Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion.
Concentrate for solution for infusion Clear, red solution.
pH = 2.7-3.3
1 ml of Doxorubicin Teva 2 mg/ml contains 2 mg doxorubicin hydrochloride 5 ml of Doxorubicin Teva 2 mg/ml contains 10 mg doxorubicin hydrochloride 10 ml of Doxorubicin Teva 2 mg/ml contains 20 mg doxorubicin hydrochloride 25 ml of Doxorubicin Teva 2 mg/ml contains 50 mg doxorubicin hydrochloride 100 ml of Doxorubicin Teva 2 mg/ml contains 200 mg doxorubicin hydrochloride
Excipients: 1 ml of Doxorubicin Teva 2 mg/ml contains 3.54 mg sodium 5 ml of Doxorubicin Teva 2 mg/ml contains 17.7 mg sodium 10 ml of Doxorubicin Teva 2 mg/ml contains 35.4 mg sodium 25 ml of Doxorubicin Teva 2 mg/ml contains 88.5 mg sodium 100 ml of Doxorubicin Teva 2 mg/ml contains 354.1 mg sodium
For a full list of excipients, see section 6.1.
Sodium chloride
Hydrochloric acid (E507)
Sodium hydroxide (E524)
Water for injections
Doxorubicin Teva 2 mg/ml concentrate for solution for infusion is supplied in vials of 5 ml (10 mg), 10 ml (20 mg), 25 ml (50 mg) or 100 ml (200 mg) containing a red-orange, clear, sterile solution.
Primary packaging material: Vials with a nominal volume of 5, 10,25 or 100 ml, colourless glass type I (Ph.Eur.), with a chlorobutyl rubber stopper with an inert fluoropolymer (PTFE) coating on the inner side and with an aluminium seal covered with a coloured polypropylene disc.
Trade package quantities: Boxes with one vial of 5, 10,25 or 100 ml.
Not all pack sizes may be marketed.
Teva Pharma B.V.
Computerweg 10
3542 DR
Utrecht
Netherlands
PA 749/83/1
Date of first authorisation: 20th November 2009