Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Strides Pharma (Cyprus) Ltd., Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Cyprus
Kauliv 20 micrograms/80 microliters solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Colourless, clear solution for injection. |
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Each cartridge of 3 mL of solution contains 750 micrograms of teriparatide (corresponding to 250 micrograms per mL).
* Teriparatide, rhPTH (1-34), produced in E. 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 |
3 mL cartridge (USP type-1 glass cartridge), with a plunger stopper (bromobutyl) and disc seal (aluminium and rubber liner seals), packed in a plastic tray sealed with lid foil and supplied in a carton.
Each cartridge contains 3 mL solution for injection corresponding to 28 doses of 20 micrograms (per 80 microliters).
Pack sizes of 1 cartridge or 3 cartridges.
Not all pack sizes may be marketed.
Strides Pharma (Cyprus) Ltd., Themistokli Dervi, 3, Julia House, 1st Floor, 1066, Nicosia, Cyprus
EU/1/22/1710/001
EU/1/22/1710/002
| Drug | Countries | |
|---|---|---|
| KAULIV | Austria, Estonia, Croatia, Ireland, Italy, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
