natgillin/translations-raw huggingface dataset:
Leukocyt-aktiveringssyndrom (APL-differentieringssyndrom) 27 % af patienter med recidiverende/refraktær APL, behandlet med arsentrioxid, har oplevet symptomer svarende til et syndrom, der kaldes retinoinsyre-APL (RA-APL) eller APLdifferentieringssyndrom, kendetegnet ved feber, dyspnø, øget vægt, lungeinfiltrater og pleura- eller perikardie-effusioner, med eller uden leukocytose. 
Leukocyte activation syndrome (APL differentiation syndrome) 27 % of patients with APL, in the relapsed/refractory setting, treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis.
Arsentrioxid skal indgives intravenøst 5 dage om ugen i en dosis på 0,15 mg/kg/dag, efterfulgt af 2 dages pause, gentaget for 5 uger, i alt 25 doser. 
Arsenic trioxide is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Risikoen for Torsade de pointes er relateret til sværhedsgraden af QT-forlængelsen, samtidig indgift af QT-forlængende lægemidler, Torsade de pointes i anamnesen, allerede eksisterende QT-intervalforlængelse, kongestiv hjertestop, indgift af kaliumsænkende diuretika, eller andre konditioner, som resulterer i hypokaliæmi eller hypomagnesiæmi. 
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Hos nydiagnosticerede patienter med lav til intermediær risiko APL udviklede 35 ud af 74 patienter (47 %) leukocytose under induktionsbehandlingen (se pkt. 
In newly diagnosed patients with low to intermediate risk APL leukocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Almindelig: (kan forekomme hos op til 1 ud af 10 personer) - nedsat antal blodceller (blodplader, røde og/eller hvide blodlegemer), øget antal hvide blodlegemer, - kulderystelser, vægtstigning, - feber på grund af infektion og lavt antal hvide blodlegemer, herpes zoster-infektion, - smerter i brystet, blødning i lungerne, hypoksi (lavt iltniveau), væskeansamling omkring hjertet eller lungerne, lavt blodtryk, unormal hjerterytme (hjerteslag), - krampeanfald, led- eller knoglesmerter, årebetændelse, - forhøjet natrium eller magnesium, ketoner i blod og urin (ketoacidose), unormale prøver for nyrefunktion, nyresvigt, - mavesmerter, - hudrødme, opsvulmet ansigt, sløret syn 
Common (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Mænd skal bruge sikker prævention under behandlingen med Arsenic trioxide Accord. 
Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Brug ikke Arsenic trioxide Accord 
Do not use Arsenic trioxide Accord
Efter fortynding i intravenøse opløsninger er Arsenic trioxide Accords kemiske og fysiske stabilitet efter anbrud dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C. 
After dilution in intravenous solutions, Arsenic trioxide Accord is chemically and physically stable for 24 hours at 25°C and 48 hours at refrigerated (2-8°C) temperatures.
Da der ikke foreligger data for alle grupper med nedsat nyrefunktion, tilrådes forsigtighed ved brug af arsentrioxid hos patienter med nedsat nyrefunktion. 
Since no data are available across all renal impairment groups, caution is advised in the use of Arsenic trioxide in patients with renal impairment.
Kvinder i den fertile alder og mænd skal anvende sikker prævention under behandling med arsentrioxid. 
Women of childbearing potential and men must use effective contraception during treatment with arsenic trioxide.
på dag 2, 4, 6 og 8 og ATRA 45 mg/m2 oralt dagligt indtil CR. Under konsolidering fik patienterne idarubicin 5 mg/m2 på dag 1 til 4 og ATRA 45 mg/m2 dagligt i 15 dage, og dernæst mitoxantron 0 mg/m2 i.v. 
Patients in the ATRA+chemotherapy treatment group received iv idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then iv mitoxantrone at 10 mg/m2 on days 1 to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
Meget almindelig: (kan forekomme hos mere end 1 ud af 10 personer) - træthed (mathed), smerter, feber, hovedpine - kvalme, opkastning, diarré, - svimmelhed, muskelsmerter, følelsesløshed eller snurrende fornemmelser i huden, - udslæt eller kløe, - øget blodsukker, ødemer (hævelse som følge af væskeophobning), - kortåndethed, hurtig hjerterytme (puls), unormalt hjertediagram (ekg), - nedsat indhold af kalium eller magnesium i blodet, unormale prøver for leverfunktion inklusive forhøjet indhold af bilirubin eller gammaglutamyltransferase i blodet. 
Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Arsenic trioxide Accord er et koncentrat til infusionsvæske, opløsning. 
Arsenic trioxide Accord is a concentrate for solution for infusion.
Recidiverende/refraktær akut promyelocyt-leukæmi (APL) Induktionsbehandling 
Relapsed/refractory acute promyelocytic leukaemia (APL)
Holdbarhed efter fortynding: Kemisk og fysisk stabilitet efter anbrud er dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C. 
Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Aseptisk teknik skal nøje overholdes under hele håndteringen af Arsenic trioxide Accord, da det ikke indeholder konserveringsmiddel. 
Preparation of Arsenic trioxide Accord Aseptic technique must be strictly observed throughout handling of Arsenic trioxide Accord since no preservative is present.
Arsentrioxid i Arsenic trioxide Accord udskilles i mælken. 
The arsenic in Arsenic trioxide Accord passes into breast milk.
Arsenic trioxide Accord indeholder natrium 
Arsenic trioxide Accord contains sodium
(kreatininclearance 50-80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/min). 
Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/min) or moderate renal impairment (creatinine clearance of 30-49 mL/min).
Pakningsstørrelser og yderligere oplysninger Arsenic trioxide Accord indeholder: 
Contents of the pack and other information What Arsenic trioxide Accord contains
Tid til knoglemarvsremission (median) 
Time to bone marrow remission (median)
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
- vejrtrækningsbesvær - feber - pludselig vægtstigning - ophobning af væske (f.eks. hævede hænder og fødder) - besvimelse - kraftig hjertebanken. 
- fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Hvis du er i den fødedygtige alder, skal du bruge sikker prævention under behandlingen med Arsenic trioxide Accord. 
If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Accord.
Arsentrioxid skal indgives intravenøst 5 dage om ugen i en dosis på 0,15 mg/kg/dag. 
Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Cytogenetik efter arsentrioxid-behandling 
Cytogenetics after arsenic trioxide therapy
Patienter i det første studie fik en gennemsnitlig dosis arsentrioxid på 0,16 mg/kg/dag (interval 0,06 til 0,20 mg/kg/dag), og patienter i multicenterstudiet fik en fast dosis på 0,15 mg/kg/dag. 
Patients in the first study received a median dose of 0.16 mg/kg/day of arsenic trioxide (range 0.06
Der er ikke gennemført fertilitetsstudier med arsentrioxid. 
Fertility studies have not been conducted with arsenic trioxide.
Behandling med arsentrioxid er blevet sammenkædet med udvikling af hyperleukocytose (≥10 x 103/µl) hos nogle patienter med recidiverende/refraktær APL. Der syntes ikke at være nogen forbindelse mellem baseline-antallet af hvide blodlegemer (WBC) og udviklingen af hyperleukocytose, ligesom der ikke syntes at være en korrelation imellem baseline WBC-tal og topWBC-tal. 
There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleukocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Hos nydiagnosticerede patienter med lav til intermediær risiko APL udviklede 63,2 % grad 3 eller 4 levertoksicitet under induktions- eller konsolideringsbehandlingen med arsentrioxid i kombination med ATRA. 
In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA.
Da der ikke foreligger data for alle grupper med nedsat leverfunktion, og da hepatotoksiske virkninger kan forekomme under behandlingen med arsentrioxid, tilrådes forsigtighed ved brug af arsentrioxid hos patienter med nedsat leverfunktion (se pkt. 
Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with Arsenic trioxide, caution is advised in the use of Arsenic trioxide in patients with hepatic impairment (see section 4.4 and 4.8).
• cisaprid (medicin som bruges til at lindre visse maveproblemer) Disse lægemidlers virkning på din hjerterytme kan forværres af Arsenic trioxide Accord. 
The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord.
Patienter med signifikant arytmi, ekg-anomali (medfødt langt QT-syndrom, tidligere eller aktuel signifikant ventrikulær eller atrial takyarytmi, klinisk signifikant bradykardi i hvile (<50 slag/minut), QTc > 450 msek. 
Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Fertilitet Der er ikke udført kliniske eller prækliniske fertilitetsstudier med arsentrioxid. 
No clinical or non-clinical fertility studies have been conducted with arsenic trioxide.
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller for nylig har taget anden medicin. 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• visse typer medicin til behandling af allergier, f.eks. høfeber (antihistaminer, f.eks. 
• some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
Arsentrioxid skal indgives intravenøst over 1-2 timer. 
Arsenic trioxide must be administered intravenously over 1-2 hours.
Indlægsseddel: Information til patienten Arsenic trioxide Accord 1 mg/ml, koncentrat til infusionsvæske, opløsning arsentrioxid 
Package leaflet: Information for the user Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Hvis din læge giver dig for meget Arsenic trioxide Accord 
If your doctor gives you more Arsenic trioxide Accord than he/she should
1 hætteglas med 10 ml indeholder 10 mg arsentrioxid. 
One vial of 10 ml contains 10 mg of arsenic trioxide.
1 ml indeholder 1 mg arsentrioxid 
One ml contains 1 mg of arsenic trioxide.
Ikke kendt* *I CALGB-studiet C9710 blev der rapporteret 2 tilfælde af CGT-forhøjelse, grad ≥3 blandt de 200 patienter, som fik arsentrioxid konsolideringscyklusser (cyklus 1 og cyklus 2), versus ingen i kontrolgruppen. 
*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
De pentavalente metabolitter, MMAV og DMAV optræder langsomt i plasma (cirka 10-24 timer efter første administration af arsentrioxid), men på grund af deres længere halveringstid, akkumuleres de mere ved gentagen dosering end AsIII. 
hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Arsentrioxid er indiceret til induktion af remission og konsolidering hos voksne patienter med: - nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL) (antal hvide blodlegemer ≤ 10 x 103/µl) i kombination med all-trans-retinoinsyre (ATRA) - recidiverende/refraktær akut promyelocyt-leukæmi (APL) (den tidligere behandling skal have omfattet et retinoid samt kemoterapi) kendetegnet ved tilstedeværelse af t(15;17) translokationen og/eller tilstedeværelse af genet promyelocyt leukæmi/retinoinsyrereceptor-alfa (PML/RAR-alfa). 
• Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
I et non-inferioritets fase 3-multicenterstudie, der sammenlignede all-trans-retinoinsyre (ATRA) plus kemoterapi med ATRA plus arsentrioxid hos nydiagnosticerede patienter med lav til intermediær risiko APL (studie APL0406; se også pkt. 
In a phase 3, multicenter, noninferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
f.eks. kinidin, amiodaron, sotalol, dofetilid) 
• some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
1 ml koncentrat til infusionsvæske, opløsning indeholder 1 mg arsentrioxid. 
One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
Anvendelse af Arsenic trioxide Accord 
Use of Arsenic trioxide Accord
QTc-forlængelse blev observeret mellem 1 og 5 uger efter arsentrioxid-infusionen og vendte derefter tilbage til baseline efter 8 uger efter arsentrioxid-infusionen. 
In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion.
Behandling med arsentrioxid skal altid afbrydes før behandlingens planlagte afslutning, hvis der observeres hepatotoksicitet af grad 3 eller derover iht. 
Treatment with arsenic trioxide must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Arsenic trioxide Accord 1 mg/ml koncentrat til infusionsvæske, opløsning 
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Du må ikke få Arsenic trioxide Accord, hvis du er gravid, da det kan skade fosteret. 
Arsenic trioxide Accord may cause harm to the foetus when used by pregnant women.
Arsenic trioxide Accord 1 mg/ml koncentrat til infusionsvæske, opløsning arsentrioxid 
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Det skal du vide, før du begynder at bruge Arsenic trioxide Accord Sådan skal du bruge Arsenic trioxide Accord Bivirkninger 
What Arsenic trioxide Accord is and what it is used for What you need to know before you use Arsenic trioxide Accord How to use Arsenic trioxide Accord Possible side effects
Fortynding: Før forsigtigt kanylen på en injektionssprøjte ind i hætteglasset via gummiproppen og træk alt indholdet op. Arsenic trioxide Accord skal derefter straks fortyndes med 100 til 250 ml 50 mg/ml (5 %) glucose injektionsvæske, opløsning, eller 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning. 
Arsenic trioxide Accord must then be diluted immediately with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection.
Fortynding af Arsenic trioxide Accord 
Dilution of Arsenic trioxide Accord
Patienter i ATRA+arsentrioxid-gruppen fik ATRA 45 mg/m2 
Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR.
Stoffer, der er substrater for disse CYP-enzymer, 
Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide.
Derefter kan arsentrioxid genoptages ved den fulde dosering, hvis den tidligere toksicitet ikke forværres. 
Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Hvis din sygdom reagerer positivt på Arsenic trioxide Accord, vil du få endnu et behandlingsforløb med 25 doser. 
If your disease responds to Arsenic trioxide Accord, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
- Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide. 
- If you have further questions, please ask your doctor or your pharmacist or nurse.
QT-forlængelse i elektrokardiogram Meget almindelig Almindelig Hyperbilirubinæmi 
Electrocardiogram QT prolonged
Psykiske forstyrrelse 
Psychiatric disorders
Sådan skal du bruge Arsenic trioxide Accord Behandlingens varighed, og hvor tit du skal have Arsenic trioxide Accord 
How to use Arsenic trioxide Accord Duration and frequency of treatment
Der tilrådes forsigtighed, når arsentrioxid administreres sammen med andre lægemidler, der vides at forårsage hepatotoksiske virkninger (se pkt. 
Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Du vil få en dosis 5 dage om ugen (efterfulgt af en pause på 2 dage) i 4 uger efterfulgt af 4 ugers behandlingspause. 
If your disease responds to Arsenic trioxide Accord, you will be given 4 additional treatment cycles of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption.
Brug af anden medicin sammen med Arsenic trioxide Accord 
Other medicines and Arsenic trioxide Accord
Behandlingen med arsentrioxid skal afbrydes midlertidigt før behandlingens planlagte afslutning, hvis der observeres en toksicitetsgrad på 3 eller derover iht. 
Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to Arsenic trioxide treatment.
Hos nydiagnosticerede patienter med lav til intermediær risiko APL opstod der gastrointestinal toksicitet, grad 3-4 neutropeni og grad 3 eller 4 trombocytopeni. 
In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with arsenic trioxide in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Efter anbrud Lægemidlet skal anvendes straks efter anbrud. 
After first opening Once opened the product should be used immediately.
• visse typer antiarytmika (medicin, som bruges til at korrigere uregelmæssig hjerterytme, 
• cisapride (a medicine used to relieve certain stomach problems).
LISTE OVER HJÆLPESTOFFER 
Induction treatment schedule
Bivirkningerne, der er listet i Tabel 2 nedenfor i henhold til anbefalede termer efter MedDRA-systemorganklasse oghyppighed, blev observeret i kliniske studier af arsentrioxid hos 52 patienter med behandlingsresistent/recidiverende APL. Bivirkningsfrekvenserne defineres som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
Hyperleukocytose 
Hyperbilirubinaemia
Myelosuppression er derfor almindelig. 
Myelosuppression is thus common.
Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart. 
From a microbiological point of view the product should be used immediately.
Denne hændelse kaldes ekstravasation. 
This event is called extravasation.
Systemorgan- klasser (SOC) 
System Organ Classes (SOC)
• Infektion (efter en operation eller andre infektioner) 
• Infection (after an operation or other infections)
I begge studier var doseringsregimet det samme. 
In both studies the dosage regimen was the same.
Infusionen tager 1-2 timer. 
The infusion will last 1-2 hours.
Pulver og solvens: 3 år. 
Powder and solvent: 3 years.
Det er vigtigt, at De læser hele indholdet i denne procedure inden tilberedning af Savene. 
It is important that you read the entire content of this procedure prior to the preparation of Savene.
FORBEREDELSE TIL INTRAVENØS ADMINISTRATION 
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Total kalcium (Hypo) 
Calcium Total (Hypo)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/06/350/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/06/350/001
CTC grad 3-4 
CTC grade 3-4
Alle bivirkninger er hurtigt reversible. 
All adverse reactions have been rapidly reversible.
Begge disse effekter kan forventes i denne stofklasse. 
Both of these effects are expected for this class of compound.
Inter- og intraindividuel farmakokinetisk variabilitet er ikke blevet undersøgt systematisk. 
Inter- and intra-individual pharmacokinetic variabilities have not been studied systematically.
Toksiciteten i kombination med doxorubicin var additiv og ikke synergistisk. 
The toxicity in combination with doxorubicin was additive and not synergistic.
Behandlingen med Savene skulle påbegyndes inden for 6 timer efter hændelsen og blev gentaget efter 24 og 48 timer. 
Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours.
Monitorering Lokale undersøgelser skal foretages regelmæssigt efter behandlingen indtil resolution. 
Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution.
Den tilsyneladende effekt var større ved kronisk end ved akut administration. 
The apparent effects were greater during chronic than acute administration.