FrancophonIA/ELRC3.0 huggingface dataset:
English: In preclinical studies in rats and rabbits receiving 150 mg/m TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Slovenian: Podatkov o nosečnicah ni. Predklinične študije na podganah in kuncih, ki so prejemali 150 mg/m TMZ, so pokazale teratogenost in/ali toksičnost za plod (glejte poglavje 5.3).
English: Myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Slovenian: mielodisplastični sindrom (MDS), sekundarni malignomi, vključno z mieloidno levkemijo
English: What Temodal looks like and contents of the pack
Slovenian: Izgled zdravila Temodal in vsebina pakiranja
English: Temodal may cause permanent infertility.
Slovenian: Zdravilo Temodal lahko povzroči trajno neplodnost.
English: †, interstitial pneumonitis/pneumonitis, pulmonary fibrosis, nasal congestion
Slovenian: †, intersticijski pnevmonitis/pnevmonitis, pljučna fibroza, kongestija nosne sluznice
English: The resulting solution contains 2.5 mg/ml TMZ.
Slovenian: Tako pridobljena raztopina vsebuje 2,5 mg/ml TMZ.
English: Dose levels include 100 mg/m 2, 150 mg/m 2, and
Slovenian: Stopnje odmerka so 100 mg/m 2, 150 mg/m 2 in
English: 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.
Slovenian: 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 pri živalih.
English: What Temodal is and what it is used for
Slovenian: Kaj je zdravilo Temodal in za kaj ga uporabljamo
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Slovenian: Odrasli in pediatrični bolniki, stari 3 leta ali več, s ponavljajočim se ali napredujočim malignim gliomom:
English: 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).
Slovenian: Moškim, ki se zdravijo s TMZ, je treba svetovati, naj ne zaplodijo otroka še šest mesecev po prejetem zadnjem odmerku in naj se pred zdravljenjem posvetujejo o možnostih shranjevanja zamrznjene sperme (glejte poglavje 4.6).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: In patients treated with TMZ in clinical trials, the most common adverse reactions were nausea, vomiting, constipation, anorexia, headache, fatigue, convulsions, and rash.
Slovenian: Pri bolnikih, ki so se v kliničnih preizkušanjih zdravili s TMZ, so bili najpogostejši neželeni učinki navzea, bruhanje, zaprtje, anoreksija, glavobol, utrujenost, konvulzije in izpuščaji.
English: It is recommended to seek advice on conservation of sperm prior to treatment.
Slovenian: Priporočamo, da se pred zdravljenjem pozanimate glede možnosti shranjevanja sperme.
English: 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).
Slovenian: 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).
English: It is incompatible with dextrose solutions.
Slovenian: Zdravilo je nekompatibilno z raztopino dekstroze.
English: If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temodal (monotherapy phase).
Slovenian: Če so vam bolezen diagnosticirali na novo, bo zdravljenje potekalo v dveh fazah: - najprej zdravljenje skupaj z radioterapijo (faza sočasnega zdravljenja), - ki ji sledi zdravljenje samo z zdravilom Temodal (faza samostojnega zdravljenja).
English: 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 10
Slovenian: Na 22. dan (21 dni po prvem odmerku) ali v roku 48 ur od navedenega dne, morate pregledati celotno krvno sliko in jo nato spremljati vsak teden, dokler ni ANC > 1,5 x 10
English: In a study of 288 subjects with newlydiagnosed 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.
Slovenian: V študiji pri 288 preiskovancih z novo diagnosticiranim multiformnim glioblastomom se je v prvem ciklu terapije nevtropenija 4. stopnje pojavila pri 3 % žensk in 0 % moških, trombocitopenija 4. stopnje pa pri 1 % žensk in 0 % moških.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Slovenian: Podatki o uporabi TMZ pri bolnikih s hudo jetrno okvaro (razred C po Childu) ali ledvično okvaro, niso na voljo.
English: 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.
Slovenian: 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/m na cikel.
English: A treatment cycle with Temodal lasts 28 days.
Slovenian: Cikel zdravljenja z zdravilom Temodal traja 28 dni.
English: It is very important to check with your doctor or pharmacist if you are not sure.
Slovenian: Zelo pomembno je, da se, če ste negotovi, posvetujete z zdravnikom ali farmacevtom.
English: The dose should be reduced or administration discontinued according to Table 3.
Slovenian: Odmerek zmanjšajte ali zdravljenje ukinite, kot je opisano v tabeli 3.
English: †, herpes simplex, infection reactivation, wound infection, gastroenteritis Neoplasm benign, malignant, and unspecified Uncommon:
Slovenian: †, herpes simplex, reaktivacija okužb, okužbe ran, gastroenteritis Benigne, maligne in neopredeljene novotvorbe
English: VIAL LABEL
Slovenian: OZNAKA NA VIALI
English: Talk to your doctor, pharmacist or nurse before taking Temodal, - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Slovenian: Pred začetkom jemanja zdravila Temodal se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - ker vas mora zdravnik pozorno opazovati zaradi možnosti pojava resne oblike okužbe dihal, imenovane pljučnica zaradi okužbe s Pneumocystis jirovecii (PCP).
English: Very Common side effects (may affect more than 1 in 10 people) are: - loss of appetite, difficulty speaking, headache - vomiting, nausea, diarrhoea, constipation - rash, hair loss - tiredness
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so: - izguba apetita, težave z govorom, glavobol - bruhanje, občutek siljenja na bruhanje, zaprtje - izpuščaj, izpadanje las - utrujenost
English: The appropriate dose of TMZ should be infused intravenously using a pump over a period of 90 minutes.
Slovenian: Ustrezni odmerek TMZ je treba infundirati intravensko, s črpalko, infundiranje pa mora trajati 90 minut.
English: Liver enzymes elevation j, weight decreased, weight increased
Slovenian: zvišane vrednosti jetrnih encimov j, zmanjšanje telesne mase, povečanje telesne mase
English: What you need to know before you use Temodal
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Temodal
English: Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
Slovenian: Zdravilo Temodal 2,5 mg/ml prašek za raztopino za infundiranje dovaja enak odmerek TMZ in zagotavlja enako izpostavljenost TMZ in njegovem aktivnem presnovku, MTIK, kot ustrezne trde kapsule Temodal (glejte poglavje 5.2).
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, erythroderma, skin exfoliation, photosensitivity reaction, urticaria, exanthema, dermatitis, sweating increased, pigmentation abnormal
Slovenian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, angioedem, multiformni eritem, luščenje kože, preobčutljivostne reakcije na svetlobo, urtikarija, eksantem, dermatitis, prekomerno potenje, nenormalna pigmentacija
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Slovenian: Anomalije trombocitov 3. ali 4. stopnje, vključno s trombocitopeničnimi sopojavi, so opažali pri 14 % bolnikov, ki so prejeli TMZ.
English: Pneumonia, dyspnoea, sinusitis, bronchitis, coughing, upper respiratory infection
Slovenian: pljučnica, dispneja, sinusitis, bronhitis, kašelj, okužba zgornjih dihal
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temodal (see also “Male fertility” below).
Slovenian: Bolnice in bolniki, ki jemljejo zdravilo Temodal, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi spodaj Plodnost pri moških).
English: Status epilepticus, hemiplegia, extrapyramidal disorder, parosmia, gait abnormality, hyperaesthesia, sensory disturbance, coordination abnormal
Slovenian: status epilepticus, hemiplegija, ekstrapiramidne motnje, parozmija, nenormalna hoja, hiperestezija, senzorične motnje, motnje koordinacije
English: Powder for solution for infusion 1 vial 100 mg
Slovenian: prašek za raztopino za infundiranje 1 viala 100 mg
English: Ataxia, balance impaired, cognition impaired, concentration impaired, consciousness decreased, dizziness, hypoesthesia, memory impaired, neurologic disorder, neuropathy d, paraesthesia, somnolence, speech disorder, taste perversion, tremor
Slovenian: ataksija, motnje ravnotežja, motnje kognitivnih procesov, motnje koncentracije, motnje zavesti, omotica, hipestezija, motnje spomina, nevrološke motnje, nevropatija d, parestezija, somnolenca, motnje govora, motnje okušanja, tremor
English: capsule shell:
Slovenian: ovojnice kapsul:
English: Temodal 5 mg hard capsules Temodal 20 mg hard capsules Temodal 100 mg hard capsules Temodal 140 mg hard capsules Temodal 180 mg hard capsules Temodal 250 mg hard capsules temozolomide
Slovenian: Temodal 20 mg trde kapsule Temodal 100 mg trde kapsule Temodal 140 mg trde kapsule Temodal 180 mg trde kapsule Temodal 250 mg trde kapsule temozolomid (temozolomidum)
English: After reconstitution: 14 hours at 25 C, including infusion time.
Slovenian: Po rekonstituciji: pri 25 C 14 ur, vključno s časom infundiranja.
English: No infusion site other than a vein is acceptable.
Slovenian: Za infundiranje se ne sme uporabiti nobenega drugega mesta, razen vene.
English: Temodal is also available as a hard capsule formulation (oral use).
Slovenian: Zdravilo Temodal je na voljo tudi v obliki trdih kapsul (za peroralno uporabo).
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count  1.5 x 10
Slovenian: SMT 3. ali 4. stopnje a: Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev  1,5 x 10
English: Convulsions, hemiparesis, aphasia/dysphasia, headache
Slovenian: konvulzije, hemipareza, afazija/disfazija, glavobol
English: There is limited information in patients over 3 years of age who have used Temodal.
Slovenian: Število podatkov pri bolnikih, starejših od 3 let, ki so uporabljali zdravilo Temodal, je omejeno.
English: The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
Slovenian: Trde kapsule za peroralno uporabo so na voljo v rjavih steklenicah s 5 ali 20 kapsulami.
English:  0.5 and < 1.5 x 10
Slovenian:  0,5 in < 1,5 x 10
English: What you need to know before you take Temodal
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Temodal
English: Temodal 2.5 mg/ml powder for solution for infusion, given as an intravenous infusion over 90 minutes, is bioequivalent to the hard capsule formulation (see section 5.2).
Slovenian: Zdravilo Temodal 2,5 mg/ml prašek za raztopino za infundiranje, ki se intravensko infundira 90 min, je biološko ekvivalentno formulaciji v trdih kapsulah (glejte poglavje 5.2).
English: This medicinal product contains 2.4 mmol sodium per vial.
Slovenian: To zdravilo vsebuje 2,4 mmol natrija na vialo.
English:  10 and < 100 x 10
Slovenian:  10 in < 100 x 10
English: - if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Slovenian: - če imate močno zmanjšano število določenih vrst krvnih celic (mielosupresija), kot na primer število levkocitov ali trombocitov.
English: In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Slovenian: Pri bolnikih, starih 3 leta ali več, se TMZ uporablja samo za zdravljenje ponavljajočega se ali napredujočega malignega glioma.
English: In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
Slovenian: Zmanjšanje števila krvnih celic je običajno kratkotrajno, vendar lahko v nekaterih primerih traja dlje časa in lahko vodi do zelo hude oblike anemije (aplastična anemija).
English: There is limited information in patients over 3 years of age who have taken Temodal.
Slovenian: Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temodal, je omejeno.
English: 9/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Slovenian: 9/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.
English: Newly-diagnosed glioblastoma multiforme
Slovenian: Novo diagnosticiran multiformni glioblastom
English: 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.
Slovenian: Analiza populacijske farmakokinetike v preskušanjih 2. faze je pokazala, da sočasna uporaba deksametazona, proklorperazina, fenitoina, karbamazepina, ondansetrona, antagonistov receptorjev H2 ali fenobarbitala ne spremeni očistka TMZ.
English: Temodal is available in a glass vial, with a butyl rubber stopper and aluminium seal with a flip-off bonnet.
Slovenian: Zdravilo Temodal je na voljo v stekleni viali z zamaškom iz butilne gume in aluminijastim tesnilom s pokrovčkom flip-off.
English: Powder for solution for infusion 100 mg
Slovenian: prašek za raztopino za infundiranje 100 mg
English: Skin and subcutaneous tissue disorders Very Common:
Slovenian: Bolezni kože in podkožja Zelo pogosti:
English: The intravenous formulation produced local irritation at the site of injection in both rabbits and rats.
Slovenian: Pri kuncih in podganah je intravenska formulacija povzročala lokalno draženje na mestu injiciranja.
English: In an open-label, two-way crossover bioequivalence study of the pharmacokinetics of oral and intravenous TMZ in patients with primary CNS malignancies, Temodal 2.5 mg/ml powder for solution for infusion administered over 90 minutes was found to be bioequivalent for Cmax and AUC
Slovenian: V odprti, dvosmerni, navzkrižno zasnovani, bioekvivalenčni študiji farmakokinetike peroralnega in intravenskega TMZ pri bolnikih s primarnimi malignomi osrednjega živčevja so ugotovili, da je zdravilo Temodal 2,5 mg/ml prašek za raztopino za infundiranje, ki ga infundirajo 90 minut, biološko ekvivalentno glede vrednosti Cmax in AUC učinkovin TMZ in MTIK, kot zdravilo Temodal trde kapsule po uporabi odmerka 150 mg/m2.
English: During the monotherapy phase, the dose and way you take Temodal will be different.
Slovenian: Med fazo zdravljenja z enim zdravilom bosta odmerek in način odmerjanja zdravila Temodal drugačna.
English: The Temodal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Slovenian: Odmerek zdravila Temodal lahko prestavijo ali zdravljenje prekinejo glede na vašo krvno sliko in na to, kako dobro prenašate zdravilo med fazo sočasnega zdravljenja.
English: 9/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 10
Slovenian: 9/l), v primerjavi s 5 % pri moških, medtem ko je pogostnost trombocitopenije (< 20 x 10
English: TMZ dose levels for monotherapy treatment
Slovenian: Ravni odmerkov TMZ za monoterapijo
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m 2 once daily, to be increased in the second cycle to 200 mg/m 2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Slovenian: Pri bolnikih, ki so že bili zdravljeni s kemoterapijo, je začetni odmerek 150 mg/m 2 enkrat na dan, v drugem ciklu pa se poveča na 200 mg/m 2 enkrat na dan 5 dni, če ni bilo hematoloških toksičnih učinkov (glejte poglavje 4.4).
English: In addition to the side effects listed above, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
Slovenian: Poleg zgoraj navedenih neželenih učinkov se lahko pri uporabi zdravila Temodal prašek za raztopino za infundiranje pojavijo tudi naslednji neželeni učinki: bolečina, draženje, srbenje, občutek toplote, otekanje ali rdečica na mestu infundiranja, tudi modrice (hematom).
English: You may be given other medicines (anti-emetics) to take before and/or after receiving Temodal to prevent or control nausea and vomiting.
Slovenian: Med prejemanjem zdravila Temodal in/ali po njem vam bodo morda dali druga zdravila (antiemetike), ki preprečujejo ali nadzorujejo slabost in bruhanje.
English: - thrombocyte count ≥ 100 x 10
Slovenian: - število trombocitov ≥ 100 x 10
English: 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).
Slovenian: V ločeni študiji 1. faze, sočasna uporaba TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti njegovemu aktivnem presnovku monometiltriazenoimidazol karboksamidu (MTIK).
English: Myopathy, muscle weakness, arthralgia, back pain, musculoskeletal pain, myalgia
Slovenian: miopatija, mišična šibkost, artralgija, bolečine v hrbtu, mišičnoskeletne bolečine, mialgija
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Slovenian: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32 (0)2 776 62 11 dpoc_belux@merck.com
English: 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.
Slovenian: Moškim, ki se zdravijo s TMZ, je treba svetovati, naj ne zaplodijo otroka še šest mesecev po zadnjem prejetem odmerku in naj se zaradi možnosti ireverzibilne neplodnosti zaradi zdravljenja s TMZ pred zdravljenjem posvetujejo o možnostih shranjevanja zamrznjene sperme.
English: Hemianopia, vision blurred, vision disorder e, visual field defect, diplopia, eye pain
Slovenian: hemianopsija, zamegljen vid, motnje vida e, izpad vidnega polja, diplopija, bolečine v očeh
English: Temodal 2.5 mg/ml must be administered by intravenous infusion only over a period of 90 minutes.
Slovenian: Zdravilo Temodal 2,5 mg/ml se sme intravensko infundirati samo v obdobju 90 minut.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temodal to prevent or control nausea and vomiting.
Slovenian: Med jemanjem zdravila Temodal in/ali po njem vam bodo morda dali druga zdravila (antiemetike), ki preprečujejo ali nadzorujejo slabost in bruhanje.
English: Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet.
Slovenian: Viala iz prozornega stekla vrste I, zamašena z zamaškom iz bromobutilne gume in aluminijastim tesnilom z rožnatim pokrovčkom flip-off.
English: A treatment cycle comprises 28 days.
Slovenian: Posamezen cikel zdravljenja traja 28 dni.
English: Deafness f, vertigo, tinnitus, earache
Slovenian: gluhost f, vertigo, tinitus, bolečine v ušesih
English: The active substance is temozolomide.
Slovenian: Učinkovina je temozolomid.
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Slovenian: In vivo je bila razpolovna doba t1/2 za MTIK podobna razpolovni dobi temozolomida, tj. 1,8 ure.
English: Temodal 2.5 mg/ml powder for solution for infusion may be administered in the same IV line with 0.9% Sodium Chloride injection.
Slovenian: Zdravilo Temodal 2,5 mg/ml prašek za raztopino za infundiranje se sme dajati v isto intravensko linijo z injekcijo 0,9% natrijevega klorida.
English: Vaginal haemorrhage, menorrhagia, amenorrhoea, vaginitis, breast pain, impotence General disorders and administration site conditions Very common:
Slovenian: vaginalne krvavitve, menoragija, amenoreja, vaginitis, bolečine v dojkah, impotenca Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) receiving Temodal only:
Slovenian: Bolniki s tumorji, ki so se pojavili znova ali so se poslabšali (maligni gliomi, kot sta multiformni glioblastom ali anaplastični astrocitom) in prejemajo samo zdravilo Temodal:
English: Do not open, crush or chew the capsules.
Slovenian: Kapsul ne smete odpirati, drobiti ali žvečiti.
English: Clinical trial experience
Slovenian: Izkušnje iz kliničnih preizkušanj
English: Each vial contains 100 mg TMZ.
Slovenian: Vsaka viala vsebuje 100 mg TMZ.
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Slovenian: Prekinitev ali ukinitev jemanja TMZ med sočasno radioterapijo in zdravljenjem s TMZ
English: Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty), - uncontrolled bleeding, - seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Slovenian: Če imate katerega koli od naštetih znakov, nemudoma obvestite zdravnika: - huda alergijska (preobčutljivostna) reakcija (koprivnica, piskanje ali druge težave pri dihanju), - nenadzorovana krvavitev, - epileptični napadi (konvulzije), - zvišana telesna temperatura, - mrzlica, - hud neprekinjen glavobol.
English: Do not store above 30 C.
Slovenian: Shranjujte pri temperaturi do 30 C.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:
Slovenian: Bolniki s tumorji, ki so se pojavili znova ali so se poslabšali (maligni gliomi, kot sta multiformni glioblastom ali anaplastični astrocitom) in jemljejo samo zdravilo Temodal:
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Slovenian: Če se kapsula poškoduje, se izogibajte stiku praška z vašo kožo, očmi ali nosom.
English: Excipient with known effect: Each vial contains 2.4 mmol sodium.
Slovenian: Pomožna snov z znanim učinkom: Ena viala vsebuje 2,4 mmol natrija.
English: CTC Grade 3
Slovenian: SMT 3. stopnje
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Slovenian: Pri uporabi TMZ v okviru daljšega režima zdravljenja lahko pride do večje pogostnosti PCP, vendar morate vse bolnike, ki prejemajo TMZ, še posebej tiste, ki prejemajo tudi steroide, skrbno opazovati, da ugotovite morebiten pojav PCP, ne glede na režim zdravljenja.