu s ukupnim rezultatima ispitivanja za sve ispitanike.
English: Lower scores indicate lower impairment (or better health-related quality of life).
Croatian: Niži rezultat pokazuje manje pogoršanje (ili bolju kvalitetu života povezanu sa zdravljem).
English: Interim analysis indicates that the effect was sustained up to one year of treatment.
Croatian: Interim analiza pokazuje da se učinak održao tijekom jedne godine liječenja.
English: Important: Do not shake.
Croatian: Važno: Nemojte protresati.
English: Health related Quality of Life
Croatian: Kvaliteta života povezana sa zdravljem
English: Repeat these steps until large air bubbles are removed.
Croatian: Ponavljajte ove korake dok ne uklonite velike mjehuriće zraka.
English: Do not inject yourself or someone else until you have been trained to inject the medicine.
Croatian: Nemojte injekciju davati ni Vi ni netko drugi dok niste uvježbani kako dati injekciju lijeka.
English: Criteria
Croatian: Kriteriji
English: Interference with coagulation test
Croatian: Interferencija s testom koagulacije
English: Adjusted p-values for multiple testing.
Croatian: Prilagođene p-vrijednosti za višestruka testiranja.
English: Adjusted p-values d
Croatian: Prilagođene p-vrijednosti d
English: There is no available information to identify potential signs and symptoms of overdose.
Croatian: Nema dostupnih podataka koji bi ukazivali na moguće znakove i simptome predoziranja.
English: Important:
Croatian: Važno:
English: • Inject the medicine in a different place each time.
Croatian: Lijek ubrizgajte svaki put na drugo mjesto.
English: Do not choose an area that is bruised, swollen, or painful.
Croatian: Nemojte odabrati područje koje ima modricu, otečeno je ili bolno.
English: Following SC administration, the time to maximum concentration is approximately 5 days.
Croatian: Nakon s.c. primjene vrijeme do najviše koncentracije iznosi približno 5 dana.
English: Each pack also contains the following items:
Croatian: U svakom pakiranju nalazi se i sljedeći pribor:
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (može se pojaviti u više od 1 na 10 osoba):
English: b) Clean your work area and wash your hands before preparing your dose.
Croatian: b) Očistite radnu površinu i operite ruke prije nego što počnete pripremati dozu.
English: Avoid vigorous agitation.
Croatian: Izbjegavajte snažno protresanje.
English: If you are allergic to lanadelumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na lanadelumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Croatian: Poznato je da se ljudski IgG-ovi izlučuju u majčino mlijeko tijekom prvih nekoliko dana nakon rođenja, što se kasnije ubrzo smanji na niske koncentracije; posljedično tomu, tijekom toga kratkog razdoblja rizik za dojenče ne može se isključiti.
English: c) Gather your TAKHZYRO and supplies and place them on your well-lit work surface.
Croatian: c) Prikupite TAKHZYRO i pribor i stavite ih na dobro osvijetljenu radnu površinu.
English: [mild, N=98] and 30 to 59 ml/min/1.73m
Croatian: [blago, N=98] i od 30 do 59 ml/min/1,73 m
English: % Reduction relative to placebo (95% CI)
Croatian: % smanjenja u odnosu na placebo (95% CI)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: With this condition your blood does not have enough of a protein called ‘C1 inhibitor', or C1 inhibitor does not work properly.
Croatian: Kod te bolesti u krvi nema dovoljno proteina pod nazivom „inhibitor C1“ ili inhibitor C1 ne djeluje pravilno.
English: The anticipated time to reach steady state concentration was approximately 70 days.
Croatian: Vrijeme predviđeno za postizanje koncentracije u stanju dinamičke ravnoteže bilo je otprilike 70 dana.
English: • The area you choose for injection should be at least 5 cm away from any scars or your belly button (navel).
Croatian: • Područje koje ste izabrali za davanje injekcije mora biti najmanje 5 cm udaljeno od bilo kakvog ožiljka ili pupka.
English: Your doctor will discuss with you the risks and benefits of taking this medicine.
Croatian: Liječnik će Vam objasniti rizike i koristi od primjene ovog lijeka.
English: Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C and for 8 hours at 2°C to 8°C.
Croatian: Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je u trajanju od 2 sata pri 25°C te 8 sati pri temperaturi od 2°C do 8°C.
English: If you inject TAKHZYRO yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”.
Croatian: Ako lijek TAKHZYRO ubrizgavate sami sebi ili ako Vam ga ubrizgava njegovatelj, Vi ili Vaš njegovatelj morate pažljivo pročitati i slijediti upute iz dijela 7, „Upute za primjenu”.
English: Before use, each vial should be visually inspected for appearance.
Croatian: Prije upotrebe svaku bočicu treba vizualno pregledati.
English: e) Gently invert the vial 3 to 5 times to ensure the solution is mixed.
Croatian: e) Pažljivo okrenite bočicu 3 do 5 puta kako biste bili sigurni da je otopina izmiješana.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (može se pojaviti u do 1 na 10 osoba):
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
Croatian: Otopina ima pH od približno 6,0 i osmolalnost od približno 300 mOsm/kg.
English: The injection of TAKHZYRO can be summarised in 5 steps:
Croatian: Primjena lijeka TAKHZYRO injekcijom može se sažeti u 5 koraka:
English: Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.
Croatian: Od tih reakcija, 97% bilo je blagog intenziteta i 90% se povuklo unutar 1 dana poslije početka s medijanom trajanja od 6 minuta.
English: The percentage of subjects who were attack free is provided in Table 3.
Croatian: Postotak ispitanika koji nisu imali napadaje prikazan je u tablici 3.
English: The frequency of adverse reactions listed in Table 1 is defined using the following convention: 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 na temelju sljedećeg dogovora: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or developmental toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak s obzirom na reproduktivnu ili razvojnu toksičnost (vidjeti dio 5.3).
English: Return the syringe to an upright position.
Croatian: Vratite štrcaljku u uspravni položaj.
English: If symptoms should occur, symptomatic treatment is recommended.
Croatian: U slučaju da se pojave simptomi predoziranja, preporučuje se simptomatska terapija.
English: e) Push the plunger slowly until all the medicine has been injected.
Croatian: e) Polako gurajte klip sve dok ne ubrizgate sav lijek.
English: If you have not had an attack for a long period, your doctor may change the dose to 300 mg every 4 weeks, especially if you have a low body weight.
Croatian: Ako niste imali napadaje dulje vrijeme, liječnik Vam može promijeniti dozu na 300 mg svaka 4 tjedna, a osobito ako ste male tjelesne težine.
English: The cHMWK formation rate was maximally reduced by 53.7% with an IC50 of 5705 ng/ml.
Croatian: Stopa stvaranja cHMWK-a bila je najviše smanjena za 53,7% uz IC50 od 5705 ng/ml.
English: This is because it has not been studied in this age group.
Croatian: To je zbog toga što lijek nije bio ispitivan u toj dobnoj skupini.
English: TAKHZYRO is not known to affect other medicines or be affected by other medicines.
Croatian: Nije poznato da TAKHZYRO utječe na druge lijekove ili da drugi lijekovi utječu na njega.
English: There were no differences in international normalised ratio (INR) between treatment groups.
Croatian: Između terapijskih skupina nije bilo razlike u međunarodnom normaliziranom omjeru (INR).
English: This leads to too much ‘plasma kallikrein', which in turn produces higher levels of ‘bradykinin' in your bloodstream.
Croatian: To dovodi do stvaranja previše „plazmatskog kalikreina“ što zauzvrat proizvodi više razine „bradikinina“ u krvotoku.
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli liječnik, ljekarnik ili medicinska sestra.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before starting to use Takhzryo.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što počnete primjenjivati Takhzyro.
English: Lanadelumab is not expected to interact directly with DNA or other chromosomal material, as it is made up entirely of naturally occurring amino acids and contains no inorganic or synthetic linkers or other nonprotein portions; therefore no genotoxicity evaluation has been conducted.
Croatian: Ne očekuje se da će lanadelumab stupiti u interakciju izravno s DNK ili drugim kromosomskim materijalom, jer se u potpunosti sastoji od prirodnih aminokiselina i ne sadrži anorganske ili sintetske linkere ili druge neproteinske dijelove; stoga nije provedena procjena genotoksičnosti.
English: The mean (SD) volume of distribution of lanadelumab in patients with HAE is 14.5 litres (4.53).
Croatian: Srednja vrijednost (SD) volumena distribucije lanadelumaba u bolesnika s HAE-om iznosi 14,5 litara (4,53).
English: This is because TAKHZYRO in the blood may interfere with some laboratory tests, leading to inaccurate results
Croatian: To je potrebno zato što TAKHZYRO u krvi može utjecati na rezultate nekih laboratorijskih pretraga i dovodi do netočnih nalaza.
English: Lanadelumab has a mean (SD) total body clearance of 0.0297 L/h (0.0124) and a terminal elimination half-life of approximately 14 days.
Croatian: Lanadelumab ima srednju vrijednost (SD) ukupnog klirensa iz tijela od 0,0297 l/h (0,0124) i terminalni poluvijek eliminacije od približno 14 dana.
English: There is no antidote available.
Croatian: Antidot nije dostupan.
English: f) Check the solution in the vial for particles or a change in the colour (normally it is colourless to slightly yellow).
Croatian: f) Pregledajte sadrži li otopina u bočici čestice ili je li promijenila boju (normalno je bezbojna do blago žuta).
English: [moderate, N=9]) had no effect on the clearance or volume of distribution of lanadelumab.
Croatian: [umjereno, N=9]) nije imalo učinka na klirens ili volumen distribucije lanadelumaba.
English: Check with your doctor, pharmacist or nurse if you are not sure or have any further questions on the use of this medicine.
Croatian: Provjerite s liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni ili imate dodatnih pitanja o primjeni ovoga lijeka.
English: It is important that you keep injecting TAKHZYRO as instructed by your doctor even if you feel better.
Croatian: Važno je da nastavite s primjenom lijeka TAKHZYRO prema uputama koje ste dobili, čak i ako se osjećate bolje.
English: Solution for injection 1 vial of 2 ml component of a multipack, can't be sold separately.
Croatian: otopina za injekciju 1 bočica od 2 ml kao dio višestrukog pakiranja, ne smije se prodavati odvojeno
English: Important: Be sure to inject into a subcutaneous space which is not too shallow (skin layer) or too deep (muscle).
Croatian: Važno: Pazite da lijek ne ubrizgate pod kožu previše plitko (u površinski sloj kože) ili previše duboko (u mišić).
English: In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
Croatian: U slučaju teške reakcije preosjetljivosti, primjenu lijeka TAKHZYRO mora se odmah prekinuti i započeti odgovarajuće liječenje.
English: Do not touch the needle tip or allow it to touch any other surface.
Croatian: Ne dodirujte vrh igle i ne dopustite da vrh igle dodirne bilo koju površinu.
English: TAKHZYRO is available as a single pack containing one 2 ml vial and in multipacks comprising 2 or 6 cartons, each carton containing 1 vial.
Croatian: TAKHZYRO je dostupan u pojedinačnom pakiranju koje sadrži jednu bočicu od 2 ml i u višestrukom pakiranju koje sadrži 2 ili 6 kutija, a svaka kutija sadrži 1 bočicu.
English: % reduction relative to placebo corresponds to 100% * (1-rate ratio).
Croatian: % smanjenje u odnosu na placebo odgovara 100% * (1 minus omjer stopa incidencije).
English: Tell your doctor if you are using TAKHZYRO before you have laboratory tests to measure how well your blood is clotting.
Croatian: Obavijestite liječnika ako ste TAKHZYRO primjenjivali prije nego što su Vam provedeni laboratorijski testovi kako bi se odredilo zgrušava li Vam se krv pravilno.
English: Vials may be stored below 25°C for a single period of 14 days, but not beyond the expiry date.
Croatian: Bočice se mogu čuvati na temperaturi ispod 25°C tijekom jednokratnog razdoblja od 14 dana, ali ne poslije isteka roka valjanosti.
English: The safety of TAKHZYRO was evaluated in a subgroup of 23 subjects aged 12 to <18 years old.
Croatian: Sigurnost primjene lijeka TAKHZYRO procijenjena je u podskupini od 23 ispitanika u dobi od 12 do <18 godina.
English: If not administered immediately after preparation, the syringe may be stored in the refrigerator (2C to 8C), protected from light and administered within 8 hours.
Croatian: Ako se ne primijeni odmah nakon pripreme, štrcaljku se može pohraniti u hladnjak (od 2C do 8C), zaštićenu od svjetlosti i primijeniti u roku od 8 sati.
English: It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the name and batch number of the medicine.
Croatian: Izrazito se preporučuje da kod svake primjene doze lijeka TAKHZYRO zapišete naziv lijeka i broj serije.
English: The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka TAKHZYRO u djece mlađe od 12 godina nisu ustanovljene.
English: Results of primary and secondary efficacy measures-ITT population
Croatian: Tablica 2. Rezultati mjera primarnog i sekundarnog ishoda - ITT populacija
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TAKHZYRO in one or more subsets of the paediatric population in the prevention of hereditary angioedema attacks.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka TAKHZYRO u jednoj ili više podskupina pedijatrijske populacije u sprječavanju napadaja hereditarnog angioedema.
English: Pharmacotherapeutic group: Other haematological agents, drugs used in hereditary angioedema, ATC code: B06AC05
Croatian: Farmakoterapijska skupina: drugi hematološki lijekovi, lijekovi za liječenje hereditarnog angioedema, ATK oznaka: B06AC05
English: TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Croatian: TAKHZYRO je indiciran za rutinsku prevenciju ponavljajućih napadaja hereditarnog angioedema (HAE) u bolesnika u dobi od 12 godina i starijih.
English: Carcinogenicity has not been evaluated in animals as based on the weight of evidence approach, lanadelumab is considered to have a low risk for carcinogenicity.
Croatian: Kancerogenost nije bila procijenjena u životinja jer se, na temelju pristupa težine dokaza, smatra da lanadelumab uključuje mali rizik u pogledu kancerogenosti.
English: The median (range) age of the study population was 42 (12 to 73) years with 88 female subjects (70%).
Croatian: Medijan (raspon) dobi ispitivane populacije bio je 42 (od 12 do 73) godine, a među ispitanicima bilo je 88 žena (70%).
English: Nutrition score Note: AE-QoL= Angioedema Quality of Life; LS=least squares; SD=standard deviation.
Croatian: Napomena: AE-QoL= kvaliteta života kod angioedema; SD=standardna devijacija.
English: Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects.
Croatian: Liječenje lanadelumabom bilo je povezano s razvojem protutijela protiv lijeka (engl. anti-drug antibodies, ADA) tijekom liječenja u 11,9% (10/84) ispitanika.
English: If you miss a dose of TAKHZYRO, inject your dose as soon as possible but there must be at least 10 days between each dose.
Croatian: Ako ste propustili dozu lijeka TAKHZYRO, primijenite svoju dozu što prije, ali između svake doze mora proteći najmanje 10 dana.
English: Be sure that you read, understand and follow the step-by-step instructions for injecting TAKHZYRO.
Croatian: Pobrinite se da pročitate, razumijete te slijedite upute za ubrizgavanje lijeka TAKHZYRO korak po korak.
English: Accordingly, in a population pharmacokinetic analysis, renal impairment (estimated GFR: 60 to 89 ml/min/1.73 m
Croatian: U skladu s tim, u analizi populacijske farmakokinetike, oštećenje funkcije bubrega (procijenjeni GFR: od 60 do 89 ml/min/1,73 m
English: A history of laryngeal angioedema attacks was reported in 65% (81/125) of subjects and 56% (70/125) were on prior long term prophylaxis (LTP).
Croatian: Povijest napadaja laringealnog angioedema bila je prijavljena u 65% (81/125) ispitanika, a 56% (70/125) primalo je prije dugoročnu profilaksu.
English: Long-term safety and efficacy of TAKHZYRO for prophylaxis to prevent HAE attacks was evaluated in an open-label HELP study extension.
Croatian: Dugoročna sigurnost primjene i djelotvornost lijeka TAKHZYRO kao profilakse za sprječavanje napadaja HAE-a procijenjene su u otvorenom produžetku ispitivanja HELP.
English: Afterwards, lanadelumab could be used during breast-feeding if clinically needed.
Croatian: Poslije toga, lanadelumab se može primjenjivati za vrijeme dojenja ako je to klinički potrebno.
English: Do not use the blunt tip vial access needle to inject TAKHZYRO as this may cause pain and bleeding.
Croatian: Nemojte upotrijebiti iglu tupog vrha za pristup u bočicu da biste ubrizgali lijek TAKHZYRO jer Vam to može prouzročiti bol i krvarenje.
English: Release the skin fold and gently remove the needle.
Croatian: Otpustite nabor kože i lagano izvucite iglu.
English: b) Clean your injection site with an alcohol wipe and allow the skin to dry completely.
Croatian: b) Očistite mjesto za primjenu injekcije alkoholnom maramicom i pustite da se koža potpuno osuši.
English: TAKHZYRO is a type of protein that blocks the activity of plasma kallikrein.
Croatian: TAKHZYRO je vrsta proteina koji blokira aktivnost plazmatskog kalikreina.
English: Table 1 summarises adverse reactions observed in the HELP study that included 84 subjects with HAE, who received at least one dose of TAKHZYRO.
Croatian: Tablica 1 sažeto prikazuje nuspojave primijećene u ispitivanju HELP u kojem je sudjelovalo 84 ispitanika s HAE-om koji su primili najmanje jednu dozu lijeka TAKHZYRO.
English: Fear/Shame score
Croatian: Rezultat - strah/sram
English: Other medicines and TAKHZYRO
Croatian: Drugi lijekovi i TAKHZYRO
English: If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, tight chest, wheezing, or a fast heart beat, tell your doctor, pharmacist or nurse immediately.
Croatian: Ako imate tešku alergijsku reakciju na TAKHZYRO sa simptomima kao što su osip, stezanje u prsnom košu, piskanje pri disanju ili brze otkucaje srca, odmah se obratite liječniku, ljekarniku ili medicinskoj sestri.
English: Although body weight was identified as an important covariate describing the variability of clearance, a 300 mg q2wks dose regimen provided sufficient exposure for the indication (see section 5.1).
Croatian: Iako je tjelesna težina ustanovljena kao važni kovarijat koji opisuje varijabilnost klirensa, režim doziranja od 300 mg svaka 2 tjedna omogućio je dovoljnu izloženost za indikaciju (vidjeti dio 5.1).
English: Alanine aminotransferase increased Common
Croatian: Pretrage povišena alanin aminotransferaza često povišena aspartat aminotransferaza često
English: Hypersensitivity reactions have been observed.
Croatian: Primijećene su reakcije preosjetljivosti.
English: Model-based treatment period HAE attack rate (attacks/4 weeks).
Croatian: Stopa napadaja HAE-a u razdoblju liječenja na temelju modela (napadaji/4 tjedna).
English: The injection should be restricted to the recommended injection sites: the abdomen, the thighs, and the upper outer arms (see section 5.2).
Croatian: Primjenu injekcije treba ograničiti na preporučena mjesta: abdomen, bedra i vanjske dijelove nadlaktica (vidjeti dio 5.2).
English: Do not remove the vial rubber stopper.
Croatian: Ne uklanjajte gumeni čep.
English: Each TAKHZYRO vial is intended for single use only (see section 6.6).
Croatian: Jedna bočica lijeka TAKHZYRO namijenjena je samo za jednokratnu upotrebu (vidjeti dio 6.6).
English: d) Remove the vial from the packaging.
Croatian: d) Izvadite bočicu iz pakiranja.
English: Pharmacokinetics of lanadelumab showed linear dose-exposure response with doses up to 400 mg and reproducible exposure following subcutaneous administration up to 12 months.
Croatian: Farmakokinetika lanadelumaba pokazala je linearni odgovor doza-izloženost pri dozama do 400 mg i ponovljivu izloženost nakon supkutane primjene do 12 mjeseci.
English: The recommended starting dose is 300 mg every 2 weeks.
Croatian: Preporučena početna doza iznosi 300 mg svaka 2 tjedna.
English: Do not use this medicine if you notice signs of deterioration such as particles in the vial or changed colour of the injection solution.
Croatian: Ovaj se lijek ne smije upotrijebiti ako primijetite znakove odstupanja u kakvoći, kao što su čestice u bočici ili promjena boje otopine za injekciju.
English: This medicine has negligible influence on the ability to drive or use machines.
Croatian: Ovaj lijek zanemarivo utječe na na sposobnost upravljanja vozilima i strojevima.
English: Table 4 Change in AE-QoL score a
Croatian: Tablica 4. Promjena u rezultatu upitnika AE-QoL
English: If you use more TAKHZYRO than you should
Croatian: Ako primijenite više lijeka TAKHZYRO nego što ste trebali
English: From a microbiological point of view, unless the method of preparation precludes the risks of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek treba upotrijebiti odmah osim ako metoda pripreme isključuje rizik od kontaminacije mikrobima.
English: This helps to reduce the amount of bradykinin in your bloodstream and prevents symptoms of HAE.
Croatian: To pomaže smanjiti količinu bradikinina u krvotoku i sprječava simptome hereditarnog angioedema.
English: The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE.
Croatian: Ispitivanje HELP bilo je multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje na usporednim skupinama provedeno u 125 ispitanika (115 odraslih i 10 adolescenata) sa simptomatskim HAE-om tipa