natgillin/translations-raw huggingface dataset:
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
TMZ spontano hidrolizira pri fiziološki vrednosti pH predvsem do aktivnih presnovkov, 3-metil(triazen-1-il)imidazol-4-karboksamida (MTIK).
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, 1.000 in 1.250 mg/m2 (skupni odmerek na 5dnevni cikel).
PET studies in humans and preclinical data suggest that TMZ crosses the blood-brain barrier rapidly and is present in the CSF.
Študije z uporabo PET pri človeku in predklinični podatki kažejo, da TMZ hitro prehaja hematoencefalno pregrado in da je prisoten v cerebrospinalni tekočini (CFS - »celebrospinal fluid«).
If you accidentally get some in your eyes or nose, flush the area with water.
Če pride zdravilo po nesreči v stik s kožo, očmi ali nosom, to področje sperite z vodo.
Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules.
Rjava steklenica tipa III z za otroke varno zaporko iz polipropilena vsebuje 5 ali 20 trdih kapsul.
The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Rezultati študije niso skladni pri podskupini s slabim odzivom (WHO PS=2, n=70), čas skupnega preživetja in napredovanje bolezni pa je podobno v obeh primerih.
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 1. faze sočasna uporaba zdravila TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti aktivnemu presnovku, monometiltriazenoimidazol karboksamidu (MTIC).
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).
Pilotno preskušanje podaljšane 42-dnevne sheme zdravljenja je pokazalo, da pri bolnikih, ki so sočasno prejemali TMZ in RT, obstaja še posebej veliko tveganje za nastanek pljučnice zaradi okužbe s Pneumocystis jirovecii (PCP).
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.
MTIK pa spontano hidrolizira do 5-amino-imidazol4- karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
The safety of TMZ in children under the age of 3 years has not been established.
Varnost TMZ pri otrocih, mlajših od 3 let, ni bila dokazana.
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).
Pri bolnikih, ki so že bili zdravljeni s kemoterapijo, je začetni odmerek 150 mg/m2 enkrat na dan, v drugem ciklu pa se poveča na 200 mg/m2 enkrat na dan 5 dni, če ni bilo hematoloških toksičnih učinkov (glejte poglavje 4.4).
Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Zdravilo Temozolomid Sandoz se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
5 capsules 20 capsules
5 trdih kapsul 20 trdih kapsul
The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Mediana vrednost časa preživetja je bila 7,34 mesecev za TMZ in 5,66 mesecev za prokarbazin (test log.
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 poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom.
Fatigue
utrujenost
• muscle damage
• mišične poškodbe,
Neoplasm benign, malignant and unspecified
Benigne, maligne in neopredeljene novotvorbe
reduced blood cell counts (pancytopenia, anaemia, leukopenia).
zmanjšano število krvnih celic (pancitopenija, anemija, levkopenija).
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).
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).
The body is imprinted with “5”.
Na telesu pa je vtisnjen znak „5”.
Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
(HPBL - »Human Peripheral Blood Lymphocyte«) so pokazali pozitiven mutageni odziv.
Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
okužba, Herpes simplex, okužba rane, faringitis, oralna kandidiaza okužba, oralna kandidiaza
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Zelo redko so poročali tudi o primerih mielodisplastičnega sindroma in sekundarnih malignostih, vključno z mieloidno levkemijo (glejte poglavje 4.8).
Baseline liver function tests should be performed prior to treatment initiation.
Pred začetkom zdravljenja je treba opraviti teste jetrne funkcije.
Your doctor will work out your exact dose.
Natančen odmerek bo določil zdravnik.
Reduce TMZ by 1 dose levela
Zmanjšajte odmerek TMZ za eno ravena
Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Pri podganah in psih so opravili študije toksičnosti enega cikla (5 dni jemanja zdravila, 23 dni brez zdravila), 3 ciklov in 6 ciklov.
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 6 mesecih je bil delež preživelih bolnikov statistično značilno večji v skupini, ki je prejemala TMZ (60 %), kot v tisti, ki je prejemala prokarbazin (44 %) (hi-kvadrat, p = 0,019).
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.
Analiza populacijske farmakokinetike v preskušanjih druge faze je pokazala, da sočasna uporaba deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2
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 študijah šestih ciklov pri podganah so opažali različne neoplazme, vključno s karcinomom dojk, keratoakantomom kože in bazalnoceličnim adenomom, v študijah pri psih pa niso opažali nobenih tumorjev ali preneoplastičnih sprememb.
Patients usually present with shortness of breath and cough.
Pri bolnikih se običajno pojavljata zasoplost in kašelj.
• bronchitis
• bronhitis,
• seizures (convulsions),
• epileptični napadi (konvulzije).
Keep the desiccant pouch in the bottle.
Zavojček sušilnega sredstva hranite v steklenici.
Each carton contains 5 or 20 hard capsules.
Vsaka škatla vsebuje 5 ali 20 trdih kapsul.
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Pri bolnikih starih 3 leta ali več, se TMZ uporablja samo za zdravljenje ponavljajočega se ali napredujočega malignega glioma.
Temozolomide Sandoz contains lactose
Temozolomid Sandoz vsebuje laktozo
• difficulty in urinating
• težave z uriniranjem,
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Zdravilo shranjujte nedosegljivo otrokom, po možnosti v zaklenjeni omari.
Dermatitis, dry skin, erythema, pruritus Dry skin, pruritus
dermatitis, suha koža, eritem, pruritus suha koža, pruritus
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING BOTTLE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, KI VSEBUJE STEKLENICO
How to store Temozolomide Sandoz Contents of the pack and other information
Shranjevanje zdravila Temozolomid Sandoz Vsebina pakiranja in dodatne informacije
hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure†
hiperbilirubinemija, holestaza, hepatitis jetrna poškodba, jetrna odpoved†
The body is imprinted with “180”.
Na telesu pa je vtisnjen znak „180”.
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
In vivo je bila razpolovna doba t1/2 za MTIK podobna razpolovni dobi TMZ, tj. 1,8 ure.
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 se zdravijo s TMZ v kombinaciji z RT ali monoterapijo po RT zaradi novo diagnosticiranega multiformnega glioblastoma ali z monoterapijo pri bolnikih s ponavljajočim se ali napredujočim gliomom, so bili zelo pogosti neželeni učinki podobni; slabost, bruhanje, zaprtje, neješčnost, glavobol in utrujenost.
Convulsions, headache
glavobol konvulzije, glavobol
Tell your doctor if you notice any of these symptoms.
Če opazite katerega od teh simptomov, povejte svojemu zdravniku.
The cap is imprinted with “TMZ”.
Na kapici je vtisnjen znak „TMZ”.
Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Zdravilo Temozolomid Sandoz pri kombiniranem zdravljenju z radioterapijo pri novo diagnosticiranem glioblastomu
The body is imprinted with “20”.
Na telesu pa je vtisnjen znak „20”.
The body is imprinted with “250”.
Na telesu pa je vtisnjen znak „250”.
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.
Pri ženskah so ugotovili 12 % pogostnost nevtropenije 4. stopnje (absolutno število nevtrofilcev (ANC) < 0,5 x 109/l), v primerjavi s 5 % pri moških, medtem ko je pogostnost trombocitopenije (< 20 x 109/l) pri ženskah znašala 9 %, v primerjavi s 3 % pri moških, torej so bile v prvem ciklu terapije pri ženskah te pogostnosti večje kot pri moških.
The 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.
• abnormal liver function tests.
• nenormalen okus, • nenormalni izvidi preiskav delovanja jeter.
Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Pred jemanjem zdravila morata biti izpolnjena naslednja pogoja za laboratorijske izvide: ANC ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
• partial paralysis
• delna paraliza,
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Med RT sta bili potrebni profilaksa proti pljučnici zaradi okužbe s Pneumocystis jirovecii (PCP) in kombinirana terapija s TMZ.
Temozolomide Sandoz may cause permanent infertility.
Zdravilo Temozolomid Sandoz lahko povzroči trajno neplodnost.
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.
The body is imprinted with “140”.
Na telesu pa je vtisnjen znak „140”.
This adds up to a 28-day treatment cycle.
To je skupaj 28 dni v enem ciklu zdravljenja.
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 temozolomida so ugotavljali, da so plazemski farmakokinetični profili pri bolnikih z blago do zmerno jetrno okvaro podobni profilom pri bolnikih z normalnim delovanjem jeter.
Absolute neutrophil count
Absolutno število nevtrofilcev
During the concomitant phase, your doctor will start Temozolomide Sandoz at a dose of 75 mg/m2
Med fazo sočasnega zdravljenja vam bo zdravnik začel dajati zdravilo Temozolomid Sandoz v odmerku 75 mg/m2 (običajni odmerek).
Very rare cases of lung side effects have been observed with temozolomide.
Pri temozolomidu so opazili zelo redke primere neželenih učinkov na pljučih.
Do not open, crush or chew the capsules.
Kapsul ne smete odpirati, zdrobiti ali žvečiti.
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Opažali so mielosupresijo (nevtropenijo in trombocitopenijo), kar so znani toksični učinki večine citotoksičnih snovi, vključno s TMZ, ki tudi omejujejo njihov odmerek.
Dose during Cycles 2-6 in absence of toxicity
Odmerek med 1. ciklom Odmerek med 2. in 6 ciklom brez toksičnosti
If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Če se kapsula poškoduje, se izogibajte stiku praška s kožo, očmi ali nosom.
Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Pred začetkom zdravljenja mora zdravnik natančno preveriti, ali ima bolnik znake te okužbe.
• wound infection
• okužbe ran,
- absolute neutrophil count (ANC) ≥ 1.5 x 109/l
- absolutno število nevtrofilcev (ANC - Absolute Neutrophil Count) ≥ 1,5 x 109/l,
• loss of weight
• izguba teka,
≥ 0.5 and < 1.5 x 109/l
≥ 0,5 in < 1,5 x 109/l
Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Peroralni TMZ so preučevali pri pediatričnih bolnikih (starih 3-18 let) s ponavljajočim se gliomom možganskega debla ali ponavljajočim se astrocitomom visoke stopnje, ki so zdravilo prejemali 5 dni, na vsakih 28 dni.
≥ 10 and < 100 x 109/l
≥ 10 in < 100 x 109/l
• if you have ever had or might now have a hepatitis B infection.
• če ste kdaj imeli ali imate okužbo z virusom hepatitisa B. Temozolomid namreč lahko povzroči reaktivacijo hepatitisa B, ki je lahko v nekaterih primerih usodna.
Edvard Thomsens Vej 14 DK-2300 København S
Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S
If you have not been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 200 mg/m2 once daily for the first 5 days.
Če se v preteklosti niste zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Sandoz 200 mg/m2 enkrat na dan prvih 5 dni.
Hypokalemia, alkaline phosphatase increased, weight increased
hipokaliemija, zvišanje vrednosti alkalne fosfataze, povečanje telesne mase hiperglikemija, povečanje telesne mase
Contact your doctor immediately if you have any of the following:
Če imate katerega koli od naštetih znakov, nemudoma obvestite zdravnika:
The major route of 14C elimination is renal.
Zdravilo 14C se izloča predvsem skozi ledvice.
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, Sepsis†
okužba s citomegalovirusom, reaktivacija okužbe, npr. citomegalovirus, virus hepatitisa B†, herpetični meningoencefalitis†, sepsa†
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Prekinitev jemanja ali ukinitev TMZ med sočasno radioterapijo in zdravljenjem s TMZ
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).
CTC Grade 3 or 4
SMT 3. ali 4. stopnje a:
Then, you will start the monotherapy phase.
Nato se bo začela faza zdravljenja z enim zdravilom.
CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
SMT 4. stopnjab a: Ravni odmerkov TMZ so podane v preglednici 2.
This medicine is an antitumour agent.
To je zdravilo proti tumorjem.
Colour of the cap
Barva ovojnice
In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Pri bolnikih, ki so že prejemali kemoterapijo, so ugotavljali koristne učinke zdravila pri bolnikih z indeksom kliničnega stanja po Karnofskyju ≥ 80.
a: 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).
Somnolence, dizziness, paresthesia
zaspanost, omotica, parestezije
Each capsule is approximately 15.8 mm in length.
Dolžina ene kapsule je približno 15,8 mm.
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, 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 shranjevanja zamrznjene sperme.
No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Podatki o uporabi TMZ pri bolnikih s hudo jetrno okvaro (razred C po
Concomitant phase
Faza sočasne terapije
≥ 100 x 10
≥ 10 in < 100 x 10
Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
možganske krvavitve, hipertenzija pljučna embolija, edem, periferni edem
New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Občasno so poročali o novih ali reaktiviranih (ponovljenih) okužbah s citomegalovirusom in o reaktiviranih okužbah z virusom hepatitisa B. Občasno so poročali o primerih možganskih okužb, ki jih povzroča herpesvirus (herpetični meningoencefalitis), vključno s smrtnimi primeri.
Micturition frequency, urinary incontinence Urinary incontinence
pogosto uriniranje, inkontinenca seča inkontinenca seča
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do
Very common:
Zelo pogosti:
The bottles also contain a desiccant pouch.
Steklenica vsebuje tudi zavojček sušilnega sredstva.
positions of guanine.
- Navodilo shranite.
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Po peroralnem jemanju TMZ, označenega s 14C, je bila srednja vrednost količine 14C, izločene v blatu 7 dni po odmerku
• difficulty controlling your bowel movements
• težave z nadzorovanjem odvajanja blata,
INSTRUCTIONS ON USE
B. NAVODILO ZA UPORABO
What Temozolomide Sandoz looks like and contents of the pack
Izgled zdravila Temozolomid Sandoz in vsebina pakiranja
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
(pomanjkanje rdečih krvnih celic), zvišana telesna temperatura in zmanjšana odpornost proti okužbam.
• impaired coordination
• motnje koordinacije,
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 večje pogostnosti PCP, vendar morate vse bolnike, ki prejemajo zdravilo TMZ, še posebej tiste, ki prejemajo tudi steroide, skrbno opazovati, da ugotovite morebiten pojav PCP, ne glede na režim zdravljenja.
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
napihnjenost trebuha, inkontinenca blata, bolezni prebavil (NOS), gastroenteritis, hemoroidi
Adverse reactions in patients with recurrent or progressive malignant glioma
Neželene reakcije pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom
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.
za TMZ, je bila približno 30 % tiste v plazmi, kar je v skladu s podatki, ki so jih dobili pri živalih.
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:
Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti (ITT, n=162) 35 % (13
Agitation, apathy, behaviour disorder, depression, hallucination
vznemirjenost, apatija, vedenjske motnje, depresija, halucinacije halucinacije, amnezija
• reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
• zmanjšano število krvnih celic (nevtropenija, trombocitopenija, limfopenjia, levkopenija),
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, KI VSEBUJE VREČKO
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Pri bolnikih, ki prejemajo TMZ, zlasti v kombinaciji z deksametazonom ali drugimi steroidi, so poročali o respiratorni odpovedi s smrtnim izidom.
Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Pneumocystis jirovecii) in reaktivacijo okužb (npr. HBV, CMV) (glejte poglavje 4.8).
• confusion
• zmedenost,
• breast pain
• trebušne bolečine,
Pneumonia, sinusitis, upper respiratory infection, bronchitis
kongestija nosne sluznice pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
Remarks Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity Table 3.
Odmerek med 1. ciklom Odmerek med 2. in 6. ciklom brez toksičnosti
Anti-emetic therapy
Antiemetično zdravljenje
If you have been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 150 mg/m2 once daily for the first
Če ste se v preteklosti zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Sandoz 150 mg/m2 enkrat na dan prvih 5 dni.
Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Pri bolnikih, zdravljenih s TMZ, so poročali o poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom (glejte poglavje 4.8).
• severe headache that does not go away.
• hud neprekinjen glavobol.