Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Pharmorubicin 2 mg/ml Solution for Injection or Infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. Red, sterile, preservative-free, aqueous solution. |
Epirubicin hydrochloride 2 mg per ml
5 ml vials contain 10 mg of epirubicin hydrochloride
10 ml vials contain 20 mg of epirubicin hydrochloride
25 ml vials contain 50 mg of epirubicin hydrochloride
100 ml vials contain 200 mg epirubicin hydrochloride.
Excipient with known effect:
Pharmorubicin 10 mg/5 ml (2 mg/ml) solution for injection or infusion contains 17.7 mg of sodium in each 5 ml vial.
Pharmorubicin 20 mg/10 ml (2 mg/ml) solution for injection or infusion contains 35.4 mg of sodium in each 10 ml vial.
Pharmorubicin 50 mg/25 ml (2 mg/ml) solution for injection or infusion contains 88.5 mg of sodium in each 25 ml vial.
Pharmorubicin 200 mg/100 ml (2 mg/ml) solution for injection or infusion contains 354 mg of sodium in each 100 ml vial.
For the 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 |
|---|
|
Hydrochloric acid |
Colourless glass 5ml, 10ml, 25ml, or 100ml vial (type I), with Teflon-faced chlorobutyl rubber bung and aluminium cap with inset grey polypropylene disk.
Colourless polypropylene 5ml, 10ml, 25ml or 100ml vial with Teflon faced halobutyl-rubber stopper and aluminium cap with plastic flip-off top.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1023
14th May 2004
| Drug | Countries | |
|---|---|---|
| PHARMORUBICIN | Nigeria, New Zealand, Singapore, United Kingdom |
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