Glypressin 0,1 mg/ml Solution for Injection

Bleeding oesophageal varices.

Initially an intravenous injection of 17 ml (2 ampoules) GLYPRESSIN u00ae solution for injection (1,7 mg terlipressin is equivalent to 2 mg terlipressin acetate) is given every 4 hours. The treatment should be maintained until the bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 8,5 ml (1 ampoule) GLYPRESSIN u00ae solution for injection (0,85 mg terlipressin is equivalent to 1 mg terlipressin acetate) intravenously every 4 hours in patients with a body weight of less than 50 kg or if adverse effects occur.

Hypersensitivity to terlipressin or any other excipient of GLYPRESSIN u00ae. Contraindicated in pregnancy.

Blood pressure, heart rate and fluid balance should be monitored during treatment. To avoid local necrosis at the injection site, GLYPRESSIN u00ae must be given intravenously. Caution should be exercised in administering GLYPRESSIN u00ae to patients with hypertension or recognised heart disease.

In patients with septic shock with a low cardiac output, GLYPRESSIN u00ae should not be used. This medicinal product contains 1,33 mmol (or 30,7 mg) of sodium per ampoule. To be taken into consideration in patients on a controlled sodium diet. Elderly population: Particular caution should be exercised in the treatment of elderly patients, as experience is limited in this group. There is no data available regarding dosage recommendation in this special patient category. Paediatric population GLYPRESSIN u00ae should not be used in children. Use of GLYPRESSIN u00ae should be confined to specialist supervision in units with facilities for regular monitoring of the cardiovascular system, haematology and electrolytes.

The hypotensive effect of non-selective u03b2-blockers on the portal vein is increased by GLYPRESSIN u00ae. Concomitant administration of GLYPRESSIN u00ae with medicines with a known bradycardiac effect (e.g. propranolol or other beta-blockers) may cause lowering of the heart rate and cardiac output. These effects are due to the reflexogenic inhibition of the cardiac activity via the vagus nerve due to the elevated blood pressure.

GLYPRESSIN u00ae must not be mixed with other medicinal products.

Pregnancy Treatment with GLYPRESSIN u00ae during pregnancy is contraindicated. GLYPRESSIN u00ae has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow. GLYPRESSIN u00ae may have harmful effects on pregnancy and the foetus.

Lactation Information on transfer of GLYPRESSIN u00ae to breast milk is insufficient. GLYPRESSIN u00ae should not be used in breastfeeding women.

No studies on the effects on the ability to drive and use machines have been performed.

The most commonly reported side-effects of GLYPRESSIN u00ae are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea and headache. The antidiuretic effect of GLYPRESSIN u00ae may cause hyponatraemia unless the fluid balance is controlled.

Common (u2265 1/100 to < 1/10) Uncommon (u2265 1/1 000 to < 1/100) Rare (u2265 1/10 000 to < 1/1 000) Not known: cannot be estimated from the available data.

Metabolism and nutrition disorders Uncommon: Hyponatraemia if fluid balance is not monitored Nervous system disorders Common: Headache Cardiac disorders Common: Bradycardia, Uncommon: Atrial fibrillation, ventricular extrasystoles, tachycardia, chest pain, myocardial infarction, fluid overload with pulmonary oedema Not known: Torsade de pointes, cardiac failure Vascular disorders Common: Peripheral vasoconstriction, peripheral ischaemia, facial pallor, hypertension Uncommon: Intestinal ischaemia, peripheral cyanosis, hot flushes Respiratory, thoracic and mediastinal disorders Uncommon: Respiratory distress, respiratory failure Rare: Dyspnoea Gastrointestinal disorders Common: Transient abdominal cramps, transient diarrhoea Uncommon: Transient nausea, transient vomiting Skin and subcutaneous tissue disorders Not known: Skin necrosis Pregnancy, puerperium and perinatal conditions Not known: Uterine constriction, decreased uterine blood flow General disorders and administrative site conditions Uncommon: Injection site necrosis

The recommended dose (2 mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent. Elevated blood pressure in patients with recognised hypertension can be controlled with 150 microgram clonidine i.v. Bradycardia may be treated with atropine. Treatment is symptomatic and supportive.