FrancophonIA/ELRC3.0 huggingface dataset:
English: A no observed adverse effect level for reproductive effects was not established.
Croatian: Za reproduktivne učinke nije utvrđena razina pri kojoj nema štetnih učinaka.
English: The carcinogenic potential of denosumab has not been evaluated in long-term animal studies.
Croatian: Kancerogeni potencijal denosumaba nije procijenjen u dugotrajnim ispitivanjima na životinjama.
English: Number of patients who had SREs (%) Median time to SRE (months)
Croatian: Broj bolesnika koji su imali SRE (%) Medijan vremena do SRE (mjeseci)
English: Any effects of XGEVA are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Croatian: Bilo koji učinak lijeka XGEVA će vjerojatno biti veći tijekom drugog i trećeg tromjesečja trudnoće budući da monoklonska protutijela prolaze kroz placentu linearno kako trudnoća napreduje, s najvećim prijenosom tijekom trećeg tromjesečja.
English: Patients should be monitored for radiological signs of malignancy, new radiolucency or osteolysis.
Croatian: Bolesnici se moraju pratiti radi radioloških pokazatelja maligne bolesti, nove radiolucencije ili osteolize.
English: Osteonecrosis of the jaw can also occur after stopping treatment.
Croatian: Osteonekroza čeljusti se također može pojaviti nakon prestanka liječenja.
English: - Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with XGEVA.
Croatian: Pogledajte dio 4. - Vaš liječnik će Vam dati karticu s podsjetnikom za bolesnika, koja sadrži važne sigurnosne informacije koje trebate znati prije i tijekom liječenja lijekom XGEVA.
English: Denosumab displayed non-linear pharmacokinetics with dose over a wide dose range, but approximately dose-proportional increases in exposure for doses of 60 mg (or 1 mg/kg) and higher.
Croatian: Denosumab je pokazao nelinearnu farmakokinetiku za dozu u širokom rasponu doza, ali približno dozno-proporcionalno povećanje u izloženosti za doze od 60 mg (ili 1 mg/kg) i više.
English: One hundred and ninety had at least 1 evaluable time point response and were included in the analysis (table 4).
Croatian: Sto devedeset bolesnika je imalo procjenjiv odgovor u barem jednoj vremenskoj točki i bili su uključeni u analizu (tablica 4).
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Croatian: Za njegov metabolizam i eliminaciju očekuje se da će slijediti puteve klirensa imunoglobulina što će rezultirati razgradnjom na male peptide i pojedinačne aminokiseline.
English: Low calcium in the blood may also lead to a change in heart rhythm called QT prolongation, which is seen by electrocardiogram (ECG).
Croatian: Niska razina kalcija u krvi može također dovesti do promjene u srčanom ritmu koja se naziva produljenje QT intervala i može se utvrditi elektrokardiogramom (EKG).
English: Non-inferiority / Superiority p-values
Croatian: p-vrijednost za ne-inferiornost/ superiornost
English: Patients should be encouraged to report symptoms indicative of hypocalcaemia.
Croatian: Bolesnike je potrebno potaknuti da prijave simptome koji ukazuju na hipokalcijemiju.
English: Following subcutaneous administration, bioavailability was 62%.
Croatian: Nakon supkutane primjene, bioraspoloživost je iznosila 62%.
English: The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
Croatian: Početak liječenja/novi ciklus liječenja treba odgoditi u bolesnika s nezacijeljenim otvorenim lezijama mekog tkiva u ustima.
English: This study did not control for prognostic factors and anti-neoplastic treatments.
Croatian: U ovom ispitivanju nisu kontrolirani prognostički faktori i antineoplastična liječenja.
English: All 20 patients (100%) with histology assessments responded.
Croatian: Svih 20 bolesnika (100%) u kojih je napravljena histološka procjena imali su terapijski odgovor.
English: • While being treated, you should maintain good oral hygiene and receive routine dental check-ups.
Croatian: • Tijekom lječenja trebate održavati dobru oralnu higijenu i ići na redovite stomatološke preglede.
English: XGEVA zoledronic acid
Croatian: XGEVA zoledronatna kiselina
English: • The vial should not be re-entered.
Croatian: • U bočicu se ne smije ponovno ubadati.
English: Study 3 prostate cancer
Croatian: Ispitivanje 3 rak prostate
English: Hypocalcaemia has very commonly been reported following XGEVA administration, mostly within the first 2 weeks.
Croatian: Hipokalcijemija je vrlo često prijavljivana nakon primjene lijeka XGEVA, većinom unutar prva 2 tjedna.
English: The primary and secondary endpoints evaluated the occurrence of one or more skeletal related events (SREs).
Croatian: Primarne i sekundarne mjere ishoda bile su pojavnost jednog ili više koštanih događaja (engl. skeletal related event, SRE).
English: Using a sensitive immunoassay < 1% of patients treated with denosumab for up to 3 years tested positive for non neutralising binding antibodies with no evidence of altered pharmacokinetics, toxicity, or clinical response.
Croatian: Korištenjem osjetljivog imunotesta, < 1% bolesnika liječenih denosumabom u trajanju do 3 godine bilo je pozitivno na neneutralizirajuća vezujuća protutijela bez dokaza o promjeni u farmakokinetici, toksičnosti ili kliničkom odgovoru.
English: The non-linearity is likely due to a saturable target-mediated elimination pathway of importance at low concentrations.
Croatian: Nelinearnost je vjerojatno posljedica zasićenja ciljno posredovanog puta eliminacije važnog za niske koncentracije.
English: There was no evidence of maternal harm prior to labour; adverse maternal effects occurred infrequently during labour.
Croatian: Nije bilo dokaza o štetnosti za majku prije poroda; nuspojave vezane za majku pojavile su se rijetko tijekom poroda.
English: Severe, untreated hypocalcaemia (see section 4.4).
Croatian: Teška, neliječena hipokalcijemija (vidjeti dio 4.4).
English: Once your vial has been left to reach room temperature (up to 25°C), it must be used within 30 days.
Croatian: Jednom kada je bočica ostavljena kako bi postigla sobnu temperaturu (do 25°C), mora se iskoristiti unutar 30 dana.
English: XGEVA should be administered under the responsibility of a healthcare professional.
Croatian: XGEVA se treba primjenjivati pod nadzorom zdravstvenog radnika.
English: • low phosphate levels in the blood (hypophosphataemia),
Croatian: • niska razina fosfata u krvi (hipofosfatemija),
English: 22.14 (14.26, NE)
Croatian: 22,14 (14,26; NP)
English: Your healthcare professional will not administer XGEVA to you if you have a very low level of calcium in your blood which has not been treated.
Croatian: Vaš zdravstveni radnik neće Vam dati lijek XGEVA ukoliko imate vrlo nisku razinu kalcija u krvi koja nije liječena.
English: Clinically significant hypercalcaemia has also been reported in this patient group weeks to months following treatment discontinuation.
Croatian: Klinički značajna hiperkalcijemija također je prijavljena u ovoj skupini bolesnika tjednima do mjesecima nakon prekida liječenja.
English: • If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with XGEVA.
Croatian: • Ako ste u tijeku stomatološkog liječenja ili ćete biti podvrgnuti stomatološkom kirurškom zahvatu (npr. vađenje zuba), obavijestite Vašeg liječnika o Vašem stomatološkom liječenju i recite Vašem stomatologu da se liječite lijekom XGEVA.
English: Examples of clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (including coma) (see section 4.4).
Croatian: Primjeri kliničke manifestacije teške simptomatske hipokalcijemije uključivali su produženje QT intervala, tetaniju, napadaje i promijenjen mentalni status (uključujući komu) (vidjeti dio 4.4).
English: In subjects who discontinued 120 mg every 4 weeks, the mean half-life was 28 days (range 14 to 55 days).
Croatian: U ispitanika u kojih je prekinuto davanje 120 mg svaka 4 tjedna, prosječni poluvijek iznosio je 28 dana (raspon 14 do 55 dana).
English: NR 26.4
Croatian: NP 26,4
English: In 190 subjects evaluable for objective tumour response, 55 subjects had giant cell tumour of bone surgery, out of which 40 subjects had complete resections.
Croatian: U 190 ispitanika u kojih se mogao procijeniti objektivni odgovor tumora, 55 ispitanika je imalo operaciju gigantocelularnog tumora kosti, od kojih je 40 ispitanika imalo potpunu resekciju.
English: Other medicines and XGEVA
Croatian: Drugi lijekovi i lijek XGEVA
English: Controlled clinical studies of XGEVA in patients with advanced malignancies involving bone over age 65 revealed similar efficacy and safety in older and younger patients.
Croatian: Kontrolirana klinička ispitivanja lijeka XGEVA u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti starijih od 65 godina pokazala su sličnu djelotvornost i sigurnost u starijih i mlađih bolesnika.
English: Hypocalcaemia can be severe and symptomatic (see section 4.8 - description of selected adverse reactions).
Croatian: Hipokalcijemija može biti teška i simptomatska (vidjeti dio 4.8 - opis izdvojenih nuspojava).
English: No treatment-related pattern in individual cancers or cancer groupings was apparent.
Croatian: Nije bilo očitog obrasca povezanog s liječenjem kod pojedinog raka ili skupina raka.
English: ONJ was confirmed in 6.9% of patients with breast cancer and prostate cancer during the extension treatment phase.
Croatian: ONČ je potvrđena kod 6,9% bolesnika s rakom dojke ili prostate tijekom faze produžetka liječenja.
English: Once removed from the refrigerator, XGEVA may be stored at room temperature (up to 25°C) for up to 30 days in the original container.
Croatian: Jednom kada se izvadi iz hladnjaka, XGEVA se može čuvati na sobnoj temperaturi (do 25°C) do 30 dana u originalnom spremniku.
English: New primary malignancy
Croatian: Nova primarna maligna bolest
English: Study 2**
Croatian: Ispitivanje 2**
English: Maternal mammary gland development was normal.
Croatian: Razvoj mliječnih žlijezda u majke bio je normalan.
English: NR = not reached; NA = not available; HCM = hypercalcaemia of malignancy; SMR = skeletal morbidity rate; HR = Hazard Ratio; RRR = Relative Risk Reduction †Adjusted p-values are presented for Studies 1, 2 and 3 (first SRE and first and subsequent SRE endpoints); *Accounts for all skeletal events over time; only events occurring ≥ 21 days after the previous event are counted.
Croatian: NP = nije postignuto; ND = nije dostupno; HCM = hiperkalcijemija maligne bolesti; SSM = stopa skeletnog morbiditeta; HR = Omjer hazarda; RRR = Redukcija relativnog rizika; †Prilagođene p-vrijednosti predstavljene su za Ispitivanja 1, 2 i 3 (mjere ishoda: prvi SRE i prvi i sljedeći SRE); *Odnosi se na sve koštane događaje tijekom vremena; samo događaji nakon ≥ 21 dana od prethodnog događaja su uračunati.
English: XGEVA is a solution for injection (injection).
Croatian: XGEVA je otopina za injekciju (injekcija).
English: Following a 6 month period after birth, bone related changes showed recovery and there was no effect on tooth eruption.
Croatian: Tijekom perioda od 6 mjeseci nakon poroda došlo je do oporavka promjena povezanih s kostima te nije bilo učinka na izbijanje zuba.
English: 22.8 (14.7, NE)
Croatian: 22,8 (14,7; NP)
English: You should not take XGEVA together with other medicines containing denosumab or bisphosphonates.
Croatian: Ne smijete uzimati lijek XGEVA zajedno s lijekovima koji sadrže denosumab ili bisfosfonate.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanjem na životinjama utvrđena je reproduktivna toksičnost (vidjeti dio 5.3).
English: Adolescent primates dosed with denosumab at 2.7 and 15 times (10 and 50 mg/kg dose) the clinical exposure had abnormal growth plates.
Croatian: Adolescenti primata koji su primali denosumab u dozi od 2,7 i 15 puta većoj (doza 10 i 50 mg/kg) od kliničke izloženosti, imali su abnormalne ploče rasta.
English: • a bisphosphonate
Croatian: • bisfosfonatima
English: Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment.
Croatian: Kod bolesnika s gigantocelularnim tumorom kosti potrebno je provoditi procjenu u redovitim intervalima kako bi se odredilo da li i dalje imaju korist od liječenja.
English: INFORMATION IN BRAILLE xgeva
Croatian: 16. PODACI NA BRAILLEOVOM PISMU xgeva
English: NR 33.2
Croatian: NP 33,2
English: • Before administration, the XGEVA solution should be inspected visually.
Croatian: • Prije primjene, XGEVA otopinu je potrebno vizualno pregledati.
English: First SRE or HCM Median time (months)
Croatian: Prvi SRE ili HCM Medijan vremena (mjeseci)
English: 4 Class effect
Croatian: 4 Učinak skupine
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: • Obratite se Vašem liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: • shortness of breath,
Croatian: • nedostatak zraka,
English: Monitoring of calcium levels should be conducted (i) prior to the initial dose of XGEVA, (ii) within two weeks after the initial dose, (iii) if suspected symptoms of hypocalcaemia occur (see section 4.8 for symptoms).
Croatian: Praćenje razine kalcija preporuča se provesti (i) prije prve doze lijeka XGEVA, (ii) unutar dva tjedna od prve doze, (iii) ukoliko se pojavi sumnja na simptome hipokalcijemije (vidjeti dio 4.8. za simptome).
English: The primary outcome measure was demonstration of non-inferiority of time to first on study skeletal related event (SRE) as compared to zoledronic acid.
Croatian: Primarna mjera ishoda bila je pokazati ne-inferiornost vremena do prvog koštanog događaja (engl. skeletal related event, SRE) tijekom ispitivanja u usporedbi sa zoledronatnom kiselinom.
English: Hypocalcaemia can occur at any time during therapy with XGEVA.
Croatian: Hipokalcijemija se može pojaviti bilo kada tijekom terapije lijekom XGEVA.
English: No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega (vidjeti dio 4.4 za preporuke u vezi praćenja razina kalcija, 4.8 i 5.2).
English: Difference in median time (months)
Croatian: Razlika u medijanu vremena (mjeseci)
English: XGEVA will be injected into your thigh, abdomen or upper arm.
Croatian: XGEVA će Vam biti ubrizgana u bedro, trbuh ili nadlakticu.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne pokazuju izravne ni neizravne štetne učinke na plodnost (vidjeti dio 5.3).
English: Of the 35 patients included in the efficacy analysis, 85.7% (95% CI: 69.7, 95.2) had a treatment response to XGEVA.
Croatian: Od 35 bolesnika koji su bili uključeni u analizu djelotvornosti, kod 85,7% ( 95% CI: 69,7; 95,2) zabilježen je terapijski odgovor na lijek XGEVA.
English: NR 25.2
Croatian: NP 25,2
English: • bone, joint, and/or muscle pain which is sometimes severe,
Croatian: • bol u kostima, zglobovima i/ili mišićima koja je ponekad teška,
English: After treatment is discontinued, monitor patients for signs and symptoms of hypercalcaemia, consider periodic assessment of serum calcium and re-evaluate the patient's calcium and vitamin D supplementation requirements (see section 4.8).
Croatian: Nakon prekida liječenja potrebno je pratiti bolesnike radi znakova i simptoma hiperkalcijemije, razmotriti periodičku procjenu kalcija u serumu i ponovno procijeniti potrebu za nadomjestkom kalcija i vitamina D u bolesnika (vidjeti dio 4.8).
English: Proportion of subjects (%)
Croatian: Udio ispitanika (%)
English: Tell your doctor if you have or have had severe kidney problems, kidney failure or have needed dialysis, which may increase your risk of getting low blood calcium, especially if you do not take calcium supplements.
Croatian: Obavijestite svog liječnika ukoliko imate ili ste imali ozbiljnih problema s bubrezima, zatajenje bubrega ili Vam je bila potrebna dijaliza budući da ta stanja mogu povećati rizik od snižene razine kalcija u krvi, posebno ako ne uzimate nadomjestke kalcija.
English: ** Including NSCLC, renal cell cancer, colorectal cancer, small cell lung cancer, bladder cancer, head and neck cancer, GI/genitourinary cancer and others, excluding breast and prostate cancer.
Croatian: ** Uključujući NSCLC, rak bubrežnih stanica, kolorektalni rak, mikrocelularni rak pluća, rak mjehura, rak glave i vrata, GI/genitourinarni rak i ostali, isključujući rak dojke i prostate.
English: • allergic reactions (e.g. wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin).
Croatian: • alergijske reakcije (npr. piskanje ili poteškoće s disanjem, oticanje lica, usana, jezika, grla ili drugih dijelova tijela; osip, svrbež ili koprivnjača na koži).
English: No specific study in patients with hepatic impairment was performed.
Croatian: Nisu provedena posebna ispitivanja u bolesnika s oštećenjima jetre.
English: If you become pregnant during treatment with XGEVA or less than 5 months after stopping treatment with XGEVA, please inform your doctor.
Croatian: Ako zatrudnite tijekom liječenja s lijekom XGEVA ili za manje od 5 mjeseci nakon prestanka liječenja lijekom XGEVA, molimo Vas obavijestite o tome svog liječnika.
English: Kaplan-Meier plots of time to first on-study SRE
Croatian: Slika 1. Kaplan-Meierove krivulje vremena do prvog SRE tijekom ispitivanja
English: Each 1.7 mL of solution contains 78 mg sorbitol (E420).
Croatian: 1,7 ml otopine sadrži 78 mg sorbitola (E420).
English: A decision must be made on whether to abstain from breast-feeding or to abstain from XGEVA therapy taking into account the benefit of breast-feeding to the newborn/infant and the benefit of therapy for the woman.
Croatian: Mora se odlučiti treba li se suzdržati od dojenja ili od terapije lijekom XGEVA uzimajući u obzir korist od dojenja za novorođenče/dojenče i korist od liječenja za ženu.
English: Drug related hypersensitivity reactions
Croatian: Reakcije preosjetljivosti povezane s lijekom
English: The number of patients across both study arms with ISS stage I, stage II, and stage III at diagnosis were 32.4%, 38.2%, and 29.3%, respectively.
Croatian: U objema skupinama ispitanika, broj bolesnika s ISS stupnjem bolesti I, II i III u vrijeme dijagnoze iznosio je 32,4%, 38,2% i 29,3%.
English: Low calcium levels in the blood
Croatian: Niska razina kalcija u krvi
English: Response criteria included elimination of giant cells based on histopathology or lack of progression by radiography.
Croatian: Kriteriji odgovora obuhvaćali su eliminaciju gigantskih stanica temeljenu na histopatološkom nalazu ili izostanak napredovanja tumora temeljen na radiološkom nalazu.
English: • removal of a tooth,
Croatian: • ispadanje zuba,
English: Consequently, osteolysis is reduced and proliferative tumour stroma is replaced with non-proliferative, differentiated, densely woven new bone.
Croatian: Posljedično, smanjuje se osteoliza, te se proliferativna tumorska stroma postepeno zamijenjuje ne-proliferativnim diferenciranim gustim novim koštanim tkivom.
English: Clinically significant hypercalcaemia after treatment discontinuation has been reported in the post-marketing setting in paediatric patients (see section 4.4).
Croatian: Klinički značajna hiperkalcijemija nakon prekida liječenja prijavljena je nakon stavljanja lijeka u promet u pedijatrijskih bolesnika (vidjeti dio 4.4).
English: In studies of denosumab (60 mg, n = 55 and 120 mg, n = 32) in patients without advanced cancer but with varying degrees of renal function, including patients on dialysis, the degree of renal impairment had no effect on the pharmacokinetics of denosumab; thus dose adjustment for renal impairment is not required.
Croatian: U ispitivanjima s denosumabom (60 mg, n = 55 i 120 mg, n = 32) u bolesnika bez uznapredovalog raka, ali s različitim stupnjevima bubrežne funkcije, uključujući bolesnike na dijalizi, stupanj oštećenja bubrega nije imao nikakvog učinka na farmakokinetiku denosumaba, te stoga prilagodba doze kod oštećenja bubrega nije potrebna.
English: Excipient with known effects
Croatian: Pomoćna tvar s poznatim učinkom
English: Disease progression was similar between XGEVA and zoledronic acid in all three studies and in the pre-specified analysis of all three studies combined.
Croatian: Progresija bolesti bila je slična kod lijeka XGEVA i zoledronatne kiseline u sva tri ispitivanja i prethodno specificiranim analizama svih triju ispitivanja kombinirano.
English: A post-hoc analysis in study 2 (patients with other solid tumours or multiple myeloma) examined overall survival for the 3 tumour types used for stratification (non-small cell lung cancer, multiple myeloma, and other).
Croatian: Post-hoc analiza u ispitivanju 2 (bolesnici s drugim solidnim tumorima ili multiplim mijelomom) ispitivala je ukupno preživljenje za 3 tipa tumora korištena za stratifikaciju (rak pluća nemalih stanica, multipli mijelom i drugi).
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to XGEVA administration.
Croatian: Tijekom liječenja invazivne stomatološke zahvate treba provesti tek nakon pažljivog razmatranja i izbjegavati ih neposredno blizu primjene lijeka XGEVA.
English: XGEVA is also used to treat giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.
Croatian: XGEVA se također primjenjuje za liječenje gigantocelularnog tumora kosti koji se ne može liječiti operacijom ili gdje operacija nije najbolji izbor, u odraslih i adolescenata kod kojih su kosti završile s rastom.
English: Zoledronic Acid (N = 859)
Croatian: Zoledronatna kiselina (N = 859)
English: Combined advanced cancer
Croatian: Kombinirani uznapredovali rak
English: The median number of doses administered was 16 for XGEVA and 15 for zoledronic acid.
Croatian: Medijan broja primijenjenih doza iznosio je 16 za lijek XGEVA i 15 za zoledronatnu kiselinu.
English: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Croatian: Sigurnost i djelotvornost denosumaba nisu ispitivani u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
English: The alterations were not considered clinically-relevant, since pharmacodynamic effects based on bone turnover markers were consistent across a wide range of body weight.
Croatian: Promjene nisu smatrane klinički značajnima budući da su farmakodinamički učinci procjenjivani na temelju biljega koštane pregradnje bili ujednačeni kod širokog raspona tjelesnih težina.
English: XGEVA is a clear, colourless to slightly yellow solution.
Croatian: XGEVA je bistra, bezbojna do blago žuta otopina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with XGEVA in all subsets of the paediatric population in the prevention of skeletal related events in patients with bone metastases and subsets of the paediatric population below the age of 12 in the treatment of giant cell tumour of bone (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka XGEVA u svim podskupinama pedijatrijske populacije u prevenciji koštanih događaja u bolesnika s metastazama na kostima i u podskupinama pedijatrijske populacije mlađe od 12 godina u liječenju gigantocelularnog tumora kosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).