FrancophonIA/ELRC3.0 huggingface dataset:
English: Consolidation therapy II, IV
Croatian: Konsolidacijska terapija II, IV
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”.
Croatian: Razne se nuspojave, kao što su pleuralni izljev, ascites, plućni edem i brzo dobivanje na težini sa ili bez površinskih edema, mogu zajednički opisati kao „retencija tekućine“.
English: Transformed CML is the stage of the disease after its progression from chronic phase to accelerated phase (AP) or blast crisis (BC).
Croatian: Transformirani KML je stadij bolesti nakon njezine progresije iz kronične faze u ubrzanu fazu ili blastičnu krizu.
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Croatian: Zbog poznatog povećanog rizika od krvarenja povezanog s primjenom imatiniba (npr. hemoragija), bolesnici liječeni imatinibom kojima je potrebna antikoagulacija trebaju primati heparin niske molekularne težine ili standardni heparin, umjesto kumarinskih derivata kao što je varfarin..
English: There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Croatian: Nije bilo promjene kinetike imatiniba nakon ponovljenog doziranja, a akumulacija je bila 1,5-2,5 puta veća u stanju dinamičke ravnoteže kada je lijek doziran jednom na dan.
English: Name and address of the manufacturers responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Croatian: Nazivi i adrese proizvođača odgovornogih za puštanje serije lijeka u promet medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Unchanged imatinib accounted for 25 % of the dose (5 % urine, 20 % faeces), the remainder being metabolites.
Croatian: Na nepromijenjeni imatinib otpadalo je 25 % doze (5 % mokraća, 20 % stolica), dok su ostalo bili metaboliti.
English: Table 3 Chemotherapy regimen used in combination with imatinib
Croatian: Tablica 3 Režim kemoterapije korišten u kombinaciji s imatinibom
English: Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Croatian: Istodobnu primjenu rifampicina ili drugih jakih CYP3A4 induktora i imatiniba potrebno je izbjegavati.
English: When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Croatian: Uz konzervativnu pretpostavku da bolesnici kod kojih nedostaju podaci nisu odgovorili na terapiju, CHR je zabilježen u 20/23 (87%) bolesnika, CCyR u 9/23 (39,1%) bolesnika odnosno MR (engl. molecular response) u 11/23 (47,8%) bolesnika.
English: imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78 % after 8 weeks of therapy.
Croatian: Liječenje imatinibom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika s CHR-om od 78 % nakon 8 tjedana terapije.
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Croatian: Zbog toga treba izbjegavati istodobnu primjenu jakih CYP3A4 induktora i imatiniba (vidjeti dio 4.5).
English: Additionally, partial cytogenetic response (PCyR) was observed in 16 % for a MCyR of 81 %.
Croatian: Osim toga, djelomični citogenetski odgovor (PCyR) uočen je u 16 %, a veliki citogenetski odgovor (MCyR) u 81 %.
English: Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Croatian: Bolesnike sa srčanom bolešću, faktorima rizika za zatajenje srca ili ranijim zatajenjem bubrega treba pažljivo pratiti, a svakog bolesnika sa znakovima ili simptomima koji ukazuju na zatajenje srca ili bubrega treba pregledati i liječiti.
English: The milk/plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Croatian: Omjer koncentracije u mlijeku i plazmi ispitivan u jedne bolesnice bio je 0,5 za imatinib i 0,9 za metabolit, što ukazuje na veću raspodjelu metabolita u mlijeko.
English: There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Croatian: Ne postoje kontrolirana ispitivanja koja demonstriraju kliničku korist, kao što je poboljšanje simptoma povezanih s bolešću ili povećano preživljenje.
English: Clinical studies in MDS/MPD
Croatian: Klinička ispitivanja kod MDS/MPD-a
English: Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Croatian: Trajanje liječenja: u kliničkim ispitivanjima liječenje imatinibom nastavljalo se sve do progresije bolesti.
English: There are no controlled trials demonstrating a clinical benefit or increased survival.
Croatian: Ne postoje kontrolirana ispitivanja koja pokazuju kliničku korist ili povećano preživljenje.
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8 %) out of 11 achieving a complete haematological response.
Croatian: Kada je terapija imatinibom primijenjena bolesnicima koji nisu odgovarali ili su slabo odgovarali na kemoterapiju, 9 od 11 bolesnika (81,8 %) postiglo je potpuni hematološki odgovor.
English: Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
Croatian: Dodatno, ispitivači su u prikazima slučajeva zabilježili i poboljšanja u simptomatologiji i drugim abnormalnostima disfunkcije organa.
English: • Numbness of the hands or feet.
Croatian: • utrnulost šaka ili stopala
English: This was a population of heavily pretreated patients, as 46 % had received prior BMT and 73 % a prior multi-agent chemotherapy.
Croatian: To je bila populacija bolesnika koja je ranije intenzivno liječena, budući da ih je 46 % ranije primilo transplantaciju koštane srži (BMT), a 73 % kemoterapiju s više lijekova.
English: Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Croatian: Na temelju farmakokinetičke analize zbirne populacije pedijatrijskih bolesnika s hematološkim poremećajima (CML, Ph+ ALL ili drugi hematološki poremećaji koji se liječe imatinibom), klirens imatiniba povećava se s rastom tjelesne površine (BSA).
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Croatian: Razina kod koje se ne uočava učinak (NOEL) i za roditeljske ženke i za F1 generaciju bila je 15 mg/kg/dan (jedna četvrtina maksimalne doze za ljude od 800 mg).
English: As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Croatian: Kao i u odraslih bolesnika, imatinib se brzo apsorbirao nakon peroralne primjene u pedijatrijskih bolesnika i u ispitivanjima faze I i faze II.
English: The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Croatian: Povećanje srednje AUC vrijednosti uz povećanje doze bilo je linearno i proporcionalno prema dozi u rasponu od 25-1000 mg imatiniba nakon peroralne primjene.
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold accumulation after repeated once-daily dosing.
Croatian: Usporedba AUC(0-24) 8. dan i 1. dan na nivou doze od 340 mg/m²/dan otkrila je 1,7 puta veću akumulaciju nakon ponovljenog doziranja jednom na dan.
English: If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines.
Croatian: Ako se uoči bubrežna disfunkcija, potrebno je uvesti odgovarajući nadzor i liječenje u skladu sa standardnim smjernicama liječenja.
English: When imatinib is co-administered with other medicinal products, there is a potential for drug interactions.
Croatian: Kada se imatinib primjenjuje istodobno s drugim lijekovima postoji mogućnost za interakcije lijekova.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n = 10).
Croatian: Limfatična blastična kriza: u ispitivanja faze I uključen je ograničeni broj bolesnika (n=10).
English: • Anorexia, weight loss or a disturbed sense of taste.
Croatian: • anoreksija, smanjenje tjelesne težine ili poremećaj u osjetu okusa
English: A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Croatian: Jedno veliko, internacionalno, otvoreno, nekontrolirano ispitivanje faze II provedeno je u bolesnika s KML-om s pozitivnim Philadelphia (Ph+) kromosomom u fazi blastične krize bolesti.
English: GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Croatian: Uzrok GI krvarenja mogle bi biti lokacije GI tumora (vidjeti dio 4.4).
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Croatian: Dodatnih 162 bolesnika s HES/KEL-om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je imatinib u dozama od 75 mg do 800 mg na dan.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Croatian: Kada se imatinib kombinirao s visokom dozom kemoterapije u Ph+ ALL bolesnika, uočena je prolazna jetrena toksičnost u obliku povišenja transaminaze i hiperbilirubinemije.
English: These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Croatian: Te se reakcije obično mogu liječiti tako da se imatinib privremeno prestane davati te da se primijene diuretici i druge odgovarajuće suportivne mjere.
English: • adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Croatian: • odraslih bolesnika s inoperabilnim dermatofibrosarkomom protuberans (DFSP) i odraslih bolesnika s rekurentnim i/ili metastazirajućim DFSP-om koji nisu podobni za kirurški zahvat.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Croatian: • bol u očima ili slabljenje vida, krvarenje u očima
English: Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Croatian: Podaci o sigurnosti primjene iz ovog ispitivanja u skladu su sa sigurnosnim profilom imatiniba u bolesnika s Ph+ ALL-om.
English: If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Croatian: Ako se tijekom primjene imatiniba razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve dok se događaj ne razriješi.
English: Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
Croatian: Bolesnici s uznapredovalim stadijima zloćudnih bolesti mogu imati brojna zbunjujuća medicinska stanja koja otežavaju utvrđivanje uzročnosti nuspojava zbog niza simptoma vezanih za osnovnu bolest, njezinu progresiju te istodobnu primjenu mnogobrojnih lijekova.
English: In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Croatian: U bolesnika s oštećenom funkcijom bubrega izgleda da je izloženost imatinibu u plazmi viša nego u bolesnika s normalnom funkcijom bubrega, vjerojatno zbog povišene razine alfa-kiselog glikoproteina (AGP) u plazmi, proteina koji veže imatinib, u tih bolesnika.
English: Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Croatian: Na temelju raspoloživih podataka nisu identificirani predispozicijski faktori (npr. veličina tumora, lokacija tumora, poremećaji koagulacije) zbog kojih bi bolesnici s GIST-om bili izloženi većem riziku od bilo kojeg tipa krvarenja.
English: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Croatian: Preporučuje se dozu smanjiti ili liječenje prekinuti zbog teške neutropenije i trombocitopenije, kao što je prikazano u donjoj tablici.
English: Imatinib medac inhibits the growth of these cells in a certain subtype of these diseases.
Croatian: Imatinib medac inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Croatian: Izgleda da prilagođavanje doze nije neophodno kada se imatinib istodobno primjenjuje s CYP2D6 supstratima, međutim, savjetuje se oprez kod CYP2D6 supstrata s uskim terapijskim prozorom, poput metoprolola.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Croatian: Ako je povećanje bilirubina >3 x institucionalne gornje granice normale (IGGN), ili jetrenih transaminaza >5 x IGGN vrijednosti, primjenu imatiniba treba ukinuti sve dok se razine bilirubina ne vrate na vrijednost <1,5 x IGGN, a razine transaminaze na vrijednost <2,5 x IGGN.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54 % and 74 %, of the respective values without rifampicin treatment.
Croatian: Prethodno liječenje s višestrukim dozama rifampicina od 600 mg, nakon čega je slijedila jednokratna doza imatiniba od 400 mg, rezultiralo je smanjenjem vrijednosti Cmax i AUC(0-∞) za najmanje 54 % odnosno 74 % bez liječenja rifampicinom.
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Croatian: Imatinib je bio teratogen u štakora kada je primjenjivan tijekom organogeneze u dozama ≥100 mg/kg, koje su približno jednake maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Croatian: Odrasli bolesnici navedeni u objavljenoj literaturi liječeni su ili s 400 mg (4 slučaja) ili s 800 mg (1 slučaj) imatiniba na dan.
English: Studies on patients receiving imatinib and its effect on fertility and gametogenesis have not been performed.
Croatian: Nisu provedena ispitivanja na bolesnicima koji primaju imatinib o njegovom učinku na plodnost i gametogenezu.
English: Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Croatian: Terapiju treba započeti liječnik s iskustvom u liječenju bolesnika s hematološkim zloćudnim bolestima, odnosno malignim sarkomima, prema potrebi.
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of imatinib.
Croatian: No, ti su edemi rijetko bili teški te se mogu liječiti diureticima, drugim suportivnim mjerama, ili smanjenjem doze imatiniba.
English: Metabolism of imatinib is mainly hepatic, and only 13 % of excretion is through the kidneys.
Croatian: Metabolizam imatiniba odvija se uglavnom preko jetre, dok se samo 13 % izlučuje preko bubrega.
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Croatian: In vitro, imatinib inhibira paracetamol O-glukuronidaciju s Ki vrijednosti od 58,5 mikromol/l.
English: Imatinib medac 400 mg hard capsules EU/1/13/876/002
Croatian: Imatinib medac 400 mg tvrde kapsule EU/1/13/876/002
English: Hyperbilirubinaemia, hepatitis, jaundice
Croatian: Hiperbilirubinemija, hepatitis, žutica
English: The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
Croatian: Liječenje se kod Vašeg djeteta može provoditi dozom koja se daje jednom na dan ili se dnevna doza može podijeliti u dvije primjene (pola ujutro i pola navečer).
English: If any of these affects you severely, tell your doctor.
Croatian: Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.
English: In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).
Croatian: Osim toga, gastrična antralna vaskularna ektazija (GAVE), rijetki uzrok gastrointestinalnog krvarenja, zabilježena je nakon stavljanja lijeka u promet u bolesnika s KML-om, ALL-om i drugim bolestima (vidjeti dio 4.8).
English: All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Croatian: Svi su bolesnici postigli potpuni hematološki odgovor, potpuni citogenetski odgovor i/ili potpuni molekularni odgovor.
English: This is because Imatinib medac could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: Imatinib medac može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
English: • Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line of treatment;
Croatian: • novodijagnosticirane kronične mijeloične leukemije (KML) za koju se transplantacija koštane srži ne smatra prvom linijom liječenja;
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg, or from 800 mg to 600 mg, and in paediatric patients from 340 mg to 260 mg/m2/day.
Croatian: Dozu u odraslih treba sniziti s 400 mg na 300 mg ili sa 600 mg na 400 mg, ili s 800 mg na 600 mg, a u pedijatrijskih bolesnika s 340 mg na 260 mg/m²/dan.
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Croatian: Ukupna dnevna doza u djece i adolescenata s KML-om ne smije prijeći 800 mg, a u onih s Ph+ ALL-om 600 mg.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Croatian: • bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema)
English: Grade 3 and 4 neutropenia was seen in 7.5 % and 2.7 % of patients, respectively, and grade 3 thrombocytopenia in 0.7 % of patients.
Croatian: Neutropenija 3. i 4. stupnja zapažena je u 7,5 % odnosno u 2,7 % bolesnika, a trombocitopenija 3. stupnja u 0,7 % bolesnika.
English: What Imatinib medac is and what it is used for
Croatian: Što je Imatinib medac i za što se koristi
English: • Numb or cold toes and fingers (signs of Raynaud's syndrome).
Croatian: • utrnuli ili hladni prsti na nogama i rukama (znakovi Raynaudovog sindroma)
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia
Croatian: Herpes zoster, herpes simplex, nazofaringitis, upala pluća
English: It is important that you do this as long as your doctor, pharmacist or nurse tells you to.
Croatian: Važno je da to činite onoliko dugo koliko Vam kaže liječnik, ljekarnik ili medicinska sestra.
English: The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits.
Croatian: Neklinički profil sigurnosti primjene imatiniba utvrđivan je u štakora, pasa, majmuna i kunića.
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10
Croatian: Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenije 3. ili 4. stupnja (ABN <1,0 x 10
English: How long to take Imatinib medac Keep taking Imatinib medac every day for as long as your doctor tells you.
Croatian: Koliko dugo uzimati Imatinib medac Imatinib medac nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
English: Dose adjustment for adverse reactions in all indications in adults and paediatric patients
Croatian: Prilagođavanje doze zbog nuspojava u svim indikacijama za odrasle i pedijatrijske bolesnike Nehematološke nuspojave
English: Therefore, caution should be exercised in patients with cardiac dysfunction.
Croatian: Zbog toga se mora oprezno postupati u bolesnika s poremećenom srčanom funkcijom.
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Croatian: Povišen kreatinin u krvi, povišena kreatin-fosfokinaza u krvi, povišena laktat-dehidrogenaza u krvi, povišena alkalna fosfataza u krvi
English: The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Croatian: Farmakokinetika imatiniba ocijenjena je na rasponu doziranja od 25 do 1000 mg.
English: Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs.
Croatian: Ispitivanjima toksičnosti višestrukih doza otkrivene su blage do umjerene hematološke promjene u štakora, pasa i majmuna, uz promjene u koštanoj srži u štakora i pasa.
English: 95 (37 %) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63 %) had not (“untreated patients”).
Croatian: Njih je 95 (37 %) prethodno primilo kemoterapiju zbog liječenja bilo ubrzane faze, bilo blastične krize („prethodno liječeni bolesnici“), a 165 (63 %) ispitanika nije („neliječeni bolesnici“).
English: Accelerated phase is an intermediate phase among the chronic phase and the onset of blast crisis; it is considered as the first manifestation of resistance to therapy.
Croatian: Ubrzana faza predstavlja prijelaznu fazu između kronične faze i početka blastične krize; smatra se prvom manifestacijom rezistencije na liječenje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Croatian: Europska Agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka imatinib u svim podskupinama pedijatrijske populacije s kroničnom mijeloičnom leukemijom s pozitivnim Philadelphia kromosomom (bcr-abl translokacija) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).