natgillin/translations-raw huggingface dataset:
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.
Kliniske undersøgelser vedrørende GIST Der er udført en åben, randomiseret, ikke- kontrolleret, multinational fase II- undersøgelse med patienter med inoperable eller metastaserende maligne gastrointestinale bindevævstumorer (GIST).
Clinical studies in GIST One phase II, open-label, randomised, uncontrolled multinational study was conducted in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST).
Disse patienter var i aldersgruppen 18– 83 år og havde en patologisk diagnose af Kit- positiv malignt GIST, der var inoperabelt og/ eller metastaserende.
These patients ranged in age from 18 to 83 years old and had a pathologic diagnosis of Kit-positive malignant GIST that was unresectable and/ or metastatic.
Der udførtes rutinemæssigt immunohistokemi med Kit antistof (A- 4502, polyklonalt kaninserum, 1: 100; DAKO Corporation, Carpinteria, CA) i overensstemmelse med analyse ved avidin- biotin - peroxidasekompleksmetode efter antigengenfinding.
Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Tumorer skulle være målelige i mindst et sygdomsområde og responskarakterisering baseret på SWOG- kriterier (Southwestern Oncology Group).
Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Bedste tumorrespons i undersøgelse STIB2222 (GIST)
Best tumour response in trial STIB2222 (GIST)
Alle doser (n=147) 400 mg (n=73) 600 mg (n=74)
All doses (n=147) 400 mg (n=73) 600 mg (n=74)
Bedste respons Komplet respons
Best response Complete response
Partielt respons Stabil sygdom Progressiv sygdom Kan ikke vurderes Ukendt
Partial response Stable disease Progressive disease Not evaluable Unknown
En betydelig gruppe patienter, som havde stabil sygdom ved interimsanalysen opnåede delvist respons med længere behandling (median opfølgningstid på 31 måneder).
patients who had stable disease at the time of the interim analysis achieved a partial response with longer treatment (median follow-up 31 months).
Median tid til respons var 13 uger (95% konfidensinterval 12- 23).
12– 23).
Median tid til svigtende behandling hos respondenter var 122 uger (95% konfidensinterval 106- 147), mens i den overordnede studiepopulation var 84 uger (95% konfidensinterval 71- 109).
Median time to treatment failure in responders was 122 weeks (95% C. I 106– 147), while in the overall study population it was 84 weeks (95% C. I 71– 109).
Kaplan- Meier estimatet for overlevelse efter 36 måneders opfølgning er 68%.
The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
I to kliniske undersøgelser (studie B2222 og et mellemgruppe studie S0033) blev den daglige dosis optrappet til 800 mg hos patienter, hvis sygdom fremskrider ved de lavere daglige doser på 400 mg eller 600 mg.
20 In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
20 Kliniske studier ved DFSP Der er udført et åbent multicenter fase II- klinisk forsøg (studie B2225) med inklusion af 12 patienter med DFSP, som blev behandlet med Glivec 800 mg daglig.
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
Tre af de partielt responderende blev sygdomsfrihed efter kirurgi.
Three of the partial responders were subsequently rendered disease free by surgery.
Den mediane varighed af behandlingen i studie B2225 var 6, 2 måneder med en maksimum varighed på 24, 3 måneder.
The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Den pædiatriske patient blev behandlet med 400 mg/ m2/ dag efterfølgende øget til 520 mg/ m2/ dag.
The paediatric patient received 400 mg/ m2/ daily, subsequently increased to 520 mg/ m2/ daily.
Translokationen t( 17: 22) [(q22: q13)], eller dets gen- produkt, var til stede i næsten alle respons på Glivec behandling.
The translocation t(17:22)[(q22: q13)], or its gene product, was present in nearly all responders to Glivec treatment.
25– 1. 000 mg.
Pharmacokinetics of Glivec The pharmacokinetics of Glivec have been evaluated over a dosage range of 25 to 1,000 mg.
Den gennemsnitlige absolutte biotilgængelighed for kapselformuleringen er 98%.
Absorption Mean absolute bioavailability for the capsule formulation is 98%.
Når imatinib indtages i forbindelse med et måltid med høj fedtprocent, reduceres absorptionen af imatinib minimalt (11% ’ s fald i Cmax og forlængelse af tmax med 1, 5 time), med et lille fald i AUC (7, 4%) sammenlignet med fastende.
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
95% til plasmaproteiner, hovedsagelig albumin og alfa- syre- glycoprotein, med en mindre binding til lipoproteiner.
Distribution 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.
Den cirkulerende hovedmetabolit i mennesker er N- demethyl- piperazinderivatet, som udviser samme potens in vitro som det stof, den er afledt af.
Metabolism The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Plasmaproteinbindingen af den N- demethylerede metabolit er sammenlignlig med den for hovedkomponenten.
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
65% af den cirkulerende radioaktivitet (AUC( 0- 48t)).
Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
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.
Imatinib blev in vitro vist at være en kompetitiv hæmmer af markørsubstrater for CYP2C9, CYP2D6 og CYP3A4/ 5.
21 Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/ 5.
Ki værdier i humane levermikrosomer var henholdsvis 27; 7, 5 og 7, 9 µmol/ l.
Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/ l, respectively.
Maksimale plasmakoncentrationer af imatinib er hos patienter 2– 4 µmol/ l, og hæmning af CYP2D6 og/ eller CYP3A4/ 5- medieret metabolisme af samtidigt administrerede lægemidler er derfor mulig.
Maximal plasma concentrations of imatinib in patients are 2– 4 µmol/ l, consequently an inhibition of CYP2D6 and/ or CYP3A4/ 5-mediated metabolism of co-administered drugs is possible.
Denne Ki værdi
Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 µM).
21 er langt højere end de forventede plasmaniveauer af imatinib hos patienter, og der forventes derfor ingen interaktion i forbindelse med samtidig administration af hverken 5- fluorouracil eller paclitaxel og imatinib.
This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon co- administration of either 5-fluorouracil or paclitaxel and imatinib.
81% af dosis inden for 7 dage i fæces (68% af dosis) og urin (13% af dosis).
Elimination Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
25% af dosis (5% urin og 20% fæces), resten er metabolitter.
Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
18 timer, hvilket indikerer, at dosering 1 gang daglig er passende.
Plasma pharmacokinetics Following oral administration in healthy volunteers, the t½ was approximately 18 h, suggesting that once-daily dosing is appropriate.
Øgningen i gennemsnitlig AUC ved dosisøgning efter oral administration var lineær og dosisproportional i intervallet 25– 1. 000 mg imatinib.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25– 1,000 mg imatinib after oral administration.
Der var ingen ændringer i imatinibs kinetik ved gentagen dosering, og akkumulering var 1, 5– 2, 5 gange ved steady- state ved dosering 1 gang daglig.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5– 2.5-fold at steady state when dosed once daily.
Hos GIST- patienter var optagelsen ved steady- state 1, 5 gange højere end den observeret hos CML - patienter ved samme dosis (400 mg daglig).
Pharmacokinetics in GIST patients In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
Ved præliminær populationsfarmakokinetikanalyse hos GIST- patienter fandtes 3 variable (albumin, leukocytter og bilirubin) at have statistisk signifikant indflydelse på imatinibs farmakokinetik.
Based on preliminary population pharmacokinetic analysis in GIST patients, there were three variables (albumin, WBC and bilirubin) found to have a statistically significant relationship with imatinib pharmacokinetics.
Fald i albuminværdier forårsagede nedsat clearance (CL/ f); og stigninger i leukocyttal forårsagede fald i Cl/ f.
Decreased values of albumin caused a reduced clearance (CL/ f); and higher levels of WBC led to a reduction of CL/ f.
Populationsfarmakokinetiske analyser hos CML- patienter har vist, at alder har en lille effekt på fordelingsvolumen (12% stigning hos patienter > 65 år).
Population pharmacokinetics Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12% increase in patients > 65 years old).
Kropsvægtens betydning for clearance af imatinib er således, at for patienter, der vejer 50 kg, forventes den gennemsnitlige clearance at være 8, 5 l/ t, mens den for patienter, der vejer 100 kg, vil stige til 11, 8 l/ t.
The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/ h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/ h.
Køn har ingen betydning for imatinib’ s kinetik.
There is no effect of gender on the kinetics of imatinib.
Ligesom hos voksne absorberedes imatinib hurtigt hos pædiatriske patienter efter oral administration i både fase I - og fase II- undersøgelser.
Pharmacokinetics in children As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Doser på 260 og 340 mg/ m2/ dag til børn gav samme optagelse som doser på henholdsvis 400 mg og 600 mg til voksne.
Dosing in children at 260 and 340 mg/ m2/ day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Sammenligningen af AUC( 0- 24) på dag 8 og dag 1 ved 340 mg/ m2/ dag dosisniveauet viste en 1, 7 gang højere lægemiddelakkumulering efter gentagen dosering, én gang daglig.
The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/ m2/ day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
Imatinib og dets metabolitter udskilles kun i ubetydelig grad via nyrerne.
Organ function impairment Imatinib and its metabolites are not excreted via the kidney to a significant extent.
1, 5 - til 2 - fold, svarende til en 1, 5- gangs stigning af plasma AGP som imatinib binder stærkt til.
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
4. 2 og 4. 4).
The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
4. 2, 4. 4 og 4. 8).
Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
5. 3 Prækliniske sikkerhedsdata
22 5.3 Preclinical safety data
22 Toksicitetsundersøgelser med gentagen dosering viste milde til moderate hæmatologiske forandringer hos rotter, hunde og aber, ledsaget af knoglemarvsændringer hos rotter og hunde.
Multiple dose toxicity studies revealed mild to moderate haematological changes in rats, dogs and monkeys, accompanied by bone marrow changes in rats and dogs.
Der sås milde til moderate stigninger i transaminaser og lette stigninger i kolesterol, triglycerider, totale protein - og albuminniveauer hos begge dyrearter.
Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Der sås forhøjet se- carbamid og se- creatinin hos adskillige af disse dyr.
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
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.
Der sås øget incidens af opportunistiske infektioner ved kronisk imatinib- behandling.
An increased rate of opportunistic infections was observed with chronic imatinib treatment.
Der fandtes i en 39- ugers undersøgelse med aber ingen NOAEL (no observed adverse effect level/ niveau ved ingen observeret bivirkningseffekt) ved den laveste dosis på 15 mg/ kg, ca.
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/ kg, approximately one-third the maximum human dose of 800 mg based on body surface.
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.
Dette sås ikke ved doser ≤20 mg/ kg.
This was not seen at doses ≤ 20 mg/ kg.
Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser > 30 mg/ kg.
A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/ kg.
Ved en dosis på 60 mg/ kg, havde hunrotterne et signifikant føtaltab efter implantation og et reduceret antal levende fostre.
At a dose of 60 mg/ kg, female rats had significant post- implantation foetal loss and a reduced number of live foetuses.
I et oralt præ - og postnatalt udviklingsstudie med rotter sås rødt, vaginalt udflåd i gruppen med 45 mg/ kg/ dag på enten dag 14 eller dag 15 efter gestation.
In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/ kg/ day group on either day 14 or day 15 of gestation.
F1 fertilitet var ikke påvirket, mens der sås et øget antal resorptioner og et nedsat antal levende fostre ved 45 mg/ kg/ dag.
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/ kg/ day.
Niveauet for ingen observeret effekt (NOEL) var 15 mg/ kg/ dag for både moderdyr og F1 generation (en ¼ af den maksimale humane dosis på 800 mg).
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/ kg/ day (one quarter of the maximum human dose of 800 mg).
Imatinib var teratogent hos rotter ved administration under organgenese ved doser ≥100 mg/ kg, ca. svarende til den maksimale kliniske dosis på 800 mg/ dag, baseret på legemsoverfladeareal.
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/ kg, approximately equal to the maximum clinical dose of 800 mg/ day, based on body surface area.
Teratogene virkninger inkluderede exencephali eller encephalocele, manglende/ reducerede frontale knogler og manglende parietalknogler.
Teratogenic effects included exencephaly or encephalocele, absent/ reduced frontal and absent parietal bones.
Disse virkninger sås ikke ved doser ≤30 mg/ kg.
These effects were not seen at doses ≤ 30 mg/ kg.
I et 2- års carcinogen studie i rotter resulterede administration af imatinib på 15, 30 og 60 mg/ kg/ dag i en signifikant reduktion i levetiden ved 60 mg/ kg/ dag for hanner og for hunner ved ≥30 mg/ kg/ dag.
23 In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/ kg/ day resulted in a statistically significant reduction in the longevity of males at 60 mg/ kg/ day and females at ≥ 30 mg/ kg/ day.
Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, bisskjoldbruskkirtlerne, binyrererne og den ikke - kirtellignende del af maven.
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non- glandular stomach.
Dette svarer til 0, 4 gange den daglige eksponering (baseret på AUC) hos børn på 340 mg/ m2/ 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.
Niveauet for ingen observeret effekt (NOEL) var 15 mg/ kg/ dag.
The no observed effect level (NOEL) was 15 mg/ kg/ day.
1, 7 eller 1 gang den humane daglige eksponering (baseret på AUC) på henholdsvis 400 mg/ dag eller 800 mg/ dag, og 1, 2 gange den daglige eksponering hos børn (baseret på AUC) på 340 mg/ m2/ dag.
The renal adenoma/ carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/ carcinomas were noted at 60 mg/ kg/ day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/ day or 800 mg/ day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/ m2/ day.
Niveauet for ingen observeret effekt (NOEL) var 30 mg/ kg/ dag.
The no observed effect level (NOEL) was 30 mg/ kg/ day.
Non- neoplastisk skade, som ikke er identificeret ved tidligere prækliniske studier, er i det kardiovaskulære system, pankreas, endokrine organer og tænder.
Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Den vigtigste ændring er hjertehypertrofi og dilation, som i nogle dyr kan føre til tegn på hjertesvigt.
The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.
Cellulose, mikrokrystallinsk Crospovidon Magnesiumstearat Silica, kolloid vandfri
Cellulose microcrystalline Crospovidone Magnesium stearate Silica colloidal, anhydrous
Gelatine Jernoxid, gul (E 172) Titandioxid (E 171)
Gelatin Iron oxide, yellow (E172) Titanium dioxide (E171)
Jernoxid, rød (E 172) Shellac Sojalecithin
Iron oxide, red (E172) Shellac Soya lecithin
6. 4 Særlige opbevaringsforhold
24 6.4 Special precautions for storage
PVC/ aluminium blister.
PVC/ aluminium blisters
Pakninger indeholdende 30 kapsler.
Packs containing 30 capsules.
24 6. 6 Regler for destruktion
6.6 Special precautions for disposal
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB STORBRITANNIEN
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB UNITED KINGDOM
07. 11. 2001 Dato for første fornyelse af tilladelsen:
07.11.2001 Date of first renewal:
Hvidt/ gult pulver i en orange/ grålig orange, uigennemsigtig kapsel, præget med ” NVR SI ”.
White to yellow powder in an orange to greyish-orange opaque capsule, marked “ NVR SI”.
26 hæmatologiske lidelser og/ eller maligne sarkomer eller som passende.
26 haematological malignancies and malignant sarcomas, as appropriate.
27 Behandlingsskema:
27 Treatment schedule:
I kliniske undersøgelser med GIST- patienter blev behandling med Glivec fortsat indtil sygdomsprogression.
In clinical trials in GIST patients, treatment with Glivec was continued until disease progression.
I tilfælde af svær neutropeni og thrombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
Haematological adverse reactions Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are 28 recommended as indicated in the table below.
30 derfor undgås (se pkt.
30 John’ s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter i Glivec- behandling.
31 recommended in section 4.2.
31 (AGP), et imatinib- bindende protein, hos disse patienter.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
32 Der er klinisk erfaring med administration af Glivec sammen med kemoterapi til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret.
In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
De mest almindelige rapporterede lægemiddelrelaterede bivirkninger var i begge patientgrupper: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt.
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Når imatinib blev kombineret med højdosis kemoterapi hos Ph+ ALL patienter, sås forbigående levertoksicitet i form af forhøjet transaminase og hyperbilirubinæmi.
33 When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Disse tilfælde blev
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “ fluid retention”.