FrancophonIA/ELRC3.0 huggingface dataset:
English: Anxiety, depression, emotional lability, insomnia
Croatian: Anksioznost, depresija, emocionalna labilnost, nesanica
English: Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Croatian: Vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
English: hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure†
Croatian: hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
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: Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Croatian: Neutropenija, trombocitopenija, limfopenija, leukopenija
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Croatian: Prije nego započnete s liječenjem, liječnik će Vam provjeriti krvnu sliku kako bi se uvjerio da imate dovoljno tih stanica.
English: Very rare (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):
English: Newly-diagnosed glioblastoma multiforme
Croatian: Novodijagnosticirani multiformni glioblastom
English: Blood and lymphatic system disorders Very common:
Croatian: Poremećaji krvi i limfnog sustava Vrlo često:
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba):
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.
Croatian: Smatra se da je za citotoksičnost MTIC-a primarno odgovorna alkilacija na položaju O6 gvanina, uz dodatnu alkilaciju na položaju N7. U nastanak citotoksičnih lezija vjerojatno je uključen poremećaj mehanizma za popravak metilne skupine.
English: The body is imprinted with “100”.
Croatian: Na tijelu je otisnuta oznaka „100“.
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Croatian: Konstipacija, mučnina, povraćanje Konstipacija, mučnina, povraćanje
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Croatian: U bolesnika koji su primali TMZ, osobito u kombinaciji s deksametazonom ili drugim steroidima,
English: Eye disorders Common:
Croatian: Poremećaji oka Često:
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: . Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Skin and subcutaneous tissue disorders Very common:
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često:
English: 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: PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
English: Vomiting, nausea, constipation
Croatian: Povraćanje, mučnina, konstipacija
English: The cap is imprinted with “TMZ”.
Croatian: Na kapici je otisnuta oznaka „TMZ“.
English: Remarks Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity Table 3.
Croatian: Doza tijekom 1. ciklusa Doza tijekom 2.-6. ciklusa ako nema toksičnih učinaka
English: Allergic reaction, fever, radiation injury, pain, taste perversion
Croatian: Alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
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 Organski sustav
English: Bottle Do not store above 25 °C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 °C.
English: Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral
Croatian: Recidivirajući ili progresivni maligni gliom Podaci o kliničkoj djelotvornosti u bolesnika s multiformnim glioblastomom (Karnofski izvedbenog statusa [KPS] ≥ 70) koji napreduje ili je recidivirao nakon kirurškog zahvata i radioterapije temelje se na dva klinička ispitivanja peroralno primijenjenog TMZ-a.
English: • muscle damage
Croatian: 20. oštećenje sluha
English: Meningoencephalitis herpetic
Croatian: Herpesni meningoencefalitis
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Croatian: U Tablici 4 navedeni su štetni događaji koji su se pojavili tijekom liječenja u bolesnika s novodijagnosticiranim multiformnim glioblastomom u fazi istodobnog liječenja i fazi monoterapije.
English: Erythema multiforme, erythroderma, urticaria, exanthema
Croatian: Multiformni eritem, eritrodermija, urtikarija, egzantem
English: Each hard capsule contains 73 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 73 mg bezvodne laktoze.
English: In the tables undesirable effects are classified according to System Organ Class and frequency.
Croatian: U tablicama su nuspojave razvrstane prema organskim sustavima i učestalosti pojavljivanja.
English: How to take Temozolomide Sandoz
Croatian: Kako uzimati Temozolomid Sandoz
English: • blood clot in the legs
Croatian: 23. krvni ugrušak u nogama
English: Remarks
Croatian: Napomene
English: Oral use Read the package leaflet before use.
Croatian: Prije uporabe pročitajte Uputu o lijeku.
English: Latvia brunch
Croatian: Sandoz d.d. Latvia brunch
English: Visual acuity reduced, eye pain, eyes dry
Croatian: Smanjena oštrina vida, bol u oku, suhoća oka
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Each hard capsule contains 131.4 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 131,4 mg bezvodne laktoze.
English: Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Croatian: Febrilna neutropenija, trombocitopenija, anemija, leukopenija
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Croatian: Poremećaji broja trombocita stupnja 3 ili 4, uključujući trombocitopeniju, opaženi su u 14 %
English: Temozolomide monotherapy in recurrent or progressive glioma
Croatian: Monoterapija temozolomidom kod ponovne pojave ili pogoršanja glioma
English: Diarrhoea, abdominal pain, dyspepsia
Croatian: Proljev, bolovi u abdomenu, dispepsija
English: Patients with hepatic or renal impairment
Croatian: Bolesnici s oštećenjem funkcije jetre ili bubrega
English: Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Croatian: Abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
English: Anxiety, emotional lability, insomnia
Croatian: Anksioznost, emocionalna labilnost, nesanica
English: Each capsule is approximately 11.4 mm in length.
Croatian: Svaka je kapsula dugačka približno 11,4 mm.
English: Titanium dioxide (E 171) Water
Croatian: Titanijev dioksid (E171) Voda
English: Pneumonia, upper respiratory infection, nasal congestion
Croatian: Upala pluća, infekcija gornjih dišnih putova, kongestija nosa
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari
English: Hyperglycaemia, weight increased
Croatian: Hiperglikemija, povećanje tjelesne težine
English: 23 %, respectively.
Croatian: nalaza iznosila je 8 %.
English: LV-1010 Rīga Tel: +371 67892006 balt.regaffairs@sandoz.com
Croatian: Tel: +371 67892006 balt.regaffairs@sandoz.com
English: Muscle weakness, arthralgia
Croatian: Mišićna slabost, artralgija
English: Reproductive system and breast disorders Uncommon:
Croatian: Poremećaji reproduktivnog sustava i dojki Manje često:
English: • the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting)
Croatian: • ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (osim alopecije, mučnine i povraćanja).
English: Hyperglycaemia, weight decreased
Croatian: Hiperglikemija, smanjenje tjelesne težine
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: nego u skupini bolesnika koji su primali prokarbazin (44 %) (hi-kvadrat p = 0,019).
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.
Croatian: Peroralno primijenjen TMZ ispitivan je u pedijatrijskih bolesnika (u dobi od 3 do 18 godina) s recidivirajućim gliomom moždanog debla ili recidivirajućim astrocitomom visokog stupnja, prema režimu doziranja jednom na dan tijekom 5 dana, svakih 28 dana.
English: Each capsule is approximately 21.4 mm in length.
Croatian: Svaka je kapsula dugačka približno 21,4 mm.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 14,6 mg bezvodne laktoze.
English: Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Croatian: Alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
English: Discontinue TMZ
Croatian: Prekinuti primjenu TMZ-a
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.
Croatian: Osip je zabilježen vrlo često u bolesnika s novodijagnosticiranim multiformnim glioblastomom koji primaju TMZ bilo u kombinaciji s RT-om ili u monoterapiji, a često u bolesnika s recidivirajućim malignim gliomom.
English: Baseline liver function tests should be performed prior to treatment initiation.
Croatian: Prije započinjanja liječenja potrebno je provesti pretrage funkcije jetre.
English: Each hard capsule contains 168 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 168 mg bezvodne laktoze.
English: Temozolomide Sandoz is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, 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.
Croatian: odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija, djece od navršene tri godine starosti, adolescenata i odraslih bolesnika s malignim gliomom,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Each capsule is approximately 19.3 mm in length.
Croatian: Svaka je kapsula dugačka približno 19,3 mm.
English: During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different.
Croatian: Doza i način uzimanja Temozolomida Sandoz u fazi monoterapije razlikovat će se od prethodne faze.
English: Male patients
Croatian: Zloćudne bolesti
English: The first dose will be 150 mg/m2.
Croatian: 150 mg/m2.
English: The bottles also contain a desiccant pouch.
Croatian: Bočice sadrže i vrećicu sa sredstvom za sušenje.
English: Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Croatian: Mišićna slabost, artralgija, bol u mišićima i kostima, mialgija
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 182,5 mg bezvodne laktoze.
English: Myopathy, back pain, musculoskeletal pain, myalgia
Croatian: Miopatija, bol u leđima, bol u mišićima i kostima, mialgija
English: The objective response rate (ORR) based on MRI scans was 8 %.
Croatian: Objektivna stopa odgovora na liječenje (ORR) na temelju MR
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Very rare cases of lung side effects have been observed with temozolomide.
Croatian: Pri primjeni temozolomida vrlo rijetko su primijećene nuspojave na plućima.
English: ul.
Croatian: A.
English: Infections and infestations Common:
Croatian: Infekcije i infestacije
English: Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Croatian: Astenija, edem lica, bol, pogoršanje stanja, tresavica, promjene na zubima
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Croatian: Jedna tvrda kapsula sadrži 102,2 mg bezvodne laktoze.
English: Temozolomide Sandoz 5 mg
Croatian: Temozolomid Sandoz 5 mg
English: Urinary incontinence
Croatian: Inkontinencija mokraće
English: Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom Temozolomid Sandoz se primjenjuje u kombinaciji s fokalnom radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: The bottles contain a desiccant pouch.
Croatian: Bočice sadrže vrećicu sa sredstvom za sušenje.
English: Patients with newly-diagnosed glioblastoma multiforme
Croatian: Bolesnici s novodijagnosticiranim multiformnim glioblastomom
English: Black iron oxide (E 172) Potassium hydroxide
Croatian: Željezov oksid, crni (E172) Kalijev hidroksid
English: Printing ink: contains shellac, black iron oxide (E 172), potassium hydroxide.
Croatian: Tinta za označavanje: sadrži šelak, crni željezov oksid (E 172), kalijev hidroksid.
English: Adult patients with newly-diagnosed glioblastoma multiforme
Croatian: Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom
English: • dizziness
Croatian: Dispneja
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Croatian: Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom
English: There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz.
Croatian: Informacije o primjeni Temozolomida Sandoz u djece starije od 3 godine su ograničene.
English: Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Croatian: Temozolomid Sandoz 5 mg tvrde kapsule Jedna kapsula sadrži 5 mg temozolomida.
English: Table 4.
Croatian: 44. bol
English: Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Croatian: Hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija,
English: Temozolomide Sandoz 20 mg
Croatian: Temozolomid Sandoz 20 mg
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Kako čuvati Temozolomid Sandoz Ovaj lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
English: Table 2.TMZ dose levels for monotherapy treatment
Croatian: Tablica 2. Razine doze TMZ-a u fazi monoterapije
English: • in adults with newly-diagnosed glioblastoma multiforme.
Croatian: 1. u odraslih s novodijagnosticiranim multiformnim glioblastomom.
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), indigo karmin (E 132), voda.
English: Temozolomide Sandoz 250 mg
Croatian: Temozolomid Sandoz 250 mg
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Croatian: Temozolomid Sandoz 250 mg tvrde kapsule Jedna kapsula sadrži 250 mg temozolomida.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Croatian: Hemiplegija, ataksija, poremećaj koordinacije, poremećaj hoda, hiperestezija, poremećaj osjeta
English: Respiratory, thoracic and mediastinal disorders Common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često:
English: The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Croatian: Farmakokinetika TMZ-a u bolesnika s normalnom funkcijom jetre bila je slična kao u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Adverse reactions in patients with recurrent or progressive malignant glioma
Croatian: Tablica 5. Nuspojave u bolesnika s recidivirajućim ili progresivnim malignim gliomom
English: The cap is imprinted with “TMZ” and the body is imprinted with “180”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „180“.
English: • uncontrolled bleeding,
Croatian: nespecificirani neurološki poremećaj,
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Croatian: Tinta za označavanje: šelak, crni željezov oksid (E 172), kalijev hidroksid.
English: Uncommon:
Croatian: Nepoznato:
English: The cap is imprinted with “TMZ” and the body is imprinted with “5”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „5“.
English: The cap is imprinted with “TMZ” and the body is imprinted with “250”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „250“.
English: Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Croatian: Temozolomid Sandoz 140 mg tvrde kapsule Jedna kapsula sadrži 140 mg temozolomida.
English: Titanium dioxide (E 171) Indigo carmine (E 132) Water
Croatian: Titanijev dioksid (E171) Indigo karmin (E132) Voda
English: Temozolomide Sandoz 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Croatian: Temozolomid Sandoz 20 mg tvrde kapsule Jedna kapsula sadrži 20 mg temozolomida.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Croatian: Tijekom radioterapije i kombiniranog liječenja TMZ-om morala se primijeniti profilaksa protiv Pneumocystis jirovecii pneumonije.
English: • haemorrhoids
Croatian: Zamagljen vid
English: TMZ dose reduction or discontinuation during monotherapy treatment
Croatian: Tablica 3. Smanjenje doze ili prekid primjene TMZ-a u fazi monoterapije
English: Temozolomide Sandoz 140 mg
Croatian: Temozolomid Sandoz 140 mg
English: Each hard capsule contains 5 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 5 mg temozolomida.
English: The cap is imprinted with “TMZ” and the body is imprinted with “140”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „140“.
English: Common (may affect up to 1 in 10 people):
Croatian: Česte (mogu se javiti u do 1 na 10 osoba):
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Croatian: Ovojnica kapsule: želatina, titanijev dioksid (E 171), voda.
English: Temozolomide Sandoz 20 mg hard capsules yellow
Croatian: Temozolomid Sandoz 20 mg tvrde kapsule žuta
English: Temozolomide Sandoz 180 mg
Croatian: Temozolomid Sandoz 180 mg
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Croatian: Titanijev dioksid (E171) Željezov oksid, žuti (E172) Indigo karmin (E132) Voda
English: General disorders and administration site conditions Very common:
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često:
English: • peeling skin
Croatian: 28. ljuštenje kože
English: • urticaria (hives)
Croatian: crvenilo kože urtikarija (koprivnjača)
English: Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Croatian: Temozolomid Sandoz 180 mg tvrde kapsule Jedna kapsula sadrži 180 mg temozolomida.
English: Each hard capsule contains 250 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 250 mg temozolomida.
English: Visual field defect, vision blurred, diplopia
Croatian: Ispad vidnog polja, zamagljen vid, diplopija
English: • reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
Croatian: infekcije usne šupljine infekcija rane smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija)
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba):
English: The cap is imprinted with “TMZ” and the body is imprinted with “20”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „20“.
English: Titanium dioxide (E 171) Red iron oxide (E 172) Water
Croatian: Titanijev dioksid (E171) Željezov oksid, crveni (E 172) Voda
English: METHOD OF ADMINISTRATION
Croatian: Način primjene
English: Each hard capsule contains 20 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 20 mg temozolomida.
English: TMZ discontinuation
Croatian: Trajni prekid primjene TMZ-a
English: Temozolomide Sandoz 5 mg hard capsules green
Croatian: Temozolomid Sandoz 5 mg tvrde kapsule zelena
English: Temozolomide Sandoz hard capsules should be administered in the fasting state.
Croatian: Temozolomid Sandoz tvrde kapsule moraju se uzimati natašte.
English: Temozolomide Sandoz 250 mg hard capsules white
Croatian: Temozolomid Sandoz 250 mg tvrde kapsule bijela
English: Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Croatian: Temozolomid Sandoz 100 mg tvrde kapsule Jedna kapsula sadrži 100 mg temozolomida.
English: Gastrointestinal disorders
Croatian: gastroenteritis, hemoroidi
English: Each hard capsule contains 140 mg temozolomide.
Croatian: Jedna tvrda kapsula sadrži 140 mg temozolomida.
English: Haemorrhage, deep venous thrombosis, oedema leg
Croatian: Krvarenje, tromboza dubokih vena, edem nogu
English: Capsule shell
Croatian: Sadržaj kapsule
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Sadržaj kapsule: bezvodna laktoza, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Temozolomide Sandoz 100 mg
Croatian: Temozolomid Sandoz 100 mg
English: Cushingoid
Croatian: Cushingoidni izgled
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Sandoz
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temozolomid Sandoz jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii (PCP).
English: The cap is imprinted with “TMZ” and the body is imprinted with “100”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „100“.
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Croatian: narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor