NAVELBINE 20MG SOFT CAPSULE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

VINORELBINE TARTRATE

Boleh didapati daripada:

Orient Europharma (M) Sdn Bhd

INN (Nama Antarabangsa):

VINORELBINE TARTRATE

Unit dalam pakej:

1Capsule Capsules

Dikeluarkan oleh:

FAREVA PAU 1

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
______________________________________________________________________________
1
NAVELBINE SOFT CAPSULE
Vinorelbine Tartrate (20mg, 30mg)
________________________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What
_Navelbine Soft Capsule_
is used for
2.
How
_Navelbine Soft Capsule_
works
3.
Before you use
_Navelbine _
_Soft Capsule _
4.
How to use
_Navelbine Soft _
_Capsule_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Navelbine Soft Capsule_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _NAVELBINE SOFT CAPSULE_ IS
USED FOR
Navelbine is used to treat non-small
cell lung cancer and advanced breast
cancer.
HOW _NAVELBINE SOFT CAPSULE _WORKS
Navelbine belongs to a family of
medicines called the vinca alkaloid
Navelbine is an antimitotic agent,
causing cell death by blocking cell
division
BEFORE YOU USE _NAVELBINE SOFT _
_CAPSULE _
_-When you must not use it: _
-
If you are allergic
(hypersensitive) to vinorelbine
(active ingredient), or any of the
related group of cancer drugs
called the vinca-alkaloids
-
If you are allergic to any other
ingredients of Navelbine (refer
to section ‘Ingredients’ in this
leaflet)
-
If you have had an operation on
your stomach or small bowel, or
if you have intestinal disorders,
or if you present disorder
affecting absorption
-
If you have a low white blood
cell count (leukocytes and/or
neutrophils) or a severe infection
currently or recently (within 2
weeks)
-
If you have a low platelet count
-
If you require long-term
oxygen therapy
-
If you are breast feeding
-
If you plan to have a yellow
fever vaccine or have just had
one
_-Before you start to use it: _
Please inform your doctor if:
-
You have a history of heart
attack or severe chest pain
-
Your ability to carry out
activities of daily living is
strongly reduced
-
You have received radiotherapy
treatment involving the liver
-
You have symptom

Ciri produk

PACKAGE INSERT
1-
NAME OF THE MEDICINAL PRODUCT
NAVELBINE® 20 mg soft capsule
NAVELBINE® 30 mg soft capsule
2-
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
FORMULATION
20 mg
30 mg
Vinorelbine tartrate (mg)
27.70
41.55
Equivalent to vinorelbine (INN) base (mg)
20
30
Each dose of 20 mg soft capsule contains: ethanol (alcohol) 5 mg,
sorbitol (E420) 5,36 mg.
Each dose of 30 mg soft capsule contains: ethanol (alcohol) 7,5 mg,
sorbitol (E420) 8,11 mg.
For excipients, refer to section 6.1.
3-
PHARMACEUTICAL FORM
SOFT CAPSULE
20 mg soft capsule: light brown soft capsule printed N20
30 mg soft capsule: pink soft capsule printed N30
4- CLINICAL PARTICULARS
4.1- THERAPEUTIC INDICATIONS
For treatment of Non-small cell lung cancer / Advanced Breast Cancer
4.2- POSOLOGY AND METHOD OF ADMINISTRATION
Navelbine® soft capsules must be given strictly by the oral route.
Navelbine® soft capsules should be
swallowed with water without chewing or sucking the capsule. It is
recommended to take the
capsule with some food.
AS A SINGLE AGENT:
The recommended regimen is:
First three administrations
60 mg/m2 of body surface area, administered once weekly.
Subsequent administrations
Beyond the third administration, it is recommended to increase the
dose of Navelbine® soft capsules
to 80 mg/m² once weekly except in those patients for whom the
neutrophil count dropped once
below 500/mm3 or more than once between 500 and 1 000/mm3 during the
first three
administrations at 60 mg/m2.
Neutrophil count
during the first 3
administrations
of 60 mg/m²
/week
Neutrophils >
1000
Neutrophils ≥
500 and < 1000
(1 episode)
Neutrophils ≥
500 and < 1000
(2 episodes)
Neutrophils <
500
Recommended
dose Starting
with the 4th
administration
80
80
60
60
DOSE MODIFICATION
For any administration planned to be given at 80 mg/m2, if the
neutrophil count is below 500/mm3,
the administration should be delayed until recovery and the dose
reduced from 80 to 60 mg/m2 per
week during the 3 following administrations.
Neutrophil count
beyond the 4th
adm