natgillin/translations-raw huggingface dataset:
Efter peroral administration genfindes cirka 5% til 10% af dosis uomdannet i urinen over 24 timer, og resten udskilles som temozolomidsyre, 5- aminoimidazol- 4- carboxamid (AIC) eller uidentificerede polære metabolitter.
Following oral administration, approximately 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4- carboxamide (AIC) or unidentified polar metabolites.
Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasma- TMZ- clearance var uafhængig af alder, nyrefunktion og tobaksforbrug.
13 Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Den maksimalt tolererede dosis (MTD) var 1. 000 mg/ m2 pr. serie for både børn og voksne.
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Enkelt- serie (5- dages dosering, 23 dages behandlingspause) og 3 - og 6- cycli toksicitetsundersøgelser blev udført på rotter og hunde.
Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
De primære målorganer for toksicitet omfattede knoglemarven, det lymforetikulære system, testes, mave- tarmkanalen og ved højere doser, der var dødelige hos 60% til 100% af de undersøgte rotter og hunde, forekom degeneration af retina.
The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60% to 100% of rats and dogs tested, degeneration of the retina occurred.
Det dosisrelaterede fald i leukocyt - og trombocyttal synes at være følsomme markører for toksicitet.
Dose- related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Forskellige neoplasier, omfattende brystcancer, keratoacanthom i huden og basalcelleadenom, fandtes i en undersøgelse omfattende 6- cycli på rotter, mens der ikke sås tumorer eller præneoplastiske forandringer i undersøgelser på hunde.
A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Resultaterne af Ames/ Salmonella og Human Perifer Blod Lymfocyt (HPBL) kromosomaberrationtest viste et positivt mutagenicitetsresultat.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Kapsel indhold: lactose, vandfri, silica kolloid, vandfri, natrium- glykolatstivelse type A, vinsyre, stearinsyre.
Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Tryk: shellac, propylenglycol, renset vand, ammoniumhydroxid, kaliumhydroxid, sort jernoxid (E 172).
Printing ink: shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, black iron oxide (E 172).
14 6. 3 Opbevaringstid
6. 3 Shelf life
Type I brune glasflasker med polypropylen børnesikrede lukninger indeholdende 5 eller 20 hårde kapsler.
Type I amber glass bottles with polypropylene child-resistant closures containing 5 -or 20 hard capsules.
Hvis en kapsel ødelægges, skal hud - og slimhindekontakt med det pulveragtige indhold undgås.
If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Patienter bør rådes til at opbevare kapslerne utilgængeligt og ude af syne for børn, helst i et aflåst skab.
Patients should be advised to keep capsules out of the reach and sight of children, preferably in a locked cupboard.
26. januar 1999.
26 January 1999.
26. januar 2009.
26 January 2009
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
15 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Hver hård kapsel indeholder 182, 2 mg vandfri lactose.
Each hard capsule contains 182.2 mg of anhydrous lactose.
Hætten bærer et tryk med ” Temodal ”.
The cap is imprinted with “Temodal”.
Bunden bærer et tryk med ” 20 mg ”, Schering - Plough- logoet og to striber.
The body is imprinted with "20 mg", the Schering-Plough logo and two stripes.
Temodal hårde kapsler anvendes konkomitant med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier af temozolomid (TMZ) - monoterapi (monoterapi fase).
Temodal hard capsules is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Konkomitant fase TMZ indgives oralt i en dosis på 75 mg/ m2 dagligt i 42 dage konkomitant med fokal strålebehandling (60 Gy indgivet i 30 fraktioner).
Concomitant phase TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
16 • common toxicity criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning) Under behandling bør en komplet blodundersøgelse foretages ugentlig.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
≥ 0, 5 og < 1, 5 x 10 / l
≥ 0.5 and < 1.5 x 10 /l
CTC Grad 3 eller 4
CTC Gr ade 3 or 4
Absolut antal neutrofile ≥ 1, 5 x 109/ l; trombocyttal ≥ 100 x 109/ l; CTC ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme, opkastning).
Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Dosis i serie 1 (monoterapi) er 150 mg/ m2 én gang dagligt i 5 dage efterfulgt af 23 dage uden behandling.
Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
Ved begyndelsen af serie 2 øges dosis til 200 mg/ m2, hvis CTC ikke- hæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen for alopeci, kvalme og opkastning), absolut antal neutrofile (ANC) er ≥ 1, 5 x 109/ l og trombocyttal er ≥ 100 x 109/ l.
At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non- haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Når dosis en gang er steget, bibeholdes den på 200 mg/ m2 per dag i de første 5 dage af hver følgende serie, undtagen hvis der forekommer toksicitet.
Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Tabel 2.
Table
Dosistrin
TMZ dose
TMZ dosis (mg/ m2/ dag)
TMZ dose levels for monotherapy treatment Remarks
Bemærkninger
(mg/m2/day)
Tabel 3.
18 Table 3.
< 1, 0 x 109/ l 9 < 50 x 10 / l
< 1.0 x 109/l < 50 x 109/l
opkastning)
TMZ dose levels are l isted in Table 2. b:
17 Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Til patienter, som ikke tidligere er behandlet med kemoterapi, indgives TMZ oralt i en dosis på 200 mg/ m2 én gang dagligt i de første 5 dage efterfulgt af en 23 - dages behandlingspause (i alt 28 dage).
In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
TMZs farmakokinetik var sammenlignelig for patienter med normal leverfunktion og patienter med let til moderat leverinsufficiens.
The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepaticimpairment.
4. 4).
However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Indgivelsesmåde Temodal hårde kapsler bør indtages fastende.
Method of administration
Kapslerne skal sluges hele med et glas vand og må ikke åbnes eller tygges.
Temodal hard capsules should be administered in the fasting state.
Hvis opkastning forekommer efter dosis er indtaget, skal en anden dosis ikke indtages samme dag.
The capsules must be swallowed whole with a glass of water and must not be opened or chewed.
4. 4).
19 Severe myelosuppression (see section 4.4).
18 Der kan være en højere forekomst af PCP, når TMZ anvendes i et længere dosisregime.
There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Mandlige patienter
20 Male patients
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Inter action with other medicinal products and other forms of interaction
19 I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
21 4.7 Effects on ability to drive and use machines
Hos patienter med nyligt diagnosticeret glioblastom multiforme, der fik TMZ samtidig med strålebehandling eller som monoterapi, blev udslæt rapporteret som værende meget almindeligt.
In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Hos patienter med tilbagevendende gliom blev udslæt rapporteret som værende almindeligt.
Convulsions were reported very commonly in the newly- diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Hypokalæmi, forhøjet alkalisk fosfatase, vægtøgning
Anorexia Hyperglycaemia, weight decreased Hypokalemia, alkaline phosphatase increased, weight increased
Hyperglycæmi, vægtøgning
Anorexia Weight decreased Hyperglycaemia, weight increased
Almindelige:
22 Psychiatric disorders Common:
Kramper, bevidsthedssvækkelse, døsighed, afasi, nedsat balanceevne, svimmelhed, forvirring, nedsat hukommelse, nedsat koncentrationsevne, neuropati, parestesi, taleforstyrrelse, tremor
Headache Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Hemiparese, afasi, nedsat balanceevne, døsighed, forvirring, svimmelhed, nedsat hukommelse, nedsat koncentrationsevne, dysfasi, neurologisk lidelse (NOS), neuropati, perifer neuropati, parestesi, taleforstyrrelse, tremor
Convulsions, headache Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Almindelige:
23 Common:
Meget almindelige:
Skin and subcutaneous tissue disorders Very common:
22
Uncommon:
Når unormale laboratorieværdier og bivirkninger blev slået sammen på tværs af konkomitante og monoterapi- behandlingsfaser, blev Grad 3 - eller Grad 4- neutrofilabnormaliteter inklusive neutropeni- bivirkninger set hos 8% af patienterne.
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil
Grad 3 - eller Grad 4- trombocytabnormaliteter, inklusive trombocytopeni- bivirkninger blev set hos 14% af patienterne, der fik TMZ.
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
I kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger gastrointestinale forstyrrelser, særligt kvalme (43%) og opkastninger (36%).
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Disse bivirkninger var oftest grad 1 eller 2, (0- 5 opkastninger inden for 24 timer) og ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standard- behandling.
These reactions were usually Grade 1 or 2 (0 – 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Køn
25 Gender
4% af de mandlige forsøgspersoner og Grad 4- thrombocytopeni hos 8% af de kvindelige vs.
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8% of female vs 4% of male subjects and Grade 4 thrombocytopenia in 8% of female vs 3% of male subjects in the first cycle of therapy.
0% af de mandlige forsøgspersoner i det første terapiforløb.
In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
24 Erfaring efter markedsføring:
Post-Marketing Experience
Én patient har taget en overdosis på 10. 000 mg (total dosis i en enkelt serie over 5 dage) og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og dødsfald.
An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi- organ failure and death.
MTICs cytotoksiske effekt formodes primært at skyldes alkyleringen ved O6- positionen i guanin med ledsagende alkylering ved N7- positionen.
The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
TMZ blev givet som salvage- behandling i opfølgningsfasen hos 161 patienter af 282 (57%) i armen med strålebehandling alene, og 62 patienter af 277 (22%) i armen med TMZ + strålebehandling.
26 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
Risiko forholdene (HR) for den totale overlevelse var 1, 59 (95% CI for HR=1, 33 - 1, 91) med en log - rank p < 0, 0001 til fordel for TMZ- gruppen.
The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Kaplan- Meier kurver for total overlevelse (intent- to- treat population)
Kaplan-Meier curves for overall survival (intent-to-treat population)
Data for tiden til forværring af neurologisk status var bedre for TMZ end for procarbazin, ligesom data for tiden til forværring af performance (reduktion til en KPS på < 70 eller en reduktion på mindst 30 points).
The
Median- tiden til progression af disse endpoints varierede fra at være 0, 7 til 2, 1 måneder længere for TMZ end for procarbazin (log rank p = < 0, 01 til 0, 03).
27 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Responsrate, baseret på den centrale reviewers vurdering, var 35% (13 CR og 43 PR) for intent- to- treat populationen (ITT) n=162.
Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Den
In 43 patients stable disease was reported.
26 6- måneders hændelses- frie overlevelse for ITT populationen var 44% med en median event- fri overlevelse på 4, 6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Særlige patientgrupper
28 Special populations
Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasma- TMZ- clearance var uafhængig af alder, nyrefunktion og tobaksforbrug.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Den maksimalt tolererede dosis (MTD) var 1. 000 mg/ m2 pr serie for både børn og voksne.
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
28 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Flaske
Bottle presentation
Brev
Sachet presentation
Brevene består af lineære lav- densitet polyethylen (inderste lag), aluminium og polyethylen terephtalat.
Sachets are composed of linear low density polyethylene (innermost layer), aluminium and polyethylene terephthalate.
Hver hård kapsel indeholder 175, 7 mg vandfri lactose.
Each hard capsule contains 175.7 mg of anhydrous lactose.
Bunden bærer et tryk med ” 100 mg ”, Schering - Plough- logoet og to striber.
The body is imprinted with "100 mg", the Schering-Plough logo and two stripes.
Det anbefales ikke at foretage dosisreduktioner, men udskydelse eller seponering af TMZ- indgift bør overvejes hver uge i henhold til hæmatologiske og ikke- hæmatologiske toksicitetskriterier.
No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non -haematological toxicity criteria.
31 • common toxicity criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning) Under behandling bør en komplet blodundersøgelse foretages ugentlig.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
≥ 10 og < 100 x 109/ l
≥ 10 and < 100 x 109/l
CTC Grad 2
CTC Gr ade 2
Tabel 3.
33 Table 3.
32 Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Baseret på TMZ’ s farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller hvilken som helst grad af nyreinsufficiens.
Based on the ph armacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renalimpairment.
IndgivelsesmådeTemodal hårde kapsler bør indtages fastende.
Method of administration
4. 4).
34 Severe myelosuppression (see section 4.4).
Patienter, som fik konkomitant TMZ og strålebehandling i en pilotundersøgelse af det længerevarende 42- dages program, viste sig at have særlig risiko for at udvikle Pneumocystis carinii lungebetændelse (PCP).
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia (PCP).
33 Malignitet
Malignancies
Mandlige patienter
35 Male patients
34 I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Kvinder i den fertile alder skal anbefales at anvende sikker krontraception for at undgå graviditet under behandling med TMZ.
Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ. pregnancy while they are receiving TMZ.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
36 4.7 Effects on ability to drive and use machines
Hos patienter med nyligt diagnosticeret glioblastom multiforme, der fik TMZ samtidig med strålebehandling eller som monoterapi, blev udslæt rapporteret som værende meget almindeligt.
In patients treated with TMZ, whe ther used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
36 Almindelige:
Common:
Almindelige:
38 Common:
37
Uncommon:
Køn
40 Gender
39 Erfaring efter markedsføring:
Post-Marketing Experience
Dette blev efterfulgt af monoterapi med TMZ (150 - 200 mg/ m2) på dag 1 - 5 i hver 28- dags serie i op til 6 serier, startende 4 uger efter afsluttet strålebehandling.
This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
TMZ blev givet som salvage- behandling i opfølgningsfasen hos 161 patienter af 282 (57%) i armen med strålebehandling alene, og 62 patienter af 277 (22%) i armen med TMZ + strålebehandling.
41 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
Risiko forholdene (HR) for den totale overlevelse var 1, 59 (95% CI for HR=1, 33 - 1, 91) med en log - rank p < 0, 0001 til fordel for TMZ- gruppen.
The hazard ratio (H R) for overall survival was 1.59 (9 5% CI for HR=1 .33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
40 ITT Population:
H R (9 5% C .I.) = 1 .5 9 (1 .3 3 – 1 .9 1) lo g -ra n k p -va lu e < .0 0 0 1
Total overlevelse
26% RT+TM Z
Sandsynlighed
10% R T O n ly
HR (95% C. I.) = 1, 59 (1, 33 log - rank p - value <, 0001
1 4 .6
– 1, 91)
Figure 1
Median- tiden til progression af disse endpoints varierede fra at være 0, 7 til 2, 1 måneder længere for TMZ end for procarbazin (log rank p = < 0, 01 til 0, 03).
42 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
41 6- måneders hændelses- frie overlevelse for ITT populationen var 44% med en median event- fri overlevelse på 4, 6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
TMZ blev givet daglig i 5 dage hver 28. dag.
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen admin istered daily for 5 days every 28 days.
Særlige patientgrupper
43 Special populations
42 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
6. 2 Uforligeligheder
44 6.2 Incompatibilities
43 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
8.
45 8.
De hårde kapsler har en uigennemsigtig hvid bund, en blå hætte og bærer et tryk med sort tryksværte.
Hard capsule The hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.
Bunden bærer et tryk med ” 140 mg ”, Schering- Plough- logoet og to striber.
The body is imprinted with "140 mg", the Schering-Plough logo and two stripes.
- voksne patienter med nydiagnosticeret glioblastoma multiforme konkomitant med
- adult patients with newly-diagnosed gliobl astoma multiforme concomitantly with radiotherapy
46 • common toxicity criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning) Under behandling bør en komplet blodundersøgelse foretages ugentlig.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
Tabel 3.
48 Table 3.