natgillin/translations-raw huggingface dataset:
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-4-carboxamide (AIC) or unidentified polar metabolites.
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,
Men being treated with TMZ 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 (see section 4.6).
Muškarcima koji se liječe TMZ-om treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko pohrane sperme zamrzavanjem
Lek Pharmaceuticals d.d.
Lek Pharmaceuticals d.d. Verovškova 57
Endocrine disorders Uncommon:
Endokrini poremećaji* Manje često:
Ear and labyrinth disorders Common:
Poremećaji uha i labirinta Često:
The 6-month event-free survival for the ITT population was 44 % with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Šestomjesečno preživljenje bez znakova bolesti u ITT populaciji iznosilo je 44 %, uz medijan preživljenja bez znakova bolesti od
Temozolomide Sandoz may make you feel tired or sleepy.
Temozolomid Sandoz može uzrokovati umor ili pospanost.
Keep the desiccant pouch in the bottle.
Ne vadite vrećicu sa sredstvom za sušenje iz bočice.
Hepatotoxicity
Hepatotoksičnost
Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules.
Bočica Bočica od smeđeg stakla tipa III, s polipropilenskim sigurnosnim zatvaračem za djecu, koja sadrži 5
Tell your doctor immediately if this occurs
Ako se to dogodi, odmah obavijestite svog liječnika.
(≥1/10,000 to <1/1,000); Very rare (<1/10,000)), Not known: frequency cannot be estimated from the available data.
<1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Anxiety, depression, emotional lability, insomnia
Anksioznost, depresija, emocionalna labilnost, nesanica
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure†
hiperbilirubinemija, kolestaza, hepatitis oštećenje jetre, zatajenje jetre†
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).
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).
Neutropenia, thrombocytopenia, lymphopenia, leukopenia
Neutropenija, trombocitopenija, limfopenija, leukopenija
Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Prije nego započnete s liječenjem, liječnik će Vam provjeriti krvnu sliku kako bi se uvjerio da imate dovoljno tih stanica.
Very rare (may affect up to 1 in 10,000 people):
Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):
Newly-diagnosed glioblastoma multiforme
Novodijagnosticirani multiformni glioblastom
Blood and lymphatic system disorders Very common:
Poremećaji krvi i limfnog sustava Vrlo često:
Rare (may affect up to 1 in 1,000 people):
Rijetke (mogu se javiti u do 1 na 1000 osoba):
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.
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.
The body is imprinted with “100”.
Na tijelu je otisnuta oznaka „100“.
Constipation, nausea, vomiting Constipation, nausea, vomiting
Konstipacija, mučnina, povraćanje Konstipacija, mučnina, povraćanje
Very common (may affect more than 1 in 10 people):
Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
U bolesnika koji su primali TMZ, osobito u kombinaciji s deksametazonom ili drugim steroidima,
Eye disorders Common:
Poremećaji oka Često:
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.
. Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Skin and subcutaneous tissue disorders Very common:
Poremećaji kože i potkožnog tkiva Vrlo često:
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.
PS = 2, n = 70), za koje su ukupno preživljenje i vrijeme do progresije bolesti bili slični u obje ispitivane skupine.
Vomiting, nausea, constipation
Povraćanje, mučnina, konstipacija
The cap is imprinted with “TMZ”.
Na kapici je otisnuta oznaka „TMZ“.
Remarks Reduction for prior toxicity Dose during Cycle 1 Dose during Cycles 2-6 in absence of toxicity Table 3.
Doza tijekom 1. ciklusa Doza tijekom 2.-6. ciklusa ako nema toksičnih učinaka
Allergic reaction, fever, radiation injury, pain, taste perversion
Alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
Table 4.Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Tablica 4. Štetni događaji koji su se pojavili tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom Organski sustav
Bottle Do not store above 25 °C.
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25 °C.
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
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.
• muscle damage
20. oštećenje sluha
Meningoencephalitis herpetic
Herpesni meningoencefalitis
Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
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.
Erythema multiforme, erythroderma, urticaria, exanthema
Multiformni eritem, eritrodermija, urtikarija, egzantem
Each hard capsule contains 73 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 73 mg bezvodne laktoze.
In the tables undesirable effects are classified according to System Organ Class and frequency.
U tablicama su nuspojave razvrstane prema organskim sustavima i učestalosti pojavljivanja.
How to take Temozolomide Sandoz
Kako uzimati Temozolomid Sandoz
• blood clot in the legs
23. krvni ugrušak u nogama
Oral use Read the package leaflet before use.
Prije uporabe pročitajte Uputu o lijeku.
Latvia brunch
Sandoz d.d. Latvia brunch
Visual acuity reduced, eye pain, eyes dry
Smanjena oštrina vida, bol u oku, suhoća oka
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SACHETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
Each hard capsule contains 131.4 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 131,4 mg bezvodne laktoze.
Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
Febrilna neutropenija, trombocitopenija, anemija, leukopenija
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Poremećaji broja trombocita stupnja 3 ili 4, uključujući trombocitopeniju, opaženi su u 14 %
Temozolomide monotherapy in recurrent or progressive glioma
Monoterapija temozolomidom kod ponovne pojave ili pogoršanja glioma
Diarrhoea, abdominal pain, dyspepsia
Proljev, bolovi u abdomenu, dispepsija
Patients with hepatic or renal impairment
Bolesnici s oštećenjem funkcije jetre ili bubrega
Abdominal distension, fecal incontinence, gastrointestinal disorder (NOS), gastroenteritis, haemorrhoids
Abdominalna distenzija, inkontinencija stolice, nespecificirani gastrointestinalni poremećaj, gastroenteritis, hemoroidi
Anxiety, emotional lability, insomnia
Anksioznost, emocionalna labilnost, nesanica
Each capsule is approximately 11.4 mm in length.
Svaka je kapsula dugačka približno 11,4 mm.
Titanium dioxide (E 171) Water
Titanijev dioksid (E171) Voda
Pneumonia, upper respiratory infection, nasal congestion
Upala pluća, infekcija gornjih dišnih putova, kongestija nosa
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
6.1 Popis pomoćnih tvari
Hyperglycaemia, weight increased
Hiperglikemija, povećanje tjelesne težine
23 %, respectively.
nalaza iznosila je 8 %.
Muscle weakness, arthralgia
Mišićna slabost, artralgija
Reproductive system and breast disorders Uncommon:
Poremećaji reproduktivnog sustava i dojki Manje često:
• the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting)
• ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (osim alopecije, mučnine i povraćanja).
Hyperglycaemia, weight decreased
Hiperglikemija, smanjenje tjelesne težine
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).
nego u skupini bolesnika koji su primali prokarbazin (44 %) (hi-kvadrat p = 0,019).
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.
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.
Each capsule is approximately 21.4 mm in length.
Svaka je kapsula dugačka približno 21,4 mm.
Each hard capsule contains 14.6 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 14,6 mg bezvodne laktoze.
Allergic reaction, fever, radiation injury, face oedema, pain, taste perversion
Alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol,
Discontinue TMZ
Prekinuti primjenu TMZ-a
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.
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.
Baseline liver function tests should be performed prior to treatment initiation.
Prije započinjanja liječenja potrebno je provesti pretrage funkcije jetre.
Each hard capsule contains 168 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 168 mg bezvodne laktoze.
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.
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,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Each capsule is approximately 19.3 mm in length.
Svaka je kapsula dugačka približno 19,3 mm.
During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different.
Doza i način uzimanja Temozolomida Sandoz u fazi monoterapije razlikovat će se od prethodne faze.
Male patients
Zloćudne bolesti
The first dose will be 150 mg/m2.
150 mg/m2.
The bottles also contain a desiccant pouch.
Bočice sadrže i vrećicu sa sredstvom za sušenje.
Muscle weakness, arthralgia, musculoskeletal pain, myalgia
Mišićna slabost, artralgija, bol u mišićima i kostima, mialgija
Each hard capsule contains 182.5 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 182,5 mg bezvodne laktoze.
Myopathy, back pain, musculoskeletal pain, myalgia
Miopatija, bol u leđima, bol u mišićima i kostima, mialgija
The objective response rate (ORR) based on MRI scans was 8 %.
Objektivna stopa odgovora na liječenje (ORR) na temelju MR
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Plana (RMP), dokumenti mogu biti podneseni istodobno.
Very rare cases of lung side effects have been observed with temozolomide.
Pri primjeni temozolomida vrlo rijetko su primijećene nuspojave na plućima.
Infections and infestations Common:
Infekcije i infestacije
Asthenia, face oedema, pain, condition aggravated, rigors, tooth disorder
Astenija, edem lica, bol, pogoršanje stanja, tresavica, promjene na zubima
Each hard capsule contains 102.2 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 102,2 mg bezvodne laktoze.
Temozolomide Sandoz 5 mg
Temozolomid Sandoz 5 mg
Urinary incontinence
Inkontinencija mokraće
Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
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).
The bottles contain a desiccant pouch.
Bočice sadrže vrećicu sa sredstvom za sušenje.
Patients with newly-diagnosed glioblastoma multiforme
Bolesnici s novodijagnosticiranim multiformnim glioblastomom
Black iron oxide (E 172) Potassium hydroxide
Željezov oksid, crni (E172) Kalijev hidroksid
Printing ink: contains shellac, black iron oxide (E 172), potassium hydroxide.
Tinta za označavanje: sadrži šelak, crni željezov oksid (E 172), kalijev hidroksid.
Adult patients with newly-diagnosed glioblastoma multiforme
Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom
• dizziness
Dispneja
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Odrasli bolesnici i pedijatrijski bolesnici u dobi od 3 godine ili stariji s recidivirajućim ili progresivnim malignim gliomom
There is limited information in patients over 3 years of age who have taken Temozolomide Sandoz.
Informacije o primjeni Temozolomida Sandoz u djece starije od 3 godine su ograničene.
Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Temozolomid Sandoz 5 mg tvrde kapsule Jedna kapsula sadrži 5 mg temozolomida.
Table 4.
44. bol
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija,
Temozolomide Sandoz 20 mg
Temozolomid Sandoz 20 mg
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Kako čuvati Temozolomid Sandoz Ovaj lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
Table 2.TMZ dose levels for monotherapy treatment
Tablica 2. Razine doze TMZ-a u fazi monoterapije
• in adults with newly-diagnosed glioblastoma multiforme.
1. u odraslih s novodijagnosticiranim multiformnim glioblastomom.
Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Ovojnica kapsule: želatina, titanijev dioksid (E 171), indigo karmin (E 132), voda.
Temozolomide Sandoz 250 mg
Temozolomid Sandoz 250 mg
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Temozolomid Sandoz 250 mg tvrde kapsule Jedna kapsula sadrži 250 mg temozolomida.
Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Hemiplegija, ataksija, poremećaj koordinacije, poremećaj hoda, hiperestezija, poremećaj osjeta
Respiratory, thoracic and mediastinal disorders Common:
Poremećaji dišnog sustava, prsišta i sredoprsja Često:
The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Farmakokinetika TMZ-a u bolesnika s normalnom funkcijom jetre bila je slična kao u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
Adverse reactions in patients with recurrent or progressive malignant glioma
Tablica 5. Nuspojave u bolesnika s recidivirajućim ili progresivnim malignim gliomom
The cap is imprinted with “TMZ” and the body is imprinted with “180”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „180“.
• uncontrolled bleeding,
nespecificirani neurološki poremećaj,
Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Tinta za označavanje: šelak, crni željezov oksid (E 172), kalijev hidroksid.
Uncommon:
Nepoznato:
The cap is imprinted with “TMZ” and the body is imprinted with “5”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „5“.
The cap is imprinted with “TMZ” and the body is imprinted with “250”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „250“.
Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Temozolomid Sandoz 140 mg tvrde kapsule Jedna kapsula sadrži 140 mg temozolomida.
Titanium dioxide (E 171) Indigo carmine (E 132) Water
Titanijev dioksid (E171) Indigo karmin (E132) Voda
Temozolomide Sandoz 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Temozolomid Sandoz 20 mg tvrde kapsule Jedna kapsula sadrži 20 mg temozolomida.
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Tijekom radioterapije i kombiniranog liječenja TMZ-om morala se primijeniti profilaksa protiv Pneumocystis jirovecii pneumonije.
• haemorrhoids
Zamagljen vid
TMZ dose reduction or discontinuation during monotherapy treatment
Tablica 3. Smanjenje doze ili prekid primjene TMZ-a u fazi monoterapije
Temozolomide Sandoz 140 mg
Temozolomid Sandoz 140 mg
Each hard capsule contains 5 mg temozolomide.
Jedna tvrda kapsula sadrži 5 mg temozolomida.
The cap is imprinted with “TMZ” and the body is imprinted with “140”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „140“.
Common (may affect up to 1 in 10 people):
Česte (mogu se javiti u do 1 na 10 osoba):
Capsule shell: gelatine, titanium dioxide (E 171), water.
Ovojnica kapsule: želatina, titanijev dioksid (E 171), voda.
Temozolomide Sandoz 20 mg hard capsules yellow
Temozolomid Sandoz 20 mg tvrde kapsule žuta
Temozolomide Sandoz 180 mg
Temozolomid Sandoz 180 mg
Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Titanijev dioksid (E171) Željezov oksid, žuti (E172) Indigo karmin (E132) Voda
General disorders and administration site conditions Very common:
Opći poremećaji i reakcije na mjestu primjene Vrlo često:
• peeling skin
28. ljuštenje kože
• urticaria (hives)
crvenilo kože urtikarija (koprivnjača)
Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Temozolomid Sandoz 180 mg tvrde kapsule Jedna kapsula sadrži 180 mg temozolomida.
Each hard capsule contains 250 mg temozolomide.
Jedna tvrda kapsula sadrži 250 mg temozolomida.
Visual field defect, vision blurred, diplopia
Ispad vidnog polja, zamagljen vid, diplopija
• reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
infekcije usne šupljine infekcija rane smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija)
Uncommon (may affect up to 1 in 100 people):
Manje česte (mogu se javiti u do 1 na 100 osoba):
The cap is imprinted with “TMZ” and the body is imprinted with “20”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „20“.
Titanium dioxide (E 171) Red iron oxide (E 172) Water
Titanijev dioksid (E171) Željezov oksid, crveni (E 172) Voda
METHOD OF ADMINISTRATION
Način primjene
Each hard capsule contains 20 mg temozolomide.
Jedna tvrda kapsula sadrži 20 mg temozolomida.
TMZ discontinuation
Trajni prekid primjene TMZ-a
Temozolomide Sandoz 5 mg hard capsules green
Temozolomid Sandoz 5 mg tvrde kapsule zelena
Temozolomide Sandoz hard capsules should be administered in the fasting state.
Temozolomid Sandoz tvrde kapsule moraju se uzimati natašte.
Temozolomide Sandoz 250 mg hard capsules white
Temozolomid Sandoz 250 mg tvrde kapsule bijela
Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Temozolomid Sandoz 100 mg tvrde kapsule Jedna kapsula sadrži 100 mg temozolomida.
Gastrointestinal disorders
gastroenteritis, hemoroidi
Each hard capsule contains 140 mg temozolomide.
Jedna tvrda kapsula sadrži 140 mg temozolomida.
Haemorrhage, deep venous thrombosis, oedema leg
Krvarenje, tromboza dubokih vena, edem nogu
Capsule shell
Sadržaj kapsule
Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Sadržaj kapsule: bezvodna laktoza, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
Temozolomide Sandoz 100 mg
Temozolomid Sandoz 100 mg
Cushingoid
Cushingoidni izgled
Talk to your doctor, pharmacist or nurse before taking Temozolomide Sandoz
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).
The cap is imprinted with “TMZ” and the body is imprinted with “100”.
Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka „100“.
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor
Each hard capsule contains 180 mg temozolomide.
Jedna tvrda kapsula sadrži 180 mg temozolomida.
At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Na početku drugog ciklusa doza se povećava na 200 mg/m2 ako je CTC stupanj nehematološke toksičnosti za prvi ciklus bio ≤ 2 (osim za alopeciju, mučninu i povraćanje) te ako je apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l, a broj trombocita ≥ 100 x 109/l.
Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Ovojnica kapsule: želatina, titanijev dioksid (E 171), žuti željezov oksid (E 172), indigo karmin (E 132), voda.
Temozolomide Sandoz 5 mg hard capsules
Temozolomid Sandoz 5 mg tvrde kapsule