MYLERAN busulfan 2mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

busulfan, Quantity: 2 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; magnesium stearate; lactose; titanium dioxide; hypromellose; triacetin

Administration route:

Oral

Units in package:

25 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 10 FEBRUARY 2005: Treatment of chronic granulocytic leukaemia. It has been shown to be superior to splenic irradiation when judged by survival times, control of spleen size and maintenance of haemoglobin levels. Although not curative, busulfan reduces the total granulocyte mass, relieves disease symptoms and improves the clinical state of the patient. Busulfan is not useful once blast transformation has occurred. Busulfan produces prolonged remission in polycythaemia vera. It is especially useful in cases resistant to radiophosphorus (32 p) and where there is marked thrombocytosis. Busulfan is useful in selected cases of essential thrombocythaemia and myelofibrosis.

Product summary:

Visual Identification: White, film-coated, round biconvex tablets engraved with GX EF3 on one side and M on the other.; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-03-02

Patient Information leaflet

1
MYLERAN
®
_busulfan _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MYLERAN tablets. It does not
contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
MYLERAN tablets against the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE MYLERAN IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
busulphan
•
any of the tablet ingredients
listed at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE MYLERAN IF YOU
ARE PLANNING TO BECOME
If you take it after the expiry date
has passed, it may not work as
well.
DO NOT TAKE MYLERAN IF THE
BOTTLE SHOWS SIGNS OF
TAMPERING.
_BEFORE YOU START TO TAKE IT _
_ _
TELL YOUR DOCTOR IF YOU ARE
ALLERGIC TO ANY OTHER MEDICINES
OR ANY OTHER FOODS, DYES OR
PRESERVATIVES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
CONDITIONS:
•
you have recently received or
are receiving radiotherapy or
chemotherapy
•
you have recently been
vaccinated or are planning to
be vaccinated
•
kidney, lung or liver disease
•
gout.
IF YOU HAVE NOT TOLD YOUR DOCTOR
ABOUT ANY OF THE ABOVE, TELL
PREGNANT OR FATHER A CHILD
THEM BEFORE YOU START TAKING
WHAT MYLERAN IS
USED FOR
MYLERAN contains busulfan as
the active ingredient. It belongs to
a group of medicines called
cytotoxics.
MYLERAN is used to treat certain
blood disorders.
It works by reducing the amount of
certain types of blood cells in your
body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MYLERAN (BUSULFAN) TABLETS
1
NAME OF THE MEDICINE
Busulfan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Myleran tablets each contain 2 mg busulfan.
List of excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Myleran tablets are round biconvex white film coated tablets engraved
GX EF3 on one face and
M on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of chronic granulocytic leukaemia. It has been shown to be
superior to splenic
irradiation when judged by survival times, control of spleen size and
maintenance of haemoglobin
levels. Although not curative, busulfan reduces the total granulocyte
mass, relieves disease
symptoms and improves the clinical state of the patient. Busulfan is
not useful once blast
transformation has occurred.
Busulfan produces prolonged remission in polycythaemia vera. It is
especially useful in cases
resistant to radiophosphorus (
32
P) and where there is marked thrombocytosis.
Busulfan is useful in selected cases of essential thrombocythaemia and
myelofibrosis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Chronic granulocytic leukaemia
Remission induction: The dosage is 0.06 mg/kg daily with a maximum
daily dose of 4 mg which
may be given as a single dose. Administration of Myleran should be
discontinued when the white
blood cell count has fallen to between 20,000 to 25,000/mm
3
or earlier if the platelet count falls
below 100,000/mm
3
otherwise there is a considerable risk of causing irreversible bone
marrow
aplasia since the counts may continue to fall for some time after
treatment is stopped. The blood
count should be monitored at least weekly during the induction phase
and the dose should be
increased only if the response after three weeks is inadequate.
Maintenance therapy: Although the white count may be controlled
without further therapy for
long periods after induction therapy most clinicians use some form of
maintenance treatment.
Dosage is us