natgillin/translations-raw huggingface dataset:
• Hoste, åndedrætsbesvær eller smerter ved vejrtrækning (tegn på lungeproblemer).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
Hvis cytopeni ikke er leukæmirelateret, reducér imatinib-dosis til 260 mg/m².
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m 3.
• Appetitløshed, vægttab eller smagsforstyrrelser.
• Anorexia, weight loss or a disturbed sense of taste.
Der ses generelt ingen bedring ved indgift af imatinib til patienter uden genetisk translokation.
Imatinib administration to patients without the genetic translocation generally results in no improvement.
Dosering ved Ph+ ALL hos voksne patienter
Posology for Ph+ ALL in adult patients
Forhøjet serumamylase
Blood amylase increased
9 Muskuloskeletale smerter under behandling med imatinib eller efter seponering er blevet
9) Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing
G-CSF (5 μg/kg, s.c.): dag 4-13, eller indtil ANC >1500 post nadir
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Cytogenetiske responskriterier: Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0 % Ph metafaser),
A major response combines both complete and partial responses: complete (0 % Ph+ metaphases), partial (1-35 %)
Børn med CML i accelereret fase og blastkrise (startdosis 340 mg/m²)
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
): dag 1-7 og 15-21
oral, days 1-7, 15-21;
Der er klinisk erfaring med administration af imatinib 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 imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Kliniske tilfælde af hypotyroidisme er rapporteret hos patienter, der har fået foretaget tyroidektomi, og som er i levothyroxin-erstatningsterapi samtidig med imatinib-behandling (se pkt.
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer) eller almindelige (kan forekomme hos op til 1 ud af 10 personer):
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
De mest almindelige rapporterede (≥ 10 %) behandlingsrelaterede bivirkninger var: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt.
The most commonly reported (≥ 10 %) treatment-related adverse reactions were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m² i.v.
(24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
• Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Pustuløst udslæt, kontusion, øget svedtendens, urticaria, ecchymose, let til knubs og mærker, hypotrichosis, hypopigmentering af huden, dermatitis exfoliativa, onychoclasi, folliculitis, petechier, psoriasis, purpura, hyperpigmentering af huden, bulløst udslæt
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation,
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi
Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia
Imatinib medac 400 mg hårde kapsler Hver hårde kapsel indeholder 50,072 mg lactosemonohydrat.
Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate.
Flushing, blødning
Flushing, haemorrhage
(24 timer), dag 1; Etoposid 250 mg/m² i.v.
(24 h), day 1; Etoposide 250 mg/m i.v.
Spørg lægen, på apoteket eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
Check with your doctor, pharmacist or nurse if you are not sure.
Samtidig anvendelse af imatinib og lægemidler, der inducerer CYP3A4 (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller Hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden over for imatinib, og dermed potentielt øge risikoen for terapeutisk svigt.
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
However, always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Ændring af dosering
Posology modification
Dosering ved Ph+ ALL hos børn
Posology for Ph+ ALL in children
DEX (6 mg/m²/dag, p.o.): dag 1-7 og 15-21
DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Imatinib medac bruges også til behandling af børn og unge med CML.
Imatinib medac is also a treatment for children and adolescents with CML.
CP 200 mg/m² i.v., dag 3, 4, 5; MTX 12 mg intrathecal, dag 1
CP 200 mg/m i.v., days 3-5; MTX 15 mg intrathecal, day 1
Imatinib medac indeholder lactose.
Imatinib medac contains lactose.
I tilfælde af tilbagevenden af ANC <1,0 x 10
In the event of recurrence of ANC < 1.0 x 10
Hvis dette gælder for dig, skal du fortælle din læge det, før du tager Imatinib medac.
If this applies to you, tell your doctor without taking Imatinib medac.
Alderen på disse patienter rangerede fra 3 måneder til 4 år, og imatinib blev givet i en dosis på 50 mg dagligt eller doser, der lå i intervallet fra 92,5 til 340 mg/m² dagligt.
The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m daily.
Dyreforsøg har dog påvist reproduktionstoksicitet (se pkt.
Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Det skal du vide, før du begynder at tage Imatinib medac
What you need to know before you take Imatinib medac
(24 timer), dag 1, og Ara-C 2 g/m² i.v.
(24 h), day 1, and Ara-C 2 g/m i.v.
Alderen på disse patienter rangerede fra 2 til 16 år, og imatinib blev givet i en dosis på 300 mg/m² dagligt eller doser, der lå i intervallet fra 200 til 400 mg dagligt.
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m daily or doses ranging from 200 to 400 mg daily.
Alderen på disse patienter rangerede fra nyfødt til 14 år, og imatinib blev givet i en dosis på 50 mg dagligt eller doser, der lå i intervallet fra 400 til 520 mg/m² dagligt.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
Meget almindelige (kan forekomme flere end 1 ud af 10 personer):
Very common (may affect more than 1 in 10 people):
Børn: I studie I2301 blev der inkluderet i alt 93 børn, unge og yngre voksne (fra 1 til 22 år) med Ph+ALL i et åbent, multicenter, ikke-radomiseret fase III sekventielt kohorte-forsøg.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Tredobbelt i.t.-terapi (aldersjusteret): dag 1
Triple IT therapy (age-adjusted): day 1
Der er udført et åbent multicenter, klinisk fase II-studie (studie B2225) med henblik på vurdering af imatinib i en blandet patientpopulation med livstruende sygdomme forbundet med Abl, Kit eller PDGFR protein-tyrosinkinaser.
One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
(3 timer, q 12 timer), dag 1-3;
(3 h, q 12 h), days 1-3; i.v.
Biokemi
Biochemistry
9/l og trombocytter ≥75 x 10
9/l and platelets ≥ 75 x 10
Hvis du ved et uheld har indtaget for mange kapsler, skal du kontakte din læge med det samme.
If you take more Imatinib medac than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Dosis kan reduceres, hvis den ikke tolereres (se pkt.
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Der findes en 400 mg kapsel (uden delekærv) til doser på 400 mg og derover (se dosisanbefalingen herunder).
For doses of 400 mg and above (see dosage recommendation below) a 400 mg capsule (not divisible) is available.
Studie AAU02 Induktionsbehandling (de novo Ph+ ALL)
Induction therapy (de novo Ph+ ALL)
Der sås svær levertoksicitet hos hunde behandlet i 2 uger, inkluderende forhøjede leverenzymer, hepatocellulær nekrose, galdevejsnekrose samt galdevejshyperplasia.
Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
• Kløe.
• Rash.
Lægemidlet bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for lactasemangel (Lapp-lactasemangel) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Trombocytæmi, lymfopeni, knoglemarvsdepression, eosinofili,
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Der sås positiv genotoksisk effekt med imatinib i en in vitro pattedyrscelleundersøgelse (kinesisk hamsterovarium) for clastogenicitet (kromosomafvigelser) ved metabolisk aktivering ved en koncentration på 125 μg/ml.
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 at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Imatinib medac er også en behandling til voksne med:
Imatinib medac is also a treatment for adults for:
Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29
Triple IT therapy (age-adjusted): days 1, 29
Patienterne blev behandlet med imatinib-doser på 260 mg/m²/dag (n=5), 340 mg/m²/dag (n=9), 440 mg/m²/dag (n = 7) og 570 mg/m²/dag (n = 5).
(n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Svaghed, pyreksi, anasarka, kuldegysninger og kulderystelser
Weakness, pyrexia, anasarca, chills, rigors
Forsigtighed tilrådes dog ved CYP2D6-substrater med et snævert terapeutisk vindue som f.eks. metoprolol.
Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Intensivering blok 1 (9 uger)
Intensification block 1 (9 weeks)
Indehaver af markedsføringstilladelsen medac
Marketing Authorisation Holder medac
Intensivering blok 2 (9 uger)
Intensification block 2 (9 weeks)
Der sås 4. grads neutropeni (ANC <0,5 x 10
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Nedsat organfunktion
Organ function impairment
CPM (250 mg/m²/dosis q12h x 4 doser, i.v.
CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4
Gynækomasti, erektil dysfunktion, menoragi, uregelmæssig menstruation, seksuel dysfunktion, smerter i brystvorterne, brystforstørrelse, skrotalt ødem
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Aktive stoffer, der kan reducere plasmakoncentrationen af imatinib Stoffer, der inducerer CYP3A4-aktivitet (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller perikon (Hypericum perforatum), kan signifikant reducere følsomheden for imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Der er udført en åben, multicenter fase II-undersøgelse (studie B2225) med henblik på at vurdere imatinib hos en blandet patientpopulation med livstruende sygdomme forbundet med Abl-, Kit- eller PDGFR-proteintyrosinkinaser.
One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
DEX (6 mg/m²/dag, p.o.): dag 1-5; 29-33
DEX (6 mg/m 2/day, PO): days 1-5; 29-33
Patienterne blev behandlet med imatinib (340 mg/m²/dag) i kombination med intensiv kemoterapi efter induktionsbehandling.
Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel: Dosisjusteringer på grund af neutropeni og trombocytopeni Terapeutisk indikation
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
I tre publikationer var der rapporteret om fem (5) patienter med DFSP og PDGFR-omlejringer.
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Imatinib monoterapi med 600 mg/dag kan gives til voksne patienter med recidiverende eller refraktiv Ph+ALL, indtil der sker sygdomsprogression.
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day can be given until disease progression occurs.
9/l) hos henholdsvis 3,6 % og <1 % af patienterne med nydiagnosticeret CML i kronisk fase.
9/l) were observed in 3.6 % and < 1 % of patients, respectively.
400 mg imatinib to gange dagligt havde en inhibitorisk effekt på CYP2D6-medieret metoprololmetabolisme, som gav en stigning af Cmax og AUC
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23 % (90 %CI [1.16 - 1.30]).
Kapselskallen (til 400 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172) og sort jernoxid (E172).
The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Perikardit*, hjertetamponade*
Pericarditis*, cardiac tamponade* Vascular disorders
• Mavesmerter med kvalme.
• Stomach pain with feeling sick (nausea).
Hos børn, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt.
Close monitoring of growth in paediatric patients under treatment with imatinib is recommended (see section 4.8).
Imatinib medac 100 mg hårde kapsler Imatinib medac 400 mg hårde kapsler
Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
G-CSF (5 μg/kg, s.c.): dag 5-14, eller indtil ANC >1500 post nadir Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 15
G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Kapselskallen (til 100 mg kapslen) består af gelatine, gul jernoxid (E172), titanidioxid (E171) rød jernoxid (E172).
The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
• Hvis du behandles for Ph-positiv ALL: Startdosis er 600 mg, som skal tages som 6 kapsler med 100 mg (eller 1 kapsel med 400 mg plus 2 kapsler med 100 mg) én gang dagligt.
The starting dose 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.
eller p.o. q6h x 6 doses)iii: dag 2 og 3
IV or PO q6h x 6 doses)iii:
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 μM, Gy= Gray
DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 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
Er du i tvivl, så spørg lægen, på apoteket eller sygeplejersken.
• If you have any further questions, ask your doctor, pharmacist or nurse.
Imatinib medac indeholder:
What Imatinib medac contains
10 Muskuloskeletale smerter og relaterede hændelser blev observeret oftere hos patienter med
10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 260 mg/m².
9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
• Have kvalme med diarré og opkastning, mavesmerter eller feber (tegn på tarmproblemer).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
Forhøjet serumkreatinin, forhøjet serumkreatinkinase og forhøjetserumlaktatdehydrogenase, forhøjet alkalisk fosfatase
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
• Kvalme opkastninger, diarré eller fordøjelsesbesvær.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
De gastrointestinale tumorer kan have været blødningskilden ved den gastrointestinale blødning (se pkt.
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når imatinib gives samtidig til thyreoidektomerede patienter (se pkt.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Det er rapporteret, at samtidig brug med L-asparaginase kan være associeret med øget hepatotoksicitet (se pkt.
Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
MESNA (360 mg/m²/dosis hver 3 time, x 8 doser/dag, i.v.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i biskjoldbruskkirtlerne, de benigne og maligne tumorer i binyremarven og ikke-kirtellignende ventrikelpapillomaer/carcinomer blev observeret ved 60 mg/kg/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 paediatric patients (based on AUC) at 340 mg/m2/day.
Hypertension, hæmatom, subduralt hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud's syndrom
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
I dyremodeller, hvor der anvendes Bcr-Abl-positive tumorceller, har stoffet som enkeltstof in vivo antitumoraktivitet.
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
9l og trombocytter ≥20 x 10
9/l and platelets ≥ 20 x 10
• Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
• Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib medac, skal du kontakte din
• Patients who are concerned about their fertility while taking Imatinib medac are advised to
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter
Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Alt efter bivirkningernes sværhedsgrad kan behandlingen derefter genoptages.
Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.
(1 time), dag 28-31,
(1 h), days 28-31, 35-38, 42-45;
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
UNIQUE IDENTIFIER - 2D BARCODE {2D barcode carrying the unique identifier included.}
9/l, gentag trin 1 og genoptag <50 x 10 behandling med imatinib i en reduceret dosis på 300 mg.
9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Studie AUS01 Induktions-konsoliderende behandling
Study AUS01
Imatinib medac er en behandling til voksne, børn og unge mod:
Imatinib medac is a treatment for adults and children and adolescents for:
8 Der er rapporteret tilfælde af letalt leversvigt og levernekrose.
8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Hvornår og hvordan skal du tage Imatinib medac
When and how to take Imatinib medac • Take Imatinib medac with a meal.
Konsolidering blok 2 (3 uger)
Consolidation block 2 (3 weeks)
Konsolidering blok 1 (3 uger)
Consolidation block 1 (3 weeks)
PEG-ASP (2.500 IE/m², i.m.
PEG-ASP (2500 IUnits/m2, IM): day 4
Reinduktion blok 2 (3 uger)
Reinduction block 2 (3 weeks)
I fire publikationer var der rapporteret om fem (5) patienter med MDS/MPD forbundet med PDGFR-omlejring.
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Induktionsbehandling I
Therapeutic indication
VP-16 (100 mg/m²/dag, i.v.
VP-16 (100 mg/m2/day, IV): days 1-5
Reinduktion blok 1 (3 uger)
Reinduction block 1 (3 weeks)
LÆGEMIDLETS NAVN Imatinib medac 400 mg hårde kapsler imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib medac 400 mg hard capsules Imatinib
LÆGEMIDLETS NAVN Imatinib medac 100 mg hårde kapsler imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib medac 100 mg hard capsules Imatinib
Imatinib medac er også en behandling til børn og unge med:
Imatinib medac is also a treatment for children and adolescents for:
ARA-C (3 g/m²/dosis q 12 h x 4, i.v.
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Meget almindelig: Almindelig:
Very common: Headache Common:
Hver 400 mg hård kapsel Imatinib medac indeholder 400 mg imatinib (som mesilat).
Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
): dag 1 og 15 Leucovorin (75 mg/m² i time 36, i.v.
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Farmakokinetik hos børn
Pharmacokinetics in paediatric patients
Start 6-MP den første dag
Start 6-MP the 1st day after cranial irradiation completion.)
Hos 4 % af GIST-patienterne blev undersøgelsesmedicinen seponeret på grund af behandlingsrelaterede bivirkninger.
In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients.