NAVELBINE 10 mg/ml concentrate for solution for infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Vinorelbine

Tilgjengelig fra:

Pierre Fabre Medicament

ATC-kode:

L01CA; L01CA04

INN (International Name):

Vinorelbine

Dosering :

10 milligram(s)/millilitre

Legemiddelform:

Concentrate for solution for infusion

Terapeutisk område:

Vinca alkaloids and analogues; vinorelbine

Autorisasjon status:

Not marketed

Autorisasjon dato:

1996-06-26

Informasjon til brukeren

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 called
the vinca-alkaloid family, used to treat cancer.
Navelbine is used to treat some types of lung cancer and some types of
breast cancer in patients over 18
years old.
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 vacci

Preparatomtale

Health Products Regulatory Authority
08 January 2024
CRN00DLJQ
Page 1 of 10
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
Vinorelbine is indicated in adult patients for treatment of:

advanced non-small-cell lung cancer as monotherapy or in combination
with other chemotherapy

as adjuvant treatment of non-small-cell lung cancer in combination
with platinum-based chemotherapy

advanced breast cancer as monotherapy or in combination with other
agents.
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