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Components:
Zoledronic Acid
Method of action:
Drugs For Treatment Of Bone Diseases, Inhibitory Bone Resorption
Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 2019.11.18

List of excipients

Mannitol

Sodium citrate

Water for injections

Incompatibilities

This medicinal product must not be allowed to come into contact with any calcium-containing solutions and it must not be mixed or given intravenously with any other medicinal product in the same infusion line.

Shelf life

Unopened bottle: 3 years.

After first opening: From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C. The refrigerated solution should then be equilibrated to room temperature prior to administration.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

100 ml solution in a transparent, colourless, plastic (cycloolefinic copolymer) bottle closed with a fluorocarbon polymer coated bromobutyl rubber stopper and an aluminum cap with a flip-off component of polypropylene.

Unit packs containing 1 bottle.

Multi-packs containing 4 (4x 1) or 5 (5x 1) bottles.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Aseptic techniques must be followed during the preparation of the infusion. For single use only.

Only clear solution free from particles and discolouration should be used.

Healthcare professionals are advised not to dispose of unused Zometa via the domestic sewage system.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Marketing authorisation number(s)

EU/1/01/176/007-9

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 20.03.2001

Date of latest renewal: 20.03.2006

Date of revision of the text

26.04.2018

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