VINORELBINE ALVOGEN SOFT CAPSULES 30MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Vinorelbine Tartrate eqv. Vinorelbine

Available from:

LOTUS INTERNATIONAL PTE. LTD.

ATC code:

L01CA04

Pharmaceutical form:

CAPSULE, LIQUID FILLED

Composition:

Vinorelbine Tartrate eqv. Vinorelbine 30.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Authorization status:

ACTIVE

Authorization date:

2021-04-28

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Vinorelbine Alvogen 20 mg soft capsule
Vinorelbine Alvogen 30 mg soft capsule
Vinorelbine Alvogen 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 38.439 mg
sorbitol.
Each soft capsule containing 30 mg vinorelbine contains 59.850 mg
sorbitol.
Each soft capsule containing 80 mg vinorelbine contains 99.905 mg
sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Vinorelbine Alvogen 20 mg soft capsule: An oval-shaped light brown
soft capsule, with the size of
11x7 mm filled with a transparent, colourless to slightly yellow
liquid.
Vinorelbine Alvogen 30 mg soft capsule: An oblong-shaped pink soft
capsule, with the size of
18x6 mm filled with a transparent, colourless to slightly yellow
liquid.
Vinorelbine Alvogen 80 mg soft capsule: An oblong-shaped pale yellow
soft capsule, with the size of
21x8 mm filled with a transparent, colourless to slightly yellow
liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vinorelbine is indicated in adults for:
•
Non-small cell lung cancer
•
Advanced Breast Cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
•
AS A SINGLE AGENT:
Adult patients
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 <500/mm
3
or more than
once between 500 and 1,000/mm
3
during the first three administrations at 60 mg/m².
2
Neutrophil count during the first 3
administrations of 60