FrancophonIA/ELRC3.0 huggingface dataset:
English: What Savene looks like and contents of the emergency kit The Savene kit consists of Savene powder for concentrate (white to off-white powder) and Savene solvent.
Danish: Udseende og pakningsstørrelse af nødhjælpssættet Savene-sættet består af Savene pulver til koncentrat (hvidt til off-white pulver) og solvens til Savene.
English: • Feeling tired, feeling sleepy, feeling dizzy, sudden fainting
Danish: • En følelse af træthed, søvnighed, svimmelhed, pludselig besvimelse
English: Savene powder for concentrate Solvent for Savene
Danish: Savene pulver til koncentrat Solvens til Savene
English: 3.1.5 Keep and store the opened solvent bottle under aseptic conditions because it is needed for dilution of the concentrate.
Danish: 3.1.5 Opbevar den åbnede flaske med solvens under aseptiske forhold, da den skal bruges til fortynding af koncentratet.
English: It can reduce the amount of tissue damage caused by anthracycline extravasation.
Danish: Det kan reducere omfanget af vævsskade forårsaget af antracyklin-ekstravasation.
English: Savene will be given by infusion into one of your veins.
Danish: Savene gives ved infusion i en af venerne.
English: The aim was to examine the pharmacokinetics of a 3-day dosing regimen of dexrazoxane and its efficacy in patients for anthracycline extravasation.
Danish: Formålet var at undersøge farmakokinetikken for et 3-dages doseringsregime med dexrazoxan og dets virkning hos patienter mod antracyklin-ekstravasationer.
English: In study TT02, 57 patients entered the study and received the first dose of Savene.
Danish: I studie TT02 deltog 57 patienter, som fik den første dosis af Savene.
English: • Concomitant vaccination with yellow fever vaccine (see section 4.5).
Danish: • Samtidig vaccination med vacciner mod gul feber (se pkt.
English: Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect dexrazoxane pharmacokinetics significantly.
Danish: Samtidig administration af doxorubicin (50 til 60 mg/m2) eller epirubicin (60 til 100 mg/m2) påvirkede ikke dexrazoxans farmakokinetik signifikant.
English: Two pharmacodynamic properties of dexrazoxane are described in the literature: Prevention of anthracycline cardiotoxicity, and Antineoplastic action
Danish: To farmakodynamiske egenskaber ved dexrazoxan er beskrevet i litteraturen: Forebyggelse af kardiotoksicitet i forbindelse med antracyklin, og Antineoplastisk virkning
English: Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines.
Danish: Savene indeholder det aktive stof dexrazoxan, der virker som modgift mod cancermedicin, der kaldes antracykliner.
English: Solvent bottle:
Danish: Flaske med solvens:
English: Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8 °C.
Danish: Kemisk og fysisk brugsstabilitet er påvist i 4 timer, når det opbevares ved 2-8 °C.
English: If you receive more Savene than you should, you will be closely monitored with specific attention to your blood cells, potential gastro-intestinal signs, skin reactions and hair loss.
Danish: Hvis De har fået for meget Savene vil De blive overvåget nøje, med speciel opmærksomhed på Deres blodceller, mulige tegn fra mave-tarm-kanalen, hudreaktioner og hårtab.
English: PHARMACEUTICAL FORM AND CONTENTS 500 ml solvent
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 500 ml solvens
English: If you receive more Savene than you should
Danish: Hvis De har fået for meget Savene
English: Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
Danish: Den initiale eliminationshalveringstid (alfa) er 0,181 timer (median 0,34 timer) og den terminale eliminationshalveringstid 1,9-9,1 timer (median 2,8 timer).
English: • Inflammation of the blood vessel where the treatment is given (phlebitis)
Danish: • Betændelseslignende reaktion (inflammation) i det blodkar, hvor behandlingen gives (flebitis)
English: 3.2.4 Savene should be administered aseptically as a 1-2 hours infusion under room temperature and normal light conditions.
Danish: 3.2.4 Savene skal indgives aseptisk som en 1-2 timers infusion ved stuetemperatur og normale lysforhold.
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),
Danish: Den gennemsnitlige eliminationshalveringstid for metabolit B med én åben ring og metabolit C er henholdsvis 0,9-3,9 timer (n = 5) og 0,5-0,8 timer (n = 3).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald skal bortskaffes i overensstemmelse med lokale retningslinjer.
English: Interaction specific to dexrazoxane:
Danish: Interaktioner, som er specifikke for dexrazoxan:
English: In study TT01, 23 patients were entered and received treatment with Savene.
Danish: I studie TT01 deltog 23 patienter, som fik behandling med Savene.
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).
Danish: Da leverdysfunktion (forhøjede transaminase- og bilirubinværdier) kan forekomme (især efter doser på over 1.000 mg/m2 dexrazoxan), anbefales det, at leverfunktionstest skal udføres regelmæssigt før hver administration af dexrazoxan til patienter, hos hvem der er kendskab til leverfunktionsforstyrrelser (se pkt.
English: Plasma potassium level must be closely monitored in patients at risk of hyperkalaemia.
Danish: Kalium-plasma-niveau skal monitoreres, hvis der er risiko for hyperkaliæmi.
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.
Danish: 3.2 Fortynding af koncentratet 3.2.1 Der kan være behov for op til fire hætteglas med Savene-koncentrat for at opnå den nødvendige dosis til patienten.
English: If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the effects from these compounds.
Danish: Hvis der er mistanke om ekstravasation gennem samme intravenøse adgang af andre blæredannende stoffer end antracykliner, f.eks. vinkristin, mitomycin og vinorelbin, har Savene ingen virkning imod virkningen fra disse stoffer.
English: NAME OF THE MEDICINAL PRODUCT Solvent for Savene
Danish: LÆGEMIDLETS NAVN Solvens til Savene
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)
Danish: Bivirkningsincidensen (MedDRA) i studierne TT01 og TT02 (n=80 patienter) (Bemærk, at tallene for sygdomme i blod- og lymfesystem vises i en særskilt tabel over laboratorieundersøgelser).
English: Clinical efficacy and safety The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies.
Danish: Det kliniske program for Savene (dexrazoxan) omfattede to åbne, enkeltgruppe, multicenterstudier.
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.
Danish: Der overordnede formål med begge studier var at undersøge effekten af intravenøs administration af Savene med henblik på at forhindre vævsskade fra utilsigtet ekstravaseret antracyklin og derved undgå den rutinemæssigt anvendte kirurgiske ekscision af det angrebne væv.
English: Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines (see section 4.8).
Danish: Anafylaktiske reaktioner, herunder angioødem, hudreaktioner, bronkospasmer, vejrtrækningsbesvær, hypotension og bevidsthedstab er blevet observeret hos patienter behandlet med dexrazoxan og antracykliner (se pkt.
English: Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.)
Danish: Solvens til Savene: 500 ml opløsningsvæske i flasker fremstillet af type I (Ph.Eur.)
English: 3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
Danish: 3.1.3 Fjern sprøjten og nålen og bland ved at vende glasset flere gange manuelt, indtil pulveret er helt opløst.
English: The terminal elimination half-life was consistent throughout days 1 - 3 (2.1 - 2.2 h).
Danish: Halveringstiden var konstant fra og med dag 1-3 (2,1-2,2 t).
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.
Danish: Studier med gentagen dosistoksicitet for dexrazoxan har vist, at de primære målorganer var væv med hurtig celledeling: knoglemarv, lymfevæv, testikler og mave-tarm-kanal.
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.
Danish: Savene-pulver skal rekonstitueres i 25 ml solvens til Savene for at fremstille et koncentrat, der skal fortyndes yderligere i den resterende solvens til Savene inden administration.
English: Skin reactions have been reported following contact with dexrazoxane.
Danish: Der er rapporteret om hudreaktioner efter kontakt med dexrazoxan.
English: Dexrazoxane displays biphasic elimination kinetics.
Danish: Dexrazoxan udviser bifasisk eliminationskinetik.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains cytotoxics after dilution with concentrate.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Indeholder cytotoksiske stoffer efter fortynding med koncentrat.
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).
Danish: Bivirkningerne var dem, som normalt forekom i forbindelse med normal kemoterapi, og som også ses med dexrazoxan: Kvalme/opkastning hos cirka en tredjedel af patienterne, neutropeni og trombocytopeni hos cirka halvdelen af patienterne og mere sjældent, forhøjede koncentrationer af leverenzymer (ALAT/ASAT).
English: Day 1: 1000 mg/m2 Day 2: 1000 mg/m2 Day 3: 500 mg/m2
Danish: Dag 1: 1.000 mg/m2 Dag 2: 1.000 mg/m2 Dag 3: 500 mg/m2
English: The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available.
Danish: Pædiatrisk population Savenes sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Dexrazoxane has been shown to possess mutagenic activity.
Danish: Dexrazoxan har vist sig at have mutagen aktivitet.
English: Dexrazoxane undergoes intracellular hydrolysis first to its two one-ring open intermediates (B and C) and then to the two-ring opened form (ADR-925) which has a structure similar to EDTA and is a strong chelator of iron and divalent cations as calcium ions.
Danish: Dexrazoxan gennemgår intracellulær hydrolyse først til sine to mellemstoffer med én åben ring (B og C) og derefter til formen med to åbne ringe (ADR-925).
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.
Danish: Sammenlignet med normale forsøgspersoner (kreatinin-clearance (CLCR) >80 ml/min) var eksponeringen 2 gange højere hos forsøgspersoner med moderat (CLCR på 30 til 50 ml/min) til svært (CLCR <30 ml/min) nedsat nyrefunktion.
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).
Danish: Modelberegninger tyder på, at tilsvarende eksponering (AUC0-inf) ville kunne opnås, hvis dosis blev reduceret med 50 % hos forsøgspersoner med en CLCR på mindre end 40 ml/min sammenlignet med kontrolforsøgspersoner (CLCR >80 ml/min) (se pkt.
English: Dexrazoxane may cause foetal harm when administered to pregnant women.
Danish: Dexrazoxan kan forårsage fosterskader, hvis det gives til gravide kvinder.
English: Other medicines and Savene Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: 3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
Danish: 3.1.2 Injicer hele indholdet i sprøjten ned i hætteglasset med Savene-pulver.
English: Hepatic and renal-function monitoring
Danish: Monitorering af lever- og nyrefunktion
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing.
Danish: Der foreligger begrænsede fertilitetsdata fra dyreforsøg, men der er observeret testikelforandringer hos rotter og kaniner efter gentagen dosering.
English: What Savene contains - The active substance is dexrazoxane.
Danish: Savene indeholder - Aktivt stof: dexrazoxan.
English: Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) Lab test
Danish: Incidens af anormale laboratorieværdier i TT01 og TT02 (n=80 patienter)
English: Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see section 4.3).
Danish: Samtidig anvendelse er kontraindiceret: Vaccine mod gul feber: Risiko for livstruende generel vaccinesygdom (se pkt.
English: Vomiting Diarrhoea Stomatitis Dry mouth
Danish: Opkastning Diarré Stomatitis Mundtørhed
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).
Danish: Dexrazoxan er ikke blevet undersøgt hos patienter med nedsat leverfunktion og anbefales derfor ikke til sådanne patienter (se pkt.
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.
Danish: 3.1 Rekonstitution af Savene-pulver til fremstilling af koncentrat 3.1.1 Anvend en sprøjte, der er forsynet med en nål, og træk aseptisk 25 ml op af flasken med solvens til Savene.
English: RECOMMENDATION FOR THE SAFE HANDLING
Danish: ANVISNING FOR SIKKER HÅNDTERING
English: In studies, dexrazoxane did not affect the pharmacokinetics of doxorubicin.
Danish: I studier har dexrazoxan ikke påvirket doxorubicins farmakokinetik signifikant.
English: Savene will be given to you under the control of a doctor experienced in the use of anti-cancer treatments.
Danish: De vil få Savene under kontrol af en læge, der har erfaring i anvendelse af behandling mod cancer.
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.
Danish: Imidlertid er razoxan (den racemiske blanding af dexrazoxan og levrazoxan) rapporteret til at være forbundet med udviklingen af maligniteter hos mus (lymfoide neoplasmer) og rotter (svulst i uterus) efter administration over en længere periode.
English: - During treatment with Savene the area where the extravasation has occurred will be examined on a regular basis and you will have blood tests taken regularly to check your blood cells.
Danish: regelmæssigt, og De skal have taget blodprøver regelmæssigt for at kontrollere Deres blodceller.
English: The apparent volumes of distribution are 0.13-1.3 l/kg (median 0.49 l/kg).
Danish: Distributionsvolumenet er 0,131,3 l/kg (median 0,49 l/kg) og uafhængigt af dosis.
English: The concentrate contains 20 mg dexrazoxane per ml and should be used immediately for further dilution.
Danish: Koncentratet indeholder 20 mg dexrazoxan pr. ml og skal straks fortyndes yderligere.
English: Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia.
Danish: Tegn og symptomer på overdosering vil sandsynligvis være leukopeni, trombocytopeni, kvalme, opkastning, diarré, hudreaktioner og alopeci.
English: Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin
Danish: Hæmoglobin Leukocytter Neutrofiler Trombocytter Natrium (Hypo) Kalium (Hypo) Kalium (Hyper) Alkalisk fosfatase Bilirubin
English: This must be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Danish: Dette skal der tages hensyn til, hvis patienterne har nedsat nyrefunktion og/eller får kaliumfattig diæt.
English: Savene solvent contains 98 mg potassium per 500 ml bottle.
Danish: Solvenset til Savene indeholder 98 mg kalium pr. 500 ml flaske.
English: Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8).
Danish: Svimmelhed, døsighed og synkope er blevet rapporteret hos nogle få patienter, som var inkluderet i Savene-studierne TT01 og TT02 (se pkt.
English: The following serious side effect has been reported in patients during treatment with Savene (frequency not known):
Danish: Nogle bivirkninger kan være alvorlige og kræver øjeblikkelig lægehjælp Følgende alvorlige bivirkninger er indberettet for patienter under behandling med Savene (hyppigheden kendes ikke):
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.
Danish: Når mus med eksperimentel ekstravasation af daunorubicin blev behandlet systemisk med dexrazoxan i kombination med lokalbehandling med DMSO på det daunorubicinpåvirkede hudområde, udviklede 67% af musene små hudsår.
English: 3.2.3 Mix the solution by agitating gently the infusion bottle.
Danish: 3.2.3 Bland opløsningen ved at ryste infusionsflasken forsigtigt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution with concentrate.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter fortynding med koncentrat.
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).
Danish: Hos patienter med moderat til svært nedsat nyrefunktion (kreatinin-clearance <40 ml/min) skal Savene-dosen nedsættes med 50 % (se pkt.
English: Dizziness Sensory loss Syncope Tremor
Danish: Svimmelhed Følelsestab Synkope Tremor
English: Savene is used to treat anthracyline extravasation in adults.
Danish: Savene anvendes til at behandle ekstravasation af antracykliner hos voksne.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10) er:
English: How to use Savene
Danish: Sådan skal De bruge Savene
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (fremstillerne), der er ansvarlig(e) for batchfrigivelse
English: • Weight loss, loss of appetite
Danish: • Vægttab, nedsat appetit
English: Thus, dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation.
Danish: Dimethylsulfoxid (DMSO) bør derfor ikke anvendes hos patienter, der får dexrazoxan indgivet for at behandle ekstravasation af antracyklin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING KIT BOX (1 KIT CONSISTING OF 10 POWDER VIALS AND 3 SOLVENT BOTTLES)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE SÆT I ÆSKE (1 SÆT BESTÅR AF 10 HÆTTEGLAS MED PULVER OG 3 FLASKER MED SOLVENS)
English: Dexrazoxane should not be administered to pregnant women unless clearly necessary.
Danish: Dexrazoxan bør kun gives til gravide kvinder, hvis det er absolut nødvendigt.
English: • Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation (see section 5.3)
Danish: • Dimethylsulfoxid (DMSO) bør ikke anvendes til patienter, som får dexrazoxan indgivet for at behandle antracyklin-ekstravasation (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SOLVENT BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE MED SOLVENS
English: Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap.
Danish: Savene-pulver: Ravgult 36-ml hætteglas (type I) med prop af chlorbutylgummi og en flip-off hætte.
English: Savene must be administered under the supervision of a physician experienced in the use of anticancer medicinal products.
Danish: Savene skal indgives under supervision af en læge, der har erfaring med anvendelse af lægemidler mod cancer.
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).
Danish: Der foreligger begrænsede fertilitetsdata fra dyreforsøg, men der er observeret testikelforandringer hos rotter og kaniner efter gentagen dosering (se pkt.
English: Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours.
Danish: Koncentrat og fortyndet infusionsvæske kan opbevares ved 2-8 °C i 4 timer.
English: Superficial thrombophlebitis Venous thrombosis limb
Danish: Overfladisk tromboflebitis Venetrombose i ekstremitet
English: glass.
Danish: glas.
English: • Wound complications
Danish: • Sårkomplikationer
English: Savene is indicated in adults for the treatment of anthracycline extravasation.
Danish: Savene er indiceret hos voksne til behandling af antracyklin-ekstravasation.
English: Savene contains potassium and sodium
Danish: Savene indeholder kalium og natrium
English: - The other ingredient(s) are: The solvent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.
Danish: - Øvrige indholdsstoffer: solvens, der indeholder natriumchlorid, kaliumchlorid, magnesiumchloridhexahydrat, natriumacetattrihydrat, natriumgluconat, natriumhydroxid og vand til injektionsvæsker.
English: Excipients with known effects: Solvent bottle:
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Flaske med solvens:
English: OTHER SPECIAL WARNING(S), IF NECESSARY To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Savene skal indgives under supervision af en læge, der har erfaring med anvendelse af cytotoksiske stoffer.
English: Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml.
Danish: Inden infusion skal Savene pulveret rekonstitueres med 25 ml Savene-solvens for at opnå en koncentration på 20 mg dexrazoxan pr. ml.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10) er:
English: Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent.
Danish: Hver ml indeholder 20 mg dexrazoxan efter rekonstitution med 25 ml solvens til Savene.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter rekonstitution og fortynding.