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HSA Approval

ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

SIN16768P

ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

April 25, 2023

AGUETTANT ASIA PACIFIC PTE. LTD.

AGUETTANT ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAGUETTANT ASIA PACIFIC PTE. LTD.
Licence HolderAGUETTANT ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INFUSION, SOLUTION CONCENTRATE

**4.2. Posology and method of administration** Posology The dosage must be adapted to each patient, taking into account losses and zinc status. The solution is a supplementation additive for parenteral nutrition intended to be used in compatible mixtures for parenteral nutrition or diluted in isotonic solutions. Recommended basal requirements by intravenous route are the following. Higher doses may be needed to compensate abnormally high losses. _Adults:_ - 2.5 to 5 mg/day. _Paediatric population:_ - premature: 0.40 to 0.50 mg/kg/day, - infants younger than 3 months: 0.25 mg/kg/day, - infants older than 3 months: 0.1 mg/kg/day, - children: 0.05 mg/kg/day to a maximum of 5 mg/day. Method of administration Recommended administration: intravenous route after dilution with a slow infusion rate. The recommended administration is by intravenous route after dilution with a slow infusion rate. The solution can be diluted in an isotonic solution (such as sodium chloride 0.9% or glucose 5%). When removing a volume using a syringe, do not use a needle with a diameter greater than 0.8 mm. Monitoring Monitor zinc concentrations during treatment. Also monitor patients clinically for signs and symptoms of zinc deficiency, especially in pediatrics. Zinc concentrations may vary depending on the assay used and the laboratory reference range.

INTRAVENOUS

Medical Information

**4.1. Therapeutic indications** Zinc supplementation solution in prolonged parenteral nutrition and in situations where a pronounced zinc deficiency may occur: e.g. severe malnutrition, hypercatabolism, digestive fistula, chronic diarrhoea.

**4.3. Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

A12CB02

zinc gluconate

Manufacturer Information

AGUETTANT ASIA PACIFIC PTE. LTD.

Laboratoire AGUETTANT

Active Ingredients

Zinc gluconate eqv elemental zinc

1mg/mL

Zinc gluconate

Documents

Package Inserts

Zinc Aguettant Concentration for Solution for Infusion PI.pdf

Approved: April 25, 2023

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