FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with TMZ may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anaemia, which in some cases has resulted in a fatal outcome.
Slovenian: Pri bolnikih, zdravljenih s TMZ, lahko pride do mielosupresije, vključno s podaljšano pancitopenijo.
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000)), Not known: frequency cannot be estimated from the available data.
Slovenian: <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: LV-1010 Rīga Tel: +371 67892006 balt.regaffairs@sandoz.com
Slovenian: Tel: +371 67892006 balt.regaffairs@sandoz.com
English: Skin and subcutaneous tissue disorders Very common:
Slovenian: Bolezni kože in podkožja Zelo pogosti:
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Slovenian: Novo diagnosticirani multiformni glioblastom Skupaj 573 bolnikov so randomizirali v dve skupini, od katerih je ena prejemala TMZ in RT (n=287),
English: Each capsule is approximately 19.3 mm in length.
Slovenian: Dolžina ene kapsule je približno 19,3 mm.
English: The median PFS was 5.4 months.
Slovenian: Mediana vrednost časa brez napredovanja bolezni je bila 5,4 mesece.
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Slovenian: Obstajajo poročila o bolnikih, ki so jemali priporočeni odmerek dlje kot 5 dni zdravljenja (do 64 dni).
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 14,6 mg brezvodne laktoze.
English: • oral infections
Slovenian: • okužbe v ustni votlini,
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Slovenian: krvavitve, edem, edem nog krvavitve, globoka venska tromboza, edem nog
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Newly-diagnosed glioblastoma multiforme
Slovenian: Novo diagnosticiranmultiformni glioblastom
English: Then, you will have 23 days without Temozolomide Sandoz.
Slovenian: Nato bo sledilo 23-dnevno obdobje, v katerem zdravila Temozolomid Sandoz ne boste jemali.
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki (pojavijo se lahko pri naveč 1 od 10.000 bolnikov):
English: Patients with hepatic or renal impairment The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno jetrno okvaro je farmakokinetika TMZ podobna kot pri tistih z normalnim delovanjem jeter.
English: Headache
Slovenian: glavobol
English: Rare (may affect up to 1 in 1,000 people):
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Slovenian: Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14 %
English: The bottles contain a desiccant pouch.
Slovenian: Steklenica vsebuje zavojček sušilnega sredstva.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Slovenian: luščenje kože, preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija,
English: Always take Temozolomide Sandoz exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Temozolomid Sandoz natančno upoštevajte navodila zdravnika.
English: Myopathy, back pain
Slovenian: mialgija miopatija, bolečine v hrbtu
English: • painful joints
Slovenian: • boleči sklepi,
English: Each hard capsule contains 168 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 168 mg brezvodne laktoze.
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovenian: stomatitis, driska, trebušne bolečine, dispepsija, disfagija stomatitis, driska, dispepsija, disfagija, suha usta
English: Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia
Slovenian: zaskrbljenost, čustvena nestabilnost, nespečnost zaskrbljenost, depresija, čustvena nestabilnost, nespečnost
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Slovenian: konvulzije, motnje zavesti, somnolenca, afazija, motnje ravnotežja, omotica, zmedenost, motnje spomina, zmanjšanje miselne zbranosti, nevropatija, parestezije, motnje govora, tremor hemipareza, afazija, motnje ravnotežja, somnolenca, zmedenost, omotica, motnje spomina, zmanjšanje miselne zbranosti, disfazija, nevrološke motnje (NOS), nevropatija, periferna nevropatija, parestezije, motnje govora, tremor
English: Method of administration Temozolomide Sandoz hard capsules should be administered in the fasting state.
Slovenian: Način uporabe Temozolomid Sandoz trde kapsule mora bolnik jemati na tešče.
English: Temozolomide Sandoz hard capsules should be administered in the fasting state.
Slovenian: Temozolomid Sandoz trde kapsule mora bolnik jemati na tešče.
English: Printing ink
Slovenian: Črnilo tiska:
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Slovenian: Astenija, edem obraza, bolečine, navali vročine, poslabšanje stanja, drgetanje, bolezni zob
English: Temozolomide Sandoz contains a medicine called temozolomide.
Slovenian: Temozolomid Sandoz vsebuje zdravilno učinkovino temozolomid.
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 182,5 mg brezvodne laktoze.
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, nausea and vomiting).
Slovenian: - število trombocitov ≥ 100 x 109/l, - skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
English: The Temozolomide Sandoz dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Slovenian: Zdravnik lahko odmerek zdravila Temozolomid Sandoz prestavi ali zdravljenje prekine glede na vašo krvno sliko in na to, kako dobro prenašate zdravilo.
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Slovenian: Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 102,2 mg brezvodne laktoze.
English: • Skin redness
Slovenian: • kožni izpuščaj,
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
English: However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Slovenian: Pri populacijski farmakokinetični analizi pri bolnikih, starih od 19 do 78 let, so ugotovili, da starost ne vpliva na očistek TMZ, vendar se zdi, da so starejši bolniki (stari > 70 let) izpostavljeni večjemu tveganju za nevtropenijo in trombocitopenijo (glejte poglavje 4.4).
English: • blood clot in the legs
Slovenian: • krvni strdki v nogah,
English: Oral use
Slovenian: Način uporabe
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Slovenian: V večjih odmerkih, ki so povzročili smrt pri 60 % do 100 % testiranih podgan in psov, pa se je pojavila degeneracija mrežnice.
English: Patients with recurrent or progressive malignant glioma
Slovenian: Bolniki s ponavljajočim se ali napredujočim malignim gliomom
English: {DD/MM/YYYY}
Slovenian: MM/LLLL
English: Temozolomide Sandoz 5 mg
Slovenian: Temozolomid Sandoz 5 mg
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Slovenian: Na začetku 2. cikla odmerek povečajte na 200 mg/m2, če je SMT za nehematološko toksičnost za 1. cikel stopnje ≤ 2 (z izjemo alopecije, slabosti in bruhanja), absolutno število nevtrofilcev (ANC) ≥ 1,5 x 10
English: • haemorrhoids
Slovenian: • zadihanost,
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting)
Slovenian: • po zmanjšanju odmerka ponovno nastopi ista nehematološka toksičnost 3. stopnje (z izjemo alopecije, slabosti in bruhanja).
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Slovenian: motnje okusa alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, bolečine, motnje okusa
English: • skin irritation or redness
Slovenian: • draženje kože ali pordelost,
English: Table 6.
Slovenian: Preglednica 6.
English: • mood swings
Slovenian: • nihanje razpoloženja,
English: • forgetfulness
Slovenian: • pozabljivost,
English: • weakness
Slovenian: • šibkost,
English: Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Slovenian: Temozolomid Sandoz 5 mg trde kapsule Ena kapsula vsebuje 5 mg temozolomida.
English: Impotence
Slovenian: nespečnost
English: Temozolomide Sandoz 20 mg
Slovenian: Temozolomid Sandoz 20 mg
English: Hearing impairment, tinnitus
Slovenian: okvara sluha okvara sluha, tinitus
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Slovenian: alergijska reakcija, zvišana telesna temperatura, radiacijske poškodbe, edem obraza, bolečine,
English: • dizziness
Slovenian: dispneja
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Slovenian: nevtropenija, trombocitopenija, limfopenija, levkopenija febrilna nevtropenija, trombocitopenija, anemija, levkopenija
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological
Slovenian: status epilepticus, ekstrapiramidne motnje, hemipareza, ataksija, motnje kognitivnih procesov, disfazija, nenormalna hoja,
English: • as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Slovenian: imenovane pljučnica zaradi okužbe s Pneumocystis jirovecii (PCP).
English: Visual acuity reduced, eye pain, eyes dry
Slovenian: očesne bolečine, suhost oči
English: Temozolomide Sandoz 250 mg
Slovenian: Temozolomid Sandoz 250 mg
English: Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Slovenian: Temozolomid Sandoz 250 mg trde kapsule Ena kapsula vsebuje 250 mg temozolomida.
English: How to take Temozolomide Sandoz
Slovenian: Kako jemati zdravilo Temozolomid Sandoz
English: • stomach or abdominal pain
Slovenian: • bolečine v želodcu ali trebuhu,
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora
English: Clinical trial experience
Slovenian: KLINIČNI PODATKI
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Slovenian: - črnilo tiska: šelak, črni železov oksid (E172), kalijev hidroksid.
English: Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Slovenian: Temozolomid Sandoz 140 mg trde kapsule Ena kapsula vsebuje 140 mg temozolomida.
English: Temozolomide Sandoz 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Slovenian: Temozolomid Sandoz 20 mg trde kapsule Ena kapsula vsebuje 20 mg temozolomida.
English: Weight decrease
Slovenian: zvišana vrednost ALT
English: • tiredness.
Slovenian: • drgetanje,
English: Temozolomide Sandoz 140 mg
Slovenian: Temozolomid Sandoz 140 mg
English: Rash, alopecia
Slovenian: izpuščaj, alopecija izpuščaj, alopecija
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known: frequency cannot be estimated from the available data.
Slovenian: občasni (≥1/1.000 do <1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you are a newly-diagnosed patient, treatment will occur in two phases:
Slovenian: Če so vam bolezen diagnosticirali na novo, bo zdravljenje potekalo v dveh fazah: • najprej zdravljenje skupaj z radioterapijo (faza sočasnega zdravljenja),
English: Temozolomide Sandoz 180 mg
Slovenian: Temozolomid Sandoz 180 mg
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Vsebina kapsule: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina.
English: You should stop breast-feeding while receiving treatment with Temozolomide Sandoz.
Slovenian: Med zdravljenjem z zdravilom Temozolomid Sandoz morate prekiniti dojenje.
English: Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Slovenian: Temozolomid Sandoz 180 mg trde kapsule Ena kapsula vsebuje 180 mg temozolomida.
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Slovenian: amenoreja, vaginitis, bolečine v dojkah
English: Patients with newly-diagnosed glioblastoma multiforme
Slovenian: Bolniki z novo diagnosticiranim multiformnim glioblastomom
English: Erythema, pigmentation abnormal, sweating increased
Slovenian: luščenje kože, preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečano znojenje
English: Each hard capsule contains 250 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 250 mg temozolomida.
English: Hepatic enzymes increased, Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Slovenian: zvišane vrednosti jetrnih encimov, zvišana vrednost gama-GT, zvišana vrednost AST *Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
English: Each hard capsule contains 5 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 5 mg temozolomida.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro.
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E171), voda.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Slovenian: Odrasli bolniki z novo diagnosticiranim multiformnim glioblastomom
English: Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Slovenian: Temozolomid Sandoz 100 mg trde kapsule Ena kapsula vsebuje 100 mg temozolomida.
English: • upset stomach
Slovenian: • želodčne težave,
English: Shellac
Slovenian: šelak,
English: Rare:
Slovenian: Neznana:
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Slovenian: Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponavljajočim se ali napredujočim malignim gliomom
English: Meningoencephalitis herpetic
Slovenian: Herpetični meningoencefalitis
English: Infections and infestations Common:
Slovenian: Infekcijske in parazitske bolezni Pogosti:
English: Temozolomide Sandoz 100 mg
Slovenian: Temozolomid Sandoz 100 mg
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Slovenian: Začeli so ga jemati prvi dan RT in so ga jemali do zadnjega dne RT, skupaj 42 dni (do največ 49 dni).
English: Each hard capsule contains 20 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 20 mg temozolomida.
English: 4.8 Undesirable effects
Slovenian: 4.8 Neželeni učinki Izkušnje iz kliničnih preizkušanj
English: Each hard capsule contains 140 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 140 mg temozolomida.
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: METHOD OF ADMINISTRATION
Slovenian: Mehanizem delovanja
English: Each hard capsule contains 180 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 180 mg temozolomida.
English: Temozolomide Sandoz 5 mg hard capsules green
Slovenian: Temozolomid Sandoz 5 mg trde kapsule zelena
English: How to store Temozolomide Sandoz
Slovenian: Shranjevanje zdravila Temozolomid Sandoz
English: Deafness, vertigo, earache
Slovenian: ušesne bolečine gluhost, vertigo, ušesne bolečine
English: • thirst
Slovenian: †, sepsa
English: Each hard capsule contains 100 mg temozolomide.
Slovenian: Ena trda kapsula vsebuje 100 mg temozolomida.
English: Hearing impairment
Slovenian: Očesne bolezni
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for
Slovenian: TMZ (75 mg/m2) enkrat na dan.
English: Temozolomide Sandoz 20 mg hard capsules yellow
Slovenian: Temozolomid Sandoz 20 mg trde kapsule rumena
English: Temozolomide Sandoz 100 mg hard capsules pink
Slovenian: Temozolomid Sandoz 100 mg trde kapsule rožnata
English: Pneumonia, upper respiratory infection, nasal congestion
Slovenian: pljučnica, okužba zgornjih dihal,
English: Temozolomide Sandoz is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Slovenian: - otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
English: • urticaria (hives)
Slovenian: • zasoplost, • driska,
English: Temozolomide Sandoz 250 mg hard capsules white
Slovenian: Temozolomid Sandoz 250 mg trde kapsule bela
English: • if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Slovenian: • če ste imeli kdaj v preteklosti alergijsko reakcijo na dakarbazin (zdravilo proti raku, ki ga včasih imenujemo tudi DTIC); med znaki alergijske reakcije so srbenje, zasoplost ali sopenje in otekanje obraza, ustnic, jezika ali grla;
English: Visual field defect, vision blurred, diplopia
Slovenian: zamegljen vid izpad vidnega polja, zamegljen vid, diplopija
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E171), indigotin (E132), voda.
English: Vomiting, nausea, constipation
Slovenian: bruhanje, slabost, zaprtje
English: • fluid retention
Slovenian: • zastajanje tekočine,
English: • tooth disorder.
Slovenian: • žeja, • bolezni zob.
English: Temozolomide Sandoz 5 mg hard capsules
Slovenian: Temozolomid Sandoz 5 mg trde kapsule
English: Temozolomide Sandoz 140 mg hard capsules blue
Slovenian: Temozolomid Sandoz 140 mg trde kapsule modra
English: Temozolomide Sandoz 20 mg hard capsules
Slovenian: Temozolomid Sandoz 20 mg trde kapsule
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Slovenian: hemiplegija, ataksija, motnje koordinacije, nenormalna hoja,
English: Check with your doctor or pharmacist if you are not sure.
Slovenian: se posvetujte z zdravnikom ali farmacevtom.
English: Temozolomide Sandoz 140 mg hard capsules
Slovenian: Temozolomid Sandoz 140 mg trde kapsule
English: Temozolomide Sandoz 250 mg hard capsules
Slovenian: Temozolomid Sandoz 250 mg trde kapsule
English: Stearic acid
Slovenian: kalijev hidroksid.
English: • fever,
Slovenian: • bruhanje,
English: Temozolomide Sandoz 100 mg hard capsules
Slovenian: Temozolomid Sandoz 100 mg trde kapsule
English: Temozolomide Sandoz 180 mg hard capsules
Slovenian: Temozolomid Sandoz 180 mg trde kapsule
English: Temozolomide Sandoz 140 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 140 mg trde kapsule temozolomid
English: • swollen legs
Slovenian: • suha usta,
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), voda.
English: Temozolomide Sandoz 5 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 5 mg trde kapsule temozolomid
English: The hard capsules have a white coloured body, a yellow coloured cap, and are imprinted with black ink.
Slovenian: Trde kapsule imajo belo telo in rumeno kapico ter vtisnjen napis s črnim črnilom.
English: Temozolomide Sandoz 250 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 250 mg trde kapsule temozolomid
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Sandoz to prevent or control nausea and vomiting.
Slovenian: (antiemetike), ki preprečujejo ali nadzorujejo slabost in bruhanje.
English: Malignancies
Slovenian: angioedem
English: Your dose of Temozolomide Sandoz may need to be adjusted.
Slovenian: Natančni odmerek zdravila Temozolomid Sandoz bo določil zdravnik.
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), indigotin (E132), voda.
English: Capsule content Anhydrous lactose Colloidal anhydrous silica
Slovenian: febrilna nevtropenija, anemija limfopenija, petehije Bolezni endokrinega sistema
English: Temozolomide Sandoz 20 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 20 mg trde kapsule temozolomid
English: CZ-140 00, Praha 4
Slovenian: L01AX03
English: Temozolomide Sandoz 100 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 100 mg trde kapsule temozolomid
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E171), rumeni železov oksid (E172), voda.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 do 10 bolnikov):
English: Temozolomide Sandoz 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Sandoz 250 mg trde kapsule - vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, - ovojnica kapsul: želatina, titanov dioksid (E171), voda,
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: ZDRAVILNE UČINKOVINE (UČINKOVIN) IN
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance disorder (NOS), peripheral neuropathy
Slovenian: hiperestezija, senzorične disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološke motnje (NOS), periferna nevropatija motnje
English: Temozolomide Sandoz 180 mg capsules temozolomide
Slovenian: Temozolomid Sandoz 180 mg trde kapsule temozolomid
English: Temozolomide Sandoz 20 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Sandoz 20 mg trde kapsule - vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, - ovojnica kapsul: želatina, titanov dioksid (E171), rumeni železov oksid
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Sandoz on your blood cells.
Slovenian: Med zdravljenjem vam bodo pogosto pregledovali kri, da bodo lahko spremljali učinke zdravila