Vinorelbine Accord 20 mg soft capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Vinorelbine tartrate

थमां उपलब्ध:

Accord Healthcare Ireland Ltd.

ए.टी.सी कोड:

L01CA04

INN (इंटरनेशनल नाम):

Vinorelbine tartrate

फार्मास्यूटिकल फॉर्म:

Capsule, soft

चिकित्सीय क्षेत्र:

vinorelbine

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2023-02-17

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VINORELBINE ACCORD 20 MG SOFT CAPSULES
VINORELBINE ACCORD 30 MG SOFT CAPSULES
vinorelbine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Accord is and what it is used for
2.
What you need to know before you take Vinorelbine Accord
3.
How to take Vinorelbine Accord
4.
Possible side effects
5.
How to store Vinorelbine Accord
6.
Contents of the pack and other information
1.
WHAT VINORELBINE ACCORD IS AND WHAT IT IS USED FOR
Vinorelbine Accord contains the active substance vinorelbine and
belongs to a family of medicines
called the vinca-alkaloid family, used to treat cancer.
Vinorelbine Accord 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 ACCORD
_ _
DO NOT TAKE VINORELBINE ACCORD
-
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 where a part of your stomach or small
bowel has been removed, or
if you have gut disorder which affects how you absorb food. These may
affect how your body
absorbs Vinorelbine Accord.
-
If you have a low white blood cell count (neutrophils, leucocytes) or
a severe infection current
or recent within two weeks.
-
If you have a low blood platelet cell count (thrombocytopenia).
-
If you plan to have a yellow fever vaccinat

उत्पाद विशेषताएं

Health Products Regulatory Authority
18 May 2023
CRN00DJ8P
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vinorelbine Accord 20 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains vinorelbine tartrate equivalent to 20 mg
vinorelbine.
Excipients with known effect
Each soft capsule contains 8.03 mg of sorbitol (as sorbitol liquid
partially dehydrated) and 2.89 mg ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft capsule
Light brown, opaque, oval shaped (9.3 mm x 6.7 mm) soft gelatin
capsule, free from surface defect, imprinted "JJ1" in black,
containing a clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vinorelbine Accord is indicated in adult patients for treatment of:
- advanced non-small-cell lung cancer as monotherapy or in combination
with other chemotherapy.
- as adjuvant treatment of non-small-cell lung cancer in combination
with platinum-based chemotherapy.
- advanced breast cancer as monotherapy or in combination with other
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of soft capsules should be considered in cases where
intravenous administration of vinorelbine is not possible (see
section 4.4).
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/m
2
once weekly except in those
patients for whom the neutrophil count dropped once <500/mm
3
or more than once between 500 and 1,000/mm
3
during the
first three administrations at 60 mg/m
2
.
Neutrophil count during the first 3 administrations
of 60 mg/m
2
/week
Neutrophils>1,000
Neutrophils
≥500 and <1,000
(1 episode)
Neutrophils
≥500 and <1,000
(2 episodes)
Neutrophils
<500
Recommended dose starting with the 4
th
administration
80
80
60
60
_Dose modification_
Health Products Regulatory Auth