Glypressin Solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:

Terlipressin

Available from:

Ferring Pharmaceuticals Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

                                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
                                
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Summary of Product characteristics

                                 
                                      
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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
                                
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