Vinorelbine Concentrate for Soln for Inf 10mg/ml

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

VINORELBINE TARTRATE

Доступна с:

Accord Healthcare Limited

код АТС:

L01CA04

ИНН (Международная Имя):

VINORELBINE TARTRATE

Фармацевтическая форма:

CONCENTRATE FOR SOLUTION FOR INFUSION

состав:

VINORELBINE TARTRATE 10 mg/ml

Тип рецепта:

POM

Терапевтические области:

ANTINEOPLASTIC AGENTS

Статус Авторизация:

Authorised

тонкая брошюра

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
VINORELBINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Vinorelbine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Vinorelbine solution is and what it is used for
2. What you need to know before you use Vinorelbine solution
3. How to use Vinorelbine solution
4. Possible side effects
5. How to store Vinorelbine solution
6. Contents of the pack and other information
1. WHAT VINORELBINE SOLUTION IS AND WHAT IT IS USED FOR
Vinorelbine solution is a concentrate for solution for infusion. The
active substance vinorelbine
belongs to a group of cytostatic agents. These agents interfere with
the growth of malignant cells.
Vinorelbine solution is indicated in adults for the treatment of
cancers, specifically non-small cell
lung cancer and breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINORELBINE SOLUTION
DO NOT USE VINORELBINE SOLUTION:
-
if you are allergic to vinorelbine or any medicine in the family of
medicines called vinca
alkaloids;
-
if you are allergic to any of the other ingredients of Vinorelbine
solution (listed in section 6);
-
if you are pregnant or think you may be pregnant;
-
if you are breast-feeding;
-
if you have a low white blood cell (neutrophil) count or a current or
recent (in the past 2 weeks)
serious infection;
-
if you have a low platelet count;
-
_if you are planning to get (or have recently had) a yellow fever
vaccine_
-
This medicine is strictly for intravenous use only and should not be
injected into the spine
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist be

Характеристики продукта

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vinorelbine 10 mg/ml concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 10 mg vinorelbine (as vinorelbine tartrate)
Each 1-ml vial contains a total of 10 mg vinorelbine (as tartrate)
Each 5-ml vial contains a total of 50 mg vinorelbine (as tartrate)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless to pale yellow solution, free from visible
particles.
pH in the range of approximately 3.0 to 4.0 and osmolality in the
range of
approximately 30 to 40 mOsm/Kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vinorelbine is indicated in adults in the treatment of:
- As a single agent in patients with metastatic breast cancer (stage
4) in which
chemotherapy with anthracycline and taxane has failed or is
inadequate.
- Non-small cell lung cancer (stage 3 or 4).
Page 2 of 15
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vinorelbine must be administered under the supervision of a doctor
experienced in the use of chemotherapy.
POSOLOGY
_Non-small cell lung cancer_.
In monotherapy the usual dose given is 25-30 mg/m² once weekly. In
combination chemotherapy the usual dose (25-30 mg/m²) is usually
maintained, while the frequency of administration is reduced e.g. day
1 and 5
every 3 weeks or day 1 and 8 every 3 weeks according to treatment
protocol.
_Metastatic breast cancer _
The usual dose given is 25-30 mg/m² once weekly.”
Maximum tolerated dose per administration: 35.4 mg/m² of body surface
area.
Maximum total dose per administration: 60 mg.
_ELDERLY_:
Clinical experience has not detected any significant differences among
elderly
patients with regard to the response rate, although greater
sensitivity in some
of these patients cannot be excluded. Age does not modify the
pharmacokinetics of vinorelbine (see section 5.2)
_DOSE ADJUSTMENT_:
Vinorelbine metabolism and clearance are mostly hepatic: only 18.5% is
e