Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Palbociclib
Pfizer Europe MA EEIG
L01XE33
palbociclib
Antineoplastic agents
Breast Neoplasms
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Revision: 16
Authorised
2016-11-09
94 B. PACKAGE LEAFLET 95 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBRANCE 75 MG HARD CAPSULES IBRANCE 100 MG HARD CAPSULES IBRANCE 125 MG HARD CAPSULES palbociclib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IBRANCE is and what it is used for 2. What you need to know before you take IBRANCE 3. How to take IBRANCE 4. Possible side effects 5. How to store IBRANCE 6. Contents of the pack and other information 1. WHAT IBRANCE IS AND WHAT IT IS USED FOR IBRANCE is an anticancer medicine containing the active substance palbociclib. Palbociclib works by blocking proteins called cyclin-dependent kinase 4 and 6, which regulate cell growth and division. Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer. IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumour and/or to other organs. It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBRANCE DO NOT TAKE IBRANCE - if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6). - use of preparations containing St. John’s Wort, an herbal product used to treat mild depression and anxiety, should be avoided while you are taking IBRANCE. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before t Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib. _Excipients with known effect _ Each hard capsule contains 56 mg of lactose (as monohydrate). IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib. _Excipients with known effect _ Each hard capsule contains 74 mg of lactose (as monohydrate). IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib. _Excipients with known effect _ Each hard capsule contains 93 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. IBRANCE 75 mg hard capsules Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white). The capsule length is 18.0 ± 0.3 mm. IBRANCE 100 mg hard capsules Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white). The capsule length is 19.4 ± 0.3 mm. IBRANCE 125 mg hard capsules Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white). The capsule length is 21.7 ± 0.3 mm. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with IBRANCE should be initiated and supervised by a physician experienced Прочетете целия документ