natgillin/translations-raw huggingface dataset:
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
V ločeni študiji faze I uporaba TMZ z ranitidinom ni spremenila obsega absorpcije TMZ ali izpostavljenosti njegovemu aktivnemu metabolitu monometil triazenoimidazol karboksamidu (MTIC).
Do not store above 30°C.
Shranjujte pri temperature do 30 °C.
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 se odmerek poveča, ostane 200 mg/m² dnevno prvih pet dni vsakega naslednjega cikla, razen v primeru toksičnosti.
In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
V obeh preskušanjih je bila primarna točka ocene učinkovitosti preživetje brez napredovanja bolezni (PBN), opredeljeno z magnetnoresonančnim slikanjem ali nevrološkim poslabšanjem.
This adds up to a 28-day treatment cycle.
Skupaj je to 28-dnevni cikel zdravljenja.
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
MTIC se spontano hidrolizira v 5-amino-imidazol-4-karboksamid (AIC), znanega posrednika pri biosintezi purina in nukleinske kisline, in v metilhidrazin, ki je verjetno aktivna alkilirajoča različica.
Temozolomide Teva should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Zdravilo Temozolomide Teva smejo predpisovati samo zdravniki, izkušeni v onkološkem zdravljenju možganskih tumorjev.
It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Ni znano, ali se TMZ pri ljudeh izloča v materino mleko, zato je treba v obdobju zdravljenja s TMZ
The lowest recommended dose is 100 mg/m².
Najmanjši priporočeni odmerek je 100 mg/m².
Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Podatki o času do poslabšanja nevrološkega stanja kažejo prednost TMZ pred prokarbazinom, kar velja tudi za podatke o času do poslabšanja telesne zmogljivosti (zmanjšanje na indeks telesne zmogljivosti Karnofsky < 70 ali zmanjšanje za vsaj 30 točk).
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
In vivo je bila vrednost t1/2 za MTIC podobna kot za TMZ, tj. 1,8 ure.
However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Vendar je pri vseh bolnikih, ki jemljejo TMZ, zlasti tistih, ki se zdravijo tudi s steroidi, treba pozorno opazovati morebitne znake PCP, ne glede na režim odmerjanja.
Pancytopenia, anaemia (grade 3-4), leukopenia
pancitopenija, anemija (stopnja 3 do 4), levkopenija
Side effects from clinical studies:
Neželeni učinki iz kliničnih študij
In some cases, it may be necessary to stop treatment with Temozolomide Teva.
V nekaterih primerih je potrebno zdravljenje z zdravilom Temozolomide Teva prekiniti.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Posebne skupine bolnikov Analiza populacijske farmakokinetike TMZ je razkrila, da je plazemski očistek TMZ neodvisen od starosti, delovanja ledvic ali uporabe tobačnih izdelkov.
There may be up to 6 treatment periods (cycles).
Zdravljenje bo obsegalo največ šest obdobij (»ciklov«).
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Teva (see also “Male fertility” below).
Bolnice in bolniki, ki jemljejo zdravilo Temozolomide Teva, morajo uporabljati učinkovito kontracepcijo (glejte tudi spodaj »Plodnost pri moških«).
What you need to know before you take Temozolomide Teva Do not take Temozolomide Teva
Kaj morate vedeti, preden boste vzeli zdravilo Temozolomide Teva Ne uporabljajte zdravila Temozolomide Teva
TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
TMZ je embriotoksična, teratogena in genotoksična alkilirajoča učinkovina.
There is limited information in patients over 3 years of age who have taken Temozolomide Teva.
Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomide Teva, je omejeno.
An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multiorgan failure and death.
Po prevelikem odmerku 10.000 mg (skupni odmerek v posameznem ciklu, v petih dneh), ki ga je vzel en bolnik, so poročali o pancitopeniji, pireksiji, odpovedi več organov in smrti.
No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Študij, s katerimi bi ugotovili učinek TMZ na presnovo ali izločanje drugih zdravil, niso opravili.
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Izkazalo se je, da je pri bolnikih, ki so se v pilotskem preskušanju sočasno zdravili s TMZ in obsevanjem v podaljšanem obdobju 42 dni, še posebej prisotno tveganje za razvoj pljučnice s povzročiteljem Pneumocystis jirovecii (PCP).
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19% and 17% respectively, of patients treated for malignant glioma.
Trombocitopenija stopnje 3 ali 4 se je pojavila pri 19 %, nevtropenija stopnje 3 ali 4 pa pri 17 % bolnikov, ki so se zdravili zaradi malignega glioma.
Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): kašelj, okužbe vključno s pljučnico.
The first dose will be 150 mg/m².
Prvi odmerek bo 150 mg/m².
- if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
- če imate hudo zmanjšano število nekaterih vrst krvnih celic (mielosupresija), na primer belih krvnih celic in krvnih ploščic.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Glede na farmakokinetične lastnosti TMZ ni verjetno, da bi bilo za bolnike s hudo okvaro jeter ali katero koli stopnjo okvare ledvic treba zmanjšati odmerek.
Laboratory results
Rezultati laboratorijskih preiskav
Men being treated with TMZ 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 (see section 4.6).
Moškim, ki se zdravijo s TMZ, je treba svetovati, naj še do šest mesecev po zadnjem odmerku ne zaplodijo otroka ter da se pred zdravljenjem pozanimajo o možnostih kriokonzervacije sperme (glejte poglavje 4.6).
Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients.
Pri bolnikih so klinično ovrednotili odmerke 500, 750, 1000 in 1250 mg/m² (skupni odmerek na cikel zdravljenja v petih dneh).
Summary of events reported with temozolomide in the post-marketing setting* Infections and infestations*
Povzetek dogodkov, o katerih so poročali pri uporabi temozolomida v obdobju trženja *
Temozolomide Teva may make you feel tired or sleepy.
Jemanje zdravila Temozolomide Teva lahko povzroči utrujenost in zaspanost.
In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
V ločeni študiji farmakokinetike so bili plazemski farmakokinetični profili pri bolnikih z blago do zmerno okvaro jeter podobni tistim, ki so jih opazili pri bolnikih z normalnim delovanjem jeter.
If Temozolomide Teva comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Če pride zdravilo Temozolomide Teva v stik s kožo ali sluznico, prizadeti predel takoj temeljito sperite z vodo in milom.
Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
V razpredelnico 5 so vključeni neželeni učinki, o katerih so poročali med kliničnimi preskušanji zdravljenja ponavljajočega se ali napredujočega malignega glioma in po začetku trženja TMZ.
In the noncomparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
V neprimerjalnem preskušanju je bilo preživetje brez napredovanja bolezni po šestih mesecih 19-odstotno, srednje preživetje brez napredovanja bolezni je bilo 2,1 meseca in srednje skupno preživetje 5,4 meseca.
No evidence of cumulative myelosuppression was observed.
Znakov kumulativne mielosupresije niso opazili.
In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Pri bolnikih, ki so se zdravili s TMZ, ne glede na to, ali je bilo zdravljenje kombinirano z obsevanjem ali samostojno po obsevanju na novo diagnosticiranega multiformnega glioblastoma ali pa samostojno zdravljenje bolnikov s ponavljajočim se ali napredujočim gliomom, so bili neželeni učinki, o katerih so najpogosteje poročali, podobni - navzeja, bruhanje, zaprtost, anoreksija, glavobol in utrujenost.
In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
V študiji z 288 posamezniki z na novo diagnosticiranim multiformnim glioblastomom se je v prvem ciklu zdravljenja nevtropenija stopnje 4 pojavila pri 3 % žensk in 0 % moških, trombocitopenija stopnje 4 pa pri 1 % žensk in 0 % moških.
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 v obdobju sledenja uporabili kot rešilno zdravljenje pri 161 bolnikih od 282 (57 %) v kraku s samim obsevanjem ter 62 bolnikih od 277 (22 %) v kraku s TMZ in obsevanjem.
Temozolomide Teva is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme.
Zdravilo Temozolomide Teva se uporablja za zdravljenje določenih vrst možganskih tumorjev: - pri odraslih z novo diagnosticiranim multiformnim glioblastomom.
Frequency groupings are defined according to the following convention: Very common (≥ 1/10);
Kategorije pogostosti ustrezajo naslednjemu dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Štiri tedne po končanem obdobju sočasnega zdravljenja s TMZ in obsevanjem se TMZ uporabi v do šestih ciklih samostojnega zdravljenja.
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 obdobju sočasnega zdravljenja je treba uporabo TMZ začasno prekiniti ali trajno opustiti, če so izpolnjena merila hematološke in nehematološke toksičnosti, navedena v razpredelnici 1.
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
nevtropenija ali limfopenija (stopnja 3 do 4), trombocitopenija (stopnja 3 do 4)
Amber glass bottle with white polypropylene child-resistant screw cap equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Rjava steklenička z belim polipropilenskim pokrovčkom na navoj z zaščito za otroke, opremljena s polietilenskim indukcijskim tesnilom, ki vsebuje 5 ali 20 kapsul.
Tell your doctor if you notice any of these symptoms.
Če imate katerega od teh simptomov,
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
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.
Razmerje tveganja (RT) za skupno preživetje je bilo 1,59 (95-odstotni interval zaupanja za RT = 1,33 - 1,91) z vrednostjo p testa log-rank < 0,0001 v korist kraka s TMZ.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V vsaki kategoriji pogostosti so neželeni učinki razvrščeni po izrazitosti, in sicer v padajočem vrstnem redu.
Once the radiotherapy is completed, you will interrupt treatment for 4 weeks.
Po končanem obsevanju boste prekinili zdravljenje za štiri tedne, da si bo vaše telo lahko opomoglo.
What Temozolomide teva is and what it is used for
Kaj je zdravilo Temozolomide Teva in za kaj ga uporabljamo
Other medicines and Temozolomide Teva
Druga zdravila in zdravilo Temozolomide Teva
Micturition frequency, urinary incontinence
pogosto uriniranje, urinska inkontinenca urinska inkontinenca
If you accidentally get some in your eyes or nose, flush the area with water.
Temozolomide Teva po nesreči v stik z očmi ali z nosom, to področje sperite z vodo.
Tell your doctor immediately if this occurs.
Če se vam to zgodi, takoj obvestite zdravnika.
In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Za populacijsko farmakokinetično analizo so bili na voljo podatki iz kliničnih preskušanj - o najnižjih vrednostih nevtrofilcev pri 101 ženski in 169 moških ter o najnižjih vrednostih trombocitov pri 110 ženskah in 174 moških.
The major route of 14C elimination is renal.
Glavna pot izločanja 14C-označenega temozolomida je preko ledvic.
TMZ Dose (mg/m²/day)
(mg/m2/dan)
Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard.
Bolnikom svetujte, naj hranijo kapsule nevidne in nedosegljive otrokom, najbolje v zaklenjeni omarici.
If you accidentally take more Temozolomide Teva capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Če ste vzeli večji odmerek zdravila Temozolomide Teva, kot bi smeli Če po nesreči vzamete več kapsul Temozolomide Teva, kot so vam jih predpisali, se nemudoma posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Teva only
Bolniki s tumorji, ki so se ponovili ali poslabšali (maligni gliom, kot sta multiformni glioblastom ali anaplastični astrocitom), ki uporabljajo samo zdravilo Temozolomide Teva
Temozolomide Teva contains lactose (a kind of sugar).
Zdravilo Temozolomide Teva vsebuje laktozo (vrsta sladkorja).
In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Zmanjšanje števila krvnih celic je ponavadi kratkotrajno, vendar lahko včasih traja dlje in privede do zelo hude oblike anemije (aplastična anemija).
If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Teva for 42 days in combination with radiotherapy.
Če imate na novo diagnosticiran multiformni glioblastom, boste morda 42 dni dobivali zdravilo Temozolomide Teva v kombinaciji z obsevanjem.
Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): izguba apetita, glavobol, zaprtost,
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).
138 bolnikih (29 % se jih je že zdravilo s kemoterapijo), drugo pa randomizirano, z učinkovino nadzorovano preskušanje TMZ in prokarbazina pri skupno 225 bolnikih (67 % se jih je prej zdravilo s kemoterapijo na podlagi nitrozouree).
A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x109/l.
Med zdravljenjem je treba narediti celotno krvno sliko na 22. dan (21 dni po prvem odmerku) ali v 48 urah po tem dnevu, pa tudi tedensko, dokler ni absolutno število nevtrofilcev > 1,5 x 109/l in število trombocitov > 100 x 109/l.
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic† , sepsis†
okužba s citomegalovirusom, reaktivacija okužb, kot sta okužbi s citomegalovirusom, z virusom hepatitisa B†, herpetični meningoencefalitis†, sepsa†
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 se med katerimkoli ciklom absolutno število nevtrofilcev zmanjša na < 1,0 x 109/l ali če je število trombocitov < 50 x 109/l, je treba v naslednjem ciklu zmanjšati odmerek za eno odmerno raven (glejte poglavje 4.2).
Take your prescribed dose of Temozolomide Teva once a day, preferably at the same time each day.
Kako jemati zdravilo Temozolomide Teva Predpisani odmerek zdravila Temozolomide Teva vzemite enkrat dnevno, najbolje vsak dan ob istem času.
Excipients with known effect Each hard capsule contains 72 mg of lactose and sunset yellow FCF (E110).
Pomožni snovi z znanim učinkom: Ena trda kapsula vsebuje 72 mg laktoze in sončno rumeno FCF (E110).
interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
intersticijski pnevmonitis/pnevmonitis, pljučna fibroza, odpoved dihalnega sistema †
The objective response rate (ORR) based on MRI scans was 8%.
Objektivno ugotovljena stopnja odziva na podlagi magnetnoresonančnega slikanja je bila 8-odstotna.
Pharmacotherapeutic group: Antineoplastic agents-other alkylating agents, ATC code: L01A X03
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki) - drugi alkilirajoči citostatiki; oznaka ATC: L01AX03.
However, caution should be exercised when TMZ is administered in these patients.
Kljub temu je potrebna previdnost, kadar se zdravilo uporablja pri teh bolnikih.
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Pred vsakim novim ciklom zdravljenja pri zdravniku znova preverite velikost odmerka; ta morda ne bo enaka kot v prejšnjem ciklu.
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Srednje preživetje je bilo pri TMZ 7,34 meseca in pri prokarbazinu 5,66 meseca (vrednost p testa log rank = 0,33).
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.
Ponavljajoč se ali napredujoč maligni gliom Podatki o klinični učinkovitosti pri bolnikih z multiformnim glioblastomom (indeks telesne zmogljivosti Karnofsky ≥ 70), ki se je po operaciji in obsevanju ponovil ali napredoval, temeljijo na dveh kliničnih preskušanjih s peroralnimi odmerki TMZ.
During the concomitant phase, your doctor will start Temozolomide Teva at a dose of 75 mg/m² (usual dose).
V obdobju sočasnega zdravljenja boste začeli jemati odmerek zdravila Temozolomide Teva 75 mg/m² (običajni odmerek).
The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Ko so samemu obsevanju dodali sočasno zdravljenje s TMZ, ki mu je v zdravljenju bolnikov z na novo diagnosticiranim multiformnim glioblastomom sledila samostojna terapija s TMZ, so dosegli statistično pomembno izboljšanje skupnega preživetja v primerjavi s samim obsevanjem (Slika 1).
Contents of the pack and other information What Temozolomide Teva contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Temozolomide Teva
At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44%) (chi-square p = 0.019).
Po šestih mesecih je bila frakcija preživelih bolnikov znatno večja v kraku s TMZ (60 %) kot v kraku s prokarbazinom (44 %) (vrednost p testa hi-kvadrat = 0,019).
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
S kombiniranjem nenormalnih rezultatov laboratorijskih preiskav in neželenih učinkov iz obdobij sočasnega in samostojnega zdravljenja so pri 8 % bolnikov opazili nepravilnosti nevtrofilcev stopnje 3 ali 4, vključno z nevtropeničnimi dogodki.
Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
DTIC): med znaki alergijske reakcije so lahko srbenje, zasoplost ali oteženo dihanje, otekanje obraza, ustnic, jezika ali grla;
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Študije s pozitronsko emisijsko tomografijo pri ljudeh in predklinični podatki kažejo, da TMZ hitro prehaja skozi krvno-možgansko pregrado in da je prisoten v cerebrospinalni tekočini.
Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Glede na vrednost AUC TMZ je izpostavljenost MTIC približno 2,4-odstotna, izpostavljenost AIC pa 23-odstotna.
Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Na podlagi populacijske farmakokinetične analize v preskušanjih faze II sočasna uporaba deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksična snov
† Including cases with fatal outcome *Frequencies estimated based on relevant clinical trials
* Pogostnosti so ocenjene na podlagi ustreznih kliničnih raziskav.
Experience in these children is very limited (see sections 4.4 and 5.1).
Izkušenj pri tehotrocih je malo (glejte poglavji 4.4 in 5.1).
Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Občasno so poročali o povišanih vrednostih bilirubina, težavah s pretokom žolča (holestazi), hepatitisu in poškodbi jeter, vključno z odpovedjo jeter s smrtnim izidom.
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Opazili so mielosupresijo (nevtropenija in trombocitopenija), znan toksični učinek, ki omejuje odmerke večine citotoksičnih učinkovin, vključno s TMZ.
Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Mehanizem delovanja Temozolomid je triazen, ki se pri fiziološki vrednosti pH hitro kemijsko pretvori v aktivni monometiltriazenoimidazolkarboksamid (MTIC).
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
Zmanjšanje odmerka ali opustitev zdravljenja v obdobju samostojne uporabe mora ustrezati priporočilom v razpredelnicah 2 in 3.