Temozolomide Teva

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
18-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
18-02-2022
Public Assessment Report Public Assessment Report (PAR)
18-09-2014

Active ingredient:

temozolomide

Available from:

Teva B.V. 

ATC code:

L01AX03

INN (International Name):

temozolomide

Therapeutic group:

Antineoplastiski līdzekļi

Therapeutic area:

Glioma; Glioblastoma

Therapeutic indications:

Pieaugušiem pacientiem ar nesen diagnosticētu multiformo glioblastomu vienlaikus ar staru terapiju (RT) un vēlāk kā monoterapijas terapiju. Par attieksmi pret bērniem vecumā no trīs gadiem, pusaudžiem un pieaugušiem pacientiem ar ļaundabīgiem glioma, piemēram, glioblastoma multiforme vai anaplastic astrocytoma, parādot atkārtošanās vai progresēšanu pēc tam, kad standarta terapija.

Product summary:

Revision: 21

Authorization status:

Autorizēts

Authorization date:

2010-01-28

Patient Information leaflet

                                41
B.
LIETOŠANAS INSTRUKCIJA
42
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
TEMOZOLOMIDE TEVA 5 MG CIETĀS KAPSULAS
TEMOZOLOMIDE TEVA 20 MG CIETĀS KAPSULAS
TEMOZOLOMIDE TEVA 100 MG CIETĀS KAPSULAS
TEMOZOLOMIDE TEVA 140 MG CIETĀS KAPSULAS
TEMOZOLOMIDE TEVA 180 MG CIETĀS KAPSULAS
TEMOZOLOMIDE TEVA 250 MG CIETĀS KAPSULAS
temozolomide
PIRMS ZĀĻU LIETOŠANAS UZMANĪGI IZLASIET VISU INSTRUKCIJU, JO TĀ
SATUR JUMS SVARĪGU INFORMĀCIJU.
•
Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.
•
Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam vai farmaceitam,
vai medmāsai.
•
Šīs zāles ir parakstītas tikai Jums. Nedodiet tās citiem. Tās
var nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.
•
Ja Jums rodas jebkādas blakusparādības, konsultējieties ar ārstu,
farmaceitu vai medmāsu. Tas
attiecas arī uz iespējamām blakusparādībām, kas nav minētas
šajā instrukcijā. Skatīt 4. punktu.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Temozolomide Teva un kādam nolūkam to lieto
2.
Kas Jums jāzina pirms Temozolomide Teva lietošanas
3.
Kā lietot Temozolomide Teva
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Temozolomide Teva
6.
Iepakojuma saturs un cita informācija
1.
KAS IR TEMOZOLOMIDE TEVA UN KĀDAM NOLŪKAM TO LIETO
Temozolomide Teva satur zāles, ko sauc par temozolomīdu. Šīs
zāles ir pretvēža līdzeklis.
Temozolomide Teva lieto pacientu ar specifisku smadzeņu audzēju
formu ārstēšanai:
•
pieaugušajiem ar pirmreizēju multiformo glioblastomu. Temozolomide
Teva vispirms lieto
vienlaicīgi ar staru terapiju (vienlaicīgās terapijas fāze) un
pēc tam vienu pašu (ārstēšanas
monoterapijas fāze);
•
bērniem no 3 gadu vecuma un pieaugušajiem ar ļaundabīgu gliomu,
piemēram, multiformo
glioblastomu vai anaplastisko astrocitomu. Temozolomide Teva lieto šo
audzēju gadījumā, ja
pēc standartterapijas konstatēts recidīvs vai audzēja
progresēšana.
2.
KAS JUMS JĀZINA PIRMS TEMOZOLOMIDE TEVA LIE
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Temozolomide Teva 5 mg cietās kapsulas
Temozolomide Teva 20 mg cietās kapsulas
Temozolomide Teva 100 mg cietās kapsulas
Temozolomide Teva 140 mg cietās kapsulas
Temozolomide Teva 180 mg cietās kapsulas
Temozolomide Teva 250 mg cietās kapsulas
2.
KVALITATĪVAIS UN KVANTĪTATĪVAIS SASTĀVS
Temozolomide Teva 5 mg cietās kapsulas
Katra cietā kapsula satur 5 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 87 mg laktozes.
Temozolomide Teva 20 mg cietās kapsulas
Katra cietā kapsula satur 20 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 72 mg laktozes un saulrieta dzelteno FCF
(E110).
Temozolomide Teva 100 mg cietās kapsulas
Katra cietā kapsula satur 100 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 84 mg laktozes.
Temozolomide Teva 140 mg cietās kapsulas
Katra cietā kapsula satur 140 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 117 mg laktozes.
Temozolomide Teva 180 mg cietās kapsulas
Katra cietā kapsula satur 180 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 150 mg laktozes.
Temozolomide Teva 250 mg cietās kapsulas
Katra cietā kapsula satur 250 mg temozolomīda (
_temozolomide_
).
_Palīgviela ar zināmu iedarbību _
Katra cietā kapsula satur 209 mg laktozes.
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3
3.
ZĀĻU FORMA
Cietā kapsula.
Temozolomide Teva 5 mg cietās kapsulas
Cietām kapsulām ir necaurspīdīgs balts korpuss un vāciņš, uz
kura ar zaļu tinti uzdrukātas divas
svītras; uz korpusa ar zaļu tinti ir uzdruka "T 5 mg". Katras
kapsulas garums ir aptuveni 16 mm.
Temozolomide Teva 20 mg cietās kapsulas
Cietām kapsulām ir necaurspīdīgs balts korpuss un vāciņš, uz
kura ar oranžu tinti uzdrukātas divas
svītras; uz korpusa ar oranžu tinti ir uzdruk
                                
                                Read the complete document

Similar products

Active ingredient temozolomide

temozolomide

ATC code L01AX03

L01AX03

Marketed by Teva B.V. 

Teva B.V. 

INN (International Name) temozolomide

temozolomide

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 18-02-2022
Public Assessment Report Public Assessment Report Bulgarian 18-09-2014
Patient Information leaflet Patient Information leaflet Spanish 18-02-2022
Summary of Product characteristics Summary of Product characteristics Spanish 18-02-2022
Public Assessment Report Public Assessment Report Spanish 18-09-2014
Patient Information leaflet Patient Information leaflet Czech 18-02-2022
Summary of Product characteristics Summary of Product characteristics Czech 18-02-2022
Public Assessment Report Public Assessment Report Czech 18-09-2014
Patient Information leaflet Patient Information leaflet Danish 18-02-2022
Summary of Product characteristics Summary of Product characteristics Danish 18-02-2022
Public Assessment Report Public Assessment Report Danish 18-09-2014
Patient Information leaflet Patient Information leaflet German 18-02-2022
Summary of Product characteristics Summary of Product characteristics German 18-02-2022
Public Assessment Report Public Assessment Report German 18-09-2014
Patient Information leaflet Patient Information leaflet Estonian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Estonian 18-02-2022
Public Assessment Report Public Assessment Report Estonian 18-09-2014
Patient Information leaflet Patient Information leaflet Greek 18-02-2022
Summary of Product characteristics Summary of Product characteristics Greek 18-02-2022
Public Assessment Report Public Assessment Report Greek 18-09-2014
Patient Information leaflet Patient Information leaflet English 18-02-2022
Summary of Product characteristics Summary of Product characteristics English 18-02-2022
Public Assessment Report Public Assessment Report English 18-09-2014
Patient Information leaflet Patient Information leaflet French 18-02-2022
Summary of Product characteristics Summary of Product characteristics French 18-02-2022
Public Assessment Report Public Assessment Report French 18-09-2014
Patient Information leaflet Patient Information leaflet Italian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Italian 18-02-2022
Public Assessment Report Public Assessment Report Italian 18-09-2014
Patient Information leaflet Patient Information leaflet Lithuanian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 18-02-2022
Public Assessment Report Public Assessment Report Lithuanian 18-09-2014
Patient Information leaflet Patient Information leaflet Hungarian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 18-02-2022
Public Assessment Report Public Assessment Report Hungarian 18-09-2014
Patient Information leaflet Patient Information leaflet Maltese 18-02-2022
Summary of Product characteristics Summary of Product characteristics Maltese 18-02-2022
Public Assessment Report Public Assessment Report Maltese 18-09-2014
Patient Information leaflet Patient Information leaflet Dutch 18-02-2022
Summary of Product characteristics Summary of Product characteristics Dutch 18-02-2022
Public Assessment Report Public Assessment Report Dutch 18-09-2014
Patient Information leaflet Patient Information leaflet Polish 18-02-2022
Summary of Product characteristics Summary of Product characteristics Polish 18-02-2022
Public Assessment Report Public Assessment Report Polish 18-09-2014
Patient Information leaflet Patient Information leaflet Portuguese 18-02-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 18-02-2022
Public Assessment Report Public Assessment Report Portuguese 18-09-2014
Patient Information leaflet Patient Information leaflet Romanian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Romanian 18-02-2022
Public Assessment Report Public Assessment Report Romanian 18-09-2014
Patient Information leaflet Patient Information leaflet Slovak 18-02-2022
Summary of Product characteristics Summary of Product characteristics Slovak 18-02-2022
Public Assessment Report Public Assessment Report Slovak 18-09-2014
Patient Information leaflet Patient Information leaflet Slovenian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 18-02-2022
Public Assessment Report Public Assessment Report Slovenian 18-09-2014
Patient Information leaflet Patient Information leaflet Finnish 18-02-2022
Summary of Product characteristics Summary of Product characteristics Finnish 18-02-2022
Public Assessment Report Public Assessment Report Finnish 18-09-2014
Patient Information leaflet Patient Information leaflet Swedish 18-02-2022
Summary of Product characteristics Summary of Product characteristics Swedish 18-02-2022
Public Assessment Report Public Assessment Report Swedish 18-09-2014
Patient Information leaflet Patient Information leaflet Norwegian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 18-02-2022
Patient Information leaflet Patient Information leaflet Icelandic 18-02-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 18-02-2022
Patient Information leaflet Patient Information leaflet Croatian 18-02-2022
Summary of Product characteristics Summary of Product characteristics Croatian 18-02-2022
Public Assessment Report Public Assessment Report Croatian 18-09-2014

Search alerts related to this product

Alerts Temozolomide Teva

Temozolomide Teva

View documents history

Documents history Documents history

Temozolomide Teva