CAELYX doxorubicin hydrochloride 20mg/10mL Injection, concentrated

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

doxorubicin hydrochloride, Quantity: 2 mg/mL

Boleh didapati daripada:

Baxter Healthcare Pty Ltd

Borang farmaseutikal:

Injection, concentrated

Komposisi:

Excipient Ingredients: ammonium sulfate; histidine; water for injections; sodium hydroxide; cholesterol; sodium methoxy PEG-40-carbonyl-distearoylphosphatidylethanolamine; sucrose; hydrogenated soy phosphatidylcholine; hydrochloric acid

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

10 x 10mL, 1 x 10mL

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

For the treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (<200 lymphocytes/mm) and extensive mucocutaneous or visceral disease. Caelyx may be used for 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 doxorubicin (or other anthracycline). INDICATIONS AS AT 21 September 2001: For the treatment of: (1) Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. (2) AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (<200 lymphocytes/cubic mm) and extensive mucocutaneous or visceral disease. 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 doxorubicin (or other anthracycline). INDICATIONS AS AT 29 February 2008: CAELYX, as monotherapy, is indicated for the treatment of metastatic breast cancer. CAELYX is also indicated for the treatment of: Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (<200 lymphocytes/mm3) 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 doxorubicin (or other anthracycline). Caelyx is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or who are unsuitable for bone marrow transplant.

Ringkasan produk:

Visual Identification: Translucent red suspension; Container Type: Vial; Container Material: Glass; Container Life Time: 20 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

1997-08-06

Risalah maklumat

CAELYX
_pegylated liposomal doxorubicin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAELYX. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using CAELYX
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CAELYX IS USED
FOR
CAELYX is used to treat cancer of
the breast and ovary. It is used to kill
cancer cells, shrink the size and delay
the growth of the tumour.
CAELYX is also used in
combination with another medicine
called bortezomib to treat multiple
myeloma, which is a cancer of the
plasma cell. Plasma cells are
produced in the bone marrow and are
a component of the immune system.
CAELYX is also used to treat
Kaposi's Sarcoma, another type of
cancer. CAELYX produces an
improvement in Kaposi's Sarcoma
including flattening, lightening and
shrinkage of the cancer. Other
symptoms of Kaposi's Sarcoma, such
as swelling around the tumour, may
also improve or disappear.
CAELYX belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
CAELYX contains a medicine called
doxorubicin hydrochloride which is
able to interact with cells in such a
way as to selectively kill cancer cells.
The doxorubicin hydrochloride in
CAELYX is enclosed in tiny spheres
called liposomes which help to
deliver the medicine from the blood
stream to the cancerous tissue rather
than healthy normal tissue.
Your doctor, however, may prescribe
CAELYX for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CAELYX HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
CAELYX
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE CAELYX IF YOU HAVE
AN ALLERGY TO CAELYX,
DOXORUBICIN HYDROCHLORIDE OR ANY

Ciri produk

1
CAELYX PI Version 1.0
CAELYX
INJECTION
DOXORUBICIN HYDROCHLORIDE
PRODUCT INFORMATION
1.
NAME OF THE MEDICINE
CAELYX
contains pegylated liposomal doxorubicin hydrochloride.
2.
QUALITATIVE AND
QUANTITATIVE
COMPOSITIONS
Each vial contains 20 mg or 50 mg doxorubicin hydrochloride (HCl) at a
concentration of
2.0 mg/1 mL in a pegylated liposomal formulation.
The pH of the suspension is 6.5.
CAELYX, a pegylated liposomal formulation of doxorubicin
hydrochloride, contains doxorubicin
encapsulated in liposomes having surface-bound methoxypolyethylene
glycol groups (pegylated
liposomes). This process is known as pegylation and protects the
liposomes from detection by the
mononuclear phagocyte system (MPS), which increases blood circulation
time.
The pegylated liposome consists of sodium
methoxy-PEG-40-carbonyl-distearoyl phosphatidyl-
ethanolamine (MPEG-DSPE), hydrogenated soy phosphatidylcholine (HSPC)
and cholesterol.
Excipients with known effect: Soya bean products.
Contains less than 1 mmol sodium (23 mg) per dose, and is essentially
‘sodium
‐
free’.
...For a full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM
CAELYX is a concentrate for infusion presented as a sterile,
translucent, red suspension in glass
vials containing 10 mL or 25 mL for single-use intravenous infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CAELYX, as monotherapy, is indicated for the treatment of metastatic
breast cancer.
CAELYX is also indicated for the treatment of:
•
Advanced epithelial ovarian cancer in women who have failed a
first-line platinum-based
chemotherapy regimen.
•
AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts
(<200
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 a