FrancophonIA/ELRC3.0 huggingface dataset:
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5), the frequency of grade 3-4 laboratory findings is presented after each table.
Icelandic: Aukaverkanir í sambandi við blóðgildi í báðum ábendingum (töflur 4 og 5) voru yfirleitt algengar eða mjög algengar, tíðni rannsóknaniðurstaðna af 3.- 4. gráðu er sýnd á eftir báðum töflunum.
English: 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, multiorgan failure and death.
Icelandic: Ofskömmtun sem nam 10.000 mg (heildarskammtur 5 daga meðferðarlotu) var metin hjá einum sjúklingi og markverðar aukaverkanir voru blóðfrumnafæð, hiti, bilun í mörgum líffærum og dauði.
English: You should stop breast-feeding while receiving treatment with Temozolomide SUN.
Icelandic: Stöðva á brjóstagjöf meðan á meðferð með Temozolomide SUN stendur.
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Icelandic: Samkvæmt greiningu á lyfjahvörfum sem sáust í II. stigs rannsóknum varð engin breyting á úthreinsun TMZ við samtímis notkun dexametasóns, próklórperazíns, fenýtóíns, karbamazepíns, ondansetrón, H2- reseptor blokka eða fenóbarbital.
English: Do not open, crush or chew the capsules, swallow whole.
Icelandic: Hylkin skal hvorki opna, mylja né tyggja, þau skal gleypa í heilu lagi.
English: Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Icelandic: Hvert hart hylki inniheldur 227,001 mg af laktósa.
English: Pneumocystis jiroveciipneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Icelandic: Farið var fram á fyrirbyggjandi meðferð gegn lungnabólgu af völdum Pneumocystis jirovecii (PCP) meðan á geislameðferð og samhliða meðferð með TMZ stóð.
English: How to store Temozolomide SUN
Icelandic: Hvernig geyma á Temozolomide SUN
English: The cap is imprinted with ‘891'.
Icelandic: Á hettuna er letrað „891“.
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).
Icelandic: Meðferð með samhliða gjöf TMZ má halda áfram þegar öllum eftirfarandi skilyrðum er fullnægt: heildar- fjöldi daufkyrninga ≥ 1,5 x 109/l; blóðflagnafjöldi ≥ 100 x 109/l; eituráhrif önnur en blóðfræðileg ≤ 1. stig skv.
English: Making a mistake in how you take this medicine may have serious health consequences.
Icelandic: Það getur haft alvarlegar afleiðingar fyrir heilsuna ef mistök eru gerð við töku lyfsins.
English: Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Icelandic: Hvert hart hylki inniheldur 18,6 mg af laktósa.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Icelandic: Ef óþol fyrir sykrum hefur verið staðfest skal hafa samband við lækni áður lyfið er tekið inn.
English: Malta/Nederland/Norge/Österreich/Portugal/
Icelandic: Malta/Nederland/Norge/Österreich/Portugal/ Slovenija/Slovenská republika/Suomi/Finland/Sverige
English: The cap is imprinted with ‘890'.
Icelandic: Á hettuna er letrað „890“.
English: Temozolomide SUN monotherapy in recurrent or progressive glioma
Icelandic: Einlyfjameðferð með Temozolomide SUN við endurteknu eða versnandi tróðfrumuæxli (glioma)
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide SUN to prevent or control nausea and vomiting.
Icelandic: Verið getur að þú fáir önnur lyf (uppsölulyf) til að taka fyrir og/eða eftir töku
English: The cap is imprinted with ‘892'.
Icelandic: Á hettuna er letrað „892“.
English: What Temozolomide SUN looks like and contents of the pack
Icelandic: Útlit Temozolomide SUN og pakkningastærðir
English: Summary of events reported with temozolomide in the post-marketing setting*
Icelandic: Samantekt á tilvikum sem greint var frá eftir markaðssetningu með temózólómíði
English: The cap is imprinted with ‘893'.
Icelandic: Á hettuna er letrað „893“.
English: If you take more Temozolomide SUN than you should
Icelandic: Ef tekinn er stærri skammtur af Temozolomide SUN en mælt er fyrir um
English: The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Icelandic: Ef TMZ var gefið samhliða geislameðferð fylgt eftir með TMZ einlyfjameðferð við meðferð sjúklinga með nýgreint margfrumna taugakímsæxli, leiddi það til tölfræðilega marktækt betri heildarlifunar samanborið við geislameðferð eina sér (mynd
English: Kubickiego 11
Icelandic: Z o. o. ul. Kubickiego 11
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Icelandic: † Þ. á m. banvæn tilvik * Tíðnin sem er áætluð byggist á viðeigandi klínískum rannsóknum.
English: Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Icelandic: Einnig hefur örsjaldan verið greint frá tilvikum mergmisþroska og afleiddra (secondary), illkynja breytinga p.m.t. kyrningahvítblæði (sjá kafla 4.8).
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity
Icelandic: TMZ meðferð á að stöðva ef: - skammtagildi -1 (100 mg/m2) veldur enn óásættanlegum eituráhrifum - sömu
English: ≥ 0.5 and < 1.5 x 109/l
Icelandic: Heildarfjöldi daufkyrninga ≥0,5 og < 1,5 x 109/l
English: Temozolomide SUN should not be administered to pregnant women.
Icelandic: Ekki má nota Temodal handa barnshafandi konum.
English: Elderly patients
Icelandic: Aðrir sérstakir sjúklingahópar
English: If a full day has gone by, check with your doctor.
Icelandic: Leitaðu upplýsinga hjá lækninum ef heill dagur er liðinn.
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Icelandic: Þaninn kviður, saurlos (fecal incontinence), truflun í meltingarvegi (óskilgreind), magaog garnabólga, gyllinæð
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Icelandic: Tafla 4. Aukaverkanir sem komu fram við meðferð meðan á samhliða- og einlyfjameðferð stóð hjá sjúklingum með nýgreint margfrumna taugakímsæxli Líffæraflokkur
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 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.
Icelandic: rauðir dílar undir húð, lág kalíumgildi í blóði, þyngdaraukning, geðsveiflur, ofskynjanir og minnisskerðing, lömun að hluta, skert samhæfing, truflað snertiskyn, sjónskerðing, augnþurrkur eðaverkur, heyrnarleysi, sýking í miðeyra, eyrnasuð, eyrnaverkur, hjartsláttarónot (þegar hægt er að finna hjartsláttinn), blóðtappi í lungum, hár blóðþrýstingur, lungnabólga, skútabólga, berkjubólga, kvef eða inflúensa, magabólga, erfiðleikar við hægðastýringu, gyllinæð, húðflögnun, aukið ljósnæmi húðar, breytingar á húðlit, aukin svitamyndun, vöðvasköddun, bakverkur, erfiðleikar við þvaglát, blæðing frá leggöngum, getuleysi, tíðateppa eða asatíðir, leggangaerting, verkur í brjóstum, hitasteypur, hrollur, upplitun tungu, breyting á lyktarskyni, þorsti, tannkvilli.
English: - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Icelandic: önnur en blóðfræðileg (nema fyrir hárlos, ógleði, uppköst) koma aftur fram eftir skammtaminnkun.
English: Temozolomide SUN may make you feel tired or sleepy.
Icelandic: Temozolomide SUN getur valdið þeytu- eða syfjutilfinningu.
English: Cases of elevations of liver enzymes have been commonly reported.
Icelandic: Algengt er að greint hafi verið frá tilfellum hækkana á lifrarensímum.
English: How to take Temozolomide SUN
Icelandic: Hvernig nota á Temozolomide SUNl
English: The body is imprinted with ‘140 mg' and two stripes.
Icelandic: Á botninn er letrað „140 mg“ og tvær rendur.
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 blurred 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.
Icelandic: sárasýking, lækkaður fjöldi blóðfrumna (daufkyrningafæð, blóðflagnafæð, eitilfrumnafæð, hvítfrumnafæð), hækkaður blóðsykur, þyngdartap, breyting á geðslagi eða árvekni, kvíði/þunglyndi, syfja, talörðugleikar, jafnvægisskerðing, sundl, ringlun, gleymska, einbeitingarörðugleikar, erfiðleikar við að sofna eða sofa, náladofi, marblettir, skjálfti, óeðlileg sjón eða þokusýn, tvísýni, heyrnarskerðing, mæði, hósti, blóðtappi í fótum, vökvasöfnun, bólgnir fætur, niðurgangur, verkur í maga eða kvið, brjóstsviði, meltingartruflanir, kyngingarörðugleikar, munnþurrkur, húðerting eðaroði, húðþurrkur, kláði, vöðvaslappleiki, liðverkir, vöðvaþrautir, tíð þvaglát, þvagleki, ofnæmisviðbrögð, hiti, áverki af geislameðferð, andlitsþroti, verkur, óeðlilegt bragðskyn, óeðlileg lifrarpróf.
English: The body is imprinted with ‘250 mg' and two stripes.
Icelandic: Á botninn er letrað „250 mg“ og tvær rendur.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting)
Icelandic: CTC (nema fyrir hárlos, ógleði, uppköst)
English: The body is imprinted with ‘5 mg' and two stripes.
Icelandic: Á botninn er letrað „5 mg“ og tvær rendur.
English: The body is imprinted with '20 mg' and two stripes.
Icelandic: Á botninn er letrað „20 mg“ og tvær rendur.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Icelandic: Sjúklingar með glaktósaóþol, Lapp laktasaskort eða vanfrásog glúkósa galaktósa, sem eru mjög sjaldgæfir arfgengir kvillar, skulu ekki nota lyfið.
English: Meningoencephalitis herpetic
Icelandic: 4. stigb skv.CTC
English: Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Icelandic: Temozolomide SUN ásamt geislameðferð við nýgreindu margfrumna taugakímsæxli (glioblastoma)
English: PEEL
Icelandic: Kyn
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Icelandic: ANC ≥ 1,5 x 109/l og fjöldi blóðflagna ≥ 100 x 109/l.
English: Erythema, pigmentation
Icelandic: Ofskynjanir, minnisleysi
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity
Icelandic: TMZ skammtahlé eða -stöðvun meðan á samhliða geisla- og TMZ-meðferð stendur a:
English: Dry skin, pruritus
Icelandic: Húð og undirhúð
English: Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Icelandic: Fullorðnir með nýgreint margfrumna taugakímsæxli Temozolomide SUN er gefið ásamt staðbundinni geislameðferð (samhliða fasi) og síðan í allt að 6 meðferðarlotumþar sem temózólómíð (TMZ) er gefið eitt og sér (einlyfjameðferð).
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide SUN should be administered without food.
Icelandic: á Cmax sé klínískt marktæk, skal ekki gefa Temozolomide SUN með fæðu.
English: Frequency not known drug reaction with eosinophilia and systemic symptoms (DRESS)
Icelandic: Lyfjaútbrot ásamt fjölgun rauðkyrninga og altækum einkennum (DRESS)
English: Temozolomide SUN 250 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 250 mg hörð hylki temózólómíð
English: Very rare cases of lung side effects have been observed with Temozolomide SUN.
Icelandic: Örsjaldan hefur orðið vart við aukaverkanir frá lungum við notkun Temozolomide SUN.
English: The body is imprinted with ‘180 mg' and two stripes.
Icelandic: Á botninn er letrað „180 mg“ og tvær rendur.
English: Temozolomide SUN 250 mg hard capsules have a white opaque body and cap, imprinted in black ink.
Icelandic: Temozolomide SUN 250 mg hörð gelatínhylki með hvítri, ógegnsærri hettu og botni og svartri áletrun.
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Icelandic: Nýgreint margfrumna taugakímsæxli Í töflu 4 má finna aukaverkanir sem komu fram við meðferð hjá sjúklingum með nýgreint margfrumna taugakímsæxli meðan á samhliðafasa og einlyfja meðferðarfasa stóð.
English: Each hard capsule contains 250 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 250 mg af temózólómíði.
English: Hepatotoxicity
Icelandic: Ranbaxy Italia
English: Each hard capsule contains 5 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 5 mg af temózólómíði.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Icelandic: Helftarlömun (hemiplegia), ósamræming vöðvahreyfinga, óeðlileg samhæfing, óeðlilegt göngulag, snertiskynsaukning, skyntruflun (sensory disturbance)
English: Temozolomide SUN 140 mg hard capsules have a white opaque body and cap, imprinted in blue ink.
Icelandic: Temozolomide SUN 140 mg hörð gelatínhylki með hvítri, ógegnsærri hettu og botni og blárri áletrun.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Icelandic: - hjá fullorðnum með nýgreint margfrumna taugakímsæxli (glioblastoma multiforme).
English: C.
Icelandic: M
English: Temozolomide SUN 140 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 140 mg hörð hylki temózólómíð
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Icelandic: Húðflögnun, ljósnæmisviðbrögð, óeðlileg
English: Each hard capsule contains 20 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 20 mg af temózólómíði.
English: In post-marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Icelandic: Eftir markaðssetningu hafa komið fram tilvik heilahimnu- og heilabólgu af völdum herpesveiru (þ.m.t. banvæn tilvik) hjá sjúklingum sem fengu TMZ ásamt geislameðferð, þ.m.t. tilvik með samhliðagjöf stera.
English: Temozolomide SUN 20 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 20 mg hörð hylki temózólómíð
English: Temozolomide SUN 250 mg hard capsules
Icelandic: Temozolomide SUN 250 mg hörð hylki
English: Temozolomide SUN 5 mg hard capsules have a white opaque body and cap, imprinted in green ink.
Icelandic: Temozolomide SUN 5 mg hörð gelatínhylki með hvítri, ógegnsærri hettu og botni og grænni áletrun.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Icelandic: Sjaldgæft er að greint hafi verið frá tilfellum hækkunar á gallrauða, truflana á gallflæði (gallteppu), lifrarbólgu og lifrarskaða, meðal annars lífshættulegrar lifrarbilunar.
English: During the monotherapy phase, the dose and way you take Temozolomide SUN can vary.
Icelandic: Í einlyfjafasanum er mismunandi hver skammtur Temozolomide SUN er og hvernig hann er tekinn.
English: In some cases, it may be necessary to stop treatment with Temozolomide SUN. - as you may have a small risk of other changes in blood cells, including leukaemia.
Icelandic: - þar sem smávægileg hætta getur verið á öðrum breytingum á blóðfrumum, að meðtöldu hvítblæði.
English: Package Leaflet: Information for the user Temozolomide SUN 20 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 20 mg hörð hylki temózólómíð
English: Stomatitis, diarrhoea,
Icelandic: Eitilfrumnafæð, depilblæðingar
English: Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum):
English: Package Leaflet: Information for the user Temozolomide SUN 250 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 250 mg hörð hylki temózólómíð
English: Each hard capsule contains 140 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 140 mg af temózólómíði.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells.
Icelandic: Blóðsýni verða tekin oft meðan á meðferð stendur til að fylgjast með aukaverkunum
English: Propylene glycol Black iron oxide (E172)
Icelandic: Própýlen glýkól Svart járnoxíð (E172)
English: Investigations Common:
Icelandic: Pakkningastærð:
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Icelandic: Aukaverkanir hjá sjúklingum með endurmein eða versnun illkynja tróðæxlis
English: Temozolomide SUN 5 mg hard capsules
Icelandic: Temozolomide SUN 5 mg hörð hylki
English: Temozolomide SUN 100 mg hard capsules
Icelandic: Temozolomide SUN 100 mg hörð hylki
English: Temozolomide SUN 180 mg hard capsules have a white opaque body and cap, imprinted in red ink.
Icelandic: Temozolomide SUN 180 mg hörð gelatínhylki með hvítri, ógegnsærri hettu og botni og rauðri áletrun.
English: Pharmacotherapeutic group: Antineoplastic agents, other alkylating agents, ATC code: L01A X03.
Icelandic: Æxlishemjandi lyf, önnur alkýlerandi efni, ATC flokkur:
English: Anorexia
Icelandic: Terapia
English: The body is imprinted with ‘100 mg' and two stripes.
Icelandic: Á botninn er letrað „100 mg“ og tvær rendur.
English: Temozolomide SUN 140 mg hard capsules
Icelandic: Temozolomide SUN 140 mg hörð hylki
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.
Icelandic: Krampar voru mjög algeng aukaverkun hjá sjúklingum með nýgreint margfrumna taugakímsæxli sem fengu einlyfjameðferð og útbrot voru mjög algeng hjá sjúklingum með nýgreint margfrumna taugakímsæxli sem fengu
English: Temozolomide SUN 100 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 100 mg hörð hylki temózólómíð
English: Propylene glycol Yellow iron oxide (E172)
Icelandic: Própýlen glýkól Gult járnoxíð (E172)
English: Package Leaflet: Information for the user Temozolomide SUN 140 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 140 mg hörð hylki temózólómíð
English: Each hard capsule contains 180 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 180 mg af temózólómíði.
English: Temozolomide SUN 5 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 5 mg hörð hylki temózólómíð
English: Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation
Icelandic: Mjög algengar (geta komið fyrir hjá fleiri en 1 af hverjum 10 einstaklingum):
English: Hearing impairment
Icelandic: Innihald hylkis
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Icelandic: Fullorðnir og börn 3 ára og eldri með illkynja glioma tróðæxli sem hefur tekið sig upp aftur eða versnað:
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick), constipation (difficulty passing stools), tiredness.
Icelandic: Lækkaður fjöldi blóðfrumna (daufkyrningafæð eða eitilfrumnafæð, blóðflagnafæð), lystarleysi, höfuðverkur, uppköst, ógleði, hægðatregða (erfiðleikar við hægðalosun), þreyta.
English: Temozolomide SUN 20 mg hard capsules
Icelandic: Temozolomide SUN 20 mg hörð hylki
English: Package Leaflet: Information for the user Temozolomide SUN 5 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 5 mg hörð hylki temózólómíð
English: Each hard capsule contains 100 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 100 mg af temózólómíði.
English: Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink.
Icelandic: Hörð gelatínuhylki með hvítri, ógegnsærri hettu og botni og blárri áletrun.
English: Temozolomide SUN 180 mg hard capsules temozolomide
Icelandic: Temozolomide SUN 180 mg hörð hylki temózólómíð
English: (difficulty passing stools), nausea (feeling sick), vomiting, rash, hair loss, tiredness.
Icelandic: höfuðverkur, hægðatregða (erfiðleikar við hægðalosun), ógleði, uppköst, útbrot, hárlos, þreyta.
English: decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Icelandic: Helftarslekja (hemiparesis), málstol (aphasia), skert jafnvægi, svefnhöfgi, ringlun, sundl, minnisskerðing, skert einbeiting, málglöp (dysphasia), taugaröskun (ótilgreind), taugakvilli, úttaugakvilli, náladofi, taltruflanir, skjálfti
English: Propylene glycol Red iron oxide (E172)
Icelandic: Própýlen glýkól Rautt járnoxíð (E172)
English: Temozolomide SUN 100 mg hard capsules have a white opaque body and cap, imprinted in pink ink.
Icelandic: Temozolomide SUN 100 mg hörð gelatínhylki með hvítri, ógegnsærri hettu og botni og bleikri áletrun.
English: Package Leaflet: Information for the user Temozolomide SUN 100 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 100 mg hörð hylki temózólómíð
English: Package Leaflet: Information for the user Temozolomide SUN 180 mg hard capsules temozolomide
Icelandic: Upplýsingar fyrir notanda lyfsins Temozolomide SUN 180 mg hörð hylki temózólómíð
English: EU/1/11/697/017 (5 hard capsules) EU/1/11/697/018 (20 hard capsules)
Icelandic: EU/1/11/697/017 (5 hörð hylki) EU/1/11/697/018 (20 hörð hylki)
English: Temozolomide SUN 180 mg hard capsules
Icelandic: Temozolomide SUN 180 mg hörð hylki
English: Hard gelatin capsules, with white opaque cap and body, imprinted in black ink.
Icelandic: Hörð gelatínuhylki með hvítri, ógegnsærri hettu og botni og svartri áletrun.