FrancophonIA/ELRC3.0 huggingface dataset:
English: During an Ontruzant infusion, chills, fever and other flu like symptoms may occur.
Croatian: Za vrijeme infuzije lijeka Ontruzant mogu se pojaviti zimica, vrućica i drugi simptomi nalik gripi.
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Croatian: Teške anafilaktičke reakcije koje zahtijevaju dodatnu hitnu intervenciju obično se javljaju tijekom prve ili druge infuzije trastuzumaba (vidjeti dio 4.4) i mogu završiti smrtnim ishodom.
English: Like all medicines, Ontruzant can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, Ontruzant može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Samsung Bioepis NL B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Samsung Bioepis NL B.V.
English: If you experience any of the above symptoms when your treatment with Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant.
Croatian: Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom Ontruzant, javite se svojem liječniku i recite mu da ste prethodno bili liječeni lijekom Ontruzant.
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Croatian: Reverzibilnost blage simptomatske i asimptomatske disfunkcije lijeve klijetke dokazana je u 79,5% bolesnika.
English: Table 13 Efficacy results from BO18225 Parameter
Croatian: Tablica 13: Rezultati djelotvornosti iz ispitivanja BO18225 Parametar
English: On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za trastuzumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) trastuzumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ontruzant.
Croatian: Vrlo rijetko su bolesnici koji su i prije liječenja imali znatne poteškoće s disanjem preminuli nakon primjene lijeka Ontruzant.
English: What you need to know before you are given Ontruzant Do not use Ontruzant if:
Croatian: Što morate znati prije nego počnete primati Ontruzant
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Croatian: Razlika nije bila statistički značajna, no više od polovine bolesnica koje su primale samo anastrozol nakon progresije bolesti počelo je primati terapiju koja je uključivala trastuzumab.
English: A vial of Ontruzant reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Croatian: Bočica lijeka Ontruzant rekonstituirana vodom za injekcije (nije priložena u pakiranju), stabilna je nakon rekonstitucije 48 sati na temperaturi od 2ºC - 8ºC i ne smije se zamrzavati.
English: Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC2+/FISH+ or IHC3+).
Croatian: Rezultati post hoc analiza podskupina pokazuju da su pozitivni učinci liječenja ograničeni na tumore s višim razinama HER2 proteina (IHC2+/FISH+ ili IHC3+).
English: p-value versus
Croatian: p-vrijednost naspram
English: Clinical experience is limited in patients above 65 years of age.
Croatian: U bolesnika u dobi iznad 65 godina kliničko je iskustvo ograničeno.
English: Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Croatian: Vezanje trastuzumaba za HER2 inhibira HER2 signalni put neovisan o ligandu i sprječava proteolitičko cijepanje njegove ekstracelularne domene, koje predstavlja aktivacijski mehanizam HER2.
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC3+/FISH+ group.
Croatian: HR za ukupno preživljenje je bio 0,75 (95% CI 0,51-1,11) u skupini IHC2+/FISH+ i 0,58 (95% CI 0,41-0,81) u skupini IHC3+/FISH+.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO16348 nakon medijana praćenja od 12 mjeseci* i 8 godina** sažeti su u tablici 6:
English: Ontruzant is given every 3 weeks for early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Croatian: Ontruzant se primjenjuje svaka 3 tjedna za rani rak dojke, metastatski rak dojke i metastatski rak želuca.
English: Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Croatian: U većine bolesnika (79%) u kojih se u tim ispitivanjima razvila disfunkcija srca došlo je do poboljšanja nakon što su primili standardnu terapiju za kongestivno zatajenje srca.
English: Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Croatian: Liječenje se može nastaviti tijekom razdoblja reverzibilne, kemoterapijom izazvane mijelosupresije, ali je bolesnike tijekom tog razdoblja potrebno pažljivo nadzirati kako bi se pravodobno opazile komplikacije neutropenije.
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Croatian: * Opaženo u kombiniranoj terapiji nakon antraciklina i u kombinaciji s taksanima.
English: The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied.
Croatian: Sigurnost nastavka ili ponovne primjene trastuzumaba u bolesnika u kojih se razvila disfunkcija srca nije prospektivno ispitana.
English: If the first dose is well tolerated the next doses may be given over 30 minutes.
Croatian: U slučaju dobrog podnošenja prve doze, sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with intravenous trastuzumab developed antibodies against trastuzumab.
Croatian: U sklopu ispitivanja neoadjuvantnog-adjuvantnog liječenja ranog raka dojke (BO22227), nakon medijana praćenja od više od 70 mjeseci, u 10,1% (30/296) bolesnika liječenih trastuzumabom za intravensku primjenu razvila su se protutijela na trastuzumab.
English: If LVEF percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Croatian: Ako postotak LVEF-a padne za ≥10 bodova ispod početne vrijednosti I TAKOĐER na manje od 50%, liječenje je potrebno prekinuti i ponoviti procjenu LVEF-a unutar približno 3 tjedna.
English: Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Croatian: Među najozbiljnije i/ili najčešće nuspojave dosad prijavljene pri primjeni lijeka Ontruzant ubrajaju se disfunkcija srca, reakcije povezane s infuzijom, hematotoksičnost (osobito neutropenija) infekcije i plućne nuspojave.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima Uvijek čuvajte ovaj lijek u zatvorenom originalnom pakiranju na temperaturi 2ºC - 8ºC u hladnjaku.
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Croatian: U ispitivanjima trajanja do 6 mjeseci nije bilo dokaza akutne toksičnosti niti toksičnosti povezane s višekratnim dozama, kao ni dokaza reprodukcijske toksičnosti u teratološkim ispitivanjima, ispitivanjima ženske plodnosti ili ispitivanjima kasne gestacijske toksičnosti/prolaza kroz placentu.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7%-10%).
Croatian: Najviša stopa srčane disfunkcije zabilježena je u bolesnika koji su primali trastuzumab istodobno s antraciklinom/ciklofosfamidom (27%), što je bilo značajno više nego kod primjene samo antraciklina/ciklofosfamida (7%-10%).
English: Docetaxel3 N=94
Croatian: Docetaksel3 N=94
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Croatian: Osim toga, neophodan je oprez pri liječenju bolesnika u kojih postoji povećan srčani rizik, npr. hipertenzija, dokumentirana bolest koronarnih arterija, kongestivno zatajenje srca, ejekcijska frakcija lijeve klijetke (LVEF) <55%, starija dob.
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Croatian: Također se primjenjuje u kombinaciji s lijekovima koji se zovu inhibitori aromataze u liječenju bolesnika s visokom razinom proteina HER2 i metastatskim rakom dojke pozitivnim na hormonske receptore (rakom dojke osjetljivim na prisutnost ženskih spolnih hormona).
English: In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
Croatian: U tom je ispitivanju 87% bolesnika bilo IHC3+, a 95% njih je bilo IHC3+ i/ili FISH pozitivno.
English: HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1).
Croatian: Prije početka liječenja obavezno je testiranje ekspresije HER2 (vidjeti dijelove 4.4 i 5.1).
English: Ontruzant is for single-use only, as the product contains no preservatives.
Croatian: Ontruzant je namijenjen samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: Other side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
Croatian: Ostale nuspojave mogu se pojaviti bilo kada tijekom liječenja lijekom Ontruzant, a ne samo u svezi s infuzijom.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Croatian: Općenito, CISH se smatra pozitivnim ako postoji više od 5 kopija HER2 gena po jezgri u više od
English: How to store Ontruzant
Croatian: Kako čuvati Ontruzant
English: +1Hypotension
Croatian: +1hipotenzija vazodilatacija
English: Do not use Ontruzant if you notice any particulate matter or discoloration prior to administration.
Croatian: Ontruzant se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
Croatian: Općenito, FISH se smatra pozitivnim ako je omjer broja genskih kopija HER2 po tumorskoj stanici i broja kopija kromosoma 17 veći ili jednak 2 ili ako postoji više od 4 kopije HER2 gena po tumorskoj stanici ako se ne koristi kontrola kromosomom 17.
English: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Croatian: kao monoterapija u liječenju bolesnika koji su primili najmanje dvije linije kemoterapije za metastatsku bolest.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (>50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Croatian: Čimbenici rizika za srčani događaj utvrđeni u četiri velika ispitivanja adjuvantnog liječenja uključivali su stariju dob (>50 godina), nizak LVEF (<55%) na početku liječenja, prije ili nakon početka liječenja paklitakselom, smanjenje LVEF-a za 10-15 bodova te prethodnu ili istodobnu primjenu antihipertenziva.
English: The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Croatian: Stopa svih stupnjeva reakcija povezanih s infuzijom lijeka varirala je od ispitivanja do ispitivanja ovisno o indikaciji, metodologiji prikupljanja podataka te o tome je li se trastuzumab primjenjivao u kombinaciji s kemoterapijom ili kao monoterapija.
English: Pulmonary events
Croatian: Plućni događaji
English: In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
Croatian: U rijetkim slučajevima, klinički tijek tih reakcija doveo je do smrtnog ishoda.
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to the trial MO16432.
Croatian: Iskustvo s istodobnom primjenom trastuzumaba i protokola s niskim dozama antraciklina zasada je ograničeno na kliničko ispitivanje MO16432.
English: If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of trastuzumab therapy has been seen.
Croatian: Ako se u bolesnika primijeti kontinuirano smanjenje funkcije lijeve klijetke, ali ostaje asimptomatsko, liječnik treba razmotriti prekid terapije trastuzumabom ako ona nije polučila nikakvu kliničku korist.
English: A study of trehalose, a major formulation excipient, did not reveal any toxicities.
Croatian: Ispitivanja trehaloze, glavne pomoćne tvari u sastavu lijeka, nisu pokazala toksičan učinak.
English: Each vial contains either: 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection.
Croatian: Jedna bočica sadrži ili: 150 mg trastuzumaba koji treba otopiti u 7,2 ml vode za injekcije, ili 420 mg trastuzumaba koji treba otopiti u 20 ml vode za injekcije.
English: MBC EBC AGC
Croatian: EBC AGC
English: Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and haemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
Croatian: Bolesnici koji su u anamnezi imali infarkt miokarda (IM), anginu pektoris koja je zahtijevala liječenje, ranije ili postojeće kongestivno zatajenje srca (NYHA klase II-IV), LVEF <55%, neku drugu kardiomiopatiju, srčanu aritmiju koja je zahtijevala liječenje, klinički značajnu bolest srčanih zalistaka, loše kontroliranu hipertenziju (hipertenzija kontrolirana standardnim liječenjem smatrala se pogodnom za ispitivanje) i hemodinamički učinkovit perikardijalni izljev bili su isključeni iz ključnih ispitivanja adjuvantnog i neoadjuvantnog liječenja ranog raka dojke trastuzumabom, pa se liječenje za te bolesnike ne može preporučiti.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 µg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Croatian: Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije <1 µg/ml (približno 3%
English: In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Croatian: U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (>95%) SISH i FISH metoda za utvrđivanje genske amplifikacije HER2.
English: As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Croatian: Kao rezultat toga, trastuzumab je i u pokusima in vitro i na životinjama inhibirao proliferaciju ljudskih tumorskih stanica koje imaju povećanu ekspresiju
English: To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Croatian: Kako bi se osigurala primjena validiranih postupaka testiranja i dobivanje točnih i ponovljivih rezultata, ispitivanje HER2 mora provesti laboratorij s primjereno obučenim osobljem.
English: Do not breast-feed your baby during Ontruzant therapy and for 7 months after the last dose of Ontruzant as Ontruzant may pass to your baby through your breast milk.
Croatian: Nemojte dojiti dijete za vrijeme terapije lijekom Ontruzant ni 7 mjeseci nakon posljednje doze lijeka jer se Ontruzant preko mlijeka može prenijeti na dijete.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Croatian: Međutim, većina reakcija povezanih s infuzijom blagog je do umjerenog intenziteta (prema NCI-CTC stupnjevanju) i uglavnom se javlja na početku liječenja tj. za vrijeme prve, druge i treće infuzije te im se učestalost smanjuje sa svakom sljedećom infuzijom.
English: FP +H N=294 HR (95% CI)
Croatian: FP +H N=294 HR (95% CI) p-vrijednost
English: (increased muscle tone or tension)
Croatian: • hipertonija (povećani tonus ili napetost mišića)
English: Ontruzant intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available.
Croatian: Intravensku infuziju lijeka Ontruzant treba primijeniti zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Croatian: U ispitivanju BCIRG 006 je 213/1075 bolesnika u skupini DCarbH (TCH), 221/1074 bolesnika u skupini AC→DH (AC→TH) i 217/1073 bolesnika u skupini AC→D (AC→T) imalo Karnofsky status ≤90 (bilo 80 ili 90).
English: Patients with EBC should be treated with Ontruzant for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Croatian: U bolesnika s ranim rakom dojke liječenje lijekom Ontruzant traje godinu dana ili do povrata bolesti, što god nastupi ranije; ne preporučuje se produljiti liječenje ranog raka dojke dulje od jedne godine (vidjeti dio 5.1).
English: The efficacy results from study BO18225 are summarized in Table 13:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO18225 sažeti su u tablici 13:
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 Ontruzant is a biosimilar medicinal product.
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC03
English: Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Croatian: Zabilježeni su i slučajevi kliničkog pogoršanja i odgođenih reakcija s brzim kliničkim pogoršanjem koji su uslijedili nakon početnog poboljšanja.
English: If you receive Ontruzant with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Croatian: Ako primate Ontruzant u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, kapecitabina, 5-fluorouracila ili cisplatina, pročitajte upute o lijeku i za te lijekove.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
English: This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Croatian: Ta intravenska formulacija nije namijenjena za potkožnu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
English: 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije Rak dojke
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Croatian: Kod manjeg broja bolesnika korištena je metoda fluorescentne in situ hibridizacije (FISH).
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1-year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Croatian: U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj trastuzumabom 1 godinu iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila
English: This translates into an absolute benefit in terms of an 8-year disease free survival rate of 6.4 percentage points in favour of 1-year trastuzumab treatment.
Croatian: To ukazuje na apsolutnu povoljnost u smislu 8-godišnjeg preživljenja bez simptoma bolesti s razlikom od 6,4 postotnih bodova u korist skupine liječene 1 godinu trastuzumabom.
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Croatian: U ključnom ispitivanju docetaksela (100 mg/m2 u jednosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega, 60% bolesnika prethodno je liječeno antraciklinskom adjuvantnom kemoterapijom.
English: Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
Croatian: Farmakokinetički podaci iz ispitivanja H4613g/GO01305 ukazali su na to da karboplatin ne utječe na farmakokinetiku trastuzumaba.
English: The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects (see section 2 under “Warnings and precautions”).
Croatian: Tijekom primjene prve doze, koju ćete primati u infuziji trajanja 90 minuta, zbog mogućnosti razvoja nuspojava bit ćete pod nadzorom stručne medicinske osobe (pogledajte dio 2 pod "Upozorenja i mjere opreza").