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BENDAMUSTINE HYDROCHLORIDE ACCORD Powder for concentrate for solution for infusion (2019)

Active ingredients: Bendamustine

Product Name and Form

Bendamustine hydrochloride Accord 2.5 mg/ml Powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White, microcrystalline powder.

Qualitative and Quantitative Composition

One vial contains 25 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).

One vial contains 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate).

1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate) when reconstituted according to section 6.6.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Bendamustine

Bendamustine is an alkylating antitumour agent with unique activity. The antineoplastic and cytocidal effect of bendamustine is based essentially on a cross-linking of DNA single and double strands by alkylation. As a result, DNA matrix functions and DNA synthesis and repair are impaired.

List of excipients

Mannitol

Pack sizes and Marketing

Type I amber glass vials of 10 ml or 50 ml with bromobutyl rubber stopper and an aluminium flip-off cap.

10 ml-vials contain 25 mg bendamustine hydrochloride and are supplied in packs of 5, 10 and 20 vials.

50 ml-vials contain 100 mg bendamustine hydrochloride and are supplied in pack of 1 and 5 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Date of first authorisation: 20th November 2015

Marketing authorization number:

PL 20075/0459