Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. A clear red solution. |
Each ml contains 2 mg epirubicin hydrochloride.
Each 5/10/25/50/100 ml vial contains 10/20/50/100/200 mg epirubicin hydrochloride.
Excipient: Contains sodium 3.54 mg/ml (0.154 mmol).
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Epirubicin |
Epirubicin is a cytotoxic active antibiotic from the anthracycline group. The mechanism of action of epirubicin is related to its ability to bind to DNA. Cell culture studies have shown rapid cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis. |
| List of Excipients |
|---|
|
Sodium Chloride |
5 and 10 ml vials: Type I tubular glass vial with 20 mm chlorobutyl RTS rubber stopper and aluminium flip-off white seal.
25 ml vial: Type I tubular glass vial with 20 mm chlorobutyl RTS rubber stopper and aluminium flip-off white/royal blue seal.
50 ml vial: Type I clear moulded glass vial with 20 mm chlorobutyl RTS rubber stopper and aluminium flip-off royal blue seal.
100 ml vial: Type I clear moulded glass vial with 20 mm chlorobutyl RTS rubber stopper and aluminium flip-off white/royal blue seal.
Pack size: 1 vial.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0024
19.02.2009
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