Myleran

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Busulfan 2mg (milled)

Disponible depuis:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

DCI (Dénomination commune internationale):

Busulfan 2 mg (milled)

Dosage:

2 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Busulfan 2mg (milled) Excipient: Lactose Magnesium stearate Opadry white OY-S-7322 Pregelatinised maize starch Purified water

Unités en paquet:

Bottle, glass, 100 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Ampac Fine Chemicals LLC

Descriptif du produit:

Package - Contents - Shelf Life: Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

1962-11-30

Notice patient

 
1 
MYLERAN™ 

Busulphan tablets 2mg 
___________________________________________________________________________________________________ 
Consumer Medicine Information 

WHAT IS IN THIS LEAFLET 

Please read this leaflet carefully 
before you start taking MYLERAN 
tablets. 

This leaflet answers some common 
questions about MYLERAN 
tablets. It does not contain all 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 expected benefits of you taking 
MYLERAN against the risks this 
medicine could have for you. 

If you have any concerns about 
taking this medicine, ask your 
doctor or pharmacist. 

Keep this leaflet with your 
medicine. You may need to read it 
again. 

WHAT MYLERAN IS 
USED FOR 

MYLERAN contains the active 
ingredient busulphan. 

MYLERAN is used to treat 
chronic granulocytic leukaemia, 
polycythaemia vera, myelofibrosis, 
and essential thrombocythaemia. 
These are different types of cancer 
affecting the blood. 

When you have blood cancer, 
abnormal cells are formed in the 
bone marrow which multiply 
uncontrollably, crowding out and 
interfering with the vital functions 
of normal healthy blood cells. 
MYLERAN helps to relieve the 
symptoms of these illnesses, and 
can make you feel better. 
Your doctor may have prescribed 
MYLERAN for another purpose. 

MYLERAN belongs to a group of 
medicines called anti-neoplastic 
agents. Within this group, 
MYLERAN belongs to a class of 
medicines called alkylating agents. 

MYLERAN works by interfering 
with the function of the bone 
marrow and reducing the number 
of cancerous blood cells which are 
causing you to feel unwell. 

Ask your doctor if you have any 
questions

Résumé des caractéristiques du produit

MYLERAN
TM
Busulfan Tablets 2mg_Datasheet_New Zealand
1
DATA SHEET
1.
PRODUCT NAME (STRENGTH PHARMACEUTICAL FORM)
MYLERAN
TM
(Busulfan Tablets 2mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MYLERAN 2mg tablets are white, film-coated, round, biconvex tablets
engraved “GX
EF3” on one side and “M” on the other, supplied in amber glass
bottles with a child
resistant closure containing 100 tablets.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MYLERAN is indicated for the palliative treatment of the chronic phase
of chronic
granulocytic leukaemia.
MYLERAN is effective in producing prolonged remission in polycythaemia
vera,
particularly in cases with marked thrombocytosis.
MYLERAN may be useful in selected cases of essential thrombocythaemia
and
myelofibrosis.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL:
MYLERAN tablets are usually given in courses or administered
continuously. The
dose must be adjusted for the individual patient under close clinical
and haematological
control. Should a patient require an average daily dose of less than
the content of the
available MYLERAN tablets, this can be achieved by introducing one or
more busulfan
free days between treatment days. The tablets should not be divided
(see Instructions
for Use/Handling).
OBESE PATIENTS
Dosing based on body surface area or adjusted ideal body weight should
be
considered in the obese (see Pharmacokinetics)
The relevant literature should be consulted for full details of
treatment schedules.
CHRONIC GRANULOCYTIC LEUKAEMIA
INDUCTION IN ADULTS:
Treatment is usually initiated as soon as the condition is diagnosed.
MYLERAN
TM
Busulfan Tablets 2mg_Datasheet_New Zealand
2
The dose is 0.06mg/kg/day, with an initial daily maximum of 4mg, which
may be given
as a single dose.
There is individual variation in the response to MYLERAN and in a
small proportion of
patients the bone marrow may be extremely sensitive. (see Special
Warnings and
Special Precautions for Use).
The blood count must be monitored at