NAVELBINE 20 mg soft capsule

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Vinorelbine tartrate

Saatavilla:

Pierre Fabre Medicament

ATC-koodi:

L01CA; L01CA04

INN (Kansainvälinen yleisnimi):

Vinorelbine tartrate

Annos:

20 milligram(s)

Lääkemuoto:

Capsule, soft

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)
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
called the vinca-alkaloid family, used to treat cancer.
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 vaccination or have just had one.
•
If you require long-term oxygen therapy
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Navelbine soft capsule
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 problems with your liver, or you have received radiotherapy
where the treatment
field included the liver.
-
You have symptoms of infection (such as fever, chills, joint pain,
cough).
-
You plan to have a vaccination. Many vaccines (liv

Valmisteyhteenveto

Health Products Regulatory Authority
08 January 2024
CRN00DLJQ
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NAVELBINE 20 mg soft capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1
Excipients with known effect:
Each dose of 20 mg soft capsule contains ethanol, sorbitol (E420).

Ethanol (alcohol) 5 mg.

Sorbitol (E420) 5.36 mg.
3 PHARMACEUTICAL FORM
Soft capsule
Light brown soft capsule printed N20
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vinorelbine is indicated in adult patients for the treatment of:

advanced non-small-cell lung cancer as monotherapy or in combination
with other chemotherapy

as adjuvant treatment of non-small-cell lung cancer in combination
with platinum-based chemotherapy

advanced breast cancer as monotherapy or in combination with other
agents.
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
Health Products Regulatory Authority
08 January 2024
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Page 2 of 11
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 / mm
3
the administration should be delayed until recovery and the dose
reduced from 80 to 60m