Ceplene

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Histamine dihydrochloride

Available from:

Laboratoires Delbert

ATC code:

L03AX14

INN (International Name):

histamine dihydrochloride

Therapeutic group:

Immunostimulants,

Therapeutic area:

Leukemia, Myeloid, Acute

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.

Product summary:

Revision: 12

Authorization status:

Authorised

Authorization date:

2008-10-07

Patient Information leaflet

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

Summary of Product characteristics

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