Navelbine 50mg/5ml concentrate for solution for infusion vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Vinorelbine tartrate

Διαθέσιμο από:

Pierre Fabre Ltd

Φαρμακολογική κατηγορία (ATC):

L01CA04

INN (Διεθνής Όνομα):

Vinorelbine tartrate

Δοσολογία:

10mg/1ml

Φαρμακοτεχνική μορφή:

Solution for infusion

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08010400; GTIN: 3573991467352

Φύλλο οδηγιών χρήσης

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 START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1. What Navelbine is and what it is used for
2. Before you use Navelbine
3. How to use Navelbine
4. Possible side effects
5. How to store Navelbine
6. Further information
1. WHAT NAVELBINE
IS AND WHAT IT IS USED FOR
Navelbine 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:
o
Non-small cell lung cancer
o
Advanced breast cancer that has not responded to other medicines.
It is not recommended for use by children under 18 years old.
2. BEFORE YOU USE NAVELBINE
DO NOT USE NAVELBINE
•
If you are allergic (hypersensitive) to the active substance
(vinorelbine), or to any of the related
family of cancer drugs called the vinca alkaloids,
•
If you are allergic to any of the other ingredients of Navelbine
(refer to section 6 in this leaflet),
•
If you are pregnant or think that you might be pregnant,
•
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.
TAKE SPECIAL CARE WITH NAVELBINE
Please inform your doctor 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, joi

Αρχείο Π.Χ.Π.

OBJECT 1
NAVELBINE 10 MG / ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 04-Jul-2017 | Pierre Fabre
Limited
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 a 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
range from 3.3 to 3.8.
4. Clinical particulars
4.1 Therapeutic indications
- As a single agent or in combination for the first line treatment of
stage 3 or 4 non small cell lung cancer.
- Treatment of advanced breast cancer stage 3 and 4 relapsing after or
refractory to an anthracycline
containing regimen.
4.2 Posology and method of administration
Strictly intravenous administration after appropriate dilution
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.
- Administration should always be followed with at least 250 ml of a
normal saline infusion to flush the
vein.
- 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.
- 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 administra