natgillin/translations-raw huggingface dataset:
In vitro hæmmer imatinib O-glucuronidationen af paracetamol med en Ki-værdi på 58,5 mikromol/l.
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/L.
Meget almindelige (kan forekomme hos flere end 1 ud af 10 mennesker) eller almindelige (kan forekomme op til 1 ud af 10 mennesker): - Hurtig vægtøgning.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): - Rapid weight gain.
Imatinib givet i kombination med kemoterapi-induktion (se Tabel 3) resulterede i en komplet hæmatologisk responsrate på 93% (147 ud af 158 evaluerbare patienter), og i en væsentlig cytogenetisk responsrate på 90% (19 ud af 21 evaluerbare patienter).
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Denne kliniske effekt var efter 2 ugers behandling forbundet med en højere reduktion i bcr-abl transkriptionen hos de imatinibbehandlede patienter end i kemoterapiarmen (p=0,02).
This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Hvis der opstår stigninger i bilirubin >3 x IULN (institutional upper limit of normal) eller i levertransaminaser >5 x IULN, skal imatinib seponeres indtil bilirubinniveauerne er faldet til <1,5 x IULN og transaminaseniveauer til <2,5 x IULN.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Cellulose, mikrokrystallinsk Copovidon
Cellulose microcrystalline Copovidone
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST, oplevede 7 (5 %) af patienterne CTC grad 3-4: gastrointestinale blødninger (3 patienter), intra-tumorale blødninger (3 patienter) eller begge dele (1 patient).
In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
- Kraftig hovedpine, svækkelse eller lammelser af lemmer eller ansigt, talebesvær, pludseligt bevidsthedstab (tegn på problemer med nervesystemet såsom blødning eller hævelse i kranie/hjerne).
- Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Imatinibs sikkerhed og virkning hos børn under 18 år med MDS/MPD, DFSP og HES/CEL er ikke klarlagt i kliniske studier.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Der er begrænset erfaring hos børn og Ph-positiv ALL og meget begrænset erfaring med børn med MDS/MPD, DFSP og HES/CEL.
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Imatinib blev in vitro vist at være en kompetitiv hæmmer af markørsubstrater for CYP2C9, CYP2D6 og
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, protein-kinasehæmmer, ATC-kode: L01XE01
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Imatinibs effekt er hos voksne og børn er baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse ved CML, på hæmatologiske og cytogenetiske responsrater ved Ph+ ALL, MDS/MPD, på hæmatologiske responsrater ved HES/CEL, på objektive responsrater hos voksne med inoperabel og/eller metastaserende DFSP.
In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Histopatologiske undersøgelser af de afdøde rotter afslørede kardiomyopati (for begge køn), kronisk progressiv nefropati (hunkøn) og papillomaer på forhuden som hovedårsag til død eller begrundelse for aflivning.
Histopathological examination of decedents revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice.
Da imatinib blev givet som ”salvage therapy” til patienter, som ikke responderede eller som responderede dårligt på kemoterapi, opnåedes komplet hæmatologisk respons hos 9 (81,8%) ud af 11 patienter.
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
30 hårde kapsler 90 hårde kapsler
30 hard capsules 90 hard capsules
Bærere af HBV, hvor behandling med (Imatinib Actavis) er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
Carriers of HBV who require treatment with Imatinib Actavis should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Til doser på 400 mg og derover (se anbefalede doser ovenfor) er en 400 mg tablet (ikke delelig) tilgængelig.
For doses of 400 mg and above (see dosage recommendation above) a 400 mg tablet (not divisible) is available.
- Hævelse, som fx af anklerne eller omkring øjnene.
- Swelling such as round your ankles or puffy eyes.
Baseret på den poolede farmakokinetiske populationsanalyse hos børn med hæmatologiske sygdomme (CML, Ph+ ALL eller andre hæmatologiske sygdomme behandlet med imatinib), stiger imatinib-clearance med stigende legemsoverflade.
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Tidligere gastrointestinale indgrebs påvirkning af lægemiddelabsorptionen er ikke undersøgt.
The effect of prior gastrointestinal surgery on drug absorption has not been investigated.
- Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer).
- Severely decreased urine output, feeling thirsty (signs of kidney problems).
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.
3 På patientårsbasis blev kardielle hændelser, herunder hjerteinsufficiens, observeret oftere hos patienter med transformeret CML end hos patienter med kronisk CML.
3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
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.
Kontinuerlig daglig eksponering for imatinib tidligt i behandlingsforløbet i kombination med kemoterapi hos kohorte 5-patienter (n=50) forbedrede den 4-årige hændelsesfri overlevelse (EFS) sammenlignet med en historisk kontrolgruppe (n=120), der fik standard-kemoterapi uden imatinib (hhv. 69,6 % vs. 31,6 %).
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs. 31.6%, respectively).
Derudover angav investigatorene symptomatisk bedring af andre organdysfunktioner i kasuistikkerne.
Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
- Bleghed, føle sig træt og stakåndet og have mørk urin (tegn på lavt antal røde blodceller).
- Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
Udskildning af fri imatinib er sandsynligvis sammenlignelig for patienter med nedsat nyrefunktion og dem med normal nyrefunktion, eftersom udskillelse via nyren kun udgør en mindre elimineringsvej for imatinib (se pkt.
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).
- Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på muskelproblemer).
- Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
- voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD) som er forbundet med platelet-derived growth factor receptor-omlejring (PDGFR-omlejring).
- adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Renal insufficiency: Patienter med nedsat nyrefunktion eller i dialyse bør gives den mindste anbefalede dosis på 400 mg daglig som startdosis.
Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
- Hvis du er kvinde og er gravid eller planlægger at blive gravid, skal du være forsigtig, når du åbner kasplerne og håndterer indholdet for at undgå hud- og øjenkontakt eller indånding af pulveret.
- If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Avaskulær nekrose/hoftenekrose*, væksthæmning hos børn*
Avascular necrosis/hip necrosis*, growth retardation in children*
Imatinib Actavis hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
Imatinib Actavis inhibits the growth of these cells in a certain subtype of these diseases.
- Hedeture, kulderystelser eller natlig svedtendens.
- Hot flushes, chills or night sweats.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes anæmi grad 3 og 4 hos henholdsvis 5,4 % og 0,7 % af patienterne, hvilket kan hænge sammen med gastrointestinal eller intra-tumoral blødning, i hvert fald hos enkelte af patienterne.
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
Polyvinylalkohol, delvist hydroliseret Talcum
Polyvinyl alchol part. hydrolised Talc
Imatinib Actavis hæmmer væksten af disse celler.
Imatinib Actavis inhibits the growth of these cells.
- Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med imatinib, eller efter du er stoppet med at tage imatinib.
- Muscle cramps or joint, muscle or bone pain, during imatinib treatment or after you have stopped taking imatinib.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 mennesker) eller sjældne (kan forekomme hos op til 1 ud af 1.000 mennesker): - Brystsmerter, uregelmæssig hjerterytme (tegn på hjerteproblemer).
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people): - Chest pain, irregular heart rhythm (signs of heart problems).
5 Pleural effusion blev observeret oftere hos patienter med GIST og hos patienter med transformeret CML (CML-AP og CML-BC) end hos patienter med kronisk CML.
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
Perikardit*, hjertetamponade*
Pericarditis*, cardiac tamponade*
Det er en potent protein-tyrosinkinasehæmmer, der hæmmer aktiviteten af Bcr-Abl-tyrosinkinase (TK) såvel som adskillige TK-receptorer: Kit, receptoren for stamcellefaktoren (SCF) kodet for af c-kit proto-onkogenet, discoidin-domænereceptorerne (DDR1 og DDR2), receptoren for den kolonistimulerende faktor (CSF-1R) og receptorerne for trombocytafledte vækstfaktorer alfa og beta (PDGFR-alfa og PDGFR-beta).
Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg - 1.000 mg imatinib daglig.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
G-CSF (5 μg/kg, s.c.): dag 34-43
G-CSF (5 μg/kg, SC): days 34-43
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.
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.
1200 til 1600 mg (varighed varierer mellem 1 og 10 dage): Kvalme, opkastning, diarré, rødme, erytem, ødem, hævelse, træthed, muskelkramper, trombocytopeni, pancytopeni, abdominalsmerter, hovedpine, nedsat appetit.
1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
- Aktivt stof: imatinib (som mesilat).
- The active substance is imatinib (as mesilate).
Total bilirubin: >1,5-3,0 ULNASAT: alt
Total bilirubin: >1.5-3.0 ULN AST: any
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi9, artralgi, knoglesmerter10
Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter6
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Pædiatriske patienter: I alt 26 pædiatriske patienter i alderen <18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosiseskalering.
Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Der er meget begrænset erfaring med imatinib hos patienter med MDS/MPD forbundet med PDGFR- omlejring (se pkt 5.1).
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Leverinsufficiens: Imatinib metaboliseres primært i leveren.
Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
CHR: I studie 0102 [ANC ≥ 1,5 x 109/l, trombocytter ≥ 100 x 109/l, ingen blaster i blodet, BM-blaster <5 % og ingen ekstramedullær sygdom].
CHR: In study 0102 [ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, no blood blasts, BM blasts < 5% and no extramedullary disease]
Imatinib farmakokinetik er evalueret i dosisintervallet: 25-1.000 mg. Plasmafarmakokinetiske profiler blev analyseret på dag 1 og på enten dag 7 eller dag 28, hvor plasmakoncentrationerne havde nået steadystate.
Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Anvendelse til børn: Der er ingen erfaring med behandling af børn under 2 år med CML og børn under 1 år med Ph+ ALL (se pkt.
Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Hyperbilirubinæmi, hepatitis, gulsot
Hyperbilirubinaemia, hepatitis, jaundice
- Under behandlingen anbefales det, at kvinder som kan blive gravide, anvender effektiv beskyttelse mod graviditet.
- Women who might become pregnant are advised to use effective contraception during treatment.
10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter 120 filmovertrukne tabletter 180 filmovertrukne tabletter
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 120 film-coated tablets 180 film-coated tablets
- Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden.
- Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Til patienter (børn) der ikke er i stand til at synke kapslerne, kan indholdet opløses i et glas almindeligt vand eller æblejuice.
For patients (children) unable to swallow the capsules, their content may be diluted in a glass of either still water or apple juice.
Imatinib Actavis kan forårsage, at din krop begynder at ophobe væske (svær væskeretention).
Imatinib Actavis may cause your body to retain water (severe fluid retention).
- Have kvalme med tab af appetitten, mørk urin, gul hud eller øjne (tegn på leverproblemer).
- Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
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)