Refrigerated Storage

NatparShire Pharmaceuticals Limited

Shire Pharmaceuticals Limited
25, 50, 75, 100 micrograms/dose powder and solvent for solution for injection

Data from Shire extended stability studies of limited scope indicate that there is no impact on the product stability or original shelf life of un-reconstituted recombinant human parathyroid hormone rhPTH(1-84) exposed to a single temperature excursion of >8°C to ≤25°C for a maximum duration of 90 days or ≥-20°C to <2°C for a maximum duration of 6 days (Shire Internal Data).

This is subject to the product being stored at the licensed storage conditions of 2°C to 8°C for the remaining period of time. Please note, stability data at Shire is continually monitored and subject to change. Please contact Shire on a case by case basis for any temperature excursions.

Contact Shire Pharmaceuticals Limited directly in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Yes - if exposed to temperatures stated above.

Keep the cartridge within its cartridge holder in the outer carton in order to protect from light.

19 November 2020
London MI Service