DAUNOXOME 2 MG/ML CONCENTRATE FOR SOLUTION FOR INF
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
19-04-2024
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Активный ингредиент:
DAUNORUBICIN CITRATE
Доступна с:
Galen Limited
дозировка:
2 Mg/Ml
Фармацевтическая форма:
Concentrate for Susp for Inf
Дата Авторизация:
2012-03-30
Характеристики продукта
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 recommended concentration
after dilution is between 0.2 mg and 1 mg daunorubicin/ml of solution. DaunoXome should be administered
intravenously over a minimum period of 30-60 minutes _(see also Sections 6.2, 6.3 and 6.6.)._
DaunoXome must not be given by the intramuscular or subcutaneous route or as a bolus injection.
DaunoXome is a liposomal preparation and should not be used interchangeably with conventional daunorubicin.
_Pediatric patients_: DaunoXome is not recommended for use in children below 18 years of age due to insufficient data
on safety and
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