NSF (Norway)

NSF is a disease involving thickening of the skin and connective tissues.

NSF may result in debilitating joint immobility, muscle weakness or impairment of the function of internal organs which may potentially be life threatening.

Cases of abnormalities of the skin including thickening/ inflammation or fibrosis (NSF) have been reported.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with

There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Nevertheless, because of reported cases of NSF that may be associated with renal impairment for other gadolinium containing contrast agents and for gadoversetamide, Optimark should not be used in these patients.

Cases of NSF have also been reported in patients with moderate renal impairment (GFR < 60ml/ min/ 1.73m2) with use of gadolinium-containing contrast agents. Optimark should be used in these patients with caution.

There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.  Children Optimark must not be administered with an autoinjector.

As there is a possibility that NSF may occur with Vasovist, it should therefore only be used in these patients after careful risk/ benefit assessment, and if the diagnostic information cannot be obtained by other means.

It should also not be used in patients who have severe problems with their kidneys or in liver transplant patients, due to a risk of a condition called nephrogenic systemic fibrosis (NSF), which causes thickening of the skin and connective tissues.

You should not be given Optimark if you suffer from severe kidney impairment, or if you are a liver transplant patient as use of Optimark in patients with these conditions has been associated with a disease called Nephrogenic Systemic fibrosis (NSF).

12  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2) and those who have had or are undergoing liver transplantation.

Precautions are necessary when examining these patients (e. g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2), and in those who have had or are undergoing liver transplantation.