Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
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. |
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.
| Active Ingredient |
|---|
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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 |
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
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