natgillin/translations-raw huggingface dataset:
• børn med nydiagnosticeret Philadelphia-kromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling.
• Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of
Kontinuerlig daglig eksponering for imatinib tidligt i behandlingsforløbet i kombination med kemoterapi hos kohorte 5-patienter (n=50) forbedrede den 4-årige hændelsesfri overlevelse (EFS) sammenlignet med en historisk kontrolgruppe (n=120), der fik standard-kemoterapi uden imatinib (hhv. 69,6% vs. 31,6%).
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs.
Imatinib forlængede signifikant RFS, idet 75% af patienterne var recidivfrie efter 38 måneder i Imatinib-gruppen i forhold til efter 20 måneder i placebo-gruppen (95% konfidensinterval, [30 - ikke estimerbare]; [14 - ikke estimerbare]); (hazard ratio = 0,398 [0,259-0,610], p<0,0001).
Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
• behandling af voksne patienter med Kit (CD117) positiv, inoperabel og/eller metastaserende maligne gastrointestinale bindevævstumorer (GIST).
• The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Alle patienter opnåede komplet hæmatologisk respons, komplet cytogenetisk respons og/eller komplet molekylært respons.
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg filmovertrukken
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
• 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.
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
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
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i Bcr-Abl-positive cellelinjer såvel som i friske leukæmiceller fra Philadelphia-kromosom-positiv (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.
• voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFRα-omlejring.
• Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Total-bilirubin: >1,5-3,0 ULN ASAT: alt
Total bilirubin: >1.5-3.0 ULN AST: any
In vitro hæmmer imatinib CYP2D6-aktiviteten ved koncentrationer svarende til dem, der påvirker CYP3A4-aktivitet.
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Der er meget begrænset erfaring hos børn med MDS/MPD, DFSP,
There is very limited experience in children with MDS/MPD, DFSP, GIST
Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag for både moderdyr og F1-generation (en ¼ af den maksimale humane dosis på 800 mg).
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Induktions-konsoliderende behandling Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Der bør vaskes hænder straks efter
Hands should be washed immediately after handling open capsules.
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
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).
Vincristin 2 mg i.v., dag 4, 11; Doxorubicin 50 mg/m i.v.
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with
Ved doser >6 mg/kg sås hos rotter i 13-ugers undersøgelsen hyperplasi af det transitoriske epithel i nyrepapillerne og i urinblæren, uden ændringer i serum- eller urinparametre.
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
6 patienter opnåede delvist respons og 21 patienter opnåede stabilisering af deres sygdom efter optrapning af dosis med et overordnede klinisk fordel på 26%.
The daily dose was escalated to 800 mg in a total of 103 patients; 6 patients achieved a partial response and 21 stabilisation of their disease after dose escalation for an overall clinical benefit of 26%.
I syv publikationer var der rapporteret om sytten (17) patienter med GIST (med eller uden Kit og PDGFRmutationer).
Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
- Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden.
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m2 en gang daglig (højst 400 mg en gang daglig) eller 340 mg/m2 en gang daglig (højst 600 mg en gang daglig), svarede til eksponeringen hos voksne, som fik imatinib 400 mg
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 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.
Derudover forlængede 36 måneders imatinib-behandling signifikant den totale overlevelse (OS) sammenlignet med 12 måneders imatinib-behandling (HR = 0,45 [0,22-0,89], p = 0,0187) (Tabel 7, Figur 2).
In addition, thirty-six (36) months of imatinib treatment significantly prolonged overall survival (OS) compared to 12 months of imatinib treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 7, Figure 2).
For doser på 400 mg og derover (se anbefalede doser nedenfor) er en 400 mg filmovertrukken tablet
For doses of 400 mg and above (see dosage recommendation below) a 400 mg film-coated tablet is available.
In vitro hæmmer imatinib proliferationen og inducerer apoptose i GIST-tumorcellerne, som udtrykker kit-mutationen.
In vitro, imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation.
Kliniske undersøgelser vedrørende inoperabel og/eller metastaserende GIST Der er udført en åben, randomiseret, ikke-kontrolleret, multinational fase II-undersøgelse med patienter med inoperable eller metastaserende maligne gastrointestinale bindevævstumorer (GIST).
Clinical studies in unresectable and/or metastatic GIST One phase II, open-label, randomised, uncontrolled multinational study was conducted in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST).
- Under behandlingen anbefales det, at kvinder som kan blive gravide, anvender effektiv
- Women who might become pregnant are advised to use effective contraception during treatment.
Der bør derfor udvises forsigtighed hos patienter med kardiel dysfunktion.
Therefore, caution should be exercised in patients with cardiac
Daunorubicin 30 mg/m2 i.v., dag 1-3, 15-16;
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Kaplan-Meier-endepunkts-estimater for primær recidivfri overlevelse (ITT-population)
Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT population)
Det bør bemærkes, at GIST-patienter kan have levermetastaser, hvilket kan
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
- Øvrige indholdsstoffer er mannitol, crospovidon, magnesiumstearat og vandfri kolloid silica.
- The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
- 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
• 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).
Den filmovertrukne tablet har en diameter på ca. 9 mm.
The tablets are approximately 9 mm in diameter.
Herpes zoster, herpes simplex, nasopharyngitis, pneumoni1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion,
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract
Mitoxantron 10 mg/m2 i.v.
Mitoxantrone 10 mg/m2 i.v.
Trykfarven består af shellac, sort jernoxid (E172) og propylenglycol.
The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.
Baseret på in vitro undersøgelser, bindes, ved kliniske relevante koncentrationer af imatinib, ca. 95% til plasmaproteiner, hovedsagelig albumin og alfa-syre-glycoprotein, med en mindre binding til
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to
Alle 65 FIP1L1-PDGFRα fusionkinase-positive patienter opnåede CHR, som vedvarede i måneder (varighed fra 1+ til 44+ måneder censureret på opgørelsestidspunktet).
All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
Der er ikke gennemført kontrollerede undersøgelser, der har vist klinisk bedring eller øget overlevelse ved disse sygdomme.
There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
- Muskelsvaghed, kramper og en unormal hjerterytme (tegn på ændringer i mængden af kalium i
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of
- Føle sig svimmel eller besvime (tegn på lavt blodtryk).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Stop imatinib 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.
400 mg/dag vs. 36 måneders behandling hos patienter efter kirurgisk resektion af GIST og en af følgende: tumordiameter >5 cm og antal mitoser >5/50 HPF (high power fields); eller tumordiameter >10 cm og uanset antal mitoser; eller tumor af enhver størrelse med antal mitoser >10/50 HPF; eller tumorer, der er bristet i bughulen.
A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day imatinib 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Alderen på denne patientgruppe varierede fra 18 til 91 år.
The ages of these patients ranged from 18 to 91 years.
Den filmovertrukne tablet har en diameter på
The diameter of the film-coated tablet is
Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this
Kaplan-Meier-estimater for total overlevelse (ITT-population)
Figure 2 Kaplan-Meier estimates for overall survival (ITT population)
anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
- Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Imatinib-behandling i 36 måneder forlængede signifikant RFS sammenlignet med 12 måneders imatinib-behandling (samlet hazard ratio (HR) = 0,46 [0,32-0,65], p<0,0001) (Tabel 7, Figur 1).
Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
- Kraftig hovedpine, svækkelse eller lammelser af lemmer eller ansigt, talebesvær, pludseligt bevidsthedstab (tegn på problemer med nervesystemet såsom blødning eller hævelse i
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Kapselskallen består af gelatine, titandioxid (E171), gul jernoxid (E172) og rød jernoxid (E172).
The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Median tid til respons var 13 uger (95% konfidensinterval 12-23).
Median time to response was 13 weeks (95% C.I.
Imatinib hæmmer også receptortyrosinkinaserne for trombocytafledte vækstfaktorer (PDGF), PDGF-R, og stamcellefaktorer (SCF), c-Kit, og hæmmer PDGF- og SCFmedierede cellulære signaler.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
1200 til 1600 mg (varighed varierer mellem 1 og 10 dage): Kvalme, opkastning, diarré, rødme, erytem, ødem, hævelse, træthed, muskelkramper, trombocytopeni, pancytopeni, abdominalsmerter,
1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache,
I en planlagt undergruppe-analyse af mutationstype var HR 0,35 [95% konfidensinterval: 0,22-0,56] for RFS ved 36 måneders behandling af patienter med mutationer i exon 11.
In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
• voksne patienter med Ph+ ALL med tilbagefald eller refraktær sygdom som monoterapi.
• Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Klassificering af nedsat leverfunktion:
Description of selected adverse reactions:
Alderen på disse patienter rangerede fra 8 til 18 år, og imatinib blev givet ved både adjuverende og metastatiske forhold i doser, der lå i intervallet fra 300 til 800 mg daglig.
The age of these patients ranged from 8 to 18 years and imatinib was given in both adjuvant and metastatic settings at doses ranging from 300 to 800 mg daily.
Dosisøgninger fra 600 mg til maksimalt 800 mg (givet som 400 mg 2 gange daglig) til patienter i 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 non-leukaemia-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.
RTC: <15% blaster i BM og PB, <30% blaster + promyelocytter i BM og PB, <20% basofilocytter i PB, ingen ekstramedullær sygdom andet end milt og lever.
NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver.
Samtidig anvendelse af rifampicin eller andre stærke CYP3A4
Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Kapslen er ca. 23 mm lang og 9 mm bred.
The capsules are approximately 23 mm long and 9 mm wide.
Hvis dette gælder for dig, skal du fortælle din læge det, før du tager Imatinib Teva B.V.
If this applies to you, tell your doctor without taking Imatinib Teva B.V.
Dette skyldes, at Imatinib Teva B.V.
This is because Imatinib Teva B.V.
Imatinib monoterapi med 600 mg/dag er sikker og effektiv hos voksne patienter med recidiverende eller refraktiv Ph+ ALL, og kan gives indtil der sker sygdomsprogression.
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Imatinib kan øge plasmakoncentrationen af andre CYP3A4metaboliserede lægemidler (for eksempel triazol-benzodiazepiner, dihydropyridincalciumantagonister, visse HMG-CoA reduktasehæmmere, såsom statiner osv.).
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e.
Behandlingsvarighed: I kliniske undersøgelser med GIST-patienter blev behandling med imatinib fortsat indtil sygdomsprogression.
Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression.
Forsigtighed tilrådes derfor, når imatinib administreres sammen med CYP3A4-substrater med snævert terapeutisk interval (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, dihydroergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel og quinidin).
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
(3 timer), dag 1-4;
(3 h), days 1-4;
(1 time), dag 28-31, 35-38, 42-45; oral, dag 26-46 oral, dag 1-5; i.v.
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Risikoen for tilbagefald var således reduceret med ca. 89% sammenlignet med placebo (hazard ratio =
The risk of recurrence was thus reduced by approximately 89% as compared with placebo (hazard ratio = 0.113 [0.049-0.264]).
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter) til sjældne (kan forekomme hos
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Methotrexat (20 mg/m2/uge, p.o.): dag 1, 8, 15, 22, 29, 36, 43, 50
Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
- 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
• 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).
Kapslen er ca. 19 mm lang og 7 mm bred.
The capsules are approximately 19 mm long and 7 mm wide.
bruges i forskellige faser af sygdommen (kronisk fase, accelereret fase og blastkrise).
In children and adolescents, Imatinib Teva B.V. can be used in different phases of the disease (chronic, accelerated phase and blast crisis).
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 kemoterapi (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).
- Hoste, åndedrætsbesvær eller smerter ved vejrtrækning (tegn på lungeproblemer).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
- Øvrige indholdsstoffer er calciumhydrogenphosphat, vandfrit, crospovidon og
- The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
VCR 2 mg total dosis i.v., dag 1, 8, 15, 22;
VCR 2 mg total dose i.v., days 1, 8, 15, 22;
Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) eller almindelige (kan forekomme hos op til 1 ud af 10 patienter): - Hurtig vægtøgning.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Af en række potentielt samtidigt administrerede lægemidler (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabin, erythromycin, fluconazol, hydroxyurea, norfloxacin, phenoxymethylpenicillin) hæmmede kun erythromycin (IC50 50 μm) og fluconazol (IC50 118 μm) 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.
Metabolisme og ernæring Almindelig:
Haemolytic anaemia Metabolism and nutrition disorders Common:
- 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 problems).
- Ondartede bindevævstumorer i mavetarmsystemet (gastrointestinale stromal tumorer (GIST)).
- Gastrointestinal stromal tumours (GIST).
er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
er 400 mg/dag til voksne patienter med MDS/MPD.
The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Må ikke opbevares ved temperaturer over 30°C.
Store below 30°C
- Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.