Zoledronic Acid Sun 4 Mg/100 Ml Solution For Infusion

Baseline creatinine clearance (ml/min)	Remove the following amount of Zoledronic acid solution for infusion (ml)	Replace with the following volume of sterile sodium chloride 9 mg/ml (0.9%) or 5% glucose solution for injection (ml)	Adjusted dose (mg zoledronic acid in 100 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 4 mg/100 ml solution for infusion.

Since no data are available on the compatibility of Zoledronic acid 4 mg/100 ml solution for infusion with other intravenously administered substances,

Zoledronic acid 4 mg/100 ml solution for infusion must not be mixed with other medications/substances and should always be given through a separate infusion line.

How to store Zoledronic acid 4 mg/100 ml

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP

Store the unopened vial below 30°C.

After opening the vial, the product should be used immediately in order to avoid microbial contamination.

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Rare (may affect up to 1 in 1,000 people)

- slow heart beat

- confusion

- unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone

- interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)

- flu-like symptoms including arthritis and joint swelling

- painful redness and/or swelling of the eye.

Very rare (may affect up to 1 in 10,000 people)

- fainting due to low blood pressure

- severe bone, joint and/or muscle pain, occasionally incapacitating.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

This medicinal product is authorised in the Member states of the EEA under the following names

Belgium: Zoledroninezuur SUN 4 mg/100 ml oplossing voor infusie

Acide zoledronique SUN 4 mg/100 ml Solution pour perfusion Zoledronsaure SUN 4 mg/100 ml Infusionslosung Denmark: Zoledronsyre SUN 4 mg/100 ml infusionsvsske, opl0sning

Finland: Tsoledronihappo SUN 4 mg/100 ml infuusioneste, liuos

France: Acide zoledronique SUN 4 mg/100 ml solution pour perfusion

Germany: Zoledronsaure SUN 4 mg/100 ml Infusionslosung

Italy: Acido Zoledronico SUN Pharma 4 mg/100 ml soluzione per infusione

The Netherlands: Zoledroninezuur SUN 4 mg/100 ml oplossing voor infusie

Norway: Zoledronsyre SUN 4 mg/100 ml infusjonsvsske, oppl0sning

Spain: Acido zoledronico SUN 4 mg/100 ml solucion para perfusion EFG

Sweden: Zoledronsyra SUN 4 mg/100 ml infusionsvatska, losning

United Kingdom: Zoledronic acid 4 mg/100 ml solution for infusion

This leaflet was last revised in 12/2014

5. How to store Zoledronic acid 4 mg/100 ml

Your doctor, pharmacist or nurse knows how to store Zoledronic acid 4 mg/100 ml properly (see section 6).

Keep this medicine out of the sight and reach of children.

This medicine must not be used after the expiry date which is stated on the carton and vial after EXP The expiry date refers to the last day of that month.

Store the unopened vial below 30°C.

After first opening:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C.

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 for infusion should then be equilibrated to room temperature prior to administration.

6. Contents of the pack and other information What Zoledronic acid 4 mg/100 ml contains

- The active substance is zoledronic acid. Each vial contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.

- The other ingredients are mannitol (E421), sodium citrate (E331) and water for injections.

What Zoledronic acid 4 mg/100 ml looks like and contents of the pack

Zoledronic acid 4 mg/100 ml is a clear and colourless solution.

It comes in 100 ml glass vials as a ready-to-use solution for infusion. The vial label has a built in edge that can be peeled and used as a hanger.

Zoledronic acid 4 mg/100 ml is supplied in packs containing one vial as unit pack or in multi-packs comprising 4 or 5 packs, each containing 1 vial.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands

Suppliers LOGO / Id here

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Folding

350--2 --87.5 mm 430--8 zigzag--48 mm

EUUK- UNITED KINGDOM

Size: 350x430 mm

100

Zoledronic acid 4mg-100ml-EUUK-PIL-350x430mm-21-01-15 21 January 2015 14:54:25