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The treatment should be maintained until 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 1 mg i. Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.
The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardic effect e. These effects are due to reflexogenic inhibition of cardiac activity via the vagus nerve due to the elevated blood pressure. Glypressin has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow.
Glypressin may have harmful effects on pregnancy and foetus. Spontaneous abortion and malformation have been shown in rabbits after treatment with Glypressin. It is not known whether terlipressin is excreted in human breast milk.
The excretion of terlipressin in milk has not been studied in animals. A risk to the suckling child cannot be excluded. Hyponatraemia if fluid not monitored. Respiratory thoracic and mediastinal disorders. Skin and subcutaneous tissue disorders.
Glypressin 0.12mg/ml Solution for Injection
Pregnancy, puerperium and perinatal conditions. General disorders and administration site disorders. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: Posterior pituitary lobe hormones vasopressin and analogues H 01 BA 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. It shows a glypressn plasma level curve which indicates that a two compartment model can be applied. 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 ferrin already included in other sections of the SPC. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Back to top Ferring Pharmaceuticals Ltd contact details. Active ingredient terlipressin acetate.
Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2.
Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended lgypressin use by health professionals. One ampoule contains 1mg terlipressin acetate in 8. For the ferribg list of excipients, see section 6. Glypressin is indicated in the treatment of bleeding oesophageal varices.
Posology In acute variceal bleeding: There is no relevant use of Glypressin in paediatric population. Method of administration Intravenous injection use. Hypersensitivity to terlipressin acetate or any of the excipients listed in section 6.
Blood pressure, heart rate and fluid balance should be monitored during treatment. To avoid local necrosis at the injection site, the injection must be given i. Caution should be exercised in treating patients with hypertension or recognised heart disease.
In patients with septic shock with a low cardiac output Glypressin should not be used. There is no data available regarding dosage recommendation in these special patient categories. Pregnancy Treatment with Glypressin during pregnancy is contraindicated ref. Breast-feeding It is not known whether terlipressin is excreted in human breast milk. No studies on the effects on the ability to drive and use machines have been performed. Sodium chloride Acetic acid Sodium acetate Water for injections.
Unused drug and waste should be destroyed in accordance with local requirements. Company contact details Ferring Pharmaceuticals Ltd. To bookmark a medicine you must sign up and log in. Sign Up Log In Cancel. To email a medicine you must sign up and log in. To view the changes to a medicine you must sign up and log in. Find out more here. Metabolism and nutrition disorders. Atrial fibrillation Ventrical extrasystoles Tachycardia Chest pain Myocardial infarction Fluid overload with pulmonary oedema Torsade de pointes Cardiac failure.
Peripheral vasoconstriction Peripheral ischaemia Facial pallor Hypertension.
Gastroenterology – Ferring Corporate
Intestinal ischaemia Peripheral cyanosis Hot flushes. Respiratory distress Respiratory failure. Transient abdominal cramps Transient diarrhoea. Transient nausea Transient vomiting. Uterine hypertonus Uterine ischemia.