Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Doxorubicin hydrochloride 2 mg/mL (actual amount depends on total phosphate assay);
Baxter Healthcare Ltd
Doxorubicin hydrochloride 2 mg/mL (actual amount depends on total phosphate assay)
2 mg/mL
Concentrate for infusion
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
Vial, glass, single dose, 50mg/25ml, 1 dose unit
Prescription
Prescription
Meiji Seika Kaisha Ltd
· Metastatic breast cancer in women for whom an anthracycline would be considered · Metastatic breast cancer in women who have failed a taxane-containing regimen
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)
1996-04-04
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 read_full_document
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 read_full_document