BUSULFEX

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

BUSULFAN

Fáanlegur frá:

TZAMAL BIO-PHARMA LTD

ATC númer:

L01AB01

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

BUSULFAN 60 MG / 10 ML

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

OTSUKA PHARMACEUT. DEV.& COMER.INC.,USA

Meðferðarhópur:

BUSULFAN

Lækningarsvæði:

BUSULFAN

Ábendingar:

For use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation.

Leyfisdagur:

2015-01-31

Vara einkenni

BUSULFEX
1
PRODUCT INFORMATION
BUSULFEX (BUSULFAN) INJECTION
1
NAME OF THE MEDICINE
BUSULFEX
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial of Busulfex contains 60 mg (6 mg/mL) of busulfan.
Busulfan, the active ingredient of Busulfex, is a white crystalline
solid that is only very slightly
soluble in water, sparingly soluble in acetone and slightly soluble in
ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
Busulfex is supplied as a sterile solution in 10 mL single-use clear
glass vials each containing 60
mg of busulfan at a concentration of 6 mg/mL for intravenous use.
Busulfex (Busulfan) injection is a potent cytotoxic drug that results
in profound myelosuppression at
the recommended dosage. It should be administered under the
supervision of a qualified physician who
is experienced in the use of cancer chemotherapeutic agents and in the
management of patients with
severe pancytopenia. Appropriate management of therapy and
complications is only possible when
adequate diagnostic and treatment facilities are readily available.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Busulfex (busulfan) Injection is indicated for use in combination with
other chemotherapeutic agents
and/or radiotherapy as a conditioning regimen prior to hematopoietic
progenitor cell transplantation
.
4.2
DOSE AND METHOD OF ADMINISTRATION
Busulfex should be administered intravenously via a central venous
catheter as a two-hour infusion
every 6 hours x 4 consecutive days for a total of 16 doses. All
patients should be premedicated with
appropriate anti-convulsant therapy (e.g. phenytoin, benzodiazepines)
to prevent seizures, as busulfan is
known to cross the blood brain barrier. Antiemetics of the 5-HT3 class
should be administered prior to
the first dose of Busulfex and continued on a fixed schedule through
administration of Busulfex or
considered through completion of the preparative regimen.
The usual adult dose of Busulfex in combination with cycloph