NAVELBINE 20 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VINORELBINE AS TARTRATE

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L01CA04

الشكل الصيدلاني:

CAPSULES

تركيب:

VINORELBINE AS TARTRATE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PIERRE FABRE MEDICAMENT, FRANCE

المجموعة العلاجية:

VINORELBINE

المجال العلاجي:

VINORELBINE

الخصائص العلاجية:

For the treatment of non small cell lung cancer. For the treatment of advanced breast cancer.

تاريخ الترخيص:

2014-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
The medicine is marketed with a doctor’s prescription only
Navelbine
®
20 mg
Soft Capsule
Navelbine
®
30 mg
Soft Capsule
The active ingredient and its
quantity:
Each soft capsule contains:
Vinorelbine
)as tartrate( 20 mg
The active ingredient and its
quantity:
Each soft capsule contains:
Vinorelbine
)as tartrate( 30 mg
For a list of inactive and allergenic ingredients in the
preparation, please see section 6 “Further Information” and
section 2 “Important information about some of the ingredients
of the medicine”.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine.
If you have further questions, refer the doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do
not pass it on to others. It may harm them, even if it seems to
you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Navelbine is intended for the treatment of non-small cell lung
cancer, treatment of advanced breast cancer.
Therapeutic group: Navelbine belongs to the group of
medicines for the treatment of cancer extracted from the vinca
plant )vinca alkaloids(.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• You are sensitive )allergic( to the active substance
vinorelbine, or to any other substance from the family of
cancer medicines called vinca alkaloids.
• You are sensitive )allergic( to any of the additional
ingredients contained in Navelbine (for more information,
please see section 6 “Further information” and section 2
“Important information about some of the ingredients of
the medicine”(.
• You are pregnant or think that you are pregnant.
• You are breastfeeding.
• You suffer from a serious liver disease.
• You have had gastric or small intestine surgery or if you
suffer from intestinal problems that affect the absorption
of food. This may affect how Navelbine is absorbed in your
body.
• Your white blood

خصائص المنتج

PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
NAVELBINE
®
20 mg
NAVELBINE
®
30 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NAVELBINE 20 mg: Each soft capsule contains
20mg Vinorelbine (as tartrate)
NAVELBINE 30 mg: Each soft capsule contains
30mg Vinorelbine (as tartrate )
For a full list of excipients, see section 6.1
Excipients with known effect:
Each dose of 20 mg soft capsule contains ethanol, sorbitol .
-
ethanol (alcohol) 5 mg
-
sorbitol 5.36 mg
each dose of 30 mg soft capsule contains ethanol, sorbitol .
-
ethanol (alcohol) 7.5 mg
-
sorbitol 8.11 mg
3.
PHARMACEUTICAL FORM
Soft capsule.
NAVELBINE 20 mg: light brown soft capsule containing light yellow to
orange-yellow
solution printed N20 in red.
NAVELBINE 30 mg: pink soft capsule containing light yellow to
orange-yellow solution
printed N30 in red.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of non small cell lung cancer.
For the treatment of advanced breast cancer
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IN ADULT PATIENTS
NAVELBINE SOFT CAPSULE IS INDICATED AS A SINGLE AGENT
FIRST THREE ADMINISTRATIONS
60mg/m² of body surface area, administered once weekly
.
EVEN FOR PATIENTS WITH BSA

2 M
2 THE TOTAL DOSE SHOULD NEVER EXCEED 120 MG PER
WEEK AT 60 MG /
M
2
AND 160 MG PER WEEK AT 80 MG/M
2
.
SUBSEQUENT ADMINISTRATIONS
Beyond the third administration, it is recommended to increase the
dose of NAVELBINE to
80mg/m² once weekly except in those patients for whom the neutrophil
count dropped once
below 500/mm
3
or more than once between 500 and 1000/mm
3
during the first three
administrations at 60mg/m².
Neutrophil count during
the first
3 administrations of
60 mg/m
2
/week
Neutrophils
> 1000
Neutrophils
≥
500
and < 1000
(1 episode)
Neutrophils
≥
500
and < 1000
(2 episodes)
Neutrophils
< 500
Recommended dose
starting with the 4
th
administration
80
80
60
60
DOSE MODIFICATION
For any administration planned to be given at 80mg/m², if the
neutrophil count is below
500/mm
3
or more than once between 500 and 1000 /