Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
doxorubicin hydrochloride, Quantity: 2 mg/mL
Sun Pharma ANZ Pty Ltd
Doxorubicin hydrochloride
Injection
Excipient Ingredients: water for injections; cholesterol; ethanol; hydrogenated soy phosphatidylcholine; ammonium sulfate; sodium methoxy PEG-40-carbonyl-distearoylphosphatidylethanolamine; histidine; hydrochloric acid; sodium hydroxide; sucrose
Intravenous Infusion
1
(S4) Prescription Only Medicine
LIPOSOMAL DOXORUBICIN SUN, as monotherapy, is indicated for the treatment of metastatic breast cancer.,LIPOSOMAL DOXORUBICIN SUN 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.,LIPOSOMAL DOXORUBICIN SUN 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). LIPOSOMAL DOXORUBICIN SUN 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 unsuitable for bone marrow transplant.
Visual Identification: Translucent, red colored liposomal suspension.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2013-12-11
LIPOSOMAL DOXORUBICIN SUN CMI V3 Page 1 of 5 LIPOSOMAL DOXORUBICIN SUN _Pegylated liposomal Liposomal Doxorubicin hydrochloride_ _ _ _CONSUMER MEDICINE INFORMATION_ _ _ _ _ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Liposomal Doxorubicin SUN. 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 Liposomal Doxorubicin SUN 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 IS LIPOSOMAL DOXORUBICIN SUN USED FOR Liposomal Doxorubicin SUN is used to treat cancer of the breast and ovary. It is used to kill cancer. Other symptoms of Kaposi's sarcoma, such as swelling around the tumour, may also improve or disappear. Liposomal Doxorubicin SUN belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Liposomal Doxorubicin SUN contains a medicine called Liposomal Doxorubicin hydrochloride which is able to interact with cells in such a way as to selectively kill cancer cells. The Liposomal Doxorubicin hydrochloride in Liposomal Doxorubicin SUN 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 Liposomal Doxorubicin SUN for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LIPOSOMAL DOXORUBICIN SUN HAS BEEN PRESCRIBED FOR YOU. cancer cells, shrink the size and delay the growth of the tumour. Liposomal Doxorubicin SUN 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. Liposomal Doxorubic Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION LIPOSOMAL DOXORUBICIN SUN (DOXORUBICIN HYDROCHLORIDE) INJECTION 1 NAME OF THE MEDICINE liposomal doxorubicin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Liposomal Doxorubicin SUN, 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. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride (HCl) at a concentration of 2.0 mg/ml in a pegylated liposomal formulation. The drug substance, doxorubicin hydrochloride is an orange-red crystalline powder. It is soluble in water, slightly soluble in methanol and practically insoluble in ethanol and acetone. 3 PHARMACEUTICAL FORM Liposomal Doxorubicin SUN 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. The pH of the suspension is 6.5. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Liposomal Doxorubicin SUN, as monotherapy, is indicated for the treatment of metastatic breast cancer. Liposomal Doxorubicin SUN 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. Liposomal Doxorubicin SUN 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). 2 Liposomal Doxorubicin SUN is also indicated, in combination with bortezom Prečítajte si celý dokument