SYTRON Oral solution Ref.[27557] Active ingredients: Sodium feredetate

Posology

Treatment

Adults and the elderly (over 65 years)

5 ml increasing gradually to 10 ml three times daily.

Paediatric population

Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.

Prophylaxis

Babies of low birth weight who are solely breast-fed

A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.

Other children (elemental iron per day)

Age 6-24 months: 12.5 mg.

Age 2-5 years: 20-30 mg.

Age 6-11 years: 30–60 mg.

Adolescents: 60 mg.

Method of administration

Oral.

For instructions on dilution of the medicinal product before administration, see section 6.6.

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur.

Treatment of overdosage:

1. Administer an emetic.
2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be introduced into the stomach following gastric emptying.
3. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.
4. In adults, a drink of mannitol or sorbitol should be given to induce small bowel emptying. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children.
5. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (adults >142μmol/l, children >90μmol/l), immediate supportive measures should be introduced. Desferrioxamine should be given by slow iv infusion (adults 5mg/kg/h, children 15mg/kg/h). The maximum dose is 80mg/kg/24h. Warning: hypotension may occur if the infusion rate is too rapid.
6. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).
7. Serum iron levels should be monitored throughout.

Unopened: 36 months.

Opened: 3 months from date of opening.

If this product has been diluted with water use within 14 days of preparation.

Do not store above 25°C.

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron.

Not all pack sizes may be marketed.

Water is the recommended diluent for this product.