Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Doxorubicin 2 mg/ml Concentrate for Solution for Infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. The product is a clear, red solution, with a pH in the range of 2.5-3.5 and osmolality between 270 mOsm/kg to 320 mOsm/kg. |
1 ml contains 2 mg Doxorubicin hydrochloride.
Each 5 ml vial contains 10 mg of Doxorubicin hydrochloride.
Each 10 ml vial contains 20 mg of Doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg of Doxorubicin hydrochloride.
Each 50 ml vial contains 100 mg of Doxorubicin hydrochloride
Each 100 ml vial contains 200 mg of Doxorubicin hydrochloride.
Excipient(s) with known effect: Contains sodium 3.5 mg/ml (0.15 mmol).
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Doxorubicin |
Doxorubicin is a cytotoxic anthracycline antibiotic obtained from Streptomyces peucetius var. caesius. The exact mechanism of the antitumour activity of doxorubicin is not known. It is generally believed that inhibition of DNA, RNA and protein synthesis is responsible for the majority of the cytotoxic effects. |
| List of Excipients |
|---|
|
Sodium chloride |
For 5 ml: Concentrate for solution for infusion is filled in 5 ml Type – I clear tubular glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal.
For 10 ml: Concentrate for solution for infusion is filled in 10 ml Type – I clear tubular glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal.
For 25 ml: Concentrate for solution for infusion is filled in 30 ml Type – I clear molded glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal.
For 50 ml: Concentrate for solution for infusion is filled in 50 ml Type-I clear molded glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal.
For 100 ml: Concentrate for solution for infusion is filled in 100 ml Type – I clear molded glass vial closed with chlorobutyl rubber stopper and aluminium flip off pink seal.
Pack sizes:
1 × 5 ml vial
1 × 10 ml vial
1 × 25 ml vial
1 × 50 ml vial
1 × 100 ml vial
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0109
12/03/2010
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