GLYPRESSIN

Nchi: Indonesia

Lugha: Kiindonesia

Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Viambatanisho vya kazi:

TERLIPRESSIN

Inapatikana kutoka:

ABBOTT INDONESIA - Indonesia

INN (Jina la Kimataifa):

TERLIPRESSIN

Kipimo:

0.86 MG

Dawa fomu:

SERBUK INJEKSI

Vitengo katika mfuko:

Dus, 1 vial @ 1 mg + 1 ampul pelarut @ 5 mL

Viwandani na:

FERRING GMBH - Federal Republic of Germany

Idhini ya tarehe:

2019-04-02

Tabia za bidhaa

Proposed packaging material
Code
GLYINJ-I-ID-01.02
Size
N/A
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
GLYINJ-I-ID-01.01
Changes
Indication, posology, overdose, pharmacokinetics, pharmacodynamics, &
manufacturers
Reference
☐
CCDS version:
☐
Core PIL version:
☒
SPC country/version/date: EU, Version 3.1,
06/2015
☐
LAC no.:
Name & Date
INS, 5-Nov-2018
GLYPRESSIN
®
Terlipressin acetate
Powder and solvent for solution for injection 1mg
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.
Excipients:
Powder: Mannitol (E 421), Hydrochloric acid 1 M.
Solvent: Sodium chloride, Hydrochloric acid 1 M, Water for injections.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder (vial): White lyophilized powder.
Solvent (ampoule): Clear, colourless liquid.
THERAPEUTIC INDICATIONS
Glypressin® is indicated in the treatment of bleeding oesophageal
varices.
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.
Paediatric and geriatric population:
No data are available regarding dosage recommendations in these
patient populations.
CONTRAINDICATIONS
Contraindicated in pregnancy.
Hypersensitivity to terlipressin or to any of the 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 recognized heart disease.
In patients with septic shock with a lo