GLYPRESSIN FOR INJECTION 1 mgvial

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

TERLIPRESSIN ACETATE

Saatavilla:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC-koodi:

H01BA04

Annos:

1 mg/vial

Lääkemuoto:

INJECTION, POWDER, FOR SOLUTION

Koostumus:

TERLIPRESSIN ACETATE 1 mg/vial

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Rentschler Biopharma SE

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1994-07-15

Pakkausseloste

20,49-I-SG-01.01; Drafted by MELM, 17-Aug-2015; ASAP, FGmbH PI,
updated manufacturer information and pack sizes
GLYPRESSIN
® 1 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION
One vial contains 1 mg terlipressin acetate, corresponding to 0.86 mg
terlipressin.
Excipients of powder: Mannitol (E 421), Hydrochloric acid.
One ampoule of solvent contains sodium chloride, hydrochloric acid and
water for injection.
PHARMACEUTICAL DOSAGE FORM
Powder and solvent for solution for injection.
INDICATIONS
Bleeding oesophageal varices.
DOSAGE AND ADMINISTRATION
Bleeding oesophageal varices
Adults: Initially an i.v. injection of 2 mg terlipressin acetate 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.
CONTRAINDICATIONS
Contraindicated in pregnancy. Hypersensitivity to terlipressin or any
other excipients of the products.
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.
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 is no data available regarding dosage recommendation in these
special patient categories.
PREGNANCY AND LACTATION
Treatment with GLYPRESSIN
®
during pregnancy is contraindicated (please refer to
Contraindications).
GLYPRESSIN
®
has been shown to cause uterine contractions and increased
intrauterine pressure in early
pregnancy and may decrease uterine blood flow. GLYPRESSIN
®
may have harmful effects on pregnancy and
foetus.

Valmisteyhteenveto

GLYINJ-I-SG-03.01
NAME OF THE MEDICINAL PRODUCT
GLYPRESSIN
®
1 mg, powder and solvent for solution for injection
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.
List of excipients:
Powder: Mannitol (E 421), Hydrochloric acid.
Solvent: Sodium chloride, hydrochloric acid and water for injections.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
THERAPEUTIC INDICATIONS
Bleeding oesophageal varices.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Initially an i.v. injection of 2 mg terlipressin acetate 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.
Method of Administration
i.v. injection
CONTRAINDICATIONS
Contraindicated in pregnancy.
Hypersensitivity to terlipressin or any other excipients of the
product.
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.
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 is no data available regarding dosage recommendation in these
special patient categories.
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 with a known bradycardic
effect (e.g. propofol,