Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
chlorambucil
EXCELLA GmbH & Co.KG
chlorambucil
2mg
tablets film-coated
Prescription
Package Leaflet: Information for the user LEUKERAN ® 2mg Film-coated Tablets chlorambucil 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 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 Leukeran is and what it is used for 2. What you need to know before you take Leukeran 3. How to take Leukeran 4. Possible side effects 5. How to store Leukeran 6. Contents of the pack and other information 1. What Leukeran is and what it is used for Leukeran contains an active substance called chlorambucil which belongs to a group of medicines called cytotoxics (also called chemotherapy). This medicine is used to treat certain type of cancers affecting human blood and lymphatic system. Your doctor will be able to explain how Leukeran might help in your particular condition. Leukeran is used in patients with: - Hodgkin’s disease and Non-Hodgkin’s Lymphoma. Together, these form a group of diseases called lymphomas. They are cancers formed from cells of the lymphatic system. - Chronic lymphocytic leukaemia. A type of blood cancer where the bone marrow produces a large number of abnormal white blood cells. - Waldenstrom’s macroglobulinaemia. A rare lymphoma associated with an uncontrolled increase of B-cells, a type of white blood cell, resulting in the release of an abnormal protein into the blood. 2. What you need to know before you take Leukeran Do not take Leukeran if: You are allergic to chlorambucil or any of the other ingredients of this medicine (listed in section 6). Leukeran should not be used for the treatment of non-malignant cancer. If you are not sure, Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS Leukeran-SPC clean.docx 2 1. NAME OF THE MEDICINAL PRODUCT Leukeran 2 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of the active ingredient chlorambucil. Excipient(s) with known effect: Each tablet also contains 67.65 mg of lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (Tablet) Brown, round, biconvex tablet, engraved on one side with“L”and “GX EG3”on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leukeran is indicated in the treatment of: - Hodgkin's disease; - Certain forms of non-Hodgkin's lymphoma; - Chronic lymphocytic leukaemia; - Waldenstrom'smacroglobulinaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION THE RELEVANT LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE TREATMENT SCHEDULES USED. LEUKERAN IS AN ACTIVE CYTOTOXIC AGENT AND SHOULD ONLY BE ADMINISTERED UNDER THE DIRECTION OF A SPECIALIST ONCOLOGY SERVICE HAVING THE FACILITIES FOR REGULAR MONITORING OF CLINICAL BIOCHEMICAL AND HAEMATOLOGICAL EFFECTS DURING AND AFTER ADMINISTRATION. Posology _Hodgkin's disease_ Used as a single agent in the palliative treatment of advanced disease, a typical dosage is 0.2 mg/kg/day for 4-8 weeks. Leukeran is usually included in combination therapy and a number of regimes have been used. Leukeran has been used as an alternative to nitrogen mustard with a reduction in toxicity but similar therapeutic results. _Non-Hodgkin's lymphoma_ Leukeran-SPC clean.docx 3 Used as a single agent the usual dosage is 0.1-0.2 mg/kg/day for 4-8 weeks initially; maintenance therapy is then given either by a reduced daily dosage or intermittent courses of treatment. Leukeran is useful in the management of patients with advanced diffuse lymphocytic lymphoma and those who have relapsed after radiotherapy. There is no significant difference in the overall response rate obtained with chlorambucil as a single agent and combination chemotherapy in patients with advanced non-Hodgkin' Baca dokumen lengkap