Etoposid-Ebewe 20mg/ml concentrate for solution for infusion

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

etoposide

Dostopno od:

EBEWE Pharma Ges. m.b.H. Nfg. KG

Koda artikla:

L01CB01

INN (mednarodno ime):

etoposide

Odmerek:

20mg/ml

Farmacevtska oblika:

concentrate for solution for infusion

Enote v paketu:

glass vial 5ml

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2015-05-15

Lastnosti izdelka

m12 - en-spc-pl-w - 12
1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Etoposid Ebewe
®
20mg/ml Concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
International nonproprietary name: etoposide
1 ml of concentrate contains 20 mg of etoposide.
Excipient(s) with known effect:
1 ml of concentrate contains 260.60 mg of Ethanol and 20 mg of Benzyl
alcohol.
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear light yellow solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
TESTICULAR CANCER
- is indicated in combination with other approved chemotherapeutic
agents for the first-line
treatment of recurrent or refractory testicular cancer in adults.
SMALL CELL LUNG CANCER
- is indicated in combination with other approved chemotherapeutic
agents for the treatment
of small-cell lung cancer in adults.
HODGKIN’S LYMPHOMA
- is indicated in combination with other approved chemotherapeutic
agents for the treatment
of Hodgkin's lymphoma in adult and paediatric patients.
NON-HODGKIN’S LYMPHOMA
- is indicated in combination with other approved chemotherapeutic
agents for the treatment
of non-Hodgkin's lymphoma in adult and paediatric patients.
ACUTE MYELOID LEUKAEMIA
- is indicated in combination with other approved chemotherapeutic
agents for the treatment
of acute myeloid leukaemia in adult and paediatric patients.
GESTATIONAL TROPHOBLASTIC NEOPLASIA
- is indicated for first-line and second-line therapy in combination
with other approved
chemotherapeutic agents for the treatment of high-risk gestational
trophoblastic neoplasia in
adults.
OVARIAN CANCER
m12 - en-spc-pl-w - 12
2
- is indicated in combination with other approved chemotherapeutic
agents for the treatment
of non-epithelial ovarian cancer in adults.
- is indicated for the treatment of platinum-resistant/refractory
epithelial ovarian cancer in
adults.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Etoposid Ebewe should only be administered and monitored und