FrancophonIA/ELRC3.0 huggingface dataset:
English: In-vitro studies on dexrazoxane in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely.
Slovenian: V študijah deksrazoksana in vitro na človeških mikrosomih so dokazali visoko stabilnost deksrazoksana, kar kaže, da se v večji meri ne presnavlja preko citokroma P450.
English: The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
Slovenian: Naslednji podatki temeljijo na dveh kliničnih študijah (TT01 in TT02) zdravila Savene, ki so ga uporabili pri bolnikih z ekstravazacijo, ki so že prejemali cikle kemoterapevtikov.
English: Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin
Slovenian: Natrij (hipo) Kalij (hipo) Kalij (hiper) Alkalna fosfataza Bilirubin
English: The concentrate should then be diluted further in the remaining Savene solvent.
Slovenian: Pripravljeni koncentrat je treba nato dodatno razredčiti v preostanku vehikla Savene.
English: This must be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Slovenian: Pri zdravljenju je treba biti pozoren na bolnike z zmanjšanim delovanjem ledvic ali pri bolnikih, ki so na dieti z nadzorovanim vnosom kalija.
English: 3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
Slovenian: 3.1.2 Vbrizgajte celotno vsebino brizge v vialo s praškom Savene.
English: The preparation should not be handled by pregnant staff.
Slovenian: S pripravkom ne smejo ravnati nosečnice.
English: • Reactions at the site of injection (pain at the site, red, swollen or painful skin at the site or hardening of the skin at the site)
Slovenian: • reakcije na mestu injiciranja (bolečina na mestu injiciranja, rdečica, otekanje ali bolečina na koži mesta injiciranja ali otrdelost kože na mestu injiciranja),
English: In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients (70.4 %), and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
Slovenian: V obeh študijah je zdravljenje z deksrazoksanom preprečilo razvoj nekroze in pri večini bolnikov (70,4 %) omogočilo nadaljevanje zdravljenja raka po režimu in zmanjšalo pojavnost posledic (opazili so le nekaj blagih dolgoročnih posledic).
English: 3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
Slovenian: 3.1.3 Odstranite injekcijsko brizgo in iglo ter vialo ročno premešajte z večkratnim obračanjem, dokler se prašek popolnoma ne raztopi.
English: Since Savene will be administered to patients undergoing cytotoxic therapy with anthracyclines its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore add to that of the other chemotherapy administered.
Slovenian: Ker se zdravilo Savene daje bolnikom, ki prejemajo citotoksično zdravljenje z antraciklini, se citotoksični potencial zdravila (zlasti nastali reverzibilni hematološki toksikološki učinki z nadirjem 11. in 12. dan) prišteje citotoksičnemu potencialu drugih uporabljenih kemoterapevtikov.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours at 2 to 8 °C.
Slovenian: Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik , pri čemer shranjevanje ne sme biti daljše od 4 ur pri 2 do 8 °C.
English: Based on the required dose for the patient expressed in mg, withdraw aseptically the corresponding volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing concentrate.
Slovenian: Glede na potreben odmerek za bolnika, izražen v mg, aseptično povlecite ustrezen volumen z 20 mg deksrazoksana na ml iz ustreznega števila vial, ki vsebujejo koncentrat.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve redno posodobljenih poročil o varnosti tega zdravila so opredeljene na seznamu referenčnih datumov Unije (seznamu EURD), ki je naveden v členu 107c(7) Direktive
English: The aim was to examine the pharmacokinetics of a 3-day dosing regimen of dexrazoxane and its efficacy in patients for anthracycline extravasation.
Slovenian: Namen raziskave je bil preveriti farmakokinetiko 3-dnevnega režima odmerjanja deksrazoksana in njegovo učinkovitost pri bolnikih, ki se zdravijo zaradi antraciklinske ekstravazacije.
English: AUCs were dose-proportional.
Slovenian: Vrednosti površine pod krivuljo (AUC) so sorazmerne odmerku.
English: Women must inform their doctor immediately if they become pregnant (see section 4.3).
Slovenian: Ženske morajo svojega zdravnika nemudoma obvestiti, če zanosijo (glejte poglavje 4.3).
English: About 2% of dexrazoxane is protein-bound.
Slovenian: Na beljakovine je vezano 2 % deksrazoksana.
English: For study purposes, patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
Slovenian: V vrednotenje učinkovitosti niso vključili bolnikov, ki so imeli ekstravazacije iz pripomočka za centralni venski pristop (CVAD - central venous access device).
English: Modelling suggested that equivalent exposure (AUC0-inf) could be achieved if dosing were reduced by 50% in subjects with CLCR less than 40 mL/min compared with control subjects (CLCR >80 mL/min) (see section 4.2).
Slovenian: Modeliranje je pokazalo, da bi lahko enako izpostavljenost (AUC0-inf) dosegli, če bi odmerke pri osebah s CLCR v vrednosti manj kot 40 ml/min zmanjšali za 50 % v primerjavi s kontrolnimi osebami (CLCR > 80 ml/min) (glejte poglavje 4.2).
English: Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see section 4.3).
Slovenian: Sočasna uporaba je kontraindicirana v naslednjih primerih: Cepivo proti rumeni mrzlici: Tveganje za smrtno generalizirano vakcinijo (glejte poglavje 4.3).
English: The overall purpose of each trial was to investigate the efficacy of intravenous Savene in preventing tissue damage from accidentally extravasated anthracycline, and thus preventing the patients from undergoing the routinely used surgical excision of the affected tissue.
Slovenian: Skupni namen obeh preskušanj je bil raziskati učinkovitost intravensko uporabljenega zdravila Savene pri preprečevanju poškodb tkiva zaradi nenamerno ekstravaziranega antraciklina in s tem preprečevanje rutinskega kirurškega izrezovanja prizadetega tkiva pri teh bolnikih.
English: Savene should not be administered if you are pregnant.
Slovenian: Zdravila Savene vam ne smejo dajati, če ste noseči.
English: 5 How to store Savene Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Savene Vsebina pakiranja in dodatne informacije
English: Clinical efficacy and safety The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies.
Slovenian: Klinična učinkovitost in varnost Klinični program za zdravilo Savene (deksrazoksan) je obsegal dve odprti multicentrični študiji brez primerjalne skupine.
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing.
Slovenian: Na voljo so omejeni podatki o plodnosti iz študij na živalih, vendar so bile pri podganah in kuncih pri ponavljajočih se odmerkih opazne spremembe na modih.
English: Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini, nalepki viale s praškom in nalepki steklenice z vehiklom poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Savene solvent also contains 1.61 g sodium per 500 ml bottle, equivalent to 81% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Vehikel zdravila Savene vsebuje tudi 1,61 g natrija v 500 ml steklenici, kar je enako 81 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: 3.1 Reconstitution of Savene powder to prepare a concentrate 3.1.1 Using a syringe fitted with a needle, withdraw aseptically 25 ml from the Savene solvent bottle.
Slovenian: 3.1 Priprava praška Savene za pripravo koncentrata 3.1.1 Z injekcijsko brizgo, ki ima nameščeno iglo, aseptično povlecite 25 ml iz steklenice z vehiklom
English: In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50% (see section 4.4 and 5.2).
Slovenian: Ledvične okvare Pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina < 40 ml/min) je treba odmerek Savene zmanjšati za 50 % (oglejte si poglavji 4.4 in 5.2).
English: 4.2 After reconstitution and dilution: - Chemical and physical in-use stability after reconstitution and subsequent dilution in the solvent has been demonstrated for 4 hours when stored at 2 to 8 °C.
Slovenian: 4.2 Po rekonstituciji in redčenju: - Dokazali so, da je zdravilo po rekonstituciji in redčenju v vehiklu kemično in fizikalno stabilno do 4 ure, če se shranjuje pri temperaturi 2 do 8 °C.
English: Treatment should be given once daily for 3 consecutive days.
Slovenian: Odmerjanje Zdravljenje traja 3 zaporedne dni, enkrat dnevno.
English: In study TT02, 57 patients entered the study and received the first dose of Savene.
Slovenian: V študiji TT02 so vključili 57 bolnikov, ki so prejeli prvi odmerek zdravila Savene.
English: • Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Slovenian: • Fenitoin: sočasna uporaba citotoksičnega zdravila lahko zmanjša absorpcijo fenitoina, kar lahko poslabša epileptične krče.
English: Other medicines and Savene Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) Lab test
Slovenian: Pojavnost nenormalnosti rezultatov laboratorijskih preiskav v TT01 in TT02 (n=80 bolnikov) Laboratorijska preiskava
English: Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants.
Slovenian: Bolnike, ki se zdravijo z antikoagulanti je treba pogosteje spremljati, saj lahko pride do interakcije med cititoksičnimi zdravili in peroralnimi antikoagulanti.
English: Infection Neutropenic infection
Slovenian: Okužbe nevtropenična okužba
English: Thus, dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation.
Slovenian: Zato se dimetilsulfoksid (DMSO) ne sme uporabiti pri bolnikih, ki za zdravljenje antraciklinske ekstravazacije prejemajo deksrazoksan.
English: Clinical trial TT04 was conducted on 6 female patients undergoing treatment for anthracycline extravasations.
Slovenian: Klinična raziskava TT04 je vključevala 6 bolnic, ki so se zdravile zaradi antraciklinskih ekstravazacij.
English: To be used within 4 hours after dilution when stored at 2-8 °C.
Slovenian: Raztopino uporabite v 4 urah po razredčitvi, shranjeno pri temperaturi od 2-8 °C.
English: The Savene solvent contains 98 mg potassium in each 500 ml bottle which may be harmful to people on a low-potassium diet or who have kidney problems.
Slovenian: Vehikel Savene vsebuje 98 mg kalija v 500 ml steklenici, ki je lahko škodljiv za osebe na dieti z nadzorovanim vnosom kalija ali bolnike z levičnimi težavami.
English: When tested in five major cytochrome P450 isoenzymes CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
Slovenian: Pri preizkušanju petih glavnih izoencimov citokroma P450 (CYP1A, CYP2C9, CYP2C19, CYP2D6 in
English: • Inflammation of a blood vessel just under the skin, often with a small blood clot
Slovenian: • vnetje krvne žile na mestu zdravljenja (flebitis), • vnetje krvne žile tik pod kožo, pogosto z majhnim krvnim strdkom,
English: 3.1.5 Keep and store the opened solvent bottle under aseptic conditions because it is needed for dilution of the concentrate.
Slovenian: 3.1.5 Odprte steklenice z vehiklom shranjujte pod aseptičnimi pogoji, ker boste vehikel potrebovali za redčenje koncentrata.
English: Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours.
Slovenian: Zdravljenje so ponovili po 24 ter 48 urah.
English: The dose will depend on your height, weight and kidney function.
Slovenian: Odmerek je odvisen od telesne višine, mase in delovanja ledvic.
English: In studies, dexrazoxane did not affect the pharmacokinetics of doxorubicin.
Slovenian: V raziskavah deksrazoksan ni vplival na farmakokinetiko doksorubicina.
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing (see section 5.3).
Slovenian: Na voljo so omejeni podatki o plodnosti iz študij na živalih, vendar so bile pri podganah in kuncih pri ponavljajočih se odmerkih opazne spremembe na modih (glejte poglaje 5.3).
English: Repeat-dose toxicity studies with dexrazoxane have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract.
Slovenian: Raziskave toksičnosti ponavljajočih se odmerkov deksrazoksana kažejo, da so bila najprej prizadeta tkiva s hitro delitvijo celic: kostni mozeg, limfna tkiva, testisi in prebavni trakt.
English: - If you have liver problems, your doctor will monitor your liver function during treatment.
Slovenian: - Če imate težave z jetri, bo zdravnik med zdravljenjem spremljal delovanje jeter.
English: In study TT01, 23 patients were entered and received treatment with Savene.
Slovenian: V študiji TT01 so vključili 23 bolnikov, ki so prejeli zdravilo Savene.
English: The overall ranges and mean of AUC0-24 between days were very similar; it does not appear that there is any significant accumulation of dexrazoxane.
Slovenian: Skupni razpon in povprečne vrednosti AUC0-24 med posameznimi dnevi so zelo podobne, kar kaže na zanemarljivo stopnjo kopičenja deksrazoksana.
English: • Pneumonia (lung infection)
Slovenian: • pljučnica (okužba pljuč),
English: 3.2 Dilution of the concentrate 3.2.1 Up to four vials containing Savene concentrate may be necessary to obtain the required dose for the patient.
Slovenian: 3.2 Redčenje koncentrata 3.2.1 Da dosežete potreben odmerek za bolnika, boste morda potrebovali do štiri viale koncentrata zdravila Savene.
English: The solution must not be mixed with any other medicines.
Slovenian: Raztopine ne smete mešati z nobenim drugim zdravilom.
English: Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 (n=80 patients) (Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations)
Slovenian: Pojavnost neželenih učinkov (MedDRA) v študijah TT01 in TT02 (n=80 bolnikov) (Številke za „Bolezni krvi in limfatičnega sistema“ so navedene v ločeni tabeli laboratorijskih preiskav)
English: Dexrazoxane has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).
Slovenian: Deksrazoksana niso preučevali pri bolnikih z okvaro jeter, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavje 4.4).
English: Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue.
Slovenian: V določenih primerih se zdravilo nenamerno infundira izven vene v okolnje tkivo, oziroma izteče iz vene v okoljnje tkivo.
English: Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution.
Slovenian: Po zdravljenju je treba prizadeto področje redno pregledovati, dokler stanje ne preneha.
English: Dexrazoxane displays biphasic elimination kinetics.
Slovenian: Izločanje Deksrazoksan ima dvofazno kinetiko izločanja.
English: Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys.
Slovenian: nespremenjena starševska spojina ima najvišjo koncentracijo, v jetrih in ledvicah se pojavijo hidrolizirani produkti.
English: Since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1 000 mg/m2 dexrazoxane), it is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders (see section 4.2).
Slovenian: Ker lahko, zlasti po odmerkih deksrazoksana nad 1.000 mg/m2, pride do disfunkcije jeter (zvišane vrednosti transaminaz in bilirubina), je pri bolnikih z dokazano okvaro jeter priporočljivo opraviti redne preiskave jetrne funkcije pred vsakim odmerkom deksrazoksana (glejte poglavje 4.2).
English: Savene will be given to you under the control of a doctor experienced in the use of anti-cancer treatments.
Slovenian: Zdravilo Savene boste prejeli pod nadzorom zdravnika, ki ima izkušnje pri uporabi zdravil proti raku.
English: Compared with normal subjects (creatinine clearance (CLCR) >80 mL/min), exposure was 2- fold greater in subjects with moderate (CLCR of 30 to 50 mL/min) to severe (CLCR <30 mL/min) renal impairment.
Slovenian: Ledvična okvara V primerjavi z zdravimi poskusnimi osebami (očistek kreatinina (CLCR) > 80 ml/min), je bila izpostavljenost pri osebah z zmerno (CLCR 30-50 ml/min) do hudo (CLCR < 30 ml/min) okvaro ledvic 2-krat večja.
English: 3.2.5 As with all parenteral products, Savene concentrate and infusion solution should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: 3.2.5 Kot vsa parenteralna zdravila je treba koncentrat zdravila Savene in raztopino zdravila Savene za infundiranje pred uporabo s prostim očesom preveriti na prisotnost delcev ali razbarvanje.
English: Dexrazoxane should not be administered to pregnant women unless clearly necessary.
Slovenian: Deksrazoksana ne smete dajati nosečnicam, razen če je nujno potrebno.
English: This risk is increased in subjects who are already immunosuppressed by their underlying disease or by concomitant chemotherapy.
Slovenian: To tveganje je večje pri osebah, ki imajo zaradi obstoječe bolezni ali hkratne kemoterapije oslabljeno delovanje imunskega sistema.
English: Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours.
Slovenian: Koncentrat in razredčena raztopina se lahko hrani 4 ure pri 2 do 8 °C.
English: Day 3: 500 mg/m2
Slovenian: 500 mg/m2
English: Contains cytotoxics.
Slovenian: Vsebuje citotoksike.
English: Interaction specific to dexrazoxane:
Slovenian: Interakcija, specifična za deksrazoksan:
English: Solvent bottle:
Slovenian: Steklenica z vehiklom:
English: Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with impaired renal function should be monitored for signs of haematological toxicity (see section 4.2 for dosing recommendations in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min)).
Slovenian: Ker lahko moteno delovanje ledvic zniža stopnjo izločanja deksrazoksana, je treba pri bolnikih z motenim delovanjem ledvic spremljati znake hematološke toksičnosti (oglejte si poglavje 4.2, ki vsebuje priporočila za odmerjanje pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina < 40 ml/min)).
English: When mice with experimental daunorubicin extravasation were treated with dexrazoxane systemically combined with topical treatment with DMSO on the daunorubicin-affected skin area, 67 % of the mice developed small skin wounds, whereas dexrazoxane treatment alone completely prevented the daunorubicin-induced skin necrosis in another group of mice.
Slovenian: Ko so miši z eksperimentalno izzvano daunorubicinsko ekstravazacijo zdravili s sistemskim deksrazoksanom in zunanjo uporabo DMSO na delu kože, prizadetem zaradi daunorubicina, so se pri 67 % miši pojavile majhne kožne ranice.
English: Savene is used to treat anthracyline extravasation in adults.
Slovenian: Zdravilo Savene se uporablja za zdravljenje ekstravazacije antraciklina pri odraslih.
English: Savene solvent contains 98 mg potassium per 500 ml bottle.
Slovenian: Vehikel zdravila Savene vsebuje 98 mg kalija v 500 ml steklenici.
English: If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če prašek ali raztopina prideta v stik s kožo ali sluznicami, prizadeto področje nemudoma temeljito sperite z vodo.
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se pri največ 1 od 10 bolnikov
English: 4.6 Fertility, pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje Ženske v rodni dobi / kontracepcija pri moških in ženskah
English: The carcinogenic potential of dexrazoxane has not been investigated, however, razoxane (the racemic mixture of dexrazoxane and levrazoxane) has been reported to be associated with the development of malignancies in mice (lymphoid neoplasms) and rats (uterine carcinomas) after administration for a prolonged period of time.
Slovenian: Karcinogenega potenciala deksrazoksana še niso raziskali, vendar je dolgoročno dajanje razoksana (racemno zmes deksrazoksana in levrazoksana), povezano s pojavom malignih tvorb pri miših (limfatične neoplazme) in podganah (maternični karcinomi).
English: Solutions containing a precipitate should be discarded.
Slovenian: Raztopine, ki vsebujejo oborino, morate zavreči.
English: 3.2.3 Mix the solution by agitating gently the infusion bottle.
Slovenian: 3.2.3 Raztopino premešajte z rahlim stresanjem infuzijske steklenice.
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL Drugi viri informacij
English: The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3),
Slovenian: Povprečni razpolovni čas izločanja je za odprti intermediat z enim obročem B 0,9-3,9 h (n=5), za odprti intermediat z enim obročem C pa 0,5-0,8 h (n=3).
English: The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Savene pri otrocih, mlajših od 18 let, nista bili dokazani.
English: The adverse reactions were those typically seen with standard chemotherapy and also with dexrazoxane: Nausea/vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/AST).
Slovenian: Opazili so neželene učinke, značilne za standardno kemoterapijo in deksrazoksan: slabost/bruhanje so opazili pri približno tretjini bolnikov, nevtropenijo in trombocitopenijo pri približno polovici bolnikov,
English: For intravenous use after reconstitution and dilution.
Slovenian: Za intravensko uporabo po rekonstituciji in razredčenju.
English: Savene powder must be reconstituted in 25 ml Savene solvent to obtain a concentrate that must be further diluted in the remaining Savene solvent prior to administration.
Slovenian: Pred dajanjem je treba prašek Savene pripraviti s 25 ml vehikla Savene, da dobite koncentrat, ki ga je treba dodatno razredčiti v preostanku vehikla Savene.
English: White to off-white lyophilisate.
Slovenian: bel do belkast liofilizat.
English: How to use Savene
Slovenian: Kako uporabljati zdravilo Savene