FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swelling such as round your ankles or puffy eyes.
Danish: • Hævelse, som fx af anklerne eller omkring øjnene.
English: Renal failure chronic Reproductive system and breast disorders
Danish: Kronisk nyresvigt Det reproduktive system og mammae
English: 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Danish: 6400 mg (enkeltdosis): Der er beskrevet et tilfælde i litteraturen om en patient, der fik kvalme, opkastning, abdominalsmerter, feber, hævelse af ansigt, nedsat neutrofiltal, stigning i transaminaser.
English: Imatinib medac 400 mg hard capsules EU/1/13/876/002
Danish: Imatinib medac 400 mg hårde kapsler EU/1/13/876/002
English: 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).
Danish: Udskillelse 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.
English: Imatinib medac 100 mg hard capsules EU/1/13/876/001
Danish: Imatinib medac 100 mg hårde kapsler EU/1/13/876/001
English: The age of these patients ranged from 20 to 72 years.
Danish: Disse patienters alder varierede fra 20 til 72 år.
English: The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Danish: Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter i blastkrise.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Danish: I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg1.000 mg imatinib dagligt.
English: 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.
Danish: 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. 1/3 af den maksimale humane dosis på 800 mg baseret på legemsoverfladeareal.
English: Imatinib medac is indicated for the treatment of
Danish: Imatinib medac er indiceret til behandling af
English: 1200 mg 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.
Danish: 1200 mg 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.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Danish: Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*,
English: There were no special safety findings in paediatric clinical trials.
Danish: Der var ingen særlige sikkerhedsmæssige fund i kliniske undersøgelser med børn.
English: Do not use any pack that is damaged or shows signs of tampering.
Danish: Pakningen må ikke anvendes, hvis den er beskadiget, eller der er tegn på, at pakningen har været åbnet.
English: 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 patients with newly diagnosed Ph+ ALL.
Danish: 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.
English: (3 h, q 12 h), day 5
Danish: (3 timer, q 12 timer), dag 5
English: 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.
Danish: I et 2-års carcinogenicitetsstudie 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.
English: There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Danish: Der sås signifikant øgning i følsomhed for imatinib (gennemsnitlig Cmax og AUC for imatinib steg med henholdsvis 26 % og 40 %) hos raske frivillige ved samtidig administration af enkeltdosis ketoconazol (en CYP3A4-hæmmer).
English: Crospovidone (type A) Lactose monohydrate Magnesium stearate
Danish: Crospovidon (type A) Lactosemonohydrat Magnesiumstearat
English: 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).
Danish: Baseret på den poolede farmakokinetiske populationsanalyse hos børn med hæmatologiske sygdomme (CML, Ph+ ALL eller andre hæmatologiske sygdomme behandlet med imatinib) stiger imatinibclearance med stigende legemsoverflade.
English: All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Danish: Alle patienter opnåede komplet hæmatologisk respons, komplet cytogenetisk repons og/eller komplet molekylært respons.
English: Maintenance (8-week cycles) Cycles 6-12
Danish: Vedligeholdelse (8-ugers cykler) Cyklus 6-12
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Danish: • Kombination af omfattende svært udslæt, følelse af at være syg, feber, højt indhold af visse hvide blodlegemer eller gul hud eller øjne (tegn på gulsot) med stakåndethed, brystsmerter/ubehag, svært nedsat urinproduktion og tørst osv. (tegn på en behandlingsrelateret allergisk reaktion).
English: Active substances that may have their plasma concentration altered by imatinib 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.
Danish: Aktive stoffer, hvis plasmakoncentration kan ændres af imatinib Imatinib øger gennemsnitligt Cmax og AUC af simvastatin (et CYP3A4-substrat) henholdsvis 2 og 3,5 gange, hvilket indikerer, at imatinib hæmmer CYP3A4.
English: • Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Danish: • Føle sig svimmel eller besvime (tegn på lavt blodtryk).
English: 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.
Danish: Imatinibs 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 steady-state.
English: 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).
Danish: Selvom resultaterne fra en farmakokinetisk analyse viste, at der var en betydelig variation mellem forsøgspersoner, øgede den gennemsnitlige eksponering af imatinib sig ikke hos patienter med varierende grad af nedsat leverfunktion, sammenlignet med patienter med normal leverfunktion (se pkt.
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Danish: Der skal udvises forsigtighed, når imatinib gives samtidig med CYP3A4-familien.
English: Imatinib medac inhibits the growth of these cells in a certain subtype of these diseases.
Danish: Imatinib medac hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
English: All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Danish: Alle patienter opnåede komplet hæmatologisk respons, cytogenetisk repons og/eller klinisk respons.
English: There are no controlled trials in paediatric patients with HES/CEL.
Danish: Der er ingen kontrollerede forsøg med pædiatriske patienter med HES/CEL.
English: The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Danish: Der er kun begrænset erfaring med imatinib hos patienter med MDS/MPD forbundet med PDGFR-omlejring (se pkt 5.1).
English: Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Danish: Nedsat leverfunktion: Imatinib metaboliseres primært i leveren.
English: • Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Danish: • Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden.
English: 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.
Danish: 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.
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Danish: Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m² en gang dagligt (højst 400 mg en gang dagligt) eller 340 mg/m² en gang dagligt (højst 600 mg en gang dagligt), svarede til eksponeringen hos voksne, som fik imatinib 400 mg eller 600 mg en gang dagligt.
English: If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Danish: Hvis en af disse undersøgelser viser abnormalitet, bør det overvejes at kombinere imatinib med profylaktisk brug af systemisk steroid (1-2 mg/kg) i en til to uger ved behandlingsstart.
English: BATCH NUMBER Lot:
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Plasma pharmacokinetics
Danish: Plasmafarmakokinetik
English: 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.
Danish: 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.
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Danish: • Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL).
English: In the clinical study 38 % of patients were ≥ 60 years of age and 12 % of patients were ≥ 70 years of age.
Danish: I den kliniske Philadelphia-kromosom-positiv (Ph undersøgelse var 38 % af patienterne ≥60 år, og 12 % af patienterne var ≥70 år.
English: The dose of 340 mg/m daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Danish: Der anbefales en dosis på 340 mg/m² dagligt til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
English: Imatinib is a small molecule protein 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).
Danish: Det er en potent protein-kinasehæmmer, der hæmmer aktiviteten af BcrAbl-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).
English: Packs containing 30 hard capsules.
Danish: Pakninger indeholdende 30 hårde kapsler.
English: 1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Danish: 1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Danish: Palmoplantar erytrodysæstesi syndrom*, lichenoid keratosis*, lichen planus*, toksisk epidermal nekrolyse*, medikamentelt udslæt med eosinofili
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Danish: • voksne og børn med nydiagnosticeret Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi.
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Danish: • voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFRα-omlejring.
English: Imatinib medac inhibits the growth of these cells.
Danish: Imatinib medac hæmmer væksten af disse celler.
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) eller sjældne (kan forekomme hos op til 1 ud af 1.000 personer):
English: 340 mg/m daily is recommended for paediatric patients with chronic phase CML and accelerated phase CML (not to exceed the total dose of 800 mg).
Danish: Der anbefales en dosering på 340 mg/m² dagligt til børn med CML i kronisk fase og i accelereret fase (må ikke overskride en total dosering på 800 mg).
English: 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).
Danish: Derudover erfaringer der efter markedsføring er rapporteret gastric antral vascular ecstasia (GAVE), en sjælden form for gastrointestinal blødning, hos patienter med CML, ALL og andre sygdomme (se pkt.
English: Packs containing 60 hard capsules.
Danish: Pakninger indeholdende 60 hårde kapsler.
English: Maintenance (8-week cycles) Cycles 1-4
Danish: Vedligeholdelse (8-ugers cykler) Cyklus 1-4
English: In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Danish: De hyppigst observerede alvorlige bivirkninger hos børn med CML var grad 3 eller 4 cytopenier med neutropeni, trombocytopeni og anæmi.
English: Muscular weakness, arthritis, rhabdomyolysis/myopathy
Danish: Musklesvaghed, arthritis, rabdomyolyse/myopati
English: The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Danish: Den almindelige startdosis i behandlingen af CML i blastkrise er 600 mg, der tages som 6 kapsler med 100 mg (eller 1 kapsel med 400 mg plus 2 kapsler med 100 mg) én gang dagligt.
English: • Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red
Danish: • Bleghed, føle sig træt og stakåndet og have mørk urin (tegn på lavt antal røde blodceller).
English: If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).
Danish: Hvis dosis tolereres, kan den øges ved manglende effekt (se pkt.
English: The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2).
Danish: De aktuelle dosisanbefalinger er baseret på et lille antal pædiatriske patienter (se pkt.
English: • Nose bleeds.
Danish: • Næseblod.
English: This inhibition has not been observed in vivo after the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Danish: Denne hæmning er ikke observeret in vivo efter administrationen af 400 mg imatinib og 1 g paracetamol.
English: Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Danish: Svimmelhed, paræstesi, smagsforstyrrelser, hypoæstesi
English: 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 %.
Danish: 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 %.
English: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN medac GmbH
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Danish: Færre end 1 % af CML-patienterne fik seponeret behandlingen permanent på grund af abnormaliteter i levertal.
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Danish: Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse Ara-C: cytosin arabinosid; CP: cyclophosphamid; DEX: dexamethason; MTX: methotrexat; 6MP: 6-mercaptopurin; VM26: teniposid; VCR: vinkristin; IDA: idarubicin; i.v.
English: Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Danish: Reaktivering af hepatitis B er forekommet hos kroniske bærere af hepatitis B-virus (HBV), efter at patienten har fået en BCR-ABL-tyrosinkinasehæmmer.
English: 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).
Danish: C-mærket imatinib, genfandtes ca. 81 % af dosis inden for 7 dage i fæces (68 % af dosis) og urin (13 % af dosis).
English: MTX 15 mg intrathecal, day 1;
Danish: MTX 15 mg intrathecal, dag 1
English: Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Danish: Reaktivering af hepatitis B er beskrevet i forbindelse med behandling med BCR-ABL tyrosinkinasehæmmere.
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Danish: Hypokaliæmi, øget appetit, hypofosfatæmi, nedsat appetit, dehydrering, gigt, hyperurikæmi, hyperkalcæmi, hyperglykæmi, hyponatriæmi
English: 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).
Danish: 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).
English: Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control.
Danish: Akut lymfoblastær leukæmi er en form af leukæmi, hvor visse abnorme hvide blodlegemer (kaldet lymfoblaster) vokser ukontrolleret.
English: Maintenance (8-week cycles) Cycle 5
Danish: Vedligeholdelse (8-ugers cykler) Cyklus 5
English: Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
Danish: I nogle tilfælde har dette medført akut leversvigt eller fulminant hepatitis, førende til levertransplantation eller død.
English: In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
Danish: Hos patienter med nedsat leverfunktion (let, moderat eller svær) bør perifere blodtal og leverenzymer monitoreres omhyggeligt (se pkt.
English: Chronic phase CML, MDS/MPD (starting dose 400 mg)
Danish: CML i kronisk fase, MDS/MPD (startdosis 400 mg) HES/CEL (ved 400 mg dosis)
English: 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.).
Danish: Imatinib kan øge plasmakoncentrationen af andre CYP3A4-metaboliserede lægemidler (for eksempel triazol-benzodiazepiner, dihydropyridin-calciumantagonister, visse HMGCoA reduktasehæmmere, såsom statiner osv.).
English: DEX 10 mg/m oral, days 1-5;
Danish: DEX 10 mg/m² oral, dag 1-5;
English: Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis.
Danish: Der sås nyretoksicitet hos aber behandlet i 2 uger, inkluderende fokal mineralisering og dilatering af nyretubuli samt tubulær nefrose.
English: If cytopenia persists for 2 weeks, reduce further to 300 mg.
Danish: Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 300 mg.
English: Pharmacotherapeutic group: protein kinase inhibitor, ATC code: L01XE01
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber Farmakoterapeutisk klassifikation: Protein-kinasehæmmer, ATC-kode: L01XE01
English: Talk to your doctor before taking Imatinib medac:
Danish: Kontakt lægen, før du tager Imatinib medac:
English: 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.
Danish: 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.
English: Posology for MDS/MPD in adult patients The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Danish: Dosering ved MDS/MPD hos voksne patienter Den anbefalede dosis af imatinib er 400 mg/dag til voksne patienter med MDS/MPD.
English: For patients unable to swallow the capsules (e.g. paediatric patients), their content may be dispersed in a glass of still mineral water or apple juice.
Danish: Patienter, der ikke er i stand til at synke kapslerne, (f.eks. børn), kan dispergere kapslerne i et glas med almindeligt vand eller æblejuice.
English: • 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).
Danish: • 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