GLYPRESSIN SOLUTION FOR INJECTION, 1 MG/8.5 ML

ZENTIVA K.S. - CZECH REPUBLICFERRING PHARMACEUTICALS (CHINA) CO., LTD. (CHINA)🇸🇬 Health Sciences Authority

Approval Date: Oct 4, 2012
Approval ID: cebb9d205b28416a
Company: ZENTIVA K.S. - CZECH REPUBLICFERRING PHARMACEUTICALS (CHINA) CO., LTD. (CHINA)
Type: Therapeutic

Approval Details

Approval Id: cebb9d205b28416a
Drug Name: GLYPRESSIN SOLUTION FOR INJECTION, 1 MG/8.5 ML
Product Name: GLYPRESSIN SOLUTION FOR INJECTION, 1 MG/8.5 ML
Approval Number: SIN14244P
Approval Date: 2012-10-04
Registrant: FERRING PHARMACEUTICALS PRIVATE LIMITED
Licence Holder: FERRING PHARMACEUTICALS PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: 4.2 Posology and method of administration Bleeding Oesophageal Varices (BOV) Posology Adults: Initially an IV injection of 2 mg terlipressin acetate (1.7 mg terlipressin free base) 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 IV every 4 hours in patients with body weight < 50 kg or if adverse effects occur. Type 1 Hepatorenal Syndrome (HRS) Posology Adults: 1 ampoule of GLYPRESSIN® solution for injection (1 mg terlipressin acetate equivalent to 0.85 mg terlipressin) every 6 to 12 hours by slow intravenous bolus injection for 7 to 14 days (administered in association with albumin 20% 100 mL IV twice daily for 7 to 14 days). If serum creatinine (SCr) has not decreased by at least 30% from the baseline value after 3 days, the dose can be increased to a maximum of 2 ampoules of GLYPRESSIN® solution for injection (2 mg terlipressin acetate, equivalent to 1.7 mg terlipressin) every 6 hours. It is however recommended that the dose not be increased in patients with severe pre-existing cardiovascular disease or in the presence of an ongoing significant adverse event e.g. pulmonary oedema, ischaemia. Treatment should be continued until about 2 days after the patient achieves HRS reversal (SCr less than or equal to 132.6 micromole/L), or be discontinued if the patient undergoes dialysis or liver transplant or if SCr remains at or above baseline after 7 days of treatment. Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction. When the patient’s symptoms resolve, GLYPRESSIN® may be re-commenced at a lower dose or at a less frequent dosing interval (e.g., every 8 – 12 hours). The lowest doses used in the clinical studies ranged from 1.7 to 2.55 mg terlipressin/day. The maximum dose studied (TAHRS Study*) was 1.7 mg terlipressin every 4 hours. *The study of Martín–Llahí et al. (2008), also known as the TAHRS study, was a supportive open-label, comparative multicentre study in 46 patients who were randomised in a 1:1 ratio to receive either intravenous terlipressin (0.85 – 1.7 mg (as 1 to 2 mg terlipressin acetate) every 4 hours) plus 20% albumin or 20% albumin alone, for a maximum of 15 days. The majority of patients had HRS type 1 (35/46) and the remainder, HRS type 2 (11/46). As an alternative to bolus injection, terlipressin can be administered as a continuous IV infusion with a starting dose of 2 mg of terlipressin acetate/24 hours and increased to a maximum of 12 mg of terlipressin acetate/24 hours. If volume expansion is needed, Glypressin can be diluted before administration. See section 6.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Administration of terlipressin as continuous IV infusion has been associated with lower rates of severe adverse events than with administration by IV bolus (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Special populations Renal impairment Terlipressin should be avoided in patients with advanced renal dysfunction, i.e., baseline serum creatinine ≥ 442 micromole/L (5.0 mg/dL), unless the benefit is judged to outweigh the risks (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment Terlipressin should be avoided in patients with severe liver disease defined as Acute-on-Chronic Liver Failure (ACLF) grade 3 and/or a Model for End-stage Liver Disease (MELD) score ≥39, unless the benefit is judged to outweigh the risks (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Elderly: There is no data available regarding dosage recommendation in the elderly. Paediatric population: There is no data available regarding dosage recommendation in the paediatric population. Method of Administration IV injection Type 1 hepatorenal syndrome: IV injection or IV infusion
Route Of Administration: INTRAVENOUS
Indication Info: 4.1 Therapeutic Indications Treatment of bleeding oesophageal varices Treatment of patients with hepatorenal syndrome (HRS) Type 1 who are actively being considered for liver transplant (see sections 4.2 and 4.4 on the risks in special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: 4.3 Contraindications Contraindicated in pregnancy. Hypersensitivity to the active substance or any other excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: H01BA04
Atc Item Name: terlipressin
Pharma Manufacturer Name: FERRING PHARMACEUTICALS PRIVATE LIMITED

Active Ingredients

Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate

1 mg/8.5 ml

Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate

1 mg/8.5 ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 4, 2012

Approval ID

cebb9d205b28416a

Type

Therapeutic

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