Epicept och Ceplene: SUMMARY OF PRODUCT CHARACTERISTICS;

2009-09-17 13:43, Edited at: 2010-06-11 12:23

Följande intressanta och läsvärda text angående Ceplene är sammanställd och presenterad av EMEA.

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 a 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 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.

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.

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 three-week or six-week treatment-free period.

For cycles 1-3, each cycle consists of 3 weeks of treatment, followed by a 3-week treatment free period. For cycles 4-10, each cycle consists of 3 weeks of treatment, followed by a 6-week treatmentfree period.

Sammanställningen i sin helhet ses på : http://www.emea.europa.eu/humandocs/PDFs/EPAR/Ceplene/H-796-PI-en.pdf

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