FDA Label for Doxorubicin Hydrochloride, Liposomal
View Indications, Usage & Precautions
Doxorubicin Hydrochloride, Liposomal Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package/Label Principal Display Panel – 20 Mg/10 Ml
Caelyx® pegylated liposomal
2 mg/ml
sterile concentrate
doxorubicin hydrochloride
20 mg/10 mL
IV after dilution.
Caelyx®
pegylated liposomal
2 mg/ml
concentrate for
solution for infusion
doxorubicin hydrochloride
20 mg/10 mL
Intravenous use after
dilution.
Do not use interchangeably
with other formulations of
doxorubicin hydrochloride.
Cytotoxic
1 vial
Baxter Logo
One ml of Caelyx pegylated
liposomal contains 2 mg
doxorubicin hydrochloride.
Excipients: α-(2-[1,2-distearoyl-sn-glycero(3)
phosphooxy]ethylcarbamoyl)
-ϖ-methoxypoly(oxyethylen)-40
sodium salt, fully hydrogenated
soy phosphatidylcholine,
cholesterol, ammonium
sulphate, sucrose, histidine,
water for injections,
hydrochloric acid and sodium
hydroxide.
Keep out of the sight and
reach of children.
Store in a refrigerator.
Do not freeze.
Read the package leaflet
before use.
Baxter Healthcare Limited
Caxton Way,
Thetford,
Norfolk,
IP24 3SE,
United Kingdom
PLGB 00116/0255
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