FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you notice any of these symptoms.
Slovenian: Če opazite katerega od teh simptomov, povejte svojemu zdravniku.
English: The cap is imprinted with “TMZ”.
Slovenian: Na kapici je vtisnjen znak „TMZ”.
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Slovenian: Zdravilo Temozolomid Sandoz pri kombiniranem zdravljenju z radioterapijo pri novo diagnosticiranem glioblastomu
English: The body is imprinted with “20”.
Slovenian: Na telesu pa je vtisnjen znak „20”.
English: The body is imprinted with “250”.
Slovenian: Na telesu pa je vtisnjen znak „250”.
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: 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.
English: 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).
Slovenian: 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.
English: • abnormal liver function tests.
Slovenian: • nenormalen okus, • nenormalni izvidi preiskav delovanja jeter.
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Slovenian: Pred jemanjem zdravila morata biti izpolnjena naslednja pogoja za laboratorijske izvide: ANC ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
English: • partial paralysis
Slovenian: • delna paraliza,
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Slovenian: Med RT sta bili potrebni profilaksa proti pljučnici zaradi okužbe s Pneumocystis jirovecii (PCP) in kombinirana terapija s TMZ.
English: Temozolomide Sandoz may cause permanent infertility.
Slovenian: Zdravilo Temozolomid Sandoz lahko povzroči trajno neplodnost.
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: 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.
English: The body is imprinted with “140”.
Slovenian: Na telesu pa je vtisnjen znak „140”.
English: This adds up to a 28-day treatment cycle.
Slovenian: To je skupaj 28 dni v enem ciklu zdravljenja.
English: 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.
Slovenian: 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.
English: Absolute neutrophil count
Slovenian: Absolutno število nevtrofilcev
English: During the concomitant phase, your doctor will start Temozolomide Sandoz at a dose of 75 mg/m2
Slovenian: Med fazo sočasnega zdravljenja vam bo zdravnik začel dajati zdravilo Temozolomid Sandoz v odmerku 75 mg/m2 (običajni odmerek).
English: Very rare cases of lung side effects have been observed with temozolomide.
Slovenian: Pri temozolomidu so opazili zelo redke primere neželenih učinkov na pljučih.
English: Do not open, crush or chew the capsules.
Slovenian: Kapsul ne smete odpirati, zdrobiti ali žvečiti.
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Slovenian: Opažali so mielosupresijo (nevtropenijo in trombocitopenijo), kar so znani toksični učinki večine citotoksičnih snovi, vključno s TMZ, ki tudi omejujejo njihov odmerek.
English: Dose during Cycles 2-6 in absence of toxicity
Slovenian: Odmerek med 1. ciklom Odmerek med 2. in 6 ciklom brez toksičnosti
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 s kožo, očmi ali nosom.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Slovenian: Pred začetkom zdravljenja mora zdravnik natančno preveriti, ali ima bolnik znake te okužbe.
English: • wound infection
Slovenian: • okužbe ran,
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Slovenian: - absolutno število nevtrofilcev (ANC - Absolute Neutrophil Count) ≥ 1,5 x 109/l,
English: • loss of weight
Slovenian: • izguba teka,
English: ≥ 0.5 and < 1.5 x 109/l
Slovenian: ≥ 0,5 in < 1,5 x 109/l
English: 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.
Slovenian: 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.
English: ≥ 10 and < 100 x 109/l
Slovenian: ≥ 10 in < 100 x 109/l
English: • if you have ever had or might now have a hepatitis B infection.
Slovenian: • 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.
English: Palpitation
Slovenian: palpitacije
English: Edvard Thomsens Vej 14 DK-2300 København S
Slovenian: Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S
English: 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.
Slovenian: Če se v preteklosti niste zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Sandoz 200 mg/m2 enkrat na dan prvih 5 dni.
English: Hypokalemia, alkaline phosphatase increased, weight increased
Slovenian: hipokaliemija, zvišanje vrednosti alkalne fosfataze, povečanje telesne mase hiperglikemija, povečanje telesne mase
English: Contact your doctor immediately if you have any of the following:
Slovenian: Če imate katerega koli od naštetih znakov, nemudoma obvestite zdravnika:
English: The major route of 14C elimination is renal.
Slovenian: Zdravilo 14C se izloča predvsem skozi ledvice.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, Sepsis†
Slovenian: okužba s citomegalovirusom, reaktivacija okužbe, npr. citomegalovirus, virus hepatitisa B†, herpetični meningoencefalitis†, sepsa†
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Slovenian: Prekinitev jemanja ali ukinitev TMZ med sočasno radioterapijo in zdravljenjem s TMZ
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, 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).
English: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid
Slovenian: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62 registros.spain@sandoz.com
English: CTC Grade 3 or 4
Slovenian: SMT 3. ali 4. stopnje a:
English: Then, you will start the monotherapy phase.
Slovenian: Nato se bo začela faza zdravljenja z enim zdravilom.
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if:
Slovenian: SMT 4. stopnjab a: Ravni odmerkov TMZ so podane v preglednici 2.
English: This medicine is an antitumour agent.
Slovenian: To je zdravilo proti tumorjem.
English: Colour of the cap
Slovenian: Barva ovojnice
English: In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Slovenian: Pri bolnikih, ki so že prejemali kemoterapijo, so ugotavljali koristne učinke zdravila pri bolnikih z indeksom kliničnega stanja po Karnofskyju ≥ 80.
English: 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).
Slovenian: 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).
English: Somnolence, dizziness, paresthesia
Slovenian: zaspanost, omotica, parestezije
English: Each capsule is approximately 15.8 mm in length.
Slovenian: Dolžina ene kapsule je približno 15,8 mm.
English: Bottle
Slovenian: Steklenica
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: 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.
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
English: Concomitant phase
Slovenian: Faza sočasne terapije
English: ≥ 100 x 10
Slovenian: ≥ 10 in < 100 x 10
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Slovenian: možganske krvavitve, hipertenzija pljučna embolija, edem, periferni edem
English: Hepatotoxicity
Slovenian: Hepatotoksičnost
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Slovenian: 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.
English: Micturition frequency, urinary incontinence Urinary incontinence
Slovenian: pogosto uriniranje, inkontinenca seča inkontinenca seča
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Slovenian: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do
English: Very common:
Slovenian: Zelo pogosti:
English: The bottles also contain a desiccant pouch.
Slovenian: Steklenica vsebuje tudi zavojček sušilnega sredstva.
English: positions of guanine.
Slovenian: - Navodilo shranite.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Slovenian: Po peroralnem jemanju TMZ, označenega s 14C, je bila srednja vrednost količine 14C, izločene v blatu 7 dni po odmerku
English: • difficulty controlling your bowel movements
Slovenian: • težave z nadzorovanjem odvajanja blata,
English: INSTRUCTIONS ON USE
Slovenian: B. NAVODILO ZA UPORABO
English: What Temozolomide Sandoz looks like and contents of the pack
Slovenian: Izgled zdravila Temozolomid Sandoz in vsebina pakiranja
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Slovenian: (pomanjkanje rdečih krvnih celic), zvišana telesna temperatura in zmanjšana odpornost proti okužbam.
English: • impaired coordination
Slovenian: • motnje koordinacije,
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 zdravilo TMZ, še posebej tiste, ki prejemajo tudi steroide, skrbno opazovati, da ugotovite morebiten pojav PCP, ne glede na režim zdravljenja.
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Slovenian: napihnjenost trebuha, inkontinenca blata, bolezni prebavil (NOS), gastroenteritis, hemoroidi
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Slovenian: Neželene reakcije pri bolnikih s ponavljajočim se ali napredujočim malignim gliomom
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: za TMZ, je bila približno 30 % tiste v plazmi, kar je v skladu s podatki, ki so jih dobili pri živalih.
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Slovenian: V obdobju trženja zdravila so ugotovili dodatne resne neželene učinke, in sicer:
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
Slovenian: Po ugotovitvi osrednjega ocenjevalca je bil delež odziva v populaciji, ki so jo želeli zdraviti (ITT, n=162) 35 % (13
English: Agitation, apathy, behaviour disorder, depression, hallucination
Slovenian: vznemirjenost, apatija, vedenjske motnje, depresija, halucinacije halucinacije, amnezija
English: • reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
Slovenian: • zmanjšano število krvnih celic (nevtropenija, trombocitopenija, limfopenjia, levkopenija),
English: K.Valdemāra 33 - 30
Slovenian: K.Valdemāra 33 - 30 LV-1010 Rīga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA, KI VSEBUJE VREČKO
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Slovenian: Pri bolnikih, ki prejemajo TMZ, zlasti v kombinaciji z deksametazonom ali drugimi steroidi, so poročali o respiratorni odpovedi s smrtnim izidom.
English: 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).
Slovenian: Pneumocystis jirovecii) in reaktivacijo okužb (npr. HBV, CMV) (glejte poglavje 4.8).
English: • confusion
Slovenian: • zmedenost,
English: • breast pain
Slovenian: • trebušne bolečine,
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Slovenian: kongestija nosne sluznice pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
English: Remarks Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity Table 3.
Slovenian: Odmerek med 1. ciklom Odmerek med 2. in 6. ciklom brez toksičnosti
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja
English: Anti-emetic therapy
Slovenian: Antiemetično zdravljenje
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 150 mg/m2 once daily for the first
Slovenian: Če ste se v preteklosti zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Sandoz 150 mg/m2 enkrat na dan prvih 5 dni.
English: Hepatic injury, including fatal hepatic failure, has been reported in patients treated with TMZ (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s TMZ, so poročali o poškodbah jeter, vključno z odpovedjo jeter s smrtnim izidom (glejte poglavje 4.8).
English: • severe headache that does not go away.
Slovenian: • hud neprekinjen glavobol.
English: • inability to fall asleep or stay asleep
Slovenian: • nezmožnost zaspati ali zbujanje ponoči, • občutek mravljincev,
English: Metabolism and nutrition disorders Very common:
Slovenian: Presnovne in prehranske motnje Zelo pogosti:
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01AX03 Mechanism of action
Slovenian: Farmakoterapevtska skupina: Antineoplastična zdravila - Drugi alkilirajoči citostatiki, oznaka ATC:
English: Reduction for prior toxicity Dose during Cycle 1
Slovenian: Zmanjšanje zaradi prejšnje toksičnosti
English: The body is imprinted with “100”.
Slovenian: Na telesu pa je vtisnjen znak „100”.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Slovenian: V nastanek citotoksičnih lezij je verjetno vpletena motnja mehanizmov za popravilo metilnih aduktov.
English: • how many capsules you need to take every dosing day.
Slovenian: Pomembno je, da v celoti razumete ali si zapomnite naslednje: • koliko kapsul morate vzeti vsak dan jemanja.
English: • pneumonia
Slovenian: • pljučnica,
English: Novartis (Hellas) S.A.C.I 18, Kifisias Ave. & Gyzi, 151 25 Marousi, Athens Τηλ: +30 216 6005011 regulatory.greece@sandoz.com
Slovenian: Novartis (Hellas) S.A.C.I 18, Kifisias Ave. & Gyzi, 151 25 Marousi, Athens
English: You might be more prone to infections, bruising or bleeding.
Slovenian: • če ste starejši od 70 let, boste bolj dovzetni za okužbe, modrice ali krvavitve.
English: Convulsions were reported very commonly in the newly-diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Slovenian: Pri bolnikih z novo diagnosticiranim multiformnim glioblastomom na monoterapiji so zelo pogosto poročali o konvulzijah, medtem ko je bil izpuščaj opisan zelo pogosto pri bolnikih z novo diagnosticiranim multiformnim glioblastomom, ki so prejemali TMZ sočasno z RT, ter pri tistih, ki so zdravilo prejemali v obliki monoterapije, pogosto pa pri tistih s ponavljajočim se gliomom.
English: • swollen stomach
Slovenian: • napihnjenost želodca,
English: You will take Temozolomide Sandoz alone once daily for the first 5 days.
Slovenian: Prvih 5 dni boste jemali samo zdravilo Temozolomid Sandoz enkrat na dan.
English: • discolouration of your tongue
Slovenian: • drgetanje, • obarvanje jezika,
English: • inflammation of your sinuses
Slovenian: • vnetje sinusov,
English: Nausea and vomiting are very commonly associated with TMZ.
Slovenian: Z jemanjem TMZ sta zelo pogosto povezana slabost in bruhanje.
English: Hyperglycaemia, weight increased
Slovenian: hiperglikemija, hujšanje hujšanje
English: • in adults with newly-diagnosed glioblastoma multiforme.
Slovenian: • pri odraslih bolnikih z novo diagnosticiranim multiformnim glioblastomom.
English: Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
Slovenian: hemianopija, zmanjšana ostrina vida, motnje vida, izpad vidnega polja, očesne bolečine zmanjšana ostrina vida,
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: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Slovenian: mišična šibkost, artralgija mišična šibkost, artralgija, mišičnoskeletne bolečine,
English: TMZ dose levels for monotherapy treatment
Slovenian: Ravni odmerkov TMZ za monoterapijo Raven odmerka
English: General disorders and administration site conditions Very common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Slovenian: Zmanjšanje odmerka ali ukinitev zdravila TMZ med monoterapijo
English: • abnormal or blurry vision
Slovenian: • nenormalen ali zamegljen vid,
English: Each hard capsule contains 131.4 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 131,4 mg brezvodne laktoze.
English: Each hard capsule contains 73 mg of anhydrous lactose.
Slovenian: Ena trda kapsula vsebuje 73 mg brezvodne laktoze.
English: Recurrent or progressive malignant glioma
Slovenian: Ponavljajoči se ali napredujoči maligni gliom
English: • reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia)
Slovenian: • zmanjšano število krvnih celic (nevtropenija ali limfopenija, trombocitopenija),
English: Skin and subcutaneous tissue disorders Common:
Slovenian: Bolezni kože in podkožja Common:
English: 9/l, and the thrombocyte count is ≥ 100 x 109/l.
Slovenian: 9/l in število trombocitov ≥ 100 x 10
English: If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Slovenian: Če po zaužitju odmerka bruha, ne sme še isti dan vzeti drugega odmerka.
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Slovenian: Pri obeh indikacijah so o večini hematoloških neželenih reakcij poročali pogosto ali zelo pogosto (preglednici 4 in 5).
English: Each capsule is approximately 21.4 mm in length.
Slovenian: Dolžina ene kapsule je približno 21,4 mm.
English: In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Slovenian: V obdobju trženja so pri bolnikih, ki so prejemali TMZ v kombinaciji z radioterapijo, vključno s primeri sočasnega dajanja steroidov, opazili primere herpetičnega meningoencefalitisa (vključno s smrtnimi primeri).
English: CTC non-haematological Toxicity (except for alopecia, nausea, vomiting)
Slovenian: SMT za nehematološko toksičnost (z izjemo alopecije, slabosti in bruhanja)
English: Each capsule is approximately 11.4 mm in length.
Slovenian: Dolžina ene kapsule je približno 11,4 mm.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 2
Slovenian: SMT za nehematološko toksičnost (z izjemo alopecije, slabosti in bruhanja) SMT 2. stopnje
English: RegAffairs.ro@sandoz.com
Slovenian: regulatory.greece@sandoz.com
English: Myopathy, back pain, musculoskeletal pain, myalgia
Slovenian: miopatija, bolečine v hrbtu, mišičnoskeletne bolečine,
English: • constipation (difficulty passing stools)
Slovenian: • zaprtje (težko odvajanje blata),
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Slovenian: V preglednici 4 so navedeni neželeni učinki, ki so nastopili med zdravljenjem pri bolnikih z novo diagnosticiranim multiformnim glioblastomom med fazo sočasne terapije in fazo monoterapije.
English: 23 %, respectively.
Slovenian: posnetkov, je bila 8 %.
English: If you accidentally take more Temozolomide Sandoz capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Temozolomid Sandoz, kot bi smeli Če pomotoma vzamete preveč kapsul Temozolomid Sandoz, se takoj posvetujte zdravnikom,