Glypressin 1mg/8.5ml solution for injection

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

TERLIPRESSIN ACETATE

Διαθέσιμο από:

Ferring Pharmaceuticals Limited Drayton Hall, Church Road, West Drayton UB7 7PS, United Kingdom

Φαρμακολογική κατηγορία (ATC):

H01BA04

INN (Διεθνής Όνομα):

TERLIPRESSIN ACETATE 1 mg

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

TERLIPRESSIN ACETATE 1 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2011-03-15

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYPRESSIN
1 MG SOLUTION FOR INJECTION
Terlipressin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includesany
possible side effects not
listed in this leaflet. please tell your doctor.
WHAT IS IN THIS LEAFLET
:
1.
What Glypressin is and what it is used for
2.
What you need to know before you are given Glypressin
3.
How you will be given Glypressin
4.
Possible side effects
5.
How to store Glypressin
6.
Contents of the pack and other information
1.
WHAT GLYPRESSIN IS AND WHAT IT IS USED FOR
Glypressin solution for injection contains the active component
terlipressin acetate.
GLYPRESSIN
IS USED IN THE TREATMENT OF BLEEDING OESOPHAGEAL VARICES
.
Oesophageal
varices
are
enlarged
blood
vessels
that
form
in
the
oesophagus
(gullet)
as
a
complication of liver disease. They may burst and bleed which is a
serious and life-threatening
condition.
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 blood flow so that bleeding is reduced.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLYPRESSIN
DO NOT USE GLYPRESSIN
-
if you are ALLERGIC (HYPERSENSITIVE) TO TERLIPRESSIN
acetate or any of the other ingredients in
Glypressin
-
if you are PREGNANT
WARNING AND PRECAUTIONS
-
if you have
HIGH BLOOD PRESSURE
-
if you have
HEART DISEASE
-
in
CHILDREN AND ELDERLY
patients as experience is limited in these age groups
-
if you have
SEPTIC SHOCK.
Septic shock is a serious condition that occurs when a major
infection leads to low blood pressure and low blood flow.
TALK TO YOUR DOCTOR IF ANY OF THESE APPLY TO YOU BEFORE USING
GLYPRESSIN.
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During treatment with Glyp

Αρχείο Π.Χ.Π.

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1.
NAME OF THE MEDICINAL PRODUCT
Glypressin 1 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 8.5 ml solution contains 1 mg terlipressin acetate,
corresponding to 0.85 mg
terlipressin
free
base.
The
concentration
of
the
solution
is
0.12
mg
terlipressin
acetate/ml,
corresponding to 0.1 mg terlipressin free base/ml.
Excipients
One ampoule contains 1.33 mmol (or 30.7 mg) sodium.
_ _
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bleeding oesophageal varices
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults:_
Initially an i.v. injection of 2 mg Glypressin solution for injection
is given every 4 hours. The
treatment should be maintained until bleeding has been controlled for
24 hours, but up to a
maximum of 48 hours. After the initial dose, the dose can be adjusted
to 1 mg i.v. every 4 hours in
patients with body weight < 50 kg or if adverse effects occur.
4.3
CONTRAINDICATIONS
Contraindicated in pregnancy.
Hypersensitivity to terlipressin or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood pressure, heart rate and fluid balance should be monitored
during treatment. To avoid local
necrosis at the injection site, the injection must be given i.v.
Caution should be exercised in treating
patients with hypertension or recognised heart disease.
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In patients with septic shock with a low cardiac output terlipressin
should not be used.
This medicinal product contains 1.33 mmol (or 30.7 mg) of sodium per
ampoule. To be taken into
consideration in patients on a controlled sodium diet.
Children and the elderly: particular caution should be exercised in
the treatment of children and
elderly patients, as experience is limited in these groups.
There are no data available regarding dosage recommendation in these
special patient categories.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERA