FrancophonIA/ELRC3.0 huggingface dataset:
English: If you weigh more than 80 kg, you may need a different dose.
Slovenian: Če tehtate več kot 80 kg, bo morda potrebno odmerek prilagoditi.
English: This stops the infection from spreading and gives the body's natural defences a chance to completely get rid of the infection.
Slovenian: To ustavi širjenje okužbe in telesu omogoči naravno obrambo, da se popolnoma znebi okužbe.
English: Not known (cannot be estimated from available data)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: A similar effect could be expected for other medicinal products that induce metabolic enzymes.
Slovenian: Podoben učinek bi lahko pričakovali pri drugih zdravilih, ki inducirajo presnovne encime.
English: However, no systematic dosage adjustment is required.
Slovenian: Vendar pa sistematična prilagoditev odmerka ni potrebna.
English: Your doctor will monitor how well the medicine works for you.
Slovenian: Zdravnik bo spremljal, kako dobro zdravilo učinkuje.
English: These cases have been associated with poor clinical outcomes.
Slovenian: Ti primeri so bili povezani s slabimi kliničnimi izidi.
English: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Denmark
Slovenian: Xellia Pharmaceuticals ApS Dalslandsgade 11, København S, 2300, Danska
English: • -if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na kaspofungin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE ZDRAVILA Shranjujte v hladilniku.
English: N Engl J Med 1987 Oct 22;317(17): 1098 (letter)
Slovenian: N Engl J Med 1987 Oct 22;317(17):1098 (pismo)
English: The number of neutropenic patients enrolled in this study was also limited (8.0 %).
Slovenian: Omejeno je bilo tudi število bolnikov z nevtropenijo, vključenih v študijo (8,0 %).
English: In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Slovenian: Na splošno je treba antimikotično zdravljenje nadaljevati vsaj še 14 dni po zadnji pozitivni kulturi.
English: Generally the increase was modest and not large enough to warrant dosage adjustment.
Slovenian: Na splošno je bilo zvečanje zmerno in ne tako veliko, da bi zahtevalo prilagoditev odmerka.
English: Children and adolescents The dose for children and adolescents may differ from the adult dose.
Slovenian: Uporaba pri otrocih in mladostnikih Odmerek za otroke in mladostnike se lahko razlikuje od odmerka za odrasle bolnike.
English: The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins.
Slovenian: Mehanizem interakcije bi morda lahko bila začetna zavora in kasnejša indukcija transportnih beljakovin.
English: • you are allergic to any other medicines
Slovenian: • če ste alergični na katero koli drugo zdravilo.
English: Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.
Slovenian: Zvišana telesna temperatura in mrzlica, ki se ne odzoveta na antibiotično zdravljenje, sta najpogostejša znaka takšne okužbe.
English: The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Slovenian: Načrt študije, diagnostična merila in merila za ocenjevanje učinkovitosti so bili podobni kot pri odgovarjajočih študijah pri odraslih bolnikih (glejte poglavje 5.1).
English: Caspofungin should not be used during pregnancy unless clearly necessary.
Slovenian: Kaspofungina se v nosečnosti ne sme uporabljati, razen če to ni nujno potrebno.
English: Approximately 75 % of a radioactive dose was recovered during 27 days: 41 % in urine and 34 % in faeces.
Slovenian: Približno 75 % radioaktivnega odmerka se je izločilo v 27 dneh: 41 % v urinu in 34 % v blatu.
English: An additional gamma-phase also occurs with a half-life of 45 hours.
Slovenian: Sledi še dodatna faza gama z razpolovnim časom 45 ur.
English: Caspofungin Accord will always be prepared and given to you by a healthcare professional.
Slovenian: Zdravilo Kaspofungin Accord bo vedno pripravil in vam ga dal zdravstveni delavec.
English: These occurrences did not result in clinically important adverse reactions.
Slovenian: Ti dogodki niso povzročili klinično pomembnih neželenih učinkov.
English: These AUC increases are probably due to reduced uptake of caspofungin by the liver.
Slovenian: To povečanje AUC je verjetno posledica manjšega privzema kaspofungina v jetra.
English: • some HIV medicines such as efavirenz or nevirapine
Slovenian: • nekatera zdravila proti HIV, kot sta efavirenz ali nevirapin
English: AUC0-24 hr measurements were not performed in this study due to the sparse plasma sampling.
Slovenian: Meritev AUC0-24h v tej študiji niso naredili zaradi redkega vzorčenja plazme.
English: This is because Caspofungin Accord can affect the way some other medicines work.
Slovenian: To je zato, ker lahko zdravilo Kaspofungin Accord vpliva na delovanje nekaterih drugih zdravil.
English: • by slow injection into a vein (intravenous infusion)
Slovenian: • s počasno injekcijo v veno (intravenska infuzija)
English: Preparation notes:
Slovenian: Opombe v zvezi s pripravo:
English: • over about 1 hour.
Slovenian: • infuzija bo trajala približno 1 uro
English: • Flushing, low blood pressure
Slovenian: • zardevanje, nizek krvni tlak
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Slovenian: Preden vi ali vaš otrok dobita to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Gender: Caspofungin plasma concentrations were on average 17-38 % higher in women than in men.
Slovenian: Spol: Plazemske koncentracije kaspofungina so bile pri ženskah povprečno za 17-38 % večje kot pri moških.
English: As with any prescription medicine, some side effects may be serious.
Slovenian: Kot pri katerem koli zdravilu na recept, so nekateri neželeni učinki lahko resni.
English: • rifampicin (an antibiotic).
Slovenian: • rifampicin (antibiotik)
English: The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Slovenian: Povprečno trajanje zdravljenja je bilo 33,7 dni, z razponom od 1 do 162 dni.
English: Data in patients with non-blood sites of infection were more limited.
Slovenian: Podatkov pri bolnikih z okužbami drugje kot v krvi je bilo manj.
English: These data suggest that caspofungin can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Slovenian: Ti podatki kažejo, da se kaspofungin lahko uporablja pri bolnikih, ki prejemajo ciklosporin, če pričakovana korist odtehta morebitno tveganje.
English: A short alpha-phase occurs immediately post-infusion, followed by a beta-phase with a halflife of 9 to 11 hours.
Slovenian: Takoj po infuziji pride do kratkotrajne faze alfa, ki ji sledi faza beta z razpolovnim časom 9 do 11 ur.
English: Tell your doctor or nurse straight away if you notice any of the following side effects - you may need urgent medical treatment:
Slovenian: Nemudoma povejte zdravniku ali medicinski sestri, če opazite katerega koli od naslednjih neželenih učinkov - morda boste potrebovali nujno medicinsko pomoč:
English: Paediatric patients (12 months to 17 years)
Slovenian: Pediatrični bolniki (stari od 12 mesecev do 17 let)
English: Therefore, elimination occurs in the absence of a distribution equilibrium, and a true estimate of the volume of distribution of caspofungin is currently impossible to obtain.
Slovenian: Tako pride do izločanja, ne da bi se doseglo porazdelitveno ravnovesje, zato je trenutno nemogoče zanesljivo oceniti volumen porazdelitve kaspofungina.
English: • you have ever had liver problems - you might need a different dose of this medicine
Slovenian: • če ste kadar koli imeli težave z jetri -morda boste potrebovali drugačen odmerek tega zdravila.
English: After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Slovenian: Ko se znaki in simptomi invazivne kandidiaze izboljšajo in kulture postanejo negativne, lahko razmislite o prehodu na peroralno antimikotično zdravljenje.
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC code: J02AX04
Slovenian: Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, oznaka ATC: J02AX04
English: The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Slovenian: Delež nevezanega kaspofungina v plazmi je od 3,5 % pri zdravih prostovoljcih do 7,6 % pri bolnikih z invazivno kandidiazo.
English: In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %.
Slovenian: Pri starejših bolnikih (starih 65 let ali več) se je površina pod krivuljo (AUC) povečala za približno 30 %.
English: There are no clinical data for caspofungin to assess its impact on fertility.
Slovenian: Za kaspofungin ni nobenih kliničnih podatkov, da bi lahko ocenili njegov vpliv na plodnost.
English: Standardised techniques for susceptibility testing have been established for yeasts by EUCAST.
Slovenian: Standardizirane tehnike za preizkušanje občutljivosti je za kvasovke določil EUCAST.
English: • serious fungal infections in your tissues or organs (called ‘invasive candidiasis').
Slovenian: • resnih glivnih okužb v vaših tkivih ali organih (imenovanih "invazivna kandidaza").
English: If you are pregnant or breast-feeding ,think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden dobite to zdravilo.
English: If this occurs, Caspofungin should be discontinued and appropriate treatment administered.
Slovenian: Če se ta pojavi, je treba Kaspofungin Accord ukiniti in uporabiti ustrezno zdravljenje.
English: Caspofungin is extensively bound to albumin.
Slovenian: Kaspofungin se močno veže na albumin.
English: Beta (1,3)-D-glucan is not present in mammalian cells.
Slovenian: Beta (1,3)-Dglukan ni prisoten v celicah sesalcev.
English: Efficacy was a secondary endpoint in this study.
Slovenian: Sekundarni opazovani dogodek v študiji je bila učinkovitost.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Slovenian: Izločanje kaspofungina iz plazme je počasno, očistek znaša 10-12 ml/min.
English: Other side effects in adults include
Slovenian: Ostali neželeni učinki pri odraslih so
English: The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Slovenian: Porazdelitev v tkiva je dosegla največjo vrednost 1,5 do 2 dni po odmerku, ko je bilo v tkiva porazdeljenih 92 % odmerka.
English: This belongs to a group of medicines called anti-fungals.
Slovenian: Spada v skupino zdravil, imenovanih antimikotiki.
English: Animal studies have shown developmental toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksični vpliv na razvoj (glejte poglavje 5.3).
English: However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
Slovenian: Vendar pa razpoložljivi podatki kažejo, da bolniki kaspofungin dobro prenašajo tudi pri dolgotrajnejši terapiji (do 162 dni pri odraslih bolnikih in do 87 dni pri pediatričnih bolnikih).
English: Excretion is slow and the terminal half-life of radioactivity was 12 to 15 days.
Slovenian: Terminalni razpolovni čas radioaktivnosti je bil 12 do 15 dni.
English: Available pharmacodynamic/ toxicological data in animals have shown excretion of caspofungin in milk.
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje kaspofungina v mleko.
English: As this was a primary therapy study, patients who were refractory to prior antifungal agents were also excluded.
Slovenian: Ker je bila to študija primarnega zdravljenja, so izključili tudi bolnike, ki se bili že prej nedovzetni za antimikotična zdravila.
English: If you are worried that you may have been given too much Caspofungin Accord, tell your doctor or nurse straight away.
Slovenian: Če pa vas skrbi, da ste morda dobili prevelik odmerek zdravila Kaspofungin Accord, se takoj pogovorite z zdravnikom ali medicinsko sestro.
English: Caspofungin resistance in Candida has been observed but the incidence may differ by species or region.
Slovenian: Rezistenca proti kaspofunginu pri Candidi so opazili, vendar se pojavnost rezistence lahko razlikuje glede na vrsto ali območje.
English: Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Prosimo, obvestite zdravnika, medicinsko sestro ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The following adverse reactions were reported:
Slovenian: Poročali so o naslednjih neželenih učinkih:
English: • cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
Slovenian: • kašelj, resne težave pri dihanju - če ste odrasli in imate invazivno aspergilozo, imate lahko resne težave z dihanjem, ki lahko povzročijo zastoj dihanja.
English: A higher exposure than in moderate hepatic impairment is expected and caspofungin should be used with caution in these patients (see sections 4.2 and 5.2).
Slovenian: Pričakovati je večjo izpostavitev kot pri bolnikih z zmerno jetrno okvaro, zato je treba pri njih kaspofungin previdno uporabljati (glejte poglavji 4.2 in 5.2).
English: It is likely that only a small fraction of the caspofungin taken up into tissues later returns to plasma as parent compound.
Slovenian: Verjetno je, da se samo majhen delež kaspofungina, ki se porazdeli v tkiva, pozneje vrne v plazmo v obliki nespremenjene učinkovine.
English: There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Slovenian: Ni podatkov, ki bi kazali, da zdravilo Kaspofungin Accord vpliva na sposobnost vožnje ali upravljanja s stroji.
English: Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
Slovenian: V celoti je podatkov o farmakokinetiki, učinkovitosti in varnosti, ki so na voljo pri bolnikih, starih od 3 do 10 mesecev, malo.
English: This infection is caused by a mould called Aspergillus.
Slovenian: Te okužbe povzroča plesen, imenovana Aspergilus.
English: • fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis') if other anti-fungal treatments have not worked or have caused side effects.
Slovenian: • glivnih okužb v vašem nosu, obnosnih votlinah ali pljučih (imenovanih "invazivna aspergiloza"), če druga protiglivna zdravljenja niso bila učinkovita ali so povzročala neželene učinke.
English: Women receiving caspofungin should not breast-feed.
Slovenian: Ženske, ki dobivajo kaspofungin, ne smejo dojiti.
English: Caspofungin Accord is used to treat the following infections in children, adolescents and adults:
Slovenian: Za kaj se uporablja zdravilo Kaspofungin Accord Zdravilo Kaspofungin Accord se uporablja za zdravljenje naslednjih okužb pri otrocih, mladostnikih in odraslih:
English: * 10.5 mL should be used for reconstitution of all vials.
Slovenian: *Za rekonstitucijo vseh vial je treba uporabiti 10,5 ml vehikla.
English: In general, treatment should continue for at least 7 days after resolution of symptoms.
Slovenian: Na splošno naj zdravljenje traja vsaj še 7 dni po prenehanju simptomov.
English: • phenytoin or carbamazepine (used for the treatment of seizures)
Slovenian: • fenitoin ali karbamezapin (ki se uporabljata za zdravljenje napadov krčev)
English: Duration of empirical therapy should be based on the patient's clinical response.
Slovenian: Trajanje empiričnega zdravljenja mora temeljiti na kliničnem odzivu bolnika.
English: Also some other medicines can affect the way Caspofungin Accord works.
Slovenian: Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila Kaspofungin Accord.
English: An increase in the incidence of cervical ribs was also noted.
Slovenian: Opazili so tudi večjo pojavnost vratnih reber.
English: In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
Slovenian: Pri pediatričnih bolnikih (starih od 12 mesecev do 17 let) je treba odmerjanje določiti glede na bolnikovo telesno površino (glejte Navodila za uporabo pri pediatričnih bolnikih, Mostellerjeva1 formula).
English: In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Slovenian: Študije in vitro kažejo, da kaspofungin ne zavira citokrom P450 encimov 1A2, 2A6, 2C9, 2C19, 2D6 ali 3A4.
English: It is unknown whether caspofungin is excreted in human milk.
Slovenian: Ni znano, ali se kaspofungin izloča v materino mleko.
English: Reconstituted concentrate: should be used immediately.
Slovenian: Pripravljeni koncentrat je treba uporabiti takoj.
English: A favourable response required both symptom resolution and microbiological clearance of the Candida infection.
Slovenian: Za oceno ugodnega odziva sta bila potrebna tako izginitev simptomov kot mikrobiološko izginotje okužbe s Candido.
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Slovenian: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Velika Britanija
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Slovenian: Ugotovili so, da rezistenco omogočijo mutacije na genih FKS1 in/ali FKS2 (pri C. glabrata).
English: Store in a refrigerator (2C to 8C).
Slovenian: Shranjujte v hladilniku (2 ˚C do 8 ˚C).
English: Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Slovenian: Klinične in laboratorijske nepravilnosti, o katerih so poročali, so bile pri vseh odraslih, zdravljenih s kaspofunginom (skupno 1.780), ponavadi blage in so le redko vodile v prekinitev zdravljenja.
English: The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n=186) and Candida peritonitis (8 %, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Slovenian: Najpogostejši diagnozi sta bili okužba krvi (kandidemija) (77 %, n = 186) in kandidiazni peritonitis (8 %, n = 19); bolniki s kandidiaznim endokarditisom, osteomielitisom ali meningitisom so bili iz študije izključeni.
English: The average exposure in an adult patient weighing 80 kg was predicted to be about 23 % lower than in an adult patient weighing 60 kg (see section 4.2).
Slovenian: Predvidoma je povprečna izpostavitev pri odraslem bolniku, ki tehta 80 kg, približno 23 % manjša kot pri odraslem bolniku, ki tehta 60 kg (glejte poglavje 4.2).
English: No dosage adjustment is necessary based on gender or race (see section 5.2).
Slovenian: Odmerjanja ni treba prilagoditi glede na spol ali raso (glejte poglavje 5.2).
English: Inadvertent administration of up to 400 mg of caspofungin in one day has been reported.
Slovenian: Poročali so o nenamernem zaužitju do 400 mg kaspofungina v enem dnevu.
English: • suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
Slovenian: • verjetnih glivnih okužb, če imate zvišano telesno temperaturo in nizko število belih krvnih celic, ki se ne izboljšata po zdravljenju z antibiotiki.
English: The plasma concentrations decrease with increasing weight.
Slovenian: Plazemske koncentracije se z naraščanjem telesne mase zmanjšajo.
English: For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
Slovenian: Pri bolnikih, ki dobivajo obe zdravili, sta nujno potrebna običajno spremljanje koncentracije takrolimusa v krvi in ustrezna prilagoditev odmerkov takrolimusa.
English: An independent expert panel determined that 41 % (26/63) of patients receiving at least one dose of caspofungin had a favourable response.
Slovenian: Neodvisni strokovni odbor je ugotovil, da je do ugodnega odziva prišlo pri 41 % (26/63) bolnikih, ki so dobili vsaj en odmerek kaspofungina.
English: Caution should apply in patients with history of allergic skin reaction (see section 4.8).
Slovenian: Previdnost je potrebna pri bolnikih z alergijskimi kožnimi reakcijami v anamnezi (glejte poglavje 4.8).
English: The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Slovenian: Varnost in učinkovitost kaspofungina so pri pediatričnih bolnikih, starih od 3 mesece do 17 let, ocenili v dveh prospektivnih, multicentričnih kliničnih preskušanjih.
English: • dexamethasone (a steroid)
Slovenian: • deksametazon (steroid)
English: The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Slovenian: Intravensko zdravljenje je v povprečju trajalo 11,9 dneva, z razponom od 1 do 28 dni.
English: The efficacy of caspofungin against these fungal pathogens has not been established.
Slovenian: Učinkovitost kaspofungina proti tem glivnim patogenom ni bila ugotovljena.
English: All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Slovenian: Vsi mladostniki so dobivali odmerke >50 mg na dan in 6 od 8 jih je dobivalo največji odmerek, 70 mg/dan.
English: Duration of treatment of invasive candidiasis should be based upon the patient's clinical and microbiological response.
Slovenian: Trajanje zdravljenja invazivne kandidiaze mora temeljiti na bolnikovem kliničnem in mikrobiološkem odzivu.
English: Mix gently until a clear solution is obtained.
Slovenian: Nežno mešajte, dokler ne dobite bistre raztopine.
English: DOSE*
Slovenian: ODMEREK*
English: The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle.
Slovenian: Raztopino za infundiranje pripravite tako, da ustrezno količino pripravljenega koncentrata (kot je prikazano v spodnji preglednici) aseptično dodate v 250 ml infuzijsko vrečko ali steklenico.
English: Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Slovenian: Bolnike s potrjeno glivno okužbo je treba zdraviti najmanj 14 dni, zdravljenje pa se mora nadaljevati vsaj še 7 dni po tem, ko nevtropenija in klinični simptomi izginejo.
English: • Treatment of invasive candidiasis in adult or paediatric patients.
Slovenian: • Zdravljenje invazivne kandidiaze pri odraslih ali pediatričnih bolnikih.
English: After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Slovenian: Po rekonstituciji in redčenju je treba raztopino aplicirati v počasni, približno enourni intravenski infuziji.