Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK
Zemplar 5 micrograms/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for Injection. A clear and colourless aqueous solution free from visible particles. |
Each ml of solution for injection contains 5 micrograms of paricalcitol.
Each 1 ml ampoule contains 5 micrograms of paricalcitol.
Each 2 ml ampoule contains 10 micrograms of paricalcitol.
Each 1 ml vial contains 5 micrograms of paricalcitol.
Each 2 ml vial contains 10 micrograms of paricalcitol.
Excipients with known effect: Ethanol (20% v/v) and propylene glycol (30% v/v).
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paricalcitol |
Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Unlike calcitriol, it is a selective vitamin D receptor (VDR) activator. Paricalcitol reduces parathyroid hormone (PTH) levels by inhibiting parathyroid proliferation and decreasing PTH synthesis and secretion, with minimal impact on calcium and phosphorus levels, and can act directly on bone cells to maintain bone volume and improve mineralization surfaces. |
| List of Excipients |
|---|
|
Ethanol (20% v/v) |
Each Type 1 glass ampoule contains 1ml or 2ml of solution for injection.
Each Type 1 glass vial contains 1ml or 2ml of solution for injection.
The presentations of Zemplar are:
Pack containing 5 ampoules of 1ml of solution for injection.
Pack containing 5 ampoules of 2ml of solution for injection.
Pack containing 5 vials of 1ml of solution for injection.
Pack containing 5 vials of 2ml of solution for injection.
Not all pack sizes may be marketed.
AbbVie Ltd., Maidenhead, SL6 4UB, UK
PL 41042/0010
Date of first authorisation: 9 August 2002
Date of Last renewal: 9 August 2007
| Drug | Countries | |
|---|---|---|
| ZEMPLAR | Austria, Brazil, Ecuador, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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