FrancophonIA/ELRC3.0 huggingface dataset:
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: 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 kateregakoli od naslednjih znakov, se nemudoma obrnite na zdravnika: - huda alergijska (preobčutljivostna) reakcija (koprivnica, hropenje ali druge težave z dihanjem)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o izdelku so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro .
English: In some cases, it may be necessary to stop treatment with Temozolomide SUN. - as you may have a small risk of other changes in blood cells, including leukaemia.
Slovenian: - ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijoče.
English: What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid SUN
English: Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Slovenian: mišična šibkost, artralgija mišična šibkost, artralgija, mišičnoskeletne bolečine, mialgija
English: You will take Temozolomide SUN only once daily for the first 5 days.
Slovenian: Prvih pet dni boste jemali samo zdravilo Temozolomid SUN enkrat dnevno.
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick), constipation (difficulty passing stools), tiredness.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): zmanjšano število krvnih celic (nevtropenija ali limfopenija, trombocitopenija), izguba apetita, glavobol, bruhanje, slabost, zaprtje (težave pri odvajanju blata).
English: If you accidentally get some in your eyes or nose, flush the area with water.
Slovenian: Če pride zdravilo Temozolomid SUN po nesreči v stik z očmi ali nosom, to področje sperite z vodo.
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Slovenian: inkontinenca blata, bolezni prebavil (NOS), gastroenteritis,
English: Erythema multiforme, erythroderma, urticaria, exanthema
Slovenian: multiformni eritem, eritroderma, urtikarija,
English: Hypokalemia, alkaline phosphatase increased, weight increased
Slovenian: hipokaliemija, zvišanje vrednosti alkalne fosfataze,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Slovenian: Zdravilo Temozolomid SUN se najprej uporablja skupaj z obsevanjem (faza sočasnega zdravljenja), nato pa še samostojno (faza monoterapije).
English: Micturition frequency, urinary incontinence
Slovenian: pogosto uriniranje, inkontinenca seča inkontinenca seča
English: Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 127,121 mg laktoze.
English: Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Slovenian: Zdravilo Temozolomid SUN pri zdravljenju na novo diagnosticiranega glioblastoma v kombianciji z obsevanjem
English: disorder, depression, hallucination
Slovenian: halucinacije, amnezija depresija, halucinacije
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Slovenian: pljučnica, okužba zgornjih dihal, kongestija nosne sluznice pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
English: At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44 %) (chi-square p=0.019).
Slovenian: Po 6 mesecih je bil delež preživelih bolnikov statistično značilno večji v skupini, ki je prejemala TMZ (60 %), kot v tisti, ki je prejemala prokarbazin (44 %)
English: - thrombocyte count ≥ 100 x 109/l
Slovenian: - število trombocitov ≥ 100 x 109/l,
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Slovenian: impotenca vaginalne krvavitve, menoragija, amenoreja, vaginitis, bolečine v dojkah
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 popolno okrevanje in 43 delno okrevanje).
English: photosensitivity reaction, pigmentation abnormal abnormal, sweating increased
Slovenian: preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečano znojenje
English: CTC Grade 4b a: TMZ dose levels are listed in Table 2. b: TMZ is to be discontinued if: - dose level -1 (100 mg/m2) still results in unacceptable toxicity
Slovenian: b: TMZ morate ukiniti, če: - raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost
English: (difficulty passing stools), nausea (feeling sick), vomiting, rash, hair loss, tiredness.
Slovenian: (težave pri odvajanju blata), slabost, bruhanje, izpuščaj, izpadanje las, utrujenost.
English: Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
Slovenian: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
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: Temozolomide SUN 20 mg
Slovenian: Temozolomid SUN 20 mg
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Slovenian: Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
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 zdravila TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti njegovemu aktivnemu presnovku,
English: Temozolomide SUN 250 mg
Slovenian: Temozolomid SUN 250 mg
English: Patients receiving Temozolomide SUN in combination with radiotherapy may experience different side effects from patients taking Temozolomide SUN alone.
Slovenian: Bolniki, ki jemljejo zdravilo Temozolomid SUN v kombinaciji z obsevanjem, lahko doživijo drugačne neželene učinke kot tisti, ki jemljejo samo zdravilo Temozolomid SUN. Lahko se pojavijo naslednji neželeni učinki, zaradi katerih bo morda potrebna zdravniška pomoč.
English: Febrile neutropenia, anaemia Lymphopenia, petechiae
Slovenian: febrilna nevtropenija, anemija limfopenija, petehije
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: Excipient with known effect Each hard capsule contains 30.97 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 30,97 mg laktoze.
English: Temozolomide SUN 5 mg
Slovenian: Temozolomid SUN 5 mg
English: Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): gripo podobni simptomi, rdeče lise pod kožo, nizka raven kalija v krvi, pridobivanje telesne teže, nihanja v razpoloženju, halucinacije in motnje spomina, delna paraliza, motena koordinacija, motnje senzorike, delna izguba vida, suhe ali boleče oči, gluhost, okužbe srednjega ušesa, zvonjenje v ušesih, bolečine v ušesih, palpitacije (kadar lahko čutite svoj srčni utrip), krvni strdek v pljučih, visok krvni tlak, pljučnica, vnetje sinusov, bronhitis, prehlad ali gripa, napihnjenost želodca, težave z nadzorom odvajanja blata, hemoroidi, luščenje kože, povečana občutljivost kože za sončno svetlobo, spremenjena barva koža, povečano potenje, mišične poškodbe, bolečine v hrbtu, težave pri uriniranju, krvavitev v nožnici, spolna impotenca, odsotne ali močne menstruacije, razdraženost nožnice, bolečine v dojkah, navali vročine, drgetanje, sprememba barve jezika, spremenjen čut za vonj, žeja, zobne bolezni.
English: Always take Temozolomide SUN exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Temozolomid SUN natančno upoštevajte zdravnikova navodila.
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, očesne bolečine, suhost oči
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Slovenian: nevtropenija ali limfopenija (3. do 4. 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.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksična snov.
English: This is because Temozolomide SUN 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 Temozolomide SUN lahko povzroči ponovno aktivacijo hepatitisa B, kar se lahko v nekaterih primerih konča s smrtnim izidom.
English: Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 163,441 mg laktoze.
English: Sodium starch glycolate (Type B) Tartaric acid
Slovenian: Laktoza Natrijev karboksimetilškrob (tipa B)
English: Capsule shell Gelatin
Slovenian: Stearinska kislina Ovoj kapsule Želatina
English: Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Slovenian: Ena trda kapsula vsebuje 227,001 mg laktoze.
English: The cap is imprinted with ‘891'.
Slovenian: Na pokrovčku je odtisnjena oznaka »891«.
English: Newly-diagnosed glioblastoma multiforme
Slovenian: Novo diagnosticiran multiformni glioblastoma
English: 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: 4 % moških preiskovancev, trombocitopenija 4. stopnje pa pri 8 % žensk in 3 % moških preiskovancev.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Slovenian: miopatija, bolečine v hrbtu, mišičnoskeletne bolečine, mialgija miopatija, bolečine v hrbtu
English: The cap is imprinted with ‘890'.
Slovenian: Na pokrovčku je odtisnjena oznaka »890«.
English: Stearic acid
Slovenian: Vinska kislina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PRETISNI OMOT)
English: Endocrine disorders Uncommon:
Slovenian: Bolezni endokrinega sistema Občasni:
English: hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure
Slovenian: hiperbilirubinemija, holestaza, hepatitis,
English: The cap is imprinted with ‘892'.
Slovenian: Na pokrovčku je odtisnjena oznaka »892«.
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
English: The cap is imprinted with ‘893'.
Slovenian: Na pokrovčku je odtisnjena oznaka »893«.
English: How to take Temozolomide SUN
Slovenian: Kako jemati zdravilo Temozolomid SUN
English: Yellow iron oxide (E172)
Slovenian: Rumeni železov oksid (E172)
English: Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): hujšanje, utrujenost, omotica, občutek mravljinčenja, zasoplost, driska, bolečine v trebuhu, razdražen želodec, izpuščaj, srbenje, izpadanje las, vročina, šibkost, drgetanje, slabo počutje, bolečina, spremenjeno okušanje.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serije Sun Pharmaceutical Industries Europe B.V.
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Slovenian: Če se kapsula poškoduje, pazite, da prašek ne pride v stik s kožo ali sluznico.
English: The body is imprinted with ‘5 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »5 mg« in dve črti.
English: Blue #1/Brilliant Blue FCF Aluminium Lake (E133)
Slovenian: Titanov dioksid (E171) Modro aluminijevo barvilo FCF št.1 (E133)
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Slovenian: hemipareza, ataksija, motnje hemiplegija, ataksija, motnje koordinacije, nenormalna hoja, hiperestezija, senzorične motnje kognitivnih procesov,
English: The body is imprinted with '20 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »20 mg« in dve črti.
English: The body is imprinted with ‘140 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »140 mg« in dve črti.
English: Endocrine disorders*
Slovenian: Bolezni endokrinega sistema
English: Dyspnoea, coughing
Slovenian: disfagija, suha usta
English: Neoplasm benign, malignant and unspecified
Slovenian: podaljšana pancitopenija, aplastična anemija† Benigne, maligne in neopredeljene novotvorbe
English: Other medicines and Temozolomide SUN
Slovenian: Zdravilo Temozolomid SUN
English: Reduction for prior toxicity Dose during Cycle 1
Slovenian: Zmanjšanje zaradi prejšnje toksičnosti Odmerek med 1. ciklom Odmerek med 2. in 6. ciklom brez toksičnosti
English: stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Slovenian: dvojni vid, okvara sluha, zasoplost, kašelj, krvni strdek v nogah, zastajanje tekočine, otekle noge, driska, bolečine v želodcu ali trebuhu, zgaga, razdražen želodec, težave pri požiranju, suha usta, razdražena ali pordečela koža, suha koža, srbenje, oslabelost mišic, boleči sklepi, bolečnost in bolečine v mišicah, pogosto uriniranje, težave pri zadrževanju urina.
English: The body is imprinted with ‘180 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »180 mg« in dve črti.
English: Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Slovenian: - odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom, sočasno z radioterapijo (RT) in pozneje kot monoterapija
English: The body is imprinted with ‘250 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »250 mg« in dve črti.
English: Signs of allergic reaction include itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat.
Slovenian: otekanje obraza, ustnic, jezika ali grla;
English: Anxiety, emotional lability, insomnia
Slovenian: čustvena nestabilnost, nespečnost
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Slovenian: zmedenost, motnje spomina, zmanjšanje miselne zbranosti, nevropatija, parestezije, motnje govora, tremor hemipareza, afazija, motnje ravnotežja, somnolenca,
English: Temozolomide SUN 20 mg hard capsules
Slovenian: Temozolomid SUN 20 mg trde kapsule
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Slovenian: stomatitis, driska, trebušne bolečine, dispepsija, disfagija stomatitis, driska, dispepsija,
English: Temozolomide SUN 250 mg hard capsules
Slovenian: Temozolomid SUN 250 mg trde kapsule
English: Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurred vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea,
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): Okužbe v ustih, okužbe ran, zmanjšano število krvnih celic (nevtropenija, trombocitopenija, limfopenija, levkopenija), povišana raven sladkorja v krvi, hujšanje, sprememba duševnega stanja ali živahnosti, tesnobnost/depresija, zaspanost, težave pri govoru, okvarjeno ravnotežje, omotica, zmedenost, pozabljivost, težave s koncentracijo,
English: Temozolomide SUN 250 mg hard capsules have a white opaque body and cap, imprinted in black ink.
Slovenian: Temozolomid 250 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo s črnim potiskom.
English: Skin exfoliation, photosensitivity reaction, pigmentation abnormal
Slovenian: luščenje kože, preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečano znojenje
English: - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Slovenian: - po zmanjšanju odmerka ponovno nastopi ista nehematološka toksičnost 3. stopnje (z izjemo alopecije, slabosti in bruhanja).
English: Temozolomide SUN 5 mg hard capsules
Slovenian: Temozolomid SUN 5 mg trde kapsule
English: Very rare cases of lung side effects have been observed with Temozolomide SUN.
Slovenian: Pri zdravljenju z zdravilom Temozolomid SUN so opazili zelo redke primere neželenih učinkov na pljuča.
English: The body is imprinted with ‘100 mg' and two stripes.
Slovenian: Na telesu so odtisnjene oznaka »100 mg« in dve črti.
English: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Slovenian: trombocitopenija, anemija, levkopenija
English: Patients with newly-diagnosed glioblastoma multiforme
Slovenian: Bolniki z na novo diagnosticiranim multiformnim glioblastomom
English: Haemorrhage, deep venous thrombosis, oedema leg
Slovenian: krvavitve, edem, edem nog krvavitve, globoka venska tromboza, edem nog
English: SUN Pharma logo
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM SUN Pharma logo
English: Temozolomide SUN 140 mg hard capsules
Slovenian: Temozolomid SUN 140 mg trde kapsule
English: Posology
Slovenian: Oznaka
English: Temozolomide SUN 180 mg hard capsules
Slovenian: Temozolomid SUN 180 mg trde kapsule
English: Temozolomide SUN 20 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 20 mg trde kapsule temozolomid
English: Temozolomide SUN 5 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 5 mg trde kapsule temozolomid
English: Temozolomide SUN 140 mg hard capsules have a white opaque body and cap, imprinted in blue ink.
Slovenian: Temozolomid 140 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo z modrim potiskom.
English: Temozolomide SUN 5 mg hard capsules have a white opaque body and cap, imprinted in green ink.
Slovenian: Temozolomid 5 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo z zelenim potiskom.
English: Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Slovenian: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/ Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
English: Temozolomide SUN 140 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 140 mg trde kapsule temozolomid
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: dokler ni ANC > 1,5 x 109/l in število trombocitov > 100 x 109/l.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Slovenian: ANC ≥ 1,5 x 109/l in število trombocitov ≥ 100 x 109/l.
English: Temozolomide SUN contains a medicine called temozolomide.
Slovenian: Kaj vsebuje zdravilo Temozolomid SUN - Zdravilna učinkovina je temozolomid.
English: Temozolomide SUN 100 mg hard capsules
Slovenian: Temozolomid SUN 100 mg trde kapsule
English: Temozolomide SUN 250 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 250 mg trde kapsule temozolomid
English: Temozolomide SUN 180 mg hard capsules have a white opaque body and cap, imprinted in red ink.
Slovenian: Temozolomid 180 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo z rdečim potiskom.
English: EXP
Slovenian: eksantem
English: See footnote b
Slovenian: PRILOGA I
English: Temozolomide SUN 180 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 180 mg trde kapsule temozolomid
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Slovenian: skupaj 42 dni (do največ 49 dni).
English: Temozolomide SUN 100 mg hard capsules temozolomide
Slovenian: Temozolomid SUN 100 mg trde kapsule temozolomid
English: Anxiety, depression, emotional lability, insomnia
Slovenian: zaskrbljenost, čustvena nestabilnost, nespečnost zaskrbljenost, depresija, čustvena nestabilnost, nespečnost
English: Urinary incontinence
Slovenian: inkontinenca seča inkontinenca seča