What Zometa contains
- The active substance of Zometa is zoledronic acid.
- The other ingredients are: mannitol, sodium citrate.
What Zometa looks like and contents of the pack
Zometa is supplied as a powder in a vial. One vial contains 4 mg of zoledronic acid.
Each pack contains the vial with powder, together with an ampoule of 5 ml water for injections, which is used to dissolve the powder. Zometa is supplied as packs containing 1, 4 or 10 vials and 1, 4 or 10 ampoules, respectively. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH TélTel 49 911 273 0
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00
Eesti Novartis Pharma Services Inc. Tel 372 60 62 400 Österreich Novartis Pharma GmbH Tel 43 1 86 6570
Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888
España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600
France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01
Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 77
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439
Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11
357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00
Latvija Novartis Pharma Services Inc. Tel 371 7 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370
Lietuva
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
This leaflet was last approved in
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
How to prepare and administer Zometa
- To prepare an infusion solution containing 4 mg Zometa, add 5 ml of water for injections from the ampoule supplied in the pack to the vial containing the Zometa powder under aseptic conditions. Shake the vial gently to dissolve the powder.
- Further dilute the Zometa reconstituted solution (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution. If a lower dose of Zometa is required, first withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml) as indicated below and then dilute it further with 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Do not mix Zometa reconstituted solution with calcium-containing or other divalent cation-containing solutions such as lactated Ringer?s solution.
Instructions for preparing reduced doses of Zometa:
Withdraw the appropriate volume of the reconstituted solution (4 mg/5 ml), as follows:
- 4.4 ml for 3.5 mg dose
- 4.1 ml for 3.3 mg dose
- 3.8 ml for 3.0 mg dose
- The Zometa infusion solution should preferably be used immediately. If the solution is not used immediately, storage prior to use is the responsibility of the care provider and should be in a refrigerator at 2°C ? 8°C. Allow the refrigerated solution to reach room temperature before administration.
- The total time between reconstitution, dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
- The solution containing Zometa is given as a single 15-minute intravenous infusion. The hydration status of patients must be assessed prior to and following administration of Zometa to assure that they are adequately hydrated.
- Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/v sodium chloride solution or 5% w/v glucose solution) showed no incompatibility with Zometa.
- Since no data are available on the compatibility of Zometa with other intravenously administered substances, Zometa must not be mixed with other medications/substances and should always be given through a separate infusion line.
How to store Zometa
- Keep Zometa out of the reach and sight of children.
- Do not use Zometa after the expiry date stated on the pack.
- The Zometa infusion solution should preferably be used immediately. If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C ? 8°C.
- The total time between reconstitution, dilution, storage in the refrigerator and end of administration must not exceed 24 hours.