Lanvis Tablets 40mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

THIOGUANINE

Boleh didapati daripada:

Aspen Medical Products Malaysia Sdn Bhd

INN (Nama Antarabangsa):

THIOGUANINE

Unit dalam pakej:

25tablet Tablets

Dikeluarkan oleh:

Excella GmbH & Co.KG

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
LANVIS TABLET
Thioguanine (40mg)
WHAT IS IN THE LEAFLET
1.
What Lanvis Tablet is used
for
2.
How Lanvis Tablet works
3.
Before you use Lanvis
Tablet
4.
How to use Lanvis Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Lanvis Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LANVIS TABLET IS USED
FOR
Lanvis Tablet contains a
medicine called thioguanine.
This belongs to a group of
medicines called cytotoxics
(also called chemotherapy).
Lanvis Tablet is used for
certain blood problems and
cancers of the blood.
Lanvis Tablet is used for acute
(fast-growing) leukaemias,
especially:
•
Acute myelogenous
leukaemia (also called
acute myeloid leukaemia
or AML) - a fast-
growing disease that
increases the number of
white blood cells produced
by the bone marrow. This
can cause infections and
bleeding.
•
Acute lymphoblastic
leukaemia (also called
acute lymphocytic
leukaemia or ALL) - a
fast-growing disease
which increases the
number of immature white
blood cells. These
immature white blood
cells are unable to grow
and function properly and
therefore cannot fight
infections and may cause
bleeding.
Ask your doctor if you would
like more explanation about
these diseases.
HOW LANVIS TABLET WORKS
Lanvis Tablet works by
reducing the number of new
blood cells your body makes.
BEFORE YOU USE LANVIS TABLET
-
_When you must not take it _
You must not take Lanvis
Tablet if you are allergic
(hypersensitive) to thioguanine
or any of the other ingredients
of Lanvis Tablet (See section
8: Product Description)
Do not take Lanvis Tablet if
the above applies to you. If you
are not sure, talk to your doctor
or pharmacist before taking
Lanvis Tablet.
_Pregnancy and breast feeding _
Do not take Lanvis Tablet if
you are planning to have a
baby. This applies to both men
and women. Lanvis Tablet may
harm your sperm or eggs.
Reliable contraceptive
precautions must
be taken to
avoid pregnancy whilst you or
your par

Ciri produk

LANVIS
TABLETS 40MG
THIOGUANINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 40mg thioguanine.
PHARMACEUTICAL FORM
Tablets. LANVIS tablets are white to off-white tablet, round, biconvex
scored and imprinting
‘T40' on upper side, without score and debossing on lower side.
CLINICAL PARTICULARS
INDICATIONS
LANVIS is indicated primarily for the treatment of acute leukaemias
especially, acute
myelogenous leukaemia and acute lymphoblastic leukaemia.
DOSAGE AND ADMINISTRATION
The exact dose and duration of administration will depend on the
nature and dosage of other
cytotoxic drugs given in conjunction with LANVIS.
LANVIS is variably absorbed following oral administration and plasma
drug levels may be
reduced following emesis or intake of food.
LANVIS can be used at various stages of treatment in short term
cycles. However it is not
recommended for use during maintenance therapy or similar long term
continuous treatments
due to the high risk of liver toxicity (see _ Special Warnings and
Precautions for Use and _
_Undesirable Effects_)
•
INDUCTION THERAPY
For adults, the usual dosage of LANVIS is between 60 and 200 mg/m
2
body surface area per
day.
For children, similar dosages to those used in adults, with
appropriate correction for body
surface area have been used.
•
ELDERLY PATIENTS
There are no specific dosage recommendations in elderly patients (See
_Dosage in renal or _
_hepatic impairment_). LANVIS has been used in various combination
chemotherapy schedules
in elderly patients with acute leukaemia at equivalent dosages to
those used in younger
patients.
•
DOSAGE IN RENAL OR HEPATIC IMPAIRMENT
Consideration should be given to reducing the dosage in patients with
impaired hepatic or
renal function.
•
TPMT-DEFICIENT PATIENTS
Patients with inherited little or no thiopurine S-methyltransferase
(TPMT) activity are at
increased risk for severe thioguanine toxicity from conventional doses
of thioguanine and
generally require substantial dose reduction. The optimal starting
dose for homozygous
defi