Vinorelbine 10mg/1ml concentrate for solution for infusion vials

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Vinorelbine tartrate

Dostupno od:

Accord-UK Ltd

ATC koda:

L01CA04

INN (International ime):

Vinorelbine tartrate

Doziranje:

10mg/1ml

Farmaceutski oblik:

Solution for infusion

Administracija rute:

Intravenous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 08010400; GTIN: 5012617017765

Uputa o lijeku

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 OR NURSE.
• IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR
DOCTOR OR NURSE. THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET:
1.
What VINORELBINE is and what it is used for
2.
What you need to know before you use
VINORELBINE
3.
How to use VINORELBINE
4.
Possible side effects
5.
How to store VINORELBINE
6.
Contents of the pack and other
information
1. WHAT VINORELBINE IS AND WHAT IT IS USED
FOR
Vinorelbine is indicated for use in adults.
Vinorelbine is used in the treatment of
cancer and belongs to a group of medicines
known as Vinca alkaloids.
Vinorelbine is used to treat certain types of
lung cancer and breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
VINORELBINE
DO NOT USE VINORELBINE
•
if you are allergic to vinorelbine or other
Vinca alkaloids
•
if you have or recently had serious
infection or severe decrease in white
blood cells (neutropenia)
•
if you have severe decrease in blood
platelets
•
if you are breast-feeding
•
if you are a woman of childbearing
potential not using effective
contraception
•
in combination with 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 nurse before using
Vinorelbine
•
if you have had a heart disease involving
lack of blood supply to the heart
(ischaemic heart disease, angina)
•
if you are having radiotherapy and the
treatment field includes the liver
•
if you present signs or symptoms
suggestive of infection (such as fever,
chills, sore throat), let your doctor know
immediately, so that he/she can carry
out any tests which may be needed
•
if you have impaired liver function
•
if you need a vaccination. You should
inform your doctor of the treatment
before

Svojstava lijeka

OBJECT 1
VINORELBINE 10MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 30-May-2014 | Accord-UK Ltd
1. Name of the medicinal product
Vinorelbine 10mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
1 ml concentrate for solution for infusion contains 10mg vinorelbine
base equivalent to 13.85mg
vinorelbine tartrate.
Each 1 ml vial contains 10 mg vinorelbine (as tartrate).
Each 5 ml vial contains 50 mg vinorelbine (as tartrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear, colourless to slightly yellow solution with a pH of 3.3 to 3.8
and an osmolarity of about
330mOsm/l.
4. Clinical particulars
4.1 Therapeutic indications
Vinorelbine is indicated in adults in the treatment of:
- Non-small cell lung cancer (stage 3 or 4).
- As single agent to patients with metastatic breast cancer (stage 4),
where treatment with anthracycline-
and taxane containing chemotherapy has failed or is not appropriate.
4.2 Posology and method of administration
_Strictly for intravenous administration after appropriate dilution ._
Intra-thecal administration is contra-indicated and may be fatal.
For instructions on dilution of the product before administration and
other handling, see section 6.6.
Vinorelbine 10mg/ml concentrate for solution for infusion should be
given in cooperation with a
physician with extensive experience in therapy with cytostatics.
Posology
_Non-small cell lung cancer_
As a single agent the normal dose is 25-30mg/m², administered once
weekly. In polychemotherapy the
schedule regimen is a function of the protocol. The normal dose could
be used (25-30mg/m²), but the
frequency of the administration be reduced to for example day 1 and 5
every third week or day 1 and 8
every third week according to the regimen.
_Advanced or metastatic breast cancer_
The normal dose is 25-30mg/m², administered once weekly.
The maximum tolerated dose per administration: 35.4 mg/m
2
body surfac