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DACOGEN Powder for concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dacogen 50 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine. After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine. Excipients ...

Pharmaceutical form

Powder for concentrate for solution for infusion (powder for infusion). White to almost white lyophilized powder.

Therapeutic indications

Dacogen is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are ...

Posology and method of administration

Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products. Posology In a treatment cycle, Dacogen is administered at a dose ...

Contraindications

Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1. Breast-feeding (see section 4.6).

Special warnings and precautions for use

Myelosuppression Myelosuppression and complications of myelosuppression, including infections and bleeding that occur in patients with AML may be exacerbated with Dacogen treatment. Therefore, patients ...

Interaction with other medicinal products and other forms of interaction

No formal clinical drug interaction studies with decitabine have been conducted. There is the potential for a drug-drug interaction with other agents which are also activated by sequential phosphorylation ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraceptive measures and avoid becoming pregnant while being treated with Dacogen. ...

Effects on ability to drive and use machines

Dacogen has moderate influence on the ability to drive and use machines. Patients should be advised that they may experience undesirable effects such as anaemia during treatment. Therefore, caution should ...

Undesirable effects

Summary of the safety profile The most common adverse drug reactions (≥35%) reported are pyrexia, anaemia and thrombocytopaenia. The most common Grade ¾ adverse drug reactions (≥20%) included pneumonia, ...

Overdose

There is no direct experience of human overdose and no specific antidote. However, early clinical study data in published literature at doses greater than 20 times higher than the current therapeutic dose, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues ATC Code: L01BC08 Mechanism of action Decitabine (5-aza-2'-deoxycytidine) is a cytidine deoxynucleoside analogue ...

Pharmacokinetic properties

The population pharmacokinetic (PK) parameters of decitabine were pooled from 3 clinical studies in 45 patients with AML or myelodysplastic syndrome (MDS) utilizing the 5-Day regimen. In each study, decitabine ...

Preclinical safety data

Formal carcinogenicity studies have not been performed with decitabine. Evidence from the literature indicates that decitabine has carcinogenic potential. The available data from in vitro and in vivo studies ...

List of excipients

Potassium dihydrogen phosphate (E340) Sodium hydroxide (E524) Hydrochloric acid (for pH adjustment)

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life Unopened vial: 3 years. Reconstituted and diluted solution: Within 15 minutes of reconstitution, the concentrate (in 10 ml of sterile water for injections) must be further diluted with cold ...

Special precautions for storage

Do not store above 25°C. For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

Nature and contents of container

20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine. Pack size: 1 vial.

Special precautions for disposal and other handling

Recommendations for safe handling Skin contact with the solution should be avoided and protective gloves must be worn. Standard procedures for dealing with cytotoxic medicinal products should be adopted. ...

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization number(s)

EU/1/12/792/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 September 2012 Date of latest renewal: 22 May 2017

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