País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
Vinorelbine Tartrate eqv. Vinorelbine
LOTUS INTERNATIONAL PTE. LTD.
L01CA04
CAPSULE, LIQUID FILLED
Vinorelbine Tartrate eqv. Vinorelbine 30.00 mg
ORAL
Prescription Only
Lotus Pharmaceutical Co., Ltd. Nantou Plant
ACTIVE
2021-04-28
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 Leer el documento completo