FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Danish: Almindelig (kan påvirke op til 1 ud af 10): Infektioner i munden, sårinfektion, fald i antallet af blodceller (neutropeni, trombocytopeni, lymfopeni, leukopeni), øget sukkerindhold i blodet, vægttab, ændring i mental tilstand eller årvågenhed, angst/depression, søvnighed, talebesvær, forringet balanceevne, svimmelhed, forvirring, glemsomhed, koncentrationsbesvær, manglende evne til at falde i søvn eller sove igennem, prikken i huden, blå mærker, rysten, unormalt eller sløret syn, dobbeltsyn, forringet hørelse, kortåndethed, hoste, blodansamlinger i benene, væskeophobning, hævede ben, diarré, mave- eller underlivssmerter, halsbrand, urolig mave, synkebesvær, mundtørhed, hudirritation eller rødme, tør hud, kløen, muskelsvaghed, ledsmerter, muskelsmerter, hyppig vandladning, besvær med at holde på vandet, allergiske reaktioner, feber, stråleskader, hævelse i ansigt, smerte, ændring i smagsopfattelse, unormale leverfunktionstests.
English: 4.4 Special warnings and precautions for use
Danish: Advarsler og forsigtighedsregler
English: Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia
Danish: Angst, depression, emotionel labilitet, søvnløshed
English: Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100): Influenzalignende symptomer, røde pletter under huden, lavt kaliumindhold i blodet, vægtøgning, humørsvingninger, hallucinationer og forringet hukommelse, delvis lammelse, forringet koordinationsevne, forringet sansning, delvist tab af syn, tørre eller smertefulde øjne, døvhed, mellemørebetændelse, ringen for ørerne, ørepine, hjertebanken, blodprop i lungerne, højt blodtryk, lungebetændelse, bihulebetændelse, bronkitis, forkølelse eller influenza, oppustet mave, besvær med at kontrollere afføringen, hæmorroider, skællende hud, øget lysfølsomhed af huden, ændring i hudfarve, øget svedtendens, muskelskade, rygsmerte, vandladningsbesvær, vaginal blødning, seksuel impotens, udeblivende eller kraftige menstruationer, vaginal irritation, brystsmerte, hedeture, skælven, misfarvning af tungen, ændring af lugtesansen, tørst, tandlidelser.
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paraesthesia, speech disorder, tremor
Danish: Kramper, bevidsthedssvækkelse, døsighed, afasi, nedsat balanceevne, svimmelhed, forvirring, nedsat hukommelse, nedsat koncentrationsevne, neuropati, parestesi, taleforstyrrelse, tremor
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paraesthesia, 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: GT increased, AST increased
Danish: Forhøjede leverenzymtal, forhøjet gamma GT, forhøjet AST
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle,
Danish: Hvis ANC falder til < 1,0 x 109/l, eller trombocyttallet er < 50 x 109/l i en behandlingsserie, skal næste behandlingsserie reduceres med et dosisniveau (se pkt.
English: Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): appetitløshed, hovedpine, forstoppelse (besvær med afføring), kvalme (følelse af ubehag i maven), opkastning, udslæt, hårtab, træthed.
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Danish: Febril neutropeni, trombocytopeni,anæmi, leukopeni
English: What Temomedac is and what it is used for
Danish: Temomedac er indiceret til behandling af:
English: Temomedac 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body
Danish: Temomedac 20 mg to striber i orange tryksværte på hætten og “T 20 mg” i orange tryksværte på bunden
English: Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Danish: Almindelig (kan påvirke op til 1 ud af 10): Vægttab, søvnighed , svimmelhed, prikken i huden, kortåndethed, diarré, mavesmerter, urolig mave, udslæt, kløen, hårtab, feber, kraftesløshed, rysten, utilpashed, smerte, ændring i smagsoplevelse.
English: Each hard capsule contains 209 mg of anhydrous lactose.
Danish: Hver hård kapsel indeholder 209 mg vandfri lactose.
English: Each hard capsule contains 117 mg of anhydrous lactose.
Danish: Hver hård kapsel indeholder 117 mg vandfri lactose.
English: Temomedac 250 mg two stripes in black ink on the cap and “T 250 mg” in black ink on the body
Danish: Temomedac 250 mg to striber i sort tryksværte på hætten og “T 250 mg” i sort tryksværte på bunden
English: vision disorder, visual field defect, eye pain eyes dry
Danish: Nedsat synsskarphed, øjensmerte, tørre øjne
English: Capsule content anhydrous lactose, sodium starch glycolate Type A, colloidal anhydrous silica, tartaric acid, stearic acid
Danish: Lactose, vandfri Natriumstivelsesglycolat type A Silica kolloid, vandfri Vinsyre
English: Temomedac 5 mg two stripes in green ink on the cap and “T 5 mg” in green ink on the body
Danish: Temomedac 5 mg to striber i grøn tryksværte på hætten og “T 5 mg” i grøn tryksværte på bunden
English: Based on a population pharmacokinetic analysis in patients 19 - 78 years of age, clearance of TMZ is not affected by age.
Danish: På baggrund af en analyse af populationsfarmakokinetikken for patienter mellem 19 - 78 år er TMZclearance ikke afhængig af alder. Ældre patienter (> 70 år) ser dog ud til at have øget risiko for udviklingen af neutropeni og trombocytopeni (se pkt.
English: Temomedac 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Danish: Temomedac 250 mg hårde kapsler: Hver kapsel indeholder 250 mg temozolomid.
English: Temomedac 5 mg hard capsules
Danish: Temomedac 5 mg hårde kapsler
English: 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).
Danish: 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).
English: Each hard capsule contains 150 mg of anhydrous lactose.
Danish: Hver hård kapsel indeholder 150 mg vandfri lactose.
English: ≥ 10 and < 100 x 109/l < 10 x 109/l
Danish: ≥ 10 og < 100 x 10
English: Temomedac 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Danish: Temomedac 20 mg hårde kapsler: Hver kapsel indeholder 20 mg temozolomid.
English: How to take Temomedac
Danish: Sådan tages Temomedac
English: Temomedac 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Danish: Temomedac 5 mg hårde kapsler: Hver kapsel indeholder 5 mg temozolomid.
English: Capsule shell gelatin, titanium dioxide (E171)
Danish: Gelatin Titandioxid (E 171)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Temomedac Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Temomedac 250 mg hard capsules
Danish: Temomedac 250 mg hårde kapsler
English: Temomedac 20 mg hard capsules
Danish: Temomedac 20 mg hårde kapsler
English: Somnolence, dizziness, paraesthesia
Danish: Søvnighed, svimmelhed, parestesier
English: indigo carmine (E132) aluminium lake
Danish: Indigotin I (E 132)
English: Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Danish: Temomedac 140 mg hårde kapsler: Hver kapsel indeholder 140 mg temozolomid.
English: nausea and vomiting).
Danish: • anfald (kramper),
English: Temomedac 140 mg two stripes in blue ink on the cap and “T 140 mg” in blue ink on the body
Danish: Temomedac 140 mg to striber i blå tryksværte på hætten og “T 140 mg” i blå tryksværte på bunden
English: Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Danish: Temomedac 180 mg hårde kapsler: Hver kapsel indeholder 180 mg temozolomid.
English: Temomedac is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Danish: • voksne patienter med nydiagnosticeret glioblastoma multiforme konkomitant med strålebehandling og herefter som monoterapi-behandling.
English: Each hard capsule contains 87 mg of anhydrous lactose.
Danish: Hver hård kapsel indeholder 87 mg vandfri lactose.
English: Temomedac 140 mg hard capsules
Danish: Temomedac 140 mg hårde kapsler
English: INFORMATION IN BRAILLE Temomedac 250 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 250 mg
English: Hemianopia, visual acuity reduced,
Danish: Hemianopi, nedsat synsskarphed, synslidelse, synsfeltdefekt, øjensmerte
English: Temomedac 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Danish: Temomedac 250 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i sort tryksværte på hætten og med "T 250 mg" i sort tryksværte på bunden.
English: Temomedac 180 mg hard capsules
Danish: Temomedac 180 mg hårde kapsler
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Danish: Hjerneblødning, hypertension Lungeemboli, ødem, perifert ødem Luftveje, thorax og mediastinum
English: Temomedac is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Danish: Temomedac anvendes til behandling af patienter med specifikke former for hjernesvulster:
English: Each hard capsule contains 84 mg of anhydrous lactose.
Danish: Hver hård kapsel indeholder 84 mg vandfri lactose.
English: INFORMATION IN BRAILLE Temomedac 5 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 5 mg
English: Temomedac 100 mg two stripes in pink ink on the cap and “T 100 mg” in pink ink on the body
Danish: Temomedac 100 mg to striber i pink tryksværte på hætten og “T 100 mg” i pink tryksværte på bunden
English: What Temomedac is and what it is used for What you need to know before you take Temomedac How to take Temomedac
Danish: Det skal du vide, før du begynder at tage Temomedac Sådan skal du tage Temomedac Bivirkninger
English: Temomedac 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Danish: Temomedac 5 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i grøn tryksværte på hætten og med "T 5 mg" i grøn tryksværte på bunden.
English: Temomedac 100 mg hard capsules
Danish: Temomedac 100 mg hårde kapsler
English: INFORMATION IN BRAILLE Temomedac 180 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 180 mg
English: INFORMATION IN BRAILLE Temomedac 20 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 20 mg
English: Temomedac 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Danish: Temomedac 20 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i orange tryksværte på hætten og med "T 20 mg" i orange tryksværte på bunden.
English: Each hard capsule contains 250 mg temozolomide.
Danish: Hver hård kapsel indeholder 250 mg temozolomid (temozolomide).
English: INFORMATION IN BRAILLE Temomedac 140 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 140 mg
English: EXPIRY DATE
Danish: UDLØBSDATO Anvendes inden
English: Each hard capsule contains 5 mg temozolomide.
Danish: Hver hård kapsel indeholder 5 mg temozolomid (temozolomide).
English: 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.
Danish: Hos patienter med nyligt diagnosticeret glioblastom multiforme, der fik TMZ samtidig med strålebehandling eller som monoterapi, blev udslæt rapporteret som værende meget almindeligt.
English: Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Danish: Temomedac 100 mg hårde kapsler: Hver kapsel indeholder 100 mg temozolomid.
English: The hard capsules (length approx. 18 mm) have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Danish: De hårde kapsler (længde ca. 18 mm) har en uigennemsigtig hvid bund og hætte med to striber i orange tryksværte på hætten og med “T 20 mg” i orange tryksværte på bunden.
English: Each hard capsule contains 140 mg temozolomide.
Danish: Hver hård kapsel indeholder 140 mg temozolomid (temozolomide).
English: Temomedac 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body
Danish: Temomedac 180 mg to striber i rød tryksværte på hætten og “T 180 mg” i rød tryksværte på bunden
English: The hard capsules (length approx. 22 mm) have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Danish: De hårde kapsler (længde ca. 22 mm) har en uigennemsigtig hvid bund og hætte med to striber i sort tryksværte på hætten og med “T 250 mg” i sort tryksværte på bunden.
English: Each hard capsule contains 20 mg temozolomide.
Danish: Hver hård kapsel indeholder 20 mg temozolomid (temozolomide).
English: NAME OF THE MEDICINAL PRODUCT Temomedac 20 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 20 mg hårde kapsler temozolomid
English: INFORMATION IN BRAILLE Temomedac 100 mg
Danish: INFORMATION I BRAILLESKRIFT Temomedac 100 mg
English: Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).
Danish: Temomedac 250 mg hårde kapsler: gelatin, titandioxid (E 171), shellac, propylenglycol, sort jernoxid (E 172).
English: NAME OF THE MEDICINAL PRODUCT Temomedac 5 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 5 mg hårde kapsler temozolomid
English: Each hard capsule contains 180 mg temozolomide.
Danish: Hver hård kapsel indeholder 180 mg temozolomid (temozolomide).
English: NAME OF THE MEDICINAL PRODUCT Temomedac 250 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 250 mg hårde kapsler temozolomid
English: Temomedac 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Danish: Temomedac 140 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i blå tryksværte på hætten og med "T 140 mg" i blå tryksværte på bunden.
English: Temomedac 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, propylene glycol and yellow iron oxide (E 172).
Danish: Temomedac 100 mg hårde kapsler: gelatin, titandioxid (E 171), rød jernoxid (E 172), shellac, propylenglycol og gul jernoxid (E 172).
English: The hard capsules (length approx. 16 mm) have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Danish: De hårde kapsler (længde ca. 16 mm) har en uigennemsigtig hvid bund og hætte med to striber i grøn tryksværte på hætten og med “T 5 mg” i grøn tryksværte på bunden.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 250 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 250 mg temozolomid
English: NAME OF THE MEDICINAL PRODUCT Temomedac 140 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 140 mg hårde kapsler temozolomid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/001-012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/001-012
English: Patients with newly-diagnosed glioblastoma multiforme If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temomedac (monotherapy phase).
Danish: Patienter med nydiagnosticeret glioblastoma multiforme Hvis du er nydiagnosticeret patient vil behandlingen ske i to faser:
English: NAME OF THE MEDICINAL PRODUCT Temomedac 180 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 180 mg hårde kapsler temozolomid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 5 mg temozolomid
English: Temomedac 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Danish: Temomedac 100 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i pink tryksværte på hætten og med "T 100 mg" i pink tryksværte på bunden.
English: Endocrine disorders* Uncommon:
Danish: Det endokrine system*
English: Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172)
Danish: Temomedac 180 mg hårde kapsler: gelatin, titandioxid (E 171), shellac, propylenglycol, rød jernoxid (E 172).
English: Temomedac 180 mg hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.
Danish: Temomedac 180 mg hårde kapsler har en uigennemsigtig hvid bund og hætte med to striber i rød tryksværte på hætten og med "T 180 mg" i rød tryksværte på bunden.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 20 mg temozolomid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 250 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 250 mg hårde kapsler temozolomid
English: The hard capsules (length approx. 20 mm) have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Danish: De hårde kapsler (længde ca. 20 mm) har en uigennemsigtig hvid bund og hætte med to striber i pink tryksværte på hætten og med “T 100 mg” i pink tryksværte på bunden.
English: Each hard capsule contains 100 mg temozolomide.
Danish: Hver hård kapsel indeholder 100 mg temozolomid (temozolomide).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 140 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 140 mg temozolomid
English: Temomedac 140 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake.
Danish: Temomedac 140 mg hårde kapsler: gelatin, titandioxid (E 171), shellac, propylenglycol, indigotin (E 132).
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Danish: Feber, asteni, rigor, alment ubehag, smerte,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 20 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 20 mg hårde kapsler temozolomid
English: The hard capsules (length approx. 22 mm) have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.
Danish: De hårde kapsler (længde ca. 22 mm) har en uigennemsigtig hvid bund og hætte med to striber i rød tryksværte på hætten og med “T 180 mg” i rød tryksværte på bunden.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 5 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 5 mg hårde kapsler temozolomid
English: NAME OF THE MEDICINAL PRODUCT Temomedac 100 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN Temomedac 100 mg hårde kapsler temozolomid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg temozolomide
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 100 mg temozolomid
English: Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty), - uncontrolled bleeding, - seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Danish: • en kraftig allergisk (overfølsomheds) reaktion (kløende udslæt, hvæsende vejrtrækning eller anden form for åndedrætsbesvær),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 140 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 140 mg hårde kapsler temozolomid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 180 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 180 mg temozolomid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 180 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 180 mg hårde kapsler temozolomid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/011
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 100 mg hard capsules temozolomide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temomedac 100 mg hårde kapsler temozolomid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/007
English: The hard capsules (length approx. 22 mm) have a white body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Danish: De hårde kapsler (længde ca. 22 mm) har en uigennemsigtig hvid bund og hætte med to striber i blå tryksværte på hætten og med “T 140 mg” i blå tryksværte på bunden.