FrancophonIA/ELRC3.0 huggingface dataset:
English: Baseline liver function tests should be performed prior to treatment initiation.
Slovenian: Pred uvedbo zdravljenja je treba opraviti osnovne preiskave delovanja jeter.
English: If a capsule is damaged, avoid contact with your skin, eyes or nose.
Slovenian: Če je kapsula poškodovana, se izogibajte stiku s kožo, očmi ali nosom.
English: • bleeding, fluid retention, swollen legs, blood clots
Slovenian: • krvavitev, zastajanje tekočin, otekle noge, krvni strdki
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Slovenian: Dodatek I: povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Slovenian: V času po prihodu zdravila na trg so ugotovili naslednje dodatne resne neželene učinke:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 trdih kapsul
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temozolomide Accord,
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Temozolomid Accord se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksična snov.
English: After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide.
Slovenian: Po 28. dnevu se bo začel nov cikel in spet boste prvih 5 dni enkrat na dan jemali temozolomid, čemur bo sledilo 23 dni brez jemanja temozolomida.
English: Other medicines and Temozolomide Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: • low potassium level in the blood, weight gain
Slovenian: • nizka raven kalija v krvi, pridobivanje telesne mase
English: If a full day has gone by, check with your doctor.
Slovenian: Če je od časa, ko bi morali vzeti vaš odmerek, že minil cel dan, se obrnite na svojega zdravnika.
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42 day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Slovenian: Zaradi tega je pri vseh bolnikih, ki prejemajo TMZ sočasno z RT v 42dnevnem režimu zdravljenja (največ 49 dni), potrebna profilaksa pred PCP ne glede na število levkocitov.
English: Store in the original bottle in order to protect from moisture.
Slovenian: Shranjujte v originalni steklenici za zagotovitev zaščite pred vlago.
English: Experience in these children is very limited (see sections 4.4 and 5.1).
Slovenian: Izkušnje z uporabo tega zdarvila pri otrocih so zelo omejene (glejte poglavji 4.4 in 5.1).
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Slovenian: Po peroralnem dajanju TMZ, označenega s 14C, je bila povprečna vrednost v blato izločenega 14C 7 dni po prvem odmerku 0,8 %, kar kaže na popolno absorpcijo.
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Slovenian: V posledičen nastanek citotoksičnih lezij, je verjetno vpletena motnja mehanizmov za popravilo metilnih aduktov.
English: • infections, wound infection, sore throat, fungal infections in the mouth, cold sores
Slovenian: • okužbe, okužbe ran, boleče grlo, glivične okužbe v ustih, herpes na ustnicah
English: Temozolomide Accord 5 mg hard capsules Temozolomide Accord 20 mg hard capsules Temozolomide Accord 100 mg hard capsules Temozolomide Accord 140 mg hard capsules Temozolomide Accord 180 mg hard capsules Temozolomide Accord 250 mg hard capsules temozolomide
Slovenian: Temozolomid Accord 100 mg trde kapsule Temozolomid Accord 140 mg trde kapsule Temozolomid Accord 180 mg trde kapsule Temozolomid Accord 250 mg trde kapsule temozolomid
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije Accord Healthcare Limited
English: Type III amber glass bottles with polypropylene child-resistant closures and a desiccant, containing 5 or 20 capsules.
Slovenian: Steklenice iz rjavega stekla stopnje hidrolitične odpornosti tipa III, z za otroke varno zaporko iz polipropilena in s sušilnim sredstvom, po 5 ali 20 kapsul.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Slovenian: - Če se pri vas pojavi zvišana telesna temperatura ali razvijete simptome okužbe, se takoj obrnite na zdravnika.
English: Patients with hepatic or renal impairment
Slovenian: Bolniki z okvaro jeter ali ledvic
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDARVILA
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom ali medicinsko sestro.
English: • bloated stomach, difficulty controlling your bowel movements, haemorrhoids (piles)
Slovenian: • napihnjen želodec, težave pri nadzoru iztrebljanja, hemoroidi (zlata žila)
English: Abdominal distension, faecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Slovenian: napihnjenost trebuha, fekalna inkontinenca, bolezni prebavil (NOS), gastroenteritis, hemoroidi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SACHET CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA ZA VREČKE
English: Tell your doctor if you notice any of these symptoms.
Slovenian: Če opazite katerega koli od teh simptomov, to sporočite svojemu zdravniku.
English: You must not breast-feed whilst you are being treated with Temozolomide Accord.
Slovenian: Med zdravljenjem z zdravilom Temozolomid Accord ne smete dojiti.
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Slovenian: Če je kapsula poškodovana, se izogibajte stiku praška s kožo, očmi ali nosom.
English: Endocrine disorders* Uncommon:
Slovenian: Bolezni endokrinega sistema* Občasni:
English: • anxiety, depression, changing emotions, inability to fall asleep or stay asleep,
Slovenian: • tesnoba, depresija, nihanje čustvenega razpoloženja, težave zaspati oziroma spati
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic reactions were observed in 14% of the patients who received TMZ.
Slovenian: Anomalije trombocitov stopnje 3 ali 4, vključno s trombocitopeničnimi učinki, so bile opažene pri 14 % bolnikov, ki so prejemali TMZ.
English: TMZ dose levels for monotherapy treatment
Slovenian: Velikosti odmerkov TMZ za monoterapijo
English: Concomitant phase
Slovenian: Faza sočasnega zdravljenja
English: Very rare cases of lung side effects have been observed with temozolomide.
Slovenian: Pri uporabi temozolomida so opazili zelo redke primere neželenih učinkov, ki so se odrazili na pljučih.
English: 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.
Slovenian: V študiji pri 288 bolnikih z novo diagnosticiranim multiformnim glioblastomom se je v prvem ciklu zdravljenja nevtropenija stopnje 4 pojavila pri 3 % bolnic in 0 % bolnikov, trombocitopenija stopnje 4 pa pri 1 % bolnic in 0 % bolnikov.
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Slovenian: mišična šibkost, artralgija mišična šibkost, artralgija, bolečina v mišicah in kosteh, mialgija
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 109/l and platelet count > 100 x 109/l.
Slovenian: Na 22. dan (21 dni po prvem odmerku) ali v 48 urah od tega dne je treba preveriti celotno krvno sliko ter nato preverjati tedensko, dokler je absolutno število nevtrofilcev ≥1.5 x 109/l in število trombocitov ≥ 100 x 109/l.
English: 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).
Slovenian: Pri bolnikih, ki so prejemali TMZ sočasno z RT v pilotnem preskušanju s podaljšanim 42-dnevnim zdravljenjem, se je izkazalo, da obstaja posebej veliko tveganje za razvoj pljučnice, ki jo povzroča Pneumocystis jirovecii (PCP).
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Slovenian: Jemanje odmerkov TMZ se lahko nadaljuje ves čas 42-dnevnega obdobja sočasnega zdravljenja (do 49 dni), če so izpolnjeni vsi od naslednjih pogojev: - absolutno število nevtrofilcev (AŠN) ≥1,5 x 109/l, - število trombocitov ≥100 x 109/l, - skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ stopnje 1 (razen alopecije, slabosti in bruhanja).
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Slovenian: - absolutno število nevtrofilcev (AŠN) ≥1,5 x 109/l, - število trombocitov ≥100 x 109/l, - skupna merila toksičnosti (SMT) za nehematološko toksičnost ≤ stopnje 1 (razen alopecije,
English: System organ class TMZ + concomitant RT n=288*
Slovenian: Organski sistem TMZ + sočasna RT
English: Nausea and vomiting are very commonly associated with TMZ.
Slovenian: S TMZ sta zelo pogosto povezana slabost in bruhanje.
English: If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Slovenian: Če bolnik po zaužitju odmerka bruha, isti dan ne sme vzeti drugega odmerka.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Discontinue TMZ
Slovenian: Prenehajte z dajanjem TMZ
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Slovenian: SMT za nehematološko toksičnost (razen alopecije, slabosti, bruhanja)
English: 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.
Slovenian: V 6-ciklični študiji pri podganah so opažali vrsto neoplazem vključno s karcinomi dojk, keratokantomom kože in adenomom bazalnih celic, medtem ko pri psih niso opažali tumorjev ali preneoplastičnih sprememb.
English: • skin irritation or redness, dry skin, itching
Slovenian: • razdraženost kože ali rdečica, suha koža, srbenje
English: • sores or ulcers in the mouth, diarrhoea, stomach pain, heartburn, difficulty swallowing, dry mouth
Slovenian: • razjede ali rane v ustih, driska, bolečine v želodcu, zgaga, težave s požiranjem, suha usta
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Slovenian: Če se kapsula poškoduje, se je treba izogibati stiku praška s kožo ali sluznicami.
English: If you are pregnant or, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdarvnikom ali farmacevtom, preden vzamete zdravilo.To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temozolomid Accord, razen če vam ga je izrecno predpisal vaš zdravnik.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children, preferably in a locked cupboard.
Slovenian: peroralna uporaba POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom, najbolje v zaklenjeni omarici.
English: You will take the capsules once daily for the first five days (“dosing days”) followed by 23 days without temozolomide, adding up to the 28 day treatment cycle.
Slovenian: Kapsule boste prvih 5 dni vsakega cikla ('dnevi jemanja') jemali enkrat na dan, nato pa 23 dni ne boste jemali temozolomida; ti obdobji skupaj tvorita 28-dnevni cikel zdravljenja.
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Slovenian: impotenca vaginalna krvavitev, menoragija, amenoreja, vaginitis, bolečine v dojkah
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Slovenian: Občasno so poročali o novih ali ponovnih (ponavljajočih se) okužbah s citomegalovirusom in ponovnih okužbah z virusom hepatitisa B. Občasno so poročali o primerih možganskih okužb, ki jih povzroča herpesvirus (herpetični meningoencefalitis), vključno s smrtnimi primeri.
English: Treatment-emergent reactions during concomitant and monotherapy treatment phases in patients with newly diagnosed glioblastoma multiforme System organ class TMZ + concomitant RT
Slovenian: Neželene reakcije med sočasnim zdravljenjem in med monoterapijo pri bolnikih z novo diagnosticiranim multiformnim glioblastomom Organski sistem TMZ + sočasna RT n=288*
English: You will take your new dose of temozolomide capsules initially at 150 mg/m² once daily for the first five days (“dosing days”) of each cycle, followed by 23 days without temozolomide; this adds up to a 28 day treatment cycle.
Slovenian: Najprej boste jemali kapsule temozolomida v odmerkih po 150 mg/m² enkrat na dan, in sicer prvih 5 dni vsakega cikla ('dnevi jemanja'), nato pa 23 dni ne boste jemali temozolomida; ti obdobji skupaj tvorita 28-dnevni cikel zdravljenja.
English: 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.
Slovenian: V prvem ciklu zdravljenja je bila pri ženskah opažena večja pojavnost nevtropenije stopnje 4 (absolutno število nevtrofilcev < 0,5 x 109/l), in sicer pri 12 % v primerjavi s 5 % pri moških ter trombocitopenije (< 20 x 109/l) pri 9 % v primerjavi s 3 % pri moških.
English: 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).
Slovenian: Bolniki, ki še niso bili zdravljeni s kemoterapijo, jemljejo TMZ peroralno v odmerkih 200 mg/m2 enkrat na dan prvih 5 dni cikla, čemur sledi 23 dni brez jemanja zdravila (skupno 28 dni).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Slovenian: Pri bolnikih, ki so bili zdravljeni s TMZ, so poročali o poškodbi jeter vključno z odpovedjo jeter s smrtnim izidom (glejte poglavje 4.8).
English: Recurrent or progressive malignant glioma
Slovenian: Ponovljen ali napredovali maligni gliom
English: Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath
Slovenian: Zaspanost, omotica, zbadanje, driska, bolečine v želodcu, prebavne motnje, izpuščaj, srbenje, izpadanje las, izguba telesne mase, vročina, slabotnost, drgetanje, slabo počutje, bolečina, spremembe okusa, kratka sapa.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Slovenian: SMT za nehematološka toksičnost (razen za alopecijo, slabost, bruhanje) SMT stopnje 2
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: Patients should be advised to keep capsules out of thesight and reach of children, preferably in a locked cupboard.
Slovenian: Bolnikom je treba svetovati, naj zdravilo shranjujejo nedosegljivo otrokom, najbolje v zaklenjeni omarici.
English: Blood and lymphatic system disorders Very rare:
Slovenian: Bolezni krvi in limfatičnega sistema Zelo redko:
English: Skin and subcutaneous tissue disorders Very rare:
Slovenian: Bolezni kože in podkožja Zelo redko:
English: Respiratory, thoracic and mediastinal disorders Very rare:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo redko:
English: 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.
Slovenian: V naboru podatkov 400 bolnikov s ponovljenim gliomom se je v prvem ciklu zdravljenja nevtropenija stopnje 4 pojavila pri 8 % bolnic in 4 % bolnikov, trombocitopenija stopnje 4 pa se je pojavila pri 8 % bolnic in 3 % bolnikov.
English: Do not open, crush or chew the capsules.
Slovenian: Kapsul ne odpirajte, drobite ali žvečite.
English: This is because Temozolomide Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: - Če ste kdaj bili ali ste okuženi s hepatitisom B. Zdravilo Temozolomid Accord lahko povzroči ponovno aktivacijo hepatitisa B, kar se lahko v nekaterih primerih konča s smrtnim izidom.
English: Do not open, crush or chew the capsules, swallow whole.
Slovenian: Kapsul ne odpirajte, drobite ali žvečite, temveč jih pogoltnite cele.
English: Table 4 provides treatment-emergent adverse reactions in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Slovenian: Preglednica 4 prikazuje neželene reakcije, ki so nastopile med zdravljenjem bolnikov z novo diagnosticiranim multiformnim glioblastomom med fazo sočasnega zdravljenja in v fazi monoterapije.
English: Summary of events reported with temozolomide in the post-marketing setting*
Slovenian: Tabelarični seznam s temozolomidom povezanih dogodkov, o katerih so poročali po prihodu zdravila na trg *
English: Hyperglycaemia, weight decreased
Slovenian: hiperglikemija, zmanjšana telesna masa zmanjšana telesna masa
English: Cough.
Slovenian: Kašelj.
English: - Once you take the medicine home, if you are confused or unsure about how to take your dose, call for re-instruction before beginning the treatment cycle.
Slovenian: - Ko jemljete zdravilo doma, pred začetkom cikla pokličite svojega zdravnika ali farmacevta in se prepričajte o pravilnem jemanju odmerka, če imate kakršnekoli dvome.
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki (pojavijo se največ pri 1 od 10.000 bolnikov):
English: printing ink: shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.
Slovenian: šelak, propilenglikol, črni železov oksid (E172) in kalijev hidroksid.
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Slovenian: hemianopsija, zmanjšana ostrina vida, motnje vida, motnje vidnega polja, bolečina v očeh zmanjšana ostrina vida, bolečina v očeh, suhe oči
English: Treatment-emergent reactions during concomitant and monotherapy treatment phases in patients with newly diagnosed glioblastoma multiforme
Slovenian: Neželene reakcije med sočasnim zdravljenjem in med monoterapijo pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
English: Adult patients with newly-diagnosed glioblastoma multiforme:
Slovenian: Odrasli bolniki z novo diagnosticiranim multiformnim glioblastomom:
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Vsebina kapsule: brezvodna laktoza, koloidni brezvodni silicijev dioksid, natrijev karboksimetilškrob (vrsta A), vinska kislina, stearinska kislina
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Slovenian: Neželeni učinki pri bolnikih s ponovljenim ali napredovalim malignim gliomom
English: Temozolomide Accord should be administered in the fasting state.
Slovenian: Zdravilo Temozolomid Accord je treba jemati na tešče.
English: In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Slovenian: Pri bolnikih, ki so predhodno že prejemali kemoterapijo in so imeli indeksom kliničnega stanja po Karnofskyju ≥ 80, so se pokazali koristni učinki zdravljenja.
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Slovenian: pljučnica, okužba zgornjih dihal, zamašen nos pljučnica, sinuzitis, okužba zgornjih dihal, bronhitis
English: INFORMATION IN BRAILLE Temozolomide 250mg
Slovenian: PODATKI V BRAILLOVI PISAVI Temozolomid 250 mg
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovenian: stomatitis, driska, bolečina v trebuhu, dispepsija, disfagija stomatitis, driska, dispepsija, disfagija, suha usta
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Slovenian: luščenje kože, preobčutljivostna reakcija na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečan potenje
English: liver enzymes elevations, hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Slovenian: zvišanje vrednosti jetrnih encimov, hiperbilirubinemija, holestaza, hepatitis poškodba jeter, odpoved jeter†
English: - children 3 years and older and adult patients with specific forms of brain tumour (e.g. glioblastoma multiforme or anaplastic.
Slovenian: - Otrok od 3 leta dalje in odraslih bolnikov s posebnimi oblikami možganskih tumorjev (npr. multiformni glioblastom ali anaplastični astrocitom), ki so se ponovili oziroma v primerih, ko se je rak po običajnem zdravljenju razširil.
English: Propylene glycol Black iron oxide (E172) Potassium hydroxide
Slovenian: Črnilo za tisk šelak propilenglikol črni železov oksid (E172) kalijev hidroksid
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Slovenian: • po zmanjšanju odmerka še vedno nastopi enaka nehematološka toksičnost 3. stopnje (razen alopecije, slabosti, bruhanja).
English: The safety of TMZ in children under the age of 3 years has not been established.
Slovenian: Varnost TMZ pri otrocih, mlajših od 3 let ni bila dokazana.
English: SPECIAL STORAGE CONDITIONS Do not store above 25ºC.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C.
English: Somnolence, dizziness, paresthesia Respiratory, thoracic and mediastinal disorders Common:
Slovenian: somnolenca, omotica, parestezija Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
English: Temozolomide Accord 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Slovenian: Temozolomid Accord 250 mg trde kapsule: Ena kapsula vsebuje 250 mg temozolomida.
English: • allergic reaction, fever, radiation injury, facial swelling, pain, changes in sense of taste
Slovenian: • alergijska reakcija, vročina, poškodbe zaradi obsevanja, otekline obraza, bolečina, spremembe okusa
English: Hearing impairment, tinnitus
Slovenian: poslabšanje sluha poslabšanje sluha, tinitus