Summary of Product Characteristics
last updated on the eMC:
05/08/2002
Go to top of the pageGo to top of the page | Each vial contains 1mg Terlipressin Acetate For excipients, see 6.1 | |
Go to top of the page | Powder and solvent for solution for injectionVial contains white, freeze-dried powder.Ampoule contains solvent. | |
Go to top of the pageGo to top of the page | Glypressin® is indicated in the treatment of bleeding oesophageal varices. | |
Go to top of the page | In acute variceal bleeding, 2mg Glypressin® should be administered by intravenous bolus, followed by 1 - 2mg every 4 - 6 hours until bleeding is controlled, up to a maximum of 72 hours.Administration is by intravenous injection. | |
Go to top of the pageGo to top of the page | 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. | |
Go to top of the pageGo to top of the page | Glypressin® may stimulate contraction of smooth muscle and is therefore contraindicated in pregnancy. There is no data concerning its use in lactation. | |
Go to top of the pageGo to top of the page | 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. | |
Go to top of the page | Increase in blood pressure in patients with known hypertension has been controlled with clonidine, 150mcg iv. | |
Go to top of the pageGo to top of the page | 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. | |
Go to top of the page | Glypressin® is administered by bolus iv injection. It shows a biphasic plasma level curve which indicates that a two compartment model can be applied.The half-life of distribution is about 8 -10 minutes.The half-life of elimination is about 50 -70 minutes.Lysine vasopressin reaches maximum plasma levels about 1 - 2 hours following iv administration and has a duration of activity of 4 - 6 hours. | |
Go to top of the page | There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. | |
Go to top of the pageGo to top of the page | Vial: Mannitol Hydrochloric Acid 1MSolvent Ampoule: Sodium Chloride Hydrochloric Acid 1MWater for Injection | |
Go to top of the pageGo to top of the pageGo to top of the page | Do not store above 25ºC. Keep container in the outer carton. | |
Go to top of the page | Powder: Type I glass vialSolvent: Type I glass ampoulePack size: Cartons containing 5 packs, each with one vial of powder and one ampoule of 5ml solvent. | |
Go to top of the page | Prior to injection, the powder should be reconstituted with the solvent provided. Use immediately after reconstitution. | |
Go to top of the page | Ferring Pharmaceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ (UK) | |
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More information about this product
Link to this document from your website: http://emc.medicines.org.uk/medicine/665/SPC/Glypressin Injection/