FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of TMZ in children under the age of 3 years has not been established.
Croatian: Sigurnost primjene TMZ-a u djece mlađe od 3 godine nije ustanovljena.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Teva (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temozolomid Teva moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
English: Warnings and precations
Croatian: Upozorenja i mjere opreza
English: Your doctor will work out your dose of Temozolomide Teva.
Croatian: Vaš liječnik će izračunati dozu lijeka Temozolomid Teva primjerenu za Vas.
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Teva will be 200 mg/m² once daily for the first 5 days.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza lijeka Temozolomid Teva bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: Temozolomide Teva is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Temozolomid Teva se primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: Temozolomide Teva is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Croatian: Temozolomid Teva je indiciran za liječenje: - odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija.
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Croatian: Pneumonija, sinusitis, infekcija gornjih dišnih puteva, bronhitis
English: Themedian 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).
Croatian: Medijan vremena do progresije bolesti prema ovim mjerama ishoda bio je za 0,7 do 2,1 mjeseca dulji u skupini koja je primala TMZ nego u skupini koja je primala prokarbazin (log-rang p = < 0,01 do 0,03).
English: This was followed by monotherapy TMZ (150 - 200 mg/m²) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Croatian: Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Croatian: karboksamid (AIC), poznati međuspoj u biosintezi purina i nukleinskih kiselina, te u metilhidrazin, za koji se vjeruje da je aktivan alkilirajući spoj.
English: Adult patients with newly-diagnosed glioblastoma multiforme Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Croatian: Preporučuje se primjena antiemetičke profilakse prije početne doze temozolomida u fazi istodobnog liječenja, a izrazito se preporučuje u fazi monoterapije.
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.
Croatian: U prvom ciklusu terapije stope neutropenije (ABN < 0,5 x 109/l) i trombocitopenije (< 20 x 109/l) stupnja 4 bile su viša u žena nego u muškaraca: 12% naspram 5% kod neutropenije i 9% naspram 3% kod trombocitopenije.
English: liver enzymes elevations
Croatian: povišene vrijednosti jetrenih enzima,
English: How to take Temozolomide Teva
Croatian: Kako uzimati Temozolomid Teva
English: Temozolomide Teva contains lactose (a kind of sugar).
Croatian: Temozolomid Teva tvrde kapsule sadrže laktozu (vrstu šećera).
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 blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, 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.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): infekcije usne šupljine, infekcija rane, smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija), povišena razina šećera u krvi, gubitak tjelesne težine, promjena psihičkog stanja ili budnosti, tjeskoba/depresija, pospanost, otežan govor, poremećaj ravnoteže, omaglica, smetenost, zaboravljivost, poteškoće s koncentracijom, nemogućnost da bolesnik zaspi ili spava, trnci, stvaranje modrica, drhtanje, poremećen ili zamagljen vid, dvostruke slike, oštećenje sluha, nedostatak zraka, kašalj, krvni ugrušak u nogama, zadržavanje tekućine, otečene noge, proljev, bol u želucu ili trbuhu, žgaravica, želučane tegobe, otežano gutanje, suha usta, nadraženost ili crvenilo kože, suha koža, svrbež, mišićna slabost, bolni zglobovi, bol u mišićima, učestalo mokrenje, poteškoće sa zadržavanjem urina, alergijska reakcija, vrućica, ozljeda zbog zračenja, oticanje lica, bol, promjena osjeta okusa, odstupanja od normalnih vrijednosti testova funkcije jetre.
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Croatian: liječnici trebaju procijeniti omjer koristi/rizika za nastavak liječenja.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Croatian: Manje često zabilježeni su slučajevi povišene razine bilirubina, poteškoće s protokom žuči (kolestaza) , hepatitis i oštećenje jetre, uključujući zatajenje jetre sa smrtnim ishodom.
English: Temozolomide Teva contains lactose
Croatian: Temozolomid Teva sadrži laktozu
English: Hepatic injury, including fatal hepatic failure, has been reportedin patients treated with TMZ (see section 4.8).
Croatian: Oštećenje jetre, uključujući zatajenje jetre sa smrtnim ishodom, prijavljeno je u bolesnika liječenih TMZ-om (vidjeti dio 4.8).
English: Temozolomide Teva should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: 4.2 Doziranje i način primjene Temozolomid Teva smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: Temozolomide Teva may make you feel tired or sleepy.
Croatian: Temozolomid Teva može uzrokovati umor ili pospanost.
English: The other ingredients are: capsule content: lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temozolomide Teva contains lactose”).
Croatian: Sadržaj kapsule: laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat, vrste A, tartaratna kiselina, stearatna kiselina (pogledajte dio 2 "Temozolomid Teva sadrži laktozu").
English: Hepatic enzymes increased, Gamma GT increased, AST increased
Croatian: Povišene vrijednosti jetrenih enzima, povišene vrijednosti gama-GT-a, povišene vrijednosti AST-a
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8%
Croatian: Nakon peroralne primjene temozolomida označenog radioizotopom 14C, u fecesu je tijekom 7 dana nakon primjene doze izlučeno prosječno 0,8% radioizotopa 14C, što ukazuje na potpunu apsorpciju.
English: Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Croatian: Slika 1. Kaplan-Meierove krivulje ukupnog preživljenja (populacija koju se namjeravalo liječiti) Rezultati ispitivanja nisu bili konzistentni u podskupini bolesnika s lošim izvedbenim statusom (SZO
English: Temozolomide Teva in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Croatian: Temozolomid Teva u kombinaciji sa zračenjem u liječenju novodijagnosticiranog multiformnog glioblastoma
English: † Including cases with fatal outcome *Frequencies estimated based on relevant clinical trials
Croatian: *Učestalost procijenjena na temelju relevantnih kliničkih studija
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 in your stomach), constipation (difficulty passing stools).
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba): smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija), gubitak teka, glavobolja, povraćanje, mučnina (loše osjećanje u želucu), zatvor (otežano pražnjenje crijeva).
English: How to store Temozolomide Teva
Croatian: Kako čuvati Temozolomid Teva
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Croatian: Bolesnici u skupini TMZ + RT su od prvog do zadnjeg dana radioterapije tijekom 42 dana (najdulje 49 dana) jedanput na dan primali i TMZ (75 mg/m2).
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
Croatian: 161 od 282 bolesnika (57%) u skupini u kojoj se primijenila samo RT te u 62 od 277 bolesnika (22%) u skupini koja je uz RT primala i TMZ.
English: Temozolomide Teva 5 mg hard capsules Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules
Croatian: Temozolomid Teva 5 mg tvrde kapsule Temozolomid Teva 20 mg tvrde kapsule Temozolomid Teva 100 mg tvrde kapsule Temozolomid Teva 140 mg tvrde kapsule Temozolomid Teva 180 mg tvrde kapsule Temozolomid Teva 250 mg tvrde kapsule
English: TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see sections 4.8).
Croatian: TMZ malo utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog umora i somnolencije
English: Titanium dioxide (E171) Sunset yellow FCF Aluminium Lake (E110)
Croatian: Tinta za označavanje šelak propilenglikol titanijev dioksid (E171) sunset yellow FCF aluminium lake (E110)
English: Following oral administration, approximately 5% to 10% of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4carboxamide (AIC) or unidentified polar metabolites.
Croatian: Nakon peroralne primjene se približno 5 do 10% doze nalazi u mokraći u nepromijenjenom obliku tijekom 24 sata, dok se ostatak izlučuje u obliku temozolomidske kiseline,
English: Summary of events reported with temozolomide in the post-marketing setting* Infections and infestations*
Croatian: Tablica 6. Sažetak štetnih događaja prijavljenih nakon stavljanja temozolomida u promet* Poremećaji krvi i limfnog sustava
English: Contains lactose, sunset yellow FCF (E110).
Croatian: Sadrži laktozu, sunset yellow FCF (E110).
English: Temozolomide Teva 5 mg
Croatian: Temozolomid Teva 5 mg
English: Table 4: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Croatian: Tablica 4. Štetni događaji koji su se pojavili tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom
English: - if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Croatian: Liječnik će detaljno pregledati bolesnike prije početka liječenja kako bi se utvrdilo postoje li znakovi ove infekcije. - ako imate smanjen broj crvenih krvnih stanica (anemiju), bijelih krvnih stanica i trombocita ili problema sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom liječenja.
English: Temozolomide Teva 20 mg
Croatian: Temozolomid Teva 20 mg
English: Hyperglycaemia, weight decreased Weight decreased
Croatian: Hiperglikemija, smanjenje tjelesne težine
English: Temozolomide Teva 250 mg
Croatian: Temozolomid Teva 250 mg
English: Propylene Glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
Croatian: Tinta za označavanje šelak propilenglikol željezov oksid, crveni (E172) željezov oksid, žuti (E172) titanijev dioksid (E171)
English: Patients with newly-diagnosed glioblastoma multiforme If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temozolomide Teva (monotherapy phase).
Croatian: Ako ste novodijagnosticirani bolesnik, liječenje će se odvijati u dvije faze: - prvo liječenje zajedno sa zračenjem (faza istodobnog liječenja)
English: Dermatitis, dry skin, erythema, pruritus
Croatian: Dermatitis, suha koža, eritem, pruritus Suha koža, pruritus
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LI JEK
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Croatian: Međutim, sve bolesnike koji primaju TMZ, a osobito bolesnike koji primaju steroide,
English: - if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Croatian: - ako imate jako smanjen broj određenih vrsta krvnih stanica (mijelosupresiju), primjerice leukocita ili trombocita.
English: Temozolomide Teva 20 mg hard capsules Temozolomide Teva 100 mg hard capsules Temozolomide Teva 140 mg hard capsules Temozolomide Teva 180 mg hard capsules Temozolomide Teva 250 mg hard capsules temozolomide
Croatian: Temozolomid Teva 20 mg tvrde kapsule Temozolomid Teva 100 mg tvrde kapsule Temozolomid Teva 140 mg tvrde kapsule Temozolomid Teva 180 mg tvrde kapsule Temozolomid Teva 250 mg tvrde kapsule temozolomid
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).
Croatian: (60%) nego u skupini bolesnika koji su primali prokarbazin (44%) (hi-kvadrat p = 0,019).
English: Blood and lymphatic system disorders Very rare:
Croatian: Poremećaji krvi i limfnog sustava Vrlo često:
English: - if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temozolomide Teva (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Croatian: - ako imate mučninu i/ili povraćanje što su vrlo česte nuspojave lijeka Temozolomid Teva (pogledajte dio 4) liječnik Vam može propisati lijek koji sprečava povraćanje (antiemetik). - ako često povraćate prije ili za vrijeme liječenja, upitajte svog liječnika u koje je vrijeme najbolje uzimati Temozolomid Teva dok povraćanje ne bude pod kontrolom.
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Croatian: TMZ-a, a prvi tumori se pojavljuju u roku od 3 mjeseca nakon početne doze.
English: prolonged pancytopenia, aplastic anaemia† Neoplasm benign, malignant and unspecified Very rare:
Croatian: dugotrajna pancitopenija, aplastična anemija† Dobroćudne, zloćudne i nespecificirane novotvorine
English: Temozolomide Teva 140 mg
Croatian: Temozolomid Teva 140 mg
English: Indigo carmine (E132) aluminium lake
Croatian: Tinta za označavanje šelak propilenglikol indigo carmine (E132) aluminium lake
English: Temozolomide Teva 180 mg
Croatian: Temozolomid Teva 180 mg
English: Pneumonia, upper respiratory infection, nasal congestion
Croatian: Pneumonija, infekcija gornjih dišnih puteva, kongestija nosa
English: Febril neutropenia, thrombocytopenia, anaemia, leukopenia
Croatian: Febrilna neutropenija, trombocitopenija, anemija, leukopenija
English: Constipation, nausea, vomiting
Croatian: Konstipacija, mučnina, povraćanje
English: Excipients with known effect Each hard capsule contains 72 mg of lactose and sunset yellow FCF (E110).
Croatian: Jedna tvrda kapsula sadrži 72 mg laktoze i sunset yellow FCF (E110).
English: Temozolomide Teva contains sunset yellow FCF (E110)
Croatian: Temozolomid Teva sadrži sunset yellow FCF (E110)
English: TMZ is administered orally at a dose of 75 mg/m² daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Croatian: TMZ se primjenjuje peroralno u dozi od 75 mg/m2 na dan tijekom 42 dana uz istodobnu radioterapiju
English: 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.
Croatian: nadraženost rodnice, bol u dojkama, navale vrućine, drhtavica, promjena boje jezika, promjena osjeta mirisa, žeđ, promjene na zubima.
English: Anxiety, emotional lability, insomnia Anxiety, depression, emotional lability, insomnia
Croatian: Anksioznost, depresija, emocionalna labilnost, nesanica
English: Temozolomide Teva 100 mg
Croatian: Temozolomid Teva 100 mg
English: Temozolomide Teva hard capsules should be administered in the fasting state.
Croatian: Temozolomid Teva tvrde kapsule moraju se uzimati natašte.
English: During the monotherapy phase, the dose and way you take Temozolomide Teva will be different.
Croatian: Doza i način uzimanja lijeka Temozolomid Teva u fazi monoterapije razlikovat će se od prethodne faze.
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Teva.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temozolomid Teva, - jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Indigo carmine (E132) aluminium lake
Croatian: Tinta za označavanje šelak propilenglikol titanijev dioksid (E171) željezov oksid, žuti (E172). indigo carmine (E132) aluminium lake
English: Temozolomide Teva 5 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, Indigo carmine (E132) aluminium lake, yellow iron oxide (E172) Temozolomide Teva 20 mg hard capsules: (including printing ink): gelatine, titanium dioxide (E171), shellac, propylene glycol, Sunset yellow FCF Aluminium Lake (E110) Temozolomide Teva 100 mg hard capsules: (including printing ink): gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol and yellow iron oxide (E172).
Croatian: Temozolomid Teva 20 mg tvrde kapsule: (uključujući tintu za označavanje): želatina, titanijev dioksid (E171), šelak, propilenglikol, sunset yellow FCF aluminium lake (E110) Temozolomid Teva 100 mg tvrde kapsule: (uključujući tintu za označavanje): želatina, titanijev dioksid (E171), crveni željezov oksid (E172) šelak, propilenglikol i žuti željezov oksid (E172).
English: Skin and subcutaneous tissue disorders Very rare:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često:
English: 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).
Croatian: a: Istodobno liječenje temozolomidom može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnju 1 (osim alopecije, mučnine i povraćanja).
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19% and 17% respectively, of patients treated for malignant glioma.
Croatian: Laboratorijski nalazi Trombocitopenija stupnja 3 ili 4 razvila se u 19%, a neutropenija stupnja 3 ili 4 u 17% bolesnika liječenih zbog malignog glioma, što je dovelo do hospitalizacije i/ili obustave liječenja TMZ-om u 8% odnosno 4% bolesnika.
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).
Croatian: U bolesnika koji prethodno nisu liječeni kemoterapijom, TMZ se primjenjuje peroralno u dozi od 200 mg/m2 jedanput na dan tijekom prvih 5 dana, nakon čega slijede
English: Temozolomide Teva 5 mg two stripes in green ink on the cap and “T 5 mg” in green ink on the body
Croatian: Temozolomid Teva 5 mg dvije zelene linije na kapici i zelena oznaka “T 5 mg” na tijelu kapsule
English: Temozolomide Teva 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body
Croatian: Temozolomid Teva 20 mg dvije narančaste linije na kapici i narančasta oznaka “T 20 mg” na tijelu kapsule
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 the 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,
Croatian: suhe ili bolne oči, gluhoća, infekcija srednjeg uha, zvonjava u ušima, bol u uhu, palpitacije (lupanje srca), krvni ugrušak u plućima, visok krvni tlak, upala pluća, upala sinusa, bronhitis, prehlada ili gripa, oticanje trbuha, poteškoće s kontroliranjem stolice, hemoroidi, ljuštenje kože, povećana osjetljivost kože na sunčevu svjetlost, promjena boje kože, pojačano znojenje, oštećenje mišića, bol u leđima, poteškoće s mokrenjem, vaginalno krvarenje, impotencija, izostanak ili obilne menstruacije,
English: Common (may affect up to 1 in 10 people): loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba): gubitak tjelesne težine, umor, omaglica, trnci, nedostatak zraka, proljev, bol u trbuhu, želučane tegobe, osip, svrbež, gubitak kose, vrućica, slabost, drhtavica,
English: CTC Grade 4b a:
Croatian: CTC stupanj 4b a: doze TMZ-a navedene su u Tablici 2. b: TMZ se mora prekinuti:
English: Marketing Authorization Holder
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Each capsule is approximately 19.5 mm in length.
Croatian: Svaka je kapsula duljine od oko 19,5 mm.
English: Each capsule is approximately 22 mm in length.
Croatian: Svaka je kapsula duljine od oko 22 mm.
English: Excipient with known effect Each hard capsule contains 117 mg of lactose.
Croatian: Jedna tvrda kapsula sadrži 117 mg laktoze.
English: Each capsule is approximately 16 mm in length.
Croatian: Svaka je kapsula duljine od oko 16 mm.