Vinorelbine PharmSol 20 mg Soft Capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC code:

L01CA04

INN (International Name):

VINORELBINE 20 mg

Pharmaceutical form:

SOFT CAPSULE

Composition:

VINORELBINE 20 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-03-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VINORELBINE PHARMSOL 20 MG SOFT CAPSULES
VINORELBINE PHARMSOL 30 MG SOFT CAPSULES
VINORELBINE PHARMSOL 80 MG SOFT CAPSULES
Vinorelbine ditartras
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vinorelbine PharmSol is and what it is used for
2.
What you need to know before you take Vinorelbine PharmSol
3.
How to take Vinorelbine PharmSol
4.
Possible side effects
5.
How to store Vinorelbine PharmSol
6.
Content of the pack and other information
1.
WHAT VINORELBINE PHARMSOL IS AND WHAT IT IS USED FOR
Vinorelbine PharmSol contains the active substance Vinorelbine and
belongs to a family of medicines
called the vinca alkaloid, family used to treat cancer.
Vinorelbine PharmSol 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 TAKE VINORELBINE PHARMSOL
DO NOT TAKE VINORELBINE PHARMSOL :
-
If you are allergic to vinorelbine, or to any of the related family of
cancer drugs called the vinca
alkaloids, or any other ingredients of this medicine (listed in
section 6)
-
If you are breast feeding
-
If you have had an operation on your stomach or small bowel, or if you
have intestinal disorders
-
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 have a yellow fever vaccine or have just had one
-
If you require long-term oxygen therapy
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vinorelbine PharmSol 20 mg Soft Capsules
Vinorelbine PharmSol 30 mg Soft Capsules
Vinorelbine PharmSol 80 mg Soft Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains vinorelbine tartrate equivalent to 20 mg
vinorelbine
Each soft capsule contains vinorelbine tartrate equivalent to 30 mg
vinorelbine
Each soft capsule contains vinorelbine tartrate equivalent to 80 mg
vinorelbine
Excipients with the known effect:
Each soft capsule containing 20 mg vinorelbine contains 10.54 mg
sorbitol.
Each soft capsule containing 30 mg vinorelbine contains 15.96 mg
sorbitol.
Each soft capsule containing 80 mg vinorelbine contains 29.35 mg
sorbitol.
Each soft capsule containing 20 mg vinorelbine contains 5 mg ethanol.
Each soft capsule containing 30 mg vinorelbine contains 7.5 mg
ethanol.
Each soft capsule containing 80 mg vinorelbine contains 20 mg ethanol.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsules Soft
20 mg soft capsule: An oval-shaped light brown soft capsule with a
size of 9.0mm x 7.0mm with black
“20” printed on the surface
30 mg soft capsule: An oblong-shaped pink soft with a size of 15.0mm x
6.0mm capsule with black
“30” printed on the surface
80 mg soft capsules: An oblong-shaped pale yellow soft capsule with a
size of 20.0mm x 8.0mm with
black “80” printed on the surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-small cell lung cancer
Advanced Breast Cancer
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IN ADULT PATIENTS
-
AS A SINGLE AGENT:
the recommended regimen is:
FIRST THREE ADMINISTRATIONS
60 mg/m² of body surface area,
ADMINISTERED ONCE WEEKLY.
SUBSEQUENT ADMINISTRATIONS
Beyond the third administration, it is recommended to increase the
dose of Vinorelbine PharmSol to
80 mg/m² once weekly except in those patients for whom the neutrophil
count dropped once below
500/mm
3
or more than once between 500 and 1000/mm
3
during the first three administrations at
60 mg/