Vinorelbine Lotus 20 mg soft capsule

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

VINORELBINE TARTRATE

Disponível em:

Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania

Código ATC:

L01CA04

DCI (Denominação Comum Internacional):

VINORELBINE TARTRATE 20 mg

Forma farmacêutica:

SOFT CAPSULE

Composição:

VINORELBINE TARTRATE 20 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTINEOPLASTIC AGENTS

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Withdrawn

Data de autorização:

2021-03-22

Folheto informativo - Bula

1
PACKAGE LEAFLET
Page 2 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Vinorelbine Lotus 20 mg soft capsule
Vinorelbine Lotus 30 mg soft capsule
Vinorelbine Lotus 80 mg soft capsule
vinorelbine (as tartrate)
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vinorelbine Lotus is and what it is used for
2.
What you need to know before you take Vinorelbine Lotus
3.
How to take Vinorelbine Lotus
4.
Possible side effects
5.
How to store Vinorelbine Lotus
6.
Contents of the pack and other information
1.
WHAT VINORELBINE LOTUS IS AND WHAT IT IS USED FOR
Vinorelbine Lotus contains the active substance vinorelbine (as
tartrate), and belongs to a family of
medicines used to treat cancer called the vinca-alkaloid family.
Vinorelbine is used to treat specific types of lung cancer and
specific types of breast cancer in patients
older than 18 years of age.
Your doctor may prescribe this medicine for any other disease or dose
other than this leaflet. Always
follow your doctor’s or pharmacist’s instructions
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VINORELBINE LOTUS
DO NOT TAKE VINORELBINE LOTUS:
-
If you are allergic to vinorelbine, 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 had an operation on your stomach or small bowel, or if you
have gut disorder
-
If you have a low white blood cell and/or blood platelets count or a
severe infection current or
recent within

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Vinorelbine Lotus 20 mg soft capsule
Vinorelbine Lotus 30 mg soft capsule
Vinorelbine Lotus 80 mg soft capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains vinorelbine tartrate 27.70 mg equivalent to
20 mg vinorelbine.
Each soft capsule contains vinorelbine tartrate 41.55 mg equivalent to
30 mg vinorelbine.
Each soft capsule contains vinorelbine tartrate 110.80 mg equivalent
to 80 mg vinorelbine.
Excipient with known effect
Each soft capsule containing 20 mg vinorelbine contains 38.44 mg
sorbitol.
Each soft capsule containing 30 mg vinorelbine contains 59.85 mg
sorbitol.
Each soft capsule containing 80 mg vinorelbine contains 99.91 mg
sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Vinorelbine Lotus 20 mg soft capsule: An oval-shaped light brown soft
capsule with a size of
11x7 mm filled with a transparent, colour less to slightly yellow
liquid.
Vinorelbine Lotus 30 mg soft capsule: An oblong-shaped pink soft
capsule with a size of 18x6 mm
filled with a transparent, colourless to slightly yellow liquid.
Vinorelbine Lotus 80 mg soft capsule: An oblong-shaped pale yellow
soft capsule with a size of
21x8 mm filled with a transparent, colourless to slightly yellow
liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult patients with non-small cell lung cancer.
Adult patients with advanced breast cancer, when other therapies are
not an option.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 _
After
the third administration, it is recommended to increase the dose of
vinorelbine 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 1,000/mm
3
during the first three administrations at 60 mg/m�