What Zoledroninezuur STADA contains
- The active substance is zoledronic acid. One vial contains 4 mg zoledronic acid, corresponding to 4.26 mg zoledronic acid monohydrate.
- The other ingredients are: mannitol (E421) sodium citrate (E331) water for injections.
What Zoledroninezuur STADA looks like and the contents of the pack
Zoledroninezuur STADA solution for infusion is a clear, colourless solution, free from visible particles.
Zoledroninezuur STADA is supplied as a solution in a vial. One vial contains 4 mg of zoledronic acid.
Zoledroninezuur STADA 4mg/100ml solution for infusion is supplied as packs containing: 1 vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
61118 Bad Vilbel
Agila Specialties Polska Sp. Zo.o.
10, Daniszewska Str.
Sanochemia Pharmazeutica AG
A - 2491 Neufeld an der Leitha
STADA Arzneimittel AG
61118 Bad Vilbel
Cell pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Duitsland
In het register ingeschreven onder
Zoledroninezuur STADA 4 mg/100 ml, oplossing voor infusie RVG 112514
<This medicines product is authorised in the Member States of the EEA under the following names:>
Nederland: Zoledroninezuur STADA 4mg/100ml, oplossing voor infusie Oostenrijk: Zoledronsäure STADA 4mg/100ml Infusionslösung Tsjechië: Zoledronic acid Stada 4mg/100ml Infuzní roztok
Duitsland: Zoledronsäure STADA 4mg/100ml Infusionslösung
Denemarken: Zoledronsyre STADA
Finland: Zoledronic acid STADA 4mg/100ml Infuusioneste, liuos Italië: ACIDO ZOLEDRONICO CRINOS
Zweden: Zoledronsyra STADA 4mg/100ml Infusionsvätska, lösning
This leaflet was last approved in juli 2013
The following information is intended for healthcare professionals only:
How to prepare and administer Zoledroninezuur STADA
- Zoledroninezuur STADA contains 4 mg of zoledronic acid in 100 ml of infusion solution for immediate use in patients with normal renal function.
- For single use only. Any unused solution should be discarded. Only clear solution free from particles and discolouration should be used. Aseptic techniques must be followed during the preparation of the infusion.
- From a microbiological point of view, the diluted 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 be equilibrated to room temperature prior to administration.
- The solution containing zoledronic acid must not be further diluted or mixed with other infusion solutions. It is given as a single 15-minute intravenous infusion in a separate infusion line. The hydration status of patients must be assessed prior to and following administration of Zoledroninezuur STADA to ensure that they are adequately hydrated.
- Zoledroninezuur STADA solution for infusion can be used immediately without further preparation for patients with normal renal function. In patients with mild to moderate renal impairment, reduced doses should be prepared as instructed below.
To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Remove the volume of Zoledroninezuur STADA solution indicated from the vial and replace with an equal volume of sterile sodium chloride 9 mg/ml (0,9%) solution for injection, or 5% glucose solution for injection.
Table 1: Preparation of reduced doses of Zoledroninezuur STADA 4 mg/100 ml solution for infusion
|Baseline ||Remove the ||Replace with ||Adjusted
|creatinine ||following ||the ||dose (mg
|clearance ||amount of ||following ||zoledronic
|(ml/min) ||Zoledroninez ||volume of ||acid in
| ||uur STADA ||sterile ||100 ml)
| ||solution for ||sodium ||
| ||infusion ||chloride 9 ||
| ||(ml) ||mg/ml ||
| || ||(0,9%) or 5% ||
| || ||glucose ||
| || ||solution for ||
| || ||injection ||
| || ||(ml) ||
|50-60 ||12.0 ||12.0 ||3.5
|40-49 ||18.0 ||18.0 ||3.3
|30-39 ||25.0 ||25.0 ||3.0
*Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min). The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/min.
- Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with zoledronic acid.
- Since no data are available on the compatibility of zoledronic acid with other intravenously administered substances, Zoledroninezuur STADA must not be mixed with other medications/substances and should always be given through a separate infusion line.
How to store Zoledroninezuur STADA
- Keep Zoledroninezuur STADA out of the reach and sight of children.
- Do not use Zoledroninezuur STADA after the expiry date stated on the pack.
- This medicinal product does not require any special storage conditions.
- The diluted Zoledroninezuur STADA infusion solution should be used immediately in order to avoid microbial contamination.