FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported ISR symptoms were injection site erythema (11 %), injection site pain (4 %) and injection site pruritus (3 %).
Croatian: Najčešće prijavljeni simptomi reakcija na mjestu injiciranja bili su eritem na mjestu injiciranja (11%), bol na mjestu injiciranja (4%) i pruritus na mjestu injiciranja (3%).
English: ● A child can self-inject the medicine provided the child's healthcare provider and the parent or caregiver agree.
Croatian: Dijete može samostalno injicirati lijek ako se njegov liječnik i roditelj ili njegovatelj s tim slože.
English: Dose linearity
Croatian: Linearnost doze
English: During treatment with Hemlibra, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites.
Croatian: Tijekom liječenja lijekom Hemlibra poželjno je druge lijekove za supkutanu primjenu injicirati na drugim anatomskim mjestima.
English: In this Study baseline Total Scores (mean = 41.14 and 44.58, respectively) and Physical Health scale scores (mean = 52.41 and 57.19, respectively) were similar for Hemlibra prophylaxis and no prophylaxis.
Croatian: U ovom su ispitivanju početne vrijednosti ukupnog rezultata (srednja vrijednost = 41,14 odnosno 44,58) i rezultata na ljestvici za ocjenu tjelesnog zdravlja (srednja vrijednost = 52,41 odnosno 57,19) bile slične za skupinu s profilaksom lijekom Hemlibra i za skupinu bez profilakse.
English: All ISRs observed in the Hemlibra clinical trials were reported as being non-serious and mild to moderate in intensity, and 95 % resolved without treatment.
Croatian: Sve reakcije na mjestu injiciranja opažene u kliničkim ispitivanjima lijeka Hemlibra prijavljene su kao nuspojave koje nisu bile ozbiljne te su bile blage do umjerene težine, a 95% njih povuklo se bez liječenja.
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with emicizumab.
Croatian: Kao i kod svih terapijskih proteina, u bolesnika liječenih emicizumabom može doći do imunosnog odgovora.
English: ● Your doctor will show you which areas of the body are suitable for injecting Hemlibra.
Croatian: Liječnik će Vam pokazati koji su dijelovi tijela pogodni za injiciranje lijeka Hemlibra.
English: Chromogenic factor VIII activity tests may be manufactured with either human or bovine coagulation proteins.
Croatian: U proizvodnji kromogenih testova za određivanje aktivnosti faktora VIII mogu se koristiti ljudski ili goveđi koagulacijski proteini.
English: However, the possibility of thrombotic events should be considered when systemic anti-fibrinolytics are used in combination with aPCC or rFVIIa in patients receiving emicizumab.
Croatian: Međutim, treba uzeti u obzir mogućnost nastupa trombotskih događaja kada se sistemski antifibrinolitici primjenjuju u kombinaciji s aPCC-om ili rFVIIa u bolesnika koji primaju emicizumab.
English: ● Be careful not to pull the plunger out of the syringe.
Croatian: Pazite da ne izvučete klip iz štrcaljke.
English: Similar pharmacokinetic profiles were observed following subcutaneous administration in the abdomen, upper arm, and thigh.
Croatian: Slični farmakokinetički profili primijećeni su i nakon supkutane primjene u abdomen, nadlakticu i bedro.
English: At the time of the interim analysis, efficacy was evaluated in 59 patients who were < 12 years old and had been receiving weekly Hemlibra prophylaxis for at least 12 weeks, including four patients aged < 2 years old, 17 patients aged 2 to < 6 years, 38 patients aged 6 to < 12 years old.
Croatian: U trenutku provođenja interim analize djelotvornost se ocjenjivala u 59 bolesnika u dobi od < 12 godina koji su primali tjednu profilaksu lijekom Hemlibra tijekom najmanje 12 tjedana, uključujući četiri bolesnika u dobi od < 2 godine, 17 bolesnika u dobi od 2 do < 6 godina i 38 bolesnika u dobi od 6 do < 12 godina.
English: To measure change in health status, the Index Utility Score (IUS) and the Visual Analog Scale (VAS) from the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) was examined.
Croatian: Promjene zdravstvenog statusa mjerile su se indeksom korisnosti i rezultatom na vizualnoj analognoj ljestvici (engl. visual analogue scale, VAS) iz upitnika EQ-5D-5L (EuroQoL Five-Dimension-Five Levels Questionnaire).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake 'Rok valjanosti' ili 'EXP'.
English: Analyses are based on data from individuals who provided responses at both baseline and Week 25 assessments.
Croatian: Analize se temelje na podacima prikupljenima u osoba koje su ispunile upitnik i pri ocjeni na početku ispitivanja i pri ocjeni u 25. tjednu.
English: Arm B: no prophylaxis
Croatian: Skupina B: bez profilakse
English: Hemlibra is a solution for injection.
Croatian: Hemlibra je otopina za injekciju.
English: The total time the medicine is stored at room temperature should not be more than 7 days.
Croatian: Ukupno vrijeme čuvanja lijeka na sobnoj temperaturi ne smije biti dulje od 7 dana.
English: If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days.
Croatian: Ako se bočice čuvaju izvan hladnjaka i zatim vrate u hladnjak, ukupno vrijeme čuvanja izvan hladnjaka ne smije biti dulje od 7 dana.
English: Emicizumab increases coagulation potential, therefore the FVIIa or FVIII dose required to achieve hemostasis may be lower than when used without Hemlibra prophylaxis.
Croatian: Budući da emicizumab povećava koagulacijski potencijal, doza FVIIa ili FVIII potrebna za postizanje hemostaze bi mogla biti manja nego ona koja se koristi kada nema profilakse lijekom Hemlibra.
English: Caution should be taken if intrinsic pathway clotting based laboratory tests are used, as misinterpretation of their results may lead to under-treatment of patients experiencing bleeding episodes, which can potentially result in severe or life-threatening bleeds.
Croatian: Potreban je oprez ako se koriste laboratorijski testovi koji se temelje na unutarnjem putu zgrušavanja, jer pogrešno tumačenje njihovih rezultata može dovesti do nedostatnog liječenja bolesnika s epizodama krvarenja,
English: There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment.
Croatian: Dostupni su ograničeni podaci o primjeni lijeka Hemlibra u bolesnika s umjerenim oštećenjem bubrežne funkcije (samo 2 bolesnika s CLcr od 30 - 59 ml/min), dok o njegovoj primjeni u bolesnika s teškim oštećenjem bubrežne funkcije nema podataka.
English: The dose and duration of treatment with bypassing agents will depend on the location and extent of bleeding, and the patient's clinical condition.
Croatian: Doza i trajanje liječenja lijekovima koji zaobilaze akivnost faktora VIII ovisit će o lokaciji i opsegu krvarenja te bolesnikovu kliničkom stanju.
English: The corresponding frequency categories for each ADR are based on 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) and not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (³ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The mean exposure time (+SD) for all patients on study was 21.38 weeks (12.01).
Croatian: Srednja vrijednost vremena izloženosti (+ standardno odstupanje) za sve bolesnike u ispitivanju iznosila je 21,38 tjedana (12,01).
English: For more information on using aPCC while receiving Hemlibra, see in section 2: “Potentially serious side effects of using aPCC while receiving Hemlibra”.
Croatian: Za više informacija o primjeni aPCC-a tijekom liječenja lijekom Hemlibra pogledajte odlomak ‘Potencijalno ozbiljne nuspojave kod primjene aPCC-a dok se liječite lijekom Hemlibra' u dijelu 2.
English: b Efficacy data from treated patients aged < 12 years who had been on study HAVEN 2 for at least 12 weeks (N = 59), as the study aimed to primarily investigate treatment effect based on age.
Croatian: Podaci o djelotvornosti u liječenih bolensika u dobi od < 12 godina koji su proveli najmanje 12 tjedana u ispitivanju HAVEN 2 (N = 59), u kojem je primarni cilj bio istražiti terapijski učinak s obzirom na dob.
English: What Hemlibra is
Croatian: Što je Hemlibra
English: Coagulation laboratory tests based on intrinsic clotting, including the activated clotting time (ACT), activated partial thromboplastin time (e.g. aPTT), measure the total clotting time including time needed for activation of FVIII to FVIIIa by thrombin.
Croatian: Laboratorijski testovi koagulacije koj se temelje na unutarnjem putu zgrušavanja, uključujući testove za određivanje aktiviranog vremena zgrušavanja (engl. activated clotting time, ACT) i aktiviranog parcijalnog tromboplastinskog vremena (npr. aPTV), mjere ukupno vrijeme zgrušavanja, uključujući vrijeme potrebno da se FVIII djelovanjem trombina aktivira u
English: It is important to know the symptoms of thrombotic microangiopathy, in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms).
Croatian: Važno je da znate simptome trombotske mikroangiopatije za slučaj da se ona razvije kod Vas (pogledajte dio 4., ‘Moguće nuspojave' za popis simptoma).
English: - Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment.
Croatian: Nadležni liječnici moraju pažljivo odvagnuti rizik od TMA i tromboembolije u odnosu na rizik od krvarenja kada razmatraju liječenje aPCC-om.
English: If you forget to use Hemlibra
Croatian: Ako ste zaboravili primijeniti lijek Hemlibra
English: ● Do not touch the needle tip or allow it to touch any surface.
Croatian: Nemojte dodirivati vrh igle niti dopustiti da dotakne bilo koju površinu.
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included 5 infants (≥ 1 month to < 2 years), 55 children (less than 12 years) and 50 adolescents (12 to < 18 years) with haemophilia A. Age did not affect the pharmacokinetics of emicizumab in paediatric patients.
Croatian: Učinak dobi na farmakokinetiku emicizumaba ocjenjivao se u populacijskoj farmakokinetičkoj analizi koja je obuhvatila 5 dojenčadi/male djece (u dobi od ≥ 1 mjeseca do < 2 godine), 55 djece (mlađe od 12 godina) i 50 adolescenata (u dobi od 12 do < 18 godina) s hemofilijom A. Dob nije utjecala na farmakokinetiku emicizumaba u pedijatrijskih bolesnika.
English: For injection, you can use your:
Croatian: Injekciju možete primijeniti u:
English: Women of childbearing potential receiving Hemlibra should use effective contraception during, and for at least 6 months after cessation of Hemlibra treatment (see section 5.2).
Croatian: Žene reproduktivne dobi koje primaju lijek Hemlibra moraju koristiti učinkovitu kontracepciju tijekom liječenja i još najmanje 6 mjeseci nakon prestanka liječenja lijekom Hemlibra (vidjeti dio 5.2).
English: If you stop using Hemlibra
Croatian: Ako prestanete primjenjivati lijek Hemlibra
English: No adequate or well-controlled drug-drug interaction studies have been conducted with emicizumab.
Croatian: Nisu provedena odgovarajuća ni dobro kontrolirana ispitivanja interakcija između emicizumaba i drugih lijekova.
English: Despite limited experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that there may be a possibility of thrombotic events using anti-fibrinolytics administered intravenously in combination with aPCC or rFVIIa.
Croatian: Unatoč tome što je iskustvo s istodobnom primjenom antifibrinolitičkih lijekova i aPCC-a ili rFVIIa u bolesnika liječenih lijekom Hemlibra ograničeno, trebate znati da može postojati mogućnost trombotskih događaja kada se antifibrinolitički lijekovi primijenjeni u venu koriste u kombinaciji s aPCC-om ili rFVIIa.
English: ● If you do not have a sharps disposal container, you may use a household container that is: - made of heavy-duty plastic.
Croatian: Ako nemate spremnik za odlaganje oštrih predmeta, možete upotrijebiti kantu za kućni otpad: - koja je načinjena od izdržljive plastike
English: All patients were treated by hemophilia experts who confirmed that adequate FVIII propylaxis was administered to patients included in the intra-patient comparison, supporting equivalent usual prophylaxis care across sites and patients.
Croatian: Sve su bolesnike liječili stručnjaci za hemofiliju koji su potvrdili da su bolesnici obuhvaćeni intraindividualnom usporedbom primili odgovarajuću profilaksu faktorom VIII, čime je potvrđeno da je na svim ispitivačkim mjestima i kod svih bolesnika primijenjeno ekvivalentno uobičajeno profilaktičko liječenje.
English: Emicizumab remains active in the presence of inhibitors against factor VIII and so will produce a false negative result in clotting based Bethesda assays for functional inhibition of factor VIII.
Croatian: Emicizumab ostaje aktivan u prisutnosti inhibitora faktora VIII, pa će uzrokovati lažno negativan nalaz na funkcionalnu inhibiciju faktora VIII u Bethesda testovima koji se temelje na zgrušavanju.
English: This is because you may be at risk of developing side effects such as blood clots.
Croatian: Naime, može postojati rizik od razvoja nuspojava poput krvnih ugrušaka.
English: The physician educational material should contain:
Croatian: Edukacijski materijal za liječnike treba sadržavati:
English: When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
Croatian: Prilikom praćenja podležeće hemostatske aktivnosti kod bolesnika, potrebno je vidjeti dio 4.4 za informacije o laboratorijskim testovima na koje emicizumab ne utječe.
English: Forty one patients ≥ 12 years old were evaluated for efficacy with a median observation time of 25.6 weeks (range 24.1-29.4).
Croatian: Djelotvornost se ocjenjivala u 41 bolesnika u dobi od ≥ 12 godina, a medijan vremena promatranja iznosio je 25,6 tjedana (raspon: 24,1 - 29,4).
English: The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Croatian: Ukupan volumen lijeka Hemlibra koji treba injicirati supkutano izračunava se na sljedeći način: Ukupna količina (mg) emicizumaba koju treba primijeniti ÷ koncentracija lijeka u bočici (mg/ml) = ukupan volumen lijeka Hemlibra (ml) koji treba injicirati.
English: Mean (±95% CI) plasma emicizumab concentration versus time profiles for patients ≥ 12 years (studies HAVEN 1 and HAVEN 3) compared with patients < 12 years (study HAVEN 2)
Croatian: Slika 1 Profili srednjih vrijednosti (± 95% CI) plazmatskih koncentracija emicizumaba kroz vrijeme u bolesnika u dobi od ≥ 12 godina (ispitivanja HAVEN 1 i HAVEN 3) u usporedbi s onima u bolesnika u dobi od < 12 godina (ispitivanje HAVEN 2)
English: Bleeds a Calculated with negative binomial regression (NBR) model b
Croatian: Izračunato primjenom modela negativne binomne regresije (NBR).
English: What Hemlibra contains
Croatian: Što Hemlibra sadrži
English: Patients in Arm C could switch to Hemlibra (3 mg/kg every two weeks) after completing at least 24 weeks without prophylaxis.
Croatian: Bolesnici u skupini C mogli su prijeći na lijek Hemlibra (3 mg/kg svaka dva tjedna) nakon najmanje 24 tjedna bez profilakse.
English: From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stanovišta, nakon prijenosa iz bočice u štrcaljku, lijek treba primijeniti odmah.
English: The developing hemostatic system in neonates and infants is dynamic and evolving, and the relative concentrations of pro- and anticoagulant proteins in these patients should be taken into consideration when making a benefit-risk assessment, including potential risk of thrombosis (e.g. central venous catheter-related thrombosis).
Croatian: Hemostatski sustav novorođenčadi i dojenčadi je dinamičan i razvija se, stoga pri ocjenjivanju koristi i rizika liječenja u tih bolesnika treba uzeti u obzir relativne koncentracije prokoagulacijskih i antikoagulacijskih proteina, kao i mogući rizik od tromboze (npr. tromboze povezane s centralnim venskim kateterom).
English: ● Peel off back to open the blister pack.
Croatian: Odlijepite stražnji pokrov da biste otvorili blister pakiranje.
English: The metabolism of emicizumab has not been studied.
Croatian: Nisu provedena ispitivanja metabolizma emicizumaba.
English: ● You must inject Hemlibra only under the skin.
Croatian: ● Lijek Hemlibra morate injicirati isključivo pod kožu.
English: ● Keep your fingers behind the safety shield and away from the needle at all times.
Croatian: Prste u svakom trenutku držite iznad sigurnosnog pokrova i podalje od igle.
English: Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis.
Croatian: Emicizumab premošćuje aktivirani faktor IX i faktor X i tako ponovno uspostavlja funkciju nedostajućeg aktiviranog faktora VIII potrebnu za učinkovitu hemostazu.
English: Arm D:
Croatian: Skupina D:
English: Hemlibra contains the active substance “emicizumab”.
Croatian: Hemlibra sadrži djelatnu tvar ‘emicizumab'.
English: Move the tip of the needle above the medicine and slowly push the plunger up to push the air bubbles out of the syringe.
Croatian: Pomaknite vrh igle iznad razine lijeka i polako pritisnite klip prema gore da istisnete mjehuriće zraka iz štrcaljke.
English: Hemlibra restores the function of missing activated factor VIII that is needed for effective blood clotting.
Croatian: Hemlibra ponovno uspostavlja funkciju nedostajućeg aktiviranog faktora VIII, koji je neophodan za učinkovito zgrušavanje krvi.
English: Most of the patients with hemophilia A in the population pharmacokinetic analysis had normal renal function (N = 332; creatinine clearance [CLcr] ≥ 90 mL/min) or mild renal impairment (N = 27; CLcr of 60-89 mL/min).
Croatian: Većina bolesnika s hemofilijom A u populacijskoj farmakokinetičkoj analizi imala je normalnu bubrežnu funkciju (N = 332; klirens kreatinina [CLcr] ≥ 90 ml/min) ili blago oštećenje bubrežne funkcije (N = 27; CLcr od 60 - 89 ml/min).
English: For more information, see in section 6 “What is needed for Hemlibra administration and is not contained in this pack”.
Croatian: Za više informacija pogledajte odlomak ‘Pribor potreban za primjenu lijeka Hemlibra koji nije uključen u pakiranje' u dijelu 6.
English: Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors).
Croatian: Profilaktička terapija lijekom Hemlibra skraćuje aPTV i uvećava prikazanu aktivnost faktora VIII (što je utvrđeno kromogenim testom s ljudskim faktorima koagulacije).
English: Do not remove the vial adapter from the clear plastic blister pack.
Croatian: Nemojte izvaditi nastavak za bočicu iz prozirnog plastičnog blistera.
English: In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt Hemlibra prophylaxis as clinically indicated.
Croatian: U slučaju trombotičkih komplikacija liječnik treba razmotriti prekid primjene rFVIIa ili FVIII te privremeno prekinuti profilaksu lijekom Hemlibra ako je to klinički indicirano.
English: ● Slowly inject all of the medicine by gently pushing the plunger all the way down.
Croatian: Polako injicirajte sav lijek lagano pritišćući klip sve do kraja.
English: ● Outer area of the upper arm (only if a caregiver is giving the injection).
Croatian: ● vanjski dio nadlaktice (samo ako injekciju daje njegovatelj)
English: Using syringes and needles
Croatian: Korištenje štrcaljki i igala
English: ● Collect all supplies listed below to prepare and give your injection.
Croatian: ● Prikupite sav pribor naveden u nastavku da biste pripremili i primijenili injekciju.
English: The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting.
Croatian: Sigurnost i djelotvornost emicizumaba nisu se formalno ispitivale u kirurškim uvjetima.
English: Following subcutaneous administration in haemophilia A patients, the absorption half-life was 1.6 days.
Croatian: Nakon supkutane primjene u bolesnika s hemofilijom A poluvrijeme apsorpcije iznosilo je 1,6 dana.
English: Experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients receiving Hemlibra prophylaxis is limited.
Croatian: Iskustvo s istodobnom primjenom antifibrinolitika i aPCC-a ili rFVIIa u bolesnika koji primaju profilaksu lijekom Hemlibra je ograničeno.
English: ● Check your dose, ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose.
Croatian: Provjerite dozu, gornji rub klipa mora biti u ravnini s oznakom na štrcaljki koja odgovara propisanoj dozi.
English: Weekly Hemlibra prophylaxis showed a statistically significant and clinically meaningful improvement compared with no prophylaxis in the pre-specified endpoints of Haem-A-QoL Physical Health Scale score at the Week 25 assessment.
Croatian: Uz tjednu profilaksu lijekom Hemlibra zabilježeno je statistički značajno i klinički važno poboljšanje u odnosu na neprimjenjivanje profilakse s obzirom na unaprijed specificiranu mjeru ishoda - Haem-A-QoL rezultat za tjelesno zdravlje u 25. tjednu.
English: In HAVEN 2, HRQoL for patients aged ≥ 8 to < 12 years was evaluated at week 25 based on the Haemo-QoL-SF questionnaire for children(see Table 13).
Croatian: U ispitivanju HAVEN 2 kvaliteta života vezana uz zdravlje u bolesnika u dobi od ≥ 8 do < 12 godina ocjenjivala se u 25. tjednu temeljem upitnika Haemo-QoL-SF namijenjenoga djeci (vidjeti Tablicu 13).
English: Patients randomized to Arm B could switch to Hemlibra prophylaxis after completing at least 24 weeks without prophylaxis.
Croatian: Bolesnici randomizirani u skupinu B mogli su prijeći na lijek Hemlibra nakon najmanje 24 tjedna bez profilakse.
English: The following adverse drug reactions (ADRs) are based on pooled data from four phase III clinical trials (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 - HAVEN 3, and BO39182HAVEN 4] and a paediatric study BH29992 - HAVEN 2]), in which a total of 373 male patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis.
Croatian: (ispitivanja u odraslih i adolescenata [BH29884 - HAVEN 1, BH30071 - HAVEN 3 i BO39182HAVEN 4] i pedijatrijsko ispitivanje BH29992 - HAVEN 2]), u kojima su ukupno 373 bolesnika muškog spola s hemofilijom A primila najmanje jednu dozu lijeka Hemlibra za rutinsku profilaksu.
English: No dose adjustments are recommended in paediatric patients (see section 5.2).
Croatian: Ne preporučuje se prilagođavati dozu u pedijatrijskih bolesnika (vidjeti dio 5.2).
English: At the time of the primary analysis, five patients underwent up-titration of their maintenance dose.
Croatian: U trenutku provođenja primarne analize, doza održavanja povećana je u pet bolesnika.
English: The paediatric population studied comprises a total of 107 patients, of which 5 (5 %) were infants and toddlers (1 month to less than 2 years of age), 55 (51 %) were children (from 2 to less than 12 years of age) and 47 (44 %) were adolescents (from 12 to less than 18 years old).
Croatian: Ispitivana pedijatrijska populacija uključivala je ukupno 107 bolesnika, od kojih je njih 5 (5%) bilo dojenčad i mala djeca (u dobi od 1 mjeseca do manje od 2 godine), 55 (51%) djeca (u dobi od 2 do manje od 12 godina), a 47 (44%) adolescenti (u dobi od 12 do manje od 18 godina).
English: Do not throw away any loose caps, vials, needles and syringes in your household waste.
Croatian: Nemojte bacati zatvarače, bočice, igle i štrcaljke u kućni otpad.
English: No fertility data are available in humans.
Croatian: Nema dostupnih podataka o utjecaju na plodnost u ljudi.