NAVELBINE 30 mg soft capsule

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Vinorelbine tartrate

Saatavilla:

PIERRE FABRE Ltd

ATC-koodi:

L01CA; L01CA04

INN (Kansainvälinen yleisnimi):

Vinorelbine tartrate

Annos:

30 Base Milligrams

Lääkemuoto:

Capsule, soft

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Vinca alkaloids and analogues; vinorelbine

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2006-04-13

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAVELBINE 20MG SOFT CAPSULE
NAVELBINE 30MG SOFT CAPSULE
NAVELBINE 80MG SOFT CAPSULE
Vinorelbine (as tartrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their their signs of illness are the same as yours.
-
If you get any of the side effects talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Navelbine soft capsule is and what it is used for
2.
Before you take Navelbine soft capsule
3.
How to take Navelbine soft capsule
4.
Possible side effects
5
How to store Navelbine soft capsule
6.
Contents of the pack and other information.
1.
WHAT NAVELBINE SOFT CAPSULE IS AND WHAT IT IS USED FOR
Navelbine contains the active substance Vinorelbine (as tartrate), and
belongs to a family of medicines used
to treat cancer called the vinca-alkaloid family.
Navelbine is used to treat some types of lung cancer and some types of
breast cancer in patients over 18
years old.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAVELBINE SOFT CAPSULE
DO NOT TAKE NAVELBINE SOFT CAPSULE

If you are allergic to Vinorelbine, or to any of the related family of
cancer drugs called the vinca
alkaloids, or any of the other ingredients of this medicine, (listed
in section 6)

If you are breast feeding.

If you have had an operation on your stomach or small bowel, or if you
have gut disorder which
affects how you absorb food. These may affect how your body absorbs
Navelbine.

If you have a low white blood cell count (neutrophils, leucocytes) or
a severe infection current or
recent within two weeks.

If you have a low blood platelet cell count (thrombocytopenia).

If you plan to have a yellow fever

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NAVELBINE 30 mg soft capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 30 mg vinorelbine (as tartrate).
Excipients: Each 30mg capsule contains:
Ethanol anhydrous
7.50 mg
Sorbitol
15.96 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft capsule
Pink soft capsule printed N30
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of non small cell lung cancer in adult patients.
Treatment of advanced breast cancer stage 3 and 4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
IN ADULT PATIENTS
AS A SINGLE AGENT, the recommended regimen is:
FIRST THREE ADMINISTRATIONS
60mg/m² of body surface area, administered once weekly
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
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