FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are not sure when to inject TAKHZYRO after a missed dose, ask your doctor, pharmacist or nurse.
Croatian: Ako niste sigurni kada morate primiti TAKHZYRO nakon propuštene doze, upitajte svog liječnika, ljekarnika ili medicinsku sestru.
English: Increased plasma kallikrein activity leads to angioedema attacks in patients with HAE through the proteolysis of high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin.
Croatian: Povećana aktivnost plazmatskog kalikreina dovodi do napadaja angioedema u bolesnika s HAE-om putem proteolize kininogena velike molekulske mase (engl. high-molecular-weight-kininogen, HMWK) čime nastaje odcijepljen (engl. cleaved) HMWK (cHMWK) i bradikinin.
English: Results are from a Poisson regression model accounting for over dispersion with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and the logarithm of time in days each subject was observed during the treatment period as an offset variable in the model.
Croatian: Rezultati se odnose na model Poissonove regresije što objašnjava varijabilnu raspršenost kod fiksnih učinaka u terapijskoj skupini (kategorična varijabla) i normaliziranu početnu stopu napadaja (kontinuirana varijabla) te logaritam vremena u danima u kojima je svaki ispitanik promatran tijekom razdoblja liječenja kao varijablu odstupanja u modelu.
English: The solution should be clear or slightly yellow.
Croatian: Otopina treba biti bistra ili blago žuta.
English: Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.
Croatian: Na temelju karakteristika lanadelumaba, ne očekuju se farmakokinetičke interakcije s istodobno primijenjenim lijekovima.
English: In a population pharmacokinetic analysis, after correcting for body weight, no influence of gender or age (12 to 75 years) was apparent on the clearance or volume of distribution of lanadelumab.
Croatian: U analizi populacijske farmakokinetike, nakon korekcije za tjelesnu težinu, nije bio vidljiv utjecaj spola ili dobi (od 12 do 75 godina) na klirens ili volumen distribucije lanadelumaba.
English: The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system.
Croatian: Reagensi koji se koriste u laboratorijskom testu aPTT-a pokreću intrinzičnu koagulaciju aktivacijom plazmatskog kalikreina u kontaktnom sustavu.
English: Lanadelumab had no effect on male or female fertility in cynomolgus monkeys (see section 5.3).
Croatian: Lanadelumab nije imao učinka na mušku ili žensku plodnost u makaki majmuna (vidjeti dio 5.3).
English: TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4)
Croatian: TAKHZYRO nije namijenjen za liječenje akutnih napadaja HAE-a (vidjeti dio 4.4).
English: Do not use the vial if the cap covering the stopper is missing.
Croatian: Nemojte upotrijebiti bočicu ako nedostaje poklopac koji pokriva čep bočice.
English: Lanadelumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Croatian: Lanadelumab je terapijsko monoklonsko protutijelo i ne očekuje se da će se vezati na proteine plazme.
English: Do not use TAKHZYRO:
Croatian: Nemojte primjenjivati TAKHZYRO:
English: Do not shake the vial as this can cause foaming.
Croatian: Nemojte tresti bočicu jer bi to moglo dovesti do stvaranja pjene.
English: As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor (see section 5.1).
Croatian: Kako je i očekivano, istodobna primjena lijeka za hitno ublažavanje simptoma, inhibitora C1-esteraze, rezultira aditivnim učinkom na odgovor lanadelumab-cHMWK na temelju mehanizma djelovanja lanadelumaba i inhibitora C1-esteraze (vidjeti dio 5.1).
English: The absolute bioavailability of lanadelumab after subcutaneous administration has not been determined.
Croatian: Apsolutna bioraspoloživost lanadelumaba nakon supkutane primjene nije bila ustanovljena.
English: No dedicated drug-drug interaction studies have been conducted.
Croatian: Nisu provedena posebna ispitivanja interakcija lijekova.
English: The PK-PD relationship between TAKHZYRO and cHMWK is described by an indirect exposureresponse pharmacological model.
Croatian: Farmakokinetički i farmakodinamički odnos između lijeka TAKHZYRO i cHMWK-a opisan je farmakološkim modelom neizravne izloženosti i odgovora.
English: Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection.
Croatian: Zamijenite iglu na štrcaljki iglom promjera 27G ili drugom iglom prikladnom za supkutanu injekciju.
English: Treatment period (Day 0 to Day 182, 26 weeks) n Attack free
Croatian: Razdoblje liječenja (od 0. do 182. dana, 26 tjedana)
English: Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%), see section 4.4.
Croatian: Primijećena je (1,2%) i reakcija preosjetljivosti (blagi i umjereni pruritus, nelagoda i trnci u jeziku), vidjeti dio 4.4.
English: Lanadelumab is a fully human, monoclonal antibody (IgG1/ κ-light chain).
Croatian: Lanadelumab je potpuno ljudsko monoklonsko protutijelo (IgG1/ kapa laki lanac).
English: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay.
Croatian: Lanadelumab može produljiti aktivirano parcijalno tromboplastinsko vrijeme (aPTT) zbog interakcije lanadelumaba i aPTT testa.
English: AE-QoL Total score
Croatian: AE-QoL ukupni rezultat
English: Important: Inject TAKHZYRO within 2 hours of preparing the dosing syringe at room temperature.
Croatian: Važno: Lijek TAKHZYRO treba primijeniti u roku od 2 sata nakon pripreme dozirne štrcaljke na sobnoj temperaturi.
English: Important: Be sure to keep the tip of the needle in the liquid to avoid drawing air in as you pull back the plunger.
Croatian: Važno: Pazite da vrh igle bude u tekućini kako bi se izbjeglo uvlačenje zraka kada povlačite klip.
English: *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: *Lanadelumab je proizveden u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: In addition to the vial, each TAKHZYRO pack also contains:
Croatian: Osim bočice, jedno pakiranje lijeka TAKHZYRO sadrži:
English: Endpoint statistics a
Croatian: Statistika mjere ishoda a
English: Alternatively, you can place the dosing syringe in a refrigerator at 2°C to 8°C and you must use it within 8 hours.
Croatian: U protivnom, pripremljenu dozirnu štrcaljku možete pohraniti u hladnjak na temperaturu od 2°C do 8°C, ali je morate primijeniti u roku od 8 sati.
English: Solution for injection 1 vial of 2 ml
Croatian: otopina za injekciju 1 bočica od 2 ml
English: This is so that you keep a record of the batches used.
Croatian: To je potrebno kako biste imali zabilježenu svaku seriju lijeka koju ste upotrijebili.
English: Store in a refrigerator (2C-8C).
Croatian: Čuvati u hladnjaku (2C-8C).
English: The ADA response was transient in 20% (2/10) of ADA positive subjects.
Croatian: Odgovor protutijela na lijek bio je prolazan u 20% (2/10) ispitanika pozitivnih na protutijela.
English: TAKHZYRO is intended for subcutaneous (SC) administration only.
Croatian: TAKHZYRO je namijenjen samo za supkutanu (s.c.) primjenu.
English: All TAKHZYRO treatment arms produced statistically significant reductions in the mean HAE attack rate compared to placebo across all primary and secondary endpoints in the Intent-to-Treat population (ITT) (Table 2).
Croatian: U svim terapijskim skupinama lijek TAKHZYRO doveo je do statistički značajnih smanjenja srednje vrijednosti stope napadaja HAE-a u usporedbi s placebom u svim mjerama primarnog i sekundarnog ishoda u populaciji planiranoj za liječenje (ITT) (tablica 2).
English: As IgG monoclonal antibodies are mainly eliminated via intracellular catabolism, renal impairment or hepatic impairment is not expected to influence clearance of lanadelumab.
Croatian: Budući da se IgG monoklonska protutijela uglavnom eliminiraju putem unutarstaničnog katabolizma, ne očekuje se da će oštećenje funkcije jetre ili bubrega utjecati na klirens lanadelumaba.
English: Step 4: Select and prepare injection site a) Choose an injection site on your stomach
Croatian: 4. korak: izaberite i pripremite mjesto za primjenu injekcije a) Izaberite mjesto u koje ćete primijeniti injekciju na trbuhu (abdomen), bedru ili nadlaktici.
English: The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising.
Croatian: Najčešće (52,4%) primijećene nuspojave povezane s lijekom TAKHZYRO bile su reakcije na mjestu primjene injekcije uključujući bol na mjestu primjene injekcije, eritem i modricu na mjestu primjene injekcije.
English: • The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and water for injections - see section 2 “TAKHZYRO contains sodium” What TAKHZYRO looks like and contents of the pack
Croatian: Drugi sastojci su natrijev hidrogenfosfat dihidrat, citratna kiselina hidrat, histidin, natrijev klorid, polisorbat 80 i voda za injekcije - pogledajte dio 2 „TAKHZYRO sadrži natrij”.
English: TAKHZYRO is not intended for treatment of acute HAE attacks.
Croatian: TAKHZYRO nije namijenjen za liječenje akutnih napadaja HAE-a.
English: No dedicated studies have been conducted to evaluate the pharmacokinetics of lanadelumab in special patient populations including gender, age, pregnant women or the presence of renal or hepatic impairment.
Croatian: Nisu provedena posebna ispitivanja za procjenu farmakokinetike lanadelumaba u posebnim populacijama bolesnika s obzirom na spol, dob, trudnoću ili prisutnost oštećenja funkcije jetre ili bubrega.
English: None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events.
Croatian: Nijedno produljenje aPTT-a u bolesnika liječenih lijekom TAKHZYRO nije bilo povezano sa štetnim događajima abnormalnog krvarenja.
English: TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.
Croatian: TAKHZYRO može bolesnik dati sam sebi ili ga bolesniku može dati njegovatelj, ali tek nakon uvježbavanja tehnike davanja s.c. injekcije koje provede zdravstveni radnik.
English: Note: CI=confidence interval; LS=least squares.
Croatian: Napomena: CI=interval pouzdanosti.
English: The site of SC injection (thigh, arm, or abdomen) and self-administration did not affect the absorption of lanadelumab.
Croatian: Mjesto primjene s.c. injekcije (bedro, ruka ili abdomen) te samoprimjena nisu utjecali na apsorpciju lanadelumaba.
English: a) Take the vial out of the refrigerator 15 minutes before use to allow it to reach room temperature (15°C to 25°C) before preparing an injection.
Croatian: 1. korak: pripremite bočicu lijeka TAKHZYRO a) Izvadite bočicu iz hladnjaka 15 minuta prije upotrebe kako bi dosegla sobnu temperaturu (od 15°C do 25°C) prije nego što počnete pripremati injekciju.
English: In the ePPND study in pregnant cynomolgus monkeys administered once weekly doses of 10 or 50 mg/kg (highest dose tested), there were no lanadelumab-related effects on pregnancy and parturition, embryo-foetal development, survival, growth, and/or postnatal development of offspring.
Croatian: U ispitivanju ePPND provedenom u skotnih makaki majmunica kojima su jednom tjedno primjenjivane doze od 10 ili 50 mg/kg (najviša ispitana doza), nije bilo učinaka na trudnoću, okot, embriofetalni razvoj, preživljenje, rast i/ili postnatalni razvoj potomstva povezanih s lanadelumabom.
English: d) Remove large air bubbles by gently tapping on the syringe with your fingers until the bubbles rise to the top of the syringe.
Croatian: d) Kako bi se uklonili veliki mjehurići zraka, lagano prstima lupkajte po štrcaljki sve dok se mjehurići zraka ne podignu u vrh štrcaljke.
English: Pull back on the plunger to withdraw the full dose in the vial.
Croatian: Povucite klip prema natrag kako biste izvukli punu dozu iz bočice.
English: TAKHZYRO total
Croatian: TAKHZYRO ukupno
English: TAKHZYRO has negligible influence on the ability to drive or use machines.
Croatian: TAKHZYRO zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.
Croatian: Ne čini se da razvoj protutijela na lijek, uključujući neutralizirajuća protutijela protiv lijeka TAKHZYRO, štetno utječe na farmakokinetički i farmakodinamički profil ili klinički odgovor.
English: b) Pull back the plunger to fill the syringe with air equal to the amount of solution in the vial.
Croatian: b) Povucite klip prema natrag kako bi se štrcaljka ispunila zrakom u količini jednakoj količini otopine u bočici.
English: This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).
Croatian: Liječenje ovim lijekom treba započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s hereditarnim angioedemom (HAE).
English: Clean the vial rubber stopper with an alcohol wipe and allow it to dry.
Croatian: Očistite gumeni čep bočice alkoholnom maramicom i ostavite da se osuši.
English: What hereditary angioedema (HAE) is
Croatian: Što je hereditarni angioedem
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles in this pack or which your doctor has prescribed.
Croatian: Upotrebljavajte samo štrcaljke, igle tupog vrha za uvođenje u bočicu i igle zašiljenog vrha za injekciju koje se nalaze u ovom pakiranju ili koje Vam je propisao liječnik.
English: TAKHZYRO should be administered within 2 hours of preparing the dosing syringe.
Croatian: TAKHZYRO treba primijeniti unutar 2 sata od pripreme dozirne štrcaljke.
English: Solutions that are discoloured or contain particles should not be used.
Croatian: Otopine koje su promijenile boju ili sadrže čestice ne smiju se upotrijebiti.
English: No dose adjustment is required for patients above 65 years of age (see section 5.2).
Croatian: U bolesnika starijih od 65 godina nije potrebna prilagodba doze (vidjeti dio 5.2).
English: TAKHZYRO is a medicine used in adults, and adolescents aged 12 years and older to prevent angioedema attacks, in patients with HAE.
Croatian: TAKHZYRO je lijek za primjenu u odraslih i adolescenata u dobi od 12 godina i starijih, kako bi se u bolesnika s hereditarnim angioedemom spriječili napadaji angioedema.
English: In a 13-week study, once weekly SC administration of lanadelumab had no effects on male or female fertility at doses of 10 or 50 mg/kg (highest dose tested).
Croatian: U ispitivanju od 13 tjedana, s.c. primjena lanadelumaba jednom tjedno nije imala učinaka na plodnost mužjaka ili ženki pri dozama od 10 ili 50 mg/kg (najviša ispitana doza).
English: • TAKHZYRO is for injection under the skin (‘subcutaneous injection').
Croatian: TAKHZYRO je namijenjen za ubrizgavanje pod kožu (potkožna injekcija).
English: Keeping a record
Croatian: Vođenje evidencije
English: Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.
Croatian: Lanadelumab omogućava neprekidnu kontrolu aktivnosti plazmatskog kalikreina i time ograničava stvaranje bradikinina u bolesnika s HAE-om.
English: • Talk to your doctor, pharmacist or nurse before using TAKHZYRO.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite TAKHZYRO.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP ili „Rok valjanosti“.
English: HELP study
Croatian: Ispitivanje HELP
English: Lanadelumab's effect on fertility has not been evaluated in humans.
Croatian: Učinak lanadelumaba na plodnost nije procjenjivan u ljudi.
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Upute za primjenu
English: In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
Croatian: U bolesnika koji su uz terapiju postojano bez napadaja može se razmotriti smanjenje doze lanadelumaba na 300 mg svaka 4 tjedna, a osobito u bolesnika male tjelesne težine.
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy and breast-feeding.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lanadelumaba tijekom trudnoće i dojenja.
English: **Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
Croatian: **Reakcije na mjestu primjene injekcije uključuju: bol, eritem, modrice, nelagodu, hematom, krvarenje, pruritus, oticanje, induraciju, paresteziju, reakciju, toplinu, edem i osip.
English: All TAKHZYRO treatment groups observed an improvement in Angioedema Quality of Life Questionnaire (AE-QoL) total and domain (functioning, fatigue/mood, fear/shame, and nutrition) scores compared to the placebo group; the largest improvement was observed in the functioning score as shown in Table 4.
Croatian: Angioedema Quality of Life Questionnaire, AE-QoL), promatrano ukupno te u rezultatima domena (funkcioniranje, umor/raspoloženje, strah/sram i prehrana), u usporedbi sa skupinom koja je primala placebo; najveće poboljšanje opaženo je u rezultatu funkcioniranja kao što pokazuje tablica 4. Smanjenje od 6 bodova smatra se klinički značajnim poboljšanjem.
English: As a precautionary measure, it is preferable to avoid the use of lanadelumab during pregnancy.
Croatian: Kao mjera opreza preporučuje se izbjegavati primjenu lanadelumaba tijekom trudnoće.
English: g) Remove the plastic cap from the vial.
Croatian: g) Uklonite s bočice plastični poklopac.
English: Disodium phosphate dihydrate Citric acid monohydrate Histidine
Croatian: Natrijev hidrogenfosfat dihidrat Citratna kiselina hidrat Histidin
English: Name and address of the manufacturer(s) of the biological active substance(s) Rentschler Biopharma SE
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari Rentschler Biopharma SE
English: Ireland
Croatian: IRSKA
English: IRELAND
Croatian: Irska
English: During the study run-in period, the mean attack rate was 3.7 attacks/month with 52% (65/125) of subjects experiencing ≥3 attacks/month.
Croatian: Tijekom uvodnog razdoblja prije početka ispitivanja (engl. run-in), srednja vrijednost stope napadaja iznosila je 3,7 napadaja mjesečno s time da je 52% (65/125) ispitanika imalo ≥3 napadaja mjesečno.
English: In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication.
Croatian: U slučaju probojnog napadaja HAE-a, potrebno je započeti individualizirano liječenje odobrenim lijekom za hitno ublažavanje simptoma.
English: The effects of lanadelumab on fertility were evaluated in sexually mature cynomolgus monkeys.
Croatian: Učinci lanadelumaba na plodnost procijenjeni su u spolno zrelih makaki majmuna.
English: TAKHZYRO is not recommended for use in children under 12 years of age.
Croatian: Ne preporučuje se primjena lijeka TAKHZYRO u djece mlađe od 12 godina.
English: Do not pull on the plunger.
Croatian: Ne gurajte klip.
English: In repeat-dose studies evaluating once weekly SC injection in both rats (up to 28 days) and cynomolgus monkeys (up to 6 months) lanadelumab was well-tolerated at doses of up to and including 50 mg/kg (highest dose tested) with no organs of toxicity identified.
Croatian: U ispitivanjima ponovljene doze u kojima se s.c. injekcija jednom tjedno procjenjivala u štakora (do 28 dana) i makaki majmuna (do 6 mjeseci) lanadelumab se dobro podnosio pri dozama do i uključujući 50 mg/kg (najviša ispitana doza) i nisu ustanovljene toksičnosti za organe.
English: HELP study extension
Croatian: Produžetak ispitivanja HELP
English: Step 3: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle a) Insert the needle into the centre of the rubber stopper.
Croatian: 3. korak: izvucite TAKHZYRO u štrcaljku i zamijenite iglu onom zašiljenog vrha za injekciju a) Uvucite iglu kroz sredinu gumenog čepa.
English: All needles and syringes should be disposed of in a sharps container.
Croatian: Sve igle i štrcaljke potrebno je odložiti u spremnik za oštre predmete.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects.
Croatian: Obratite se liječniku, ljekarniku ili medicinskoj sestri ako opazite neku od sljedećih nuspojava.
English: • Reactions where the injection is given - symptoms include pain, skin redness, bruising, discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.
Croatian: reakcije na mjestu primjene injekcije - simptomi uključuju bol, crvenilo kože, modricu, nelagodu, oticanje, krvarenje, svrbež, otvrdnuće kože, trnce, toplinu i osip.
English: Percentage of subjects who were attack free through treatment
Croatian: Postotak ispitanika koji nisu imali napadaje do kraja razdoblja liječenja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA POJEDINAČNOG PAKIRANJA
English: If a dose of TAKHZYRO is missed, the patient should be instructed to administer the dose as soon as possible ensuring at least 10 days between doses.
Croatian: U slučaju propuštene doze lijeka TAKHZYRO bolesniku je potrebno savjetovati da dozu primijeni što prije, s tim da razmak između doza mora biti najmanje 10 dana.
English: • Use each vial of TAKHZYRO only once.
Croatian: Bočicu lijeka TAKHZYRO upotrijebite samo jedanput.
English: Store in a refrigerator (2C to 8C).
Croatian: Čuvati u hladnjaku (2C - 8C).
English: Rotation of the injection site is recommended.
Croatian: Preporučuje se mijenjati mjesta primjene injekcije.
English: What TAKHZYRO is and what it is used for
Croatian: Što je TAKHZYRO i za što se koristi
English: There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.
Croatian: Nema kliničkih podataka o primjeni lanadelumaba u bolesnika s HAE-om i normalnom aktivnosti proteina C1-INH.
English: What you need to know before you use TAKHZYRO
Croatian: Što morate znati prije nego počnete primjenjivati TAKHZYRO
English: A total of 212 adult and adolescent subjects with symptomatic type I or II HAE received at least one dose of lanadelumab in this study, including 109 subjects who entered as rollover subjects from the HELP study and 103 new or non-rollover subjects (including 19 subjects from Phase1b study) who had an historical baseline attack rate of ≥1 attack per 12 weeks Subjects were allowed to initiate self-administration after receiving the first 2 doses from a health care professional in clinic and completing appropriate training.
Croatian: I ili II primilo je najmanje jednu dozu lanadelumaba, uključujući 109 ispitanika koji su sudjelovanje u ovom ispitivanju nastavili nakon ispitivanja HELP te 103 nova ispitanika ili ispitanika koji nisu prethodno sudjelovali u ispitivanju HELP (uključujući 19 ispitanika iz ispitivanja faze 1b) koji su kao povijesnu početnu stopu napadaja imali ≥1 napadaj u 12 tjedana.
English: c) Slowly turn the vial upside down with needle and syringe attached.
Croatian: c) Polako okrenite bočicu naopako zajedno s iglom i štrcaljkom.
English: Slowly push the plunger, allowing air to go back into the vial, until the solution reaches the top of the syringe.
Croatian: Polako gurajte klip tako da se zrak vrati u bočicu i nastavite sve dok otopina ne dosegne vrh štrcaljke.