Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
doxorubicin hydrochloride
Baxter Holding B.V.
L01DB
doxorubicin
Antineoplastic agents
Sarcoma, Kaposi; Multiple Myeloma; Ovarian Neoplasms; Breast Neoplasms
Caelyx pegylated liposomal is indicated:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk;for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;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;for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (
Revision: 36
Authorised
1996-06-20
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER CAELYX PEGYLATED LIPOSOMAL 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION doxorubicin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Caelyx pegylated liposomal is and what it is used for 2. What you need to know before you use Caelyx pegylated liposomal 3. How to use Caelyx pegylated liposomal 4. Possible side effects 5 How to store Caelyx pegylated liposomal 6. Contents of the pack and other information 1. WHAT CAELYX PEGYLATED LIPOSOMAL IS AND WHAT IT IS USED FOR Caelyx pegylated liposomal is an antitumour agent. Caelyx pegylated liposomal is used to treat cancer of the breast in patients at risk for heart problems. Caelyx pegylated liposomal is also used to treat cancer of the ovary. It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival. Caelyx pegylated liposomal is also used in combination with another medicine, bortezomib, to treat multiple myeloma (a cancer of the blood) in patients who have received at least 1 prior therapy. Caelyx pegylated liposomal is also used to produce an improvement in your Kaposi’s sarcoma including flattening, lightening and even shrinkage of the cancer. Other symptoms of Kaposi’s sarcoma, such as swelling around the tumour, may also improve or disappear. Caelyx pegylated liposomal contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells. The doxorubicin hydrochlor Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of Caelyx pegylated liposomal contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation. Caelyx pegylated liposomal is doxorubicin hydrochloride encapsulated in liposomes with surface-bound methoxypolyethylene glycol (MPEG). This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time. Excipients with known effect Contains fully hydrogenated soy phosphatidylcholine (from soyabean) – see section 4.3. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) The dispersion is sterile, translucent and red. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caelyx pegylated liposomal is indicated: - As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. - For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. - 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. - For treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm 3 ) and extensive mucocutaneous or visceral disease. Caelyx pegylated liposomal 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 anthracycline). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Caelyx pegylated liposomal should on Läs hela dokumentet