Active ingredients: Bendamustine
Bendamustine hydrochloride Accord 2.5 mg/ml Powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
White, microcrystalline powder.
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.
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.
Mannitol
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.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
PL 20075/0459
Date of first authorisation: 20th November 2015