- Approval Id
- ebeda2a9293db992
- Drug Name
- ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
- Product Name
- ZINC AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
- Approval Number
- SIN16768P
- Approval Date
- 2023-04-25
- Registrant
- AGUETTANT ASIA PACIFIC PTE. LTD.
- Licence Holder
- AGUETTANT ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- **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.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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.
- Contraindications
- **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_.
- Atc Code
- A12CB02
- Atc Item Name
- zinc gluconate
- Pharma Manufacturer Name
- AGUETTANT ASIA PACIFIC PTE. LTD.
- Company Detail Path
- /organization/8f107f06297f4124/aguettant-asia-pacific-pte-ltd
