natgillin/translations-raw huggingface dataset:
Fordeling Baseret på in vitro undersøgelser, bindes, ved kliniske relevante koncentrationer af imatinib, ca. 95 % til plasmaproteiner, hovedsagelig albumin og alfa-syre-glycoprotein, med en mindre binding til lipoproteiner. 
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Pruritus, ansigtsødem, tør hud, erythem, alopeci, natlig svedtendens, lysoverfølsomhedsreaktion 
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Imatinib kan øge plasmakoncentrationen af andre CYP3A4-metaboliserede lægemidler (for eksempel triazol-benzodiazepiner, dihydropyridin-calciumantagonister, visse HMG-CoA reduktasehæmmere, såsom statiner osv.). 
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Pakninger indeholdende 24, 48, 60, 96, 120 eller 180 kapsler. 
Pack containing either 24, 48, 60, 96, 120 or 180 capsules
- Hvis du ikke er i stand til at synke kapslerne, kan du åbne dem og opløse pulveret i et glas almindeligt vand eller æblejuice. 
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
- Muskelsvaghed, kramper og en unormal hjerterytme (tegn på ændringer i mængden af kalium i dit blod). 
- Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
(1 time), dag 2831, 35-38, 42-45; 6-MP 60 mg/m2 oral, dag 26-46 
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
10 Muskuloskeletale smerter og relaterede hændelser blev observeret oftere hos patienter med CML end hos patienter med GIST. 
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Behandlingsskema: Eksisterende data har vist, at imatinib er effektiv og sikker ved administration af 600 mg/dag i kombination med kemoterapi i induktionsfasen, i konsoliderings- og vedligeholdelsesfaser af kemoterapi (se pkt. 
Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
Meget almindelige (kan forekomme hos flere end 1 af 10 brugere): - Hovedpine eller følelse af træthed. 
Very common (may affect more than 1 in 10 people): - Headache or feeling tired.
Hyperkaliæmi, hypomagnesiæmi 
Hyperkalaemia, hypomagnesaemia
Hver filmovertrukken tablet indeholder 0,19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat). 
Each film-coated tablet contains 0.19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med GIST. 
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
4 Flushing var almindeligst host patienter med GIST, og blødning (hæmatom og blødning) var almindeligst hos patienter med GIST og med transformeret CML (CML-AP og CML-BC). 
4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Farmakokinetik hos den pædiatriske population 
Pharmacokinetics in paediatric population
- Føle sig svimmel eller besvime (tegn på lavt blodtryk). 
- Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Ved doser >6 mg/kg, sås hos rotter i 13-ugers undersøgelsen hyperplasi af det transitoriske epithel i nyrepapillerne og i urinblæren, uden ændringer i serum- eller urinparametre. 
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Pleuraekssudat5, faryngolaryngeale smerter, pharyngitis 
Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Disse patienter fik imatinib i en periode varierende mellem 24 dage og 60 måneder (median 47 måneder). 
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
- Bækkensmerter, nogle gange med kvalme og opkastninger med uventet vaginalblødning, føle sig svimmel eller besvime pga. nedsat blodtryk (tegn på problemer med dine æggestokke eller livmoder). 
- Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med imatinib i alle undergrupper af den pædiatriske population med Philadelphiakromosom (bcr-abl translokation)-positiv kronisk myeloid leukæmi (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Derudover er der efter markedsføring rapporteret gastric antral vascular ecstasia (GAVE), en sjælden form for gastrointestinal blødning, hos patienter med CML, ALL og andre sygdomme (se pkt. 
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).
2 Hovedpine var almindeligst hos GIST-patienter. 
2 Headache was the most common in GIST patients.
Børn med CML i accelereret fase og blastkrise (startdosis 340 mg/m2) 
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Patienter, der ikke er i stand til at synke de filmovertrukne tabletter, kan dispergere tabletterne i et glas almindeligt vand eller æblejuice. 
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Der sås positiv genotoksisk effekt med imatinib i en in vitro pattedyrscelleundersøgelse (kinesisk hamsterovarium) for clastogenicitet (kromosomafvigelser) ved metabolisk aktivering. 
Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation.
Behandlingen kan gives én gang daglig eller alternativt deles i to - én dosis om morgenen og én om aftenen. 
Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
(0,5 time), dag 7, 8, 14, 15; CP 500 mg/m2 i.v. 
(0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
- Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL). 
- Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
I en fertilitetsundersøgelse med hanrotter doseret i 70 dage før parring, sås nedsat testikel- og epididymisvægt samt reduceret antal bevægelige sædceller ved 60 mg/kg, ca. svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal. 
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Doser på 400 mg og 600 mg bør administreres 1 gang daglig, mens daglige doser på 800 mg bør administreres som 400 mg 2 gange daglig, én dosis om morgnen og én dosis om aftenen. 
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Børn med CML i kronisk fase (ved dosis 340 mg/m2) 
Paediatric chronic phase CML (at dose 340 mg/m2)
Hvis dosis tolereres, kan den øges ved manglede effekt (se pkt. 
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).
Der anbefales en dosering på 340 mg/m2 daglig til børn med CML i kronisk fase og i fremskredne faser (må ikke overskride en total dosering på 800 mg). 
The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Tabel 2 Respons hos voksne CML-patienter (studie) 
Table 2 Response in adult CML study
- Udslæt, rød hud med små blærer på læber, øjne, hud eller mund, afskallet hud, feber, hævede røde eller lilla hudområder, kløe, brændende fornemmelse, pustuløst udslæt (tegn på hudproblemer). 
- Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
I kliniske undersøgelser i CML blev der hos 2,4 % af nydiagnosticerede patienter, hos 4 % af patienterne i sen kronisk fase efter svigtende interferonbehandling, hos 4 % af patienterne i accelereret fase efter svigtende interferonbehandling og hos 5 % af patienterne i blastkrise efter svigtende interferonbehandling observeret seponering af undersøgelsesmedicinen på grund af lægemiddelrelaterede bivirkninger. 
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
- Kronisk nyresvigt. 
- Chronic renal failure.
Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg tablet med delekærv tilgængelig. 
For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Bedring blev rapportert for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/ mediastinale, muskuloskeletale/bindevævs/kar og gastroentestinale organsystemer. 
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 
10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Færre end 1 % af CML-patienterne fik seponeret behandlingen permanent på grund af abnormaliteter i levertal. 
Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients.
6 doser)iii: dag 2, 3, 16, og 17 
Days 2, 3, 16, and 17
En stor international, åben, ikke-kontrolleret fase II undersøgelse var udført med patienter med Philadelphia-kromosompositiv (Ph+) CML i blaskritisk fase af sygdommen. 
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Hvis noget af det ovenstående gælder for dig, skal du fortælle din læge det, før du tager Imatinib Actavis. 
If any of these apply to you, tell your doctor before taking Imatinib Actavis.
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i Bcr-Abl-positive cellelinier såvel som i friske leukæmiceller fra Philadelphia-kromosompositiv (Ph+) CML og hos patienter med akut lymfoblastisk leukæmi (ALL). 
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Pakninger indeholdende 10, 30, 60 eller 90 kapsler. 
Pack containing either 10, 30, 60, or 90 capsules.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, copovidon, crospovidon, natriumstearylfumarat, silica (vandskyende kolloid, kolloid vandfri), polyvinylalkohol, delvist hydroliseret, talcum, gul jernoxid (E172), titandioxid (E171), rød jernoxid (E172), lecithin (soya) (E322), xanthangummi (E415). 
- The other ingredients are cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
Trombotisk mikroangiopati 
Thrombotic microangiopathy
Der anbefales en dosis på 340 mg/m2 daglig til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides). 
The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Ara-C 1.000 mg/m2/12 timer i.v. 
Ara-C 1,000 mg/m2 /12 h i.v.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes både gastrointestinale og intra-tumorale blødninger (se pkt. 
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
Da dyreundersøgelser har vist reproduktionstoksicitet, og den potentielle risiko for humane fostre er ukendt, bør kvinder i den fødedygtige alder tilrådes at udvise forsigtighed ved åbning af kapsler og håndtering af indholdet, samt at undgå hud- og øjenkontakt eller inhalation (se pkt. 
Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Imatinib hæmmer også receptortyrosinkinaserne for trombocytafledte vækstfaktorer (PDGF), PDGF-R, og hæmmer PDGF-medierede cellulære signaler. 
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Nøje monitoring af leverfunktionen skal udføres i tilfælde, hvor imatinib kombineres med kemoterapiregimer, som også vides at være forbundet med leverdysfunktion (se pkt. 
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see sections 4.5 and 4.8).
Imatinib øger gennemsnitligt Cmax og AUC af simvastatin (et CYP3A4-substrat) henholdsvis 2 og 3,5 gange, hvilket indikerer, at imatinib hæmmer CYP3A4. 
Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Hver filmovertrukken tablet indeholder 0,75 mg lecithin (soya) (E322) Alle hjælpestoffer er anført under pkt. 
Each film-coated tablet contains 0.75 mg lecithin (soya) (E322) For the full list of excipients, see section 6.1.
Imatinib ansås ikke som værende genotoksisk i in vitro bakteriecelleundersøgelse (Ames test), i in vitro pattedyrscelleundersøgelse (muselymfom) samt i in vivo rottemikronukleusundersøgelse. 
Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Pakninger indeholdende 30 eller 90 kapsler. 
Pack containing either 30 or 90 capsules.
Recidiverendet/refraktær Ph+ ALL: Da imatinib blev brugt som enkeltstofbehandling ved recidiverende/refraktær Ph+ ALL var resultatet hos 53 ud af 411 evaluerbare patienter en hæmatologisk responsrate på 30% (9% komplet) og en væsentlig cytogenetisk responsrate på 23%. 
Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
(1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32 
(1 h) day 1; AraC 60 mg/m2 i.v., days 22-25, 29-32
Hvis dette gælder for dig, skal du fortælle din læge det, før du tager Imatinib Actavis. 
If this applies to you, tell your doctor without taking Imatinib Actavis.
Dosering ved Ph+ ALL hos børn Dosering hos børn bør baseres på legemsoverflade (mg/m2). 
Posology for Ph+ ALL in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
- voksne patienter med Ph+ ALL med tilbagefald eller refraktær sygdom som monoterapi. 
- adult patients with relapsed or refractory Ph+ ALL as monotherapy.
I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel: 
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Herpes zoster, herpes simplex, nasopharyngitis, pneumoni1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis 
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
- Du må ikke amme, mens du er i behandling med Imatinib Actavis. 
- Do not breast-feed during the treatment with Imatinib Actavis.
- voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) uden FIP1L1-PDGFR-omlejring. 
- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Hvornår og hvordan skal du tage Imatinib Actavis 
When and how to take Imatinib Actavis
10 hårde kapsler 30 hårde kapsler 60 hårde kapsler 90 hårde kapsler 
10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
- Vægtøgning. 
- Weight gain.
- voksne og børn med nydiagnosticeret Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi. 
- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Af en række potentielle samtidigt administrerede lægemidler (acetaminophen, acicolvir, allopurinol, amphotericin, cytarabin, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) viste kun erythromycin (IC50 50 µM) og fluconazol (IC50 118 μm) hæmning af imatinib-metabolismen i et omfang der kunne have klinisk betydning. 
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 µM) and fluconazole (IC50 118 µM) showed inhibition of imatinib metabolism which could have clinical relevance.
6.6 Særlige regler for bortskaffelse 
6.6 Special precautions for disposal
5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering. 
Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made.
Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 200 mg/m2. 
If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Pakningsstørrelser: Kapslerne findes i blisterpakninger af aluminium med 24, 48, 60, 96, 120 eller 180 kapsler. 
Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Methotrexat (20 mg/m2/uge, p.o.): dag 8, 15, 22, 29, 36, 43, 50 
Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Dosering ved CML hos pædiatrisk populasion Dosering til børn bør baseres på legemsoverfladeareal (mg/m2). 
Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
Dosisøgning fra 340 mg/m2 daglig til 570 mg/m2 daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn ved fravær af alvorlige bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni ved følgende omstændigheder: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås. 
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Tabletterne findes i blisterpakninger af aluminium med 10, 20, 30, 60, 90, 120 eller 180 filmovertrukne tabletter. 
The tablets are supplied in aluminium blister packs of 10, 20, 30, 60, 90, 120 or 180 film-coated tablets.
- Hvis du behandles for DSFP: 
- If you are being treated for DFSP:
Dosisøgninger fra 600 mg til maksimalt 800 mg (som 400 mg to gange dagligt) til patienter med blastkrise kan, hvis der ikke opstår svære bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni, overvejes i følgende tilfælde: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås. 
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér imatinib-behandlingen indtil ANC ≥ 1 x 109/l og trombocytter 109/l, og genoptag behandling med 200 mg/m2. 
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 200 mg/m2.
- Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL). 
- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 µM, Gy= Gray 
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Papillomaer/carcinomer i fedtkirtlerne på forhuden/klitoris blev set fra 30 mg/kg/dag og højere, som svarer til cirka 0,5 eller 0,3 gange den daglige humane eksponering (baseret på AUC) på henholdsvis 400 mg/dag eller 800 mg/dag. 
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.