CAELYX CONCENTRATE FOR INFUSION 2 mgml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Doxorubicin Hydrochloride

Disponível em:

BAXTER HEALTHCARE (ASIA) PTE LTD

Código ATC:

L01DB01

Dosagem:

2.00 mg/ml

Forma farmacêutica:

INJECTION

Composição:

Doxorubicin Hydrochloride 2.00 mg/ml

Via de administração:

INTRAVENOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Glaxosmithkline Manufacturing S.p.A. (Parma, Italy)

Status de autorização:

ACTIVE

Data de autorização:

1998-11-16

Folheto informativo - Bula

1
PRODUCT NAME
CAELYX
®
Concentrate for Infusion
(pegylated liposomal doxorubicin hydrochloride)
FOR SINGLE USE INTRAVENOUS ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CAELYX
®
is a sterile, translucent, red liposomal dispersion, concentrate for
intravenous
infusion only.
Each CAELYX
®
vial contains 2 mg/mL doxorubicin HCl in a pegylated liposomal
formulation
and delivers 10 mL (20 mg) or 25 mL (50 mg) in a concentrate for
infusion for single
intravenous use.
_ _
For excipients, see “
_List of Excipients_
”.
CLINICAL INFORMATION
INDICATIONS
BREAST CANCER
CAELYX
®
, as monotherapy, is indicated for the treatment of metastatic breast
cancer.
OVARIAN CANCER
CAELYX
®
is indicated for the treatment of advanced ovarian cancer in women who
have
failed a first-line platinum based chemotherapy regimen.
MULTIPLE MYELOMA
CAELYX
®
is indicated in combination with bortezomib for the treatment of
progressive
multiple myeloma in patients who have received at least one prior
therapy and have not
previously received bortezomib. Patients should have already undergone
or are unsuitable for
bone marrow transplant.
AIDS-RELATED KAPOSI’S SARCOMA
CAELYX
®
is also indicated for AIDS-related Kaposi’s sarcoma (KS) in patients
with low CD4
counts (<200 CD4 lymphocytes/mm
3
) and extensive mucocutaneous or visceral disease.
CAELYX
®
may be used as first-line systemic chemotherapy, or as second line
chemotherapy
in AIDS-KS patients with disease that has progressed with, or in
patients intolerant to, prior
combination systemic chemotherapy comprising at least two of the
following agents: a vinca
alkaloid, bleomycin and standard doxorubicin (or other
anthracyclines).
DOSAGE AND ADMINISTRATION
CAELYX
®
exhibits unique pharmacokinetic properties and must not be used
interchangeably
with other formulations of doxorubicin hydrochloride.
CAELYX
®
should only be administered under the supervision of a qualified
oncologist
specialized in the administration of cytotoxic agents.
BREAST/OVARIAN CANCER
CAELYX
®
is administered intravenou

Características técnicas

SGP HA-30-02-245 C 319
CAELYX
CAELYX
PRODUCT NAME
CAELYX Concentrate for Infusion
(pegylated liposomal doxorubicin hydrochloride)
FOR SINGLE USE INTRAVENOUS ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
CAELYX is a sterile, translucent, red liposomal dispersion,
concentrate for intravenous
infusion only.
Each CAELYX vial contains 2 mg/mL doxorubicin HCl in a pegylated
liposomal formulation and
delivers 10 mL (20 mg) or 25 mL (50 mg) in a concentrate for infusion
for single intravenous
use.
For excipients, see “_List of Excipients_”.
CLINICAL INFORMATION
INDICATIONS
BREAST CANCER
CAELYX, as monotherapy, is indicated for the treatment of metastatic
breast cancer.
OVARIAN CANCER
CAELYX is indicated for the treatment of advanced ovarian cancer in
women who have failed
a first-line platinum based chemotherapy regimen.
MULTIPLE MYELOMA
CAELYX is indicated in combination with bortezomib for the treatment
of progressive
multiple myeloma in patients who have received at least one prior
therapy and have not
previously
received
bortezomib.
Patients
should
have
already
undergone
or
are
unsuitable for bone marrow transplant.
AIDS-RELATED KAPOSI’S SARCOMA
CAELYX is also indicated for AIDS-related Kaposi’s sarcoma (KS) in
patients with low CD4
counts (<200 CD4 lymphocytes/mm
3
) and extensive mucocutaneous or visceral disease.
CAELYX
may
be
used
as
first-line
systemic
chemotherapy,
or
as
second
line
chemotherapy in AIDS-KS patients with disease that has progressed
with, or in patients
intolerant to, prior combination systemic chemotherapy comprising at
least two of the
following
agents:
a
vinca
alkaloid,
bleomycin
and
standard
doxorubicin
(or
other
anthracyclines).
DOSAGE AND ADMINISTRATION
CAELYX exhibits unique pharmacokinetic properties and must not be used
interchangeably
with other formulations of doxorubicin hydrochloride.
CAELYX should only be administered under the supervision of a
qualified oncologist
specialized in the administration of cytotoxic agents.
BREAST/OVARIAN CANCER
CAELYX is administered intravenously a