natgillin/translations-raw huggingface dataset:
Reduce TMZ by 1 dose levela
Zmanjšajte odmerek TMZ
Titanium dioxide (E171)
Želatina Titanov dioksid (E171)
Titanium dioxide (E171) Sodium laurilsulfate
Titanov dioksid (E171) Natrijev lavrilsulfat
What Temozolomide SUN looks like and contents of the pack
Izgled zdravila Temozolomid SUN in vsebina pakiranja
Dermatitis, dry skin, erythema, pruritus
dermatitis, suha koža, eritem,
- in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
- pri otrocih, starih 3 leta ali več, in pri odraslih bolnikih z malignega glioma, na primer multiformnega glioblastoma ali anaplastičnega astrocitoma.
The objective response rate (ORR) based on MRI scans was 8 %.
Objektivno ugotovljena stopnja odzivanja bolnikov na zdravljenje določena na podlagi NMR posnetkov, je bila 8 %.
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Zmanjšanje odmerka ali ukinitev zdravila TMZ med monoterapijoToksičnost Toksičnost
The cap is imprinted with ‘929'.
Na pokrovčku je odtisnjena oznaka »929«.
5x1 hard capsule 20x1 hard capsule
20x1 trdih kapsul
Agitation, apathy, behaviour
vznemirjenost, apatija, vedenjske motnje,
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 - the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
SMT stopnja 4b a: Ravni odmerkov TMZ so podane v preglednici 2. b: TMZ morate ukiniti, če: raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost po zmanjšanju odmerka ponovno nastopi ista nehematološka toksičnost 3. stopnje (z izjemo alopecije, slabosti in bruhanja).
- The active substance is temozolomide.
- Zdravilna učinkovina je temozolomid.
The cap is imprinted with ‘930'.
Na pokrovčku je odtisnjena oznaka »930«.
Convulsions were reported very commonly in the newlydiagnosed 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.
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.
Take the missed dose as soon as possible during the same day.
drugega odmerka ne vzemite istega dne.
If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days.
Če ste se že zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomid SUN 150 mg/m2 enkrat dnevno.
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.
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,
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.
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.
If you have not been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days.
Če se še nikoli niste zdravili s kemoterapijo, bo prvih pet dni vaš odmerek zdravila Temozolomid SUN 200 mg/m2 enkrat dnevno.
For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.
Pakiranje z 20 kapsulami je pakirano v škatlo s 4 pretisnimi omoti po 5 kapsul.
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
In vivo je bila razpolovna doba t1/2 za MTIK podobna razpolovni dobi temozolomida, t.j.
Propylene glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
Rdeči železov oksid (E172) Rumeni železov oksid (E172) Titanov dioksid (E171)
- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
- otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Če opazite kakršnokoli spremembo v videzu kapsul, obvestite farmacevta.
Otitis media, tinnitus, hyperacusis, earache
otitis media, tinitus,
Excipient with known effect Each hard capsule contains 18.16 mg of lactose.
Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 18,16 mg laktoze.
Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
AST *Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
Excipient with known effect Each hard capsule contains 90.801 mg of lactose.
Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 90,801 mg laktoze.
Blood and lymphatic system disorders Very common:
Bolezni krvi in limfatičnega sistema Pogosti:
This medicine is an antitumour agent.
To je protitumorsko zdravilo.
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.
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.
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.
Če imate kateregakoli od naslednjih znakov, se nemudoma obrnite na zdravnika: - huda alergijska (preobčutljivostna) reakcija (koprivnica, hropenje ali druge težave z dihanjem)
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o izdelku so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro .
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.
- ker morda obstaja manjše tveganje za druge spremembe krvnih celic, vključno z levkemijoče.
What you need to know before you take Temozolomide SUN Do not take Temozolomide SUN
Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid SUN
Muscle weakness, arthralgia Muscle weakness, arthralgia, musculoskeletal pain, myalgia
mišična šibkost, artralgija mišična šibkost, artralgija, mišičnoskeletne bolečine, mialgija
You will take Temozolomide SUN only once daily for the first 5 days.
Prvih pet dni boste jemali samo zdravilo Temozolomid SUN enkrat dnevno.
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.
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).
If you accidentally get some in your eyes or nose, flush the area with water.
Če pride zdravilo Temozolomid SUN po nesreči v stik z očmi ali nosom, to področje sperite z vodo.
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
inkontinenca blata, bolezni prebavil (NOS), gastroenteritis,
Erythema multiforme, erythroderma, urticaria, exanthema
multiformni eritem, eritroderma, urtikarija,
Hypokalemia, alkaline phosphatase increased, weight increased
hipokaliemija, zvišanje vrednosti alkalne fosfataze,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Zdravilo Temozolomid SUN se najprej uporablja skupaj z obsevanjem (faza sočasnega zdravljenja), nato pa še samostojno (faza monoterapije).
Micturition frequency, urinary incontinence
pogosto uriniranje, inkontinenca seča inkontinenca seča
Excipient with known effect Each hard capsule contains 127.121 mg of lactose.
Ena trda kapsula vsebuje 127,121 mg laktoze.
Temozolomide SUN in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Zdravilo Temozolomid SUN pri zdravljenju na novo diagnosticiranega glioblastoma v kombianciji z obsevanjem
disorder, depression, hallucination
halucinacije, amnezija depresija, halucinacije
Pneumonia, sinusitis, upper respiratory infection, bronchitis
pljučnica, okužba zgornjih dihal, kongestija nosne sluznice pljučnica, sinusitis, okužba zgornjih dihal, bronhitis
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).
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 %)
- thrombocyte count ≥ 100 x 109/l
- število trombocitov ≥ 100 x 109/l,
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
impotenca vaginalne krvavitve, menoragija, amenoreja, vaginitis, bolečine v dojkah
Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n=162.
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).
photosensitivity reaction, pigmentation abnormal abnormal, sweating increased
preobčutljivostne reakcije na svetlobo, nenormalna pigmentacija eritem, nenormalna pigmentacija, povečano znojenje
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
b: TMZ morate ukiniti, če: - raven odmerka -1 (100 mg/m2) še vedno povzroči nesprejemljivo toksičnost
(difficulty passing stools), nausea (feeling sick), vomiting, rash, hair loss, tiredness.
(težave pri odvajanju blata), slabost, bruhanje, izpuščaj, izpadanje las, utrujenost.
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
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.
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).
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Neželeni učinki, ki so nastopili med zdravljenjem med fazo sočasne in monoterapije pri bolnikih z novo diagnosticiranim multiformnim glioblastomom
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).
V ločeni študiji 1. faze sočasna uporaba zdravila TMZ in ranitidina ni povzročila spremembe obsega absorpcije temozolomida ali izpostavljenosti njegovemu aktivnemu presnovku,
Patients receiving Temozolomide SUN in combination with radiotherapy may experience different side effects from patients taking Temozolomide SUN alone.
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.
Febrile neutropenia, anaemia Lymphopenia, petechiae
febrilna nevtropenija, anemija limfopenija, petehije
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.
Pri obeh indikacijah so o večini hematoloških neželenih reakcij poročali pogosto ali zelo pogosto (preglednici 4 in 5).
Excipient with known effect Each hard capsule contains 30.97 mg of lactose.
Ena trda kapsula vsebuje 30,97 mg laktoze.
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.
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.
Always take Temozolomide SUN exactly as your doctor has told you.
Pri jemanju zdravila Temozolomid SUN natančno upoštevajte zdravnikova navodila.
Hemianopia, visual acuity reduced, vision disorder, visual field defect, eye pain
hemianopija, zmanjšana ostrina vida, motnje vida, izpad vidnega polja, očesne bolečine zmanjšana ostrina vida, očesne bolečine, suhost oči
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
nevtropenija ali limfopenija (3. do 4. stopnje)
However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
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.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksična snov.
This is because Temozolomide SUN could cause hepatitis B to become active again, which can be fatal in some cases.
- 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.
Excipient with known effect Each hard capsule contains 163.441 mg of lactose.
Ena trda kapsula vsebuje 163,441 mg laktoze.
Sodium starch glycolate (Type B) Tartaric acid
Laktoza Natrijev karboksimetilškrob (tipa B)
Capsule shell Gelatin
Stearinska kislina Ovoj kapsule Želatina
Excipient with known effect Each hard capsule contains 227.001 mg of lactose.
Ena trda kapsula vsebuje 227,001 mg laktoze.
The cap is imprinted with ‘891'.
Na pokrovčku je odtisnjena oznaka »891«.
Newly-diagnosed glioblastoma multiforme
Novo diagnosticiran multiformni glioblastoma
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.
4 % moških preiskovancev, trombocitopenija 4. stopnje pa pri 8 % žensk in 3 % moških preiskovancev.
Myopathy, back pain, musculoskeletal pain, myalgia
miopatija, bolečine v hrbtu, mišičnoskeletne bolečine, mialgija miopatija, bolečine v hrbtu
The cap is imprinted with ‘890'.
Na pokrovčku je odtisnjena oznaka »890«.
Stearic acid
Vinska kislina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BLISTER)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (PRETISNI OMOT)
Endocrine disorders Uncommon:
Bolezni endokrinega sistema Občasni:
hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure
hiperbilirubinemija, holestaza, hepatitis,
The cap is imprinted with ‘892'.
Na pokrovčku je odtisnjena oznaka »892«.
Respiratory, thoracic and mediastinal disorders Common:
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
The cap is imprinted with ‘893'.
Na pokrovčku je odtisnjena oznaka »893«.
How to take Temozolomide SUN
Kako jemati zdravilo Temozolomid SUN
Yellow iron oxide (E172)
Rumeni železov oksid (E172)
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.
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.
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca, odgovornega za sproščanje serije Sun Pharmaceutical Industries Europe B.V.
If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Če se kapsula poškoduje, pazite, da prašek ne pride v stik s kožo ali sluznico.
The body is imprinted with ‘5 mg' and two stripes.
Na telesu so odtisnjene oznaka »5 mg« in dve črti.
Blue #1/Brilliant Blue FCF Aluminium Lake (E133)
Titanov dioksid (E171) Modro aluminijevo barvilo FCF št.1 (E133)
Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
hemipareza, ataksija, motnje hemiplegija, ataksija, motnje koordinacije, nenormalna hoja, hiperestezija, senzorične motnje kognitivnih procesov,
The body is imprinted with '20 mg' and two stripes.
Na telesu so odtisnjene oznaka »20 mg« in dve črti.
The body is imprinted with ‘140 mg' and two stripes.
Na telesu so odtisnjene oznaka »140 mg« in dve črti.
Endocrine disorders*
Bolezni endokrinega sistema
Dyspnoea, coughing
disfagija, suha usta
Neoplasm benign, malignant and unspecified
podaljšana pancitopenija, aplastična anemija† Benigne, maligne in neopredeljene novotvorbe
Other medicines and Temozolomide SUN
Zdravilo Temozolomid SUN
Reduction for prior toxicity Dose during Cycle 1
Zmanjšanje zaradi prejšnje toksičnosti Odmerek med 1. ciklom Odmerek med 2. in 6. ciklom brez toksičnosti
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.
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.
The body is imprinted with ‘180 mg' and two stripes.
Na telesu so odtisnjene oznaka »180 mg« in dve črti.
Temozolomide SUN is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
- odraslih bolnikov z novo diagnosticiranim multiformnim glioblastomom, sočasno z radioterapijo (RT) in pozneje kot monoterapija
The body is imprinted with ‘250 mg' and two stripes.
Na telesu so odtisnjene oznaka »250 mg« in dve črti.
Signs of allergic reaction include itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat.
otekanje obraza, ustnic, jezika ali grla;
Anxiety, emotional lability, insomnia
čustvena nestabilnost, nespečnost
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
zmedenost, motnje spomina, zmanjšanje miselne zbranosti, nevropatija, parestezije, motnje govora, tremor hemipareza, afazija, motnje ravnotežja, somnolenca,
Temozolomide SUN 20 mg hard capsules
Temozolomid SUN 20 mg trde kapsule
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
stomatitis, driska, trebušne bolečine, dispepsija, disfagija stomatitis, driska, dispepsija,
Temozolomide SUN 250 mg hard capsules
Temozolomid SUN 250 mg trde kapsule
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,
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,
Temozolomide SUN 250 mg hard capsules have a white opaque body and cap, imprinted in black ink.
Temozolomid 250 mg trde želatinske kapsule imajo bel neprosojen pokrovček in telo s črnim potiskom.