FrancophonIA/ELRC3.0 huggingface dataset:
English: Before you start using Hemlibra, it is very important to talk to your doctor about using “bypassing agents” (medicines that help blood clot but which work in a different way from factor VIII).
Croatian: Prije nego što počnete primjenjivati lijek Hemlibra, vrlo je važno da razgovarate sa svojim liječnikom o primjeni ‘lijekova koji zaobilaze akivnost faktora VIII' (lijekova koji pridonose zgrušavanju krvi, ali djeluju na drugačiji način od faktora VIII).
English: Thrombotic events
Croatian: Trombotski događaji
English: Hemlibra is a medicine used for treating patients of all ages with
Croatian: Hemlibra je lijek koji se primjenjuje za liječenje bolesnika svih dobi:
English: Hemlibra can be used in adolescents and children of all ages.
Croatian: Hemlibra se može primjenjivati u adolescenata i djece svih dobi.
English: The patient should not take two doses on the same day to make up for a missed dose.
Croatian: Bolesnik ne smije primijeniti dvije doze u istom danu kako bi nadoknadio propuštenu dozu.
English: Treatment for the TMA events included supportive care with or without plasmapheresis and haemodialysis.
Croatian: Liječenje događaja TMA uključivalo je potpornu skrb uz plazmaferezu i hemodijalizu ili bez njih.
English: Emicizumab can be administered interchangeably at these anatomical sites (see section 4.2).
Croatian: Emicizumab se može naizmjence primjenjivati na tim anatomskim mjestima (vidjeti dio 4.2).
English: In rare cases, a blood clot can form inside blood vessels and block them, which may be life-threatening.
Croatian: U rijetkim se slučajevima može stvoriti krvni ugrušak unutar krvne žile i začepiti je, što može biti opasno po život.
English: Evidence of improvement was seen within one week following discontinuation of aPCC and interruption of Hemlibra.
Croatian: Dokazi poboljšanja primijećeni su unutar tjedan dana nakon prestanka primjene aPCC-a i prekida liječenja lijekom Hemlibra.
English: ● Thigh (front and middle).
Croatian: ● bedro (prednji i srednji dio)
English: Your doctor or nurse will give more information about this.
Croatian: Više informacija o tome dat će Vam liječnik ili medicinska sestra.
English: ● If your prescribed dose is more than 2 mL, you will need to have more than one subcutaneous injection of Hemlibra; contact your healthcare provider for the injection instructions.
Croatian: Ako je propisana doza veća od 2 ml, morat ćete primijeniti više od jedne potkožne injekcije lijeka Hemlibra; obratite se svom zdravstvenom radniku za upute za injiciranje.
English: Modelling shows that less frequent dosing in patients with hypoalbuminemia and low body weight for their age results in lower emicizumab exposures; simulations indicate that these patients would still benefit from clinically meaningful bleed control.
Croatian: Modeliranje pokazuje da rjeđa primjena u bolesnika s hipoalbuminemijom i malom tjelesnom težinom za njihovu dob dovodi do manje izloženosti emicizumabu; simulacije ukazuju na to da bi tim bolesnicima ipak koristila klinički značajna kontrola krvarenja.
English: The safety and efficacy of emicizumab in patients receiving ongoing immune tolerance induction have not yet been established.
Croatian: Sigurnost i djelotvornost emicizumaba u bolesnika u kojih se provodi indukcija imunološke tolerancije nisu još ustanovljene.
English: Emicizumab did not cause any changes in the reproductive organs of male or female cynomolgus monkeys up to the highest tested dose of 30 mg/kg/week (equivalent to 11 times the human exposure at the highest dose of 3 mg/kg/week, based on AUC).
Croatian: Emicizumab nije uzrokovao promjene na reproduktivnim organima mužjaka ni ženki makaki majmuna pri primjeni doza sve do najviše ispitivane doze do 30 mg/kg na tjedan (kojom se postiže izloženost 11 puta veća od izloženosti u ljudi kod primjene najviše doze od 3 mg/kg na tjedan, na temelju AUC-a).
English: % reduction (RR), p-value
Croatian: % smanjenja (RR), p-vrijednost
English: Ctrough, ss (µg/mL) Cmax/Ctrough ratio
Croatian: Ctrough, ss (µg/ml) Omjer Cmax/Ctrough
English: ● At the request of the European Medicines Agency;
Croatian: Ažurirani RMP treba dostaviti: ● na zahtjev Europske agencije za lijekove;
English: Due to its long half-life, these effects on coagulation assays may persist for up to 6 months after the last dose (see section 5.2).
Croatian: Zbog dugog poluvijeka emicizumaba, ti učinci na testove koagulacije mogu potrajati do 6 mjeseci nakon posljednje doze (vidjeti dio 5.2).
English: The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.
Croatian: Režim primjene doze održavanja treba odabrati na temelju preferencija liječnika i bolesnika/njegovatelja kako bi se pridonijelo adherenciji bolesnika
English: The median observation time for these patients was 29.6 weeks (range: 18.4 to 63.0 weeks).
Croatian: Medijan vremena promatranja za te bolesnike iznosio je 29,6 tjedana (raspon: 18,4 - 63,0 tjedna).
English: There are no data in patients over 77 years old.
Croatian: Nema podataka o primjeni u bolesnika starijih od 77 godina.
English: Annualized bleed rate and percent of patients with zero bleeds were calculated (see Table 11).
Croatian: Izračunavala se anualizirana stopa krvarenja i postotak bolesnika s nula krvarenja (vidjeti Tablicu 11).
English: Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical trials
Croatian: Karakterizacija interakcije između emicizumaba i liječenja aPCC-om u pivotalnim kliničkim ispitivanjima
English: ● Do not rub the injection site after injection.
Croatian: Nemojte trljati mjesto injiciranja nakon injekcije.
English: For comprehensive instructions on the administration of Hemlibra, see section 6.6 and package leaflet.
Croatian: Za sveobuhvatne upute o primjeni lijeka Hemlibra vidjeti dio 6.6 i uputu o lijeku.
English: Hemlibra is intended for use under the guidance of a healthcare professional.
Croatian: Hemlibra je namijenjena za primjenu pod nadzorom zdravstvenog radnika.
English: Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg.
Croatian: U 68% slučajeva, epizoda liječenja aPCC-om sastojala se od samo jedne infuzije doze < 100 jedinica/kg.
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included thirteen subjects aged 65 years and older (no subjects were older than 77 years of age).
Croatian: Učinak dobi na farmakokinetiku emicizumaba ocjenjivao se u populacijskoj farmakokinetičkoj analizi koja je obuhvatila trinaest ispitanika u dobi od 65 i više godina (nijedan ispitanik nije bio stariji od 77 godina).
English: The overly shortened intrinsic clotting time will then disturb all single factor assays based on aPTT, such as the one stage FVIII activity assay (see section 4.4, Table 1).
Croatian: Prekomjerno skraćeno vrijeme unutarnjeg puta zgrušavanja zatim će poremetiti nalaze svih jednostupanjskih testova koji se temelje na aPTV-u, kao što je jednostupanjski test za određivanje aktivnosti FVIII (vidjeti dio 4.4, Tablica 1).
English: specifically, interruption of emicizumab may not have an immediate effect.
Croatian: privremeni prekid primjene emicizumaba možda neće imati trenutan učinak.
English: ● Do not inject air into the medicine as this could create air bubbles in the medicine.
Croatian: Nemojte ubrizgavati zrak u lijek jer bi se tako mogli stvoriti mjehurići zraka u lijeku.
English: Then, continue to inject the medicine as scheduled.
Croatian: Nakon toga nastavite injicirati lijek u skladu s uobičajenim rasporedom.
English: Population pharmacokinetics analyses in patients with haemophilia A showed that race did not affect the pharmacokinetics of emicizumab.
Croatian: Populacijske farmakokinetičke analize u bolesnika s hemofilijom A pokazale su da rasa nije utjecala na farmakokinetiku emicizumaba.
English: The dose of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and corresponding amount of Hemlibra solution (in mL) to be injected:
Croatian: Doza lijeka Hemlibra ovisi o Vašoj tjelesnoj težini, pa će Vaš liječnik izračunati količinu (u mg) i odgovarajući volumen lijeka Hemlibra (u ml) koji treba injicirati:
English: Treated spontaneous bleeds
Croatian: Liječena spontana krvarenja
English: ● To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
Croatian: Da biste pravilno uveli iglu pod kožu, slobodnom rukom uhvatite nabor kože na čistom mjestu za injiciranje.
English: ● Repeat the steps above until you have removed the larger air bubbles.
Croatian: Ponavljajte prethodno opisane korake sve dok ne uklonite veće mjehuriće zraka.
English: Only patients from the NIS were included in this comparison, because bleed and treatment data were collected with the same level of granularity as used in HAVEN 3.
Croatian: Ta je usporedba obuhvatila samo bolesnike iz neintervencijskog ispitivanja jer su se podaci o krvarenjima i liječenju prikupljali s istom razinom granularnosti kao i u ispitivanju HAVEN 3.
English: Once completed, keep the vial adapter onto the vial and return to Step 5 “Remove air bubbles”.
Croatian: Nakon toga ostavite nastavak za bočicu u bočici i vratite se na 5. korak „Uklonite mjehuriće zraka“.
English: In the event of breakthrough bleeding, patients receiving emicizumab prophylaxis should be managed with available therapies.
Croatian: U slučaju probojnog krvarenja bolesnike koji primaju profilaksu emicizumabom treba liječiti dostupnim terapijama.
English: This rapid improvement is distinct from the usual clinical course observed in atypical hemolytic uremic syndrome and classic TMAs, such as thrombotic thrombocytopenic purpura (see section 4.8).
Croatian: Takvo brzo poboljšanje razlikuje se od uobičajenog kliničkog tijeka primjećenog kod sindroma atipične hemolitičke uremije i klasičnih oblika TMA, kao što je trombotska trombocitopenijska purpura (vidjeti dio 4.8).
English: Adverse reactions (preferred term, MedDRA)
Croatian: Nuspojave (preporučeni pojam, MedDRA)
English: Clinical study in paediatric patients
Croatian: Kliničko ispitivanje u pedijatrijskih bolesnika
English: Duration of aPCC treatment
Croatian: Trajanje liječenja aPCC-om
English: ● Stomach area (abdomen), except for 5 cm around the navel (belly button).
Croatian: ● trbuh (abdomen), osim područja 5 cm oko pupka
English: ● a reaction in the area where the injection is given (redness, itching, pain)
Croatian: ● reakcija na mjestu primjene injekcije (crvenilo, svrbež, bol)
English: Do not use Hemlibra:
Croatian: Nemojte primijeniti lijek Hemlibra:
English: No dose adjustments are recommended in patients ≥ 65 years of age (see sections 5.1 and 5.2).
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika u dobi od ≥ 65 godina (vidjeti dijelove 5.1 i 5.2).
English: ● If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose.
Croatian: Ako zaboravite primijeniti planiranu injekciju, injicirajte zaboravljenu dozu što je prije moguće, prije dana primjene sljedeće doze prema rasporedu.
English: The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia A.
Croatian: Farmakokinetika emicizumaba određivala se analizom bez odjeljaka u zdravih ispitanika te populacijskom farmakokinetičkom analizom baze podataka koja je obuhvaćala 389 bolesnika s hemofilijom A.
English: After proper training in subcutaneous injection technique, a patient may self-inject Hemlibra, or the patient's caregiver may administer it, if their physician determines that it is appropriate.
Croatian: Nakon propisne obuke o tehnici supkutanog injiciranja bolesnik može sam injicirati lijek Hemlibra ili mu ga može primijeniti njegovatelj, ako liječnik utvrdi da je to prikladno.
English: Hemlibra can be used in all age groups.
Croatian: Hemlibra se može primjenjivati u svim dobnim skupinama.
English: If you inject Hemlibra 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 si lijek Hemlibra injicirate sami ili Vam injekciju daje njegovatelj, Vi ili njegovatelj morate pažljivo pročitati i slijediti upute navedene u dijelu 7.
English: Preclinical data reveal no special hazards for humans based on studies of acute and repeated dose toxicity, including safety pharmacology endpoints and endpoints for reproductive toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja akutne i toksičnosti ponovljenih doza, uključujući farmakološke mjere ishoda za sigurnost te mjere ishoda za reproduktivnu toksičnost.
English: ● Decision about dose modifications should take into account the half-life of medications;
Croatian: Pri donošenju odluke o prilagođavanju doze treba uzeti u obzir poluvijek lijekova; konkretno,
English: The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection site reactions (20 %), arthralgia (15 %) and headache (14 %).
Croatian: Najčešće nuspojave lijeka prijavljene u ≥ 10% bolesnika koji su primili najmanje jednu dozu lijeka Hemlibra bile su reakcije na mjestu injiciranja (20%), artralgija (15%) i glavobolja (14%).
English: No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed.
Croatian: Nisu primijećene inkompatibilnosti između lijeka Hemlibra i polipropilenskih ili polikarbonatnih štrcaljki, polikarbonatnih nastavaka za bočicu i igala od nehrđajućeg čelika.
English: Thrombotic microangiopathy b Thrombotic event
Croatian: Trombotska mikroangiopatija b Trombotski događaj
English: ● You should use a different injection site for each injection, at least 2.5 cm away from the area you used for your previous injection.
Croatian: Svaki put odaberite drugo mjesto za injiciranje, koje mora biti udaljeno najmanje 2,5 cm od mjesta primjene prethodne injekcije.
English: Reminder to report any adverse events associated with the use of emicizumab.
Croatian: Podsjetnik da prijave sve nuspojave povezane s primjenom emicizumaba.
English: It is important to know the symptoms of such internal blood clots, in case they develop (see section 4, “Possible side effects” for a list of symptoms).
Croatian: Važno je da znate simptome takvih unutarnjih krvnih ugrušaka za slučaj da se oni razviju kod Vas (pogledajte dio 4., ‘Moguće nuspojave' za popis simptoma).
English: Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years.
Croatian: Relativna bioraspoloživost smanjivala se s porastom dobi, ali nisu opažene klinički važne razlike u farmakokinetici emicizumaba između ispitanika mlađih od 65 godina i onih u dobi od
English: ● Move the safety shield forward 90°, away from the syringe barrel.
Croatian: Pomaknite sigurnosni pokrov za 90° od tijela štrcaljke.
English: ● Hold plunger firmly to ensure it does not pull back in.
Croatian: Čvrsto držite klip kako se ne bi povukao natrag.
English: Description of the signs and symptoms of the following safety concerns and reminder of the importance of immediately stopping using Hemlibra and aPCC and notifying their treating physician if symptoms occur : - Destruction of red blood cells (thrombotic microangiopathy) - Blood clots (thromboembolism)
Croatian: Opis znakova i simptoma sljedećih sigurnosnih problema i napomenu da je važno da odmah prekinu primjenu lijeka Hemlibra i aPCC-a i obrate se svom liječniku ako se pojave simptomi: - Propadanja crvenih krvnih stanica (trombotska mikroangiopatija) - Krvnih ugrušaka (tromboembolija)
English: Such intrinsic pathway based tests will yield overly shortened clotting times with emicizumab, which does not require activation by thrombin.
Croatian: Takvi testovi koji se temelje na unutarnjem putu zgrušavanja pokazat će prekomjerno skraćeno vrijeme zgrušavanja kod primjene emicizumaba, koji ne zahtijeva aktivaciju trombinom.
English: Clinical studies in adults and adolescents
Croatian: Klinička ispitivanja u odraslih i adolsecenata
English: Preparing the syringe for injection:
Croatian: Priprema štrcaljke za injekciju:
English: What Hemlibra is and what it is used for
Croatian: Što je Hemlibra i za što se koristi
English: Two hundred and sixtysix (71 %) were adults, 47(13 %) were adolescents (≥ 12 to < 18 years), 55 (15 %) were children (≥ 2 to < 12 years) and five (1 %) were infants and toddlers (1 month to < 2 years).
Croatian: Dvjesto šezdeset šest (71%) bolesnika bile su odrasle osobe, njih 47 (13%) bili su adolescenti (u dobi od ≥ 12 do < 18 godina), 55 (15%) djeca (u dobi od ≥ 2 do < 12 godina), a 5 (1%) dojenčad i mala djeca (u dobi od 1 mjeseca do < 2 godine).
English: The primary objective of the study was to evaluate the efficacy of Hemlibra prophylaxis given every four weeks in maintaining adequate bleed control, based on treated bleeds.
Croatian: Primarni cilj ispitivanja bio je ocijeniti djelotvornost profilakse lijekom Hemlibra primijenjenim svaka četiri tjedna u održavanju odgovarajuće kontrole krvarenja, na temelju broja liječenih krvarenja.
English: If FVIII is required in the perioperative period, please refer to section 4.5.
Croatian: Ako je u perioperacijskom razdoblju potrebno primijeniti FVIII, potrebno je vidjeti dio 4.5.
English: Visual Analogue Scale Adjusted mean
Croatian: Vizualna analogna ljestvica
English: The median duration of exposure across the studies was 33 weeks (range: 0.1 to 94.3 weeks).
Croatian: Medijan trajanja izloženosti kroz sva ispitivanja iznosio je 33 tjedna (raspon: 0,1 - 94,3 tjedna).
English: If bleeding is not controlled with the initial dose of aPCC up to 50 U/kg, additional aPCC doses should be administered under medical guidance or supervision with consideration made to laboratory monitoring for the diagnosis of TMA or thromboembolism and verification of bleeds prior to repeated dosing.
Croatian: Ako se krvarenje ne može kontrolirati početnom dozom aPCC-a do 50 jedinica/kg, dodatne doze aPCC-a treba primijeniti pod vodstvom ili nadzorom liječnika te razmotriti laboratorijsko praćenje radi dijagnosticiranja TMA ili tromboembolije i potvrde krvarenja prije ponovnog doziranja.
English: Mild hepatic impairment did not affect the pharmacokinetics of emicizumab (see section 4.2).
Croatian: Blago oštećenje jetrene funkcije nije utjecalo na farmakokinetiku emicizumaba (vidjeti dio 4.2).
English: Disposing of the medicine and supplies: Important: Always keep the sharps disposal container out of reach of children.
Croatian: Zbrinjavanje lijeka i pribora za primjenu: Važno: Uvijek držite spremnik za odlaganje oštrih predmeta izvan dohvata djece.
English: The patient should then administer the next dose on the usual scheduled dosing day.
Croatian: Nakon toga bolesnik treba primijeniti sljedeću dozu prema uobičajenom rasporedu.
English: Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
Croatian: bolesnika su zabilježeni trombocitopenija, mikroangiopatska hemolitička anemija i akutno oštećenje bubrega, bez teške deficijencije aktivnosti enzima ADAMTS13.
English: Use of aPCC should be avoided unless no other treatment options/alternatives are available.
Croatian: Primjenu aPCC-a treba izbjegavati, osim ako nisu dostupne druge mogućnosti liječenja.
English: No dosage adjustments of Hemlibra are recommended.
Croatian: Ne preporučuje se prilagođavati dozu lijeka Hemlibra.
English: Do not use the syringe if the needle touches any surface
Croatian: Nemojte upotrijebiti štrcaljku ako igla dotakne bilo koju površinu.
English: Haem-A_QoL scales range from 0 to 100; lower scores are reflective of better HRQoL.
Croatian: Rezultati upitnika Haem-A-QoL kreću se u rasponu od 0 do 100; niži rezultati odražavaju bolju kvalitetu života vezanu uz zdravlje.
English: Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure.
Croatian: Emicizumab je humanizirano monoklonsko modificirano imunoglobulinsko (IgG4) protutijelo bispecifične strukture.
English: ● Make sure that you use a new injection needle for each injection and dispose of it after a single use.
Croatian: Za svaku injekciju obavezno upotrijebite novu iglu i bacite je nakon samo jedne uporabe.
English: Use only recommended places for injection.
Croatian: Primijenite injekciju samo u preporučena mjesta.
English: No patients with such characteristics were enrolled in clinical trials.
Croatian: U klinička ispitivanja nije bio uključen nijedan bolesnik s takvim značajkama.
English: Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Croatian: Tablica 3 Karakterizacija liječenja aPCC-om* temeljem objedinjenih kliničkih ispitivanja faze III
English: 6 mg/kg every four weeks
Croatian: 6 mg/kg svaka četiri tjedna
English: If a patient misses a scheduled subcutaneous injection of Hemlibra, the patient should be instructed to take the missed dose as soon as possible, up to a day before the day of the next scheduled dose.
Croatian: Ako bolesnik propusti primijeniti supkutanu injekciju lijeka Hemlibra, treba ga uputiti da propuštenu dozu primijeni što je prije moguće, a najkasnije dan prije dana primjene sljedeće planirane doze.
English: Following single subcutaneous injection in healthy subjects, the elimination half-life was approximately 4 to 5 weeks.
Croatian: Poluvrijeme eliminacije nakon jedne supkutane injekcije u zdravih ispitanika iznosilo je približno 4 - 5 tjedana.
English: Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment beyond a maximum of 100 U/kg in the first 24-hours.
Croatian: Nadležni liječnici moraju pažljivo odvagnuti rizik od TMA i tromboembolije u odnosu na rizik od krvarenja kada razmatraju liječenje aPCC-om u dozi većoj od maksimalnih 100 jedinica/kg tijekom prva 24 sata.
English: ● or with severe haemophilia A who have not developed factor VIII inhibitors (the FVIII blood level is less than 1%).
Croatian: ● koji imaju tešku hemofiliju A i u kojih su se nisu razvili inhibitori faktora VIII (razina faktora VIII u krvi manja od 1%)
English: Selecting and preparing an injection site:
Croatian: Odabir i priprema mjesta za injiciranje:
English: When people have this condition, the lining of the blood vessels can be damaged and blood clots may develop in small blood vessels.
Croatian: Kod osoba s ovim stanjem može doći do oštećenja unutarnje stijenke krvnih žila i stvaranja krvnih ugrušaka u malim krvnim žilama.
English: Roche Austria GmbH Engelhorngasse 3 A-1211 Wien Austria
Croatian: Roche Austria GmbH Engelhorngasse 3 A-1211 Beč Austrija
English: ADRs from the phase III clinical trials in patients who received Hemlibra are listed by MedDRA system organ class (Table 2).
Croatian: Nuspojave iz kliničkih ispitivanja faze III zabilježene u bolesnika koji su primali lijek Hemlibra navedene su prema MedDRA organskim sustavima (Tablica 2).
English: Note: Used for withdrawing medicine from the vial to the syringe.
Croatian: Napomena: Koristi se za izvlačenje lijeka iz bočice u štrcaljku.
English: The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]).
Croatian: Djelotvornost lijeka Hemlibra za rutinsku profilaksu u bolesnika s hemofilijom A i inhibitorima FVIII ili bez njih ocjenjivala se u četirima kliničkim ispitivanjima (tri ispitivanja u odraslih i adolescenata [HAVEN 3, HAVEN 1 i HAVEN 4] i jednom ispitivanju u pedijatrijskih bolesnika [HAVEN 2]).