Glypressin

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Terlipressin acetate 1mg equivalent to 0.86 mg terlipressin

Dostępny od:

Pharmaco (NZ) Ltd

INN (International Nazwa):

Terlipressin acetate 1 mg (=0.86 mg terlipressin)

Dawkowanie:

1 mg/5mL

Forma farmaceutyczna:

Injection with diluent

Skład:

Active: Terlipressin acetate 1mg equivalent to 0.86 mg terlipressin Excipient: Mannitol Sodium chloride Water for injection

Sztuk w opakowaniu:

Ampoule, glass, diluent, 5 mL

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

PolyPeptide Laboratories AB

Wskazania:

GLYPRESSIN is indicated for the treatment of bleeding oesophageal varices.

Podsumowanie produktu:

Package - Contents - Shelf Life: Ampoule, glass, diluent - 5 mL - 60 months from date of manufacture stored at or below 25°C protect from light - Combination pack, 5 x powder + diluent - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, lyophilized powder - 1 mg - 36 months from date of manufacture stored at or below 25°C protect from light

Data autoryzacji:

2004-07-27

Charakterystyka produktu

NEW ZEALAND DATA SHEET 

GLYPRESSIN INJECTION 
– GLYP006 

16 April  2013 
GLYPRESSIN INJECTION WITH DILUENT

Terlipressin (as diacetate) 

PRESENTATION 

GLYPRESSIN INJECTION 1MG TERLIPRESSIN
DIACETATE/5ML: POWDER AND SOLVENT FOR SOLUTION FOR 
INJECTION:   
Powder (vial): white, lyophilized powder.  Solvent (ampoule):
clear, colourless liquid.  Each vial of 
powder contains 1mg terlipressin diacetate
(equivalent to terlipressin free base 0.86mg).  The 
concentration of the reconstituted solution is 0.2mg
terlipressin diacetate/mL.   

For full list of excipients see PHARMACEUTICAL PRECAUTIONS. 

USES 

ACTIONS 
Pharmacotherapeutic group: Posterior pituitary lobe
hormones (vasopressin and analogues), 
ATC code: H01B A04. 

Terlipressin initially has an effect
of its own, but is converted
by enzymatic cleavage to lysine 
vasopressin.  Doses of 1 and 2mg effectively reduce
the portal venous pressure and produce 
marked vasoconstriction.  The lowering of portal pressure and
azygos blood flow is dependent on 
dose.  The effect of the low dose is reduced after 3
hours, while haemodynamic data show that 
2mg is more effective than 1mg as the
higher dose produces a dependable effect throughout the 
period of treatment (4 hours). 

PHARMACOKINETICS 
The pharmacokinetics follows a two-compartment model. 
It has been found that the half-life is 
approximately 40
minutes, metabolic clearance is approximately 9mL/kg/min
and the distribution 
volume is approximately 0.5 L/kg. 

The desired concentration of lysine vasopressin in plasma
is found initially after approximately 30 
minutes and reaches a peak value of 60 to 120 minutes after
administration of GLYPRESSIN.  
Because of 100% cross-reaction between
terlipressin and lysine vasopressin, there is no specific 
RIA method for these substances. 

PRE