natgillin/translations-raw huggingface dataset:
Patienter, der ikke er i stand til at synke de filmovertrukne tabletter, kan dispergere tabletterne i et glas almindeligt vand eller æblejuice.
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Der sås positiv genotoksisk effekt med imatinib i en in vitro pattedyrscelleundersøgelse (kinesisk hamsterovarium) for clastogenicitet (kromosomafvigelser) ved metabolisk aktivering.
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.
Behandlingen kan gives én gang daglig eller alternativt deles i to - én dosis om morgenen og én om aftenen.
Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
(0,5 time), dag 7, 8, 14, 15; CP 500 mg/m2 i.v.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
- Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL).
- Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
I en fertilitetsundersøgelse med hanrotter doseret i 70 dage før parring, sås nedsat testikel- og epididymisvægt samt reduceret antal bevægelige sædceller ved 60 mg/kg, ca. svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal.
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Doser på 400 mg og 600 mg bør administreres 1 gang daglig, mens daglige doser på 800 mg bør administreres som 400 mg 2 gange daglig, én dosis om morgnen og én dosis om aftenen.
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Børn med CML i kronisk fase (ved dosis 340 mg/m2)
Paediatric chronic phase CML (at dose 340 mg/m2)
Hvis dosis tolereres, kan den øges ved manglede effekt (se pkt.
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).
Der anbefales en dosering på 340 mg/m2 daglig til børn med CML i kronisk fase og i fremskredne faser (må ikke overskride en total dosering på 800 mg).
The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Tabel 2 Respons hos voksne CML-patienter (studie)
Table 2 Response in adult CML study
- Udslæt, rød hud med små blærer på læber, øjne, hud eller mund, afskallet hud, feber, hævede røde eller lilla hudområder, kløe, brændende fornemmelse, pustuløst udslæt (tegn på hudproblemer).
- Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
I kliniske undersøgelser i CML blev der hos 2,4 % af nydiagnosticerede patienter, hos 4 % af patienterne i sen kronisk fase efter svigtende interferonbehandling, hos 4 % af patienterne i accelereret fase efter svigtende interferonbehandling og hos 5 % af patienterne i blastkrise efter svigtende interferonbehandling observeret seponering af undersøgelsesmedicinen på grund af lægemiddelrelaterede bivirkninger.
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
- Kronisk nyresvigt.
- Chronic renal failure.
Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg tablet med delekærv tilgængelig.
For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Bedring blev rapportert for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/ mediastinale, muskuloskeletale/bindevævs/kar og gastroentestinale organsystemer.
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
30 filmovertrukne tabletter 60 filmovertrukne tabletter 90 filmovertrukne tabletter
10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Færre end 1 % af CML-patienterne fik seponeret behandlingen permanent på grund af abnormaliteter i levertal.
Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients.
6 doser)iii: dag 2, 3, 16, og 17
Days 2, 3, 16, and 17
En stor international, åben, ikke-kontrolleret fase II undersøgelse var udført med patienter med Philadelphia-kromosompositiv (Ph+) CML i blaskritisk fase af sygdommen.
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Hvis noget af det ovenstående gælder for dig, skal du fortælle din læge det, før du tager Imatinib Actavis.
If any of these apply to you, tell your doctor before taking Imatinib Actavis.
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i Bcr-Abl-positive cellelinier såvel som i friske leukæmiceller fra Philadelphia-kromosompositiv (Ph+) CML og hos patienter med akut lymfoblastisk leukæmi (ALL).
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Pakninger indeholdende 10, 30, 60 eller 90 kapsler.
Pack containing either 10, 30, 60, or 90 capsules.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, copovidon, crospovidon, natriumstearylfumarat, silica (vandskyende kolloid, kolloid vandfri), polyvinylalkohol, delvist hydroliseret, talcum, gul jernoxid (E172), titandioxid (E171), rød jernoxid (E172), lecithin (soya) (E322), xanthangummi (E415).
- The other ingredients are cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
Trombotisk mikroangiopati
Thrombotic microangiopathy
Der anbefales en dosis på 340 mg/m2 daglig til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Ara-C 1.000 mg/m2/12 timer i.v.
Ara-C 1,000 mg/m2 /12 h i.v.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes både gastrointestinale og intra-tumorale blødninger (se pkt.
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
Da dyreundersøgelser har vist reproduktionstoksicitet, og den potentielle risiko for humane fostre er ukendt, bør kvinder i den fødedygtige alder tilrådes at udvise forsigtighed ved åbning af kapsler og håndtering af indholdet, samt at undgå hud- og øjenkontakt eller inhalation (se pkt.
Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Imatinib hæmmer også receptortyrosinkinaserne for trombocytafledte vækstfaktorer (PDGF), PDGF-R, og hæmmer PDGF-medierede cellulære signaler.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Nøje monitoring af leverfunktionen skal udføres i tilfælde, hvor imatinib kombineres med kemoterapiregimer, som også vides at være forbundet med leverdysfunktion (se pkt.
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see sections 4.5 and 4.8).
Imatinib øger gennemsnitligt Cmax og AUC af simvastatin (et CYP3A4-substrat) henholdsvis 2 og 3,5 gange, hvilket indikerer, at imatinib hæmmer CYP3A4.
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.
Hver filmovertrukken tablet indeholder 0,75 mg lecithin (soya) (E322) Alle hjælpestoffer er anført under pkt.
Each film-coated tablet contains 0.75 mg lecithin (soya) (E322) For the full list of excipients, see section 6.1.
Imatinib ansås ikke som værende genotoksisk i in vitro bakteriecelleundersøgelse (Ames test), i in vitro pattedyrscelleundersøgelse (muselymfom) samt i in vivo rottemikronukleusundersøgelse.
Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Pakninger indeholdende 30 eller 90 kapsler.
Pack containing either 30 or 90 capsules.
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%.
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%.
(1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32
(1 h) day 1; AraC 60 mg/m2 i.v., days 22-25, 29-32
Hvis dette gælder for dig, skal du fortælle din læge det, før du tager Imatinib Actavis.
If this applies to you, tell your doctor without taking Imatinib Actavis.
Dosering ved Ph+ ALL hos børn Dosering hos børn bør baseres på legemsoverflade (mg/m2).
Posology for Ph+ ALL in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
- voksne patienter med Ph+ ALL med tilbagefald eller refraktær sygdom som monoterapi.
- adult patients with relapsed or refractory Ph+ ALL as monotherapy.
I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as indicated in the table below.
Herpes zoster, herpes simplex, nasopharyngitis, pneumoni1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
- Du må ikke amme, mens du er i behandling med Imatinib Actavis.
- Do not breast-feed during the treatment with Imatinib Actavis.
- voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) uden FIP1L1-PDGFR-omlejring.
- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Hvornår og hvordan skal du tage Imatinib Actavis
When and how to take Imatinib Actavis
10 hårde kapsler 30 hårde kapsler 60 hårde kapsler 90 hårde kapsler
10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
- Vægtøgning.
- Weight gain.
- voksne og børn med nydiagnosticeret Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi.
- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Af en række potentielle samtidigt administrerede lægemidler (acetaminophen, acicolvir, allopurinol, amphotericin, cytarabin, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) viste kun erythromycin (IC50 50 µM) og fluconazol (IC50 118 μm) hæmning af imatinib-metabolismen i et omfang der kunne have klinisk betydning.
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 µM) and fluconazole (IC50 118 µM) showed inhibition of imatinib metabolism which could have clinical relevance.
6.6 Særlige regler for bortskaffelse
6.6 Special precautions for disposal
5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made.
Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 200 mg/m2.
If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Pakningsstørrelser: Kapslerne findes i blisterpakninger af aluminium med 24, 48, 60, 96, 120 eller 180 kapsler.
Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Methotrexat (20 mg/m2/uge, p.o.): dag 8, 15, 22, 29, 36, 43, 50
Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Dosering ved CML hos pædiatrisk populasion 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).
Dosisøgning fra 340 mg/m2 daglig til 570 mg/m2 daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn ved fravær af alvorlige bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni ved følgende omstændigheder: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås.
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Tabletterne findes i blisterpakninger af aluminium med 10, 20, 30, 60, 90, 120 eller 180 filmovertrukne tabletter.
The tablets are supplied in aluminium blister packs of 10, 20, 30, 60, 90, 120 or 180 film-coated tablets.
- Hvis du behandles for DSFP:
- If you are being treated for DFSP:
Dosisøgninger fra 600 mg til maksimalt 800 mg (som 400 mg to gange dagligt) til patienter med blastkrise kan, hvis der ikke opstår svære bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni, overvejes i følgende tilfælde: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås.
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér imatinib-behandlingen indtil ANC ≥ 1 x 109/l og trombocytter 109/l, og genoptag behandling med 200 mg/m2.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 200 mg/m2.
- Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL).
- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 µM, Gy= Gray
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
Papillomaer/carcinomer i fedtkirtlerne på forhuden/klitoris blev set fra 30 mg/kg/dag og højere, som svarer til cirka 0,5 eller 0,3 gange den daglige humane eksponering (baseret på AUC) på henholdsvis 400 mg/dag eller 800 mg/dag.
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Den totale daglige dosis til børn må ikke overstige 800 mg for CML-patienter og 600 mg for Ph+ALLpatienter.
The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Reaktivering af hepatitis B er beskrevet i forbindelse med behandling med BCR-ABLtyrosinkinasehæmmere.
Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
18 Gy i 10 fraktioner for patienter, som er CNS3 ved diagnosticering VCR (1,5 mg/m2/dag, i.v.
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter i blasttkrise.
The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Hvis du har glemt at tage Imatinib Actavis
If you forget to take Imatinib Actavis
Hos børn, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt.
Close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).
Dosisjusteringer på grund af neutropeni og trombocytopeni:
Dose adjustments for neutropenia and thrombocytopenia:
VCR 1,3 g/m2 i.v., dag 1; Prednisolon 60 mg/m2 oral, dag 1-5
VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
Neutropeni, trombocytopeni, anæmi
Neutropenia, thrombocytopenia, anaemia
Periorbitalt ødem, dermatitis/eksem/udslæt
Periorbital oedema, dermatitis/eczema/rash
Der er ingen kontrollerede undersøgelser der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse.
There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Akut febril neutrofil dermatose (Sweets syndrom), misfarvning af negle, angioødem, vesikulært udslæt, erythema multiforme, leukocytoklastisk vasculitis, Stevens-Johnson syndrom, akut generaliseret eksantematøs pustulose (AGEP)
Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP)
Pakningsstørrelser og yderligere oplysninger Imatinib Actavis indeholder
Contents of the pack and other information What Imatinib Actavis contains
: dag 29-33
MESNA IV days 29-33
Tredobbelt i.t.-terapi (aldersjusteret): dag 1 og 22
Triple IT therapy (age-adjusted): days 1 and 22
Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter med Ph+ ALL.
The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
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/m2.
Cerebralt ødem*
Cerebral oedema*
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
Patienternes alder varierede fra 25 til 72 år.
The age of these patients ranged from 25 to 72 years.
EU/1/13/825/001 30 kapsler EU/1/13/825/002 90 kapsler
EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
(3 timer, q 12 timer), dag 1-3; Vinkristin 2 mg i.v., dag 4, 11; Doxorubicin 50 mg/m2 i.v.
(3 h, q 12 h), days 1-3; vincristine 2 mg i.v., days 4, 11; doxorubicine 50 mg/m2 i.v.
De mest almindelige rapporterede (≥ 10 %) lægemiddelrelaterede bivirkninger var i begge patientgrupper: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt.
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, bisskjoldbruskkirtlerne, binyrererne og den ikke-kirtellignende del af maven.
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
): dag 1-5
(1 h), days 1-5
- Hoste, åndedrætsbesvær eller smerter ved vejrtrækning (tegn på lungeproblemer).
- Cough, having difficulty breathing or painful breathing (signs of lung problems).
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hård kapsel, dvs. det er i det væsentlige natrium-frit.
This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
DFSP (ved 800 mg dosis) ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l
DFSP (at dose 800 mg) ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
Katarakt, glaukom, papilødem
Cataract, glaucoma, papilloedema
(1 time), dag 26, 46; Ara-C 75 mg/m2 i.v.
(1 h), days 26, 46; Ara-C 75 mg/m2 i.v.
Induktionsbehandling (de novo Ph+ ALL)
Induction therapy (de novo Ph+ ALL)
DEX (6 mg/m2/dag p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 8-28
DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28
(24 timer), dag 1, 15; 6-MP 25 mg/m2 oral, dag
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Nydiagnostiseret Ph+ ALL: I et kontrolleret studie (ADE10) hvor imatinib blev sammenlignet med kemoterapi-induktion hos 55 nydiagnostiserede patienter i alderen 55 år og derover, gav imatinib brugt som monoterapi anledning til en signifikant højere ratio af hæmalogisk respons end kemopterapi (96,3% vs. 50%, p=0,0001).
Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Hvor længe skal du tage Imatinib Actavis
How long to take Imatinib Actavis
Hvis der opstår alvorlige ikke-hæmatologiske bivirkninger ved behandling med imatinib, skal behandlingen seponeres, indtil bivirkningerne er ophørt Herefter kan behandlingen genoptages alt efter den oprindelige alvorlighed af bivirkningen.
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.