Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Accord Healthcare S.L.U., World Trade Centre, Moll de Barcelona s/n, Edifici Est, 6ª Planta, 08039, Barcelona, Spain
Sondelbay 20 micrograms/80 microliters solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless, clear solution. |
Each dose contains 20 micrograms of teriparatide* in 80 microliters. One pre-filled pen of 2.4 mL contains 600 micrograms of teriparatide. Each millilitre of the solution for injection contains 250 micrograms of teriparatide.
* Teriparatide, rhPTH(1-34), produced in Escherichia. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Teriparatide |
Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone. Teriparatide is a bone formation agent to treat osteoporosis. The skeletal effects of teriparatide depend upon the pattern of systemic exposure. |
| List of Excipients |
|---|
|
Glacial acetic acid |
2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (bromobutyl rubber), disc seal (bromobutyl lined aluminium seals), assembled into a disposable pen.
Sondelbay is available in pack sizes of 1 pre-filled pen or 3 pre-filled pens. Each pre-filled pen contains 28 doses of 20 micrograms (per 80 microliters).
Not all pack sizes may be marketed.
Accord Healthcare S.L.U., World Trade Centre, Moll de Barcelona s/n, Edifici Est, 6ª Planta, 08039, Barcelona, Spain
EU/1/22/1628/001
EU/1/22/1628/002
| Drug | Countries | |
|---|---|---|
| SONDELBAY | Austria, Estonia, Spain, Finland, France, Croatia, Italy, Lithuania, Poland |
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