Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium feredetate
iron 27.5mg/5ml
B03AB03
Sodium feredetate
5.5mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010101; GTIN: 5060090470270
SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION 190MG/ 5ML Each 5ml dose contains Sodium Feredetate 190mg (equivalent to 27.5mg of elemental iron/5ml) Also contains sorbitol (E420), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ponceau 4R lake (E124) and ethanol. For oral administration. Read the package leaflet before use. Keep out of the sight and reach of children. IMPORTANT WARNING: CONTAINS IRON. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN, AS OVERDOSE MAY BE FATAL. Store in the original package in order to protect from light. Use with in three months of opening. Use as directed by your physician. 500ML SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION 500ML READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET 1. What Sodium Feredetate is and what it is used for 2. What you need to know before you take Sodium Feredetate 3. How to take Sodium Feredetate 4. Possible side effects 5. How to store Sodium Feredetate 6. Contents of the pack and other information 1. WHAT SODIUM FEREDETATE IS AND WHAT IT IS USED FOR The name of your medicine is Sodium Feredetate 190 mg/5 ml Oral Solution (called Sodium Feredetate throughout this leaflet). Sodium Feredetate is used to treat ANAEMIA CAUSED BY TOO LITTLE IRON IN THE BODY (iron deficiency anaemia). The form of iron used in this product means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not discolour teeth. It is to be taken by: - pregnant women when other forms of oral iron may not be well tolerated Pročitajte cijeli dokument
OBJECT 1 SODIUM FEREDETATE 190MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 12-May-2017 | Concordia International - formerly AMCo 1. Name of the medicinal product Sodium Feredetate 190mg/5ml Oral Solution 2. Qualitative and quantitative composition Each 5ml dose contains Sodium Feredetate 190mg (equivalent to 27.5mg of elemental iron/5ml) Also contains the following excipients with known effect Ponceau 4R lake (E124) Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Sorbitol liquid (E420) Ethanol 0.08mg/5ml 5.0mg/5ml 1.0mg/5ml 1500mg/5ml 0.014ml/5ml For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution. Red coloured liquid. 4. Clinical particulars 4.1 Therapeutic indications Iron deficiency anaemia, notably in paediatrics. In pregnancy when other forms of oral iron may not be well tolerated. Anaemias secondary to rheumatoid arthritis. 4.2 Posology and method of administration For oral administration: Treatment: Children: 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. Adults: 5ml increasing gradually to 10ml three times daily. Elderly (over 65 years): As for adults. 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 4.3 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 contrain Pročitajte cijeli dokument