Navelbine

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

VINORELBINE TARTRATE

متاح من:

Pierre Fabre Medicament 45 Place Abel Gance, 92100 Boulogne, France

ATC رمز:

L01CA04

INN (الاسم الدولي):

VINORELBINE TARTRATE 10 mg/ml

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

VINORELBINE TARTRATE 10 mg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTINEOPLASTIC AGENTS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2006-11-23

نشرة المعلومات

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CORE PATIENT INFORMATION LEAFLET: 

Package Leaflet: Information for the user 

NAVELBINE® 10MG/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 any further questions, ask your doctor
or pharmacist. 
- If you get any side effects, talk to your doctor
, or pharmacist. This includes any possible side 
effects 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 prostate cancer,
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 
vincaalkaloids, 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 and/or platelet count, or
a severe infection current or recent 
(within 2 weeks). 
- If you plan to receive a yellow fever
vaccination or have just had 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 received

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Navelbine 10mg/ml, concentrate for solution for infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

ACTIVE 
INGREDIENT 

FORMULATION 

10 mg/1ml 
50 mg/5 ml 
vinorelbine tartrate (mg) 
13.85 
69.25 
equivalent to vinorelbine 
(INN) base (mg) 
10.00 
50.00 

For the full list of excipients refer to 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 

- Navelbine is indicated as single agent or in combination for the
first line treatment of stage 3 or 4 
Non-small cell lung cancer 
- Navelbine is indicated in the treatment of stage 3 or
4 advanced breast cancer relapsing or 
refractory to an anthracycline containing regimen. 

4.2. POSOLOGY AND METHOD OF ADMINISTRATION 

Strictly intravenous administration after appropriate dilution. 
Intra-thecal administration of Navelbinemay be fatal. 
Instructions for use and handling: see section 6.6. 

It is recommended to infuse Navelbine over 6-10 minutes after
dilution in 20-50 ml of sodium 
chloride 9 mg/ml (0.9%) solution for injection or in
glucose solution for injection 5%. 

Administration should always be followed with at least 250 ml of an
isotonic solution infusion to 
flush the vein. 

- NON-SMALL CELL LUNG CANCER AND ADVANCED BREAST 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. 
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- ADMINISTRATION IN THE ELDERLY 
Clinical experience has not identified re