FrancophonIA/ELRC3.0 huggingface dataset:
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.
Croatian: Ako primjenjujete lijek Fulphila, morate prekinuti s dojenjem, osim ako Vam liječnik ne savjetuje drugačije.
English: - experience a cough, fever and difficulty breathing.
Croatian: Molimo obavijestite svog liječnika ako kašljete, imate vrućicu ili otežano dišete.
English: Before you inject Fulphila you must do the following:
Croatian: Ako primijenite više lijeka Fulphila nego što biste trebali
English: Your platelet count may become low which might result in bruising.
Croatian: Broj trombocita može pasti što može dovesti do nastanka modrica. - bol u prsnom košu.
English: Capillary leak syndrome1
Croatian: Sindrom povećane propusnosti kapilara1
English: Injecting Fulphila yourself
Croatian: Samostalno davanje lijeka Fulphila
English: Common side effects (may affect up to 1 in 10 people) - pain at the site of injection.
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) - bol na mjestu primjene injekcije. - bolovi općenito te bolovi u zglobovima i mišićima.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: To može biti znak akutnog respiratornog distres sindroma odraslih (ARDS); - ako imate znakove jedne od sljedećih ili kombinacije sljedećih nuspojava:
English: How to use Fulphila
Croatian: Što Fulphila sadrži
English: You can use:
Croatian: Zbog sigurnosti:
English: - redness at the site of injection.
Croatian: Otopina za injekciju
English: SC
Croatian: X
English: Vascular disorders
Croatian: Staklena štrcaljka
English: NAME OF THE MEDICINAL PRODUCT Fulphila 6 mg solution for injection in pre-filled syringe
Croatian: Fulphila 6 mg otopina za injekciju u napunjenoj štrcaljki
English: 1 tablet bottle (glass) + syringe (plastic)
Croatian: Oralna otopina Kroz usta boca (staklo) + štrcaljka (plastika)
English: MA (EU) Number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Immediate Packaging Content (concentration)
Croatian: Unutarnje pakovanje Sastav (koncentracija)
English: The vacuolations did not recover after 2 weeks.
Croatian: Vakuolizacije se nisu oporavile nakon 2 tjedna.
English: Date of first authorisation: 08 January 2018
Croatian: Datum prvog odobrenja: 08. siječnja 2018.
English: This is particularly important if you are having major surgery.
Croatian: To je naročito bitno ako se podvrgavate većem kirurškom zahvatu.
English: Unopened vial 2 years.
Croatian: Neotvorena bočica 2 godine.
English: The product dissolves rapidly (usually in less than 1 minute).
Croatian: Prašak se brzo otapa (obično manje od 1 minute).
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se uz pomoć sljedeće formule:
English: You or someone else might also administer ADYNOVI as an injection, but only after receiving adequate training.
Croatian: Vi ili netko drugi također možete primijeniti ADYNOVI kao injekciju, ali tek nakon što ste prošli adekvatnu obuku.
English: Uncommon (PTPs)*
Croatian: Manje često (PTPs)*
English: The osmolality is ≥ 380 mOsmol/kg.
Croatian: Osmolalnost je ≥380 mOsmol/kg.
English: • Administer as soon as possible, but no later than 3 hours after reconstitution.
Croatian: • Primijeniti što je prije moguće, ali ne duže od 3 sata nakon rekonstitucije.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Croatian: Morate se odmah obratiti liječniku ako se pojavi neki od sljedećih ranih simptoma alergijskih reakcija:
English: Do not draw air into the syringe.
Croatian: Ne uvlačite zrak u štrcaljku.
English: After reconstitution, the solution has a pH of 6.7 to 7.3.
Croatian: Nakon rekonstitucije otopina ima pH od 6,7 do 7,3.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Croatian: Vaš će liječnik provesti odgovarajuće laboratorijske pretrage kako bi bio siguran da imate dovoljne razine faktora VIII.
English: ADYNOVI can be used only in adolescents and adults (12 years and above).
Croatian: ADYNOVI se može primijeniti samo u adolescenata i odraslih (12 godina i više).
English: Repeat injections every 12 to 24 hours.
Croatian: Ponavljati injekcije svakih 12 do 24 sata.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog gledišta, osim ako metoda rekonstitucije isključuje rizik kontaminacije mikroorganizmima, lijek je potrebno odmah upotrijebiti.
English: If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.
Croatian: Ako imate srčanu bolest, molimo Vas da obavijestite svog liječnika, jer postoji povećani rizik od komplikacija zgrušavanja krvi (koagulacije).
English: You should check with your doctor if you are not sure.
Croatian: Trebate provjeriti s liječnikom ako niste sigurni.
English: Instructions for injection
Croatian: Upute za injekciju
English: The specific activity of ADYNOVI is approximately 4000-6500 IU/mg protein.
Croatian: Specifična aktivnost lijeka ADYNOVI je otprilike 4000-6500 IU/mg proteina.
English: The medicinal product is provided in one of the following configurations:
Croatian: Ovaj lijek dolazi u jednoj od sljedeći konfiguracija:
English: The long-term safety of ADYNOVI in children below 12 years has not yet been established.
Croatian: Dugoročna sigurnost lijeka ADYNOVI u djece mlađe od 12 godina još nije ustanovljena.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Croatian: Nastavite sa sljedećom injekcijom prema rasporedu i nastavite dalje onako kako Vam je preporučio liječnik.
English: Do not throw away any medicines via waste water or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Do not touch the exposed purple plastic spike.
Croatian: Ne dotičite izloženi plastični ljubičasti šiljak.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju anafilaktičnog šoka, potrebno je provesti standardno medicinsko liječenje za šok.
English: Required international units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Croatian: Potreban broj međunarodnih jedinica (IU) = tjelesna težina (kg) x željeno povećanje faktora VIII (%) x 0,5
English: What ADYNOVI is and what it is used for
Croatian: Što je ADYNOVI i za što se koristi
English: Paediatric population < 12 years of age
Croatian: Pedijatrijska populacija < 12 godina
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količina koja će se primjenjivati i učestalost primjene uvijek trebaju biti usmjerene na kliničku učinkovitost u pojedinačnom slučaju.
English: The safety and efficacy of ADYNOVI in previously untreated patients have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka ADYNOVI u prethodno neliječenih bolesnika nisu još ustanovljene.
English: Frequency of doses (hours)/duration of therapy (days)
Croatian: Učestalost doza (sati)/trajanje liječenja (dani)
English: Every 24 hours at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata tijekom najmanje 1 dana, do zacjeljenja.
English: A higher dose may be required in children less than 12 years of age, see section 4.2.
Croatian: Za djecu mlađu od 12 godina možda će biti potrebna veća doza, vidjeti dio 4.2.
English: Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).
Croatian: Dvadeset i pet od 137 ispitanika bili su adolescenti (12 do manje od 18 godina).
English: Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
Croatian: Primijenite tijekom razdoblja od najviše 5 minuta (maksimalna brzina primjene je 10 ml po min).
English: Frequencies have been evaluated according to the following convention: 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 the available data).
Croatian: Učestalost pojavljivanja prikazana je prema sljedećoj konvenciji: 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), nije poznato (nije se moglo procijeniti iz dostupnih podataka).
English: At the end of this period the product shall not be put back in the refrigerator, but shall be used or discarded.
Croatian: Na kraju tog razdoblja lijek ne smijete vratiti natrag u hladnjak, nego iskoristiti ili baciti.
English: Warnings and precautions Talk to your doctor before using ADYNOVI.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primijenite ADYNOVI.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Napominjemo da ASK nije usporediva između različitih koncentrata faktora i između različitih kliničkih ispitivanja.
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Croatian: Ako se pojave teške i iznenadne alergijske reakcije (anafilaktičke reakcije), primjena injekcije mora se odmah prekinuti.
English: Results for the full-analysis population were similar to those for the per-protocol population.
Croatian: Rezultati za populaciju s potpunim podacima za analizu bili su slični onima za populaciju liječenu prema planu ispitivanja.
English: This date should never exceed the one initially mentioned on the outer carton.
Croatian: Taj datum nikad ne bi trebao prijeći datum otisnut na vanjskom pakiranju.
English: The human coagulation factor VIII has been modified to prolong its duration of action.
Croatian: Ljudski faktor koagulacije VIII je izmijenjen kako bi se produljilo trajanje djelovanja.
English: Use the product within 3 hours once the powder is completely dissolved.
Croatian: Lijek primijenite u roku od 3 sata nakon što se prašak u potpunosti otopi.
English: • Do not use if the BAXJECT II Hi-Flow device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Croatian: • Ne koristiti ako su uređaj BAXJECT II Hi-Flow, njegov sustav sterilnih barijera ili pakiranje oštećeni ili pokazuju znakove dotrajalosti.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Croatian: Faktor VIII se stoga u trudnoći i tijekom dojenja smije koristiti samo ako za to postoje jasne indikacije.
English: The powder must not be mixed with other medicinal products or solvents or used with other reconstitution devices.
Croatian: Prašak se ne smije miješati s drugim lijekovima ili otapalima ili se koristiti s drugim uređajima za pripremu.
English: PK parameters
Croatian: FK parametri
English: The European Medicines Agency has deferred the obligation to submit results of studies with ADYNOVI in one or more subsets of the paediatric population in the treatment of congenital factor VIII deficiency.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ADYNOVI u jednoj ili više podskupina pedijatrijske populacije za liječenje nedostatka kongenitalnog faktora VIII.
English: These could be early symptoms of anaphylactic shock; additional symptoms may include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Croatian: To bi mogli biti rani simptomi anafilaktičkog šoka; dodatni simptomi mogu uključivati izrazitu omaglicu, gubitak svijesti i izrazito otežano disanje.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja rekonstituiranog lijeka odgovornost su korisnika.
English: ADYNOVI contains sodium, see section 2.
Croatian: ADYNOVI sadrži natrij, vidjeti dio 2.
English: Repeat injections every 8 to 24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: Ponoviti injekcije svakih 8 do 24 sata do odgovarajućeg zacjeljivanja rane, a zatim nastaviti liječenje još najmanje 7 dana da bi se aktivnost faktora VIII održavala na razini od 30% do 60% (IU/dl).
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doza koja se bazira na tjelesnoj težini može zahtijevati prilagodbu u bolesnika s premalom ili prekomjernom težinom.
English: Abbreviations: Cmax: maximum observed activity; AUC: area under the curve; MRT: mean residence time; CL: clearance; Vss: body weight adjusted volume of distribution at steady-state,
Croatian: Skraćenice: Cmax: maksimalna zabilježena aktivnost; AUC: područje ispod krivulje; MRT: srednja vrijednost vremena zadržavanja; CL: klirens; Vss: volumen distribucije u stanju dinamičke ravnoteže prilagođen tjelesnoj težini,
English: Usually, the replacement therapy with ADYNOVI is a life-long treatment.
Croatian: Nadomjesna terapija lijekom ADYNOVI obično je cjeloživotna.
English: Common * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients.
Croatian: Često * Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients).
English: The dose in adolescents is also calculated to body weight and is the same dose as for adults.
Croatian: Doza u adolescenata također se izračunava prema tjelesnoj težini i jednaka je dozi za odrasle.
English: Incremental recovery was comparable with both products.
Croatian: Prirast po jedinici doze bio je usporediv s oba proizvoda.
English: Design
Croatian: Dizajn
English: The clearance value of 12.18 ml/(kg·h) for subject 122001 in age group 12 to < 18 years was not included in the analysis of clearance.
Croatian: Vrijednost klirensa 12,18 ml/(kg·h) za ispitanika 122001 u dobnoj skupini 12 do < 18 godina nije uključena u analizu klirensa.
English: Nonclinical data are limited to 1 month exposure and no studies in juvenile animals were conducted with ADYNOVI.
Croatian: Neklinički podaci ograničeni su na 1 mjesec izlaganja i nisu provedena nikakva ispitivanja lijeka ADYNOVI na mladim životinjama.
English: No studies on genotoxicity, carcinogenicity or reproductive toxicity have been performed with ADYNOVI.
Croatian: Nisu provedena ispitivanja genotoksičnosti, kancerogenosti ili reproduktivne toksičnosti s lijekom ADYNOVI.
English: Terminal half--life [h] MRT [h] CL [mL/(kg·h)]
Croatian: Terminalni poluvijek [h] MRT [h] CL [mL/(kg·h)]
English: The change in PK parameters was similar in both the adult and adolescent populations and between one-stage clotting and chromogenic substrate assays.
Croatian: Promjena PK parametara bila je slična u populaciji odraslih i adolescenata i između jednostupanjskog testa zgrušavanja i testa s kromogenim supstratom.
English: Perioperative haemostatic efficacy was rated as excellent (blood loss less than or equal to that expected for the same type of procedure performed in a non-haemophilic patient, and required blood components for transfusions less than or similar to that expected in non-haemophilic population) for all 26 (21 major, 5 minor) procedures.
Croatian: Perioperativna hemostatska djelotvornost ocijenjena je kao odlična (gubitak krvi manji od ili jednak očekivanom za istu vrstu postupka koja je provedena na bolesniku koji nema hemofiliju, a potrebne krvne komponente za transfuzije manje od ili jednake onima koje su očekivane u populaciji koja nema hemofiliju) za svih 26 (21 većih, 5 manjih) postupaka.
English: The medicinal product contains traces of mouse and hamster proteins.
Croatian: Lijek sadrži tragove proteina miša i hrčka.
English: See 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: Adjustments of doses and administration intervals may be considered based on achieved FVIII levels and individual bleeding tendency (see section 5.2).
Croatian: Prilagodba doza i intervala primjene može se uzeti u obzir na temelju ostvarenih razina FVIII i sklonosti pojedinca krvarenju (vidjeti dio 5.2).
English: Swirl gently until all material is dissolved (Figure 3).
Croatian: Nježno okrećite bočicu dok se sav materijal ne otopi (slika 3).
English: The listed warnings and precautions also apply to adolescents.
Croatian: Navedena upozorenja i mjere opreza odnose se također na adolescente.
English: (pre- and postoperative)
Croatian: (prije i poslije kirurškog zahvata)
English: If this happens your medicine may stop working properly and you may experience persistent bleeding.
Croatian: U tom slučaju Vaš lijek može prestati liječiti kako treba i može se javiti krvarenje koje ne prestaje.
English: Repeat injections every 8 to 24 hours until threat is resolved.
Croatian: Ponoviti injekcije svakih 8 do 24 sata dok se ne ukloni opasnost.
English: The mean clearance (based on body weight) of ADYNOVI was higher and the mean half-life was lower in children less than 12 years of age than adults.
Croatian: Srednja vrijednost klirensa (na temelju tjelesne težine) lijeka ADYNOVI bila je veća i srednja vrijednost poluvijeka bila je manja u djece mlađe od 12 godina nego kod odraslih.
English: Immune tolerance induction (ITI) No clinical data for use of ADYNOVI in ITI are available.
Croatian: Indukcija imunološke tolerancije (IIT) Nema dostupnih kliničkih podataka za upotrebu lijeka ADYNOVI u IIT-u.
English: If you inject more ADYNOVI than recommended, tell your doctor as soon as possible.
Croatian: Ako ste injicirali više lijeka ADYNOVI nego što je preporučeno, obavijestite svog liječnika što je prije moguće.
English: Detailed instructions for self-administration are given at the end of this package leaflet.
Croatian: Detaljne upute za samostalnu primjenu navedene su na kraju ove upute o lijeku.
English: Individual PK with full sampling a
Croatian: Pojedinačna farmakokinetika s punim uzorkovanjem a
English: What ADYNOVI is and what it is used for What you need to know before you use ADYNOVI How to use ADYNOVI
Croatian: Što je ADYNOVI i za što se koristi Što morate znati prije nego počnete primjenjivati ADYNOVI
English: In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Croatian: U bolesnika s hemofilijom A (urođeni nedostatak faktora VIII), on nedostaje ili ne djeluje pravilno.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Croatian: Farmakoterapijska skupina: antihemoragici, krvni koagulacijski faktor VIII, ATK oznaka: B02BD02.
English: ADYNOVI must not be mixed with other medicinal products or solvents.
Croatian: ADYNOVI se ne smije miješati s drugim lijekovima ili otapalima.
English: Overall, 95.9% of bleeding episodes were controlled with 1 to 2 infusions and 85.5% were controlled with only 1 infusion.
Croatian: Sveukupno je 95,9% epizoda krvarenja bilo kontrolirano sa 1 do 2 infuzija i 85,5% sa samo 1 infuzijom.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima treba savjetovati da smjesta prestanu uzimati lijek i jave se svome liječniku.
English: ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse.
Croatian: ADYNOVI će obično Vaš liječnik ili medicinska sestra injicirati u venu (intravenski).
English: Thus it was not possible to conclude on the potential risks of PEG accumulation in various tissues/organs relevant for chronic use of ADYNOVI in the paediatric population.
Croatian: Prema tome nije moguće donijeti zaključak o potencijalnoj opasnosti PEG nakupljanja u raznim tkivima/organima relevantnoj za kroničnu primjenu lijeka ADYNOVI u pedijatrijskoj populaciji.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskom saznanju da 1 IU faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: Do not remove the device from the package.
Croatian: Nemojte vaditi uređaj iz pakiranja.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti faktora VIII odgovara količini faktora VIII u jednom ml normalne ljudske plazme.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza odnose se na odrasle osobe i na djecu.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30 °C.
Croatian: Kemijska i fizička stabilnost rekonstituiranog lijeka dokazana je tijekom 3 sata pri temperaturi ne višoj od 30 °C.
English: At least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
Croatian: Najmanje 1 dan, dok se ne zaustavi krvarenje na koje upućuje bol, ili do zacjeljenja.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim kardiovaskularnim faktorima rizika, nadomjesna terapija u kojoj se koristi faktor VIII može povećati kardiovaskularni rizik.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu različito reagirati na faktor VIII, pokazujući različitu duljinu poluvijeka i povrata.
English: Use of a Luer-lock syringe is recommended.
Croatian: Preporučuje se koristiti luer-lock štrcaljku.
English: If you think that the effect of ADYNOVI is insufficient, talk to your doctor.
Croatian: Ako mislite da učinak lijeka ADYNOVI nije dovoljan, obratite se svom liječniku.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Croatian: Faktor VIII nužan je da bi se stvarali krvi ugrušci i zaustavila krvarenja.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesnog liječenja ovisi o težini nedostatka faktora VIII, o mjestu i opsegu krvarenja te o kliničkom stanju bolesnika.
English: Patients developing factor VIII inhibitors
Croatian: Bolesnici koji razviju inhibitore faktora VIII
English: The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
Croatian: Srednja (SD) dob bila je 3,3 (1,55) odnosno 8,1 (1,92) godina.
English: Turn the package over.
Croatian: Okrenite pakiranje naopako.
English: Table 2: Adverse reactions reported for ADYNOVI
Croatian: Tablica 2: Prijavljene nuspojave za lijek ADYNOVI
English: The median (IQR) observed intraoperative blood loss (n = 14) was 10.0 (20.0) ml compared to the predicted average blood loss (n = 14) of 150.0 (140.0) ml for major orthopaedic surgeries.
Croatian: Medijan (interkvartilni raspon) zabilježenog intraoperacijskog gubitka krvi (n=14) bio je 10,0 (20,0) ml u usporedbi s predviđenim prosječnim gubitkom krvi (n=14) od 150,0 (140,0) ml za veće ortopedske kirurške zahvate.
English: Use within 3 hours of reconstitution.
Croatian: Primijeniti unutar 3 sata od pripreme otopine.