Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TERLIPRESSIN
ABBOTT INDONESIA - Indonesia
TERLIPRESSIN
0.86 MG
SERBUK INJEKSI
Dus, 1 vial @ 1 mg + 1 ampul pelarut @ 5 mL
FERRING GMBH - Federal Republic of Germany
2019-04-02
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 Διαβάστε το πλήρες έγγραφο