Alkeran Tablets 2mg

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

MELPHALAN

Disponibil de la:

Aspen Medical Products Malaysia Sdn Bhd

INN (nume internaţional):

MELPHALAN

Unități în pachet:

25Tablet Tablets

Produs de:

Excella GmbH & Co.KG

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ALKERAN TABLETS
Melphalan (2mg)
WHAT IS IN THE LEAFLET
1.
What Alkeran Tablet is used
for
2.
How Alkeran Tablet works
3.
Before
you
use
Alkeran
Tablet
4.
How to use Alkeran Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Alkeran Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ALKERAN TABLET IS USED
FOR
Alkeran Tablet is used for:
•
Multiple myeloma – a type
of cancer that develops from
cells
in
the
bone
marrow
called plasma cells. Plasma
cells help to fight infection
and
disease
by
producing
antibodies
•
Advanced
cancer
of
the
ovaries
•
Advanced breast cancer
•
Polycythaemia rubra 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
HOW ALKERAN TABLET WORKS
Alkeran
Tablet
contains
a
medicine
called
melphalan.
This
belongs
to
a
group
of
medicines
called
cytotoxics
(also
called
chemotherapy).
Alkeran Tablet is used to treat
cancer. It works by reducing the
number of abnormal cells your
body makes.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE
YOU
USE
ALKERAN
TABLET
-
_When you must not take it _
Do not take this medicine if:
•
you
have
an
allergy
to
Melphalan,
or
any
of
the
other
ingredients
listed
at
the end of this leaflet
•
You are breastfeeding
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should
start
taking
this
medicine, talk to your doctor.
-
_Before you start to use it _
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Before you take Alkeran Tablet,
tell your doctor or pharmacist if:
•
you

Caracteristicilor produsului

1
ALKERAN TABLETS
MELPHALAN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg melphalan.
PHARMACEUTICAL FORM
Film-coated tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Melphalan tablets are indicated in the treatment of:
multiple myeloma;
advanced ovarian adenocarcinoma;
Melphalan tablets may be used in the treatment of:
breast carcinoma: melphalan either alone or in combination with other
drugs
has a significant therapeutic effect in a proportion of patients
suffering from
advanced breast carcinoma;
polycythaemia
rubra
vera:
melphalan
is
effective
in
the
treatment
of
a
proportion of patients suffering from polycythaemia vera.
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Melphalan is a cytotoxic drug which falls into the general class of
alkylating agents. It should
be prescribed only by physicians experienced in the management of
malignant disease with
such agents.
Since melphalan is myelosuppressive, frequent blood counts are
essential during therapy and
the
dosage
should
be
delayed
or
adjusted
if
necessary
(_see _
_Special _
_Warnings _
_and _
_Precautions for Use_).
The absorption of melphalan after oral administration is variable.
Dosage may need to be
cautiously increased until myelosuppression is seen, in order to
ensure that potentially
therapeutic levels have been reached.
THROMBOEMBOLIC EVENTS
Melphalan
in
combination
with
lenalidomide
and
prednisone
or
in
combination
with
thalidomide and prednisone or dexamethasone is associated with an
increased risk of venous
thromboembolism. Thromboprophylaxis should be administered for at
least the first 5 months
of treatment especially in patients with additional thrombotic risk
factors. The decision to take
2
antithrombotic prophylactic measures should be made after careful
assessment of an
individual patient's underlying risk factors (see _Special Warnings
and Precautions for Use _and_ _
_Undesirable Effects_).
If the patient experiences any thromboembolic events, treatment must
be discontinued and
standard anticoagulation therapy starte