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Terlyx

IV Injection
Radius Pharmaceuticals Ltd.
Weight:
1 mg/8.5 ml

best Price:

? 2,200.00
? 2,200.00

Generic

Terlipressin Acetate

Indications

For use in the short term management of bleeding oesophageal varices. "Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC (International Ascites Club) criteria".

Contraindications

Treatment with Terlipressin Acetate during pregnancy is contraindicated. Terlipressin Acetate has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease the uterine blood flow. Terlipressin Acetate may have harmful effects on pregnancy and foetus. Spontaneous abortion and malformation of the foetus have been shown in rabbits after treatment with Terlipressin Acetate. It is not known whether Terlipressin Acetate is excreted in human breast milk. The excretion of Terlipressin Acetate in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Terlipressin Acetate should be made taking into account the benefit of breast-feeding to the child and the benefit of Terlipressin Acetate therapy to the woman.

Side Effects

Cardiac, pulmonary and vascular disease: During treatment regular monitoring and control of blood pressure, ECG, heart rate, serum levels of sodium and potassium, as well as fluid balance are required. Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure. Septic shock: In patients with septic shock with a low cardiac output terlipressin should not be used. Injection site reaction: To avoid local necrosis at the injection site, the injection must be administered intravenously. Torsade de pointes: During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including �Torsade de pointes� have been reported. 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. Therefore, extreme caution should be exercised in the use of terlipressin in patients with a history of QT interval prolongation, electrolyte abnormalities, or concomitant medications that can prolong the QT interval. Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy. Paediatric population and elderly patients: 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. Excipients: This medicinal product contains 1.33 mmol (30.7 mg) of sodium per ampoule, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Pregnancy And Lactation

Elderly patients: There is no data available regarding dosage recommendation in the elderly. Paediatric population: There is no data available regarding dosage recommendation in the paediatric population.

Therapeutic

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

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