Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: RANBAXY PHARMACEUTICALS (Pty) Ltd, (a Sun Pharma company), 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa
ZOBONE SOLUTION FOR INFUSION.
(Concentrate for solution for infusion)
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. Clear and colourless solution. |
Each 5 mL vial concentrate contains 4,264 mg zoledronic acid (as monohydrate), equivalent to 4 mg zoledronic acid anhydrous.
One mL concentrate contains approximately 0, 8 mg zoledronic acid (anhydrous).
This medicine contains 24 mg sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zoledronic acid |
Zoledronic acid belongs to the class of bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclastic bone resorption. |
| List of Excipients |
|---|
|
Mannitol |
ZOBONE SOLUTION FOR INFUSION:
Clear colourless solution in 5 mL colourless tubular glass vial with grey rubber stopper sealed with baby blue flip top aluminum seal.
Vial: 5 ml clear Type-I Neutral glass vial.
Stopper: Grey bromobutyl flange rubber stopper.
Seal: White aluminium seal and baby blue flip top aluminium seal.
Pack size: Packed in unit pack containing 1x 5 ml single vial.
RANBAXY PHARMACEUTICALS (Pty) Ltd, (a Sun Pharma company), 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa
47/34/1168
10 August 2022
| Drug | Countries | |
|---|---|---|
| ZOBONE | Brazil, Ecuador, Singapore, South Africa |
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