natgillin/translations-raw huggingface dataset:
Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations 
Tablica 5. Nuspojave u bolesnika s recidivirajućim ili progresivnim malignim gliomom Infekcije i infestacije
Convulsions, consciousness 
konvulzije, smanjena razina svijesti,
Newly-diagnosed glioblastoma multiforme 
Novo dijagnosticirani multiformni glioblastom
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). 
TMZ se primjenjuje peroralno u dozi od 75 mg/m2 na dan tijekom 42 dana uz istodobnu radioterapiju
Side effects from clinical studies 
Nuspojave iz kliničkih ispitivanja:
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 pet dana, svakih 28 dana.
Excipient with known effect Each hard capsule contains 227.001 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 227,001 mg laktoze.
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % 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. 
ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8% žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4) 
neutropenija ili limfopenija (stupanj 3-4),
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jiroveciipneumonia (PCP). 
Pneumonija uzrokovana s Pneumocystis jirovecii Bolesnici koji su u pilot istraživanju istodobno primali TMZ i RT prema produljenom 42-dnevnom režimu liječenja bili su izloženi osobitom riziku od razvoja pneumonije uzrokovane Pneumocystis jirovecii.
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain 
impotencija vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Temozolomide SUN 20 mg 
Temozolomid SUN 20 mg
Temozolomide SUN 5 mg 
Temozolomid SUN 5 mg
Cytotoxic. 
TMZ-a.
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. 
Česte (mogu se javiti u do 1 na 10 osoba): gubitak tjelesne težine, pospanost, omaglica, trnci, nedostatak zraka, proljev, bol u trbuhu, želučane tegobe, osip, svrbež, gubitak kose, vrućica, slabost, drhtavica, loše osjećanje, bol, promjene osjeta okusa.
Temozolomide SUN 250 mg 
Temozolomid SUN 250 mg
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. 
žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
Allergic reaction, fever, radiation injury, pain, taste perversion 
promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol, promjena osjeta okusa
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma. 
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.
Stomatitis, diarrhoea, abdominal pain, dyspepsia, dysphagia 
stomatitis, proljev, bolovi u abdomenu, dispepsija, disfagija stomatitis, proljev, dispepsija,
Temozolomide SUN is at first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). 
se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).
neuropathy, paresthesia, speech disorder, tremor neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor 
nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor
The cap is imprinted with ‘890'. 
Na kapici je otisnuta oznaka '890'.
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./ 
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Temozolomide SUN 140 mg 
Temozolomid SUN 140 mg
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). 
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
Excipient with known effect Each hard capsule contains 30.97 mg of lactose. 
Jedna tvrda kapsula sadrži 30,97 mg laktoze.
The cap is imprinted with ‘891'. 
Na kapici je otisnuta oznaka '891'.
Temozolomide SUN 180 mg 
Temozolomid SUN 180 mg
- if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). 
Što morate znati prije nego počnete uzimati Temozolomid SUN Nemojte uzimati Temozolomid SUN - ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia). 
Manje česte (mogu se javiti u do 1 na 100 osoba): smanjen broj krvnih stanica (pancitopenija,
Sun Pharma Laboratorios, S.L. 
Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55
The cap is imprinted with ‘892'. 
Na kapici je otisnuta oznaka '892'.
The cap is imprinted with ‘893'. 
Na kapici je otisnuta oznaka '893'.
Febrile neutropenia, thrombocytopenia, anaemia, leukopenia 
limfopenija, leukopenija febrilna neutropenija, trombocitopenija, anemija, leukopenija
The body is imprinted with '20 mg' and two stripes. 
Na tijelu je otisnuta oznaka '20 mg' i dvije crte.
Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. 
Kad se jednom poveća, doza ostaje na razini od 200 mg/m2 na dan tijekom prvih 5
Temozolomide SUN monotherapy in recurrent or progressive glioma 
Monoterapija Temozolomid SUN-om u bolesnika s ponovnom pojavom ili pogoršanjem glioma
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ 
Nederland/Pays-Bas/Niederlande/Нидерландия /Nizozemsko/
Temozolomide SUN 100 mg 
Temozolomid SUN 100 mg
Pneumocystis jiroveciipneumonia (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.
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: 
Davanje TMZ-a može se nastaviti tijekom 42 dana faze istodobnog liječenja (do najviše
The body is imprinted with ‘140 mg' and two stripes. 
Na tijelu je otisnuta oznaka '140 mg' i dvije crte.
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:
decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor 
parestezije, poremećaj govora, tremor hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija, periferna neuropatija, parestezije, poremećaj govora, tremor
In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % 
Prema podacima za 400 ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8%
Contains lactose. 
Progutati ih cijele.
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, 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. 
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, tupi bolovi i probadanja 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.
Hearing impairment, tinnitus 
oštećenje sluha oštećenje sluha, tinitus
The body is imprinted with ‘5 mg' and two stripes. 
Na tijelu je otisnuta oznaka '5 mg' i dvije crte.
The body is imprinted with ‘250 mg' and two stripes. 
Na tijelu je otisnuta oznaka '250 mg' i dvije crte.
The body is imprinted with ‘180 mg' and two stripes. 
Na tijelu je otisnuta oznaka '180 mg' i dvije crte.
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. 
Manje česte (mogu se javiti u do 1 na 100 osoba): simptomi nalik gripi, crvene potkožne mrlje, niska razina kalija u krvi, povećanje tjelesne težine, promjene raspoloženja, halucinacije i poremećaj pamćenja, djelomična paraliza, poremećaj koordinacije, poremećaj osjeta, djelomičan gubitak vida, suhe ili bolne oči, gluhoća, infekcija srednjeg uha, zvonjava u ušima, bol u uhu, palpitacije (osjećaj lupanja 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, nadraženost rodnice, bol u dojkama, navale vrućine, drhtavica, promjena boje jezika, promjena osjeta mirisa, žeđ, promjene na zubima.
Temozolomide SUN 250 mg hard capsules 
Temozolomid SUN 250 mg tvrde kapsule
Very rare cases of lung side effects have been observed with Temozolomide SUN. 
Pri primjeni Temozolomid SUN-a vrlo rijetko su primijećene nuspojave na plućima.
Propylene glycol Black iron oxide (E172) 
šelak propilenglikol željezov oksid, crni (E172)
Temozolomide SUN 5 mg hard capsules 
Temozolomid SUN 5 mg tvrde kapsule
- The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, yellow iron oxide (E172), blue #1/Brilliant Blue FCF Aluminium Lake (E133). 
- Drugi sastojci su: sadržaj kapsule: laktoza, natrijev škroboglikolat, vrste B, tartaratna kiselina, stearatna kiselina (pogledajte dio 2 "Temozolomid SUN sadrži laktozu") ovojnica kapsule: želatina, titanijev dioksid (E171), natrijev laurilsulfat tinta za označavanje: šelak, propilenglikol, žuti željezov oksid (E172), Blue #1/Brilliant Blue
Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93 
20143 Milano Italia tel.
What Temozolomide SUN is and what it is used for What you need to know before you take Temozolomide SUN How to take Temozolomide SUN Possible side effects 
Kako uzimati Temozolomid SUN Moguće nuspojave Kako čuvati Temozolomid SUN
Temozolomide SUN 140 mg hard capsules 
Temozolomid SUN 140 mg tvrde kapsule
Temozolomide SUN 20 mg hard capsules temozolomide 
Temozolomid SUN 20 mg tvrde kapsule temozolomid
Temozolomide SUN 250 mg hard capsules have a white opaque body and cap, imprinted in black ink. 
Temozolomid SUN 250 mg tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s crnom tintom.
Temozolomide SUN 180 mg hard capsules 
Temozolomid SUN 180 mg tvrde kapsule
Temozolomide SUN 20 mg hard capsules 
Temozolomid SUN 20 mg tvrde kapsule
Temozolomide SUN 140 mg hard capsules temozolomide 
Temozolomid SUN 140 mg tvrde kapsule temozolomid
Each hard capsule contains 20 mg temozolomide. 
Jedna tvrde kapsula sadrži 20 mg temozolomida.
Temozolomide SUN 250 mg hard capsules temozolomide 
Temozolomid SUN 250 mg tvrde kapsule temozolomid
Propylene glycol Red iron oxide (E172) 
šelak propilenglikol željezov oksid, crveni (E172)
Temozolomide SUN 140 mg hard capsules have a white opaque body and cap, imprinted in blue ink. 
Temozolomid SUN 140 mg tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s plavom tintom.
Each hard capsule contains 5 mg temozolomide. 
Jedna tvrde kapsula sadrži 5 mg temozolomida.
Temozolomide SUN 5 mg hard capsules have a white opaque body and cap, imprinted in green ink. 
Temozolomid SUN 5 mg tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute sa zelenom tintom.
Each hard capsule contains 140 mg temozolomide. 
Jedna tvrde kapsula sadrži 140 mg temozolomida.
Temozolomide SUN 5 mg hard capsules temozolomide 
Temozolomid SUN 5 mg tvrde kapsule temozolomid
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, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l. 
(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.
Each hard capsule contains 180 mg temozolomide. 
Jedna tvrde kapsula sadrži 180 mg temozolomida.
Package Leaflet: Information for the user Temozolomide SUN 250 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 250 mg tvrde kapsule temozolomid
Summary of events reported with temozolomide in the post-marketing setting* 
Nakon stavljanja lijeka u promet zabilježene su sljedeće dodatne ozbiljne nuspojave: Tablica 6. Sažetak štetnih događaja prijavljenih nakon stavljanja temozolomida u promet Infekcije i infestacije*
During the monotherapy phase, the dose and way you take Temozolomide SUN can vary. 
Doza i način uzimanja Temozolomid SUN-a u fazi monoterapije razlikovat će se od prethodne faze.
Temozolomide SUN 100 mg hard capsules 
Temozolomid SUN 100 mg tvrde kapsule
Temozolomide SUN 20 mg hard capsules have a white opaque body and cap, imprinted in yellow ink. 
Temozolomid SUN 20 mg želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute sa žutom tintom.
Package Leaflet: Information for the user Temozolomide SUN 20 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 20 mg tvrde kapsule temozolomid
The body is imprinted with ‘100 mg' and two stripes. 
Na tijelu je otisnuta oznaka '100 mg' i dvije crte.
Temozolomide SUN 180 mg hard capsules temozolomide 
Temozolomid SUN 180 mg tvrde kapsule temozolomid
Neutropenia, thrombocytopenia, lymphopenia, leukopenia 
trombocitopenija, anemija, leukopenija
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, 
parestezije, poremećaj govora, tremor hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje,
United Kingdom 
United Kingdom tel.
Propylene glycol Yellow iron oxide (E172) 
šelak propilenglikol željezov oksid, žuti (E172)
Package Leaflet: Information for the user Temozolomide SUN 5 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 5 mg tvrde kapsule temozolomid
Fever, asthenia, rigors, malaise, pain, taste perversion 
vrućica, astenija, tresavica, slabost, bol, promjena osjeta okusa
Other special populations 
Druge posebne populacije bolesnika Spol
Temozolomide SUN 100 mg hard capsules temozolomide 
Temozolomid SUN 100 mg tvrde kapsule temozolomid
Package Leaflet: Information for the user Temozolomide SUN 180 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 180 mg tvrde kapsule temozolomid
Package Leaflet: Information for the user Temozolomide SUN 140 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 140 mg tvrde kapsule temozolomid
CTC Grade 2 
Razina doze
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ 
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/
Cerebral haemorrhage, hypertension 
gastroenteritis, hemoroidi
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, 
somnolencija, afazija, poremećaj ravnoteže, omaglica, konfuzija, narušeno pamćenje, narušena koncentracija, neuropatija,
Temozolomide SUN 180 mg hard capsules have a white opaque body and cap, imprinted in red ink. 
Temozolomid SUN 180 mg tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s crvenom tintom.
Imprint 
PRILOG
Hard gelatin capsule, with white opaque cap and body, imprinted in yellow ink. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute sa žutom tintom.
Temozolomide SUN may make you feel tired or sleepy. 
Upravljanje vozilima i strojevima Temozolomid SUN može uzrokovati umor ili pospanost.
Patients with newly-diagnosed glioblastoma multiforme 
Bolesnici s novodijagnosticiranim multiformnim glioblastomom:
Temozolomide SUN 100 mg hard capsules have a white opaque body and cap, imprinted in pink ink. 
Temozolomid SUN 100 mg tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s rozom tintom.
Package Leaflet: Information for the user Temozolomide SUN 100 mg hard capsules temozolomide 
Uputa o lijeku: Informacije za korisnika Temozolomid SUN 100 mg tvrde kapsule temozolomid
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry 
dispneja, kašalj dispneja, kašalj
TMZ dose levels for monotherapy treatment Dose level 
Razine doze TMZ-a u fazi monoterapije
- The other ingredients are: capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 "Temozolomide SUN contains lactose") capsule shell: gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, titanium dioxide (E171), blue #1/Brilliant Blue FCF Aluminium Lake (E133). 
ovojnica kapsule: želatina, titanijev dioksid (E171), natrijev laurilsulfat tinta za označavanje: šelak, propilenglikol, titanijev dioksid (E171), Blue #1/Brilliant Blue FCF Aluminium Lake (E133).
EU/1/11/697/017 (5 hard capsules) EU/1/11/697/018 (20 hard capsules) 
EU/1/11/697/017 (5 tvrdih kapsula) EU/1/11/697/018 (20 tvrdih kapsula)
Hard gelatin capsules, with white opaque cap and body, imprinted in blue ink. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s plavom tintom.
Hard gelatin capsules, with white opaque cap and body, imprinted in black ink. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s crnom tintom.
Stomatitis, diarrhoea, 
neutropenija, trombocitopenija,
Hard gelatin capsules, with white opaque cap and body, imprinted in green ink. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute sa zelenom tintom.
Propylene glycol Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) 
šelak propilenglikol titanijev dioksid (E171)
Hard gelatin capsules, with white opaque cap and body, imprinted in red ink. 
Tvrde želatinske kapsule s bijelom neprozirnom kapicom i tijelom, otisnute s crvenom tintom.
EU/1/11/697/015 (5 hard capsules) EU/1/11/697/016 (20 hard capsules) 
EU/1/11/697/015 (5 tvrdih kapsula) EU/1/11/697/016 (20 tvrdih kapsula)
EU/1/11/697/023 (5 hard capsules) EU/1/11/697/024 (20 hard capsules) 
EU/1/11/697/023 (5 tvrdih kapsula) EU/1/11/697/024 (20 tvrdih kapsula)
Name and address of the manufacturer responsible for batch release 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Sun Pharmaceutical Industries Europe BV
- the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. 
CTC stupanj nehematološke toksičnosti (osim alopecije, mučnine i povraćanja) CTC stupnja 2
EU/1/11/697/013 (5 hard capsules) EU/1/11/697/014 (20 hard capsules) 
EU/1/11/697/013 (5 tvrdih kapsula) EU/1/11/697/014 (20 tvrdih kapsula)
EU/1/11/697/023 (5 capsules in blister) EU/1/11/697/024 (20 capsules in blister) 
EU/1/11/697/023 (5 kapsula u blisteru) EU/1/11/697/024 (20 kapsula u blisteru)
EU/1/11/697/021 (5 hard capsules) EU/1/11/697/022 (20 hard capsules) 
EU/1/11/697/021 (5 tvrdih kapsula) EU/1/11/697/022 (20 tvrdih kapsula)
EU/1/11/697/019 (5 hard capsules) EU/1/11/697/020 (20 hard capsules) 
EU/1/11/697/019 (5 tvrdih kapsula) EU/1/11/697/020 (20 tvrdih kapsula)
Then, you will have 23 days without Temozolomide SUN. 
Zatim slijede 23 dana bez uzimanja Temozolomid SUN-a, što čini ukupno 28 dana terapijskog ciklusa.