HYCAMTIN 1 MG HARD CAPSULES

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

TOPOTECAN HYDROCHLORIDE

Διαθέσιμο από:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Διεθνής Όνομα):

TOPOTECAN HYDROCHLORIDE

Μονάδες σε πακέτο:

10Capsule Capsules

Κατασκευάζεται από:

GlaxoSmithKline Manufacturing S.p.A

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HYCAMTIN
®
HARD CAPSULES
Topotecan Hydrochloride (1mg)
1
WHAT IS IN THIS LEAFLET
1.
What Hycamtin is used for
2.
How Hycamtin works
3.
Before you use Hycamtin
4.
How to use Hycamtin
5.
While you are using Hycamtin
6.
Side effects
7.
Storage and Disposal of Hycamtin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT HYCAMTIN IS USED FOR
Hycamtin is used to treat small cell
lung cancer that has come back after
chemotherapy.
Your doctor will decide with you
whether Hycamtin therapy is better
than further treatment with your initial
chemotherapy.
HOW HYCAMTIN WORKS
Hycamtin helps to destroy tumours.
BEFORE YOU USE HYCAMTIN_ _
_- When you must not use it _
•
if you are allergic (hypersensitive)
to topotecan or any of the other
ingredients of Hycamtin.
•
if you are breast feeding.
•
if your blood cell counts are too
low. Your doctor will tell you
whether this is the case, based on
the results of your last blood test.
Tell your doctor if any of these applies
to you.
_ _
_Pregnancy _
Hycamtin is not recommended for
pregnant women. It may harm the
baby if conceived before, during or
soon after treatment. You should use
an effective method of contraception.
Ask your doctor for advice. Do not try
and become pregnant until a doctor
advises you it is safe to do so.
Male patients who may wish to father
a child, should ask their doctor for
family planning advice or treatment. If
pregnancy occurs during treatment, tell
your doctor immediately.
_Breast-feeding _
Do not breast-feed if you are being
treated with Hycamtin. Do not restart
breast-feeding until the doctor tells
you it is safe to do so.
_- Before you start to use Hycamtin _
Before you are given this medicine
your doctor needs to know:
•
if you have any kidney or liver
problems. Your dose of Hycamtin
may need to be adjusted.
_- Taking Hycamtin with food and drink _
Hycamtin may be taken with or
without food. The capsule must be
swallowed whole, and must not be
che

Αρχείο Π.Χ.Π.

Novartis
Page 2
Malaysian Package Leaflet
22-May-2017
Hycamtin Hard Capsules
2
1.
NAME OF THE MEDICINAL PRODUCT
HYCAMTIN 1 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1 mg of topotecan (as hydrochloride).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The capsules are opaque, pink and imprinted with “HYCAMTIN” and
“1 mg”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYCAMTIN capsules are indicated as monotherapy for the treatment of
adult patients with relapsed
small cell lung cancer (SCLC) for whom re-treatment with the
first-line regimen is not considered
appropriate (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
HYCAMTIN capsules should only be prescribed and therapy supervised by
a physician experienced in
the use of chemotherapeutic agents.
Posology
Prior to administration of the first course of topotecan, patients
must have a baseline neutrophil count
of
≥
1.5 x 10
9
/l, a platelet count of
≥
100 x 10
9
/l and a haemoglobin level of ≥9 g/dl (after transfusion if
necessary).
_ _
_Initial dose _
The recommended dose of HYCAMTIN capsules is 2.3 mg/m
2
body surface area per day administered
for five consecutive days with a three-week interval between the start
of each course. If well tolerated,
treatment may continue until disease progression (see sections 4.8 and
5.1).
The capsule(s) must be swallowed whole, and must not be chewed crushed
or divided.
Hycamtin capsules may be taken with or without food (see section 5.2).
_Subsequent doses _
Topotecan should not be re-administered unless the neutrophil count is
≥
1 x 10
9
/l, the platelet count is
≥
100 x 10
9
/l, and the haemoglobin level is
≥
9 g/dl (after transfusion if necessary).
Standard oncology practice for the management of neutropenia is either
to administer topotecan with
other medicinal product (e.g. G-CSF) or to reduce the dose to maintain
neutrophil counts.
Novartis
Page 3
Malaysian Package Leaflet
22-May-2017
Hycamtin Hard Capsules