Revised SPC: Variquel (terlipressin acetate) 0.2 mg/ml, solution for injection

SPC updated with information reflecting license extension for emergency treatment of hepatorenal syndrome. Painful breathing, respiratory arrest and injection site necrosis (all uncommon) and abdominal cramps (common) have been added as adverse effects.

SPS commentary:

SPC also advises caution and strict monitoring when used for coronary diseases (e.g. advanced arteriosclerosis); pre-existing seizures and history of ischemic cardiovascular disease because terlipressin can induce ischemia.

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