Caelyx

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Doxorubicin hydrochloride 2 mg/mL (actual amount depends on total phosphate assay);  

থেকে পাওয়া:

Baxter Healthcare Ltd

INN (International Name):

Doxorubicin hydrochloride 2 mg/mL (actual amount depends on total phosphate assay)

ডোজ:

2 mg/mL

ফার্মাসিউটিকাল ফর্ম:

Concentrate for infusion

রচনা:

Active: Doxorubicin hydrochloride 2 mg/mL (actual amount depends on total phosphate assay)   Excipient: Ammonium sulfate Carbamoyl-methoxypolyethylene glycol distearoyl glycerophosphoethanolamine sodium Cholesterol Histidine Lecithin Sucrose Water for injection

প্যাকেজ ইউনিট:

Vial, glass, single dose, 50mg/25ml, 1 dose unit

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Meiji Seika Kaisha Ltd

থেরাপিউটিক ইঙ্গিত:

· Metastatic breast cancer in women for whom an anthracycline would be considered · Metastatic breast cancer in women who have failed a taxane-containing regimen

পণ্য সারাংশ:

Package - Contents - Shelf Life: Vial, glass, single dose, 50mg/25ml - 1 dose units - 20 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 20mg/10ml - 1 dose units - 20 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

অনুমোদন তারিখ:

1996-04-04

তথ্য লিফলেট

New Zealand Consumer Medicine Information
CAELYX CMI 25 January 2022
Page 1 of 8
CAELYX
_PEGYLATED LIPOSOMAL DOXORUBICIN HYDROCHLORIDE _
2mg/mL concentrate for infusion
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using CAELYX.
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 they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. 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.
New Zealand Consumer Medicine Information
CAELYX CMI 25 January 2022
Page 2 of 8
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 may have prescribed CAELYX for another

পণ্য বৈশিষ্ট্য

NEW ZEALAND DATA SHEET
CAELYX Data Sheet 9 June 2022
Page 1 of 29
Baxter Healthcare Ltd
1 CAELYX (2mg/mL concentrate for infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of CAELYX contains 2mg doxorubicin hydrochloride in a pegylated
liposomal formation.
Each vial contains 20mg or 50mg doxorubicin hydrochloride.
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.For the full list of
excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for infusion.
CAELYX is a concentrate for infusion presented as a sterile,
translucent, red suspension in glass vials
containing 10mL or 25mL for single‐use intravenous infusion, with a
pH of 6.5.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
CAELYX is indicated for the treatment of:

Metastatic breast cancer in women for whom an anthracycline would be
considered.

Metastatic breast cancer in women who have failed a
taxane‐containing regimen.

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 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 are un