ALKERAN FOR INJECTION 50 mgvial

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

MELPHALAN

Disponible desde:

DCH AURIGA SINGAPORE

Código ATC:

L01AA03

Dosis:

50 mg/vial

formulario farmacéutico:

INJECTION

Composición:

MELPHALAN 50 mg/vial

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

GLAXO OPERATIONS UK LIMITED (Trading as Glaxo Wellcome Operations) (note: Sterile Diluent)

Estado de Autorización:

ACTIVE

Fecha de autorización:

2002-04-10

Información para el usuario

ALKERAN
TM
 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 a
solvent-diluent.
PHARMACEUTICAL FORM
Powder for injection with solvent.
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 drugs.
_ _
_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. 
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 general class of
alkylating agents. 
It should be prescribed only

Ficha técnica

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 a solvent-diluent
.
PHARMACEUTICAL FORM
Powder for injection with solvent.
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 drugs
.
_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
.
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 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 myelosuppressiv