ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML [SIN16768P]

Product Info

ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

[SIN16768P]

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.

4.2. 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.

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.