ALKERAN TABLET 2 mg (Revised formula)

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

MELPHALAN

제공처:

DCH AURIGA SINGAPORE

ATC 코드:

L01AA03

복용량:

2.00 mg

약제 형태:

TABLET, FILM COATED

구성:

MELPHALAN 2.00 mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

Excella GmbH & Co. KG

승인 상태:

ACTIVE

승인 날짜:

2002-02-26

환자 정보 전단

ALKERAN
TM
 TABLETS 
Melphalan 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 2 mg melphalan. 
PHARMACEUTICAL FORM 
Film-coated tablets. 
CLINICAL PARTICULARS 
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.
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.

제품 특성 요약

ALKERAN
TM
TABLETS
Melphalan
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each
tablet
contains
2
mg
melphalan.
PHARMACEUTICAL
FORM
Film-coated
tablets.
CLINICAL
PARTICULARS
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 rubra vera.
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.
CARCINOMA
OF
THE
BREAST
_ALKERAN _has been given orally at a