Glypressin 0.12 mg/ml solution for injection

One ampoule contains 1mg terlipressin acetate in 8.5ml solution for injection.

For excipients, see section 6.1

Solution for injection.

Clear, colourless liquid.

Glypressin is indicated in the treatment of bleeding oesophageal varices.

In acute variceal bleeding, 2mg Glypressin should be administered by intravenous bolus, followed by 1 – 2 mg every 4 – 6 hours until bleeding is controlled, up to a maximum of 72 hours.

Administration is by intravenous injection.

Contraindicated in pregnancy.

Hypersensitivity to terlipressin or any other excipients of the product.

Since Glypressin has antidiuretic and pressor activity it should be used with great caution in patients with hypertension, atherosclerosis, cardiac dysrhythmias or coronary insufficiency. Constant monitoring of blood pressure, serum sodium and potassium and fluid balance is essential.

None known

Glypressin^® may stimulate contraction of smooth muscle and is therefore contraindicated in pregnancy. There is no data concerning its use in lactation.

Not applicable

Glypressin^® is only recommended for the short-term treatment of bleeding oesophageal varices, so few side effects have been reported. Those noted have included abdominal cramps, headache, transient blanching and increased arterial blood pressure.

The recommended dose (2mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.

Pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues) (H 01 BA 04)

Glypressin^® may be regarded as a circulating depot of lysine vasopressin. Following intravenous injection, three glycyl moieties are enzymatically cleaved from the N-terminus to release lysine vasopressin.

The slowly released vasopressin reduces blood flow in the splanchnic circulation in a prolonged manner, thereby helping to control bleeding from ruptured oesophageal varices.

Glypressin^® is administered by bolus intravenous injection. It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.

The half-life of distribution (T_1/2α) is about 8 -10 minutes.

The half-life of elimination (T_1/2β) is about 50 -70 minutes.

Lysine vasopressin reaches maximum plasma levels about 1 - 2 hours following intravenous administration and has a duration of activity of 4 - 6 hours.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Sodium chloride

Acetic acid

Sodium acetate

Water for injections

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

2 years

Store in a refrigerator (2-8 °C). Keep the ampoules in the ourter carton in order to protect from light.

Type I clear glass ampoules.

Pack size: 5 x 8.5ml

Unused drug and waste should be destroyed in accordance with local requirements.

Ferring Pharmaceuticals Ltd.,

The Courtyard

Waterside Drive

Langley, Berkshire

SL3 6EZ

UK

PL 03194/0101

11/05/2009

11/05/2009