natgillin/translations-raw huggingface dataset:
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.
dag 3-5; MTX 15 mg intrathecal, dag 1; Methylprednisolon 40 mg intrathecal, dag 1
days 3-5; MTX 15 mg intrathecal, day 1; methylprednisolone 40 mg intrathecal, day 1
8 Der er rapporteret tilfælde af letalt leversvigt og levernekrose.
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
Det skal du vide, før du begynder at tage Imatinib Actavis
What you need to know before you take Imatinib Actavis
Imatinib Actavis indeholder natrium
Imatinib Actavis contains sodium
Tredobbelt i.t.-terapi (aldersjusteret): dag 1, 29 VCR (1,5 mg/m2, i.v.
Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Der er udført et åbent multicenter fase II-klinisk forsøg (studie B2225) med inklusion af 12 patienter med DFSP, som blev behandlet med imatinib 800 mg daglig.
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
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/m2 daily.
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/m2 daily or doses ranging from 200 to 400 mg daily.
Aktive stoffer hvis plasmakoncentration kan ændres af imatinib:
Active substances that may have their plasma concentration altered by imatinib:
DAUN (45 mg/m2/dag bolus, i.v.
DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Stoffer der hæmmer cytochrom P450 isoenzym CYP3A4-aktivitet (f.eks. proteasehæmmere som f.eks. indinavir, lopinavir/ritonavir, ritonavir, saquinavir, teleprevir, nelfinavir, boceprevir; azol-antimykotika inklusiv ketoconazol, itraconazol, , posaconazol, voriconazol; bestemte makrolider som f.eks. erythromycin, clarithromycin og telithromycin) kan nedsætte metabolismen og øge koncentrationen af imatinib.
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Elimination Baseret på fremkomne stof(fer) efter oral dosis af 14-mærket imatinib, genfandtes ca. 81 % af dosis inden for 7 dage i fæces (68 % af dosis) og urin (13 % af dosis).
of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Hæmolytisk anæmi, trombotisk mikroangiopati
Haemolytic anaemia, thrombotic microangiopathy
- Smerte eller oppustning af maven, luft i maven, halsbrand eller forstoppelse.
- Pain or swelling in your abdomen, flatulence, heartburn or constipation.
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/m2 daily.
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),
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.
Dosering ved HES/CEL Den anbefalede dosis af imatinib er 100 mg/dag til voksne patienter med HES/CEL.
Posology for HES/CEL The recommended dose of imatinib is 100 mg/day for adult patients with HES/CEL.
Aktive stoffer der kan øge plasmakoncentrationen af imatinib:
Active substances that may increase imatinib plasma concentrations:
1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; Methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Brug af anden medicin sammen med Imatinib Actavis
Other medicines and Imatinib Actavis
Svaghed, pyrexia, anasarka, kuldegysninger og kulderystelser
Weakness, pyrexia, anasarca, chills, rigors
Der 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.
Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med imatinib samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin Plasma AUC for imatinib blev reduceret med 73 % sammenlignet med patienter som ikke blev behandlet med EIAEDs.
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
- Øvrige indholdsstoffer: Kapselindhold: mikrokrystallinsk cellulose, copovidon, crospovidon, natriumstearylfumarat, silica (vandskyende kolloid, kolloid vandfri).
- The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
- Næseblod.
- Nose bleeds.
Shellac Glaze-45% Sort jernoxid (E172) Propylenglycol Ammoniumhydroxid 28%
Shellac Glaze-45% Black iron oxide (E172) Propylene glycol Ammonium Hydroxide 28%
- Udslæt.
- Bruising.
(RTC) Cytogenetisk hovedrespons2
Return to chronic phase (RTC) Major cytogenetic response2
(3 timer), dag 1; Daunorubicin 60 mg/m2 i.v.
(3 h), day 1; daunorubicin 60 mg/m2 i.v.
Almindelige (kan forekomme hos op til 1 ud af 10 brugere): - Appetitløshed, vægttab eller smagsforstyrrelser.
Common (may affect up to 1 in 10 people): - Anorexia, weight loss or a disturbed sense of taste.
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-randomiseret 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, non-randomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Daunorubicin 30 mg/m2 i.v., dag 1-3, 15-16; 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 1-28; MTX 15 mg intrathecal, dag
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8; prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28; MTX
Aktive stoffer der kan reducere plasmakoncentrationen af imatinib:
Active substances that may decrease imatinib plasma concentrations:
Trombocytæmi, lymfopeni, knoglemarvsdepression, eosinofili, lymfadenopati
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
(q 12 timer), dag 2-3, i 4
(q 12 h), days 2-3, for
(1 time), dag 1-5; VM26 60 mg/m2 i.v.
(1 h), days 1-5; VM26 60 mg/m2 i.v.
Dosering ved DFSP Den anbefalede dosis af imatinib er 800 mg/dag til voksne patienter med DSFP.
Posology for DFSP The recommended dose of imatinib is 800 mg/day for adult patients with DFSP.
Patienterne bør, på baggrund af risikoen for øget bivirkningsincidens ved højere doser, monitoreres tæt efter dosistitrering.
Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Palpitationer, takykardi, hjerteinsufficiens3, lungeødem
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Imatinib Actavis er indiceret til behandling af - børn med nydiagnosticeret Philadelphiakromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi
Imatinib Actavis is indicated for the treatment of - 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 treatment.
ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
- Mavesmerter med kvalme.
- Stomach pain with feeling sick (nausea).
5.1) 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.
- 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).
Da dyreforsøg 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, og undgå hud- og øjenkontakt eller inhalation (se pkt.
Handling of opened capsules by women of child-bearing potential 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).
DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33
DEX (6 mg/m2/day, PO): days 1-5; 29-33
Din læge vil fortælle dig, præcis hvor mange Imatinib Actavis-tabletter, du skal tage.
Your doctor will tell you exactly how many tablets of Imatinib Actavis to take.
RTC <15 % blaster I BM og PB, <30 % blaster + promyelocytter in BM og PB, <20 % basofilocytter i
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,
Kapslerne findes i blisterpakninger af aluminium med 30 eller 90 kapsler.
Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Lægen vil fortælle dig, hvor mange Imatinib Actavis-tabletter, du skal give dit barn.
The doctor will tell you how many tablets of Imatinib Actavis to give to your child.
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.
Prægeblæk: shellac, sort jernoxid (E172), propylenglycol, ammoniakopløsning, kaliumhydroxid.
Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. det er i det væsentlige natrium-frit.
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Induktionsbehandling CP 1,2 g/m2 i.v.
Induction therapy CP 1.2 g/m2 i.v.
Stivhed i led og muskler
Joint and muscle stiffness
Remissionsinduktion DEX 10 mg/m2 oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; IDA 8 mg/m2 i.v.
Remission induction DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m2 i.v.
Prægeblæk: shellac glaze-45%, sort jernoxid (E172), propylenglycol, ammonium hydroxid 28%.
Printing ink: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium Hydroxide 28%.
Lægen vil fortælle dig, hvor mange Imatinib Actavis-kapsler, du skal give dit barn.
The doctor will tell you how many capsules of Imatinib Actavis to give to your child.
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
G-CSF (5 μg/kg, s.c.): dag 27-36, eller indtil ANC >1500 post nadir ARA-C (3 g/m2, q12h, i.v.
G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Jernoxid, gul (E 172) Titandioxid (E171) Jernoxid, rød (E 172) Lecithin (soya) (E322) Xanthangummi (E415)
Iron oxide yellow (E172) Titanium dioxide (E171) Iron oxide red (E172) Lecithin (soya) (E322) Xanthan gum (E415)
EU/1/13/825/003 24 kapsler EU/1/13/825/004 48 kapsler EU/1/13/825/019 60 kapsler EU/1/13/825/005 96 kapsler EU/1/13/825/006 120 kapsler EU/1/13/825/007 180 kapsler
EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
(1 time), dag 1-3; Vinkistin 1,3 mg/m2 i.v., dag 1, 8, 15, 21; Prednisolon 60
(1 h), days 1-3; vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21; prednisolone 60 mg/m2/day oral
Pakningsstørrelser Tabletterna findes i blisterpakninger af aluminium med 10, 30, 60 eller 90 filmovertrukne tabletter
Pack sizes: The tablets are supplied in aluminium blister packs of 10, 30, 60 or 90 film-coated tablets.
(1 time) dag 4-5; Ara-C 2x 2 g/m2 i.v.
(1 h) days 4-5; Ara- C 2x 2 g/m2 i.v.
Imatinib Actavis 400 mg filmovertrukne tabletter 21 måneder
Imatinib Actavis 400 mg film-coated tablets 21 month
(24 timer), dag 1; Etoposid 250 mg/m2 i.v.
(24 h), day 1; etoposide 250 mg/m2 i.v.
Imatinib Actavis 50 mg hårde kapsler Imatinib Actavis 100 mg hårde kapsler Imatinib Actavis 400 mg hårde kapsler
Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules
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, bullous eruptions
(3 timer), dag 1-4; Mitoxantron 10 mg/m i.v.
(3 h), days 1-4; mitoxantrone 10 mg/m i.v.
Den sædvanlige dosis af Imatinib Actavis er Brug til voksne
How much Imatinib Actavis to take Use in adults
Din læge vil fortælle dig, præcis hvor mange Imatinib Actavis-kapsler, du skal tage.
Your doctor will tell you exactly how many capsules of Imatinib Actavis to take.
Sort jernoxid (E172) Propylenglycol Ammoniakopløsning Natriumhydroxid
Black iron oxide (E172) Propylene glycol Ammonia solution Potassium hydroxide
Tabel 1 Opsummering af bivirkninger
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
aANC < 0,5 x 109/l og/eller trombocytter < 10 x 109/l
aANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Stoffer, der inducerer CYP3A4-aktivitet (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller Hypericum perforatum), kan signifikant reducere følsomheden for imatinib og dermed potentielt øge risikoen for terapeutisk svigt.
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.
(1 time) dag 4-5;
(24 h), day 4;
Forhøjet serumkreatinin, forhøjet serumkreatinfosfokinase og øget serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Imatinib Actavis 100 mg filmovertrukne tabletter 2 år
Imatinib Actavis 100 mg film-coated tablets 2 years
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.
- Mundtørhed, tør hud eller tørre øjne.
- Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
Flatulens, abdominal udspilling, gastrooesophageal refluks, obstipation, mundtørhed, gastritis
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Kronisk nyresvigt
Renal failure chronic
(24 timer), dag 1, Ara-C 1 g/m2 i.v.
(24 h), day 1, Ara-C 1 g/m2 i.v.
Ifosfamid (1,8 g/m2/dag, i.v.
Ifosfamide (1.8 g/m2/day, IV): days 1-5
(24 timer), dag 4; DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m2 i.v.
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
EU/1/13/825/015 10 tabletter EU/1/13/825/016 30 tabletter EU/1/13/825/017 60 tabletter EU/1/13/825/018 90 tabletter
EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
Svær
Rare
Forhøjede leverenzymer
GENERAL CLASSIFICATION FOR SUPPLY
PEG-ASP (2.500 IE/m2, i.m.
PEG-ASP (2500 IUnits/m2, IM): day 4
(24 timer), dag 1, og Ara-C 2 g/m2 i.v.
(24 h), day 1, and Ara-C 2 g/m2 i.v.
Gennem alle faser af omsorgen bør behandlingen overvåges af hæmatologiske eksperter, som er ansvarlige for denne sygdom.
Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Methotrexat (20 mg/m2/uge, p.o.): dag 8, 15, 22 VP-16 (100 mg/m2, i.v.
Methotrexate (20 mg/m2/week, PO): days 8, 15, 22 VP-16 (100 mg/m2, IV): days 29-33
Imatinib Actavis 400 mg hårde kapsler Aluminium/PVC/PVDC blister.
Imatinib Actavis 400 mg hard capsules Al/PVC-PVDC blister.
Hos 4 % af GIST-patienterne blev undersøgelsesmedicinen seponeret på grund af lægemiddelrelaterede bivirkninger.
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
(3 timer), dag 1-4; Mitoxantron 10 mg/m2 i.v.
(3 h), days 1-4; mitoxantrone 10 mg/m2 i.v.
Seponer 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.
Natriumstearylfumarat Silica, vandskyende kolloid Silica, kolloid vandfri
Sodium stearyl fumarate Silica, hydrophobic colloidal Silica, colloidal anhydrous
Imatinib Actavis 50 mg hårde kapsler Aluminium/PVC/aclar blister.
Imatinib Actavis 50 mg hard capsules Al/PVC/Aclar blister.
Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i bisskjoldbruskkirtlerne, 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 children (based on AUC) at 340 mg/m2/day.
Præfase
Prephase
Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi, pankreatitis
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE)
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
EU/1/13/825/008 10 tabletter EU/1/13/825/009 20 tabletter EU/1/13/825/010 30 tabletter EU/1/13/825/011 60 tabletter EU/1/13/825/012 90 tabletter EU/1/13/825/013 120 tabletter EU/1/13/825/014 180 tabletter
EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
- 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).
- Kvalme, opkastninger, diarré eller fordøjelsesbesvær.
- Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
Imatinib Actavis 100 mg hårde kapsler Aluminium/PVC/aclar blister.
Imatinib Actavis 100 mg hard capsules Al/PVC/Aclar blister.
Forsigtighed tilrådes derfor, når imatinib administreres sammen med CYP3A4-substrater med snævert terapeutisk interval (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, diergotamin, 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).
Kapslerne findes i blisterpakninger af aluminium med 10, 30, 60 eller 90 kapsler.
Pack sizes: The capsules are supplied in aluminium blister packs of 10, 30, 60, or 90 capsules.
Væskeretention og ødem, træthed
Fluid retention and oedema, fatigue
Glaslegemeblødning*
Vitreous haemorrhage*
Imatinib Actavis 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
Imatinib Actavis 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate).
Vægttab
Headache2
Hvis din daglige dosis er 800 mg (8 tabletter), skal du tage 4 tabletter om morgenen og 4 tabletter om aftenen.
If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
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
Øjenirritation, øjensmerter, orbitalt ødem, sclerablødning, retinablødning, blepharitis, makulært ødem
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
(2 timer, q 12 timer), dag 2-3
(2 h, q 12 h), days 2-3 (total of 8 courses)
Rund, bikonveks mørkegul til brun filmovertrukken tablet, præget med virksomhedslogoet på den ene side og "36" med delekærv på den anden side.
Round, biconvex dark yellow to brownish film-coated tablet, embossed with company logo on one side and “36” with score line on the other side.
cyklus
4 cycles
- Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt kalium-, urinsyre- og calcium og lavt fosforniveau i blodet).
- Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Opbevar dette lægemidlet utilgængeligt for børn.
Keep this medicine out of the sight and reach of children.
DEX 10 mg/m2 oral, dag 1-5; VCR 2 mg i.v., dag 6, 13, 20; Daunorubicin 45 mg/m2 i.v., dag 6-7, 13-14
Induction therapy I DEX 10 mg/m2 oral, days 1-5; VCR 2 mg i.v., days 6, 13, 20; daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
L-ASP (6000 IE/m2,i.m.
L-ASP (6000 IUnits/m2, IM): day 44
Induktionsbehandling II
ANNEX II
Vaskulære sygdomme4
Vascular disorders4