natgillin/translations-raw huggingface dataset:
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.
Denne hæmning er ikke observeret in vivo efter administrationen af 400 mg Imatinib og 1 g paracetamol.
Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFR-omlejring (5 patienter fra studie B2225).
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Der er ingen kontrollerede undersøgelser, undtagen hos nyligt diagnosticerede kronisk fase CML-patienter, der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse.
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter)
Very common (may affect more than 1 in 10 people)
Der er klinisk erfaring med administration af Imatinib sammen med kemoterapi til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret.
In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR)
The high rate of CHR is accompanied by the development of a completecytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Silica, kolloid vandfri Magnesiumstearat
Silica colloidal, anhydrous Magnesium stearate
INFORMATION I BRAILLESKRIFT Imatinib Accord 100 mg
INFORMATION IN BRAILLE Imatinib Accord 100 mg
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Imatinib Accord-behandling indtil ANC 1,0 x 109/l og trombocytter 20 x 109/l og genoptag herefter behandlingen med 300 mg.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
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.
Stop Imatinib Accord indtil ANC 1,5 x 109/l og trombocytter 75 x 109/l.
Stop Imatinib Accord until ANC ≥ 1.5x109/l and platelets ≥ 75x109/l.
Undersøgelse 0110 37 måneders data Kronisk fase, IFNsvigt (n=532)
Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
• Kronisk nyresvigt.
• Chronic renal failure
Medianvarigheden af førstevalgsbehandling var henholdsvis 82 og 8 måneder i Imatinibog INF-armene syv år efter, at den sidste patient var rekrutteret.
Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Imatinib and IFN arms, respectively.
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 adults patients with Ph+ ALL.
Hvis du har glemt at tage Imatinib Accord - Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanker om det.
- If you forget a dose, take it as soon as you remember.
Aktive stoffer hvis plasmakoncentration kan ændres af imatinib 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.
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%.
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%.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Imatinib Accord-behandlingen indtil ANC 1,0 x 109l og trombocytter 20 x 109l og genoptag behandling med 200 mg/m2.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
INFORMATION I BRAILLESKRIFT Imatinib Accord 400 mg
INFORMATION IN BRAILLE Imatinib Accord 400 mg
(3 timer), dag 1-4; mitoxantron 10 mg/m2 i.v.
(3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Palmoplantar erytrodysæstesi syndrom*, lichenoid keratosis*, lichen planus*, toksisk epidermal nekrolyse*, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS)*, pseudoporfyri* Knogler, led, muskler og bindevæv
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Derudover er der efter markedsføring rapporteret gastric antral vascular ecstasia (GAVE), en sjælden form for gastrointestinal blødning, hos patienter med CML, ALL og andre sygdomme (se pkt.
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Tabel 3 Respons hos voksne CML-patienter
Posology for CML in adult patients
(24 timer), dag 1, Ara-C 1 g/m2 i.v.
(24 h), day 1, Ara-C 1 g/ m2 i.v.
(24 timer), dag 1, og Ara-C 2 g/m2 i.v.
(24 h), day 1, and Ara-C 2 g/ m2 i.v.
Vedligeholdelse (8-ugers cykler) Cyklus 1-4
Maintenance (8-week cycles) Cycles 1cy
Imatinib Accord kan føre til, at din krop kan begynde at ophobe væske
Imatinib Accord may cause your body to retain water (severe fluid retention).
(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/ m2 i.v.
Elimination Baseret på fremkomne stof(fer) efter oral dosis af 14C-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).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
C. ANDRE FORHOLD OG BETINGELSER FOR
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
• PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C.
• For PVC/PVdC/Alu blisters Do not store above 30C.
Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i accelereret fase.
The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i blastkrise.
The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
(1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32
Ara-C 60 mg/ m2 i.v., days 22-25, 29-32
DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3-5; MTX 15 mg intrathecal, dag 1
DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3-5; MTX 15mg intrathecal, day 1
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 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Hæmoragisk corpus luteum/ hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet Meget almindelig Væskeretention og ødem, træthed Almindelig
Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administrative site conditions Very common Fluid retention and oedema, fatigue Common
Hvornår og hvordan skal du tage Imatinib Accord - Tag Imatinib Accord sammen med et måltid.
- Take Imatinib Accord with a meal.
Øre og labyrint Ikke almindelig
Vitreous haemorrhage* Ear and labyrinth disorders Uncommon
Børn: I studie I2301 blev der inkluderet i alt 93 børn, unge og yngre voksne (fra 1 til 22 år) med Ph+ ALL i et åbent, multicenter, ikke-radomiseret fase III sekventielt kohorte-forsøg.
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, nonrandomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Forhøjet serumkreatinin, forhøjet serumkreatinfosfokinase og forhøjet serumlaktatdehydrogenase, forhøjet alkalisk fosfatase
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Hæmatologisk respons1 Fuldstændigt hæmatologisk respons (CHR) Intet tegn på leukæmi (NEL) Remission til kronisk fase (RTC)
Haematological response Complete haematological response (CHR) No evidence of leukaemia
Desuden kan Imatinib Accord 400 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i pakningsstørrelser med 30 x 1, 60 x 1 eller 90 x 1 filmovertrukne tabletter.
Additionally Imatinib Accord 400 mg tablets are available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1 or 90x1 film-coated tablets.
6-MP (75 mg/m2/dag, p.o.): dag 11-56 (tilbagehold 6-MP i de 6-10 dage med kraniebestråling med start dag 1 i cyklus 5.
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the
Plasmaeksponeringen af levothyroxin kan muligvis mindskes, når Imatinib gives samtidig til thyreoidektomerede patienter (se pkt.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Desuden kan Imatinib Accord 100 mg tabletter fås i perforeret enhedsdosis-blister af PVC/PVdC/alu i pakningsstørrelser med 30 x 1, 60 x 1, 90 x 1, 120 x 1 eller 180 x 1 filmovertrukne tabletter.
Additionally Imatinib Accord 100 mg tablets are also available in PVC/PVdC/Alu perforated unit dose blister in pack-sizes of 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets.
Der er gennemført en større, åben, international, randomiseret, fase III multicenterundersøgelse med patienter med nydiagnosticeret Ph+ CML.
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.In addition, children and adolescents have been treated in two phase I studies and one phase II study.
ARA-C (3 g/m2/dosis q 12 h x 4, i.v.
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Dosering ved MDS/MPD Den anbefalede dosis af Imatinib Accord er 400 mg/dag til voksne patienter med MDS/MPD.
The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD.
Imatinib Accord 400 mg tabletter
Imatinib Accord 400 mg tablets
Dosis er 800 mg pr. dag, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg om morgenen og 4 tabletter à 100 mg eller én tablet à 400 mg om aftenen.
The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening.
Imatinib Accord 400 mg filmovertrukne tabletter er brun-orange, ovale, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T2' på hver sin side af delekærven på den ene side, jævne på den anden.
Imatinib Accord 400 mg film-coated tablets are brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
Imatinib Accord 100 mg filmovertrukne tabletter er brun-orange, runde, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T1' på hver sin side af delekærven på den ene side, jævne på den anden side.
Imatinib Accord 100 mg film-coated tablets are brownish orange, round biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side.
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 Accord i en reduceret dosis på 260 mg/m2.
In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2.
Sådan skal du tage Imatinib Accord
How to take Imatinib Accord
Hvis du behandles for MDS/MPD
Posology for MDS/MPD
Renale adenomer/carcinomer, papillomaer i blæren og urinrøret, adenocarcinomer i tyndtarmen, adenomer i bisskjoldbruskkirtlerne, de benigne og maligne tumorer i binyremarven og ikkekirtellignende 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 and adolescents (based on AUC) at 340 mg/m2/day.
Alu/alu-blister: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
This medicinal product does not require any special storage conditions.
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 Accord i en reduceret dosis på 300 mg.
In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Imatinib Accord at reduced dose of 300 mg.
Overordnet var den gennemsnitlige daglige dosis 406 ± 76 mg hos patienter, der fik Imatinib som førstevalg.
Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
(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;
Leverinsufficiens: Imatinib metaboliseres primært i leveren.
Imatinib is mainly metabolised through the liver.
Dosering ved HES/CEL Den anbefalede dosis af Imatinib Accord er 100 mg/dag til voksne patienter med HES/CEL.
The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL.
Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat).
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
- Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Accord, skal du kontakte din læge.
- Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l
ANC < 1.0x109/l and/or platelets < 50 x 109/l
• 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).
Ikke relevant Ikke relevant
Not applicable
Hvis du har taget for meget Imatinib Accord
If you forget to take Imatinib Accord
Meget almindelig Neutropeni, trombocytopeni, anæmi Almindelig
Blood and lymphatic system disorders Very common Neutropenia, thrombocytopenia, anaemia Common
Imatinib Accord 100 mg filmovertrukne tabletter Imatinib Accord 400 mg filmovertrukne tabletter imatinib
Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib
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.
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.
Tag ikke Imatinib Accord - hvis du er allergisk over for imatinib eller et af de øvrige indholdsstoffer i Imatinib Accord
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3, 4, 5; MTX
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
LÆGEMIDLETS NAVN Imatinib Accord 400 mg filmovertrukne tabletter imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 400 mg film-coated tablets imatinib
Dosering ved DFSP Den anbefalede dosis af Imatinib er 800 mg/dag til voksne patienter med DFSP.
The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Meget almindelig Hovedpine2 Almindelig
Confusional state Nervous system disorders Very common Headache2
LÆGEMIDLETS NAVN Imatinib Accord 100 mg filmovertrukne tabletter imatinib
NAME OF THE MEDICINAL PRODUCT Imatinib Accord 100 mg film-coated tablets imatinib
Hver Imatinib Accord 400 mg tablet indeholder 400 mg imatinib (som mesilat).
Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate).
PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C.
For PVC/PVdC/Alu blisters Do not store above 30C.
I tilfælde af tilbagevenden af ANC <1,0 x 109/l og/eller trombocytter <50 x 109/l, gentages trin 1 og Imatinib Accord reintroduceres med nedsat dosering på 400 mg.
In the event of recurrence of ANC < 1.0x109/1 and/or platelets < 50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
Hæmolytisk anæmi, trombotisk mikroangiopati Metabolisme og ernæring Almindelig
Haemolytic anaemia, thrombotic microangiopathy
Brun-orange, runde, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T1' på hver sin side af delekærven på den ene side, jævne på den anden side.
Brownish orange, round, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side.
Disse patienter fik imatinib i en periode varierende mellem 24 dage og
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna,
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Imatinib Accord 100 mg filmovertrukne tabletter
Imatinib Accord 100 mg film-coated tablets
Imatinib Accord indeholder: - Aktivt stof: imatinibmesilat.
- The active substance is imatinib mesilate.
I tre publikationer var der rapporteret om tre (3) patienter med HES og CEL forbundet med PDGFR-omlejring.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Brun-orange, ovale, bikonvekse filmovertrukne tabletter, præget med ‘IM' og ‘T2' på hver sin side af delekærven på den ene side, jævne på den anden.
Brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side.
12 mg intrathecal, dag 1
MTX 15 mg intrathecal, day1;
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 400 mg imatinib (som mesilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg imatinib (as mesilate)
Det skal du vide, før du begynder at tage Imatinib Accord Sådan skal du tage Imatinib Accord Bivirkninger
What Imatinib Accord is and what it is used for What you need to know before you take Imatinib Accord How to take Imatinib Accord Possible side effects
aANC<0,5 x 109/l og/eller trombocytter <10 x 109/l
aANC < 0.5x109/1 and/or platelets < 10 x 109/1
Hyperkaliæmi, hypomagnesiæmi
Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common
Imatinib Accord 400 mg filmovertrukne tabletter
Imatinib Accord 400 mg film-coated tablets
Den sædvanlige dosis af Imatinib Accord er
Other medicines and Imatinib Accord
SÆRLIGE OPBEVARINGSBETINGELSER PVC/PVdC/alu-blister:
SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C.
Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonalt 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.
Hvis din daglige dosis er 800 mg (8 tabletter à 100 mg eller to tabletter à 400 mg), skal du tage 4 tabletter à 100 mg eller én tablet à 400 mg om morgenen og 4 tabletter à 100 mg eller én tablet à 400 mg om aftenen.
If your daily dose is 800 mg (8 tablets of 100 mg or 2 tablets of 400 mg).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg imatinib (as mesilate)
Meget almindelig Periorbitalt ødem, dermatitis/eksem/udslæt Almindelig
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common Periorbital oedema, dermatitis/eczema/rash Common
Dosering ved CML hos voksne patienter Den anbefalede dosis af Imatinib er 400 mg/dag til voksne patienter med CML i kronisk fase.
The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML.
Hver Imatinib Accord 100 mg tablet indeholder 100 mg imatinib (som mesilat).
Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate).
dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Imatinib Accord 100 mg tabletter EU/1/13/845/001-004
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004
Imatinib Accord 400 mg tabletter EU/1/13/845/009-011
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011
Startdosis er 600 mg, som skal tages som 6 tabletter à 100 mg eller én tablet à 400 mg plus to tabletter à 100 mg én gang daglig.
If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 6 tablets of 100 mg or one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Forhøjet serumamylase
Increased hepatic enzymes
Brug af anden medicin sammen med Imatinib Accord Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly.
Studie AUS01 Induktionskonsoliderende behandling
Study AUS01
Hypromellose 6 cps (E464) Talkum (E553b) Polyethylenglycol Jernoxid, gul (E 172) Jernoxid, rød (E 172)
Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172)
Trombose/emboli* Luftveje, thorax og mediastinum Almindelig
Respiratory, thoracic and mediastinal disorders Common
): dag 4
(24 h), day 4;