RIBOMUSTIN Powder for solution for infusion Ref.[50298] Active ingredients: Bendamustine

Source: Marketing Authorisation Holder  Revision Year: 2022  Publisher: Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND, Telephone: 0800 800 806, Fax: (09) 588 1398, Email: medinfo@janau.jnj.com

Product name and form

RIBOMUSTIN 25 mg Powder for infusion.

RIBOMUSTIN 100 mg Powder for infusion.

Pharmaceutical Form

RIBOMUSTIN (bendamustine hydrochloride) powder for concentrate for solution for infusion is a lyophilised product.

It is administered by intravenous infusion after reconstitution with 10 mL (for the 25 mg vial) or 40 mL (for the 100 mg vial) water for injection and further dilution with physiological saline (0.9%).

White, microcrystalline powder.

Qualitative and quantitative composition

Each 25 mg vial contains 25 mg of bendamustine hydrochloride and 30 mg of mannitol.

Each 100 mg vial contains 100 mg of bendamustine hydrochloride and 120 mg of mannitol.

RIBOMUSTIN contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent.

The pH of the reconstituted solution is 2.5-3.5.

For a full list of excipients, see section 6.1.

Active Ingredient 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

RIBOMUSTIN is supplied in Type I brown glass vials of 26 ml or 60 ml with rubber stopper and an aluminum flip-off cap.

26 mL-vials contain 25 mg bendamustine hydrochloride; supplied in cartons containing 1 vial.

60 mL-vials contain 100 mg bendamustine hydrochloride; supplied in cartons containing 1 vial.

The vials are for single use only.

Not all presentations may be marketed.

Marketing authorization holder

Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND, Telephone: 0800 800 806, Fax: (09) 588 1398, Email: medinfo@janau.jnj.com

Marketing authorization dates and numbers

14 May 2015

Drugs

Drug Countries
RIBOMUSTIN Australia, Brazil, Ecuador, Israel, New Zealand, South Africa

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