ALKERAN

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

MELPHALAN

Disponible depuis:

GLAXO WELLCOME INDONESIA - Indonesia

DCI (Dénomination commune internationale):

MELPHALAN

Dosage:

2 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, BOTOL @ 25 TABLET SALUT SELAPUT

Fabriqué par:

EXCELLA GMBH & CO. KG - Federal Republic of Germany

Date de l'autorisation:

2021-06-10

Résumé des caractéristiques du produit

Page 1 of 7
ALKERAN™ TABLETS
MELPHALAN
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg melphalan.
2.
PHARMACEUTICAL FORM
Film-coated tablets.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
_ALKERAN_
tablets are indicated in the treatment of:
•
multiple myeloma;
•
advanced ovarian adenocarcinoma.
_ALKERAN_
tablets may be used in the treatment of:
•
breast carcinoma:
_ALKERAN_
either alone or in combination with other drugs
has a significant therapeutic effect in a proportion of patients
suffering from
advanced breast carcinoma;
•
polycythaemia rubra vera:
_ALKERAN_
is effective in the treatment of a
proportion of patients suffering from polycythaemia vera.
3.2 DOSAGE AND ADMINISTRATION
GENERAL
_ALKERAN_
is a cytotoxic drug which falls into the general class of alkylating
agents. It
should be prescribed only by physicians experienced in the management
of malignant
disease with such agents.
Since
_ALKERAN_
is myelosuppressive, frequent blood counts are essential during
therapy
and the dosage should be delayed or adjusted if necessary (
_see Warnings and _
_Precautions_
).
The absorption of
_ALKERAN_
after oral administration is variable. Dosage may need to be
cautiously increased until myelosuppression is seen, in order to
ensure that potentially
therapeutic levels have been reached.
MULTIPLE MYELOMA
A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided
doses for 4 days
repeated at intervals of 6 weeks. Numerous regimens have, however,
been used and the
scientific literature should be consulted for details.
The administration of oral
_ALKERAN_
and prednisone may be more effective than
_ALKERAN_
alone. The combination is usually given on an intermittent basis.
Prolonging treatment beyond one year in responders does not appear to
improve results.
ADVANCED OVARIAN ADENOCARCINOMA
A typical regimen is 0.2 mg/kg bodyweight/day orally for 5 days. This
is repeated every
4 to 8 weeks, or as soon as the peripheral blood count has recovered.
Page 2 of 7
CARCINOMA OF THE BREAST
_ALKERAN