País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
doxorubicin hydrochloride
Teva B.V.
L01DB01
doxorubicin
Antineoplastic agents
Breast Neoplasms
Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.
Revision: 24
Authorised
2000-07-13
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER MYOCET LIPOSOMAL 50 MG POWDER, DISPERSION AND SOLVENT FOR CONCENTRATE FOR DISPERSION FOR INFUSION Liposomal 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, pharmacist or nurse. - 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Myocet liposomal is and what it is used for 2. What you need to know before you are given Myocet liposomal 3. How Myocet liposomal is given 4. Possible side effects 5. How to store Myocet liposomal 6. Contents of the pack and other information 1. WHAT MYOCET LIPOSOMAL IS AND WHAT IS IT USED FOR Myocet liposomal contains a medicine called “doxorubicin”, which damages tumour cells. This type of medicine is called “chemotherapy”. The medicine is contained inside very small droplets of fat called “liposomes”. Myocet liposomal is used in adult women for the first-line treatment of breast cancer that has spread (“metastatic breast cancer”). It is used with another medicine called “cyclophosphamide”. Please also read the patient information leaflet carefully that comes with that medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYOCET LIPOSOMAL DO NOT HAVE MYOCET LIPOSOMAL: • if you are allergic to doxorubicin or any of the other ingredients of this medicine (listed in section 6). Do not have Myocet liposomal if this applies to you. If you are not sure, talk to your doctor or nurse before having Myocet liposomal. WARNING AND PRECAUTIONS Talk to your doctor or nurse before having Myocet liposomal. Check with your doctor or nurse b Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Liposome–encapsulated doxorubicin–citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl). Excipient(s) with known effect: The reconstituted medicinal product contains approximately 108 mg sodium for a 50 mg doxorubicin HCl dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder, dispersion and solvent for concentrate for dispersion for infusion Myocet liposomal is supplied as a three-vial system as follows: Vial 1 - doxorubicin HCl is a red lyophilised powder. Vial 2 - liposomes is a white to off-white, opaque and homogeneous dispersion. Vial 3 - buffer is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myocet liposomal, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in adult women. _ _ _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of Myocet liposomal should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy. Posology When Myocet liposomal is administered in combination with cyclophosphamide (600 mg/m 2 ) the initial recommended dose of Myocet liposomal is 60-75 mg/m 2 every three weeks. _Older people _ Safety and efficacy of Myocet liposomal have been assessed in 61 patients with metastatic breast cancer, age 65 and over. Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet liposomal in this population was comparable to that observed in patients less than 65 years old. _Patients with hepatic impairment _ As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and durin Leia o documento completo