DAUNOXOME Concentrate for solution for infusion (2014)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Galen Limited |
|---|---|
| Διεύθυνση | Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA, Ireland |
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Περιεχόμενα
Name of the medicinal product
DaunoXome 2 mg/mL concentrate for solution for infusion.
Qualitative and quantitative composition
Daunorubicin present as citrate salt; equivalent to daunorubicin base, 2 mg/ml, encapsulated in liposomes. Each single dose vial of DaunoXome contains 50 mg daunorubicin. For excipients, see Section 6.1. ...
Pharmaceutical form
Concentrate for solution for infusion. Each vial contains a translucent red liposomal dispersion free from visible particles.
Therapeutic indications
AIDS-related Kaposis Sarcoma in patients with low CD4 cell counts (<200cells/mm³) and extensive mucocutaneous or visceral disease. DaunoXome should not be used to treat AIDS-related KS that may be effectively ...
Posology and method of administration
DaunoXome should be administered by intravenous infusion. The recommended initial dose of DaunoXome in patients with AIDS-related Kaposis sarcoma is 40 mg/m² every two weeks. The dosage of DaunoXome must ...
Contraindications
Hypersensitivity to DaunoXome, any of its excipients or other anthracyclines/anthracenediones. Breast feeding.
Special warnings and precautions for use
The decision to treat must be based on an evaluation, by the physician, of the benefits and risks for the individual patient. Cardiotoxicity DaunoXome and other anthracyclines can cause cardiotoxicity, ...
Interaction with other medicinal products and other forms of interaction
Daunorubicin hydrochloride is mainly metabolised in the liver; concomitant medication influencing liver function may also therefore influence the metabolism or pharmacokinetics of daunorubicin hydrochloride ...
Fertility, pregnancy and lactation
Fertility and Contraceptive Measures Daunorubicin could induce chromosomal damage in human spermatozoa. Men should receive counselling on sperm cryopreservation before the start of daunorubicin treatment ...
Effects on ability to drive and use machines
No studies have been performed on the effects of DaunoXome on the ability to drive and use machines. However, patients should be informed that dizziness has been reported during treatment with DaunoXome. ...
Undesirable effects
The adverse reactions considered at least possibly related to treatment with DaunoXome are listed below, by body system organ class and absolute frequency. Frequencies are defined as follows: very common ...
Overdose
From experience with non-liposomal anthracyclin preparations, the primary anticipated toxicity from such an overdose would be myelosuppression. Furthermore other side effects may occur in more pronounced ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agent ATC code: L01DB02 The active ingredient of DaunoXome is daunorubicin, a cytotoxic anthracycline antibiotic isolated from Streptomyces coeruleorubidus. The ...
Pharmacokinetic properties
Following the administration of DaunoXome, daunorubicin is present in plasma bound to liposomes and as free (protein-bound and non-protein-bound) drug. The pharmacokinetic data of free daunorubicin is ...
Preclinical safety data
Daunorubicin is mutagenic both in vitro and in vivo, and carcinogenic in vivo. A high incidence of mammary tumours was observed in rats treated with daunorubicin. Although no such studies have been conducted ...
List of excipients
Liposome: Colfosceril stearate Cholesterol Citric acid Buffer: Sucrose Glycine Calcium chloride dihydrate Hydrochloric acid Sodium hydroxide Water for injection
Incompatibilities
DaunoXome may only be mixed with 5% dextrose for infusion. If DaunoXome is mixed with saline, aggregation of the liposomes may result. Admixtures containing bacteriostatic agents such as benzyl alcohol ...
Shelf life
Shelf life: The shelf life is 12 months when stored at 2-8ºC. Chemical and physical in-use stability has been demonstrated for DaunoXome diluted with 5% dextrose, see table below for details. From a microbial ...
Special precautions for storage
Store concentrate in a refrigerator (at 2-8ºC). Do not freeze. Keep the vial in the outer carton in order to protect from light.
Nature and contents of container
DaunoXome is presented in 50-ml sterile Type 1glass Ph. Eur. vial. Each vial contains 25 ml liquid for infusion. The closure consists of a butyl rubber stopper and aluminum ring seal fitted with a removable ...
Special precautions for disposal and other handling
Do not store partially used vials for future patient use. Vials are for single use only. Discard any unused product. Visually examine the vial for evidence of deterioration. Evidence of deterioration include ...
Marketing authorization holder
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK
Marketing authorization number(s)
PA1329/009/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 May 1996 Date of last renewal: 24 May 2010
Date of revision of the text
August 2014
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