dm+d

385997009

Refrigerated Storage

OrfadinSwedish Orphan Biovitrum

Swedish Orphan Biovitrum
Orfadin
2mg, 5mg, 10mg, 20mg capsules; 4mg/ml Oral Suspension

In the event of an inadvertent temperature excursion the following data may be used:
During the shelf life, the patient may store the capsules for a single period of 2 months (for 2 mg capsules) or 3 months (for 5 mg, 10 mg and 20 mg capsules) at a temperature not above 25°C, after which the medicinal product must be discarded.

After first opening, the in-use stability of the 4mg/ml oral suspension is a single period of 2 months at a temperature not above 25°C, after which it must be discarded.

Contact Swedish Orphan Biovitrum in cases where additional stability data is required. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

Yes - see above
8 November 2022
London MI Service