NAVELBINE 10 mg/ml concentrate for solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Vinorelbine tartrate

Verfügbar ab:

PIERRE FABRE Ltd

ATC-Code:

L01CA; L01CA04

INN (Internationale Bezeichnung):

Vinorelbine tartrate

Dosierung:

10 Base mg/ml

Darreichungsform:

Concentrate for solution for infusion

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Vinca alkaloids and analogues; vinorelbine

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1996-06-26

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAVELBINE
10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Vinorelbine (as tartrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further question, ask your doctor or your pharmacist.

If you get any of the side effects, talk to your doctor or pharmacist.
This includes and possible side
effect not listed in this leaflet; see section 4.
WHAT IS IN THIS LEAFLET
1. What Navelbine is and what it is used for
2. What you need to know before you are given Navelbine
3. How Navelbine is given
4. Possible side effects
5. How to store Navelbine
6. Contents of the pack and other information
1. WHAT NAVELBINE IS AND WHAT IT IS USED FOR
Navelbine contains the active substance Vinorelbine (as tartrate), and
belongs to a family of medicines used
to treat cancer called the vinca-alkaloid family. Navelbine is used to
treat some types of lung and breast
cancer in patients over 18 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NAVELBINE
DO NOT USE NAVELBINE

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 a low white blood cell (neutrophils, leucocyte) count or a
severe infection current or recent
(within 2 weeks),

If you have a low platelet count (thrombocytopenia),

If you plan to receive a yellow fever vaccination or have just
received one.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you are given Navelbine if:

you have a history of heart attack or severe chest pain,

you have problems with your liver or you have received radiotherapy
where the treatment field included
the liver,

you have signs or symptoms of infection (such as fever, chills, joint
pain, cough),

you plan to have a vaccination. Many vaccin

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NAVELBINE 10 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vinorelbine 10 mg/ml as vinorelbine tartrate.
Each 1ml vial contains 10 mg Vinorelbine as vinorelbine tartrate
Each 4ml vial contains 40 mg Vinorelbine as vinorelbine tartrate
Each 5ml vial contains 50 mg Vinorelbine as vinorelbine tartrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion. Navelbine is a clear,
colourless to pale yellow solution with a pH of 3.3 – 3.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of non small cell lung cancer
-
Treatment of advanced breast cancer
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intra-thecal administration of Navelbine may be fatal.
Navelbine must only be administered by the intravenous route as an
infusion over 6 – 10 minutes.
Instructions for use and handling: see section 6.6.
ADMINISTRATION
It is recommended to infuse Navelbine over 6 to 10 minutes after
dilution in a 50 ml infusion bag with sodium
chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose
solution for injection.
The infusion time of 6 to 10 minutes must be followed as the risk of
venous irritation is increased if the
infusion exposure time is increased.
Administration should always be followed with at least 250 ml of a
normal saline infusion to flush the vein to
avoid the risk of venous irritation.
It is vital to ensure that the cannula is accurately placed in the
vein before starting to infuse Navelbine. If the
drug extravasates into the surrounding tissue during the
administration considerable local irritation may occur.
In this case, the administration should be stopped, the vein flushed
with 0.9 % sodium chloride solution and the
remaining dose administered in another vein.
The management of any extravasation should be according to local
hospital guidelines and policies.
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