Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
Natpar 25 micrograms/dose powder and solvent for solution for injection.
Natpar 50 micrograms/dose powder and solvent for solution for injection.
Natpar 75 micrograms/dose powder and solvent for solution for injection.
Natpar 100 micrograms/dose powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. The powder is white and the solvent is a clear, colourless solution. |
Natpar 25 micrograms: Each dose contains 25 micrograms parathyroid hormone (rDNA)* in 71.4 microlitre solution following reconstitution. Each cartridge contains 350 micrograms parathyroid hormone (rDNA).
Natpar 50 micrograms: Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 700 micrograms parathyroid hormone (rDNA).
Natpar 75 micrograms: Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1050 micrograms parathyroid hormone (rDNA).
Natpar 100 micrograms: Each dose contains 100 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution. Each cartridge contains 1400 micrograms parathyroid hormone (rDNA).
* Parathyroid hormone (rDNA), produced in E. coli using recombinant DNA technology, is identical to the 84 amino acid sequence of endogenous human parathyroid hormone.
Excipient(s) with known effect: Each dose contains 0.32 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Parathyroid hormone |
Endogenous parathyroid hormone (PTH) is secreted by the parathyroid glands as a polypeptide of 84 amino acids. PTH exerts its action via cell-surface parathyroid hormone receptors, present in bone, kidney and nerve tissue. PTH has a variety of critical physiological functions that include its central role in modulating serum calcium and phosphate levels within tightly regulated levels, regulating renal calcium and phosphate excretion, activating vitamin D, and maintaining normal bone turnover. |
| List of Excipients |
|---|
|
Powder: Sodium chloride Solvent: Metacresol |
The glass dual-chamber cartridge inside the cartridge holder is made from type I glass with 2 bromobutyl rubber stoppers and a crimp cap (aluminium) with a bromobutyl rubber seal.
Natpar 25 micrograms: Each cartridge in the purple cartridge holder contains 350 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Natpar 50 micrograms: Each cartridge in the red cartridge holder contains 700 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Natpar 75 micrograms: Each cartridge in the grey cartridge holder contains 1050 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Natpar 100 micrograms: Each cartridge in the blue cartridge holder contains 1400 micrograms of parathyroid hormone (rDNA) as powder in the first chamber and 1000 microlitres of solvent in the second chamber (corresponding to 14 doses).
Pack size: Carton containing 2 cartridges.
Carton/cartridge colours are used to indicate the different strengths:
25 micrograms – Purple
50 micrograms – Red
75 micrograms – Grey
100 micrograms – Blue
Takeda Pharmaceuticals International AG Ireland Branch, Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland
EU/1/15/1078/001
EU/1/15/1078/002
EU/1/15/1078/003
EU/1/15/1078/004
Date of first authorisation: 24 April 2017
Date of latest renewal: 15 April 2021
| Drug | Countries | |
|---|---|---|
| NATPAR | Austria, Cyprus, Estonia, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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