CEPLENE Solution for injection (2023)
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Περιεχόμενα
Name of the medicinal product
Ceplene 0.5 mg/0.5 mL solution for injection.
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.
Pharmaceutical form
Solution for injection. Clear, colourless aqueous solution.
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 ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV. Patients receiving systemic ...
Special warnings and precautions for use
Ceplene should be administered 1 to 3 minutes after IL-2 administration, and not concomitantly. Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia, ...
Interaction with other medicinal products and other forms of interaction
While posology differs, when Ceplene is used in conjunction with IL-2, physicians should also refer to the Summary of Product Characteristics (SmPC) for IL-2 and observe the respective medicinal product ...
Fertility, pregnancy and lactation
Contraception in males and females Women of childbearing potential and sexually active men must use effective methods of contraception during treatment with Ceplene and IL-2. Pregnancy For Ceplene, no ...
Effects on ability to drive and use machines
Ceplene has minor or moderate influence on the ability to drive and use machines. Administration of Ceplene can cause hypotension and may result in dizziness, light-headedness and blurred vision. Patients ...
Undesirable effects
Acute myeloid leukaemia Adverse reactions were reported to be at least possibly related to IL-2 and Ceplene treatment in almost all patients in studies in AML. The most common adverse reactions experienced ...
Overdose
Administration of Ceplene or IL-2 by rapid infusion or into vascular spaces, at higher doses than the approved ones, may exaggerate the adverse reactions associated with Ceplene.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Immunostimulants, other immunostimulants <b>ATC code:</b> L03AX14 Mechanism of action Ceplene/IL-2 is an immunotherapy which aims to induce immune-mediated destruction ...
Pharmacokinetic properties
Absorption Histamine is rapidly absorbed after subcutaneous injection. Maximum plasma concentration is reached approximately 10 minutes after end of subcutaneous infusion. Histamine concentrations and ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity, local tolerance and genotoxicity. Effects in non-clinical studies were observed only at exposures ...
List of excipients
Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies this medicinal product should not be mixed with other medicinal products, diluents or infusion solutions.
Shelf life
<u>Unopened vials:</u> 3 years.
Special precautions for storage
<u>Ceplene:</u> Do not freeze. <u>Interleukin-2 (IL-2; aldesleukin):</u> Diluted IL-2 (aldesleukin) dispensed in capped polypropylene tuberculin syringes is to be stored in the refrigerator (2°C–8°C). ...
Nature and contents of container
2 mL type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 mL of solution (0.70 mL including overfill). Each carton contains 14 vials.
Special precautions for disposal and other handling
Ceplene The vials contain 0.70 mL of solution (including overfill) to facilitate the dose extraction of a single 0.5 mL dose. Patients should be provided with capped polypropylene syringes and instructed ...
Marketing authorization holder
Laboratoires Delbert, 49 Rue Rouelle, 75015 Paris, France
Marketing authorization number(s)
EU/1/08/477/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 07/10/2008 Date of latest renewal: 26/07/2018
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