Actual Medicinal Product (AMP) Orfadin 5mg capsules (Swedish Orphan Biovitrum Ltd)

Stability Information

Stability: Lack of data and/or stability concerns exist. MCA use may be acceptable but is likely to be off-label and require mitigation measures. Keep medicines in MCAs for the shortest time necessary. Generally, up to 5 weeks maximum unless otherwise specified, or up to 8 weeks if the MCA is airtight (sealed). Consider the risk of potency loss or dose variability and monitor for changes in efficacy or adverse effects after MCA initiation.
Notes: Fridge medicine. Stable outside of the fridge for 3 months at a temperature not above 25°C.
Provenance: This recommendation is based on the products Nitisinone 2mg, 5mg, 10mg and 20mg hard capsules (Logixx Pharma Ltd).
Generic: Nitisinone
Formulation: Nitisinone 5mg capsules

Nitisinone
- Nitisinone 5mg capsules
  - Orfadin 5mg capsules (Swedish Orphan Biovitrum Ltd)