Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Package Inserts
Zinc Aguettant Concentration for Solution for Infusion PI.pdf
Approved: April 25, 2023