GLYPRESSIN SOLUTION terlipressin 0.85 mg/8.5 mL solution for injection ampoule

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

terlipressin, Quantity: 0.85 mg

Beszerezhető a:

Ferring Pharmaceuticals Pty Ltd

INN (nemzetközi neve):

Terlipressin

Gyógyszerészeti forma:

Injection, solution

Összetétel:

Excipient Ingredients: sodium chloride; water for injections; sodium acetate trihydrate; acetic acid

Az alkalmazás módja:

Intravenous

db csomag:

5 ampoules

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

GLYPRESSIN is indicated for the:,?treatment of bleeding oesophageal varices (BOV);,?treatment of patients with Type 1 hepatorenal syndrome (HRS) who are actively beingconsidered for liver transplant.

Termék összefoglaló:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2012-05-14

Betegtájékoztató

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 of the available
information. It does not take the
place of talking to your doctor, nurse
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
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GLYPRESSIN IS
USED FOR
GLYPRESSIN contains terlipressin.
GLYPRESSIN is used to treat
Bleeding Oesophageal Varices
(BOV), 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.
GLYPRESSIN is also used to treat
hepatorenal syndrome, type 1
(HRS-1). GLYPRESSIN is given
when a patient with HRS-1 is being
considered for a liver transplant.
HRS-1 is a condition in which the
kidneys suddenly fail to work in a
person with severe liver disease.
HRS-1 is a life-threatening
complication of severe liver disease.
The cause of HRS-1 is not fully
understood. It is thought to be due to
the kidneys drastically reducing their
own blood flow, in response to large
changes in blood flow in other parts
of the body caused by severe liver
disease.
GLYPRESSIN works in HRS-1 by
improving the blood flow in the
kidneys.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WH

Termékjellemzők

Page 1 of 14
#28325-v12
AUSTRALIAN PRODUCT INFORMATION - GLYPRESSIN
® (TERLIPRESSIN)
SOLUTION FOR INJECTION
1. NAME OF THE MEDICINE
Terlipressin (as terlipressin acetate).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
One ampoule of GLYPRESSIN contains 0.85 mg terlipressin (equivalent to
1 mg terlipressin
acetate) in 8.5 mL of solution. The concentration of terlipressin is
0.1 mg/mL (equivalent to
terlipressin acetate 0.12 mg/mL).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for Injection. Clear, colourless liquid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GLYPRESSIN is indicated for the:
•
treatment of bleeding oesophageal varices;
•
treatment of patients with hepatorenal syndrome (HRS) Type 1 who are
actively being
considered for liver transplant.
4.2 DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
GLYPRESSIN
must only be administered intravenously.
BLEEDING OESOPHAGEAL VARICES (BOV)
_Adults: _
Initially an i.v. injection of 1.7 mg terlipressin (2 mg terlipressin
acetate) is given every 4 hours.
When the bleeding is under control the dose can be adjusted to 0.85 mg
terlipressin (1 mg
terlipressin acetate) i.v. every 4 hours. After the initial dose, the
dose can also be adjusted to
Page 2 of 14
#28325-v12
0.85 mg (1 mg terlipressin acetate) i.v. every 4 hours in patients
with body weight < 50 kg or if
adverse effects occur. The treatment should not continue for more than
48 hours in total.
_Children and Elderly:_ _ _
No data are available regarding dosage recommendations in these
patient populations.
HEPATORENAL SYNDROME (HRS)
0.85
mg
terlipressin
every
6
hours
by
slow
intravenous
bolus
injection
for
7
to
14
days
(administered in association with albumin 20% 100 mL i.v. twice daily
for 7 to 14 day