FrancophonIA/ELRC3.0 huggingface dataset:
English: Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Icelandic: Temozolomide Sandoz 250 mg hörð hylki Hvert hylki inniheldur 250 mg temózólómíð.
English: Bottle Do not store above 25 °C.
Icelandic: Skammtapoki Geymið ekki við hærri hita en 25°C.
English: Method of administration Temozolomide Sandoz hard capsules should be administered in the fasting state.
Icelandic: Gefa á Temozolomide Sandoz hörð hylki á fastandi maga.
English: ≥ 100 x 10
Icelandic: ANC ≥ 1,5 x 10
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Icelandic: Almenn viðmiðun eituráhrifa (CTC) önnur en blóðfræðileg (nema fyrir hárlos, ógleði, uppköst)
English: Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Icelandic: Temozolomide Sandoz 140 mg hörð hylki Hvert hylki inniheldur 140 mg temózólómíð.
English: Each hard capsule contains 250 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 250 mg temózólómíð.
English: TMZ discontinuation
Icelandic: TMZ stöðvun
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Icelandic: Aukaverkanir hjá sjúklingum með endurmein eða versnun illkynja tróðæxlis
English: Other sources of information
Icelandic: Pakkningar og aðrar upplýsingar
English: Temozolomide Sandoz contains lactose
Icelandic: Temozolomide Sandoz inniheldur laktósa
English: Each hard capsule contains 5 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 5 mg temózólómíð.
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Icelandic: Þaninn kviður, saurlos (fecal incontinence), truflun í meltingarvegi (óskilgreind), maga- og garnabólga, gyllinæð
English: Anxiety, emotional lability, insomnia
Icelandic: Kvíði, tilfinningasveiflur, svefnleysi
English: Do not open, crush or chew the capsules, swallow whole.
Icelandic: Hylkin má hvorki opna, mylja né tyggja, gleypið þau heil.
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Icelandic: Krampar, skert meðvitund, svefnhöfgi, málstol (aphasia), skert jafnvægi, sundl, ringlun, minnisskerðing, skert einbeiting, taugakvilli, náladofi, taltruflanir, skjálfti
English: • haemorrhoids
Icelandic: Blóðflagnafjöldi
English: Table 4.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: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Icelandic: Útsetning fyrir lyfjum sem tengjast vanmyndunarblóðleysi, þ.m.t. karbamazepíni, fenytóíni og súlfametoxazóli/trímetóprími getur í sumum tilfellum gert mat erfiðara.
English: Hearing impairment
Icelandic: AÐRAR FORSENDUR
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 þ m.t. kyrningahvítblæði (sjá kafla 4.8).
English: This adds up to a 28-day treatment cycle.
Icelandic: Meðferðarlota nær yfir 28 daga.
English: INSTRUCTIONS ON USE
Icelandic: SEM SKULU KOMA FRAM Á
English: • tiredness.
Icelandic: • þvagleki,
English: Each hard capsule contains 140 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 140 mg temózólómíð.
English: Uncommon (may affect up to 1 in 100 people):
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum):
English: Stearic acid
Icelandic: Eiturverkun á lifur
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Icelandic: Blóðvökvaúthreinsun, dreifingarrúmmál og helmingunartími eru óháð skömmtum.
English: Lactose
Icelandic: Laktósi
English: Contact your doctor immediately if you have any of the following:
Icelandic: Láttu lækninn vita strax ef þú finnur fyrir þessum aukaverkunum.
English: Temozolomide Sandoz 140 mg hard capsules blue
Icelandic: Temozolomide Sandoz 140 mg hörð hylki blár
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Icelandic: Í rannsóknum á lyfjahvörfum hjá sjúklingum með væga til miðlungs alvarlega skerta lifrarstarfsemi var lyfjahvarfaferlið í blóðvökva svipað og hjá sjúklingum með eðlilega lifrarstarfsemi.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Icelandic: ANC ≥ 1,5 x 109/l og fjöldi blóðflagna ≥ 100 x 109/l.
English: Capsules should not be opened.
Icelandic: Ekki má opna hylkin.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance disorder (NOS), peripheral neuropathy
Icelandic: Helftarlömun (hemiplegia), ósamræming vöðvahreyfinga, óeðlileg samhæfing, óeðlilegt göngulag, snertiskynsaukning, skyntruflun (sensory disturbance)
English: Each hard capsule contains 20 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 20 mg temózólómíð.
English: • swollen stomach
Icelandic: vöðvaskemmdir,
English: Temozolomide Sandoz may cause permanent infertility.
Icelandic: Temodal getur valdið varanlegri ófrjósemi.
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,
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: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Icelandic: CTC (nema fyrir hárlos, ógleði, uppköst)
English: How to store Temozolomide Sandoz
Icelandic: Hvernig geyma á TEMOZOLOMIDE SANDOZ
English: Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Icelandic: Temozolomide Sandoz 180 mg hörð hylki Hvert hylki inniheldur 180 mg temózólómíð.
English: • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma.
Icelandic: 3 ára og eldri og fullorðnum með illkynja tróðæxli, svo sem margfrumna taugakímsæxli eða stjarnfrumnaæxli af villivaxtargerð.
English: Temozolomide Sandoz 180 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Icelandic: Temozolomide Sandoz 180 mg hörð hylki - innihald hylkisins: vatnsfrír laktósi, vatnsfrí kísilkvoða, natríum-glýkolatsterkja tegund A, vínsýra, sterínsýra.
English: Domaniewska 50 C PL - 02 672 Warszawa Tel.: +48 22 209 6828 maintenance.pl@sandoz.com
Icelandic: +48 22 209 6828 maintenance.pl@sandoz.com
English: • high blood pressure
Icelandic: hár blóðþrýstingur,
English: • peeling skin
Icelandic: • bólgnir fætur,
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: Blood and lymphatic system disorders Very common:
Icelandic: Blóð og eitlar Mjög algengar:
English: See section 4.
Icelandic: Building 4, floor 4
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Icelandic: FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: Respiratory, thoracic and mediastinal disorders Common:
Icelandic: Öndunarfæri, brjósthol og miðmæti Algengar:
English: • headache
Icelandic: • hiti,
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Icelandic: Húðflögnun, ljósnæmisviðbrögð, óeðlileg litun húðar
English: Plasma concentrations increase in a dose-related manner.
Icelandic: Blóðvökvastyrkur eykst í réttu hlutfalli við skammta.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Icelandic: Heiti og heimilisfang framleiðanda sem ábyrgur er fyrir lokasamþykkt viðkomandi lotu skal koma fram í útprentuðum fylgiseðli.
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 tróðæxli sem hefur tekið sig upp aftur eða versnað:
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Icelandic: Tafla 3. TMZ skammtaminnkun eða -stöðvun meðan á einlyfjameðferð stendur Eituráhrif
English: Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Icelandic: Temozolomide Sandoz 100 mg hörð hylki Hvert hylki inniheldur 100 mg temózólómíð.
English: • vaginal bleeding
Icelandic: • lágt kalíumgildi í blóði,
English: Temozolomide Sandoz 250 mg hard capsules white
Icelandic: Temozolomide Sandoz 250 mg hörð hylki hvítur
English: Each hard capsule contains 100 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 100 mg temózólómíð.
English: Temozolomide Sandoz 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Icelandic: Temozolomide Sandoz 5 mg hörð hylki - innihald hylkisins: vatnsfrír laktósi, vatnsfrí kísilkvoða, natríum-glýkolatsterkja tegund A, vínsýra, sterínsýra.
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 auknu bilirubini, vandamálum með gallflæði (gallteppu), lifrarbólgu og lifrarskaða, þ.m.t. banvænni lifrarbilun.
English: reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Icelandic: Lækkuð blóðgildi (blóðfrumnafæð, blóðleysi, hvítfrumnafæð).
English: Each hard capsule contains 180 mg temozolomide.
Icelandic: Hvert hart hylki inniheldur 180 mg temózólómíð.
English: Temozolomide Sandoz 5 mg hard capsules green
Icelandic: Temozolomide Sandoz 5 mg hörð hylki grænn
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Sandoz should be administered without food.
Icelandic: á Cmax sé klínískt marktæk skal ekki gefa Temozolomide Sandoz með fæðu.
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Icelandic: Lungnabólgu af völdum Pneumocystis jirovecii (PCP) gæti komið oftar fram hjá þeim sem taka TMZ samkvæmt lengri meðferðaráætlun.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Icelandic: B (HBV), stórfrumuveiru (CMV)) hafa komið fram í meðferð með TMZ (sjá kafla 4.8).
English: Temozolomide Sandoz 20 mg hard capsules yellow
Icelandic: Temozolomide Sandoz 20 mg hörð hylki gulur
English: Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
Icelandic: Þróttleysi, andlitsroði, hitasteypur, versnun á sjúkdómsástandi, kuldahrollur, upplitun tungu, lyktarglöp, þorsti
English: General disorders and administration site conditions Very common:
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar:
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), vatn.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Icelandic: Síflog (status epilepticus), utanstrýturöskun, helftarslekja (hemiparesis), ósamræming vöðvahreyfinga, vitsmunaskerðing, málglöp (dysphasia), óeðlilegt göngulag, snertiskynsaukning, snertiskynsminnkun, taugaröskun (ótilgreind), úttaugakvilli
English: Headache
Icelandic: Þungun
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Icelandic: Munnbólga, niðurgangur, meltingartruflanir, kyngingarörðugleikar, munnþurrkur
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Icelandic: Prentblek: shellac, kalíumhýdroxíð, svart járnoxíð (E172).
English: Table 2.TMZ dose levels for monotherapy treatment
Icelandic: Tafla 2 TMZ skammtagildi í einlyfjameðferð
English: • tooth disorder.
Icelandic: • tannkvillar.
English: • difficulty in urinating
Icelandic: • erfiðleikar við þvaglát,
English: Haemorrhage, oedema, oedema leg
Icelandic: Húðbólga, þurr húð, hörundsroði, kláði
English: Uncommon:
Icelandic: Fylgiseðill:
English: • heartburn
Icelandic: • hitasteypur,
English: Temozolomide Sandoz 5 mg hard capsules
Icelandic: Temozolomide Sandoz 5 mg hörð hylki
English: The hard capsules have a white coloured body, a yellow coloured cap, and are imprinted with black ink.
Icelandic: Hörðu hylkin eru úr hvítri skel og gulu loki með svartri áletrun.
English: • shivering
Icelandic: Brotthvarf
English: • increased skin sensitivity to sunlight
Icelandic: • aukið ljósnæmi húðar,
English: • frequent urination
Icelandic: Heildarfjöldi daufkyrninga
English: Pregnancy
Icelandic: Getuleysi
English: The hard capsules have a white coloured body, a white coloured cap, and are imprinted with black ink.
Icelandic: Hörðu hylkin eru úr ógegnsærri hvítri skel, með hvítt lok og eru með svartri áletrun.
English: System organ class
Icelandic: Stig CTC
English: Temozolomide Sandoz 100 mg hard capsules
Icelandic: Temozolomide Sandoz 100 mg hörð hylki
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 19 November 2014
Icelandic: 19. nóvember 2014
English: Temozolomide Sandoz 140 mg hard capsules
Icelandic: Temozolomide Sandoz 140 mg hörð hylki
English: Temozolomide Sandoz 20 mg hard capsules
Icelandic: Temozolomide Sandoz 20 mg hörð hylki
English: • allergic reactions.
Icelandic: • ofnæmi.
English: • absent or heavy menstrual periods,
Icelandic: tíðateppa eða miklar blæðingar,
English: Vascular disorders Common:
Icelandic: Innihald hylkis:
English: Temozolomide Sandoz 250 mg hard capsules
Icelandic: Temozolomide Sandoz 250 mg hörð hylki
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Icelandic: svefnhöfgi, málstol (aphasia), skert jafnvægi, sundl, ringlun, minnisskerðing, skert einbeiting, taugakvilli, náladofi, taltruflanir, skjálfti málstol (aphasia), skert jafnvægi, svefnhöfgi, ringlun, sundl, minnisskerðing, skert einbeiting, málglöp (dysphasia), taugaröskun (ótilgreind), taugakvilli, úttaugakvilli, náladofi, taltruflanir, skjálfti
English: • muscle aches and pains
Icelandic: Lifur og gall*
English: The bottles contain a desiccant pouch.
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: Temozolomide Sandoz 20 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 20 mg hylki temózólómíð
English: Temozolomide Sandoz 5 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 5 mg hylki temózólómíð
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Icelandic: vatnsfrír laktósi, vatnsfrí kísilkvoða, natríum-glýkolatsterkja tegund A, vínsýra, sterínsýra.
English: Temozolomide Sandoz 20 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 20 mg hörð hylki temózólómíð
English: 9/l, and the thrombocyte count is ≥ 100 x 109/l.
Icelandic: 9/l og fjöldi blóðflagna ≥ 100 x 10
English: • difficulty concentrating
Icelandic: • einbeitingarörðugleikar,
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Icelandic: Þróttleysi, andlitsbjúgur, verkur, versnun á sjúkdómsástandi, kuldahrollur, tannkvilli
English: Temozolomide Sandoz 140 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 140 mg hylki temózólómíð
English: Temozolomide Sandoz 250 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 250 mg hylki temózólómíð
English: Temozolomide Sandoz 5 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 5 mg hörð hylki temózólómíð
English: Clinical trial experience
Icelandic: Upplýsingar úr klínískum rannsóknum
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Icelandic: Vart varð við mergbælingu (daufkyrningafæð og blóðflagnafæð), sem er þekkt skammtatakmarkandi eiturverkun flestra frumueyðandi lyfja, að meðtöldu TMZ.
English: The bottles also contain a desiccant pouch.
Icelandic: Glösin innihalda einnig þurrkefni í litlum poka.
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Icelandic: • fækkun blóðfrumna (daufkyrningafæð eða eitilfrumnafæð, blóðflagnafæð)
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), indigókarmín (E132), vatn.
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Icelandic: Helftarblinda (hemianopia), skert sjónskerpa, sjóntruflun, sjónsviðseyður, augnverkur
English: • increased sweating
Icelandic: • aukin svitamyndun,
English: Temozolomide Sandoz 140 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 140 mg hörð hylki temózólómíð
English: Temozolomide Sandoz 180 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 180 mg hylki temózólómíð
English: • dry mouth
Icelandic: • munnþurrkur,
English: Temozolomide Sandoz 250 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 250 mg hörð hylki temózólómíð
English: Temozolomide Sandoz 180 mg hard capsules maroon
Icelandic: Temozolomide Sandoz 180 mg hörð hylki
English: Gastrointestinal disorders Very common:
Icelandic: Meltingarfæri Mjög algengar:
English: CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30 % of that in plasma, which is consistent with animal data.
Icelandic: 30% miðað viðþað sem er í blóðvökva, sem er í samræmi við þær upplýsingar sem fengist hafa af rannsóknum á dýrum.
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Icelandic: Sýking, áblásturssótt (herpes simplex), sárasýking, kokbólga, hvítsveppasýking í munni
English: Lymphopenia, petechiae
Icelandic: B. FYLGISEÐILL
English: Cases of diabetes insipidus have been uncommonly reported.
Icelandic: Í sjaldgæfum tilvikum hefur verið tilkynnt um þvaghlaupssýki.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Icelandic: Glösin innihalda þurrkefni í litlum poka.
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Icelandic: Mælt er með fyrirbyggjandi meðferð með ógleðistillandi lyfjum áður en fyrsti skammtur samhliða fasa er gefinn og eindregið er mælt með fyrirbyggjandi meðferð með ógleðistillandi lyfjum meðan á einlyfjameðferðarfasa stendur.
English: • hallucination and memory impairment
Icelandic: ofskynjanir og skert minni,
English: Temozolomide Sandoz 100 mg capsules temozolomide
Icelandic: Temozolomide Sandoz 100 mg hylki temózólómíð
English: • bronchitis
Icelandic: • brjóstsviði,
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), gult járnoxíð (E172), rautt járnoxíð (E 172), vatn.
English: • urticaria (hives)
Icelandic: Helftarslekja (hemiparesis),
English: Temozolomide Sandoz 180 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 180 mg hörð hylki temózólómíð
English: Temozolomide Sandoz 100 mg hard capsules temozolomide
Icelandic: Temozolomide Sandoz 100 mg hörð hylki temózólómíð
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Icelandic: Ofnæmi, hiti, áverki af geislameðferð, andlitsbjúgur, verkur, truflað bragðskyn
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Icelandic: Lungnablóðrek, bjúgur, útlimabjúgur
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Icelandic: Lungnabólga, skútabólga (sinusitis), sýking í efri hluta öndunarvegar, berkjubólga
English: Common (may affect up to 1 in 10 people):
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum):
English: Cushingoid
Icelandic: Cushingssjúkdómur
English: Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia
Icelandic: Lungnabólga, sýking í efri hluta öndunarvegar, nefstífla
English: CZ-140 00, Praha 4
Icelandic: L01AX03
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
Icelandic: Venjulegur upphafsskammtur, hafir þú áður undirgengist krabbameinsmeðferð, er 150 mg/m2, einu sinni á dag fyrstu 5 dagana.
English: Somnolence, dizziness, paresthesia
Icelandic: Hægðatregða, ógleði, uppköst
English: Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.
Icelandic: Greint hefur verið frá sjaldgæfum tilfellum sýkinga í heila af völdum herpesveiru (heilahimnu- og heilabólgu af völdum herpesveiru) þar með talið banvænum tilvikum.
English: Impotence
Icelandic: Lystarleysi
English: • muscle weakness
Icelandic: • breytt lyktarskyn,
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Icelandic: 4 má finna aukaverkanir sem komu fram við meðferð hjá sjúklingum með nýgreint margfrumna taugakímsæxli meðan á samhliðafasa og einlyfja meðferðarfasa stóð.
English: Febrile neutropenia, anaemia
Icelandic: Ofskynjanir, minnisleysi
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), gult járnoxíð (E172), vatn.
English: Gelatin
Icelandic: Kyn
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), gult járnoxíð (E172), indigókarmín (E132), vatn.
English: Laboratory parameters
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: Anti-emetic therapy may be administered prior to or following administration of TMZ.
Icelandic: Gefa má ógleðistillandi meðferð fyrir eða eftir gjöf TMZ.
English: HBV
Icelandic: V
English: Bottle
Icelandic: Dreifing
English: Temozolomide Sandoz 100 mg hard capsules pink
Icelandic: Temozolomide Sandoz 100 mg hörð hylki bleikur
English: Myopathy, back pain
Icelandic: Vöðvakvilli, bakverkur
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Sandoz
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en Temozolomide Sandoz er notað - þar sem fylgjast á vel með hvort einkenni alvarlegrar sýkingar í brjóstholi sem kallast Pneumocystis jirovecii lungnabólga (PCP) komi fram hjá þér.
English: The hard capsules have a white coloured body, a green coloured cap, and are imprinted with black ink.
Icelandic: Hörðu hylkin eru úr hvítri skel og grænu loki með svartri áletrun.
English: • blood clot in the legs
Icelandic: • blóðtappi í fótum,
English: Strada Livezeni 7a 540472 Targu Mures Tel: +40 21 407 51 60
Icelandic: 540472 Targu MuresTel:
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Icelandic: - gelatínhylkin: gelatín, títandíoxið (E 171), rautt járnoxíð (E172), vatn.