DOXORUBICIN HYDROCHLORIDE injectable, liposomal

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

Disponible depuis:

Zydus Lifesciences Limited

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DOXORUBICIN HYDROCHLORIDE - DOXORUBICIN HYDROCHLORIDE INJECTABLE,
LIPOSOMAL
ZYDUS LIFESCIENCES LIMITED
----------
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
SPL UNCLASSIFIED
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
20 MG/10 ML CONTAINER LABEL
NDC 49315-008-03
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
20 MG/10 ML
(2 MG/ML)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
10 mL Single-Dose Vial
Rx only
20 MG/10 ML CARTON LABEL
NDC 49315-008-03
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
20 MG/10 ML
(2 MG/ML)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
Sterile
Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉)
Do not freeze
10 mL Single-Dose Vial
Rx only
50 MG/25 ML CONTAINER LABEL
NDC 49315-009-07
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
50 MG/25 ML
(2 MG/ML)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
25 mL Single-Dose Vial
Rx only
50 MG/25 ML CARTON LABEL
NDC 49315-009-07
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION
50 MG/25 ML
(2 MG/ML)
Cytotoxic Agent Must be diluted
LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL
FOR INTRAVENOUS INFUSION ONLY
Sterile
Refrigerate at 2⁰ to 8℃ (36⁰ to 46℉)
Do not freeze
25 mL Single-Dose Vial
Rx only
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injectable, liposomal
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:49315-008
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN -
UNII:80168379AG)
DOXORUBICIN
HYDROCHLORIDE
2 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL
2000)-1,2-DISTEAROYL-SN-GLYCERO-3-
PHOSPHOETHANOLAMINE, SODIUM SALT (UNII: 3L6NN8ZZKU)
3.19 mg
in 1 mL
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
9.