TERLIPRESSIN ACETATE AFT

v. injection of 2 mg Terlipressin Acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.

Paediatric population There is no relevant use of Terlipressin Acetate AFT in paediatric population. Method of administration Intravenous injection use

Frequency of undesirable effects Frequency System organ class Common ≥1/100 to <1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥1/10,000 to ≤1/1,000 Frequency System organ class Common ≥1/100 to <1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥1/10,000 to ≤1/1,000 Metabolism and nutrition disorders Hyponatraemia if fluid not monitored Nervous system Disorders Headache Cardiac disorders Bradycardia Atrial fibrillation Ventrical extrasystoles Tachycardia Chest pain Myocardial infarction Fluid overload with pulmonary oedema Torsade de pointes Cardiac failure Vascular disorders Peripheral vasoconstriction Peripheral ischaemia Facial pallor Hypertension Intestinal ischaemia Peripheral cyanosis Hot flushes Respiratory thoracic and mediastinal disorders Respiratory distress Respiratory failure Dyspnoea Gastrointestinal disorders Transient abdominal cramps Transient diarrhoea Transient nausea Transient vomiting Skin and subcutaneous tissue disorders Skin necrosis Pregnancy, puerperium and perinatal conditions Uterine hypertonus Uterine ischemia General disorders and administration site disorders Injection site necrosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Blood pressure, heart rate and fluid balance should be monitored during treatment. v. Caution should be exercised in treating patients with hypertension or recognised heart disease. In patients with septic shock with a low cardiac output Terlipressin Acetate AFT should not be used.

8). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) or medications with concomitant effect on QT prolongation. 5).

Children and the elderly:

Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups. There is no data available regarding dosage recommendation in these special patient categories.

Contraindicated in pregnancy. 1.