Vinorelbine Medac 20 mg Soft Capsules

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Доступно од:

medac Gesellschaft Fur klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel, Germany

АТЦ код:

L01CA04

INN (Међународно име):

VINORELBINE 20 mg

Фармацеутски облик:

SOFT CAPSULE

Састав:

VINORELBINE 20 mg

Тип рецептора:

POM

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Authorised

Датум одобрења:

2022-03-08

Информативни летак

palmultiple (MT-English) Vinorelbine medac 20 mg/30 mg/80 mg Soft
Capsules
National version: 03/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
VINORELBINE MEDAC 20 MG SOFT CAPSULES
VINORELBINE MEDAC 30 MG SOFT CAPSULES
VINORELBINE MEDAC 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 medac is and what it is used for
2.
What you need to know before you take Vinorelbine medac
3.
How to take Vinorelbine medac
4.
Possible side effects
5.
How to store Vinorelbine medac
6.
Content of the pack and other information
1.
WHAT VINORELBINE MEDAC IS AND WHAT IT IS USED FOR
Vinorelbine medac contains the active substance Vinorelbine and
belongs to a family of medicines called
the vinca alkaloid, family used to treat cancer.
Vinorelbine medac 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 MEDAC
DO NOT TAKE VINORELBINE MEDAC:
-
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 oxyge

Карактеристике производа

spcmultiple (MT-English) Vinorelbine medac 20 mg/30 mg/80 mg Soft
Capsules
National version: 03/2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vinorelbine medac 20 mg Soft Capsules
Vinorelbine medac 30 mg Soft Capsules
Vinorelbine medac 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 the 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 9.0 mm x 7.0 mm with
black “20” printed on the surface
30 mg soft capsule: An oblong-shaped pink soft with a size of 15.0 mm
x 6.0 mm capsule with black
“30” printed on the surface
80 mg soft capsules: An oblong-shaped pale yellow soft capsule with a
size of 20.0 mm x 8.0 mm 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 medac to
80 mg/m² once weekly except in those patients for whom the neutrophil
count dropped once belo