Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Terlipressin
Ferring Pharmaceuticals Pty Ltd
Medicine Registered
GLYPRESSIN ® _SOLUTION FOR INJECTION_ _Terlipressin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GLYPRESSIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given GLYPRESSIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GLYPRESSIN IS USED FOR GLYPRESSIN is used to treat bleeding veins in the lower end of the food-pipe in people with serious liver disease. When the liver is diseased, there is less blood flowing through it. This causes the blood to 'back up' in the veins in the lower end of the food pipe (and upper part of the stomach). The veins in the lining of the food pipe (and stomach) then become very large and stretched, much like varicose veins. Because the veins are also very fragile, they can rupture and then bleed severely into the stomach. GLYPRESSIN contains terlipressin, a substance which acts to stop the bleeding by lowering the blood pressure in the veins of the food- pipe. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY GLYPRESSIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. GLYPRESSIN is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN GLYPRESSIN _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE GLYPRESSIN IF YOU HAVE AN ALLERGY TO TERLIPRESSIN, THE ACTIVE INGREDIENT, OR TO ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to GLYPRESSIN may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE GLYPRESSIN IF YOU ARE PREGNANT. It may affect your dev Read the complete document
Page 1 of 9 #28325-v6A PRODUCT INFORMATION GLYPRESSIN ® SOLUTION FOR INJECTION NAME OF THE MEDICINE Terlipressin (as terlipressin acetate). The chemical name is _N_-[_N_-(_N_-Glycylglycyl)glycyl]-8- L - lysinevasopressin. Terlipressin has an empirical formula of C 52 H 74 N 16 O 15 S 2 and a molecular weight of 1227.4. CAS No: 14636-12-5. The pKa is approximately 10. Terlipressin is freely soluble in water. Although the active ingredient is terlipressin, the drug substance included in this product contains non-stoichiometric amounts of acetic acid and water, and this material is freely soluble in water. The structural formula of terlipressin is DESCRIPTION GLYPRESSIN is for intravenous injection. It consists of a clear, colourless liquid containing 0.85 mg terlipressin (equivalent to 1 mg terlipressin acetate) in 8.5 mL solution in an ampoule. The concentration of terlipressin is 0.1 mg/mL (equivalent to terlipressin acetate 0.12 mg/mL). LIST OF EXCIPIENTS GLYPRESSIN contains the following excipients: Sodium chloride, acetic acid, sodium acetate trihydrate, Water for Injections PHARMACOLOGY PHARMACODYNAMICS Terlipressin belongs to the pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues), ATC code: H 01 BA 04. Terlipressin is a dodecapeptide that has three glycyl residues attached to the N-terminal of lysine vasopressin (LVP). Terlipressin acts as a pro-drug and is converted via enzymatic cleavage of its three glycyl residues to the biologically active lysine vasopressin. A large body of evidence has consistently shown that terlipressin give Read the complete document