FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Croatian: Na temelju farmakokinetičkih podataka u 10 od tih pedijatrijskih bolesnika, čini se da je farmakokinetički profil lijeka sličan onomu u bolesnika u dobi od ≥ 18 godina.
English: Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Croatian: Noxafil može povećati rizik od nuspojava nekih drugih lijekova jer može povećati količinu tih lijekova u krvi.
English: Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Croatian: Opažena je korelacija između ukupne izloženosti lijeku podijeljene s najmanjom inhibitornom koncentracijom (AUC/MIK) i kliničkog ishoda.
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose of posaconazole oral suspension.
Croatian: Izlučeni metaboliti u mokraći i stolici čine oko 17% primijenjene radioaktivno označene doze posakonazol oralne suspenzije.
English: The other ingredients are: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc, iron oxide yellow (E172).
Croatian: Drugi sastojci su: hipromeloza acetat sukcinat; celuloza, mikrokristalična; hidroksipropilceluloza (E463); silicijev dioksid, dentalni tip; karmeloza natrij, umrežena; magnezijev stearat; poli(vinilni alkohol), makrogol 3350, titanijev dioksid (E171), talk, željezov oksid, žuti (E172).
English: In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 2.6-fold.
Croatian: U zdravih dobrovoljaca koji su bili natašte pokazalo se da raspodjela ukupne dnevne doze (800 mg) na četiri doze od 200 mg povećava izloženost posakonazolu 2,6 puta u usporedbi s raspodjelom dnevne doze na dvije doze od 400 mg.
English: Metabolism and nutrition disorders Common:
Croatian: Poremećaji metabolizma i prehrane
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: To trebaju uzeti u obzir bolesnici koji su na dijeti s kontroliranim unosom natrija.
English: The safety and efficacy of Noxafil in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Noxafil u djece mlađe od 18 godina nisu ustanovljene.
English: Posaconazole plasma concentrations following administration of posaconazole concentrate for solution for infusion single dose increased in a greater than dose proportional manner over the range of 50-200 mg; by comparison, dose-dependent increases were observed over a range of 200-300 mg.
Croatian: Koncentracije posakonazola u plazmi nakon intravenske primjene jednokratne doze posakonazol koncentrata za otopinu za infuziju bile su povećane u rasponu većem od 50 do 200 mg kao što bi trebale biti povećane obzirom na dozu; usporedbe radi, povećanja ovisna o dozi bila su zamijećena u rasponu od 200 do 300 mg.
English: Monitoring of hepatic function
Croatian: Nadzor jetrene funkcije
English: 11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Croatian: Jedanaest od 24 bolesnika koji su imali dokazanu ili vjerojatnu fuzariozu uspješno je liječeno posakonazol oralnom suspenzijom od 800 mg na dan u podijeljenim dozama tijekom medijana od 124 dana, a najdulje 212 dana.
English: • patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)
Croatian: • bolesnici čiji je imunološki sustav oslabljen zbog kemoterapije koju primaju za liječenje akutne mijeloične leukemije (AML) ili mijelodisplastičnog sindroma (MDS)
English: Similarly, administration of 400 mg posaconazole with esomeprazole (40 mg daily) decreased mean Cmax and AUC by 46 % and 32 %, respectively, compared to dosing with 400 mg posaconazole alone.
Croatian: Slično tomu, primjena 400 mg posakonazola s esomeprazolom (40 mg na dan) snizila je prosječan Cmax za 46%, a AUC za 32% u usporedbi s primjenom samog posakonazola u dozi od 400 mg.
English: Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Croatian: Sačuvajte azolne antimikotike, uključujući posakonazol, za bolesnike koji primaju vinka alkaloide, uključujući vinkristin, a u kojih nema drugih opcija za antimikotičko liječenje (vidjeti dio 4.5).
English: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Croatian: Jedanaest od 16 bolesnika uspješno je liječeno (potpuno ili djelomično povlačenje početnih znakova i simptoma na kraju liječenja) posakonazol oralnom suspenzijom od 800 mg na dan u podijeljenim dozama tijekom medijana od 296 dana, a najdulje 460 dana.
English: What Noxafil is and what it is used for What you need to know before you take Noxafil How to take Noxafil
Croatian: Što je Noxafil i za što se koristi Što morate znati prije nego počnete uzimati Noxafil Kako uzimati Noxafil
English: • are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
Croatian: • ako uzimate vinkristin, vinblastin ili druge „vinka alkaloide“ (lijekove koji se primjenjuju za liječenje raka).
English: Patients with a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Croatian: U bolesnika male tjelesne težine (<60 kg) postoji veća vjerojatnost viših plazmatskih koncentracija posakonazola pa se ti bolesnici moraju pomno nadzirati zbog mogućih nuspojava.
English: The safety and efficacy of Noxafil concentrate for solution for infusion in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Noxafil koncentrata za otopinu za infuziju u djece mlađe od 18 godina nisu ustanovljene.
English: Noxafil should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous (IV) infusion over approximately 90 minutes (see sections 4.2, 4.4, and 4.8).
Croatian: Noxafil se primjenjuje sporom intravenskom (i.v.) infuzijom tijekom približno 90 minuta, kroz centralnu vensku liniju, uključujući centralni venski kateter ili periferno postavljen centralni kateter (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Maximum duration of exposure to the concentrate for solution for infusion was shorter than with the oral suspension.
Croatian: Maksimalno trajanje izlaganja koncentratu za otopinu za infuziju bilo je kraće nego u slučaju oralne suspenzije.
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Croatian: Istodobna primjena azolnih antimikotika, uključujući posakonazol, s vinkristinom povezana je s ozbiljnim nuspojavama (vidjeti dio 4.4).
English: 9 of 11 patients were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 268 days and up to 377 days.
Croatian: Devet od 11 bolesnika uspješno je liječeno posakonazol oralnom suspenzijom od 800 mg na dan u podijeljenim dozama tijekom medijana od 268 dana, a najdulje 377 dana.
English: After oral administration, posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Croatian: Nakon peroralne primjene, posakonazol je povećao Cmax rifabutina za 31%, a AUC za 72%.
English: • high level of “eosinophils” a type of white blood cell (eosinophilia) - this can happen if you have inflammation
Croatian: • visoki broj eozinofila, vrste bijelih krvnih stanica (eozinofilija) - to može nastati ako imate upalu
English: • vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
Croatian: • vinkristin, vinblastin i drugi vinka alkaloidi (primjenjuju se za liječenje raka),
English: • a blockage in your gut (intestinal obstruction) especially in the “ileum”.
Croatian: • blokada crijeva (opstrukcija crijeva), osobito završnog dijela tankog crijeva (ileum).
English: • terfenadine (used to treat allergies)
Croatian: • terfenadin (primjenjuje se za liječenje alergija),
English: In patients, mean maximum plasma concentrations (Cmax) after posaconazole concentrate for solution for infusion are 4-fold increased compared to administration of oral suspension.
Croatian: U bolesnika su srednje vrijednosti maksimalne koncentracije u plazmi (Cmax) nakon primjene posakonazol koncentrata za otopinu za infuziju bile 4 puta veće nego nakon primjene oralne suspenzije.
English: There is no paediatric experience with posaconazole concentrate for solution for infusion (see sections 4.2 and 5.3).
Croatian: Nema iskustva s primjenom posakonazol koncentrata za otopinu za infuziju u pedijatrijskoj populaciji (vidjeti dijelove 4.2 i 5.3).
English: Race There is insufficient data among different races with posaconazole tablets.
Croatian: Rasa Nema dovoljno podataka za posakonazol tablete u različitim rasama.
English: Do not take Noxafil
Croatian: Nemojte uzimati Noxafil
English: - The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
Croatian: - Pomoćne tvari u suspenziji su polisorbat 80, simetikon, natrijev benzoat (E211), natrijev citrat dihidrat, citratna kiselina hidrat, glicerol, ksantanska guma, tekuća glukoza, titanijev dioksid (E171), umjetna aroma trešnje koja sadrži benzilni alkohol i propilenglikol, i pročišćena voda.
English: Noxafil is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Croatian: Noxafil je također dostupan u obliku 40 mg/ml oralne suspenzije i koncentrata za otopinu za infuziju od 300 mg.
English: Similar recommendations apply to posaconazole concentrate for solution for infusion; however, a specific study has not been conducted with posaconazole concentrate for solution for infusion.
Croatian: Slične preporuke vrijede i za posakonazol koncentrat za otopinu za infuziju, no nije provedeno posebno ispitivanje s posakonazol koncentratom za otopinu za infuziju.
English: • mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
Croatian: • blaga do teška mučnina, povraćanje, grčevi i proljev čiji je uzročnik obično virus, bol u trbuhu
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz
Croatian: Rifamicinski antibiotici (rifampicin, rifabutin), određeni antikonvulzivi (fenitoin, karbamazepin, fenobarbital, primidon) i efavirenz
English: • bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool
Croatian: • krvarenje u želudac ili crijeva - znakovi uključuju povraćanje krvi ili krv u stolici
English: altered medicine levels, blood phosphorus decreased, chest x-ray abnormal
Croatian: promjene u koncentraciji lijeka, snižene razine fosfora u krvi, odstupanja u rendgenskom nalazu prsnog koša
English: There is no experience with overdose of posaconazole concentrate for solution for infusion.
Croatian: Nema iskustva s predoziranjem posakonazol koncentratom za otopinu za infuziju.
English: • shivering, feeling generally unwell
Croatian: • drhtavica, opće loše osjećanje
English: Posaconazole has a distribution volume of 261 L, indicating extravascular distribution.
Croatian: Volumen distribucije posakonazola iznosi 261 l, što upućuje na raspodjelu izvan krvnih žila.
English: Summary of posaconazole concentrate for solution for infusion bridging study Study 5520 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole concentrate for solution for infusion.
Croatian: Sažetak ispitivanja posakonazol koncentrata za otopinu za infuziju s ciljem povezivanja podataka Ispitivanje 5520 bilo je nekomparativno, multicentrično ispitivanje provedeno kako bi se procijenila farmakokinetička svojstva, sigurnost i podnošljivost posakonazol koncentrata za otopinu za infuziju.
English: C-posaconazole, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Croatian: C-posakonazola, radioaktivnost se uglavnom otkrila u stolici (77% radioaktivno označene doze), a glavnu je komponentu činio izvorni spoj (66% radioaktivno označene doze).
English: After administration of
Croatian: Nakon primjene
English: Posaconazole concentrate for solution for infusion safety In initial studies of healthy volunteers, administration of a single dose of posaconazole infused over 30 minutes via a peripheral venous catheter was associated with a 12 % incidence of infusion site reactions (4 % incidence of thrombophlebitis).
Croatian: U početnim ispitivanjima sa zdravim dobrovoljcima, primjena jednokratne doze posakonazola infuzijom tijekom 30 minuta kroz periferni venski kateter bila je povezana s incidencijom reakcija na mjestu infuzije od 12% (incidencija tromboflebitisa bila je 4%).
English: Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Croatian: Posakonazol je povećao Cmax rifabutina za 31%, a AUC za 72%.
English: • digoxin (used to treat heart failure)
Croatian: • digoksin (primjenjuje se za liječenje zatajenja srca),
English: Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Croatian: Ispitanici su postigli srednju vrijednost predviđenog Cava u stanju dinamičke ravnoteže od 1970 ng/ml.
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Croatian: Osobito je važno pokušati postići najveće koncentracije lijeka u plazmi bolesnika inficiranih plijesni Aspergillus (vidjeti dijelove 4.2 i 5.2 za preporučeno doziranje i učinke hrane na apsorpciju).
English: • stroke - signs include pain, weakness, numbness, or tingling in the limbs
Croatian: • moždani udar - znakovi uključuju bol, slabost, utrnulost ili trnce u udovima
English: The pharmacokinetics of posaconazole concentrate for solution for infusion are comparable in young and elderly subjects.
Croatian: Farmakokinetika posakonazol koncentrata za otopinu za infuziju usporediva je u mlađih i starijih ispitanika.
English: torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Croatian: torsades de pointes, iznenadna smrt, ventrikularna tahikardija, kardiorespiratorni arest, zatajenje srca, infarkt miokarda
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45 % and 50 %, respectively.
Croatian: Efavirenz (400 mg jedanput na dan) je snizio Cmax posakonazola za 45%, a AUC za 50%.
English: Each mL contains 18 mg of posaconazole.
Croatian: Jedan ml sadrži 18 mg posakonazola.
English: In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Noxafil.
Croatian: Pored gore navedenih lijekova, postoje i drugi lijekovi koji nose rizik od nastanka poteškoća sa srčanim ritmom, koji se može povećati ako se uzimaju s lijekom Noxafil.
English: Posaconazole is highly protein bound (> 98 %), predominantly to serum albumin.
Croatian: Posakonazol se visokom postotku veže za proteine (>98%), uglavnom za serumski albumin.
English: electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Croatian: poremećaj ravnoteže elektrolita, anoreksija, smanjen tek, hipokalijemija, hipomagnezijemija
English: • blood clots in your legs (deep vein thrombosis) - signs include intense pain or swelling of the legs
Croatian: • krvni ugrušci u nogama (duboka venska tromboza) - znakovi uključuju jaku bol ili oticanje nogu
English: During post-marketing surveillance severe hepatic injury with fatal outcome has been reported (see section 4.4).
Croatian: Tijekom praćenja nakon stavljanja u promet prijavljena su teška oštećenja jetre sa smrtnim ishodom (vidjeti dio 4.4).
English: What you need to know before you take Noxafil
Croatian: Što morate znati prije nego počnete uzimati Noxafil
English: • cisapride (used to treat stomach problems)
Croatian: • cisaprid (primjenjuje se za liječenje želučanih tegoba),
English: If you think that you may have taken too much Noxafil, talk to a doctor or go to the hospital straight away.
Croatian: Ako uzmete više lijeka Noxafil nego što ste trebali Ako mislite da ste uzeli previše lijeka Noxafil, odmah se obratite liječniku ili otiđite u bolnicu.
English: C-posaconazole as oral suspension, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Croatian: C-posakonazola u obliku oralne suspenzije, radioaktivnost se uglavnom otkrila u stolici (77% radioaktivno označene doze), a glavnu je komponentu činio izvorni spoj (66% radioaktivno označene doze).
English: Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.
Croatian: Neki lijekovi mogu povećati rizik od nuspojava lijeka Noxafil jer povećavaju njegovu količinu u krvi.
English: Loading dose of 200 mg (5 mL) once a day on the first day, then 100 mg (2.5 mL) once a day for 13 days.
Croatian: Udarna doza od 200 mg (5 ml) jedanput na dan prvog dana, a zatim 100 mg (2,5 ml) jedanput na dan tijekom 13 dana.
English: In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
Croatian: Osim toga, istodobna primjena midazolama i posakonazol oralne suspenzije (200 mg ili 400 mg) produljila je srednju vrijednost terminalnog poluvijeka midazolama sa približno 3-4 sata na 8-10 sati.
English: • if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.
Croatian: • ako uzimate: terfenadin, astemizol, cisaprid, pimozid, halofantrin, kinidin, bilo koji lijek koji sadrži ergot alkaloide kao što su ergotamin ili dihidroergotamin ili statine kao što su simvastatin, atorvastatin ili lovastatin.
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Croatian: Epidemiological Cut-off) za vrste roda Aspergillus ECOFF vrijednosti za posakonazol prema kojima se razlikuje divlji tip populacije od izolata sa stečenom rezistencijom određene su metodologijom propisanom od strane Europskog odbora za testiranje osjetljivosti na antimikrobne lijekove (engl.
English: Excipient with known effect: Each vial contains 462 mg (20 mmol) sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica sadrži 462 mg (20 mmol) natrija.
English: In a study (Study 03579) of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL) (see section 5.2).
Croatian: U ispitivanju (ispitivanje 03579) u kojem je sudjelovalo 136 pedijatrijskih bolesnika s neutropenijom u dobi od 11 mjeseci do 17 godina koji su liječeni posakonazol oralnom suspenzijom u dozama do najviše 18 mg/kg/dan podijeljeno u 3 doze, približno 50% njih dostiglo je unaprijed specificiranu ciljnu vrijednost (Cav u 7. danu liječenja između 500ng/ml - 2500 ng/ml) (vidjeti dio 5.2).
English: In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole.
Croatian: Pored gore navedenih lijekova postoje i drugi lijekovi koji nose rizik od nastanka poteškoća sa srčanim ritmom, koji se može povećati ako se uzimaju s posakonazolom.
English: Noxafil concentrate for solution for infusion should be inspected visually for particulate matter prior to administration.
Croatian: Noxafil koncentrat za otopinu za infuziju mora se prije primjene pregledati kako bi se uočile eventualne čestice.
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Croatian: Ukupan odgovor na liječenje Uspjeh prema vrstama uzročnika Sve mikološki potvrđene vrste roda Aspergillus A. fumigatus
English: There is no experience with overdose of posaconazole tablets.
Croatian: Nema iskustva s predoziranjem posakonazol tabletama.
English: Each vial of Noxafil contains 462 mg (20 mmol) of sodium.
Croatian: Jedna bočica lijeka Noxafil sadrži 462 mg (20 mmol) natrija.
English: Two different dosing groups were evaluated in Cohorts 1 and 2: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Cohort 1) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Cohort 2).
Croatian: U Kohortama 1 i 2 ocjenjivale su se dvije skupine koje su primale različite doze: 200 mg dvaput na dan 1. dana, a zatim 200 mg jedanput na dan (Kohorta 1), odnosno 300 mg dvaput na dan 1. dana, a zatim 300 mg jedanput na dan (Kohorta 2).
English: The recommended dose is 200 mg (one 5 mL spoonful) taken four times daily.
Croatian: Preporučena doza je 200 mg (jedna žličica od 5 ml) četiri puta na dan.
English: Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows: 100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
Croatian: Bolesnici su liječeni posakonazolom ili flukonazolom u obliku oralne suspenzije (oba lijeka su se primjenjivala na sljedeći način: 100 mg dvaput na dan 1. dana, a nakon toga 100 mg jedanput na dan tijekom 13 dana).
English: The subject population in Cohort 3 included: 1) patients with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia, or 2) patients who had undergone a HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.
Croatian: Populacija ispitanika u Kohorti 3 obuhvaćala je: 1) bolesnike s AML-om ili MDS-om koji su nedavno primili kemoterapiju i koji su razvili ili se očekivalo da će razviti značajnu neutropeniju, ili 2) bolesnike koji su podvrgnuti HSCT-u i koji su primali imunosupresivnu terapiju za prevenciju ili liječenje GVHD-a.
English: • high blood levels of creatinine - shown in blood tests
Croatian: • visoke razine kreatinina u krvi - vidi se na krvnim pretragama
English: If you are not sure, talk to your doctor or pharmacist before taking Noxafil.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego počnete uzimati Noxafil.
English: • inability to sleep (insomnia)
Croatian: • nesanica (insomnija)
English: • a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak
Croatian: • poremećaj razine soli u tijelu koji se vidi na krvnim pretragama - znakovi uključuju osjećaj smetenosti ili slabosti
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja vidjeti u dijelu 6.3.