Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Special Warnings

Surgery should not be delayed in patients requiring urgent amputation (e.g. in infected gangrene).
Patients should be advised to quit smoking.

Iloprost elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 4.2 "Dosage and method of administration").

In patients with low blood pressure care should be taken to avoid further hypotension and patients with significant heart disease should be closely monitored.

The possibility of orthostatic hypotension should be borne in mind in patients getting up from the lying to an upright position after the end of administration.

For patients with a cerebrovascular event [e.g. transient ischemic attack, stroke] within the last 3 months a careful benefit-risk evaluation should be undertaken (see also section 4.3 “Contraindications”).

Special Precautions

Currently only sporadic reports of use in children and adolescents are available.
The paravascular infusion of undiluted Ilomedin can lead to local changes at the injection site.

Oral ingestion and contact with mucous membranes must be avoided. On contact with the skin, iloprost may provoke long-lasting but painless erythema. Therefore, adequate precautions must be applied to avoid contact of iloprost with the skin. If contact with skin occurs, the area must be immediately washed with plenty of water or saline.

This medicinal product contains 0.8% ethanol (alcohol) which corresponds to 4 mg ethanol/ampoule.

This medicinal product contains less than 1mmol of sodium (23 mg) per ampoule; that is, to say essentially ‘sodium-free’.

Effects on Driving