Clinical Pharmacology Details


Feredetate trihydrate


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Indications & Dose:

adults, children and infants for iron deficiency
anaemia:


• Notably in paediatrics;


• In pregnancy when other forms of oral iron may not be well tolerated;


• In anaemias secondary to rheumatoid arthritis.


DOSE


Adults and the elderly (over 65 years):


5ml increasing gradually to 10ml three times daily.
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 breastfed 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 

Contraindications:

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis. Iron is contraindicated in patients receiving repeated blood transfusions or in patients receiving parenteral iron therapy.


 

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Counselling:

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Patient And Carer Advice: