Navelbine 80mg capsules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Vinorelbine tartrate

Beszerezhető a:

Pierre Fabre Ltd

ATC-kód:

L01CA04

INN (nemzetközi neve):

Vinorelbine tartrate

Adagolás:

80mg

Gyógyszerészeti forma:

Oral capsule

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 08010400; GTIN: 3573994000600

Betegtájékoztató

UK Navelbine 20mg, 30mg, 80mg soft capsule: PL 00603/0029; PL
00603/0030; PL 00603/0032
Date last approved: Dec 2016
PL 00603/0029 - 0072; PL 00603/0030 – 0073; PL 00603/0032 - 0075
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.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
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
Storing Navelbine soft capsule
6.
Further information.
1.
WHAT NAVELBINE SOFT CAPSULE IS AND WHAT IT IS USED FOR
Navelbine belongs to a family of medicines used to treat cancer called
the vinca-alkaloid family.
Navelbine is used to treat:
o
Non-small cell lung cancer
o
Advanced breast cancer that has not responded to other medicines.
It is
NOT
recommended for use by children under 18 years old.
2.
BEFORE YOU TAKE NAVELBINE SOFT CAPSULE
DO NOT TAKE NAVELBINE SOFT CAPSULE
•
If you are allergic (hypersensitive) to the active ingredient,
vinorelbine, or any of the related family of
cancer drugs called the vinca alkaloids.
•
If you are allergic to any of the other ingredients in Navelbine
capsules (refer to section 6 of this
leaflet).
•
If you are pregnant or think that you might be pregnant.
•
If you are breast feeding.
•
If you have a severe liver disease.
•
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
Nav

Termékjellemzők

OBJECT 1
NAVELBINE 80MG SOFT CAPSULE
Summary of Product Characteristics Updated 20-Apr-2017 | Pierre Fabre
Limited
1. Name of the medicinal product
NAVELBINE
®
80 mg soft capsule
2. Qualitative and quantitative composition
Each soft capsule contains 80mg vinorelbine as tartrate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Soft capsule.
Pale yellow soft capsule printed N80.
4. Clinical particulars
4.1 Therapeutic indications
As a single agent or in combination for:
• The first line treatment of stage 3 or 4 non small cell lung
cancer.
• The treatment of advanced breast cancer stage 3 and 4 relapsing
after or refractory to an anthracycline
containing regimen.
4.2 Posology and method of administration
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
Neutrophils
≥ 500 and < 1000
Neutrophils
< 500
(1 episode)
(2 episodes)
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 60mg/m
2
per week during the 3 following administrations.
If the neutrophil count is below 1500 /mm
3
and/or the platelet count below 100000/mm
3
, then the
treatment should be delayed until recovery.
Neutrophil count beyond the 4
th
administration of 80 mg/m
2
/week
Neutrophils
> 1000
Neutrophils
≥ 500 and < 1000
(1 episode)
Neutroph