FrancophonIA/ELRC3.0 huggingface dataset:
English: Store in the original bottle in order to protect from moisture.
Danish: Opbevares i den originale flaske for at beskytte mod fugt.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer):
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Danish: Stomatitis, diarre, mavesmerter, dyspepsi, dysfagi
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 20 mg hard capsules.
Danish: LÆGEMIDLETS NAVN Temozolomide Accord 20 mg hårde kapsler.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 personer):
English: If you have been treated before with chemotherapy, you will take your first dose of temozolomide at 150 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Danish: Hvis De har været behandlet med kemoterapi tidligere, skal De tage den første dosis temozolomid på 150 mg/m² en gang daglig i de første fem dage (“behandlingsdage”) efterfulgt af 23 dage uden behandling med temozolomid.
English: 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 jirovecii pneumonia (PCP).
Danish: Patienter, som fik konkomitant TMZ og RT i en pilotundersøgelse om det forlængede 42 dagesprogram, viste sig at have særlig risiko for at udvikle Pneumocystis jirovecii lungebetændelse (PCP).
English: You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.
Danish: For at undgå eller behandle opkastning vil De eventuelt få ordineret anden medicin, der skal tages før og/eller efter, De har taget temozolomid.
English: If you have not been treated before with chemotherapy, you will take your first dose of temozolomide at 200 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Danish: Hvis De ikke tidligere har været behandlet med kemoterapi, skal De tage den første dosis TMZ på 200 mg/m² en gang daglig i de første fem dage (“behandlingsdage”) efterfulgt af 23 dage uden behandling med temozolomid.
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, konfusion, svimmelhed, nedsat hukommelse, nedsat koncentrationsevne, dysfasi, neurologisk sygdom (NOS), neuropati, perifer neuropati, paræstesi, taleforstyrrelse, tremor
English: Date of first authorisation: 15 March 2010 Date of the latest renewal: 12 January 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 12. januar 2015
English: • muscle weakness, painful joints, muscle aches and pains
Danish: • muskelslaphed, smertefulde led, muskelsmerter
English: INFORMATION IN BRAILLE Temozolomide 5mg
Danish: Temozolomide 5 mg
English: confusion, forgetfulness, difficulty concentrating, tingling sensation, “pins and needles”, difficulty speaking or understanding language, shaking, stroke.
Danish: svimmelhed, konfusion, glemsomhed, koncentrationsproblemer, snurrende fornemmelser, prikken i huden, talebesvær eller vanskeligheder med at forstå sproget, rysten, slagtilfælde
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Danish: Hemiplegi, ataksi, nedsat koordinationsevne, unormal gang, hyperæstesi, føleforstyrrelse
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 personer):
English: Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SACHET CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BREV KARTON
English: Respiratory, thoracic and mediastinal disorders Common:
Danish: Luftveje, thorax og mediastinum Almindelig:
English: 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 jirovrcci pneumonia (PCP).
Danish: Patienter, som fik konkomitant TMZ og RT i en pilotundersøgelse om det forlængede 42 dagesprogram, viste sig at have særlig risiko for at udvikle Pneumocystis jirovicii lungebetændelse (PCP).
English: Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Danish: Temozolomide Accord 20 mg hårde kapsler: Hver kapsel indeholder 20 mg temozolomid.
English: INFORMATION IN BRAILLE Temozolomide 20mg
Danish: Temozolomide 20 mg
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 personer):
English: Temozolomide Accord 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Danish: Temozolomide Accord 250 mg hårde kapsler: Hver kapsel indeholder 250 mg temozolomid.
English: Patients with recurrent or progressive malignant glioma
Danish: Patienter med tilbagevende eller progressivt malignt gliom
English: Do not open, crush or chew the capsules, swallow whole.
Danish: Kapslerne må ikke åbnes, knuses eller tygges; de skal sluges hele.
English: SACHET LABEL
Danish: BREV ETIKET
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, konfusion, nedsat hukommelse, nedsat koncentrationsevne, neuropati, paræstesi, taleforstyrrelse, tremor
English: • bleeding, fluid retention, swollen legs, blood clots
Danish: • blødning, væskeophobning, hævede ben, blodpropper
English: The safety and efficacy of TMZ in children under the age of 3 years have not beenestablished.
Danish: TMZs sikkerhed og virkning hos børn under 3 år er ikke klarlagt.
English: Uncommon side-effects (may affect up to 1 in 100 people):
Danish: Ualmindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer):
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Danish: Bivirkninger hos patienter med recidiverende eller progressivt malignt gliom
English: Vascular disorders Common:
Danish: Vaskulære sygdomme Almindelig:
English: Hyperglycaemia, weight increased
Danish: Hyperglycæmi, vægtøgning
English: SACHET CARTON
Danish: Mave-tarmkanalen
English: Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
Danish: Asteni, rødmen, hedeture, forværret tilstand, rigor, misfarvning af tungen, parosmi, tørst
English: Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Danish: Temozolomide Accord 5 mg hårde kapsler: Hver kapsel indeholder 5 mg temozolomid.
English: • allergic reaction, fever, radiation injury, facial swelling, pain, changes in sense of taste
Danish: • overfølsomhedsreaktioner, feber, stråleskader, hævelser af ansigtet, smerter, smagsændringer
English: Each hard capsule contains 5 mg of temozolomide.
Danish: Hver hårde kapsel indeholder 5 mg temozolomid.
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Danish: Muskelslaphed, artralgier, muskuloskeletale smerter, myalgier
English: Temozolomide Accord 250 mg hard capsules: gelatine, titanium dioxide (E 171), water.
Danish: Temozolomide Accord 250 mg hårde kapsler: gelatine, titandioxid (E171), vand.
English: INFORMATION IN BRAILLE Temozolomide 100mg
Danish: Temozolomide 100 mg
English: Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Danish: Temozolomide Accord 180 mg hårde kapsler: Hver kapsel indeholder 180 mg temozolomid.
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Danish: Obstipation, kvalme, opkastning Obstipation, kvalme, opkastning
English: Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Danish: Temozolomide Accord 140 mg hårde kapsler: Hver kapsel indeholder 140 mg temozolomid.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules temozolomide STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg of temozolomide.
Danish: LÆGEMIDLETS NAVN Temozolomide Accord 100 mg hårde kapsler temozolomid ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hårde kapsel indeholder 100 mg temozolomid.
English: Each hard capsule contains 180 mg of temozolomide.
Danish: Hver hårde kapsel indeholder 180 mg temozolomid.
English: Temozolomide Accord should be administered in the fasting state.
Danish: Temozolomide Accord hårde kapsler bør indtages fastende.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis De er i tvivl om, hvordan De skal tage denne medicin.
English: INFORMATION IN BRAILLE Temozolomide 180mg
Danish: Temozolomide 180 mg
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Danish: Titandioxid (E171) Jernoxid, gult (E172) Indigocarmin (E132) Vand
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 100 mg hard capsules.
Danish: LÆGEMIDLETS NAVN Temozolomide Accord 100 mg hårde kapsler.
English: Each hard capsule contains 250 mg of temozolomide.
Danish: Hver hårde kapsel indeholder 250 mg temozolomid.
English: • shortness of breath, cough
Danish: • kortåndethed, hoste
English: exanthema
Danish: exantem
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 vides ikke, om TMZ udskilles i modermælk.
English: • Headache
Danish: • hovedpine
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hårde kapsel indeholder 20 mg temozolomid.
English: Vomiting, nausea, constipation
Danish: Opkastning, kvalme, obstipation
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Danish: Feber, asteni, rigor, utilpashed, smerter, smagsforstyrrelser
English: Adult patients with newly-diagnosed glioblastoma multiforme:
Danish: Patienter med nydiagnosticeret glioblastoma multiforme:
English: Each capsule is approximately 11 mm in length.
Danish: Hver kapsel har en længde på cirka 11 mm.
English: Diarrhoea, abdominal pain, dyspepsia
Danish: Diarre, mavesmerter, dyspepsi
English: Each capsule is approximately 21 mm in length.
Danish: Hver kapsel har en længde på cirka 21 mm.
English: Each capsule is approximately 15 mm in length.
Danish: Hver kapsel har en længde på cirka 15 mm.
English: Temozolomide Accord 5 mg hard capsules have a white body, a green cap, and are imprinted ‘TMZ' on cap and ‘5' on body with black ink.
Danish: Temozolomide Accord 5 mg hårde kapsler har en hvid krop, en grøn hætte, påtrykt ‘TMZ' på hætten & ‘5' på kroppen med sort blæk.
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.
Danish: Mænd, som behandles med TMZ, bør frarådes at få få børn op til 6 måneder efter, de har fået den sidste dosis og de tilrådes at søge råd med hensyn til kryokonservering af sædvæske før behandlingen (se pkt.
English: Do not store above 25 °C.
Danish: Flaske Må ikke opbevares ved temperaturer over 25 °C.
English: TMZ dose levels for monotherapy treatment
Danish: Dosisniveauer af TMZ under monoterapi
English: You will take your new dose of temozolomide capsules initially at 150 mg/m² once daily for the first five days (“dosing days”) of each cycle, followed by 23 days without temozolomide; this adds up to a 28 day treatment cycle.
Danish: De skal nu tage temozolomid i en dosis på 150 mg/m² en gang om dagen i de første fem dage i hver serie (“behandlingsdage”) efterfulgt af 23 dage uden behandling med temozolomid.
English: Anti-emetic therapy
Danish: Antiemetisk behandling:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg temozolomide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hårde kapsel indeholder 100 mg temozolomid.
English: Temozolomide Accord 5 mg hard capsules temozolomide
Danish: Temozolomide Accord 5 mg hårde kapsler temozolomid
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer):
English: Capsule shell:
Danish: Kapselindhold
English: INFORMATION IN BRAILLE Temozolomide 140mg
Danish: Temozolomide 140 mg
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC
Danish: Dosis øges i den anden serie til 200 mg/m2 én gang dagligt i
English: Palpitation
Danish: Palpitationer
English: The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Danish: De hårde kapsler er transparente blå/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘140' på kroppen.
English: Temozolomide Accord 180 mg hard capsules temozolomide
Danish: Temozolomide Accord 180 mg hårde kapsler temozolomid
English: Temozolomide Accord 250 mg hard capsules have a white body, a white cap, and are imprinted ‘TMZ' on cap and ‘250' on body with black ink.
Danish: Temozolomide Accord 250 mg hårde kapsler har en hvid krop, en hvid hætte, påtrykt ‘TMZ' på hætten & ‘250' på kroppen med sort blæk.
English: Not known
Danish: Hyppighed ikke kendt:
English: Temozolomide Accord 140 mg hard capsules: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Danish: Temozolomide Accord 140 mg hårde kapsler: gelatine, titandioxid (E171), indigocarmin (E132), vand.
English: Visual field defect, vision blurred, diplopia
Danish: Synsfeltdefekt, sløret syn, diplopi
English: The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ' on cap & ‘5' on body.
Danish: De hårde kapsler er grønne/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘5' på kroppen.
English: Temozolomide Accord 20 mg hard capsules temozolomide
Danish: Temozolomide Accord 20 mg hårde kapsler temozolomid
English: Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring
English: Temozolomide Accord 250 mg hard capsules temozolomide
Danish: Temozolomide Accord 250 mg hårde kapsler temozolomid
English: Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Danish: Temozolomide Accord 100 mg hårde kapsler: Hver kapsel indeholder 100 mg temozolomid.
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hårde kapsel indeholder 102,2 mg vandfrit lactose.
English: Temozolomide Accord 5 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Danish: Temozolomide Accord 5 mg hårde kapsler: gelatine, titandioxid (E171), gult jernoxid (E172), indigocarmin (E132), vand.
English: - children 3 years and older and adult patients with specific forms of brain tumour (e.g. glioblastoma multiforme or anaplastic.
Danish: hos børn i alderen 3 år og ældre og voksne patienter med specielle hjernesvulster (fx glioblastoma multiforme eller anaplastisk astrocytom), hvis der er tegn på, de er vendt tilbage eller er forværret efter standardbehandling.
English: Eye disorders Common:
Danish: Øjne Almindelig:
English: Each capsule is approximately 19 mm in length.
Danish: Hver kapsel har en længde på cirka 19 mm.
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Danish: De hårde kapsler er pink/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘100' på kroppen.
English: Temozolomide Accord 140 mg hard capsules temozolomide
Danish: Temozolomide Accord 140 mg hårde kapsler temozolomid
English: • shingles, flu-like symptoms
Danish: • helvedesild, influenzalignende symptomer
English: TMZ interruptiona
Danish: TMZ afbrydelsea
English: • muscle damage, back pain
Danish: • muskelskade, rygsmerter
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ualmindelige (kan forekomme hos op til 1 ud af 100 personer):
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste
Danish: Allergisk reaktion, feber, stråleskade, ansigtsødem, smerter, smagsforstyrrelse
English: Each hardcapsule contains 131.4 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være særlig opmærksom på: Hver hårde kapsel indeholder 131,4 mg vandfrit lactose.
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: Det anbefales også, at de søger råd med hensyn til kryokonservering af sædvæske før behandlingen på grund af risikoen for irreversibel infertilitet efter behandlingen med TMZ.
English: Capsule contents Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Danish: Lactose, vandfri Silica, kolloid vandfri Natriumglykolatstivelse type A Vinsyre
English: Temozolomide Accord 140 mg hard capsules have a white body, a blue cap, and are imprinted ‘TMZ' on cap and ‘140' on body with black ink.
Danish: Temozolomide Accord 140 mg hårde kapsler har en hvid krop, en blå hætte, påtrykt ‘TMZ' på hætten & ‘140' på kroppen med sort blæk.
English: EU/1/10/615/002
Danish: EU/1/10/615/001 EU/1/10/615/002
English: The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ' on cap & ‘250' on body.
Danish: De hårde kapsler er hvide/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘250' på kroppen.
English: Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Danish: Temozolomide Accord 20 mg hårde kapsler: gelatine, titandioxid (E171), gult jernoxid (E172), vand.
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Danish: Allergisk reaktion, feber, stråleskade, smerter, smagsforstyrrelse
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Danish: Dosis øges i den anden serie til 200 mg/m2 én gang dagligt i 5 dage, såfremt der ikke er hæmatologisk toksicitet (se pkt.
English: Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are imprinted ‘TMZ' on cap and ‘100' on body with black ink.
Danish: Temozolomide Accord 100 mg hårde kapsler har en hvid krop, en pink hætte, påtrykt ‘TMZ' på hætten & ‘100' på kroppen med sort blæk.
English: Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Danish: Temozolomide Accord 100 mg hårde kapsler: gelatine, titandioxid (E171), rødt jernoxid (E172), vand.
English: Febrile neutropenia, anaemia Lymphopenia, petechiae
Danish: Febril neutropeni, anæmi
English: Temozolomide Accord 100 mg hard capsules temozolomide
Danish: Temozolomide Accord 100 mg hårde kapsler temozolomid
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Danish: De hårde kapsler er gule/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘20' på kroppen.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 250 mg hard capsules.
Danish: Temozolomide Accord 250 mg hårde kapsler.
English: Temozolomide Accord 20 mg hard capsules have a white body, a yellow cap, and are imprinted ‘TMZ' on cap and ‘20' on body with black ink.
Danish: Temozolomide Accord 20 mg hårde kapsler har en hvid krop, en gul hætte påtrykt ‘TMZ' på hætten & ‘20' med sort blæk.
English: Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.
Danish: Behandlingen kan blive udsat eller stoppet afhængig af Deres blodtal, og af hvordan De tåler behandlingen med temozolomid.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Danish: - De skal straks kontakte Deres læge, hvis De får feber eller symptomer på en infektion.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Each hard capsule contains 168 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hårde kapsel indeholder 168 mg vandfrit lactose.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: De skal kontakte lægen, hvis De har fået at vide, at De ikke tåler visse sukkerarter.
English: Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Danish: Temozolomide Accord 180 mg hårde kapsler: gelatine, titandioxid (E171), gult jernoxid (E172), rødt jernoxid (E172), vand.
English: Cough.
Danish: Hoste.
English: Convulsions were reported very commonly in the newlydiagnosed 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.
Danish: Hos patienter med nydiagnosticeret glioblastoma multiforme, der fik TMZ samtidig med RT, var rapportering om udslæt meget almindelig.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
Danish: Temozolomide Accord 140 mg hårde kapsler.
English: Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Danish: Temozolomide Accord 180 mg hårde kapsler har en hvid krop, en rødbrun hætte, påtrykt ‘TMZ' på hætten & ‘180' på kroppen med sort blæk.
English: EU/1/10/615/014
Danish: EU/1/10/615/013 EU/1/10/615/014
English: because of the possibility of irreversible infertility due to therapy with TMZ.
Danish: Amning bør derfor afbrydes under behandling med TMZ.
English: EU/1/10/615/036
Danish: EU/1/10/615/035 EU/1/10/615/036
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules.
Danish: Temozolomide Accord 5 mg hårde kapsler.
English: Titanium dioxide (E171) Iron oxide red (E172)
Danish: Titandioxid (E171) Jernoxid, rødt (E172) Vand
English: The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ' on cap & ‘180' on body.
Danish: De hårde kapsler er rødbrune/hvide hårde gelatinekapsler påtrykt ‘TMZ' på hætten & ‘180' på kroppen.
English: EU/1/10/615/022
Danish: EU/1/10/615/021 EU/1/10/615/022
English: • pain with urination
Danish: • smertefuld vandladning
English: Embolism pulmonary, oedema, oedema peripheral
Danish: Lungeemboli, ødemer, perifere ødemer
English: EU/1/10/615/028
Danish: EU/1/10/615/027 EU/1/10/615/028
English: Based on your blood counts and how you tolerate temozolomide during each treatment cycle, the dose may be adjusted, delayed or stopped.
Danish: Dosis kan blive ændret, eller behandlingen kan blive udsat eller stoppet afhængig af Deres blodtal og af hvordan De tåler behandlingen med temozolomid.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 180 mg hard capsules.
Danish: Temozolomide Accord 180 mg hårde kapsler.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: 20 mg kapsel indeholder 14.6 mg vandfrit lactose.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Jernoxid, gult (E172) Vand
English: EU/1/10/615/026
Danish: EU/1/10/615/025 EU/1/10/615/026
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Danish: RT i 42 dages regimet (højst 49 dage), uanset lymfocyttallet.
English: Each hard capsule contains 140 mg of temozolomide.
Danish: Hver hårde kapsel indeholder140 mg temozolomid.