Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Histamine dihydrochloride
Laboratoires Delbert
L03AX14
histamine dihydrochloride
Immunostimulants,
Leukemia, Myeloid, Acute
Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
Revision: 12
Authorised
2008-10-07
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER CEPLENE 0.5 MG/0.5 ML SOLUTION FOR INJECTION histamine dihydrochloride This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 further questions, please 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ceplene is and what it is used for 2. What you need to know before you use Ceplene 3. How to use Ceplene 4. Possible side effects 5. How to store Ceplene 6. Content of the pack and other information 1. WHAT CEPLENE IS AND WHAT IS USED FOR Ceplene belongs to a group of medicines called immunomodulatory medicines. These medicines help the body’s immune system fight diseases like cancer by improving the immune system’s natural role in fighting disease. The active substance in Ceplene is histamine dihydrochloride; it is identical to a naturally occurring substance in the body. It is used together with low doses of interleukin-2 (IL-2), another medicine which helps the immune system to fight diseases like cancer. Ceplene is used in adult patients, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML) which is a cancer of blood forming cells in the bone marrow. It is used to maintain the remission (the period during which the disease is less severe or not detectable). Ceplene with IL-2 will help your immune system attack any remaini Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Ceplene 0.5 mg/0.5 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One vial of 0.5 mL of solution contains 0.5 mg of histamine dihydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ceplene maintenance therapy should be administered following completion of consolidation therapy in patients concomitantly treated with IL-2 under the supervision of a physician experienced in the management of acute myeloid leukaemia. Posology For dosing instructions for Ceplene in combination with IL-2, see posology below. _Interleukin-2 (IL-2) _ _ _ IL-2 is administered twice daily as a subcutaneous injection 1 to 3 minutes prior to the administration of Ceplene; each dose of IL-2 is 16,400 IU/kg (1 µg/kg). Interleukin-2 (IL-2) is commercially available as a recombinant IL-2; aldesleukin. The dispensing and storage directions in the section 6.6 are specific to aldesleukin. 3 _ _ _Ceplene _ _ _ 0.5 mL solution is sufficient for a single dose (see section 6.6). Ceplene is administered 1 to 3 minutes after each injection of IL-2. Each 0.5 mL Ceplene dose is injected slowly, over 5-15 minutes. _Treatment cycles _ _ _ Ceplene and IL-2 are administered for 10 treatment cycles: each cycle consists of a treatment period of 21 days (3 weeks) followed by a Przeczytaj cały dokument