MedPath
HSA Product

Niuliva Solution For Infusion In Pre-Filled Syringe 600 I.U./2.4 ml

Product approved by Health Sciences Authority (SG)

Basic Information

Niuliva Solution For Infusion In Pre-Filled Syringe 600 I.U./2.4 ml

INJECTION, SOLUTION

Regulatory Information

SIN14068P

December 30, 2011

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

June 3, 2025

XJ06BB04

Company Information

GRIFOLS ASIA PACIFIC PTE. LTD.

GRIFOLS ASIA PACIFIC PTE. LTD.

Active Ingredients

Human antihepatitis B immunoglobulin

Strength: 600 I.U./2.4 ml

Detailed Information

Contraindications

**Contraindications** Hypersensitivity to any of the components. (See special warnings about excipients, section “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Hypersensitivity to human immunoglobulins.

Indication Information

**Therapeutic indications** Niuliva® is indicated for: **Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure during the maintenance phase in non replicator patients.** **Immunoprophylaxis of hepatitis B** - In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable antihepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.

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