Saturday, October 8, 2016

Glypressin Injection





Glypressin Injection


Terlipreressin acetate




Read all of this leaflet carefully before this medicine is administered to you.


  • Keep this leaflet, you may need to use it again

  • If you have further questions, please ask your doctor or pharmacist.


Your medicine is called Glypressin Injection. Each carton has:


  • one vial of freeze-dried powder containing 1mg of the active ingredient, terlipressin acetate, and mannitol. Hydrochloric acid is added to adjust the acidity

  • one ampoule of liquid (solvent) containing a 5ml solution of sodium chloride in water for injection to dissolve the powder before injection. Hydrochloric acid is added to adjust the acidity to make it suitable for injection.


Marketing Authorisation Holder:



Ferring Pharmaceuticals Ltd.

The Courtyard

Waterside Drive

Langley

Berkshire

SL3 6EZ

(UK)




Manufacturer:



Ferring GmbH

Wittland 11

D-24109 Kiel

Germany





What Glypressin Injection is and what it is used for


Glypressin Injection consists of a powder and solvent for solution for injection. The white, freeze-dried powder contains terlipressin acetate.


Glypressin Injection is used in the treatment of bleeding oesophageal varices.


Bleeding oesophageal varices are enlarged blood vessels that form in the stomach or oesophagus as a complication of liver disease. They may burst and bleed and this is a serious and life-threatening conditon.


When injected into the bloodstream, the active ingredient, terlipressin acetate is broken down to release a substance called lysine vasopressin. This acts on the walls of the blood vessels, causing them to narrow and restrict the blood flow to the affected veins so that bleeding is reduced.




Before you use Glypressin Injection



Glypressin Injection should not be used:


  • if you are pregnant

  • if you are allergic to any of the ingredients listed.


Please consult your doctor before Glypressin Injection is administered to you:


  • if you have hypertension (high blood pressure)

  • if you have a heart condition (such as an irregular heart beat)

  • if you have heart disease e.g. coronary insufficiency (a condition in which the arteries of the heart become hardened, narrow or blocked leading to an insufficient blood supply to the heart muscle)

  • if you have atherosclerosis (a disease of the arteries in which fatty plaques develop on the inner lining of the arteries, preventing blood from flowing normally).



How Glypressin Injection is administered


The doctor will administer the appropriate dose by injection into a vein.


The usual dose of Glypressin Injection in acute bleeding from oesophageal varices is 2mg followed by 1 or 2mg every 4 to 6 hours until bleeding is controlled, up to a maximum of 72 hours.


During treatment, your blood pressure, serum sodium and potassium and fluid balance will normally be monitored constantly.




Glypressin Injection Side Effects


Like all medicines, Glypressin Injection can have side effects. They include abdominal cramps, headache, blanching of the skin and raised blood pressure.


If you experience one or more of these side effects or any other undesirable effects, please inform your doctor or pharmacist immediately.




Storing Glypressin Injection


Keep Glypressin Injection out of the reach and sight of children.


Do not store above 25°C. Keep container in the outer carton.


Do not use after the expiry date marked on the packaging.


Glypressin Injection PL 03194/0018


This leaflet was revised in September 2005.


2009050023







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