natgillin/translations-raw huggingface dataset:
Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, biskjoldbruskkirtlerne, binyrererne og den ikkekirtellignende 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.
Din læge vil fortælle dig, præcis hvor mange Imatinib Teva-tabletter, du skal tage.
Your doctor will tell you exactly how many tablets of Imatinib Teva to take.
Jernoxid, gul (E 172) Talcum
Iron oxide yellow (E172) Talc
Pakningsstørrelser indeholdende 60 eller 120 hårde kapsler i blisterpakninger.
Pack sizes of 60 or 120, hard capsules in blisters.
Der sås 4. grads neutropeni (ANC <0,5 x 109/l) og trombopeni (trombocyttal <10 x 109/l) hos henholdsvis 3,6% og < 1% af patienterne med nydiagnosticeret CML i kronisk fase.
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/l) and thrombocytopenia (platelet count < 10 x 109/l) were observed in 3.6% and < 1% of patients, respectively.
Forhøjet serumkreatinin, forhøjet serumkreatinkinase og forhøjet serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
600 mg som skal tages som 6 tabletter én gang daglig.
600 mg to be taken as 6 tablets once a day.
Startdosis er 600 mg, som skal tages som 1 tablet á 400 mg og 2 tabletter á 100 mg eller som halvanden 400 mg tablet én gang daglig.
The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Imatinib Teva 100 mg hårde kapsler er ikke-tansperante orange kapsler præget i sort blæk med 7629 på kapselbunden og TEVA på kapseltoppen.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
månedligt i 13 måneder; prednisolon 200 mg oral, 5 dag per måned i 13 måneder 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.
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 January 2013
ANC ≥1,5 x 109/l og trombocytter ≥75 x 109/l.
1.5 x 109/l and platelets ≥ 75 x 109/l.
Seponer Imatinib Teva indtil ANC ≥ 1,5 x 109/l og trombocytter ≥75 x 109/l.
Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l.
Pakningsstørrelser indeholdende 30x1 eller 90x1 filmovertrukne tabletter i perforeret enkeltdosisblister.
Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Imatinib Teva 100 mg hårde kapsler findes i pakninger med 60 eller 120 hårde kapsler i blisterpakninger.
Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Ikke transparent orange kapsel præget i sort blæk med 7629 på kapselbunden og præget i sort blæk med TEVA på kapseltoppen.
Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
mg/m2/dag oral
Prednisolone 60 mg/m2/day oral
Mørk gul til brunlig-orange aflang filmovertrukken tablet med delekærv på den ene side.
Dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Alderen på disse patienter rangerede fra 2 til 16 år, og imatinib blev givet i en dosis på 300 mg/m2 dagligt eller doser,
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3, 4, 5; MTX 12 mg intrathecal, dag
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
600 mg som skal tages som 6 kapsler én gang daglig.
600 mg to be taken as 6 capsules once a day.
9/l, myelocytter+metamyelocytter <5% i blod, ingen blaster og promyelocytter i blod, basofile <20%, ingen ekstramedullær påvirkning Cytogenetiske responskriterier: fuldstændig (0% Ph+ metafaser), delvis (1-35%), mindre (3665%) eller minimal (66-95%).
Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): WBC < 10 x 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (3665%) or minimal (66-95%).
- Tag Imatinib Teva sammen med et måltid.
When and how to take Imatinib Teva - Take Imatinib Teva with a meal.
Kapslen er fra 19,1 mm til 19,7 mm lang og 6,91 mm bred.
The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm. Imatinib Teva 400 mg hard capsules
Afhængigt af din tilstand er den almindelige startdosis enten 400 mg eller 600 mg: 400 mg som skal tages som én tablet én gang daglig.
Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 1 tablet once a day,
600 mg som skal tages som én kapsel af 400 mg plus 2 kapsler af 100 mg én gang daglig.
The starting dose is 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
Overordnet var den gennemsnitlige daglige dosis 406 ± 76 mg hos patienter som fik imatinib som førstevalg.
Overall, in patients receiving first-line imatinib, the average daily dose delivered was 406 ±76 mg.
Din læge vil fortælle dig, præcis hvor mange Imatinib Teva-kapsler, du skal tage.
Your doctor will tell you exactly how many capsules of Imatinib Teva to take.
Hvis din daglige dosis er 800 mg (2 tabletter), skal du tage én tablet om morgenen og én tablet om aftenen.
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.
Stop Imatinib Teva indtil
Stop imatinib until ANC ≥
Pakningsstørrelser indeholdende 30x1 eller 90x1 hårde kapsler i perforeret enkeltdosisblister.
Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Dosering til børn bør baseres på legemsoverfladeareal (mg/m2).
Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
Titandioxid (E171) Jernoxid, gul (E 172) Jernoxid, rød (E 172)
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
a ANC < 0.5 x 109/l og/eller trombocytter < 10 x 109/l
a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
Ikke transparent orange kapsel præget i sort blæk med 7630 på kapselbunden og præget i sort blæk med TEVA på kapseltoppen.
Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Pakningsstørrelser indeholdende 20x1, 60x1, 120x1 eller 180x1 filmovertrukne tabletter i perforeret enkeltdosisblister.
Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Imatinib Teva 100 mg hårde kapsler findes i pakninger med 20x1, 60x1, 120x1 eller 180x1 hårde kapsler i perforerede enkeltdosisblisterpakninger.
Imatinib Teva 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Imatinib Teva 400 mg hårde kapsler findes i pakninger med 30x1 eller 90x1 hårde kapsler i perforerede enkeltdosisblisterpakninger.
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Imatinib Teva 100 mg filmovertrukne tabletter findes i pakninger med 20x1, 60x1, 120x1 eller 180x1 filmovertrukne tabletter i perforerede enkeltdosisblisterpakninger.
Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Pakningsstørrelser indeholdende 20x1, 60x1, 120x1 eller 180x1 hårde kapsler i perforeret enkeltdosisblister.
Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Sådan skal du tage Imatinib Teva
How to take Imatinib Teva
Af disse 117 patienter var 61 positive for FIP1L1-PDGFRα fusionkinase.
FIP1L1-PDGFRα fusion kinase was identified.
): dag 4
See section 4
): dag 1-5
days 1-3;
Dosis kan reduceres ved intolerance (se pkt.
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Imatinib Teva 100 mg filmovertrukne tabletter er mørkegule til brun-orange runde filmovertrukne tabletter med delekærv på den ene side.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
Imatinib Teva 400 mg hårde kapsler findes i pakninger med 30 eller 90 hårde kapsler i blisterpakninger.
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
ANC < 1,0 x 109/l og/eller trombocytter < 50 x 109/l
ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
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.
DEX (6 mg/m2/dag p.o.): dag 1-5; 29-33
DEX (6 mg/m2/day PO): days 1-5; 29-33
Imatinib Teva 400 mg filmovertrukne tabletter findes i pakninger med 30x1 eller 90x1 filmovertrukne tabletter i perforerede enkeltdosisblisterpakninger.
Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets in perforated unit dose blisters.
Konsolidering blok 2 (3 uger))
Consolidation block 2 (3 weeks)
Kapselskallen består af gelatine, titandioxid (E 171), gul jernoxid (E 172) og rød jernoxid (E 172).
The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Imatinib Teva 400 mg filmovertrukne tabletter er mørkegule til brun-orange runde filmovertrukne tabletter med delekærv på den ene side.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Imatinib Teva 400 mg filmovertrukne tabletter Pakningsstørrelser indeholdende 30 eller 90 filmovertrukne tabletter i blisterpakninger.
Imatinib Teva 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Imatinib Teva 100 mg filmovertrukne tabletter findes i pakninger med 60 eller 120 filmovertrukne tabletter i blisterpakninger.
Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
Major respons n (%) [95% CI]
Cytogenetic response Major response n (%) [95% CI]
Imatinib Teva 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
Imatinib Teva 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m2 i.v., dag 1, 8; prednison 60 mg/m2 oral, dag 1-7, 15-21; IDA 9 mg/m2 oral, dag 1
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Undersøgelser
diagnosis
Hæmatologisk respons
Haematological adverse reactions
Hvis din daglige dosis er 800 mg (2 kapsler), skal du tage én kapsel om morgenen og én kapsel om aftenen.
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in the evening.
Imatinib Teva 400 mg hårde kapsler
Imatinib Teva 400 mg hard capsules
Remission til kronisk fasehronic phase
Return to chronic phase (RTC)
EU/1/12/808/033 30 hårde kapsler EU/1/12/808/034 30 x 1 hårde kapsler EU/1/12/808/035 90 hårde kapsler EU/1/12/808/036 90 x 1 hårde kapsler EU/1/12/808/037 30 hårde kapsler EU/1/12/808/038 30 x 1 hårde kapsler EU/1/12/808/039 90 hårde kapsler EU/1/12/808/040 90 x 1 hårde kapsler
EU/1/12/808/033 30 hard capsules EU/1/12/808/034 30 x 1 hard capsules EU/1/12/808/035 90 hard capsules EU/1/12/808/036 90 x 1 hard capsules EU/1/12/808/037 30 hard capsules EU/1/12/808/038 30 x 1 hard capsules EU/1/12/808/039 90 hard capsules EU/1/12/808/040 90 x 1 hard capsules
Anvendelse til børn
Use in adults
Hvor længe skal du tage Imatinib Teva
How much Imatinib Teva to take
Imatinib Teva 400 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
Imatinib Teva 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
• Flåd fra øjet med kløe, rødme og hævelse (betændelse af øjets bindehinde), øget tåreflåd eller sløret syn.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
Imatinib Teva 100 mg hårde kapsler imatinib
Imatinib Teva 100 mg hard capsules imatinib
Imatinib Teva 400 mg kapsler Hver kapsel indeholder 400 mg imatinib (som mesilat).
Imatinib Teva 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Imatinib Teva 100 mg hårde kapsler
Imatinib Teva 100 mg hard capsules
Imatinib Teva 400 mg hårde kapsler imatinib
Imatinib Teva 400 mg hard capsules imatinib
): dag 1
(1 h) day 1;
DEX 10 mg/m2 oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; IDA 8 mg/m2 i.v.
DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14;
EU/1/12/808/021 20 x 1 hårde kapsler EU/1/12/808/022 60 hårde kapsler EU/1/12/808/023 60 x 1 hårde kapsler EU/1/12/808/024 120 hårde kapsler EU/1/12/808/025 120 x 1 hårde kapsler EU/1/12/808/026 180 x 1 hårde kapsler EU/1/12/808/027 20 x 1 hårde kapsler EU/1/12/808/028 60 hårde kapsler EU/1/12/808/029 60 x 1 hårde kapsler EU/1/12/808/030 120 hårde kapsler EU/1/12/808/031 120 x 1 hårde kapsler EU/1/12/808/032 180 x 1 hårde kapsler
EU/1/12/808/021 20 x 1 hard capsules EU/1/12/808/022 60 hard capsules EU/1/12/808/023 60 x 1 hard capsules EU/1/12/808/024 120 hard capsules EU/1/12/808/025 120 x 1 hard capsules EU/1/12/808/026 180 x 1 hard capsules EU/1/12/808/027 20 x 1 hard capsules EU/1/12/808/028 60 hard capsules EU/1/12/808/029 60 x 1 hard capsules EU/1/12/808/030 120 hard capsules EU/1/12/808/031 120 x 1 hard capsules EU/1/12/808/032 180 x 1 hard capsules
Imatinib Teva 100 mg kapsler Hver kapsel indeholder 100 mg imatinib (som mesilat).
Imatinib Teva 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Imatinib Teva 400 mg filmovertrukne tabletter imatinib
Imatinib Teva 400 mg film-coated tablets imatinib
Hæmolytisk anæmi, trombotisk mikroangiopati
Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common
Imatinib Teva 100 mg filmovertrukne tabletter imatinib
Imatinib Teva 100 mg film-coated tablets imatinib
Imatinib Teva 400 mg filmovertrukne tabletter findes i pakninger med 30 eller 90 filmovertrukne tabletter i blisterpakninger.
Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
Startdosis er 400 mg, som skal tages som 4 tabletter én gang daglig.
The starting dose is 400 mg, to be taken as 4 tablets once a day.
Startdosis er 400 mg, som skal tages som 4 kapsler én gang daglig.
The starting dose is 400 mg, to be taken as 4 capsules once a day.
EU/1/12/808/001 20 x 1 filmovertrukne tabletter EU/1/12/808/002 60 filmovertrukne tabletter EU/1/12/808/003 60 x 1 filmovertrukne tabletter EU/1/12/808/004 120 filmovertrukne tabletter EU/1/12/808/005 120 x 1 filmovertrukne tabletter EU/1/12/808/006 180 x 1 filmovertrukne tabletter EU/1/12/808/007 20 x 1 filmovertrukne tabletter EU/1/12/808/008 60 filmovertrukne tabletter EU/1/12/808/009 60 x 1 filmovertrukne tabletter EU/1/12/808/010 120 filmovertrukne tabletter EU/1/12/808/011 120 x 1 filmovertrukne tabletter EU/1/12/808/012 180 x 1 filmovertrukne tabletter
EU/1/12/808/001 20 x 1 film-coated tablets EU/1/12/808/002 60 film-coated tablets EU/1/12/808/003 60 x 1 film-coated tablets EU/1/12/808/004 120 film-coated tablets EU/1/12/808/005 120 x 1 film-coated tablets EU/1/12/808/006 180 x 1 film-coated tablets EU/1/12/808/007 20 x 1 film-coated tablets EU/1/12/808/008 60 film-coated tablets EU/1/12/808/009 60 x 1 film-coated tablets EU/1/12/808/010 120 film-coated tablets EU/1/12/808/011 120 x 1 film-coated tablets EU/1/12/808/012 180 x 1 film-coated tablets
Aktivt stof: imatinib (som mesilat).
What Imatinib Teva contains - The active substance is imatinib (as mesilate).
EU/1/12/808/013 30 filmovertrukne tabletter EU/1/12/808/014 30 x 1 filmovertrukne tabletter EU/1/12/808/015 90 filmovertrukne tabletter EU/1/12/808/016 90 x 1 filmovertrukne tabletter EU/1/12/808/017 30 filmovertrukne tabletter EU/1/12/808/018 30 x 1 filmovertrukne tabletter EU/1/12/808/019 90 filmovertrukne tabletter EU/1/12/808/020 90 x 1 filmovertrukne tabletter
EU/1/12/808/013 30 film-coated tablets EU/1/12/808/014 30 x 1 film-coated tablets EU/1/12/808/015 90 film-coated tablets EU/1/12/808/016 90 x 1 film-coated tablets EU/1/12/808/017 30 film-coated tablets EU/1/12/808/018 30 x 1 film-coated tablets EU/1/12/808/019 90 film-coated tablets EU/1/12/808/020 90 x 1 film-coated tablets
Startdosis er 100 mg, som skal tages som 1 tablet á 100 mg én gang daglig.
The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day.
Daunorubicin 30 mg/m2 i.v., dag 1-3, 15-16;
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Startdosis er 100 mg, som skal tages som 1 kapsel á 100 mg én gang daglig.
The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
50016 Zaragoza Spanien
10000 Zagreb Croatia
Seponer Imatinib Teva indtil ANC ≥ 1,5 x 109/l og trombocytter ≥75 x 10
Stop imatinib until ANC ≥ 1.5 x 10
Vaskulære sygdomme4
Vascular disorders4 Common
Startdosis er 100 mg, som skal tages som 1 kapsel én gang daglig.
The starting dose is 100 mg, to be taken as 1 capsule once a day.
• Kraftige mavesmerter, blod i opkast, afføring eller urin, sortfarvet afføring (tegn på mave-tarm-sygdomme).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Indlægsseddel: Information til brugeren Imatinib Teva 400 mg hårde kapsler imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg hard capsules imatinib
Indlægsseddel: Information til brugeren Imatinib Teva 100 mg filmovertrukne tabletter imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
Indlægsseddel: Information til brugeren Imatinib Teva 400 mg filmovertrukne tabletter imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib
Startdosis er 100 mg, som skal tages som 1 tablet én gang daglig.
The starting dose is 100 mg, to be taken as 1 tablet once a day.
Cytogenetisk hovedrespons2 Fuldstændigt (Bekræftet3) [95% CI]
Complete (Confirmed3) [95% CI]
Imatinib Teva 100 mg filmovertrukne tabletter
Imatinib Teva 100 mg film-coated tablets
Indlægsseddel: Information til brugeren Imatinib Teva 100 mg hårde kapsler imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg hard capsules imatinib
I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 260 mg/m2.
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Imatinib Teva 400 mg filmovertrukne tabletter
Imatinib Teva 400 mg film-coated tablets
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 tablet á 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen.
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to treatment.
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 μM, Gy= Gray
VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/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
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 kapsel á 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen.
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Tredobbelt i.t.-terapi (aldersjusteret): dag 8, 15
IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
4.5), CYP3A4 substrater med et snævert terapeutisk vindue (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, diergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel, quinidin) eller warfarin og andre coumarin-derivater (se pkt.
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Klassificering af nedsat leverfunktion: Nedsat leverfunktion
Liver dysfunction classification:
- Hver Imatinib Teva-filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
- Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
I tilfælde af tilbagevenden af ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentages trin 1 og Imatinib Teva reintroduceres med nedsat dosering på 400 mg.
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonært ødem,ascites, perifert ødem).
Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking imatinib.
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 PEG-ASP (2500 IUnits/m2, IM): day 4
Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling med Imatinib Teva.
During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly.
I tilfælde af recidiverende ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentag trin 1 og genoptag behandling med Imatinib Teva i en reduceret dosis på 300 mg.
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.