Terlipressin Acetate for injection

1mg/vial   Strength

Indication: For the treatment of esophageal variceal bleeding.

Clinical application: intravenous injection.

Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection contains the active ingredient terlipress in, which is a synthetic pituitary hormone (this hormone is usually produced by the pituitary gland found in the brain).

It will be given to you by injection into a vein.

Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection is used for the treatment of:

• bleeding from dilated (widening) veins in the food pipe leading to your stomach (called bleeding oesophageal varices).

• emergency treatment of type 1 hepatorenal syndrome (rapidly progressive renal failure) in patients with liver cirrhosis (scarring of the liver) and ascites (abdominal dropsy).

This medicine will always be given to you by a doctor into your vein. The doctor will decide the most appropriate dose for you and your heart and blood circulation will be continuously monitored during the injection. Please ask your doctor for further information regarding its use.

Use in adults

1. Short term management of bleeding oesophageal varices

Initially 1-2 mg terlipress in acetate (5-10 ml of Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection) is given by injection into your vein. Your dose will depend on your body weight.

After the initial injection, your dose may be reduced to 1 mg terlipress in acetate (5 ml) every 4 to 6 hours.

2. Type 1 hepatorenal syndrome

The usual dose is 1 mg terlipress in acetate every 6 hours for at least 3 days. If the reduction of serum creatinine is less than 30 % after 3 days of treatment your doctor should consider doubling the dose to 2 mg every 6 hours.

If there is no response to Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection or in patients with complete response, treatment with Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection should be interrupted.

When a reduction in serum creatinine is seen, treatment with Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection should be maintained to a maximum of 14 days.

Use in the elderly

If you are over 70 years of age speak with your doctor before you receive Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection.

Use in patients with kidney problems

Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection should be used with caution in patients with long standing kidney failure.

Use in patients with liver problems

No dose adjustment is required in patients with liver failure.

Use in children and adolescents

Terlipress in acetate EVER Pharma 0.2 mg/ml solution for injection is not recommended for use in children and adolescents due to insufficient experience.

Duration of treatment

The use of this medicine is limited to 2 – 3 days for short term management of bleeding oesophageal varices and to a maximum of 14 days for treatment of type 1 hepatorenal syndrome, depending on the course of your condition.