natgillin/translations-raw huggingface dataset:
Table 4 provides treatment-emergent adverse reactions in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
U Tablici 4 navedene su nuspojave koje su se pojavile tijekom liječenja u bolesnika s novodijagnosticiranim multiformnim glioblastomom u fazi istodobnog liječenja i fazi monoterapije.
Read the package leaflet before use .
Prije uporabe pročitajte Uputu o lijeku.
Infections and infestations* Uncommon:
Infekcije i infestacije* Manje često:
If you have not been treated before with chemotherapy, you will take your first dose of temozolomide at 200 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Ako niste prethodno liječeni kemoterapijom, prva doza temozolomida bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana („dani doziranja“) nakon čega slijede 23 dana bez temozolomida.
Treatment-emergent reactions during concomitant and monotherapy treatment phases in patients with newly diagnosed glioblastoma multiforme System organ class TMZ + concomitant RT
Tablica 4Nuspojave koje su se pojavile tijekom faze istodobnog liječenja i faze monoterapije u bolesnika s novodijagnosticiranim multiformnim glioblastomom Organski sustav TMZ + istodobna RT
• bloated stomach, difficulty controlling your bowel movements, haemorrhoids (piles)
• nadutost trbuha, poteškoće s kontroliranjem stolice, hemoroidi
At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC
Na početku drugog ciklusa doza se povećava na 200 mg/m2 ako je CTC stupanj nehematološke toksičnosti za prvi ciklus bio ≤ 2
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA VREĆICI
≥ 10 and < 100 x 109/l
 10 i < 100 x 109/l
Table 1.TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om
Hepatic enzymes increased,
povišene vrijednosti jetrenih enzima
If you have been treated before with chemotherapy, you will take your first dose of temozolomide at 150 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
Ako ste ranije već liječeni kemoterapijom, prva doza lijeka temozolomida bit će 150 mg/m2 jedanput na dan tijekom prvih 5 dana („dani doziranja“) nakon čega slijede 23 dana bez temozolomida.
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.
Prema podacima za 400 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.
Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
konvulzije, smanjena razina svijesti, somnolencija, afazija, poremećaj ravnoteže, omaglica, konfuzija, narušeno pamćenje, narušena koncentracija, neuropatija, 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
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VREĆICE
INFORMATION IN BRAILLE Temozolomide 20mg
Temozolomid 20 mg
Febrile neutropenia, anaemia Lymphopenia, petechiae
febrilna neutropenija, anemija limfopenija, petehije
• flu-like symptoms, red spots under the skin
• simptomi nalik gripi, crvene potkožne mrlje
• skin irritation or redness, dry skin, itching
• nadraženost ili crvenilo kože, suha koža, svrbež
printing ink: shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.
Tinta za označavanje: šelak, propilenglikol, crni željezov oksid (E172), kalijev hidroksid
Pneumonia, sinusitis, upper respiratory infection, bronchitis
pneumonija, infekcija gornjih dišnih puteva, kongestija nosa pneumonija, sinusitis, infekcija gornjih dišnih puteva, bronhitis
CTC Grade 3 or 4 a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC nonhaematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
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).
confusion, forgetfulness, difficulty concentrating, tingling sensation, “pins and needles”, difficulty speaking or understanding language, shaking, stroke.
smetenost, zaboravljivost, poteškoće s koncentracijom, osjećaj trnaca, „mravinjanje i bockanje“,
Concomitant phase
Faza istodobnog liječenja
Propylene glycol Black iron oxide (E172) Potassium hydroxide
Šelak propilenglikol željezov oksid, crni (E172) kalijev hidroksid
Somnolence, dizziness, paresthesia Respiratory, thoracic and mediastinal disorders Common:
somnolencija, omaglica, parestezije Poremećaji dišnog sustava, prsišta i sredoprsja Često:
liver enzymes elevations, hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
povišene vrijednosti jetrenih enzima, hiperbilirubinemija, kolestaza, oštećenje jetre, zatajenje jetre†
Skin exfoliation, photosensitivity reaction, pigmentation abnormal
eksfolijacija kože, reakcija fotoosjetljivosti, poremećaj pigmentacije eritem, poremećaj pigmentacije, pojačano znojenje
INFORMATION IN BRAILLE Temozolomide 5mg
Temozolomid 5 mg
Convulsions were reported very commonly in the newlydiagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
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.
Patients with recurrent or progressive malignant glioma
Bolesnici s recidivirajućim ili progresivnim malignim gliomom
- thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
- broj trombocita ≥ 100 x 109/l - nehematološka toksičnost prema općim kriterijima toksičnosti (engl. common toxicity criteria,
Temozolomide Accord 250 mg hard capsules: Each capsule contains 250 mg temozolomide.
Temozolomid Accord 250 mg tvrde kapsule: Svaka kapsula sadrži 250 mg temozolomida.
Vaginal haemorrhage, menorrhagia, amenorrhea, vaginitis, breast pain
Impotencija vaginalno krvarenje, menoragija, amenoreja, vaginitis, bol u dojkama
Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg temozolomide.
Temozolomid Accord 5 mg tvrde kapsule: Svaka kapsula sadrži 5 mg temozolomida.
INFORMATION IN BRAILLE Temozolomide 250mg
Temozolomid 250 mg
Blood and lymphatic system disorders Very rare:
Poremećaji krvi i limfnog sustava Vrlo rijetko:
INFORMATION IN BRAILLE Temozolomide 100mg
Temozolomid 100 mg
Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg temozolomide.
Temozolomid Accord 20 mg tvrde kapsule: Svaka kapsula sadrži 20 mg temozolomida.
• allergic reaction, fever, radiation injury, facial swelling, pain, changes in sense of taste
• alergijska reakcija, vrućica, ozljeda zbog zračenja, oticanje lica, bol, promjena osjeta okusa
hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
hiperbilirubinemija, kolestaza, hepatitis, oštećenje jetre, zatajenje jetre†
There is limited information in patients over 3 years of age who have taken Temozolomide Accord.
Informacije o primjeni lijeka Temozolomid Accord u djece starije od 3 godine su ograničene.
Not Known
I DOHVATA
Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg temozolomide.
Temozolomid Accord 140 mg tvrde kapsule: Svaka kapsula sadrži 140 mg temozolomida.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJRKA IZVAN POGLEDA
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Smatra se da je citotoksičnost MTIC-a prvenstveno posljedica alkilacije DNK većinom na položajima gvanina O6 i N7. U odnosu na AUC temozolomida izloženost MTIC-u iznosi ~2,4%, a izloženost AIC-u 23%.
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 5 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 5 mg tvrde kapsule
Febrile neutropenia, thrombocytopenia, anaemia, leukopenia
neutropenija, trombocitopenija, limfopenija, leukopenija febrilna neutropenija, trombocitopenija, anemija, leukopenija
Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
status epilepticus, ekstrapiramidalni poremećaj, hemipareza, ataksija, narušene kognitivne funkcije, disfazija, poremećaj hoda, hiperestezija, hipoestezija, nespecificirani neurološki poremećaj, periferna neuropatija hemiplegija, ataksija, poremećaj koordinacije, poremećaj hoda, hiperestezija, poremećaj osjeta
• long or repeated fits, tremors or jerking movement, partial paralysis, difficulty with your coordination and balance, changes in sensation of touch
• dugi ili ponavljajući napadaji, nevoljno drhtanje ili brzi, nevoljni pokreti, djelomična oduzetost,
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 20 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 20 mg tvrde kapsule
diabetes insipidus Respiratory, thoracic and mediastinal disorders
dijabetes insipidus Poremećaji dišnog sustava, prsišta i sredoprsja
Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg temozolomide.
Temozolomid Accord 180 mg tvrde kapsule: Svaka kapsula sadrži 180 mg temozolomida.
Each hardcapsule contains 131.4 mg of anhydrous lactose.
Jedna tvrda kapsula sadrži 131,4 mg laktoze, bezvodne.
Myopathy, back pain, musculoskeletal pain, myalgia
miopatija, bol u leđima, bol u mišićima i kostima, mialgija miopatija, bol u leđima
INFORMATION IN BRAILLE Temozolomide 180mg
Temozolomid 180 mg
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Tablica 3. Smanjenje doze ili prekid primjene TMZ-a u fazi monoterapije
See package leaflet for further information.
Za dodatne informacije pogledajte Uputu o lijeku.
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 capsule is approximately 21 mm in length.
Svaka kapsula je dugačka približno 21 mm.
Uncommon side-effects (may affect up to 1 in 100 people):
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
Each capsule is approximately 15 mm in length.
Svaka kapsula je dugačka približno 15 mm.
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 250 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 250 mg tvrde kapsule
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 140 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 140 mg tvrde kapsule
Each capsule is approximately 11 mm in length.
Svaka kapsula je dugačka približno 11 mm.
Temozolomide Accord 250 mg hard capsules: gelatine, titanium dioxide (E 171), water.
Temozolomid Accord 250 mg tvrde kapsule: želatina, titanijev dioksid (E171), voda.
Titanium dioxide (E171) Indigo carmine (E132).
Ovojnica kapsule želatina voda titanijev dioksid (E171) indigo karmin (E132)
Temozolomide Accord 5 mg hard capsules have a white body, a green cap, and are imprinted ‘TMZ' on cap and ‘5' on body with black ink.
Temozolomid Accord 5 mg tvrde kapsule imaju bijelo tijelo, zelenu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝5˝na tijelu.
Temozolomide Accord 180 mg hard capsules temozolomide
Temozolomid Accord 180 mg tvrde kapsule temozolomid
Temozolomide Accord 140 mg hard capsules: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Temozolomid Accord 140 mg tvrde kapsule: želatina, titanijev dioksid (E171), indigo karmin (E132), voda.
INFORMATION IN BRAILLE Temozolomide 140mg
Temozolomid 140 mg
Temozolomide Accord 250 mg hard capsules have a white body, a white cap, and are imprinted ‘TMZ' on cap and ‘250' on body with black ink.
Temozolomid Accord 250 mg tvrde kapsule imaju bijelo tijelo, bijelu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝250˝na tijelu.
Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
stomatitis, proljev, bolovi u abdomenu, dispepsija, disfagija stomatitis, proljev, dispepsija, disfagija, suha usta
Adult patients with newly-diagnosed glioblastoma multiforme:
Bolesnici s novodijagnosticiranim multiformnim glioblastomom:
• loss of appetite
• gubitak teka
Each hard capsule contains 5 mg of temozolomide.
Svaka tvrda kapsula sadrži 5 mg temozolomida.
Temozolomide Accord 5 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Temozolomid Accord 5 mg tvrde kapsule: želatina, titanijev dioksid (E171), žuti željezov oksid (E172), indigo karmin (E132), voda.
Temozolomide Accord 20 mg hard capsules temozolomide
Temozolomid Accord 20 mg tvrde kapsule temozolomid
Each capsule is approximately 19 mm in length.
Svaka kapsula je dugačka približno 19 mm.
Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
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.
Embolism pulmonary, oedema, oedema peripheral
cerebralno krvarenje, hipertenzija plućna embolija, edem, periferni edem
Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg temozolomide.
Temozolomid Accord 100 mg tvrde kapsule: Svaka kapsula sadrži 100 mg temozolomida.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/615/005
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/615/005
Shellac
dizurija
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 180 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 180 mg tvrde kapsule
Each hard capsule contains 250 mg of temozolomide.
Svaka tvrda kapsula sadrži 250 mg temozolomida.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Ovojnica kapsule želatina voda titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Temozolomide Accord 5 mg hard capsules temozolomide
Temozolomid Accord 5 mg tvrde kapsule temozolomid
The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ' on cap & ‘250' on body.
Tvrde kapsule su bijelo/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝250˝ na tijelu.
Temozolomide Accord 140 mg hard capsules temozolomide
Temozolomid Accord 140 mg tvrde kapsule temozolomid
If you get any side effects, talk to your doctor, pharmacist or nurse.
Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Method of administration
NAČIN PRIMJENE
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 250 mg temozolomida.
TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Davanje TMZ-a može se nastaviti tijekom 42 dana faze istodobnog liječenja (do najviše 49 dana) ako su zadovoljeni svi sljedeći uvjeti: - apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l - broj trombocita ≥ 100 x 109/l
Each hard capsule contains 20 mg of temozolomide.
Svaka tvrda kapsula sadrži 20 mg temozolomida.
Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are imprinted ‘TMZ' on cap and ‘100' on body with black ink.
Temozolomid Accord 100 mg tvrde kapsule imaju bijelo tijelo, ružičastu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝100˝na tijelu.
NAME OF THE MEDICINAL PRODUCT Temozolomide Accord 100 mg hard capsules.
NAZIV LIJEKA Temozolomid Accord 100 mg tvrde kapsule
Each hard capsule contains 140 mg of temozolomide.
Svaka tvrda kapsula sadrži 140 mg temozolomida.
The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ' on cap & ‘5' on body.
Tvrde kapsule su zeleno/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝5˝ na tijelu.
Each hard capsule contains 180 mg of temozolomide.
Svaka tvrda kapsula sadrži 180 mg temozolomida.
Temozolomide Accord 100 mg hard capsules temozolomide
Temozolomid Accord 100 mg tvrde kapsule temozolomid
Temozolomide Accord 250 mg hard capsules temozolomide
Temozolomid Accord 250 mg tvrde kapsule Temozolomid
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 250 mg hard capsules temozolomide
NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 250 mg tvrde kapsule Temozolomid
Temozolomide Accord 20 mg hard capsules have a white body, a yellow cap, and are imprinted ‘TMZ' on cap and ‘20' on body with black ink.
Temozolomid Accord 20 mg tvrde kapsule imaju bijelo tijelo, žutu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝20˝na tijelu.
Temozolomide Accord 140 mg hard capsules have a white body, a blue cap, and are imprinted ‘TMZ' on cap and ‘140' on body with black ink.
Temozolomid Accord 140 mg tvrde kapsule imaju bijelo tijelo, plavu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝140˝na tijelu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 20 mg temozolomida.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 5 mg temozolomida.
Ingestion can be lethal.
Gutanje može biti smrtonosno.
Temozolomide Accord 20 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Temozolomid Accord 20 mg tvrde kapsule: želatina, titanijev dioksid (E171), žuti željezov oksid (E172), voda.
Temozolomide Accord 180 mg hard capsules: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Temozolomid Accord 180 mg tvrde kapsule: želatina, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172), voda.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 20 mg hard capsules temozolomide
NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 20 mg tvrde kapsule Temozolomid
SACHET LABEL
NALJEPNICA NA VREĆICI
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 140 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 140 mg temozolomida.
Temozolomide Accord 100 mg hard capsules: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Temozolomid Accord 100 mg tvrde kapsule: želatina, titanijev dioksid (E171), crveni željezov oksid (E172), voda.
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 pneumonije uzrokovane
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 180 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 180 mg temozolomida.
The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ' on cap & ‘180' on body.
Tvrde kapsule su smeđe/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝180˝ na tijelu.
Each hard capsule contains 100 mg of temozolomide.
Svaka tvrda kapsula sadrži 100 mg temozolomida.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 140 mg hard capsules temozolomide
NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 140 mg tvrde kapsule Temozolomid
Micturition frequency, urinary incontinence
učestalo mokrenje, inkontinencija mokraće inkontinencija mokraće
TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8) .
4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima TMZ malo utječe na sposobnost upravljanja vozilima i rada na strojevima zbog umora i somnolencije (vidjeti dio 4.8).
Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are imprinted ‘TMZ' on cap and ‘180' on body with black ink.
Temozolomid Accord 180 mg tvrde kapsule imaju bijelo tijelo, narančastu kapicu i crnom tintom otisnutu oznaku ˝TMZ˝na kapici i ˝180˝na tijelu.
Uncommon hyperbilirubinemia, cholestasis, hepatitis hepatic injury, hepatic failure†
Manje često hiperbilirubinemija, kolestaza, hepatitis, oštećenje jetre, zatajenje jetre†
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 180 mg hard capsules temozolomide
NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 180 mg tvrde kapsule Temozolomid
The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘100' on body.
Tvrde kapsule su ružičasto/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝100˝ na tijelu.
reduced, vision disorder, visual field defect, eye pain eyes dry
zamagljen vid ispad vidnog polja, zamagljen vid, diplopija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg temozolomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži 100 mg temozolomida.
Titanium dioxide (E171) Iron oxide yellow (E172)
Ovojnica kapsule želatina voda titanijev dioksid (E171) željezov oksid, žuti (E172)
Capsule shell Gelatine
kalijev hidroksid
Table 4.
Tablica 1.
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 49 dana) ako su zadovoljeni svi sljedeći uvjeti: - apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l
• the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
• ako se nakon smanjenja doze ponovno jave isti nehematološki toksični učinci stupnja 3 (osim alopecije, mučnine i povraćanja)
Each hard capsule contains 14.6 mg of anhydrous lactose.
Pomoćna tvar s poznatim učinkom Jednatvrda kapsula sadrži 14,6 mg laktoze, bezvodne.
Dyspnoea
dispneja
The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘140' on body.
Kapsule su prozirne plavo/bijele tvrde želatinske kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝140˝ na tijelu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temozolomide Accord 100 mg hard capsules temozolomide
NAZIV LIJEKA I PUT(EVI) PRIMJENE Temozolomid Accord 100 mg tvrde kapsule Temozolomid
Allergic reaction, fever, radiation injury, face oedema, pain, taste
alergijska reakcija, vrućica, ozljeda zbog zračenja, edem lica, bol, promjena osjeta okusa alergijska reakcija, vrućica, ozljeda zbog zračenja, bol,
OF THE SIGHT AND OF CHILDREN
I DOHVATA DJECE
The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ' on cap & ‘20' on body.
Tvrde kapsule su žuto/bijele tvrde kapsule s otisnutom oznakom ˝TMZ˝ na kapici i ˝20˝ na tijelu.
Fever, asthenia, rigors, malaise, pain, taste perversion
vrućica, astenija, tresavica, malaksalost, bol, promjena osjeta okusa
TMZ dose levels for monotherapy treatment
Razine doze TMZ-a u fazi monoterapije