DAUNOXOME 2 MG/ML CONCENTRATE FOR SOLUTION FOR INF
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
DAUNORUBICIN CITRATE
Available from:
Galen Limited
Dosage:
2 Mg/Ml
Pharmaceutical form:
Concentrate for Susp for Inf
Authorization date:
2012-03-30
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
DaunoXome 2 mg/mL concentrate for solution for infusion
2 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.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Each vial contains a translucent red liposomal dispersion free from visible particles.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
AIDS-related Kaposi’s Sarcoma in patients with low CD4 cell counts (<200cells/mm
3
) and extensive mucocutaneous
or visceral disease.
DaunoXome should not be used to treat AIDS-related KS that may be effectively treated with local therapy.
4.2 Posology and method of administration
DaunoXome should be administered by intravenous infusion. The recommended initial dose of DaunoXome in patients
with AIDS-related Kaposi’s sarcoma is 40 mg/m
2
every two weeks. The dosage of DaunoXome must be adjusted for
each patient. Therapy should be continued as long as disease control can be maintained.
DaunoXome should be diluted with 5% dextrose for infusion before administration. The r
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