Glypressin 1mg, powder and solvent for solution for injection (5ml)

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

TERLIPRESSIN ACETATE

Prieinama:

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

ATC kodas:

H01BA04

INN (Tarptautinis Pavadinimas):

TERLIPRESSIN ACETATE 0.2 mg/ml

Vaisto forma:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sudėtis:

TERLIPRESSIN ACETATE 0.2 mg/ml

Recepto tipas:

POM

Gydymo sritis:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Autorizacija statusas:

Withdrawn

Leidimo data:

2006-10-27

Pakuotės lapelis

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYPRESSIN 1 MG POWDER AND SOLVENT FOR 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 includes any
possible side effects not listed
in this leaflet. See section 4.
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.
Content of the pack and other information
1.
WHAT GLYPRESSIN IS AND WHAT IT IS USED FOR
GLYPRESSIN consists of a powder and solvent for solution for
injection. The white, freeze-dried
powder contains the active component terlipressin.
GLYPRESSIN IS USED IN THE TREATMENT OF BLEEDING OESOPHAGEAL VARICES.
Oesophageal varices are enlarged blood vessels that form in
oesophageous (gullet) as a complication
to liver disease. They may burst and bleed which is a serious and
life-threatening condition.
When injected into the bloodstream the active component, terlipressin,
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 to the affected veins so that bleeding
is reduced.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLYPRESSIN
DO NOT USE GLYPRESSIN
-
if you are ALLERGIC TO TERLIPRESSIN acetate or any of the other
ingredients of this medicine (listed
in section 6)
-
if you are PREGNANT
WARNINGS AND PRECAUTIONS
Talk to your doctor before using GLYPRESSIN
-
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 p

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glypressin 1 mg, powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 1 mg terlipressin acetate, corresponding to 0.86 mg
terlipressin. The concentration
of the reconstituted solution is 0.2 mg terlipressin acetate/ml._ _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder (vial):
White lyophilized powder
Solvent (ampoule):
Clear, colourless liquid
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bleeding oesophageal varices
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Initially an i.v. injection of 2 mg Glypressin 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 the active substance or to any of the excipients
listed in section 6.1.
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.
In patients with septic shock with a low cardiac output terlipressin
should not be used.
Paediatric population and elderly patients: Particular caution should
be exercised in the treatment of
children and elderly patients, as experience is limited in these
groups.
No data are available regarding dosage recommendation in these special
patient categories.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The hypotensive effect of non-selective beta-blockers on the portal
vein is increased with terlipressin.
Concomitant treatment with medicinal products wit