BUSULFAN RAZ 6 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUSULFAN

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

L01AB01

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BUSULFAN 6 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

TILLOMED LABORATORIES LIMITED, UK

Therapeutic area:

BUSULFAN

Therapeutic indications:

BUSULFAN RAZ is indicated for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation.

Authorization date:

2023-02-08

Summary of Product characteristics

BUSULFAN RAZ 6 MG/ML
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINE
BUSULFAN RAZ 6 MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial of BUSULFAN RAZ 6 MG/ML contains 60 mg (6 mg/mL) of
busulfan
.
Busulfan, the active ingredient of BUSULFAN RAZ 6 MG/ML, 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
Concentrate for Solution for infusion
.
Clear colorless solution.
BUSULFAN RAZ 6 MG/ML 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
.
Busulfan Raz 6 mg/ml (Busulfan) concentrate for solution for infusion
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
BUSULFAN RAZ 6 MG/ML 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
BUSULFAN RAZ 6 MG/ML 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 BUSULFAN RAZ 6 MG/ML and continued on a fixed
schedule through
administrat