BUSILVEX INJECTION

Land: Suður-Afríka

Tungumál: enska

Heimild: South African Health Products Regulatory Authority (SAHPRA)

Fáanlegur frá:

Pierre Fabre South Africa (Pty) Ltd

Skammtar:

See ingredients

Lyfjaform:

INJECTION

Samsetning:

EACH AMPOULE CONTAINS BUSULFAN 60,0 mg

Leyfisstaða:

Canceled

Leyfisdagur:

2007-01-11

Upplýsingar fylgiseðill

CURRENT APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
BUSILVEX (Solution for injection)
COMPOSITION OF THE MEDICINE, THAT IS, WHAT THIS MEDICINE CONTAINS:
Each 10 ml ampoule contains 60 mg busulfan (1 ml of concentrate
contains 6 mg
busulfan) After dilution: 1 ml of solution contains 0,5 mg busulfan.
The product also contains the following inactive ingredients:
Polyethylene glycol 400
and dimethylacetamide.
APPROVED INDICATION AND USE, THAT IS, WHAT THIS MEDICINE IS USED FOR:
BUSILVEX is used in adults as a treatment prior to transplantation in
combination
with cyclophosphamide. You will receive this preparative medicine
before receiving a
transplant of either bone marrow or haematopoietic progenitor cell.
INSTRUCTION BEFORE TAKING THE MEDICINE:
Do not use BUSILVEX:
-
if you are hypersensitive to busulfan or any of the other
-
ingredients if you are pregnant or think you are pregnant
-
if you suffer from hepatic insufficiency
-
there is no experience of use of Bulsufex in children
Take special care with BUSILVEX:
BUSILVEX is a potent cytotoxic drug that results in profound decrease
of blood cells.
At the recommended dose, this is the desired effect. Therefore,
careful monitoring
will be performed. It is possible that the use of BUSILVEX may
increase the risk of
suffering another malignancy in the future.
You should tell your doctor if:
-
You have a liver, kidney, heart or lung problem
-
You have a history of seizures
-
You are currently taking other medicines
IF YOU ARE PREGNANT OR BREAST FEEDING YOUR BABY WHILE TAKING THIS
MEDICINE PLEASE
CONSULT YOUR DOCTOR, PHARMACIST OR OTHER HEALTH CARE PROFESSIONAL FOR
ADVICE.
If you are taking medicines on a regular basis, concomitant use of
medicine may
cause undesirable interactions. Please consult your doctor, pharmacist
or other
health care professional for advice.
Particular caution should be taken if you use itraconazole (used for
certain types of
infections) or ketobemidone (used to treat pain) because this may
increase

Vara einkenni

Page 1 of 11
SCHEDULING STATUS:
S4
PROPRIETARY NAME:
BUSILVEX® (Solution for injection)
COMPOSITION:
Each 10 ml vial contains 60 mg busulfan (1 ml of concentrate contains
6 mg busulfan)
After dilution: 1 ml of solution contains 0,5 mg busulfan - refer to
DOSAGE AND DIRECTIONS FOR USE.
PHARMACOLOGICAL CLASSIFICATION:
A 26 Cytostatics
PHARMACOLOGICAL ACTION:
Busulfan is a cytotoxic agent that results in myelosuppression.
Busulfan is a bifunctional alkylating
agent in which two labile methanesulphonate groups are attached to
opposite ends of a four carbon
alkyl chain. In aqueous media, release of the methanesulphonate groups
produces carbonium ions
that can alkylate DNA, thought to be an important biological mechanism
for its cytotoxic effect.
PHARMACOKINETICS:
In studies performed to assess the pharmacokinetic profile of
busulfan, the main parameters obtained
were: Cl tot ranged from 2,25 and 2,74 ml.min-1.kg-1, elimination t½
ranged between 2,8 and 3,9
hours; terminal volume of distribution Vz ranged between 0,62 and 0,85
l.kg-1.
The pharmacokinetics were compared in patients receiving oral (1
mg/kg) and IV (0,8 mg/kg)
busulfan. Similar blood exposure was achieved while a lower inter
individual variability was observed
with the IV form (24 % and 14 % for oral and IV respectively)
Busulfan achieved concentrations in the cerebrospinal fluid
approximately equal to those in plasma
although the concentrations are probably insufficient for
antineoplastic activity. Reversible binding to
plasma elements was about 7 % while irreversible binding, primarily to
albumin was about 32 %.
Page 2 of 11
Busulfan is metabolised by conjugation with glutathione, both
spontaneously and through glutathione
S-transferase (GST).
Approximately 30 % of the administered dose are excreted in the urine
over 48 hours, with about 1 %
as the unchanged drug. Negligible amounts are recovered in faeces.
INDICATIONS:
Conditioning treatment prior to haematopoeietic progenitor cell
transplantation in adults when the
combination of busulfan and cyclop