natgillin/translations-raw huggingface dataset:
Temozolomide Teva is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Zdravilo Temozolomide Teva je indicirano za zdravljenje: - odraslih, ki imajo na novo diagnosticiran multiformni glioblastom - sočasno z obsevanjem,
Muscle weakness, arthralgia, musculoskeletal pain, myalgia
šibkost mišic, artralgija šibkost mišic, artralgija,
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).
TMZ se 42 dni uporablja peroralno v odmerku 75 mg/m² dnevno, sočasno s fokalnim obsevanjem
Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
O izpuščaju so zelo pogosto poročali pri bolnikih z na novo diagnosticiranim multiformnim glioblastomom, ki so se sočasno zdravili s TMZ in obsevanjem ali s samim TMZ, pogosto pa pri bolnikih s ponavljajočim se gliomom.
Table 3.
Razpredelnica 3.
These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Izrazitost teh učinkov je bila ponavadi stopnje 1 ali 2 (0 do 5 epizod bruhanja v 24 urah).
Accidental ingestion can be lethal for children.
Zaužitje zdravila je lahko za otroke smrtno nevarno.
Temozolomide Teva should not be administered to pregnant women.
Nosečnice ne smejo jemati zdravila Temozolomide Teva.
Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
epileptični status, ekstrapiramidna motnja, hemipareza, ataksija, poslabšana kognicija, disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološka motnja, periferna nevropatija hemiplegija, ataksija, nenormalna koordinacija, nenormalna hoja, hiperestezija,
Temozolomide Teva 180 mg two stripes in red ink on the cap and “T 180 mg” in red ink on the body
Temozolomide Teva 180 mg dve rdeči progi na kapici in rdeč napis “T 180 mg” na telesu
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m² per cycle both in children and in adults.
Kljub temu je bil največji odmerek, ki so ga prenašali, enak pri otrocih in odraslih (1000 mg/m² na cikel).
≥ 0.5 and < 1.5 x 109/l
absolutno število nevtrofilcev ≥ 0,5 in < 1,5 x 109/l
Temozolomide Teva contains a medicine called temozolomide.
Zdravilo Temozolomide Teva vsebuje zdravilno učinkovino temozolomid.
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
V razpredelnici 4 so neželeni učinki, ki so se pojavili v obdobjih sočasnega in samostojnega zdravljenja pri bolnikih z na novo diagnosticiranim multiformnim glioblastomom.
In patients previously treated with chemotherapy, the initial dose is 150 mg/m² once daily, to be increased in the second cycle to 200 mg/m² once daily, for 5 days if there is no haematological toxicity (see section 4.4) Special populations
V drugem ciklu se poveča na 200 mg/m² enkrat dnevno, in sicer za pet dni, če ni hematološke toksičnosti (glejte poglavje 4.4).
Each capsule is approximately 22 mm in length.
Ena kapsula je dolga približno 22 mm.
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Zmanjšanje odmerka ali opustitev TMZ med samostojnim zdravljenjem toksičnost zmanjšanje odmerka TMZ za eno ravena opustitev uporabe TMZ
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
zavesti, somnolenca, afazija, poslabšano ravnotežje, omotica, zmedenost, poslabšanje spomina, poslabšanje koncentracije, nevropatija, parestezija, motnja govora, tremor ravnotežje, somnolenca, zmedenost, omotica, poslabšanje spomina, poslabšanje koncentracije, disfazija, nevrološka motnja, nevropatija, periferna nevropatija, parestezija, motnja govora, tremor
Diarrhoea, abdominal pain, dyspepsia
diareja, bolečina v trebuhu, dispepsija
Response rate, based on the central reviewer assessment, was 35% (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Stopnja odziva v populaciji, ki naj bi jo zdravili (ITT) (n = 162) je bila po oceni glavnega pregledovalca 35
- if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temozolomide Teva (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Temozolomide Teva (glejte poglavje 4), vam bo zdravnik morda predpisal zdravilo, ki preprečuje bruhanje (antiemetik).
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
5.2 Farmakokinetične lastnosti TMZ se pri fiziološki vrednosti pH spontano hidrolizira v aktivno različico, 3-metil-(triazen-1
Anti-emetic therapy may be administered prior to or following administration of TMZ.
Pred odmerkom TMZ ali po njem se lahko uporabijo antiemetiki.
Skin exfoliation, photosensitivity reaction, pigmentation abnormal
luščenje kože, preobčutljivostna reakcija na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, močnejše potenje
CTC Grade 4b a:
stopnja 3 po splošnih merilih toksičnosti stopnja 4b po splošnih merilih toksičnosti a:
The median PFS was 5.4 months.
Srednje preživetje brez napredovanja bolezni je bilo 5,4 meseca.
Table 2.
Razpredelnica 2.
Common (may affect up to 1 in 10 people): loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): zmanjšanje telesne mase, utrujenost, omotica, mravljinčenje, zasoplost, driska, bolečina v trebuhu, želodčne težave, izpuščaj, srbenje, izpadanje las, vročina, šibkost, drgetanje, slabo počutje, bolečina, spremenjeno okušanje.
You will take your new dose of Temozolomide Teva alone once daily for the first 5 days (“dosing days”) of each cycle.
Prvih pet dni vsakega cikla zdravljenja (»dnevi odmerjanja«) boste enkrat dnevno vzeli novi odmerek zdravila Temozolomide Teva.
allergic reactions.
alergijska reakcija, vročina,
Temozolomide Teva 250 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), Ammonium hydroxide (E527).
Temozolomide Teva 250 mg trde kapsule: (vključno s tiskarskim črnilom): želatina, titanov dioksid (E171), šelak, propilenglikol, črni železov oksid (E172), amonijev hidroksid (E527).
Patients usually present with shortness of breath and cough.
Ponavadi sta to zasoplost in kašelj.
Each capsule is approximately 16 mm in length.
Ena kapsula je dolga približno 16 mm.
Myopathy, back pain, musculoskeletal pain, myalgia
miopatija, bolečine v hrbtu, bolečine v mišicah in kosteh, mialgija miopatija, bolečina v hrbtu
There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12% vs 5%, and thrombocytopenia (< 20 x 109/l), 9% vs 3%, in women vs men in the first cycle of therapy.
Enako velja za trombocitopenijo (< 20 x 109/l ) - 9 % pri ženskah in 3 % pri moških.
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.
pojavila pri 8 % žensk in 4 % moških, trombocitopenija stopnje 4 pa pri 8 % žensk in 3 % moških.
Excipient with known effect Each hard capsule contains 117 mg of lactose.
Ena trda kapsula vsebuje 117 mg laktoze.
Propylene Glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
rumeni železov oksid (E172), titanov dioksid (E171).
Each capsule is approximately 18 mm in length.
Ena kapsula je dolga približno 18 mm.
The following additional serious adverse reactions have been identified during post-marketing exposure:
V obdobju trženja zdravila so ugotovili dodatne resne neželene učinke, in sicer: Razpredelnica 6.
Concomitant phase
Obdobje sočasnega zdravljenja
Dose in Cycle 1 (monotherapy) is 150 mg/m² once daily for 5 days followed by 23 days without treatment.
Odmerek v prvem ciklu (samostojno zdravljenje) je 150 mg/m² enkrat dnevno.
Excipient with known effect Each hard capsule contains 209 mg of lactose.
Ena trda kapsula vsebuje 209 mg laktoze.
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.
Med neželenimi učinki je bila supresija kostnega mozga z okužbo ali brez nje, v nekaterih primerih huda in dolgotrajna, ki je privedla do smrti.
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
Discontinue TMZ
TMZ.
Temozolomide Teva 5 mg hard capsules
Temozolomide Teva 5 mg trde kapsule
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Odrasli in pediatrični bolniki, stari tri leta ali več, s ponavljajočim se ali napredujočim malignim gliomom
Titanium dioxide (E171)
Ovoj kapsul želatina, titanov dioksid (E171).
General disorders and administration site conditions Very Common:
Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
Hyperglycaemia, weight decreased Weight decreased
hiperglikemija, zmanjšanje telesne mase zmanjšanje telesne mase
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Prekinitev ali opustitev odmerjanja temozolomida v obdobju sočasnega zdravljenja z obsevanjem toksičnost prekinitev zdravljenja s TMZa opustitev zdravljenja s TMZ
Temozolomide Teva 250 mg hard capsules
Temozolomide Teva 250 mg trde kapsule
Recurrent or progressive malignant glioma
Bolniki s ponavljajočim se ali napredujočim malignim gliomom
Dose during Cycles 2-6 in absence of toxicity
opombe zmanjšanje zaradi predhodne toksičnosti odmerek v prvem ciklu odmerek v drugem in šestem ciklu, brez toksičnosti
In some cases, your Temozolomide Teva dose will be reduced or treatment stopped.
Naslednje odmerke zdravila Temozolomide Teva boste morda vzeli z zamikom ali pa boste zdravilo prenehali jemati.
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
stomatitis, diareja, bolečine v trebuhu, dispepsija, disfagija stomatitis, diareja, dispepsija, disfagija, suha usta
Temozolomide Teva 140 mg hard capsules
Temozolomide Teva 140 mg trde kapsule
Vomiting, nausea, constipation
bruhanje, navzeja, zaprtost
This is because Temozolomide Teva could cause hepatitis B to become active again, which can be fatal in some cases.
V tem primeru vam bo zdravnik predpisal tudi zdravilo za preprečevanje te vrste pljučnice (PCP); - če ste kdaj bili ali ste okuženi s hepatitisom B. Zdravilo Temozolomide Teva lahko povzroči ponovno aktivacijo hepatitisa B, kar se lahko v nekaterih primerih konča s smrtnim izidom.
Visual field defect, vision blurred, diplopia
meglen vid nepravilnost vidnega polja, meglen vid, diplopija
Very rare cases of lung side effects have been observed with Temozolomide Teva.
Med bolniki, ki so se zdravili z zdravilom Temozolomide Teva, so opazili zelo redke primere neželenih učinkov na pljuča.
Temozolomide Teva 20 mg hard capsules
Temozolomide Teva 20 mg trde kapsule
How to store Temozolomide Teva
Shranjevanje zdravila Temozolomide Teva
Temozolomide Teva 250 mg hard capsules Each hard capsule contains 250 mg temozolomide.
Temozolomide Teva 250 mg trde kapsule Ena trda kapsula vsebuje 250 mg temozolomida.
Temozolomide Teva 250 mg hard capsules Temozolomide
Temozolomide Teva 250 mg trde kapsule temozolomid
Temozolomide Teva 140 mg hard capsules Temozolomide
Temozolomide Teva 140 mg trde kapsule temozolomid
< 0.5 x 109/l
< 0,5 x 109/l število trombocitov
Excipient with known effect Each hard capsule contains 87 mg of lactose.
Ena trda kapsula vsebuje 87 mg laktoze.
The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Pri bolnikih z normalnim delovanjem jeter in pri tistih z blago ali zmerno okvaro jeter je bila farmakokinetika TMZ primerljiva.
Temozolomide Teva 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Temozolomide Teva 250 mg trde kapsule imajo belo neprosojno telo s črnim natisnjenim napisom »T 250 mg« in belo neprosojno kapico z dvema črnima progama.
Temozolomide Teva 5 mg hard capsules Temozolomide
Temozolomide Teva 5 mg trde kapsule temozolomid
Temozolomide Teva 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Temozolomide Teva 20 mg trde kapsule imajo belo neprosojno telo z oranžnim natisnjenim napisom »T 20 mg« in belo neprosojno kapico z dvema oranžnima progama.
Febril neutropenia, thrombocytopenia, anaemia, leukopenia
nevtropenija, trombocitopenija, limfopenija, levkopenija febrilna nevtropenija, trombocitopenija, anemija, levkopenija
Temozolomide Teva 100 mg hard capsules
Temozolomide Teva 100 mg trde kapsule
Temozolomide Teva 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Temozolomide Teva 250 mg trde kapsule: Ena kapsula vsebuje 250 mg temozolomida.
Take the missed dose as soon as possible during the same day.
Če ste pozabili vzeti zdravilo Temozolomide Teva Vzemite izpuščeni odmerek čim prej, še istega dne.
Temozolomide Teva 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Temozolomide Teva 5 mg trde kapsule imajo belo neprosojno telo z zelenim natisnjenim napisom »T 5 mg« in belo neprosojno kapico z dvema zelenima progama.
Temozolomide Teva 20 mg hard capsules Temozolomide
Temozolomide Teva 20 mg trde kapsule temozolomid
Temozolomide Teva 5 mg hard capsules Each hard capsule contains 5 mg temozolomide.
Temozolomide Teva 5 mg trde kapsule Ena trda kapsula vsebuje 5 mg temozolomida.
Reproductive system and breast disorders Uncommon:
Infekcijske in parazitske bolezni Redki:
Excipient with known effect Each hard capsule contains 84 mg of lactose.
Ena trda kapsula vsebuje 84 mg laktoze.
Temozolomide Teva 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Temozolomide Teva 5 mg trde kapsule: Ena kapsula vsebuje 5 mg temozolomida.
Treatment with concomitant TMZ can be continued when all of the following conditions are met:
stopnja 2 po splošnih merilih toksičnosti stopnja 3 ali 4 po splošnih merilih toksičnosti a: Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev
Temozolomide Teva 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.
Temozolomide Teva 140 mg trde kapsule imajo belo neprosojno telo z modrim natisnjenim napisom »T 140 mg« in belo neprosojno kapico z dvema modrima progama.
Temozolomide Teva 20 mg hard capsules Each hard capsule contains 20 mg temozolomide.
Temozolomide Teva 20 mg trde kapsule Ena trda kapsula vsebuje 20 mg temozolomida.
Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder,
poslabšanje zdravstvenega stanja, rigor, težave z zobmi
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-4carboxamide (AIC) or unidentified polar metabolites.
Po peroralnem vnosu se v 24 urah približno 5 do 10 % odmerka pojavi v urinu v nespremenjeni obliki.
Temozolomide Teva 180 mg hard capsules Each hard capsule contains 180 mg temozolomide.
Temozolomide Teva 180 mg trde kapsule Ena trda kapsula vsebuje 180 mg temozolomida.
You will again take Temozolomide Teva once daily for 5 days followed by 23 days without Temozolomide Teva.
Znova boste pet dni jemali Temozolomide Teva enkrat dnevno,
In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m² once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Pri bolnikih, ki se še niso zdravili s kemoterapijo, se TMZ prvih pet dni daje peroralno v odmerku 200 mg/m² enkrat dnevno.
Temozolomide Teva 140 mg hard capsules Each hard capsule contains 140 mg temozolomide.
Temozolomide Teva 140 mg trde kapsule Ena trda kapsula vsebuje 140 mg temozolomida.
Hepatic enzymes increased, Gamma GT increased, AST increased
povišanje ravni jetrnih encimov, povišanje ravni gamaglutamiltransferaze, povišanje ravni aspartat-aminotransferaze
Temozolomide Teva 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Temozolomide Teva 140 mg trde kapsule: Ena kapsula vsebuje 140 mg temozolomida.
Malignancies
mialgija
Temozolomide Teva 180 mg hard capsules Temozolomide
Temozolomide Teva 180 mg trde kapsule temozolomid
Temozolomide Teva 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Temozolomide Teva 180 mg trde kapsule: Ena kapsula vsebuje 180 mg temozolomida.
Temozolomide Teva 180 mg hard capsules
Temozolomide Teva 180 mg trde kapsule
Fever, asthenia, rigors, malaise, pain, taste perversion
vročina, astenija, rigor, slabo počutje, bolečina,
Temozolomide Teva 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Temozolomide Teva 20 mg trde kapsule: Ena kapsula vsebuje 20 mg temozolomida.
Temozolomide Teva 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Temozolomide Teva 100 mg trde kapsule: Ena kapsula vsebuje 100 mg temozolomida.
Temozolomide Teva 100 mg hard capsules Each hard capsule contains 100 mg temozolomide.
Temozolomide Teva 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg temozolomida.
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).
Bolniki v kraku s TMZ in obsevanjem so se sočasno zdravili s TMZ (75 mg/m²) enkrat dnevno.
Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence,
suhe ali boleče oči, naglušnost, vnetje srednjega ušesa, zvonjenje v ušesih, bolečina v ušesu, palpitacije (ko lahko čutite svoj srčni utrip), krvni strdek v pljučih, visok krvni tlak, pljučnica, vnetje sinusov, bronhitis, prehlad ali gripa, otekel želodec, nezmožnost nadzora nad odvajanjem blata,
(difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
(nevtropenija ali limfopenija, trombocitopenija), izguba apetita, glavobol, bruhanje, slabost, zaprtost.
Temozolomide Teva 100 mg hard capsules Temozolomide
Temozolomide Teva 100 mg trde kapsule temozolomid
Adult patients with newly-diagnosed glioblastoma multiforme Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Pred začetnim odmerkom v obdobju sočasnega zdravljenja, še zlasti pa v obdobju samostojnega zdravljenja, se priporoča antiemetična profilaksa.
Temozolomide Teva 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body.
Temozolomide Teva 100 mg trde kapsule imajo belo neprosojno telo z rožnatim natisnjenim napisom »T 100 mg« in belo neprosojno kapico z dvema rožnatima progama.
CTC Non-haematological Toxicity (except for alopecia, nausea, vomiting)
< 10 x 109/l nehematološka toksičnost po splošnih merilih toksičnosti (razen za alopecijo, navzejo, bruhanje)
EU/1/09/606/011 5 capsules EU/1/09/606/012 20 capsules
EU/1/09/606/011 5 kapsul EU/1/09/606/012 20 kapsul
4.8 Undesirable effects
4.8 Neželeni učinki Izkušnje iz kliničnih preskušanj
A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
V študiji na podganah, ki je obsegala šest ciklov, so opazili različne neoplazme, vključno s karcinomom mlečnih žlez, keratoakantomom in adenomom bazalnih celic,
The hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.
Trde kapsule imajo belo neprosojno telo s črnim natisnjenim napisom »T 250 mg« in belo neprosojno kapico z dvema črnima natisnjenima progama.
- as you may have a small risk of other changes in blood cells, including leukaemia.
- ker morda obstaja majhno tveganje za druge spremembe krvnih celic, vključno z levkemijo; - če vam je slabo, vas sili na bruhanje ali bruhate, kar so zelo pogosti neželeni učinki zdravila
The hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Trde kapsule imajo belo neprosojno telo z oranžnim natisnjenim napisom »T 20 mg« in belo neprosojno kapico z dvema oranžnima natisnjenima progama.
Psychiatric disorders Common:
Žilne bolezni Pogosti:
Excipient with known effect Each hard capsule contains 150 mg of lactose.
Ena trda kapsula vsebuje 150 mg laktoze.
Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužbe v ustih, okužba rane, zmanjšano število krvnih celic (nevtropenija, trombocitopenija, limfopenija, levkopenija), povišana raven sladkorja v krvi, zmanjšanje telesne mase, spremembe duševnega stanja ali zbranosti, anksioznost oziroma depresija, zaspanost, težave pri govoru, poslabšano ravnotežje, omotica, zmedenost,
The hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body.
Trde kapsule imajo belo neprosojno telo z zelenim natisnjenim napisom »T 5 mg« in belo neprosojno kapico z dvema zelenima natisnjenima progama.
TMZ is to be discontinued if: dose level -1 (100 mg/m²) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Uporabo TMZ je treba opustiti: če toksičnost pri ravni odmerka -1 (100 mg/m²) še vedno ni sprejemljiva,
Temozolomide Teva contains lactose
Zdravilo Temozolomide Teva vsebuje laktozo
Titanium dioxide (E171) Yellow iron oxide (E172) Indigo carmine (E132) aluminium lake
Črnilo šelak, propilenglikol, titanov dioksid (E171), rumeni železov oksid (E172), indigotin (E132).
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).
20 minut po vnosu (srednji čas med 0,5 in 1,5 ure).
Each hard capsule contains 100 mg temozolomide
Ena trda kapsula vsebuje 100 mg temozolomida.