LUCASSIN terlipressin 0.85 mg powder for injection vial

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

terlipressin

Հասանելի է:

Ikaria Australia Pty Ltd

INN (Միջազգային անվանումը):

Terlipressin

Լիազորման կարգավիճակը:

Registered

Տեղեկատվական թերթիկ

Lucassin
®
CMI (June 2018) – Issue 4
1
LUCASSIN
®
Terlipressin 0.85 mg powder for injection
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about LUCASSIN. 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 expected benefits of you having
LUCASSIN against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT IS LUCASSIN
USED FOR?
LUCASSIN contains terlipressin.
This medicine is used to treat:
1) HEPATORENAL SYNDROME, TYPE 1
(HRS-1). LUCASSIN 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.
LUCASSIN works in HRS-1 by
improving blood flow in the kidneys.
2) BLEEDING OESOPHAGEAL
VARICES (BOV), which are 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. LUCASSIN acts
to stop the bleeding by lowering the
blood pressure in the veins of the
food- pipe.
Your doctor may have prescribed
LUCASSIN for another reason. Ask
your doctor if you have any

Ապրանքի հատկությունները

LUCASSIN PI –7 June 2018
Page 1
AUSTRALIAN PRODUCT INFORMATION
LUCASSIN TERLIPRESSIN 0.85 MG POWDER FOR INJECTION VIAL
1.
NAME OF THE MEDICINE:
Terlipressin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
of
LUCASSIN
contains
0.85
mg
terlipressin
free
base
and
approximately
two
equivalents (0.084 mg) of acetic acid. Thus, the drug substance is
present mainly in the form of
terlipressin diacetate. Terlipressin diacetate is freely soluble in
water;
pKa 10.01 calculated.
Mannitol is used as the caking agent; glacial acetic acid and/or
sodium hydroxide are used to
adjust the pH to achieve a final product pH of 4.3 - 7.5.
For the full list of excipients, see Section 6.1 List of Excipients
3.
PHARMACEUTICAL FORM
LUCASSIN is supplied as a sterile, lyophilized powder for injection in
single-use clear glass vials
for intravenous administration. Each vial must be reconstituted with
5mL of 0.9% sodium
chloride injection prior to use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUCASSIN is indicated for the treatment of patients with
•
hepatorenal
syndrome
(HRS)
type
1
who
are
actively
being
considered
for
a
liver
transplant
•
bleeding oesophageal varices
4.2
DOSE AND METHOD OF ADMINISTRATION
LUCASSIN must be administered intravenously.
_HEPATORENAL SYNDROME TYPE 1 (HRS-1) _
The recommended starting dose is 0.85 mg terlipressin every 6 hours by
slow intravenous bolus
injection. If serum creatinine (SCr) has not decreased by at least 30%
from the baseline value
after 3 days, the dose can be increased to 1.7 mg terlipressin every 6
hours.
It is recommended that the dose should not be increased in patients
with severe pre-existing
cardiovascular
disease
or
in
the
presence
of
an
ongoing
significant
adverse
event
e.g.
pulmonary oedema, ischaemia (see Section 4.4 Special Warnings and
Precautions for Use).
Treatment with LUCASSIN should be continued until about 2 days after
the patient achieves
LUCASSIN PI –7 June 2018
Page 2
HRS reversal (SCr ≤132.6 µmol/L). Treatment should be terminated if
the patient un