Doxorubicin Hydrochloride Liposome Injection

Drug Facts

Composition & Product

Active Ingredients

Doxorubicin (2 mg)

Inactive Ingredients

Sodium N-(carbonyl-methoxypolyethylene Glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine Hydrogenated Soybean Lecithin Cholesterol Ammonium Sulfate Histidine Hydrochloric Acid Sodium Hydroxide Sucrose

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Active Since 2023-12-19

Medication Information

Description

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

Health Care Provider Letter

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

Structured Label Content

Health Care Provider Letter (HEALTH CARE PROVIDER LETTER)

Package/label Principal Display Panel – 20 Mg/10 Ml (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

Advanced Ingredient Data

[{"name": "doxorubicin", "unii": "80168379AG", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE", "unii": "3L6NN8ZZKU", "classCode": "IACT", "strengthNumerator": "3.19", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "hydrogenated soybean lecithin", "unii": "H1109Z9J4N", "classCode": "IACT", "strengthNumerator": "9.58", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "cholesterol", "unii": "97C5T2UQ7J", "classCode": "IACT", "strengthNumerator": "3.19", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ammonium sulfate", "unii": "SU46BAM238", "classCode": "IACT", "strengthNumerator": "0.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "histidine", "unii": "4QD397987E", "classCode": "IACT", "strengthNumerator": "1.55", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "hydrochloric acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sucrose", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "94", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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"}

Doxorubicin Hydrochloride Liposome Injection

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information