Zometa

Mannitol

Sodium citrate

Water for injections

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.

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.

This medicinal product does not require any special storage conditions.

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.

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.

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

EU/1/01/176/007-9

Date of first authorisation: 20.03.2001

Date of latest renewal: 20.03.2006

26.04.2018

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain