FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse reactions are “amino acid level decreased” (hypophenylalaninaemia), vomiting and rhinitis.
Croatian: Najčešće prijavljene nuspojave bile su „snižena razina aminokiseline“ (hipofenilalaninemija), povraćanje i rinitis.
English: The safety, efficacy and population pharmacokinetics of Kuvan were studied in a multicentre, openlabel, randomised, controlled study in children <4 years old with a confirmed diagnosis of PKU.
Croatian: Sigurnost, djelotvornost i populacijska farmakokinetika Kuvana bile su ispitane u multicentričnom otvorenom, randomiziranom, kontroliranom ispitivanju u djece u dobi <4 godine s potvrđenom dijagnozom PKU.
English: HPA and PKU are due to abnormally high levels of phenylalanine in the blood which can be harmful.
Croatian: HPA i PKU posljedica su prekomjerno visokih koncentracija fenilalanina u krvi koje mogu biti štetne.
English: • Place the prescribed number of tablets in the medicine cup.
Croatian: • Stavite propisani broj tableta u čašicu za lijek.
English: Patients should be advised not to swallow the desiccant capsule found in the bottle.
Croatian: Bolesnike treba upozoriti da ne progutaju spremnik sa sredstvom za sušenje koji se nalazi u boci.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX07
Croatian: Farmakoterapijska skupina: Drugi lijekovi koji djeluju na probavni sustav i metabolizam, različiti lijekovi koji djeluju na probavni sustav i metabolizam, ATK oznaka: A16AX07
English: If after approximately 4 weeks, a patient's phenylalanine tolerance had not increased by >20% versus baseline, the Kuvan dose was increased in a single step to 20 mg/kg/day.
Croatian: Ako se nakon približno 4 tjedna bolesnikova tolerancija na fenilalanin nije poboljšala za >20% u odnosu na početnu, doza Kuvana povisila se u jednom koraku na 20 mg/kg/dan.
English: A calculated dose of 451 mg to 499 mg should be rounded up to 500 mg corresponding to 5 tablets.
Croatian: Izračunatu dozu od 451 do 499 mg treba zaokružiti na 500 mg, što odgovara količini od 5 tableta.
English: It may take a few minutes for the tablets to dissolve.
Croatian: Otapanje tableta može potrajati nekoliko minuta.
English: If only a portion of this solution needs to be administered, an oral syringe should be used to withdraw the volume of solution to be administered.
Croatian: Ako treba primijeniti samo dio te otopine, oralnom štrcaljkom treba izvući volumen otopine koji će se primijeniti.
English: Total dose (mg/day)
Croatian: Ukupna doza (mg/dan)
English: Health disturbances
Croatian: Zdravstvene tegobe
English: Date of the first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
Croatian: Datum posljednje obnove odobrenja: 2. prosinca 2013.
English: If you are not able to give your child's dose within 30 minutes after dissolving the powder, you will need to prepare a new solution as the unused solution should not be used beyond 30 minutes.
Croatian: Ako ne uspijete svom djetetu dati dozu unutar 30 minuta od otapanja praška, morat ćete pripremiti novu otopinu jer se otopina ne smije primijeniti ako je prošlo više od 30 minuta od pripreme.
English: Emesis has been observed in both the safety pharmacology and the repeated-dose toxicity studies.
Croatian: Povraćanje je primijećeno u ispitivanjima sigurnosne farmakologije kao i u ispitivanjima toksičnosti ponovljene doze.
English: If you notice these signs, contact your doctor immediately.
Croatian: Ako primijetite bilo koju navedenu nuspojavu, odmah obavijestite liječnika.
English: The oral syringe and the cup should be stored for next use.
Croatian: Oralnu štrcaljku i čašicu treba spremiti za sljedeću uporabu.
English: Date of first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
Croatian: Datum prvog odobrenja: 2. prosinca 2008.
English: The dietary phenylalanine intake should be maintained at a constant level during this period.
Croatian: Tijekom tog razdoblja unos fenilalanina hranom mora se održavati na konstantnoj razini.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Za opis učestalosti koji se koristi u daljnjem tekstu primjenjuju se sljedeće definicije: Vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka) Unutar svake grupe učestalosti, nuspojave su prikazane po redoslijedu opadanja ozbiljnosti.
English: If you are not able to give your child's dose within 15 to 20 minutes after dissolving the tablets, you will need to prepare a new solution as the unused solution should not be used beyond 20 minutes.
Croatian: Ako ne uspijete svom djetetu dati dozu unutar 15 do 20 minuta od otapanja tableta, morat ćete pripremiti novu otopinu jer se otopina ne smije primijeniti ako je prošlo više od 20 minuta od pripreme.
English: Kuvan 500 mg is for use in patients above 25 kg body weight only.
Croatian: Kuvan od 500 mg je namijenjen samo za primjenu u bolesnika tjelesne težine iznad 25 kg.
English: A satisfactory response is defined as a ≥30 percent reduction in blood phenylalanine levels or attainment of the therapeutic blood phenylalanine goals defined for an individual patient by the treating physician.
Croatian: Zadovoljavajući odgovor definira se kao smanjenje koncentracije fenilalanina u krvi za ≥ 30 posto ili postizanje terapijskih koncentracija fenilalanina u krvi, koje je za individualnog bolesnika odredio njegov liječnik.
English: Based on the in vitro and in vivo results, co-administration of Kuvan is unlikely to increase systemic exposure to drugs that are substrates for BCRP.
Croatian: Na temelju in vitro i in vivo rezultata, istodobna primjena lijeka Kuvan vjerojatno neće povećati sistemsku izloženost lijekovima koji su supstrati za BCRP.
English: Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan.
Croatian: Sapropterin je sintetička verzija prirodnog 6R-BH4, koji je kofaktor hidroksilaza za fenilalanin, tirozin i triptofan.
English: Check to make sure that the amount of liquid lines up with the amount that your doctor tells you.
Croatian: Provjerite poklapa li se količina tekućine s količinom koju je liječnik rekao da uporabite.
English: Kuvan is provided as 100 mg tablets.
Croatian: Kuvan je dostupan u obliku tableta od 100 mg.
English: How to take Kuvan
Croatian: Kako uzimati Kuvan
English: BH4 is a cofactor for nitric oxide synthetase.
Croatian: BH4 je kofaktor sintetaze dušičnog oksida.
English: Prolonged exposure to low blood phenylalanine and tyrosine levels during infancy has been associated with impaired neurodevelopmental outcome.
Croatian: Produljena izloženost niskim koncentracijama fenilalanina i tirozina u krvi u ranom djetinjstvu povezuje se s neurorazvojnim oštećenjima.
English: When the oral syringe is dry, put the plunger back into the barrel.
Croatian: Kad oralna štrcaljka bude suha, vratite klip u tijelo štrcaljke.
English: These devices are supplied to the specialized paediatric centers for inborn errors of metabolism to be provided to the caregivers of the patients.
Croatian: Taj pribor nabavljaju pedijatrijski centri specijalizirani za urođene poremećaje metabolizma te njime opskrbljuju njegovatelje ovih bolesnika.
English: 1 bottle per carton.
Croatian: Svaka kutija sadrži po 1 bocu.
English: BH4 is required by the body to use an amino acid called phenylalanine in order to build another amino acid called tyrosine.
Croatian: BH4 je tijelu potreban za pretvaranje aminokiseline koja se naziva fenilalanin u drugu aminokiselinu koja se zove tirozin.
English: In the pivotal clinical trials and in the post-marketing experience for Kuvan, the following adverse reactions have been identified.
Croatian: U ključnim kliničkim ispitivanjima i nakon stavljanja u promet lijeka Kuvan uočene su sljedeće nuspojave.
English: Maternal blood phenylalanine levels must therefore be strictly controlled before and during pregnancy.
Croatian: Majčine koncentracije fenilalanina u krvi moraju se stoga strogo kontrolirati prije i tijekom trudnoće.
English: In the clinical trial extension period, patients maintained dietary phenylalanine tolerance while on Kuvan treatment in conjunction with a Phe-restricted diet, demonstrating sustained benefit over 3.5 years.
Croatian: U razdoblju produženja kliničkog ispitivanja, bolesnici su održavali toleranciju unosa fenilalanina hranom tijekom liječenja Kuvanom uz prehranu siromašnu fenilalaninom, pokazujući kontinuiranu korist tijekom 3,5 godina.
English: For patients above 20 kg body weight, the calculated daily dose based on body weight should be rounded to the nearest multiple of 100 mg.
Croatian: Za bolesnike tjelesne težine veće od 20 kg dnevnu dozu izračunatu na temelju tjelesne težine treba zaokružiti na najbliži višekratnik broja 100.
English: Available disease-associated maternal and/or embryofoetal risk data from the Maternal Phenylketonuria Collaborative Study on a moderate amount of pregnancies and live births (between 300-1,000) in PKU-affected women demonstrated that uncontrolled phenylalanine levels above 600 μmol/l are associated with a very high incidence of neurological, cardiac, facial dysmorphism, and growth anomalies.
Croatian: Maternal Phenylketonuria Collaborative Study), koje je uključilo umjeren broj trudnoća i živorođene djece (između 300-1000) u žena s PKU, pokazali su da su nekontrolirane razine fenilalanina iznad 600 μmol/l povezane s vrlo visokom incidencijom neuroloških i srčanih anomalija, dismorfije lica i anomalija rasta.
English: See leaflet for further information.
Croatian: Za dodatne informacije vidjeti uputu.
English: There was a significant difference in dietary phenylalanine tolerance in the sapropterin treatment group as compared to the placebo group.
Croatian: U skupini liječenoj sapropterinom uočena je značajna razlika u toleranciji unosa fenilalanina hranom u odnosu na skupinu koja je dobivala placebo.
English: Be sure you know whether to use Kuvan 100 mg powder for oral solution, or both medicines to prepare your dose.
Croatian: Morate znati trebate li uzimati Kuvan 100 mg prašak za oralnu otopinu ili oba lijeka kako biste pripremili svoju dozu.
English: Response to this medicinal product is determined by a decrease in blood phenylalanine.
Croatian: Odgovor na ovaj lijek određuje se smanjenjem koncentracije fenilalanina u krvi.
English: Depending on the dose (in mg/kg/day) the appropriate number of tablets should be dissolved in a volume of water as depicted in Tables 1-4, whereby the volume of the solution to be administered is calculated according to the prescribed total daily dose.
Croatian: Ovisno o dozi (u mg/kg na dan), potrebno je otopiti odgovarajući broj tableta u volumenu vode kako je prikazano u tablicama 1-4, a volumen otopine koji će se primijeniti izračunava se prema propisanoj ukupnoj dnevnoj dozi.
English: If maternal phenylalanine levels are not strictly controlled before and during pregnancy, this could be harmful to the mother and the foetus.
Croatian: Ako se majčine koncentracije fenilalanina u krvi ne kontroliraju strogo prije i tijekom trudnoće, može doći do štetnog utjecaja na majku i fetus.
English: For PKU patients, the total daily dose is taken once a day at the same time each day, preferably in the morning.
Croatian: Za bolesnike s PKU, ukupnu dnevnu dozu treba uzimati jednom dnevno, svakog dana u isto vrijeme, poželjno ujutro.
English: Give your child the prescribed amount of solution within 30 minutes after dissolving.
Croatian: Dajte svom djetetu propisanu količinu otopine unutar 30 minuta od pripreme otopine.
English: The dose is adjusted, usually between 5 and 20 mg/kg/day, to achieve and maintain adequate blood phenylalanine levels as defined by the physician.
Croatian: Doza se po potrebi prilagođava, obično između 5 i 20 mg/kg/dnevno, kako bi se dostigle i održale odgovarajuće koncentracije fenilalanina u krvi koje odredi liječnik.
English: Supplies needed to prepare and give your child's dose of Kuvan
Croatian: Pribor potreban za pripremu i davanje propisane doze Kuvana Vašem djetetu:
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake „EXP“.
English: Frequency, type and severity of adverse reactions in children were essentially similar to those in adults.
Croatian: Pedijatrijska populacija Učestalost, vrsta i težina nuspojava u djece bile su u biti slične onima u odraslih.
English: Emesis is considered to be related to the pH of the solution containing sapropterin.
Croatian: Smatra se da je povraćanje povezano s pH otopine koja sadrži sapropterin.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).
Croatian: Vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Kuvan is not expected to affect the ability to drive and use machines.
Croatian: Ne očekuje se djelovanje Kuvana na sposobnost upravljanja vozilima i strojevima.
English: Your doctor may adjust your dose, usually between 5 and 20 mg for each kg of body weight per day, depending on your condition.
Croatian: Liječnik može prilagoditi dozu, obično između 5 i 20 mg dnevno na svaki kilogram tjelesne težine, ovisno o Vašem stanju.
English: High-density polyethylene (HDPE) bottle with child-resistant closure.
Croatian: Boca od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu.
English: Physician-supervised restriction of dietary phenylalanine intake prior to and throughout pregnancy is the first choice of treatment in this patient group.
Croatian: Ograničeni unos fenilalanina hranom, pod kontrolom liječnika, prije i tijekom trudnoće, prvi je izbor u liječenju ove skupine bolesnika.
English: The baseline blood phenylalanine levels for the Kuvan-treated group and the placebo group were similar, with mean ± SD baseline blood phenylalanine levels of 843 ± 300 μmol/l and 888 ± 323 μmol/l, respectively.
Croatian: Početne koncentracije fenilalanina u krvi za skupinu liječenu Kuvanom i za placebo skupinu bile su slične, sa srednjom vrijednošću ± SD početnih koncentracija fenilalanina od 843 ± 300 μmol/l, odnosno 888 ± 323 μmol/l.
English: Following intravenous administration in rats, sapropterin dihydrochloride is mainly excreted in the urine.
Croatian: Nakon intravenske primjene kod štakora sapropterindiklorid uglavnom se izlučuje u urin.
English: Once responsiveness to the medicinal product has been established, the dose may be adjusted within the range of 5 to 20 mg/kg/day according to response to therapy.
Croatian: Kada se jednom ustanovi pozitivan odgovor na ovaj lijek, doza se može podesiti u rasponu od 5 do 20 mg/kg/na dan, ovisno o odgovoru na terapiju.
English: When the oral syringe is dry, the plunger should be put back into the barrel.
Croatian: Kad oralna štrcaljka bude suha, klip treba vratiti u cilindar štrcaljke.
English: Push on the plunger slowly, a small amount at a time, until all of the solution in the oral syringe is given.
Croatian: Polako potiskujte klip, tako da izlazi malo po malo tekućine, sve dok ne date svu otopinu iz oralne štrcaljke.
English: 30 soluble tablets 120 soluble tablets 240 soluble tablets
Croatian: 30 tableta za oralnu otopinu 120 tableta za oralnu otopinu 240 tableta za oralnu otopinu
English: Following oral administration it is mainly eliminated through faeces while a small proportion is excreted in urine.
Croatian: Nakon peroralne primjene uglavnom se eliminira fecesom, a u manjem udjelu urinom.
English: In particular you should tell your doctor if you are using: - levodopa (used to treat Parkinson's disease) - medicines for treatment of cancer (e.g. methotrexate) - medicines for treatment of bacterial infections (e.g. trimethoprim) - medicines that cause dilation of blood vessels, (such as glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin, minoxidil).
Croatian: Osobito trebate obavijestiti svog liječnika ako uzimate: - levodopu (za liječenje Parkinsonove bolesti) - lijekove za liječenje raka (npr. metotreksat) - lijekove za liječenje bakterijskih infekcija (npr. trimetoprim) - lijekove koji uzrokuju širenje krvnih žila (kao što je gliceriltrinitrat (GTN), izosorbiddinitrat
English: As HPA due to either PKU or BH4 deficiency is a chronic condition, once responsiveness is demonstrated, Kuvan is intended for long-term use (see section 5.1).
Croatian: Budući da je HPA, uzrokovana PKU ili nedostatkom BH4, kronično stanje, ovaj je lijek namijenjen dugoročnoj primjeni kod bolesnika koji pokažu pozitivan odgovor na Kuvan (vidjeti dio 5.1).
English: Caution is recommended when using such medicinal products while taking Kuvan.
Croatian: Preporučuje se oprez kod primjene ovakvih lijekova zajedno s Kuvanom.
English: Kuvan contains potassium citrate (E332)
Croatian: Kuvan sadrži kalij citrat (E332)
English: Your doctor may adjust your dose up to 20 mg for each kg of body weight per day, depending on your condition.
Croatian: Liječnik može prilagoditi dozu do 20 mg na svaki kilogram tjelesne težine, ovisno o Vašem stanju.
English: The rationale for administration of Kuvan in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase.
Croatian: Smisao primjene Kuvana bolesnicima koji imaju nedostatak BH4 je u nadomještanju nedovoljnih koncentracija BH4 čime se ponovo uspostavlja aktivnost fenilalanin hidroksilaze.
English: An internal tear notch is located in the corner of the sachet to facilitate opening of the sachet.
Croatian: Unutarnji urez smješten je u kutu vrećice radi lakšeg otvaranja vrećice.
English: Give your child the prescribed amount of solution within 15 to 20 minutes after dissolving.
Croatian: Dajte svom djetetu propisanu količinu otopine unutar 15 do 20 minuta od pripreme otopine.
English: - The active substance is sapropterin dihydrochloride.
Croatian: - Djelatna tvar je sapropterindiklorid.
English: Caution should be exercised when prescribing Kuvan to patients receiving treatment with levodopa.
Croatian: Potreban je oprez prilikom propisivanja lijeka Kuvan bolesnicima koji se istodobno liječe levodopom.
English: Approximately 35% of the 579 patients aged 4 years and over who received treatment with sapropterin dihydrochloride (5 to 20 mg/kg/day) in the clinical trials for Kuvan experienced adverse reactions.
Croatian: Otprilike 35% bolesnika od njih 579 u dobi od 4 godine i više koji su liječeni sapropterindikloridom (5 do 20 mg/kg na dan) tijekom kliničkih ispitivanja lijeka Kuvan imalo je nuspojave.
English: Store the oral syringe and the medicine cup for next use.
Croatian: Oralnu štrcaljku i čašicu za lijek spremite za sljedeću uporabu.
English: The solution may then be transferred to another cup for administration of the medicinal product.
Croatian: Otopinu zatim treba prenijeti u drugu čašu za primjenu lijeka.
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea
Croatian: proljev, povraćanje, bol u abdomenu, dispepsija, mučnina Nepoznato: gastritis, ezofagitis
English: Take Kuvan as a single daily dose with a meal to increase the absorption, and at the same time each day, preferably in the morning.
Croatian: Kuvan uzmite jednom dnevno za vrijeme jela, kako bi se povećala apsorpcija, te svakog dana u isto vrijeme, poželjno ujutro.
English: Talk to your doctor or pharmacist before taking Kuvan, particularly: - if you are 65 years of age or older - if you have problems with your kidney or liver - if you are ill. Consultation with a physician is recommended during illness as blood phenylalanine levels may increase - if you have predisposition to convulsions
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Kuvan, osobito: - ako imate 65 godina ili više; - ako imate problema s bubrezima ili jetrom; - ako ste bolesni.
English: If an unsatisfactory reduction in blood phenylalanine levels is observed, then the dose can be increased weekly to a maximum of 20 mg/kg/day, with continued weekly monitoring of blood phenylalanine levels over a one month period.
Croatian: Ako se koncentracija fenilalanina u krvi ne smanji u zadovoljavajućoj mjeri, doza lijeka može se u tjednim razmacima postupno povećati do maksimalno 20 mg/kg/na dan, uz nastavak praćenja koncentracije fenilalanina u krvi jednom tjedno tijekom mjesec dana.
English: The rationale for administration of Kuvan in patients with BH4-responsive PKU is to enhance the activity of the defective phenylalanine hydroxylase and thereby increase or restore the oxidative metabolism of phenylalanine sufficient to reduce or maintain blood phenylalanine levels, prevent or decrease further phenylalanine accumulation, and increase tolerance to phenylalanine intake in the diet.
Croatian: Smisao primjene Kuvana bolesnicima koji imaju PKU s pozitivnim odgovorom na BH4 je u poticanju aktivnosti defektne fenilalanin hidroksilaze čime se povećava ili ponovo uspostavlja oksidativni metabolizam fenilalanina, dovoljan da smanji ili održi koncentracije fenilalanina u krvi, spriječi ili smanji daljnje nakupljanje fenilalanina te poveća toleranciju na unos fenilalanina hranom.
English: Drink the dissolved preparation of Kuvan with a meal within 15 to 20 minutes of its preparation.
Croatian: Otopinu Kuvana popijte uz obrok, unutar 15 do 20 minuta nakon pripreme otopine.
English: It is recommended that blood phenylalanine and tyrosine levels be tested one or two weeks after each dose adjustment and monitored frequently thereafter under the direction of the treating physician.
Croatian: Preporučuje se da se koncentracije fenilalanina i tirozina u krvi provjere jedan ili dva tjedna nakon svake prilagodbe doze te da se često prate i nakon toga prema nalogu nadležnog liječnika.
English: • Empty the contents of the sachet(s) into 120 ml to 240 ml of water.
Croatian: • Sadržaj vrećice istresite u 120 ml do 240 ml vode.
English: Sapropterin was found to be weakly mutagenic in bacterial cells and an increase in chromosome aberrations was detected in Chinese hamster lung and ovary cells.
Croatian: Primijećeno je da je sapropterin blago mutagen u bakterijskim stanicama, a također je zabilježeno povećanje aberacija kromosoma stanica pluća i jajnika kineskog hrčka.
English: Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment (see section 4.2).
Croatian: Kuvan je također indiciran za liječenje hiperfenilalaninemije (HPA) u odraslih i pedijatrijskih bolesnika svih dobi s nedostatkom tetrahidrobiopterina (BH4) kod kojih se pokazalo da odgovaraju na ovakvo liječenje (vidjeti dio 4.2).
English: Common side effects (may affect up to 1 in 10 people) Sore throat, nasal congestion or stuffy nose, cough, diarrhoea, vomiting, stomach ache, too low levels of phenylalanine in blood tests, indigestion and feeling sick (nausea) (see section 2: "Warnings and precautions").
Croatian: Česte nuspojave (mogu se pojaviti kod 1 od 10 osoba) grlobolja, nabreklost sluznice nosa i začepljeni nos, kašalj, proljev, povraćanje, bolovi u želucu, preniske koncentracije fenilalanina u nalazima krvi, probavne smetnje i osjećaj mučnine (vidjeti dio 2: „Upozorenja i mjere opreza“).