Busulfan 2mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Busulfan

Disponibil de la:

Aspen Pharma Trading Ltd

Codul ATC:

L01AB01

INN (nume internaţional):

Busulfan

Dozare:

2mg

Forma farmaceutică:

Tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 08010100; GTIN: 5060249171720

Prospect

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUSULFAN 2MG TABLETS
busulfan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
•
WHAT IS IN THIS LEAFLET:
1.
What Busulfan is and what it is used for
2.
What you need to know before you take Busulfan
3.
How to take Busulfan
4.
Possible side effects
5.
How to store Busulfan
6.
Contents of the pack and other information
1.
WHAT BUSULFAN IS AND WHAT IT IS USED FOR
Busulfan tablets contain a medicine called busulfan. This belongs to a
group of medicines called
cytotoxics (also called chemotherapy). Busulfan is used for certain
blood problems and cancers of the
blood. It works by reducing the number of new blood cells your body
makes.
Busulfan is used for:
•
CHRONIC MYELOID LEUKAEMIA
- a disease that increases the number of white blood cells.
This can cause infections and bleeding.
•
POLYCYTHAEMIA VERA
a disease which increases the number of red cells in your blood.
This makes the blood thicken and causes blood clots. This leads to
headaches, dizziness
and shortness of breath.
•
THROMBOCYTHAEMIA
a disease which affects platelets (blood cells which help blood to
clot). There may be an increase in platelets - which causes blood
clots. Or the platelets
do not work properly - which causes bleeding such as nose bleeds,
bleeding gums and
bruising easily.
•
MYELOFIBROSIS
a disease where bone marrow (where blood cells are made) is replaced
by
scar (fibrous) tissue. This causes red and white blood cells to be
made wrongly. This can
cause tiredness, bloated stomac

Caracteristicilor produsului

OBJECT 1
BUSULFAN 2 MG TABLETS
Summary of Product Characteristics Updated 09-Nov-2017 | Aspen
1. Name of the medicinal product
Busulfan 2 mg tablets
2. Qualitative and quantitative composition
Each 2 mg tablet contains 2 mg of the active substance busulfan
Excipient with known effect: lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet
Busulfan 2 mg tablets are white, film-coated, round biconvex tablets
engraved “GX EF3” on one side and
“M” on the other.
4. Clinical particulars
4.1 Therapeutic indications
Busulfan is indicated as conditioning treatment prior to haemopoietic
progenitor cell transplantation in
patients when the combination of high-dose busulfan and
cyclophosphamide is considered the best
available option.
Busulfan is indicated for the palliative treatment of the chronic
phase of chronic myeloid leukaemia.
Busulfan is effective in producing prolonged remission in
polycythaemia vera, particularly in cases with
marked thrombocytosis.
Busulfan may be useful in selected cases of essential thrombocythaemia
and myelofibrosis.
4.2 Posology and method of administration
General
The bioavailability of oral Busulfan shows large intra-individual
variations ranging from 47% to 103%
(mean 80%) in adults and from 22% to 120% (mean 68%) in children (see
section 5.2).
There are other formulations available which may be more suitable for
paediatric patients.
Busulfan 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 Busulfan tablets,
this can be achieved by introducing
one or more busulfan free days between treatment days. The tablets
should not be divided (see section
6.6).
_Obese_
Dosing based on body surface area or adjusted ideal body weight should
be considered in the obese (see
section 5.2).
The relevant literature should be consulted for full details