BONDRONAT Concentrate for solution for infusion Ref.[7990] Active ingredients: Ibandronic acid

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands

Product name and form

Bondronat 6 mg concentrate for solution for infusion.

Pharmaceutical Form
Concentrate for solution for infusion.

Qualitative and quantitative composition

One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Ibandronic acid	Ibandronic acid belongs to the bisphosphonate group of compounds which act specifically on bone. Their selective action on bone tissue is based on the high affinity of bisphosphonates for bone mineral. Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear. In vivo, ibandronic acid prevents experimentally-induced bone destruction caused by cessation of gonadal function, retinoids, tumours or tumour extracts.

List of Excipients
Sodium chloride Acetic acid (99%) Sodium acetate Water for injections

Pack sizes and marketing

Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial with a bromobutyl rubber stopper). Not all pack sizes may be marketed.

Marketing authorization holder

Atnahs Pharma Netherlands B.V., Strawinskylaan 3127, 1077 ZX Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/96/012/011
EU/1/96/012/012
EU/1/96/012/013

Date of first authorisation: 25 June 1996
Date of latest renewal: 25 June 2006

Drugs

Drug	Countries
BONDRONAT	Austria, Australia, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Singapore, Turkey, United Kingdom, South Africa

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