FrancophonIA/ELRC3.0 huggingface dataset:
English: • reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia)
Danish: • reduceret antal blodceller (neutropeni eller lymfopeni, thrombocytopeni)
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Nervous system disorders Very common:
Danish: Nervesystemet Meget almindelig
English: • upset stomach
Danish: • urolig mave
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Danish: Plasmahalveringstiden (t½) er ca. 1,8 timer.
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Danish: Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA hovedsageligt ved O6 -og N7-positionen i guanin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FLASKER
English: • fever
Danish: • feber
English: ≥ 0.5 and < 1.5 x 109/l
Danish: ≥ 0,5 og < 1,5 x 109/l
English: Hepatotoxicity
Danish: Hepatotoksicitet
English: ≥ 10 and < 100 x 109/l
Danish: ≥ 10 og < 100 x 109/l
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Danish: Hvis en kapsel ødelægges, skal hud- og slimhindekontakt med det pulveragtige indhold undgås.
English: The body is imprinted with “5”.
Danish: Kroppen bærer et tryk med ”5”.
English: Temozolomide Sandoz hard capsules should be administered in the fasting state.
Danish: Temozolomide Sandoz hårde kapsler bør indtages fastende.
English: METHOD OF ADMINISTRATION
Danish: ADMINISTRATIONSMETODE UDLØBSDATO
English: You will take your new dose of Temozolomide Sandoz alone once daily for the first 5 days (“dosing days”) of each cycle.
Danish: Du vil tage din nye dosis én gang dagligt i de første 5 dage ("doseringsdage") i hver cyklus.
English: You will again receive Temozolomide Sandoz once daily for 5 days, followed by 23 days without Temozolomide Sandoz.
Danish: Du vil igen tage Temozolomide Sandoz én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temozolomide Sandoz.
English: • thirst
Danish: • tørst
English: • impaired balance
Danish: • forringet balanceevne
English: Common:
Danish: Almindelig:
English: 5 x 1 hard capsule in sachet 20 x 1 hard capsule in sachet
Danish: 5 x 1 hård kapsel in breve 20 x 1 hård kapsel in breve
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Danish: * Frekvensestimaterne er baseret på relevante kliniske forsøg.
English: Psychiatric disorders Common:
Danish: Psykiske forstyrrelser Almindelig
English: Neoplasm benign, malignant and unspecified
Danish: Benigne, maligne og uspecificerede tumorer
English: 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.
Danish: MTIC's cytotoksiske effekt formodes primært at skyldes alkyleringen ved O6-positionen i guanin med ledsagende alkylering ved N7-positionen.
English: • difficulty with holding your urine
Danish: • svært ved at holde på vandet
English: Posology
Danish: Brev
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Danish: Opsvulmet abdomen, fækal inkontinens, gastrointestinal lidelse (NOS), gastroenteritis, hæmorroider
English: Contents of the pack and other information What Temozolomide Sandoz contains
Danish: Pakningsstørrelser og yderligere oplysninger Temozolomide Sandoz indeholder
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Danish: Bivirkninger hos patienter med tilbagevendende eller progressivt malignt gliom Infektioner og parasitære sygdomme
English: Patients with hepatic or renal impairment
Danish: Patienter med nedsat lever- eller nyrefunktion
English: In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Danish: Dette fald i antallet af blodceller er oftest forbigående, men i nogle tilfælde kan det være længerevarende og medføre en meget alvorlig type anæmi (aplastisk anæmi).
English: General disorders and administration site conditions Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig
English: The body is imprinted with “250”.
Danish: Kroppen bærer et tryk med ”250”.
English: Reproductive system and breast disorders Uncommon:
Danish: Det reproduktive system og mammae Ikke almindelig Impotens
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Danish: Reduktion eller seponering af TMZ-dosis under monoterapi Toksicitet
English: • radiation injury
Danish: • stråleskader
English: Keep out of the sight and reach of children, preferably in a locked cupboard.
Danish: Opbevares utilgængeligt for børn, helst i et aflåst skab.
English: 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.
Danish: Den maksimalt tolererede dosis (MTD) var 1.000 mg/m2 pr serie for både børn og voksne.
English: • constipation (difficulty passing stools)
Danish: • forstoppelse (besvær med afføring)
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 150 mg/m2 once daily for the first
Danish: Hvis de tidligere er blevet behandlet med kemoterapi, vil din første dosis af Temozolomide Sandoz være på 150 mg/m én gang dagligt i de første 5 dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON INDEHOLDENDE FLASKE
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Danish: Hvis en kapsel er beskadiget, må indholdet ikke komme i kontakt med hud, øjne eller næse.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Danish: Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 109/l), 12 % vs. 5 %, og thrombocytopeni (< 20 x 109/l), 9 % vs. 3 %, hos kvinder vs. mænd i det første terapiforløb.
English: Hepatic enzymes increased, Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Danish: Ikke almindelig Forhøjede leverenzymtal, forhøjet gamma GT, forhøjet AST *En patient, der kun var randomiseret til strålebehandlingsgruppen, fik TMZ + strålebehandling.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 10
Danish: Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 109/l), 12 % vs. 5 %, og thrombocytopeni (< 20 x 109/l), 9 % vs.
English: If you forget to take Temozolomide Sandoz
Danish: Hvis du har glemt at tage Temozolomide Sandoz
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Danish: TMZ's farmakokinetik var sammenlignelig for patienter med normal leverfunktion og patienter med let til moderat leverinsufficiens.
English: Convulsions, headache
Danish: Kramper, hovedpine
English: Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
Danish: Desuden anbefales det at søge råd med hensyn til kryokonservering af sædvæske før behandling på grund af muligheden for irreversibel infertilitet efter behandling med TMZ.
English: hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure†
Danish: Hyperbilirubinæmi, kolestase, hepatitis, leverskade, leversvigt†
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Danish: Neutropeni, trombocytopeni, lymfopeni, leukopeni
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known: frequency cannot be estimated from the available data.
Danish: < 1/10); ikke almindelig (≥ 1/1.000 til <1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Danish: • reduceret antal blodceller (pancytopeni, anæmi, leukopeni).
English: The body is imprinted with “180”.
Danish: Kroppen bærer et tryk med ”180”.
English: Agitation, apathy, behaviour disorder, depression, hallucination
Danish: Ikke almindelig Uro, apati, ændret opførsel, depression, hallucination
English: The body is imprinted with “20”.
Danish: Kroppen bærer et tryk med ”20”.
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Danish: Opbevar lægemidlet utilgængeligt for børn, helst i et aflåst skab.
English: 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.
Danish: I et gentaget glioma datasæt med 400 forsøgspersoner forekom Grad 4-neutropeni hos 8 % af de kvindelige vs. 4 % af de mandlige forsøgspersoner og Grad 4-thrombocytopeni hos 8 % af de kvindelige vs. 3 % af de mandlige forsøgspersoner i det første terapiforløb.
English: Titanium dioxide (E 171) Water
Danish: Titandioxid (E 171) Vand
English: Recurrent or progressive malignant glioma
Danish: Tilbagevendende eller progressivt malignt gliom
English: Hyperglycaemia, weight increased
Danish: Hyperglykæmi, vægtøgning
English: Dyspnoea
Danish: Dyspnø
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Danish: Hudeksfoliering, øget lysoverfølsomhedsreaktion, unormal pigmentering
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
Danish: På grund af træthed og søvnighed påvirker TMZ i mindre grad evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: • reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
Danish: • fald i antallet af blodceller (neutropeni, thrombocytopeni, lymfopeni, leukopeni)
English: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid
Danish: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62 registros.spain@sandoz.com
English: a: 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).
Danish: a: Samtidig behandling med TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut neutrofiltal ≥ 1,5 x 109/l; trombocyttal ≥ 100 x 109/l; CTC ikke-hæmatologisk toksicitet ≤ Grad 1 (undtagen alopeci, kvalme, opkastning).
English: • double vision
Danish: • dobbeltsyn
English: Anxiety, depression, emotional lability, insomnia
Danish: Angst, depression, emotionel labilitet, søvnløshed
English: • difficulty controlling your bowel movements
Danish: • besvær med at kontrollere afføringen
English: • abnormal liver function tests.
Danish: • unormale leverfunktionstests
English: • flu-like symptoms
Danish: • influenzalignende symptomer
English: The body is imprinted with “140”.
Danish: Kroppen bærer et tryk med ”140”.
English: • forgetfulness
Danish: • glemsomhed
English: - thrombocyte count ≥ 100 x 109/l
Danish: − trombocyttal ≥ 100 x 109/l
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Danish: Afbrydelse eller seponering af TMZ-dosis under konkomitant strålebehandling og TMZ
English: Newly-diagnosed glioblastoma multiforme
Danish: Nydiagnosticeret glioblastoma multiforme
English: Malignancies
Danish: Malignitet
English: Women of childbearing potential
Danish: Kvinder i den fertile alder
English: Somnolence, dizziness, paresthesia
Danish: Søvnighed, svimmelhed, parestesier
English: TMZ interruptiona
Danish: TMZ-afbrydelsea
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Danish: I meget sjældne tilfælde har der også været observeret myelodysplastisk syndrom og sekundær malignitet, herunder myeloid leukæmi (se pkt.
English: This medicine is an antitumour agent.
Danish: Denne medicin er et middel mod kræftsvulster.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL BREV
English: K.Valdemāra 33 - 30
Danish: K.Valdemāra 33 - 30 LV-1010 Rīga
English: 9/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Danish: 3 %, hos kvinder vs. mænd i det første terapiforløb.
English: • abnormal or blurry vision
Danish: • unormalt eller sløret syn
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Danish: Stomatitis, diarré, abdominal smerte, dyspepsi, dysfagi
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting)
Danish: • den samme Grad 3 ikke-hæmatologisk toksicitet (undtagen alopeci, kvalme, opkastning)
English: • if you have nausea (feeling sick in your stomach) and/or vomiting which are both very common side effects of Temozolomide Sandoz (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Danish: • Hvis du har kvalme og/eller kaster op, hvilket er meget almindelige bivirkninger ved Temozolomide Sandoz (se pkt.
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Danish: I Tabel 4 vises de bivirkninger, der er fremkommet hos patienter med nydiagnosticeret glioblastoma multiforme under behandlingsfaserne med konkomitant behandling og monoterapi.
English: Anxiety, emotional lability, insomnia
Danish: Angst, emotionel labilitet, søvnløshed
English: a: 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,
Danish: a: Samtidig behandling med TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut neutrofiltal ≥ 1,5 x 109/l; trombocyttal ≥ 100 x 109/l; CTC ikke-hæmatologisk toksicitet ≤ Grad 1
English: Hypokalemia, alkaline phosphatase increased, weight increased
Danish: Ikke almindelig Hypokalæmi, forhøjet alkalisk fosfatase, vægtøgning
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Danish: Vaginal blødning, menorrhagia, amenorré, vaginitis, brystsmerte
English: Patients with recurrent or progressive malignant glioma
Danish: Patienter med tilbagevendende eller progressivt malignt gliom
English: Black iron oxide (E 172) Potassium hydroxide
Danish: Sort jernoxid (E 172) Kaliumhydroxid
English: Each capsule is approximately 15.8 mm in length.
Danish: Hver kapsel er ca. 15,8 mm lang.
English: • blood clot in the legs
Danish: • blodansamlinger i benene
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Danish: Asteni, ansigtsødem, smerte, forværret tilstand, rigor, tandlidelse
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Danish: Kramper, bevidsthedssvækkelse, døsighed, afasi, nedsat balanceevne, svimmelhed, forvirring, nedsat hukommelse, nedsat koncentrationsevne, neuropati, parestesi, taleforstyrrelse, tremor
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Danish: Der er rapporteret om leverskade, herunder letalt leversvigt, hos patienter, der er blevet behandlet med TMZ (se pkt.
English: • in adults with newly-diagnosed glioblastoma multiforme.
Danish: • hos voksne med nydiagnosticeret glioblastoma multiforme (hjernesvulster).
English: • loss of appetite
Danish: • appetitløshed
English: • heartburn
Danish: • halsbrand
English: • change in your sense of smell
Danish: • ændring af lugtesansen
English: It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Danish: Det er ukendt, om TMZ udskilles i human mælk.
English: Colour of the cap
Danish: Kapslens farve
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 behandlede):
English: Dermatitis, dry skin, erythema, pruritus Dry skin, pruritus
Danish: Dermatitis, tør hud, erythem, kløe Tør hud, kløe
English: 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).
Danish: TMZ indgives oralt i en dosis på 75 mg/m2 dagligt i 42 dage konkomitant med fokal strålebehandling
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON INDEHOLDENDE BREVE
English: Rare:
Danish: Sjælden
English: • swollen stomach
Danish: • oppustet mave
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Danish: Febril neutropeni, trombocytopeni, anæmi, leukopeni
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Danish: CTC ikke-hæmatologisk toksicitet (undtagen alopeci, kvalme, opkastning)
English: Table 6.
Danish: Tabel 6.
English: • peeling skin
Danish: • skællende hud
English: The bottles contain a desiccant pouch.
Danish: Flaskerne indeholder et tørremiddel i pose.
English: • increased sweating
Danish: • øget svedtendens
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Danish: Ikke almindelig Hemianopsi, nedsat synsskarphed, synslidelse, synsfeltdefekt, øjensmerte
English: Dysuria
Danish: Dysuri
English: 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 medicine.
Danish: Ved at indberette bivirkninger kan du være medvirkende til yderligere at dokumentere sikkerheden ved anvendelsen af dette lægemiddel.
English: Muscle weakness, arthralgia
Danish: Muskelsvaghed, artralgi
English: The body is imprinted with “100”.
Danish: Kroppen bærer et tryk med ”100”.
English: • dry skin
Danish: • tør hud
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Danish: Muskelsvaghed, artralgi, muskuloskeletal smerte, myalgi
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Danish: Hemiparese, afasi, nedsat balanceevne, døsighed, forvirring, svimmelhed, nedsat hukommelse, nedsat koncentrationsevne, dysfasi, neurologisk lidelse (NOS), neuropati, perifer neuropati, parestesi, taleforstyrrelse, tremor
English: Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig
English: • breast pain
Danish: • brystsmerte
English: • hearing impairment
Danish: • forringet hørelse
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100 Rare
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til
English: LV-1010 Rīga Tel: +371 67892006 balt.regaffairs@sandoz.com
Danish: Tel: +371 67892006 balt.regaffairs@sandoz.com
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 behandlede):
English: Each capsule is approximately 11.4 mm in length.
Danish: Hver kapsel er ca. 11,4 mm lang.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 behandlede):
English: Each bottle contains either 5 or 20 capsules.
Danish: Hver flaske indeholder 5 eller 20 kapsler.Flaskerne indeholder også en pose med tørremiddel.
English: Do not store above 25°C
Danish: Må ikke opbevares ved temperaturer over 25° C
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Danish: Allergisk reaktion, feber, stråleskade, ansigtsødem, smerte, smagsforstyrrelse
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Danish: Allergisk reaktion, feber, stråleskade, smerte, smagsforstyrrelse
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral
Danish: Dataene vedrørende den kliniske effekt hos patienter med glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), der progredierer eller recidiverer efter kirurgi og strålebehandling,
English: • rash
Danish: • rysten
English: - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Danish: − almindelige toksicitetskriterier (CTC, common toxicity criteria) for ikke-hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning)
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Danish: Trombocyt-abnormiteter af Grad 3 eller Grad 4, inklusiveherunder trombocytopeni-bivirkninge, blev set hos 14 % af de patienter, der fik TMZ.
English: TMZ discontinuation
Danish: TMZ-seponering
English: Other medicines and Temozolomide Sandoz
Danish: Brug af anden medicin sammen med Temozolomide Sandoz
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Danish: − kapselindhold: vandfri lactose, kolloid vandfri silica, natriumstivelsesglycolat (type A),
English: Bottle
Danish: Flaske
English: Endocrine disorders Uncommon:
Danish: Det endokrine system Ikke almindelig Cushingoide symptomer
English: Each capsule is approximately 21.4 mm in length.
Danish: Hver kapsel er ca. 21,4 mm lang.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Danish: Voksne patienter med nydiagnosticeret glioblastoma multiforme
English: How to store Temozolomide Sandoz Contents of the pack and other information
Danish: Opbevaring af Temozolomide Sandoz Pakningsstørrelser og yderligere oplysninger
English: • skin irritation or redness
Danish: • hudirritation eller rødme
English: • muscle damage
Danish: • muskelskade
English: Each capsule is approximately 19.3 mm in length.
Danish: Hver kapsel er ca. 19.3 mm lang.
English: • fluid retention
Danish: • væsketilbageholdelse
English: Erythema, pigmentation abnormal, sweating increased
Danish: Erythem, unormal pigmentering, svedtendens
English: Do not store above 25 °C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: Cases of elevations of liver enzymes have been commonly reported.
Danish: Der er set almindelige tilfælde af forhøjede leverenzymer.
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and
Danish: Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA hovedsageligt ved O6- og N7-positionen i guanin.