Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Zerlinda 4 mg/100 ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear and colourless solution with no visible particles. The pH of the solution is approximately 5.5-6.5 and the osmolality is 280-320 mOsmol/kg. |
Each bag with 100 ml of solution contains 4 mg zoledronic acid (as monohydrate).
Each ml of the solution contains 0.04 mg zoledronic acid (as monohydrate).
Excipient with known effect: Each ml contains 3.56 mg sodium.
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 |
|---|
|
Sodium chloride |
The bags are made of M312A material, a 5-layer, polyolefine based co-extruded film, PVC and plasticizer free. The two tubing ports have spike port tips with a polypropylene cap and a polypropylene injection point with a polypropylene breakable cap.
The bag is supplied with a polyester alox/polypropylene over-wrapping.
Pack size:
1 × 100 ml bag
10 × 100 ml bag
Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
PA1986/119/001
Date of first authorisation: 4th November 2013
Date of last renewal: 3rd October 2018
| Drug | Countries | |
|---|---|---|
| ZERLINDA | Ireland, Poland, Romania |
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