FrancophonIA/ELRC3.0 huggingface dataset:
English: Vidaza is used in adults who are not able to have a stem cell transplantation to treat:
Croatian: Vidaza se primjenjuje kod odraslih kojima se ne mogu transplantirati matične stanice za liječenje:
English: Breast-feeding (see section 4.6).
Croatian: Dojenje (vidjeti dio 4.6).
English: An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce CYP 1A2, 2C19, or 3A4 or 3A5.
Croatian: In vitro ispitivanje azacitidina na kulturi ljudskih hepatocita upućuje na to da azacitidin u koncentracijama od 1,0 µM do 100 µM (t.j. do približno 30 puta veća koncentracija od klinički dosežne) ne inducira CYP 1A2, 2C19, ili 3A4 ili 3A5.
English: Details on storage of the reconstituted product are provided below.
Croatian: Pojedinosti o čuvanju rekonstituiranog lijeka navedene su niže.
English: • Swelling of the legs and feet, back pain, reduced passing of water, increased thirst, rapid pulse, dizziness and nausea, vomiting or reduced appetite and feelings of confusion, restlessness or fatigue.
Croatian: • Oticanje nogu i stopala, bol u leđima, smanjeno mokrenje, povećanu žeđ, brzi puls, omaglicu i mučninu, povraćanje ili smanjeni apetit te osjećaj smetenosti, nemira ili umora.
English: Azacitidine undergoes spontaneous hydrolysis and deamination mediated by cytidine deaminase.
Croatian: Azacitidin prolazi spontanu hidrolizu i deaminaciju posredovanu citidin deaminazom.
English: 4 mL of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
Croatian: 4 mL vode za injekcije treba uvući u štrcaljku, osiguravajući da se istisne sav zrak iz štrcaljke.
English: The differences between the IRC and investigator assessments of response were a consequence of the International Working Group (IWG) criteria requiring improvement in peripheral blood counts and maintenance of these improvements for a minimum of 56 days.
Croatian: International Working Group, IWG) koji zahtijevaju poboljšanje periferne krvne slike i održavanje tih poboljšanja tijekom minimalno 56 dana.
English: There is no known specific antidote for azacitidine overdose.
Croatian: Nema poznatog antidota za predoziranje azacitidinom.
English: There are no human data on the effect of azacitidine on fertility.
Croatian: Nema podataka o utjecaju azacitidina na plodnost kod ljudi.
English: Serious adverse reactions such as gastrointestinal haemorrhage and intracranial haemorrhage have been reported.
Croatian: Prijavljene su ozbiljne nuspojave poput gastrointestinalnog krvarenja i intrakranijalnog krvarenja.
English: After administration of the recommended dose for the first cycle, the dose for subsequent cycles should be reduced or its administration delayed based on nadir counts and haematological response (see section 4.2).
Croatian: Nakon primjene preporučene doze za prvi ciklus, dozu za sljedeće cikluse treba smanjiti ili odgoditi njenu primjenu na temelju najnižih vrijednosti i hematološkog odgovora (vidjeti dio 4.2).
English: These actions are thought to correct problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Croatian: Pretpostavlja se da takvo djelovanje ispravlja nepravilnosti u sazrijevanju i rastu mladih krvnih stanica u koštanoj srži koje uzrokuju mijelodisplastične poremećaje, i ubija stanice raka pri leukemiji.
English: Azacitidine can be administered to patients with renal impairment without initial dose adjustment (see section 5.2).
Croatian: Azacitidin se može primjenjivati bolesnicima s oštećenjem bubrega bez prilagodbe početne doze (vidjeti dio 5.2).
English: Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
Croatian: Azacitidin s najboljom potpornom skrbi (engl. best supportive care, BSC) (n = 179) uspoređivan je s režimom konvencionalne skrbi (engl. conventional care regimens, CCR).
English: Therefore, based on the assessment of all available information for pericarditis, including spontaneous reports identified in the Safety Topic Review, the already listed ADR of pericardial effusion in the Vidaza SmPC and the fact that pericarditis is a listed term for some other products of the same class, the SmPC section 4.8 should be updated by including the term pericarditis under the SOC cardiac disorders with frequency ‘uncommon'.
Croatian: Stoga, na temelju procjene svih dostupnih informacija za perikarditis, uključujući spontano prijavljivanje navedeno u pregledu podataka o sigurnosti, već navedene nuspojave perikardijalnog izljeva u sažetku opisa svojstava lijeka Vidaza i činjenica da je perikarditis naveden i kod nekoliko drugih lijekova iste skupine, dio 4.8 Sažetka opisa svojstava lijeka treba ažurirati uključivanjem naziva perikarditis u klasifikaciji organskih sustava srčanih poremećaja s „manje čestom“ učestalošću.
English: In addition, although the study was not powered to demonstrate a statistically significant difference when comparing azacitidine to the preselection CCR treatment groups, the survival of Vidaza treated patients was longer when compared to CCR treatment options BSC alone, low-dose cytarabine plus BSC and were similar when compared to standard intensive chemotherapy plus BSC.
Croatian: Uz to, iako ispitivanje nije imalo dovoljnu snagu da se dokaže statistički značajna razlika između skupine liječene azacitidinom i skupine liječene CCR-om prije selekcije, preživljenje bolesnika liječenih Vidazom bilo je dulje u usporedbi s mogućnostima liječenja CCR-om samo BSC-om, niskom dozom citarabina uz BSC te je bilo slično kad se usporedilo sa standardnom intenzivnom kemoterapijom uz BSC.
English: The vial should then be turned upside down, making sure the needle tip is below the level of the liquid.
Croatian: Bočicu treba okrenuti naopačke, osiguravajući da vrh igle bude ispod razine tekućine.
English: No accumulation occurs after subcutaneous administration of 75 mg/m2 azacitidine once daily for 7 days.
Croatian: Ne dolazi do nakupljanja azacitidina nakon supkutane primjene 75 mg/m2 jedanput dnevno tijekom 7 dana.
English: You are more prone to bleeding and bruising.
Croatian: Skloniji ste krvarenju i modricama.
English: Reconstitution procedure
Croatian: Postupak rekonstitucije
English: Renal impairment has no major effect on the pharmacokinetic exposure of azacitidine after single and multiple subcutaneous administrations.
Croatian: Oštećenje bubrega nema veliki utjecaj na farmakokinetičku izloženost azacitidinu nakon supkutane primjene jednokratne i višekratnih doza.
English: Injection sites should be rotated.
Croatian: Mjesta injiciranja treba mijenjati.
English: However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table.
Croatian: Međutim, ako oporavak nije postignut unutar 14 dana, dozu treba smanjiti prema sljedećoj tablici.
English: • Bleeding due to a catheter line.
Croatian: • krvarenje zbog katetera
English: • Chest pain or shortness of breath which may be accompanied with a fever.
Croatian: • Bol u prsnom košu ili nedostatak zraka koji mogu biti praćeni vrućicom.
English: Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets ≤ 50.0 x 109/l and/or absolute neutrophil count (ANC) ≤ 1 x 109/l.
Croatian: Hematološka toksičnost definirana je kao najniža vrijednost dosegnuta u određenom ciklusu ako su trombociti ≤ 50,0 x 109/L i/ili ako je apsolutni broj neutrofila (ABN) ≤ 1 x 109/L.
English: Cardiac events
Croatian: Srčani događaji
English: Vidaza treatment improved peripheral blood counts and led to a reduced need for RBC and platelet transfusions.
Croatian: Liječenje Vidazom poboljšalo je perifernu krvnu sliku i dovelo do smanjenja potrebe za transfuzijama eritrocita i trombocita.
English: • An infection of the nose and throat, or sore throat.
Croatian: • infekcija nosa i grla ili grlobolja
English: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
Croatian: Preporučena početna doza za prvi ciklus liječenja za sve je bolesnike, bez obzira na početne hematološke laboratorijske vrijednosti, 75 mg/m2 površine tijela, a injicira se supkutano, jednom dnevno tijekom 7 dana, nakon čega slijedi stanka od 21 dana (28-dnevni ciklus liječenja).
English: • AML with >30% marrow blasts according to the WHO classification.
Croatian: • AML-a s >30 % blasta u koštanoj srži prema klasifikaciji SZO-a.
English: The efficacy and safety of Vidaza was studied in an international, multicentre, controlled, open-label, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with >30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Croatian: Djelotvornost i sigurnost Vidaze bila je ispitana u međunarodnom, multicentričnom, kontroliranom, otvorenom ispitivanju faze 3 na usporednim skupinama bolesnika u dobi od 65 i više godina s novodijagnosticiranom de novo ili sekundarnom AML s > 30 % blasta u koštanoj srži prema klasifikaciji SZO-a, koji nisu zadovoljavali kriterije za THMS.
English: Immune system disorders hypersensitivity reactions
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivos ti
English: One vial contains 100 mg azacitidine.
Croatian: Jedna bočica sadrži 100 mg azacitidina.
English: Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thrombocytopenia as required.
Croatian: Većina hematoloških nuspojava rješava se rutinskim praćenjem kompletne krvne slike i odgađanjem sljedećeg ciklusa primjene azacitidina, prema potrebi profilaktičkom primjenom antibiotika i/ili stimulirajućeg čimbenika rasta (npr. G-CSF) kod neutropenije te transfuzije kod anemije ili trombocitopenije.
English: This could be due to an infection as a result of having low levels of white blood cells, which can be life-threatening.
Croatian: To može nastati uslijed infekcije nastale zbog niskih razina bijelih krvnih stanica što može biti opasno za život.
English: • Dehydration.
Croatian: • dehidracija
English: Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza.
Croatian: Nekrotizirajući fasciitis, uključujući slučajeve sa smrtnim ishodom, zabilježen je u bolesnika liječenih Vidazom.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
English: Adult population (MDS, CMML and AML [20-30% marrow blasts])
Croatian: Odrasla populacija (MDS, KMML i AML [20-30 % blasta u koštanoj srži])
English: Table 1 below contains adverse reactions associated with azacitidine treatment obtained from the main clinical studies in MDS and AML and post marketing surveillance.
Croatian: Donja tablica 1 sadrži nuspojave povezane s liječenjem azacitidinom, dobivene iz glavnih kliničkih ispitivanja MDS-a i AML-a i postmarketinškog praćenja.
English: • if you have liver disease.
Croatian: • ako imate bolest jetre
English: An increased incidence of tumours in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine administered intraperitoneally for 50 weeks.
Croatian: Povećana učestalost tumora limforetikularnog sustava, pluća, mliječnih žlijezda i kože primijećena je kod miševa kojima je azacitidin primjenjivan intraperitonejski tijekom 50 tjedana.
English: If unexplained reductions in serum bicarbonate (< 20 mmol/L) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).
Croatian: Ako dođe do neobjašnjenog smanjenja serumskih bikarbonata (< 20 mmol/L) ili povišenja serumskog kreatinina ili dušika iz ureje u krvi, potrebno je smanjiti dozu ili odgoditi njenu primjenu (vidjeti dio 4.2).
English: In the event of overdose, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary.
Croatian: U slučaju predoziranja bolesniku treba nadzirati krvnu sliku i po potrebi primijeniti simptomatsko liječenje.
English: In human liver S9 fractions, formation of metabolites was independent of NADPH implying that azacitidine metabolism was not mediated by cytochrome P450 isoenzymes.
Croatian: U S9 frakcijama ljudske jetre, nastanak metabolita bio je neovisan o NADPH-u, što upućuje na to da metabolizam azacitidina nije posredovan izoenzimima citokroma P450.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično ROK VALJANOSTI
English: A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe.
Croatian: Novu supkutanu iglu (preporučeno od 25 G) treba dobro pričvrstiti na štrcaljku.
English: It is thought to work by altering the way the cell turns genes on and off and also by interfering with the production of new RNA and DNA.
Croatian: Smatra se da djeluje tako da mijenja način na koji se geni u stanicama „aktiviraju“ i „deaktiviraju“ te ometanjem stvaranja nove RNK i DNK.
English: Absorption Following subcutaneous administration of a single 75 mg/m2 dose, azacitidine was rapidly absorbed with peak plasma concentrations of 750 ± 403 ng/mL occurring at 0.5 h after dosing (the first sampling point).
Croatian: Nakon supkutane primjene jednokratne doze od 75 mg/m2, azacitidin se brzo apsorbirao te se vršna koncentracija azacitidina u plazmi od 750 ± 403 ng/mL postigla za 0,5 h nakon primjene (prva točka uzorkovanja).
English: • Headache.
Croatian: • glavobolja
English: Area under the curve and maximum plasma concentration (Cmax) of subcutaneous admiminstration of azacitidine were approximately proportional within the 25 to 100 mg/m2 dose range.
Croatian: Pri supkutanoj primjeni azacitidina, površina ispod krivulje i maksimalna koncentracija u plazmi (Cmax) bile su približno proporcionalne unutar raspona doza od 25 do 100 mg/m2.
English: Special populations Elderly patients
Croatian: Posebne populacije Starije osobe
English: The hazard ratio for the treatment effect was 0.58 (95 % CI: 0.43, 0.77).
Croatian: Omjer hazarda za učinke liječenja bio je 0,58 (95 % CI: 0,43, 0,77).
English: As part of the inclusion criteria, patients were required to have an ECOG performance status of 0-2 and intermediate- or poor-risk cytogenetic abnormalities.
Croatian: U sklopu kriterija uključenja bolesnici su morali imati ECOG funkcionalni status od 0 - 2 i citogenetske abnormalnosti srednjeg ili visokog rizika.
English: No formal studies have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena službena ispitivanja kod bolesnika s oštećenjem jetre.
English: The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates.
Croatian: Rekonstituirani lijek je homogena, mutna suspenzija bez nakupina.
English: The efficacy and safety of Vidaza were studied in an international, multicenter, controlled, open-label, randomised, parallel-group, Phase 3 comparative study (AZA PH GL 2003 CL 001) in adult patients with: intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system.
Croatian: Djelotvornost i sigurnost Vidaze ispitivane su u međunarodnom, multicentričnom kontroliranom, otvorenom, randomiziranom, komparativnom ispitivanju faze 3 u paralelnim skupinama (AZA PH GL 2003 CL 001) u odraslih bolesnika sa: srednjim 2 i visokim rizikom MDS-a prema međunarodnom prognostičkom numeričkom sustavu rangiranja (IPSS), refraktornom anemijom sa suviškom blasta (RAEB), refraktornom anemijom sa suviškom blasta u transformaciji (RAEB-T) i modificiranom kroničnom mijelomonocitnom leukemijom (mKMML) prema francusko-američko-britanskom (FAB) klasifikacijskom sustavu.
English: PHARMACEUTICAL FORM Powder for suspension for injection.
Croatian: OBLIK Prašak za suspenziju za injekciju.
English: Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA.
Croatian: Ugradnjom azacitidina u DNK inaktivira se DNK-a metiltransferaza, što dovodi do hipometilacije DNK-a.
English: Vidaza 25 mg/mL powder for suspension for injection Azacitidine
Croatian: Vidaza 25 mg/mL prašak za suspenziju za injekciju azacitidin
English: The majority of skin and subcutaneous adverse reactions were associated with the injection site.
Croatian: Većina nuspojava na koži i potkožnome tkivu povezana je s mjestom primjene.
English: Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
Croatian: Manji citogenetički odgovor bio je statistički značajno veći (p = 0,0015) u skupini liječenoj azacitidinom (34 %) u odnosu na kombinirane skupine liječene CCR-om (10 %).
English: In patients with one or more cytogenetic abnormalities at baseline, the percentage of patients with a major cytogenetic response was similar in the azacitidine and combined CCR groups.
Croatian: Kod bolesnika s jednom ili više citogenetičkih abnormalnosti na početku liječenja, postotak bolesnika sa znatnim citogenetičkim odgovorom bio je sličan u skupini liječenoj azacitidinom i kombiniranim skupinama liječenim CCR-om.
English: However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined.
Croatian: Međutim, ako oporavak nije postignut unutar 14 dana, treba odrediti celularnost koštane srži.
English: It is unknown whether azacitidine/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se azacitidin ili njegovi metaboliti u majčino mlijeko.
English: If unexplained elevations in serum creatinine or blood urea nitrogen (BUN) to ≥ 2-fold above baseline values and above upper limit of normal (ULN) occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50 % on the next treatment cycle (see section 4.4).
Croatian: Ako dođe do neobjašnjenog povećanja serumskog kreatinina ili dušika iz ureje u krvi (BUN) na vrijednosti ≥ 2 puta veće od početne vrijednosti i iznad gornje granice normale (GGN), sljedeći ciklus treba odgoditi sve dok se vrijednosti ne vrate na normalnu ili početnu vrijednost, a dozu u sljedećem ciklusu liječenja treba smanjiti za 50 % (vidjeti dio 4.4).
English: If recovery is achieved within 14 days, no dose adjustment is necessary.
Croatian: Ako je oporavak postignut unutar 14 dana, prilagodba doze nije potrebna.
English: Uncommon Rare
Croatian: Manje često Rijetko Nepoznato
English: Each pack contains one vial of Vidaza.
Croatian: Jedno pakiranje sadrži jednu bočicu Vidaze.
English: The most commonly reported gastrointestinal adverse reactions associated with azacitidine treatment included constipation, diarrhoea, nausea and vomiting.
Croatian: Najčešće prijavljene gastrointestinalne nuspojave povezane s primjenom azacitidina su konstipacija, proljev, mučnina i povraćanje.
English: The hazard ratio for the treatment effect was 0.85 (95% CI= 0.69, 1.03).
Croatian: Omjer hazarda za učinak liječenja iznosio je 0,85 (95 % CI = 0,69; 1,03).
English: Although no clinically relevant differences in the frequency of adverse reactions were noted between subjects with normal renal function compared to those with renal impairment, patients with renal impairment should be closely monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney (see section 4.2).
Croatian: Premda nisu uočene klinički značajne razlike u učestalosti nuspojava između ispitanika s normalnom funkcijom bubrega i onih s oštećenjem bubrega, bolesnike s oštećenjem bubrega treba pažljivo pratiti zbog toksičnosti jer se azacitidin i/ili njegovi metaboliti primarno izlučuju putem bubrega (vidjeti dio 4.2).
English: • Being short of breath when you move.
Croatian: • nedostatak zraka pri kretanju
English: This can cause low levels of red and white blood cells and platelets.
Croatian: Može prouzročiti niske razine crvenih i bijelih krvnih stanica i trombocita.
English: The most common serious adverse reactions (≥ 10%) noted from AZA-AML-001 within the azacitidine treatment arm included febrile neutropenia (25.0%), pneumonia (20.3%), and pyrexia (10.6%).
Croatian: Najčešće ozbiljne nuspojave (≥ 10 %) zabilježene u ispitivanju AZA-AML-001 u skupini liječenoj azacitidinom uključivale su febrilnu neutropeniju (25,0 %), pneumoniju (20,3 %) i pireksiju (10,6 %).
English: DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancersuppressing functions to cancer cells.
Croatian: Hipometilacija DNK-a, aberantno metiliranih gena uključenih u regulaciju normalnog staničnog ciklusa, diferencijaciju i puteve stanične smrti, može rezultirati ponovnom ekspresijom tumor-supresorskih gena i obnavljanjem njihove funkcije u tumorskim stanicama.
English: Table 1: ADRs reported in patients with MDS or AML treated with azacitidine (clinical studies and post- marketing)
Croatian: Tablica 1: Nuspojave zabilježene u bolesnika s MDS-om ili AML-om liječenih azacitidinom (klinička ispitivanja i ispitivanja nakon stavljanja lijeka u promet)
English: Vidaza treatment was associated with a median time to death or transformation to AML of 13.0 months versus 7.6 months for those receiving CCR treatment, an improvement of 5.4 months with a stratified log-rank p-value of 0.0025.
Croatian: Liječenje Vidazom bilo je povezano s medijanom vremena do smrti ili pretvorbe u AML od 13,0 mjeseci naspram 7,6 mjeseci za bolesnike liječene CCR-om, što je poboljšanje od 5,4 mjeseci sa stratificiranom log-rang p-vrijednošću od 0,0025.
English: • A type of anaemia where your red and white blood cells and platelets are reduced.
Croatian: • vrsta anemije kod koje su smanjene crvene i bijele krvne stanice i trombocita
English: • if you have decreased counts of platelets, red or white blood cells.
Croatian: • ako imate smanjen broj trombocita, crvenih ili bijelih krvnih stanica
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „EXP“.
English: Azacitidine can be administered to patients with renal impairment without initial dose adjustment provided these patients are monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney.
Croatian: Azacitidin se može primjenjivati bolesnicima s oštećenjem bubrega bez prilagodbe početne doze, uz uvjet da ih se prati zbog toksičnosti jer se azacitidin i/ili njegovi metaboliti primarno izlučuju putem bubrega.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to
Croatian: • akutne mijeloične leukemije (AML) s 20-30 % blasta i displazijom više loza, prema klasifikaciji
English: Pregnancy, breast-feeding and fertility
Croatian: Trudnoća, dojenje i plodnost