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
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. |
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 |
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.
Janssen-Cilag (New Zealand) Ltd, Auckland, NEW ZEALAND, Telephone: 0800 800 806, Fax: (09) 588 1398, Email: medinfo@janau.jnj.com
14 May 2015
| Drug | Countries | |
|---|---|---|
| RIBOMUSTIN | Australia, Brazil, Ecuador, Israel, New Zealand, South Africa |
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