FrancophonIA/ELRC3.0 huggingface dataset:
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Estonian: Krambid, teadvuse hägunemine, unisus, afaasia, tasakaaluhäired, pearinglus, segasus, mäluhäired, kontsentreerumisraskused, neuropaatia, paresteesia, kõnehäire, treemor
English: Reduction for prior toxicity
Estonian: Vähendamine eelnenud toksilisuse tõttu Annus 1. tsükli ajal
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Estonian: Üks kõvakapsel sisaldab 102,2 mg veevaba laktoosi.
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Estonian: Üks kõvakapsel sisaldab 182,5 mg veevaba laktoosi.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Estonian: - neutrofiilide koguarv (ANC) ≥ 1,5 x 109/l - trombotsüütide arv ≥ 100 x 109/l - üldise toksilisuse kriteeriumi (CTC) mittehematoloogiline toksilisus ≤ 1. aste (v.a alopeetsia,
English: 4.2 Posology and method of administration Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Estonian: Temozolomide Accord't peaks ordineerima ajukasvajate onkoloogilise ravikogemusega arst.
English: Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Estonian: Temozolomide Accord 20 mg kõvakapslid: üks kapsel sisaldab 20 mg temosolomiidi.
English: Pregnancy,breast-feeding and fertility
Estonian: Rasedus, imetamine ja viljakus
English: hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Estonian: hüperbilirubineemia, kolestaas, hepatiit, maksakahjustus, maksapuudulikkus†
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Estonian: Hemiparees, afaasia, tasakaaluhäired, unisus, segasus, pearinglus, mäluhäired, keskendumisraskused, düsfaasia, neuroloogilised häired (NOS), neuropaatia, perifeerne neuropaatia, paresteesia, kõnehäired, treemor
English: The following side effects may occur if you are a newly diagnosed patient taking Temozolomide Accord for a specific brain tumour (glioblastoma multiforme) in combination treatment with radiotherapy and then later taking temozolomide on its own.
Estonian: Kui te olete esmakordselt diagnoositud patsient, kes võtab Temozolomide Accord'i spetsiifilise ajukasvaja korral (multiformne glioblastoom) samaaegselt koos kiiritusraviga ja seejärel ainult temosolomiidi, võivad ilmneda järgmised kõrvaltoimed.
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Estonian: TMZ ravi saanud patsientidel on teatatud maksakahjustustest, sh surmaga lõppenud maksapuudulikkusest (vt lõik 4.8).
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.
Estonian: Kui te ei ole eelnevalt keemiaravi saanud, on temosolomiidi esimeseks annuseks 200 mg/m2 üks kord ööpäevas 5 esimese päeva jooksul („annustamispäevad”), seejärel olete te 23 päeva ilma temosolomiidita.
English: INFORMATION IN BRAILLE Temozolomide 5mg
Estonian: Temozolomide 5 mg
English: Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Estonian: Temozolomide Accord 180 mg kõvakapslid: üks kapsel sisaldab 180 mg temosolomiidi.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Estonian: Epileptiline staatus, ekstrapüramidaalhäired, hemiparees, ataksia, tunnetuse häired, düsfaasia, ebanormaalne kõnnak, hüperesteesia, hüpoesteesia, neuroloogiline häire (NOS), perifeerne neuropaatia
English: Anxiety, depression, emotional lability, insomnia
Estonian: Ärevus, depressioon, emotsionaalne labiilsus, unetus
English: Abdominal distension, faecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Estonian: Kõhupuhitus, roojapidamatus, seedetraktihäire (mitte elundispetsiifiline, NOS), gastroenteriit, hemorroidid
English: Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Estonian: Temozolomide Accord 5 mg kõvakapslid: üks kapsel sisaldab 5 mg temosolomiidi.
English: Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Estonian: Temozolomide Accord 140 mg kõvakapslid: üks kapsel sisaldab 140 mg temosolomiidi.
English: INFORMATION IN BRAILLE Temozolomide 20mg
Estonian: Temozolomide 20 mg
English: a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), - uncontrolled bleeding, - Seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Estonian: Väga sage (võib tekkida rohkem kui ühel inimesel 10-st): - ebaloomulikud verenäitajad - peavalu - iiveldus või oksendamine - kõhukinnisus - söögiisu kadumine - väsimus.
English: Contains lactose.
Estonian: ABIAINED Sisaldab laktoosi.
English: Skin and subcutaneous tissue disorders Very rare:
Estonian: Naha ja nahaaluskoe kahjustused Väga harv:
English: Dry skin, pruritus
Estonian: Nahakuivus, pruuritus
English: Rash, pruritus, alopecia
Estonian: Lööve, sügelus, alopeetsia,
English: INFORMATION IN BRAILLE Temozolomide 250mg
Estonian: Temozolomide 250 mg
English: Each capsule is approximately 21 mm in length.
Estonian: Kapsli pikkus on ligikaudu 21 mm.
English: INFORMATION IN BRAILLE Temozolomide 100mg
Estonian: Temozolomide 100 mg
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Estonian: Kui TMZ manustatakse pikemaajalise raviskeemi alusel võib PCP esinemissagedus olla suurem.
English: TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Estonian: TMZ manustatakse suukaudselt annuses 75 mg/m2 ööpäevas 42 päeva jooksul samaaegselt fokaalse
English: Each capsule is approximately 15 mm in length.
Estonian: Kapsli pikkus on ligikaudu 15 mm.
English: Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
Estonian: Multiformne erüteem, erütrodermia, urtikaaria, eksanteem Üldised häired ja manustamiskoha reaktsioonid Väga sage
English: Each capsule is approximately 11 mm in length.
Estonian: Kapsli pikkus on ligikaudu 11 mm.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SACHET CARTON
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Kotikese karp
English: SACHET CARTON
Estonian: Uuringud Sage
English: Adult patients with newly-diagnosed glioblastoma multiforme
Estonian: Täiskasvanud patsiendid esmaselt diagnoositud multiformse glioblastoomiga
English: Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Estonian: Temozolomide Accord 100 mg kõvakapslid: üks kapsel sisaldab 100 mg temosolomiidi.
English: Nervous system disorders Very common:
Estonian: Närvisüsteemi häired Väga harv
English: Febrile neutropenia, anaemia Lymphopenia, petechiae
Estonian: Febriilne neutropeenia, aneemia Lümfopeenia, petehhiad
English: Titanium dioxide (E171) Indigo carmine (E132).
Estonian: Titaandioksiid (E171) Indigokarmiin (E132)
English: Each capsule is approximately 19 mm in length.
Estonian: Kapsli pikkus on ligikaudu 19 mm.
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Estonian: Asteenia, näoturse, valu, seisundi ägenemine, külmavärinad, hammaste kahjustused
English: Special populations Paediatric population
Estonian: Patsientide erigrupid
English: Temozolomide Accord 180 mg hard capsules temozolomide
Estonian: Temozolomide Accord 180 mg kõvakapslid temosolomiid
English: Temozolomide Accord 5 mg hard capsules temozolomide
Estonian: Temozolomide Accord 5 mg kõvakapslid temosolomiid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 250 mg temosolomiidi.
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.
Estonian: Temozolomide Accord 250 mg kõvakapslite keha on valge ja kaas on valge; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘250'.
English: INFORMATION IN BRAILLE Temozolomide 180mg
Estonian: Temozolomide 180 mg
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.
Estonian: Kui te olete varem keemiaravi saanud, on temosolomiidi esimeseks annuseks 150 mg/m2 üks kord ööpäevas 5 esimese päeva jooksul ja seejärel olete te 23 päeva ilma temosolomiidita.
English: Respiratory, thoracic and mediastinal disorders Common:
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Sage:
English: The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Estonian: Kõvakapslid on läbipaistvad sinised/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘140'.
English: Temozolomide Accord 250 mg hard capsules: gelatine, titanium dioxide (E 171), water.
Estonian: Temozolomide Accord 250 mg kõvakapslid: želatiin, titaandioksiid (E171)ja vesi.
English: Very rare:
Estonian: Väga harv
English: Propylene glycol Black iron oxide (E172) Potassium hydroxide
Estonian: Propüleenglükool Must raudoksiid (E172) Kaaliumhüdroksiid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 20 mg temosolomiidi.
English: Temozolomide Accord 20 mg hard capsules temozolomide
Estonian: Temozolomide Accord 20 mg kõvakapslid temosolomiid
English: Stearic acid
Estonian: Viinhape Steariinhape
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste
Estonian: Allergiline reaktsioon, palavik, kiirituskahjustus, näoturse, valu, maitsetundlikkuse häired
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 5 mg temosolomiidi.
English: Common (may affect up to 1 in 10 people):
Estonian: Aeg-ajalt (võib tekkida kuni ühel inimesel 100-st): - muutused vererakkudes.
English: INFORMATION IN BRAILLE Temozolomide 140mg
Estonian: Temozolomide 140 mg
English: Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath
Estonian: Sage (võib tekkida kuni ühel inimesel 10-st): - unisus - pearinglus - kihelustunne - kõhulahtisus - kõhuvalu - seedehäired - lööve - sügelus - juuste väljalangemine - kehakaalu vähenemine - palavik - nõrkus - värinad - halb enesetunne - valud - maitsetundlikkuse muutused - hingeldamine.
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Estonian: Kerge või mõõduka maksakahjustusega patsientidel oli TMZ farmakokineetika võrreldav normaalse maksafunktsiooniga patsientidega.
English: exanthema
Estonian: Imendumine
English: Titanium dioxide (E171) Iron oxide yellow (E172) Indigo carmine (E132)
Estonian: Titaandioksiid (E171) Kollane raudoksiid (E172) Indigokarmiin (E132)
English: Temozolomide Accord 5 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Estonian: Temozolomide Accord 5 mg kõvakapslid: želatiin titaandioksiid (E171), kollane raudoksiid (E172), indigokarmiin (E132) ja vesi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 140 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 140 mg temosolomiidi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 180 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 180 mg temosolomiidi.
English: Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Estonian: Ravikavatsusliku populatsiooni analüüsil (ITT n = 162) oli ravivastus tsentraalse retsensendi hinnangul 35% (13 täieliku ja 43 osalise vastusega).
English: Baseline liver function tests should be performed prior to treatment initiation.
Estonian: Enne ravi alustamist tuleb teha analüüsid ravieelse maksafunktsiooni hindamiseks.
English: Temozolomide Accord 140 mg hard capsules: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Estonian: Temozolomide Accord 140 mg kõvakapslid: želatiin, titaandioksiid (E171), indigokarmiin (E132) ja vesi.
English: Do not double the next dose to make up for a forgotten dose, unless your doctor tells you to do so.
Estonian: Ärge võtke kahekordset annust, kui annus jäi eelmisel korral võtmata, välja arvatud raviarsti poolt määratud juhtudel.
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Estonian: Raviga seotud kõrvaltoimed: Taastuv või progresseeruv pahaloomuline glioom
English: The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ' on cap & ‘5' on body.
Estonian: Kõvakapslid on rohelised/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘5'.
English: Temozolomide Accord 250 mg hard capsules temozolomide
Estonian: Temozolomide Accord 250 mg kõvakapslid temosolomiid
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.
Estonian: Temozolomide Accord 140 mg kõvakapslite keha on valge ja kaas on sinine; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘140'.
English: Temozolomide Accord 100 mg hard capsules temozolomide
Estonian: Temozolomide Accord 100 mg kõvakapslid temosolomiid
English: EU/1/10/615/002
Estonian: EU/1/10/615/001 EU/1/10/615/002
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.
Estonian: Temozolomide Accord 180 mg kõvakapslite keha on valge ja kaas on kastanpruun; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘180'.
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.
Estonian: Temozolomide Accord 20 mg kõvakapslite keha on valge ja kaas on kollane; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘20'.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Estonian: Titaandioksiid (E171) Kollane raudoksiid (E172)
English: Temozolomide Accord 140 mg hard capsules temozolomide
Estonian: Temozolomide Accord 140 mg kõvakapslid temosolomiid
English: The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ' on cap & ‘250' on body.
Estonian: Kõvakapslid on valged/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘250'.
English: Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Estonian: Temozolomide Accord 20 mg kõvakapslid: želatiin, titaandioksiid (E171), kollane raudoksiid (E172) ja vesi.
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.
Estonian: Temozolomide Accord 100 mg kõvakapslite keha on valge ja kaas on roosa; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘100'.
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Estonian: TMZ manustamist tuleb jätkata kogu 42 päeva jooksul (vajadusel kuni 49 päeva), kui kõik järgmised tingimused on täidetud: - neutrofiilide koguarv (ANC) ≥ 1,5 x 109/l
English: Temozolomide Accord should be administered in the fasting state.
Estonian: Temozolomide Accord ravi ajal tuleb imetamine katkestada.
English: Capsule contents Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Estonian: Veevaba laktoos Kolloidne veevaba ränidioksiid Naatriumtärklisglükolaat, tüüp A
English: Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Estonian: Temozolomide Accord 180 mg kõvakapslid: želatiin, titaandioksiid (E171), kollane raudoksiid (E172), punane raudoksiid (E172) ja vesi.
English: * Frequencies estimated based on relevant clinical trials.
Estonian: Teadmata eosinofiilia ja süsteemsete sümptomitega ravimireaktsioon (DRESS) *Asjakohaste kliiniliste uuringute andmete põhjal hinnatud kõrvaltoimete esinemissagedus.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Estonian: päevaks, v.a kui tekib toksilisus.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 140 mg kõvakapslid
English: Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Estonian: Temozolomide Accord 100 mg kõvakapslid: želatiin, titaandioksiid (E171), punane raudoksiid (E172) ja vesi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg temozolomide.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kõvakapsel sisaldab 100 mg temosolomiidi.
English: The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Estonian: Kõvakapslid on kollased/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘20'.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 250 mg hard capsules.
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 250 mg kõvakapslid
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: • rash
Estonian: Rasedus
English: Date of first authorisation:15 March 2010 Date of latest renewal: 12 January 2015
Estonian: Müügiloa viimase uuendamise kuupäev: 12. jaanuar 2015
English: Skin and subcutaneous tissue disorders Common:
Estonian: Naha ja nahaaluskoe kahjustused Sage
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Estonian: Kõhukinnisus, iiveldus, oksendamine
English: diabetes insipidus Respiratory, thoracic and mediastinal disorders
Estonian: Respiratoorsed, rindkere ja mediastiinumi häired Sage
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.
Estonian: Kuidas Temozolomide Accord välja näeb ja pakendi sisu Temozolomide Accord 5 mg kõvakapslite keha on valge ja kaas on roheline; kapsli kaanel on musta tindiga märgistus ‘TMZ' ja kehal ‘5'.
English: The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ' on cap & ‘180' on body.
Estonian: Kõvakapslid on kastanpruunid/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘180'.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 20 mg hard capsules.
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 20 mg kõvakapslid
English: The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Estonian: Kõvakapslid on roosad/valged kõvad želatiinkapslid, mille kaanele on trükitud ‘TMZ' ja kehale ‘100'.
English: Anxiety, emotional lability, insomnia
Estonian: Ärevus, emotsionaalne labiilsus, unetus
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 20 mg hard capsules temozolomide
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 20 mg kõvakapslid temosolomiid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 5 mg hard capsules temozolomide
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 5 mg kõvakapslid
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 180 mg hard capsules.
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 180 mg kõvakapslid
English: Vascular disorders Common:
Estonian: Vaskulaarsed häired Sage
English: Titanium dioxide (E171) Iron oxide red (E172)
Estonian: Titaandioksiid (E171) Punane raudoksiid (E172)
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules.
Estonian: 5 või 20 kapslit lapsekindla polüpropüleenkorgiga ja kuivatusainega III tüüpi merevaigukollasest klaasist pudelis.
English: NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 100 mg hard capsules.
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 100 mg kõvakapslid
English: Haemorrhage, deep venous thrombosis, oedema leg
Estonian: Hemorraagia, süvaveenide tromboos, jalgade tursed
English: Musculoskeletal and connective tissue disorders Common:
Estonian: Lihas-skeleti ja sidekoe kahjustused Sage
English: Patients in the control arm received RT only.
Estonian: *Patsient, kes oli randomiseeritud ainult RT gruppi, sai TMZ + RT.
English: EU/1/10/615/014
Estonian: EU/1/10/615/013 EU/1/10/615/014
English: Capsule shell Gelatine
Estonian: Kapsli kest Želatiin
English: Cushingoid
Estonian: INN: Temozolomidum
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 250 mg hard capsules temozolomide
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 250 mg kõvakapslid temosolomiid
English: EU/1/10/615/036
Estonian: EU/1/10/615/035 EU/1/10/615/036
English: diabetes insipidus
Estonian: Psühhiaatrilised häired
English: Infections and infestations Common:
Estonian: Infektsioonid ja infestatsioonid Harv
English: Excipients with known effect:
Estonian: Teadaolevat toimet omav abiaine:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 100 mg hard capsules temozolomide
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 100 mg kõvakapslid temosolomiid
English: EU/1/10/615/022
Estonian: EU/1/10/615/021 EU/1/10/615/022
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 180 mg hard capsules temozolomide
Estonian: RAVIMPREPARAADI NIMETUS Temozolomide Accord 180 mg kõvakapslid temosolomiid
English: EU/1/10/615/028
Estonian: EU/1/10/615/027 EU/1/10/615/028
English: Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.
Estonian: Väga harv (võib tekkida kuni ühel inimesel 10 000-st): - nahapunetus - sügelev lööve, millega kaasnevad kollased või valged muhud, mis on ümbritsetud punakast põletikust - nahaketendus
English: EU/1/10/615/026
Estonian: EU/1/10/615/025 EU/1/10/615/026
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Estonian: Titaandioksiid (E171), Kollane raudoksiid (E172) Punane raudoksiid (E172)
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Estonian: Lihasnõrkus, artralgia, skeletilihaste valu, müalgia
English: Blood and lymphatic system disorders Very common:
Estonian: Vere ja lümfisüsteemi häired Väga sage
English: Endocrine disorders* Uncommon:
Estonian: Endokriinsüsteemi häired* Aeg-ajalt magediabeet
English: Cough.
Estonian: Sugu
English: EU/1/10/615/006
Estonian: EU/1/10/615/005 EU/1/10/615/006
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Estonian: haavainfektsioonid, farüngiit, suuõõne kandidiaas
English: Hyperglycaemia, weight decreased
Estonian: Hüperglükeemia, kehakaalu langus
English: EU/1/10/615/034
Estonian: EU/1/10/615/033 EU/1/10/615/034
English: Batch
Estonian: Kotike