CARMUSTINE RAZ 100 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

CARMUSTINE

Tersedia dari:

RAZ PHARMACEUTICS LTD, ISRAEL

Kode ATC:

L01AD01

Bentuk farmasi:

POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

CARMUSTINE 100 MG

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

EMCURE PHARMACEUTICALS LTD., INDIA

Area terapi:

CARMUSTINE

Indikasi Terapi:

Carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved agents in the following:• Brain tumors - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors.• Multiple myeloma - in combination with glucocorticoid such as prednisone. • Hodgkin’s disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.• Non-Hodgkin’s lymphomas - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.

Tanggal Otorisasi:

2019-08-14

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CARMUSTINE RAZ 100MG
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 100 mg carmustine.
Each vial of solvent contains 3 ml dehydrated alcohol (that is
equivalent to 2,37 g).
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Powder and solvent for concentrated solution for infusion.
Appearance of powder for reconstitution: Yellowish.
Appearance of solvent: Clear, colorless, mobile liquid.
Appearance of reconstituted solution: colorless to light yellow pH:
4.0 to 6.8.
The osmolarity of the solution for infusion that is reconstituted with
dehydrated ethanol
and sterilized water is 15.6 mOsmol/l. The solution for infusion that
is diluted with
physiological saline or with 5% glucose solution is isotonic with the
plasma.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carmustine is indicated as palliative therapy as a single agent or in
established
combination therapy with other approved agents in the following:
•
Brain tumors - glioblastoma, medulloblastoma, astrocytoma and
metastatic
brain tumors.
•
Multiple myeloma - in combination with glucocorticoid such as
prednisone.
•
Hodg
kin’
s disease - as secondary therapy in combination with other
approved drugs in patients who relapse while being treated with
primary
therapy, or who fail to respond to primary therapy.
•
Non-Hodg
kin’
s lymphomas - as secondary therapy in combination with
other approved drugs in patients who relapse while being treated with
primary therapy, or who fail to respond to primary therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Posology of intravenous administration:
The recommended dose of Carmustine as a single agent in previously
untreated
patients is 150 to 200 mg/m
2
intravenously every 6 weeks. This may be given as a
single dose or divided into two daily injections such as 75 to 100
mg/m
2
on two
successive days.
When Carmustine is used in combination with other myelosuppressive
medicinal
products or in patients in whom bone marr