natgillin/translations-raw huggingface dataset:
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8% indicationg complete absorption.
13 TMZ, označenega s 14C, je bila srednja vrednost količine 14C, izločene v blatu 7 dni po odmerku 0, 8%, kar kaže na popolno absorpcijo.
TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
TMZ se v majhni meri veže na beljakovine (10% do 20%), zato ni pričakovati, da bi medsebojno deloval z zdravili z učinkovinami, ki se dobro vežejo na beljakovine.
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Prehajanje v CSF so potrdili pri enem bolniku.
CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30% of that in plasma, which is consistent with animal data.
Izpostavljenost TMZ v CSF, določena na podlagi AUC za TMZ, je bila približno 30% tiste v plazmi, kar je v skladu s podatki, ki so jih dobili na živalih.
The half-life (t1/2) in plasma is approximately 1.8 hours.
Razpolovni čas (t1/ 2) v plazmi je približno 1, 8 ure.
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.
Po peroralni uporabi se v 24 urah s sečem v nespremenjeni obliki izloči približno 5% do 10% odmerka, preostanek pa se izloči v obliki temozolomidske kisline, 5- aminoimidazol- 4- karboksamida (AIC) ali neopredeljenih polarnih presnovkov.
13 Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Analiza populacijske farmakokinetike TMZ je pokazala, da plazemski očistek TMZ ni odvisen od starosti, delovanja ledvic ali kajenja.
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.
Pri otrocih je bila vrednost AUC večja kot pri odraslih, medtem ko je bil največji odmerek, ki so ga bolniki še prenašali (MTD – » maximum tolerated dose «), pri obojih 1. 000 mg/ m2 na cikel.
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.
V večjih odmerkih, ki so povzročili smrt pri 60% do 100% testiranih podgan in psov, pa se je pojavila degeneracija mrežnice.
Dose- related reductions in leukocytes and platelets appear to be sensitive indicators of toxicity.
Kaže, da je od odmerka odvisen upad števila levkocitov in trombocitov občutljiv kazalec toksičnosti zdravila.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Rezultati testa Ames/ Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL – » Human Peripheral Blood Lymphocyte «) so pokazali pozitiven mutageni odziv.
Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Vsebina kapsul: brezvodna laktoza, brezvoden koloidni silicijev dioksid, natrijev karboksimetilškrob tipa A, vinska kislina, stearinska kislina.
Printing ink: shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, black iron oxide (E 172).
Napis: šelak, propilenglikol, prečiščena voda, amonijev hidroksid, kalijev hidroksid, črni železov oksid (E 172).
Type I amber glass bottles with polypropylene child-resistant closures containing 5 -or 20 hard capsules.
Steklenice iz rjavega stekla tip I s polipropilensko, za otroke varno zaporko, ki vsebujejo po 5 ali 20 trdih kapsul.
Patients should be advised to keep capsules out of the reach and sight of children, preferably in a locked cupboard.
Bolnikom je treba svetovati, naj zdravilo shranjujejo nedosegljivo otrokom, po možnosti v zaklenjeni omari.
Any unused product or waste material should be disposed of in accordance with local requirements.
15 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
26 January 1999.
26. januar 1999.
Date of last renewal:
Datum zadnje obnove:
26 January 2009
26. januar 2009.
15 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Each hard capsule contains 182.2 mg of anhydrous lactose.
Pomožna snov: ena trda kapsula vsebuje 182, 2 mg brezvodne laktoze.
The hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.
Trde kapsule imajo neprozorno belo telo, neprozorno rumeno kapico in tiskan napis s farmacevtskim črnilom.
The body is imprinted with "20 mg", the Schering-Plough logo and two stripes.
Na kapici je napis “ Temodal ”, na telesu kapsule pa so natisnjeni oznaka "20 mg", znak družbe Schering- Plough in dve črti.
Concomitant phase 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).
Faza sočasne terapije TMZ naj bolnik jemlje peroralno v odmerku 75 mg/ m2 na dan 42 dni, sočasno z žariščno radioterapijo (60 Gy, danih v 30 delnih odmerkih).
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l
- absolutno število nevtrofilcev (ANC – Absolute Neutrophil Count) ≥ 1, 5 x 109/ l,
- thrombocyte count ≥ 100 x 109/l
- število trombocitov ≥ 100 x 109/ l,
TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
V fazi sočasne terapije odmerjanje zdravila TMZ začasno prekinite ali stalno ukinite glede na merila hematološke in nehematološke toksičnosti, kot je navedeno v preglednici 1.
Absolute neutrophil count
Toksičnost Absolutno število nevtrofilcev
≥ 0.5 and < 1.5 x 10 /l
Ukinitev TMZ < 0, 5 x 109/ l
< 0.5 x 109/l
≥ 0, 5 in < 1, 5 x 10 / l
CTC Grade 2
SMT 2. stopnja
CTC Gr ade 3 or 4
SMT 3. ali 4. stopnja
Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev ≥ 1, 5 x 109/ l; število trombocitov ≥ 100 x 109/ l; SMT za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
V 1. ciklu (monoterapija) je odmerek zdravila 150 mg/ m2 enkrat na dan 5 dni, temu pa naj sledi 23 dni brez terapije.
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, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
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 109/ l in število trombocitov ≥ 100 x 109/ l.
Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Ko pa odmerek enkrat povečate, naj ostane na ravni 200 mg/ m2 na dan v prvih 5 dneh vsakega naslednjega cikla, razen če nastopi toksičnost.
2.
Preglednica 2.
TMZ dose
Raven
TMZ dose levels for monotherapy treatment Remarks
Odmerek TMZ (mg/ m2/ dan)
(mg/m2/day)
Pripombe
18 Table 3.
18 Preglednica 3.
Reduce TMZ by 1 dose levela
Zmanjšajte odmerek TMZ za eno ravena < 1, 0 x 109/ l
Absolute neutrophil count Thrombocyte count CTC non-haematological Toxicity
Absolutno število nevtrofilcev Število trombocitov SMT za nehematološko toksičnost (z izjemo alopecije, slabosti in bruhanja)
< 1.0 x 109/l < 50 x 109/l
9 < 50 x 10 / l SMT 3. stopnja
TMZ dose levels are l isted in Table 2. b:
Ravni odmerkov TMZ so podane v preglednici 2.
TMZ is to be discontinued if:
TMZ morate ukiniti, če: raven odmerka - 1 (100 mg/ m2) še vedno povzroči nesprejemljivo toksičnost
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).
Bolniki, ki še niso bili zdravljeni s kemoterapijo, naj jemljejo TMZ peroralno v odmerku 200 mg/ m2 enkrat na dan prvih 5 dni, temu pa naj sledi 23- dnevni premor (skupaj 28 dni).
Patients with hepatic or renal impairment
Bolniki z z jetrno ali ledvično okvaro
Hypersensitivity to the active substanceor to any of the excipients.
19 Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Hypersensitivity to dacarbazine (DTIC).
Preobčutljivost za ali dakarbazin (DTIC).
19 Severe myelosuppression (see section 4.4).
Huda mielosupresija (glejte poglavje 4. 4).
However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Pri uporabi TMZ v okviru daljšega režima zdravljenja lahko pride do večjega pogostnosti PCP, vendar morate vse bolnike, ki prejemajo TMZ, še posebej tiste, ki prejemajo tudi steroide, skrbno opazovati, da ugotovite morebiten nastanek PCP, ne glede na režim zdravljenja.
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Če med katerimkoli ciklom ANC pade na < 1, 0 x 109/ l ali število trombocitov na < 50 x 109/ l, morate odmerek zdravila v naslednjem ciklu zmanjšati za eno odmerno stopnjo (glejte poglavje 4. 2).
20 Male patients
20 Videti je, da je pri starejših bolnikih tveganje za nevtropenijo ali trombocitopenijo večje, kot pri mlajših.
4.5 Inter action with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
21 Ni znano, ali se TMZ izloča v materino mleko, zato je treba med zdravljenjem s TMZ dojenje prekiniti.
Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
TMZ ima lahko genotoksične učinke, zato morate moškim, ki se zdravijo z njim svetovati, da naj ne zaplodijo otroka še šest mesecev po zadnjem vzetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih za shranitev zmrznjene sperme.
21 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Convulsions were reported very commonly in the newly- diagnosed 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.
Pri bolnikih z novo diagnosticiranim glioblastomom multiforme na monoterapiji so zelo pogosto poročali o konvulzijah, medtem ko je bil izpuščaj opisan zelo pogosto pri bolnikih z novo diagnosticiranim multiformnim glioblastomom, ki so prejemali TMZ sočasno z RT, ter pri tistih, ki so zdravilo prejemali v obliki monoterapije, pogosto pa pri tistih s ponavljajočim se gliomom.
Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5);the frequency of grade 3-4 laboratory findings is presented after each table.
Pogostnosti laboratorijskih izvidov 3. ali 4. stopnje jakosti je navedena za vsako preglednico.
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
V preglednici 4 so podani neželeni učinki, ki so nastopili med zdravljenjem pri bolnikih z novo diagnosticiranim glioblastomom multiforme med fazo sočasne terapije in fazo monoterapije.
Table 4.
Preglednica 4:
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim glioblastomom multiforme
System Organ Class Infections and infestations
Telesni sistem
concomitant RT n=288*
TMZ + sočasna radioterapija n=288 *
monotherapy n=224
monoterapija n=224
22 Psychiatric disorders Common:
Pogosti:
Headache Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
glavobol konvulzije, motnje zavesti, somnolenca, afazija, motnje ravnotežja, omotica, zmedenost, motnje spomina, zmanjšanje miselne zbranosti, nevropatija, parestezije, motnje govora, tremor
Convulsions, headache Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
konvulzije, glavobol hemipareza, afazija, motnje ravnotežja, somnolenca, zmedenost, omotica, motnje spomina, zmanjšanje miselne zbranosti, disfazija, nevrološke motnje (NOS), nevropatija, periferna nevropatija, parestezije, motnje govora, tremor
Respiratory, thoracic and mediastinal disorders Common:
23 Bolezni dihal, prsnega koša in mediastinalnega prostora
Pneumonia, upper respiratory infection, nasal congestion
dispneja, kašelj pljučnica, okužba zgornjih dihal, kongestija nosne sluznice
Pneumonia, sinusitis, upper respiratory infection, bronchitis
dispneja, kašelj pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
Gastrointestinal disorders Very common:
Zelo pogosti:
23 Common:
Pogosti:
Skin and subcutaneous tissue disorders Very common:
Bolezni kože in podkožja
Common:
stomatitis, driska, trebušne bolečine, dispepsija, disfagija
Dermatitis, dry skin, erythema, pruritus
stomatitis, driska, dispepsija, disfagija, suha usta napihnjenost trebuha, inkontinenca blata, bolezni prebavil (NOS), gastroenteritis, hemoroidi
Dry skin, pruritus
Pogosti:
*A patient who was randomised to the RT arm only, received TMZ + RT.
* Bolnik, ki je bil randomiziran v del študije samo z RT, je prejemal TMZ + RT.
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
24 Opažali so mielosupresijo (nevtropenijo in trombocitopenijo), kar so znani toksični učinki večine citotoksičnih snovi, vključno s TMZ, ki tudi omejujejo njihov odmerek.
24 abnormalities including neutropenic events were observed in 8% of the patients.
Ko so sešteli nenormalne laboratorijske izvide in neželene sopojave iz faze sočasne terapije in faze monoterapije, so pri 8% bolnikov opažali anomalije nevtrofilcev 3. ali 4. stopnje, vključno z nevtropeničnimi sopojavi.
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14% of the patients who received TMZ.
Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14% bolnikov, ki so prejeli TMZ.
In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
V kliničnih preskušanjih so bili najpogostnejši neželeni učinki, povezani z zdravljenjem, prebavne motnje, natančneje slabost (43%) in bruhanje (36%).
Opportunistic infections, including PCP
oportunistične okužbe, vključno s pljučnico zaradi okužbe s PCP
This led to hospitalisation and/or discontinuation of TMZ in 8% and 4%, respectively.
Zaradi njiju je bila potrebna hospitalizacija in/ ali prekinitev zdravljenja s TMZ pri 8% in.
25 Gender
Spol
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.
Po podatkih o ponavljajočem se gliomu pri 400 preiskovancih se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 8% žensk in pri 4% moških preiskovancev, trombocitopenija 4. stopnje pa pri 8% žensk in 3% moških preiskovancev.
L01A X03
Antineoplastična zdravila – Drugi alkilirajoči citostatiki, oznaka ATC:
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
L01A X03 26 Temozolomid je zdravilo iz skupine triazenov, ki se pri fiziološkem pH hitro kemično pretvori v aktivni monometil triazenoimidazol karboksamid (MTIC).
Newly-diagnosed glioblastoma multiforme
Novo diagnosticiran glioblastoma multiforme
26 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
TMZ so bolniki jemali kot zadnji poskus terapije v fazi spremljanja pri 161 bolnikih od 282 (57%) v delu študije samo z RT in pri 62 bolnikih od 277 (22%) v delu študije s TMZ + RT.
The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1, 59 (95% IZ za KT=1, 33 - 1, 91) z logaritmičnim rangom p < 0, 0001 v prid delu študije s TMZ.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Ocenjena verjetnost preživetja bolnika 2 leti ali več (26% v primerjavi z 10%) je bila večja za del študije z RT in TMZ.
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 TMZ.
Podatki o klinični učinkovitosti zdravila pri bolnikih z multiformnim glioblastomom (indeks kliničnega stanja po Karnofskyju [KPS – » Karnofsky performance status «] ≥ 70), ki napreduje ali se je
One was a non-comparative trial in 138 patients (29% received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67% received prior treatment with nitrosourea based chemotherapy).
Eno je bilo neprimerjalno preskušanje pri 138 bolnikih (29% jih je pred tem že prejemalo kemoterapijo), drugo pa randomizirano, z učinkovino nadzorovano kontrolirano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67% jih je pred tem že prejemalo kemoterapijo na osnovi nitrozouree).
The objective response rate (ORR) based on MRI scans was 8%.
Objektivno ugotovljena stopnja odzivanja bolnikov na zdravljenje, določena na podlagi NMR posnetkov, je bila 8%.
The
Izsledki glede časa do poslabšanja nevrološkega statusa so bili v prid TMZ v primerjavi s prokarbazinom, kar velja tudi za izsledke glede časa do poslabšanja stanja zmogljivosti bolnika po Karnofskyju (upad na KPS < 70 ali zmanjšanje za najmanj 30 točk).
27 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Mediana vrednost časa do napredovanja bolezni za naštete končne točke je bila za 0, 7 do 2, 1 meseca daljša za TMZ kot za prokarbazin (test log. ranga p = < 0, 01 do 0, 03).
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
V multicentričnem prospektivnem preskušanju 2. faze za oceno varnosti in učinkovitosti peroralnega TMZ pri zdravljenju bolnikov z anaplastičnim astrocitomom ob prvem recidivu je bila 6- mesečna vrednost PFS (preživetje brez napredovanja bolezni) 46%.
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4- carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
TMZ spontano hidrolizira pri fiziološki vrednosti pH predvsem do aktivnih presnovkov, 3- metil - (triazen- 1- il) imidazol- 4- karboksamida (MTIK), MTIK pa spontano hidrolizira do 5- amino- imidazol- 4 - karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, in metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
After oral administration to adult patients, TMZ is absorbed rapidely, with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
28 Po peroralnem vnosu se pri odraslih zdravilo TMZ hitro absorbira in doseže največjo koncentracijo že v 20 minutah po zaužitju odmerka (srednja vrednost časa med 0, 5 in 1, 5 ure).
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8% indicationg complete absorption.
Po peroralnem jemanju TMZ, označenega s 14C, je bila srednja vrednost količine 14C, izločene v blatu 7 dni po odmerku 0, 8%, kar kaže na popolno absorpcijo.
The half-life (t1/2) in plasma is approximately 1.8 hours.
Razpolovni čas (t1/ 2) v plazmi je približno 1, 8 ur.
The major route of 14C elimination is renal.
Zdravilo 14C se izloča predvsem prek ledvic.
28 Special populations
Posebne skupine bolnikov
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
29 Rezultati testa Ames/ Salmonella in testa kromosomskih aberacij v človeških limfocitih iz periferne krvi (HPBL – » Human Peripheral Blood Lymphocyte «) so pokazali pozitiven mutageni odziv.
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172)
Ovojnica kapsul: želatina, titanov dioksid (E 171), natrijev lavrilsulfat, rumeni železov oksid (E 172).
Bottle presentation
Oblika steklenice
Store in the original bottle in order to protect from moisture.
Shranjujte v originalni steklenici, da bi zagotovili zaščito pred vlago.
Sachet presentation
Oblika vrečke
Type I amber glass bottles with polypropylene child-resistant closures containing 5 -or 20 hard capsules.
Steklenice iz rjavega stekla tip I s propilensko, za otroke varno zaporko, ki vsebujejo po 5 ali 20 kapsul.
Sachet presentation
30 Oblika vrečke
Each sachet contains 1 hard capsule and is dispensed in a cardboard carton.
Vsaja vrelja vsebuje 1 trdo kapsulo in se nahaja v kartonasti škatli.
The carton contains 5 or 20 hard capsules, individually sealed in sachets.
Kartonasta škatla vsebuje 5 ali 20 trdih kapsul, posamezno zavarjenih v vrečke.
Patients should be advised to keep capsules out of the reach and sight of children, preferably in a locked cupboard.
Bolnikom je treba svetovati, naj zdravilo shranjujtejo nedosegljivo otrokom, po možnosti v zaklenjeni omari.
Each hard capsule contains 175.7 mg of anhydrous lactose.
Pomožna snov: ena trda kapsula vsebuje 175, 7 mg brezvodne laktoze.
The hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.
Trde kapsule imajo neprozorno belo telo, neprozorno rožnato kapico in tiskan napis s farmacevtskim črnilom.
The body is imprinted with "100 mg", the Schering-Plough logo and two stripes.
Na kapici je napis “ Temodal ”, na telesu kapsule pa so natisnjeni oznaka "100 mg", znak družbe Schering- Plough in dve črti.
No dose reductionsare recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non -haematological toxicity criteria.
Zmanjševanje odmerka ni priporočeno, vendar se boste vsak teden odločili o morebitni odložitvi jemanja TMZ ali njegovi ukinitvi na podlagi kriterijev hematološke in nehematološke toksičnosti.
≥ 0.5 and < 1.5 x 10 /l
< 0, 5 x 109/ l