natgillin/translations-raw huggingface dataset:
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Zato boste morda imeli pogostejše podplutbe ali krvavitve, anemijo (pomanjkanje rdečih krvnih celic), vročino in zmanjšano odpornost proti okužbam.
In very rare cases, patients taking Temozolomide SUN and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Pri zelo redkih bolnikih, ki jemljejo zdravilo Temozolomid SUN in podobna zdravila, obstaja majhno tveganje za razvoj sekundarnega raka, vključno z levkemijo.
Temozolomide SUN is used in these tumours if they return or get worse after standard treatment.
Zdravilo Temozolomid SUN se uporablja za zdravljenje teh tumorjev, če se po standardnem zdravljenju ponovijo ali poslabšajo.
Tell your doctor if you notice any of these symptoms.
Če opazite katerega od teh simptomov,
Frequency not known:
Pogostnost neznani:
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.
Oba učinka sta bila ponavadi 1. ali 2. stopnje (od 0 do 5 epizod bruhanja v 24 urah) in sta prenehala sama ali pa ju je bilo mogoče hitro obvladati s standardnim antiemetičnim zdravljenjem.
TMZ + concomitant RT n=288*
TMZ + sočasna radioterapija n=288*
Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Stopnje odmerka so 100 mg/m2, 150 mg/m2 in 200 mg/m2.
Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Opazili so zelo redke primere hudega izpuščaja z otekanjem kože, vključno z dlanmi in podplati, ali boleče pordelosti kože in/ali mehurjev na telesu ali v ustih.
If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide SUN until the vomiting is under control.
Če pred zdravljenjem ali med njim pogosto bruhate, vprašajte zdravnika, kdaj je najbolje jemati zdravilo Temozolomid SUN, dokler se bruhanje ne umiri.
Pharmacotherapeutic group: Antineoplastic agents, other alkylating agents, ATC code: L01A X03.
Farmakoterapevtska skupina: Antineoplastična zdravila - drugi alkilirajoči citostatiki, oznaka ATC: L01A X03
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Vsakič ko začnete nov ciklus, z zdravnikom ponovno preverite odmerek, saj se lahko razkikuje od prejšnjega.
The first dose will be 150 mg/m2.
Prvi odmerek bo 150 mg/m2.
Take your prescribed dose of Temozolomide SUN once a day, preferably at the same time each day.
Predpisani odmerek zdravila Temozolomid SUN vzemite enkrat dnevno, najbolje vsak dan ob istem času.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neuporabljena zdravila ali odpadni material morajo biti odstranjeni v skladu z lokalnimi zahtevami.
In some cases, your Temozolomide SUN dose will be reduced or treatment stopped.
V nekaterih primerih je treba odmerek zdravila Temozolomid SUN zmanjšati ali zdravljenje končati.
Summary of events reported with temozolomide in the post-marketing setting*
Povzetek dogodkov, o katerih so poročali pri uporabi temozolomida v obdobju trženja
drug reaction with eosinophilia and systemic symptoms (DRESS)
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
- as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
- ker vas mora zdravnik pozorno opazovati zaradi možnosti pojava resne oblike okužbe dihal, imenovane pljučnica zaradi okužbe s Pneumocystis jirovecii (PCP).
Before each new treatment cycle, your blood will be tested to see if the Temozolomide SUN dose needs to be adjusted.
Pred vsakim ciklom zdravljenja boste opravili preiskavo krvi, da bi ugotovili, ali je treba odmerek zdravila Temozolomid SUN prilagoditi.
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 ponovil po kirurškem posegu in RT, temeljijo na dveh kliničnih preskušanjih s peroralno uporabo TMZ.
Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of Temozolomide SUN.
V preglednici 5 so navedeni neželeni učinki, ki so jih prijavili v kliničnih preskušanjih pri ponavljajočem ali napredujočem malignem gliomu in po trženju zdravila Temozolomid SUN.
You may have to take different strengths to make up the dose.
Odmerek boste morda morali sestaviti z različnimi jakostmi.
During the monotherapy phase, the dose and way you take Temozolomide SUN can vary.
Med fazo monoterapije se odmerek in način jemanja zdravila Temozolomid SUN lahko spreminjata.
After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating 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.
If Temozolomide SUN comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Če pride zdravilo Temozolomid SUN v stik s kožo ali sluznico, jo takoj temeljito sperite z milom in vodo.
Ask your doctor or pharmacist to write it down (including the marking) - which days are your dosing days.
Prosite zdravnika ali farmacevta, da vam to napiše (vključno z oznako)
Allergic reactions, including anaphylaxis, angioedema
alergijske reakcije, vključno z anafilaksijo, angioedem
Pack size: blisters are packed in cartons containing 5 or 20 hard capsules.
Velikost pakiranja: pretisni omoti so pakirani v kartonskih škatlah s 5 ali 20 trdimi kapsulami.
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 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.
The hard capsules are available in blister packs containing 5 capsules.
Trde kapsule so na voljo v pretisnem omotu s 5 kapsulami.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila mora biti navedena ime in naslov proizvajalca,
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide SUN (see also “Male fertility” below).
Bolnice in bolniki, ki jemljejo zdravilo Temozolomid SUN, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi spodaj ″Plodnost pri moških)
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide SUN only
Bolniki s tumorji, ki so se ponovili ali poslabšali (maligni gliomi, na primer multiformni glioblastom ali anaplastični astrocitom), ki jemljejo samo zdravilo Temozolomid SUN
During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m2 (usual dose).
Med fazo sočasnega zdravljenja vam bo zdravnik predpisal zdravilo Temozolomid SUN v odmerku 75 mg/m2 (običajni odmerek).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Temozolomid SUN Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The Temozolomide SUN dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Odmerjanje zdravila Temozolomid SUN se lahko prilagodi, prestavi ali prekine, odvisno od vaše krvne slike in tega, kako prenašate zdravilo med vsakim ciklom zdravljenja.
Dose during Cycles 2-6 in absence of toxicity
Odmerek med 2. in 6. ciklom brez toksičnosti
common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).
občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
- if you have nausea (feeling sick) and/or vomiting which are very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
- vam je slabo in/ali bruhate, kar sta zelo pogosta neželena učinka zdravila Temozolomid SUN (glejte poglavje 4 ),vam bo zdravnik morda predpisal zdravilo, ki preprečuje bruhanje
TMZ dose (mg/m2/day)
Raven odmerka Odmerek TMZ (mg/m2/dan)
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 Child-u) ali ledvično okvaro niso na voljo.
Temozolomide SUN contains lactose (a kind of sugar).
Zdravilo Temozolomid SUN vsebuje laktozo (vrsta sladkorja).
TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji TMZ ima blag vpliv na sposobnost vožnje in upravljanja s stroji zaradi utrujenosti in zaspanosti (glejte poglavje 4.8).
Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells.
Med zdravljenjem boste pogosto imeli preiskave krvi za spremljanje neželenih učinkov zdravila Temozolomid SUN na krvne celice.
Temozolomide SUN should not be administered to pregnant women.
Zdravila Temozolomid SUN se ne sme dajati nosečnicam.
If you have been newly-diagnosed with glioblastoma multiforme you may be receiving Temozolomide SUN for 42 days in combination with radiotherapy.
Če imate na novo diagnosticiran multiformni glioblastom, boste morda 42 dni dobivali zdravilo Temozolomid SUN v kombinaciji z obsevanjem.
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, ki vključujejo pljučnico.
- if the numbers of certain kinds of blood cells, such as your white blood cells or platelets are severely reduced (known as myelosuppression).
- če imate hudo zmanjšano število nekaterih vrst krvnih celic (znano kot mielosupresija), na primer belih krvnih celic ali krvnih ploščic.
You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle.
Nov odmerek zdravila Temozolomid SUN boste prvih pet dni v vsakem ciklu jemali enkrat dnevno (»dnevi odmerjanja«).
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, zaprtje
- if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted.
- če imate težave z ledvicami ali jetri, bo morda treba vaš odmerek zdravila Temozolomid SUN
Tell your doctor immediately if this occurs.
Če pride to tega, nemudoma pokličite zdravnika.
What Temozolomide SUN is and what it is used for What you need to know before you take Temozolomide SUN How to take Temozolomide SUN Possible side effects
Kaj je zdravilo Temozolomid SUN in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid SUN Kako jemati zdravilo Temozolomid SUN
- if you are older than 70 years of age, you might be more prone to infection, bruising or bleeding.
- če dobite vročino ali simptome okužbe, se takoj obrnite na zdravnika - če ste starejši od 70 let, boste lahko bolj nagnjeni k okužbam, podplutbam ali krvavitvam.
There is limited information in patients over 3 years of age who have taken Temozolomide SUN.
Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomid SUN, je omejeno
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..
Cases of elevations of liver enzymes have been commonly reported.
Pogosto so poročali o primerih povišanih vrednosti jetrnih encimov.
The Temozolomide SUN dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Odmerjanje zdravila Temozolomid SUN se lahko prestavi ali prekine, odvisno od vaše krvne slike in tega, kako prenašate zdravilo med fazo sočasnega zdravljenja.
Frequency groupings are defined according to the following convention: very common (≥ 1/10);
Skupine pogostnosti so opredeljene skladno s konvencijo: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10),
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Menijo, da je citotoksičnost MTIK predvsem posledica alkilacije DNA, predvsem gvanina na položajih O6 in N7.
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 3 leta ali več, s ponavljajočim se ali napredujočim malignim gliomom: Posamezen cikel zdravljenja traja 28 dni.
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Pred zdravljenjem bo zdravnik preveril vašo kri, da bi se prepričal, ali imate dovolj teh celic.
Do not open, crush or chew the capsules, swallow whole.
Kapsule ne odpirajte, drobite ali žvečite; pogoltnite celo.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Convulsions, consciousness
konvulzije, motnje zavesti,
If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with Temozolomide SUN only (monotherapy phase).
Če ste na novo diagnosticiran bolnik, bo zdravljenje potekalo v dveh fazah: - najprej zdravljenje skupaj z obsevanjem (faza sočasnega zdravljenja) - pozneje samo zdravljenje z zdravilom Temozolomid SUN (faza monoterapije).
If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Če se kapsula poškoduje, se izogibajte stiku praška z vašo kožo, očmi ali nosom .
Temozolomide SUN should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Zdravilo Temozolomid SUN smejo predpisati le zdravniki, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Če ste vzeli večji odmerek zdravila Temozolomid SUN, kot bi smeli Če po nesreči vzamete več kapsul zdravila Temozolomid SUN, se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p=0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p=0.0063).
V randomiziranem, z učinkovino nadzorovanem preskušanju je bil PFS po 6 mesecih statistično značilno daljši pri TMZ kot pri prokarbazinu (21 % v primerjavi z 8 %, hi-kvadrat, p = 0,008), z mediano vrednostjo PFS 2,89 meseca za temozolomid in 1,88 meseca za prokarbazin (test log.
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 nedosegljive otrokom, najbolje v zaklenjeni omarici.
Temozolomide SUN monotherapy in recurrent or progressive glioma
Monoterapija z zdravilom Temozolomid SUN pri ponavljajočem se ali napredujočem gliomu
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen1-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).
This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past.
(višino in maso) in glede na to, ali imate ponavljajoče tumorje ter ali ste se v preteklosti zdravili s kemoterapijo.
Temozolomide SUN may cause permanent infertility.
Zdravilo Temozolomid SUN lahko povzroči trajno neplodnost.
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.
MTIK pa spontano hidrolizira do 5-amino-imidazol-4karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
If you vomit after taking your dose, do not take a second dose on the same day.
Če po zaužitju odmerka bruha, ne sme še isti dan vzeti drugega odmerka.
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†
Aluminium/aluminium unit dose blisters, consisting of an OPA [Oriented Poly Amide] / Aluminium / PVC [Polyvinyl chloride] forming film and peelable Aluminium lidding foil with heat seal laquer.
Pretisnih omotih aluminij/aluminij, sestavljenih iz filma iz orientiranega poliamida (OPA)/aluminija/polivinilklorida (PVC ) in toplotno zavarjene odstranljive aluminijaste prekrivne folije.
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ Toxicity
Prekinitev jemanja ali ukinitev TMZ med sočasno radioterapijo in zdravljenjem s TMZ
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.
Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Bolniki s ponavljajočim se ali napredujočim malignim gliomom Pri bolnikih, ki so močno bruhali (stopnja 3 ali 4) v prejšnjih ciklih zdravljenja je potrebno antiemetično zdravljenje.
You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN.
Zdravilo Temozolomid SUN boste spet jemali pet dni enkrat dnevno, temu pa bo sledilo 23 dni brez jemanja zdravila.
TMZ dose levels for monotherapy treatment Dose level
Ravni odmerkov TMZ za monoterapijo
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 ali fenobarbitala ne spremeni očistka TMZ.
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).
Med zdravljenjem s TMZ so opazili oportunistične okužbe (kot je pljučnica, ki jo povzroča Pneumocystis jirovecii) in reaktivacijo okužb (kot sta HBV, CMV) (glejte poglavje 4.8).
Propylene glycol
Šelak Propilenglikol
Dry skin, pruritus
pruritus suha koža, pruritus
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
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).
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.
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.
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Neželeni učinki pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom Infekcijske in parazitske bolezni
Temozolomide SUN contains lactose
Zdravilo Temozolomid SUN vsebuje laktozo
Temozolomide SUN is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Zdravilo Temozolomid SUN se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Skupaj 573 bolnikov so randomizirali v dve skupini, od katerih je ena prejemala TMZ in RT (n=287), druga pa samo RT (n=286).
Patients usually present with shortness of breath and cough.
Pri bolnikih se ponavadi pojavi zasoplost in kašelj.
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).
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).
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
- skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption,
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): pordečelost kože, urtikarija (koprivnica), kožni izpuščaj, alergijske reakcije.
Pneumocystis jiroveciipneumonia (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.
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.
The major route of 14C elimination is renal.
Zdravilo 14C se izloča predvsem preko ledvic.
How to store Temozolomide SUN Contents of the pack and other information
Možni neželeni učinki Shranjevanje zdravila Temozolomid SUN Vsebina pakiranja in dodatne informacije
If a capsule is damaged, avoid contact with your skin, eyes or nose.
Če je kapsula poškodovana, ne sme priti v stik s kožo, očmi ali nosom.