Alkeran Injection 50mg

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

MELPHALAN

Saadav alates:

Aspen Medical Products Malaysia Sdn Bhd

INN (Rahvusvaheline Nimetus):

MELPHALAN

Ühikuid pakis:

1 Unit Units; 10 ml Units

Valmistatud:

Cenexi - Laboratories Thissen S.A.

Infovoldik

Not Applicable

Toote omadused

1
ALKERAN™ INJECTION
MELPHALAN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Injections supplied as a unit pack comprising a vial containing 50mg
sterile, anhydrous
melphalan (as the hydrochloride) with a vial containing 10ml
solvent-diluent.
PHARMACEUTICAL FORM
Alkeran Powder for Injection is a white to off-white freeze-dried
powder. Solvent
Diluent for Alkeran Injection is a clear, colourless solution with an
alcoholic odour,
practically free from visible particles.
CLINICAL PARTICULARS
INDICATIONS
_ALKERAN_ Injection, administered by regional arterial perfusion, is
indicated in the
treatment of:
localised malignant melanoma of the extremities;
localised soft tissue sarcoma of the extremities.
_ _
_ALKERAN_
Injection,
at
conventional
intravenous
dosage,
may
be
used
in
the
treatment of:
multiple myeloma: _ALKERAN_ Injection, either alone or in combination
with other
cytotoxic drugs, is as effective as the oral formulation in the
treatment of multiple
myeloma;
advanced ovarian cancer: _ALKERAN_ Injection produces an objective
response
in approximately 50% of the patients with advanced ovarian
adenocarcinoma,
when given alone, or in combination with other cytotoxic.
_ALKERAN_ Injection, at high intravenous dosage, may be used in the
treatment of:
multiple myeloma: complete remissions have been achieved in up to 50%
of
patients given high-dose _ ALKERAN_ Injection, with or without
haematopoietic
stem cell rescue, either as first-line treatment or to consolidate a
response to
conventional cytoreductive chemotherapy;
advanced neuroblastoma in childhood: high-dose _ ALKERAN_ Injection
with
haematopoietic stem cell rescue has been used either alone, or
combined with
radiotherapy
and/or
other
cytotoxic
drugs,
to
consolidate
a
response
to
conventional treatment.
2
A significant increase in the duration of disease-free survival was
demonstrated in a
prospective randomised trial of high-dose _ ALKERAN_ Injection versus
no further
treatment.
DOSAGE AND ADMINISTRATION
GENERAL
_ALKERAN_ is a cytotoxic drug which falls into the g