FrancophonIA/ELRC3.0 huggingface dataset:
English: H-1114 Budapest Tel: +36 1 430 2890 registration.hungary@sandoz.com
Slovak: Tel: +36 1 430 2890 registration.hungary@sandoz.com
English: Temozolomide Sandoz contains lactose
Slovak: Sandoz obsahuje laktózu
English: ul.
Slovak: A.
English: Very rare cases of lung side effects have been observed with temozolomide.
Slovak: Sandoz sa pozorovali veľmi zriedkavé prípady vedľajších účinkov na pľúcach.
English: Lymphopenia, petechiae
Slovak: febrilná neutropénia, anémia lymfopénia, petechie
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Slovak: alergická reakcia, horúčka, radiačné poškodenie, opuch tváre, bolesť, porucha chuti alergická reakcia, horúčka, radiačné poškodenie, bolesť,
English: Each hard capsule contains 168 mg of anhydrous lactose.
Slovak: Každá tvrdá kapsula obsahuje 168 mg bezvodej laktózy.
English: The body is imprinted with “100”.
Slovak: Na tele kapsuly je vytlačené „100“.
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).
Slovak: 1,5 x 109/l počet trombocytov ≥ 100 x 109/l celkové kritériá toxicity (Common Toxicity Criteria - CTC) nehematologickej toxicity (okrem alopécie, nauzey a vracania) ≤
English: Micturition frequency, urinary incontinence Urinary incontinence
Slovak: časté močenie, inkontinencia moču inkontinencia moču
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Slovak: Každá tvrdá kapsula obsahuje 182,5 mg bezvodej laktózy.
English: Dyspnoea
Slovak: dyspnoe
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Slovak: Ak je kapsula poškodená, musíte zabrániť kontaktu práškového obsahu s kožou, sliznicou alebo očami.
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Slovak: Každá tvrdá kapsula obsahuje 102,2 mg bezvodej laktózy.
English: Rash, pruritus, alopecia
Slovak: vyrážka, pruritus, alopécia
English: LV-1010 Rīga Tel: +371 67892006 balt.regaffairs@sandoz.com
Slovak: +371 67892006 balt.regaffairs@sandoz.com
English: Neoplasm benign, malignant and unspecified
Slovak: Benígne a malígne nádory, vrátane nešpecifikovaných novotvarov (cysty a polypy)
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Slovak: Počas RT a pri kombinovanej liečbe TMZ bola nutná profylaxia proti pneumónii vyvolanej Pneumocystis jirovecii (PCP).
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Slovak: Absolútny počet neutrofilov < 1,0 x 109/l
English: BATCH NUMBER
Slovak: Počet trombocytov
English: {DD/MM/YYYY}
Slovak: SN: {číslo}
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,
Slovak: Na začiatku 2. cyklu sa dávka zvýši na 200 mg/m2, ak je CTC
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Slovak: somnolencia, afázia, porucha rovnováhy, závrat, zmätenosť, porucha pamäti, porucha koncentrácie, neuropatia parestézia, porucha reči, tremor hemiparéza, afázia, porucha rovnováhy, somnolencia,
English: Rare (may affect up to 1 in 1,000 people):
Slovak: Zriedkavé (môžu postihovať menej ako 1 z 1 000 osôb):
English: Strength
Slovak: únava
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Slovak: zmätenosť, závrat, porucha pamäti, porucha koncentrácie, dysfázia, neurologická porucha (NOS), neuropatia, periférna neuropatia, parestézia, porucha reči, tremor
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Slovak: 0,008) s mediánom PFS 2,89, respektíve 1,88 mesiacov (log-rank p =
English: A treatment cycle with Temozolomide Sandoz lasts 28 days.
Slovak: Sandoz trvá 28 dní.
English: • hot flushes
Slovak: • návaly horúčavy
English: 9/l, and the thrombocyte count is ≥ 100 x 109/l.
Slovak: 1,5 x 109/l a počet trombocytov ≥ 100 x 109/l.
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Slovak: Tabuľka 5. Nežiaduce reakcie u pacientov s rekurentným alebo progredujúcim malígnym gliómom
English: See package leaflet for further information.
Slovak: - Túto písomnú informáciu si uschovajte.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Slovak: Dospelí pacienti s novodiagnostikovaným multiformným glioblastómom
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological
Slovak: status epilepticus, extrapyramídová porucha, hemiparéza, ataxia, kognitívna porucha, dysfágia, nezvyčajná chôdza, hyperestézia, hypoestézia, neurologická porucha (NOS),
English: Printing ink: contains shellac, black iron oxide (E 172), potassium hydroxide.
Slovak: Atramentová potlač: obsahuje šelak, čierny oxid železitý (E 172), hydroxid draselný.
English: Distribution TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Slovak: Distribúcia TMZ vykazuje nízku viazanosť na proteíny (10
English: Patients with newly-diagnosed glioblastoma multiforme
Slovak: Pacienti s novodiagnostikovaným multiformným glioblastómom
English: TMZ discontinuation
Slovak: Prerušenie liečby TMZ
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr. Absorption After oral administration to adult patients, TMZ is absorbed rapidly with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Slovak: Absorpcia TMZ sa po perorálnom podaní dospelým pacientom vstrebáva rýchlo a maximálne koncentrácie sa dosahujú už za 20 minút po podaní (priemerný čas medzi 0,5 a 1,5 hodinou).
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Slovak: Atramentová potlač: šelak, čierny oxid železitý (E 172), hydroxid draselný.
English: Erythema multiforme, erythroderma, urticaria, exanthema
Slovak: multiformný erytém, erytrodermia, urtikária, exantém
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovak: stomatitída, hnačka, bolesť brucha, dyspepsia, dysfágia stomatitída, hnačka, dyspepsia, dysfágia, sucho v ústach
English: - organizačná zložka
Slovak: REGISTRAČNÉ ČÍSLA
English: Metabolism and nutrition disorders Very common:
Slovak: Poruchy metabolizmu a výživy
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Slovak: Dospelí a pediatrickí pacienti vo veku 3 a viac rokov s rekurentným alebo progredujúcim malígnym gliómom
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).
Slovak: Pacienti v ramene s TMZ + RT súbežne dostávali TMZ (75 mg/m2) jedenkrát denne,
English: • discolouration of your tongue
Slovak: Vášho jazyka
English: 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: +33 1 49 64 48 43 regaff.france@sandoz.com
Slovak: 49, avenue Georges Pompidou F-92593 Levallois-Perret
English: Posology
Slovak: PODANIA
English: Male patients
Slovak: Pacienti mužského pohlavia
English: Haemorrhage, oedema, oedema leg Haemorrhage, deep venous thrombosis, oedema leg
Slovak: hemorágia, edém, edém nôh hemorágia, hlboká žilová trombóza, edém nôh
English: Musculoskeletal and connective tissue disorders Common:
Slovak: Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
English: • skin eruption
Slovak: • olupovanie pokožky
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Slovak: obstipácia, nauzea, vracanie obstipácia, nauzea, vracanie
English: The cap is imprinted with “TMZ” and the body is imprinted with “180”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “180”.
English: • breast pain
Slovak: • hnačka • bolesť brucha
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovak: Obsah kapsuly: bezvodá laktóza, koloidný oxid kremičitý bezvodý, sodná soľ kroskarmelózy typ A, kyselina vínna, kyselina stearová.
English: The cap is imprinted with “TMZ” and the body is imprinted with “5”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “5”.
English: TMZ dose reduction or discontinuation during monotherapy treatment
Slovak: Tabuľka 3. Znižovanie dávok a prerušovanie liečby počas fázy monoterapie
English: Capsule shell Gelatin
Slovak: hydroxid draselný
English: • The active substance is temozolomide.
Slovak: Liečivo je temozolomid.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Slovak: 1,5 x 109/l - počet trombocytov ≥ 100 x 109/l
English: The cap is imprinted with “TMZ” and the body is imprinted with “140”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “140”.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count
Slovak: Pred začatím liečby musia spĺňať laboratórne parametre nasledujúce hodnoty: ANC ≥
English: • cough
Slovak: • kašeľ
English: The cap is imprinted with “TMZ” and the body is imprinted with “250”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “250”.
English: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol
Slovak: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol Τηλ: 00357 - 25372425 info.pth@cytanet.com.cy
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Slovak: 1/1 000 až < 1/100); zriedkavé
English: Temozolomide Sandoz 140 mg hard capsules blue
Slovak: Sandoz 140 mg tvrdé kapsuly modrá
English: Capsule content Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Slovak: Obsah kapsuly bezvodá laktóza koloidný oxid kremičitý bezvodý sodná soľ karboxymetylškrobu typ A kyselina vínna kyselina stearová
English: EU/1/10/617/005 EU/1/10/617/006 EU/1/10/617/027 EU/1/10/617/028
Slovak: EU/1/10/617/006 EU/1/10/617/027 EU/1/10/617/028
English: Check with your doctor or pharmacist if you are not sure.
Slovak: Požiadajte svojho lekára alebo lekárnika,
English: Each hard capsule contains 250 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 250 mg temozolomidu.
English: Psychiatric disorders Common:
Slovak: Farmakoterapeutická skupina:
English: • forgetfulness
Slovak: • zábudlivosť
English: Domaniewska 50 C PL - 02 672 Warszawa Tel.: +48 22 209 6828 maintenance.pl@sandoz.com
Slovak: +48 22 209 6828 maintenance.pl@sandoz.com
English: Temozolomide Sandoz 180 mg
Slovak: Sandoz 180 mg
English: Each hard capsule contains 5 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 5 mg temozolomidu.
English: Black iron oxide (E 172) Potassium hydroxide
Slovak: Atramentová potlač šelak čierny oxid železitý (E 172) hydroxid draselný
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Slovak: bolesť, porucha chuti alergická reakcia, horúčka, radiačné poškodenie, bolesť,
English: Visual field defect, vision blurred, diplopia
Slovak: rozmazané videnie výpadok v zornom poli, rozmazané videnie, diplopia
English: • inflammation of your sinuses
Slovak: • zápal prínosových dutín
English: • allergic reaction
Slovak: • reakcia z precitlivenosti
English: The cap is imprinted with “TMZ” and the body is imprinted with “20”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “20”.
English: nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 10
Slovak: 2. stupeň, absolútny počet neutrofilov (ANC) ≥
English: Temozolomide Sandoz 140 mg
Slovak: Sandoz 140 mg
English: Temozolomide Sandoz 20 mg
Slovak: Sandoz 20 mg
English: Temozolomide Sandoz 20 mg hard capsules yellow
Slovak: Sandoz 20 mg tvrdé kapsuly žltá
English: Sachet Do not store above 25 °C.
Slovak: Vrecko Uchovávajte pri teplote neprevyšujúcej 25°C.
English: Temozolomide Sandoz 5 mg hard capsules green
Slovak: Temozolomide Sandoz 5 mg tvrdé kapsuly zelená
English: Each hard capsule contains 20 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 20 mg temozolomidu.
English: Each hard capsule contains 140 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 140 mg temozolomidu.
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Slovak: horúčka, asténia, zimnica, malátnosť, bolesť, zmena chuti
English: Temozolomide Sandoz 5 mg hard capsules
Slovak: Temozolomide Sandoz 5 mg tvrdé kapsuly
English: Vomiting, nausea, constipation
Slovak: vracanie, nauzea, obstipácia
English: • stomach or abdominal pain
Slovak: • hnačka • bolesť žalúdka alebo brucha
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Slovak: neutropénia, trombocytopénia, lymfopénia, leukopénia febrilná neutropénia, trombocytopénia, anémia, leukopénia
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral
Slovak: Údaje o klinickej účinnosti u pacientov s multiformným glioblastómom (Karnofsky performance status - Karnofského skóre [KPS] ≥
English: Discontinue TMZ
Slovak: Dávka TMZ
English: CTC Grade 3
Slovak: 3. stupňa
English: Temozolomide Sandoz 250 mg
Slovak: Sandoz 250 mg
English: Each hard capsule contains 180 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 180 mg temozolomidu.
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), indigokarmín (E 132), voda.
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100 Rare
Slovak: 1/100 až < 1/10); menej časté (≥
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Slovak: nehematologickej toxicity (okrem alopécie, nauzey a vracania) po 1. cykle ≤
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Slovak: Po perorálnom podaní sa močom vylúči približne 5 % až 10 % podanej dávky v nezmenenej forme v priebehu 24 hodín.
English: The cap is imprinted with “TMZ” and the body is imprinted with “100”.
Slovak: Na vrchnáku je vytlačené “TMZ” a na tele kapsuly je vytlačené “100”.
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Slovak: O6 s dodatočnou alkyláciou prebiehajúcou v polohe N7.
English: Meningoencephalitis herpetic
Slovak: Herpetická meningoencefalitída
English: Each hard capsule contains 100 mg temozolomide.
Slovak: Každá tvrdá kapsula obsahuje 100 mg temozolomidu.
English: Titanium dioxide (E 171) Red iron oxide (E 172) Water
Slovak: Obal kapsuly želatína oxid titaničitý (E 171) červený oxid železitý (E 172) čistená voda
English: • weight gain
Slovak: • zvýšenie telesnej hmotnosti
English: Cushingoid
Slovak: Cushingoidný stav
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), žltý oxid železitý (E 172), indigokarmín (E 132), voda.
English: Temozolomide Sandoz 100 mg hard capsules pink
Slovak: Sandoz 100 mg tvrdé kapsuly ružová
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for
Slovak: Dávka v 1. cykle (monoterapie) je 150 mg/m2 jedenkrát denne počas 5 dní, po ktorých nasleduje 23 dní bez liečby.
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), voda.
English: Temozolomide Sandoz 5 mg capsules temozolomide
Slovak: Temozolomide Sandoz 5 mg kapsuly temozolomid
English: Temozolomide Sandoz 140 mg hard capsules temozolomide
Slovak: Sandoz 140 mg tvrdé kapsuly temozolomid
English: Temozolomide Sandoz 140 mg capsules temozolomide
Slovak: Sandoz 140 mg kapsuly temozolomid
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovak: NÁZOV LIEKU A CESTA PODANIA
English: The hard capsules have a white coloured body, a transparent blue coloured cap, and are imprinted with black ink.
Slovak: Tvrdé kapsuly majú biele telo kapsuly, priehľadný vrchnák modrej farby a sú potlačené čiernym atramentom.
English: Temozolomide Sandoz 250 mg hard capsules white
Slovak: Sandoz 250 mg tvrdé kapsuly biela
English: Temozolomide Sandoz 5 mg hard capsules temozolomide
Slovak: Temozolomide Sandoz 5 mg tvrdé kapsuly temozolomid
English: • increased sweating
Slovak: • zvýšené potenie
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Slovak: žltý oxid železitý (E 172) indigokarmín (E 132)
English: • headache
Slovak: • hluchota
English: Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
Slovak: asténia, začervenanie, návaly tepla, zhoršenie stavu, zimnica, zmena zafarbenia jazyka, parosmia, smäd asténia, opuch tváre, bolesť,
English: nausea, vomiting).
Slovak: nauzey a vracania).
English: • impaired sensations
Slovak: • reakcie z precitlivenosti
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Slovak: Trombocytopénia 3. alebo 4. stupňa a neutropénia sa vyskytli u 19
English: Temozolomide Sandoz 180 mg capsules temozolomide
Slovak: Sandoz 180 mg kapsuly temozolomid
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance disorder (NOS), peripheral neuropathy
Slovak: hemiparéza, ataxia, kognitívna porucha, dysfágia, nezvyčajná chôdza, hyperestézia, hypoestézia, neurologická porucha (NOS), periférna neuropatia hyperestézia, senzorická porucha
English: Dysuria
Slovak: myalgia
English: Hearing impairment
Slovak: únava únava
English: Temozolomide Sandoz 100 mg
Slovak: Sandoz 100 mg
English: • earache
Slovak: • únava
English: Sachet
Slovak: Kundl
English: Temozolomide Sandoz 180 mg hard capsules temozolomide
Slovak: Sandoz 180 mg tvrdé kapsuly temozolomid
English: Temozolomide Sandoz 250 mg capsules temozolomide
Slovak: Sandoz 250 mg kapsuly temozolomid
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Slovak: V súbore údajov od 400 jedincov s rekurentným gliómom sa v prvom cykle liečby pozorovala neutropénia 4. stupňa
English: The hard capsules have a white coloured body, a yellow coloured cap, and are imprinted with black ink.
Slovak: Tvrdé kapsuly majú biele telo kapsuly, žltý vrchnák a sú potlačené čiernym atramentom.
English: Uncommon (may affect up to 1 in 100 people):
Slovak: Menej časté (môžu postihovať menej ako 1 zo 100 osôb):
English: Temozolomide Sandoz 250 mg hard capsules temozolomide
Slovak: Sandoz 250 mg tvrdé kapsuly temozolomid
English: Temozolomide Sandoz 20 mg hard capsules temozolomide
Slovak: Sandoz 20 mg tvrdé kapsuly temozolomid
English: Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: +39 02 96 54 3494 regaff.italy@sandoz.com
Slovak: +39 02 96 54 3494 regaff.italy@sandoz.com
English: • diarrhoea
Slovak: • vyrážka
English: Temozolomide Sandoz 20 mg capsules temozolomide
Slovak: Sandoz 20 mg kapsuly temozolomid
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), červený oxid kremičitý (E 172), voda.
English: Lot
Slovak: Rīga
English: EU/1/10/617/001 EU/1/10/617/002
Slovak: EU/1/10/617/002
English: Temozolomide Sandoz 140 mg hard capsules
Slovak: Sandoz 140 mg tvrdé kapsuly
English: Temozolomide Sandoz 100 mg hard capsules temozolomide
Slovak: Sandoz 100 mg tvrdé kapsuly temozolomid
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Slovak: OZNAČENIE OBALU A PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), žltý oxid kremičitý (E 172), voda.
English: • haemorrhoids
Slovak: • dýchavičnosť
English: Temozolomide Sandoz 100 mg capsules temozolomide
Slovak: Sandoz 100 mg kapsuly temozolomid
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Slovak: hemiplégia, ataxia, nezvyčajná koordinácia, nezvyčajná chôdza,
English: Titanium dioxide (E 171) Indigo carmine (E 132) Water
Slovak: indigokarmín (E 132)
English: The hard capsules have a white coloured body, a pink coloured cap, and are imprinted with black ink.
Slovak: Tvrdé kapsuly majú biele telo kapsuly, ružový vrchnák a sú potlačené čiernym atramentom.
English: • peeling skin
Slovak: • popraskaná pokožka
English: 9/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Slovak: u 8 % žien oproti 3 % mužov.
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Slovak: Obal kapsuly: želatína, oxid titaničitý (E 171), žltý oxid kremičitý (E 172), červený oxid kremičitý (E 172), voda.
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Slovak: Nežiaduce udalosti, ktoré sa vyskytli u pacientov s novodiagnostikovaným multiformným glioblastómom počas súbežnej fázy liečby a monoterapie
English: Common (may affect up to 1 in 10 people):
Slovak: Časté (môžu postihovať menej ako 1 z 10 osôb):
English: Temozolomide Sandoz 20 mg hard capsules
Slovak: Sandoz 20 mg tvrdé kapsuly
English: Temozolomide Sandoz 180 mg hard capsules
Slovak: Sandoz 180 mg tvrdé kapsuly
English: Fatigue
Slovak: dyzúria
English: The hard capsules have a white coloured body, a green coloured cap, and are imprinted with black ink.
Slovak: Tvrdé kapsuly majú biele telo kapsuly, zelený vrchnák a sú potlačené čiernym atramentom.
English: Hepatic enzymes increased,
Slovak: status epilepticus,
English: • bruising, shaking
Slovak: • pocit pichania • modriny, trasenie
English: Temozolomide Sandoz 180 mg hard capsules maroon
Slovak: Sandoz 180 mg tvrdé kapsuly gaštanová
English: Temozolomide Sandoz 250 mg hard capsules
Slovak: Sandoz 250 mg tvrdé kapsuly
English: Cerebral haemorrhage, hypertension
Slovak: impotencia vaginálna hemorágia, menorágia,
English: Skin and subcutaneous tissue disorders Very common:
Slovak: Poruchy pečene a žlčových ciest* Často:
English: The hard capsules have a white coloured body, a white coloured cap, and are imprinted with black ink.
Slovak: Tvrdé kapsuly majú biele telo kapsuly, biely vrchnák a sú potlačené čiernym atramentom.
English: How to store Temozolomide Sandoz
Slovak: Ako uchovávať Temozolomide
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Slovak: zhoršenie stavu, zimnica, porucha zubov
English: Gelatin
Slovak: Laktóza
English: EU/1/10/617/021 EU/1/10/617/022
Slovak: EU/1/10/617/022
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Slovak: hemiplégia, ataxia, nezvyčajná extrapyramídová porucha, hemiparéza, ataxia, kognitívna porucha, dysfágia, nezvyčajná chôdza, hyperestézia, hypoestézia, neurologická porucha (NOS), periférna neuropatia koordinácia, nezvyčajná chôdza,
English: • mood swings
Slovak: • zmeny nálady
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Slovak: Osobitné upozornenia a opatrenia pri používaní Oportunistické infekcie a reaktivácia infekcií