Vinorelbine 10mg/ml concentrate for solution for infusion concentrate for solution for infusion

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

vinorelbine (vinorelbine tartrate)

Disponible des:

Accord Healthcare Limited

Codi ATC:

L01CA04

Designació comuna internacional (DCI):

vinorelbine (vinorelbine tartrate)

Dosis:

10mg/ml

formulario farmacéutico:

concentrate for solution for infusion

Unidades en paquete:

(1) glass vial 1ml

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2017-08-16

Informació per a l'usuari

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 before usin

Fitxa tècnica

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).
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
excreted
unchanged in the u