UK and IE joint SmPC now split into individual territory SmPCs due to Brexit – no other changes were made. [change in section 4.8: reporting of adverse events]

in section 4.4. Special warnings and precautions for use

text revision/addition highlighted in red:

Fluid overload and Electrolyte Balance

To avoid fluid overload or dehydration, careful adjustment of parenteral support is required in patients taking Revestive. Electrolyte balance and fluid status should be carefully monitored throughout treatment, especially during initial therapeutic response and discontinuation of Revestive treatment

Fluid overload:

Fluid overload has been observed in clinical trials. Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.

Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy. Patients should be advised to contact their physician in case of sudden weight gain, face swelling, swollen ankles and/or dyspnoea. In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs. This assessment should be conducted more frequently within the first months of treatment.

Dehydration:

Patients with SBS are susceptible to dehydration that may lead to acute renal failure.

Section 4.8

Information on reporting of adverse reactions for Ireland was updated

10. date of revision of text

20 May 2020