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DOXORUBICIN Teva Sol. (2011)

Active ingredients: Doxorubicin

Product Name and Form

Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical form

Concentrate for solution for infusion Clear, red solution.

pH = 2.7-3.3

Qualitative and Quantitative Composition

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.

Chemical substance
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
Hydrochloric acid (E507)
Sodium hydroxide (E524)
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Teva Pharma B.V.
Computerweg 10
3542 DR
Utrecht
Netherlands

Date of first authorisation: 20th November 2009

Marketing authorization number:

PA 749/83/1