国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ferrous fumarate
Advanz Pharma
B03AA02
Ferrous fumarate
28mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09010101; GTIN: 5021691018179
PATIENT INFORMATION LEAFLET FERROUS FUMARATE 140MG/5ML ORAL SUSPENSION Please read this leaflet carefully before you start to take your medicine. This leaflet does not contain all the information about your medicine. If you have any questions, or you are not sure about anything, ask your doctor or pharmacist. THE NAME OF YOUR MEDICINE IS: Ferrous Fumarate 140mg/5ml Oral Suspension. ACTIVE INGREDIENT: The active ingredient in Ferrous Fumarate 140mg/5ml Oral Suspension is 140mg Ferrous Fumarate, in each 5ml spoonful. It is an oral iron preparation. Ferrous Fumarate 140mg/5ml Oral Suspension is a smooth brown suspension which separates on standing, with an elderberry odour. It is packed in amber glass bottles with polypropylene cap with melinex/pulpboard/aluminium foil wad. The bottle contains 200ml of suspension. WHAT ELSE IS IN YOUR MEDICINE? As well as the active ingredient Ferrous Fumarate 140mg/5ml Oral Suspension also contains nipastat GL75, methylcellulose 20, glucose liquid, sucrose granulated, granular lecithin, elderberry flavor (bush C7529), sodium metabisulphite (E223), water purified. This medicinal product contains 4g of glucose per 5ml spoonful when taken according to the dosage recommendations, each dose supplies up to 8g of glucose. It also contains 0.25g of sucrose per 5ml spoonful. When taken according to the dosage recommendations, each dose supplies up to 0.5g of sucrose. This product is unsuitable if you have a hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose isomaltase deficiency. Ferrous Fumarate 140mg/5ml Oral Suspension is made for the Product Licence Holder, Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK PL 12762/0083 by Laleham Health and Beauty Limited, Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK. WHAT IS THIS MEDICINE USED FOR? This medicine is taken by mouth to treat or prevent iron deficiency. For prevention of deficiency during pregnancy, a combination of iron and folic a 阅读完整的文件
OBJECT 1 FERROUS FUMARATE 140MG/5ML SYRUP Summary of Product Characteristics Updated 24-Jul-2014 | Concordia International - formerly AMCo 1. Name of the medicinal product Fersamal 140mg/5ml Syrup Ferrous fumarate 140mg/5ml Syrup 2. Qualitative and quantitative composition Each 5ml of syrup contains approximately 140mg ferrous fumarate BP (45mg elemental iron). 3. Pharmaceutical form Syrup 4. Clinical particulars 4.1 Therapeutic indications Prophylaxis and treatment of iron deficiency states. For prophylaxis during pregnancy, a combination of iron and folic acid is usually recommended. 4.2 Posology and method of administration Each 5 ml of Fersamal syrup contains 140 mg Ferrous Fumarate which approximates to 45 mg of elemental iron - section 2 SmPC. For oral administration Prevention of iron deficiency: Adults and elderly: Fersamal syrup one 5 ml spoonful twice a day. Children: 6-24 months of age: 12.5mg/day 2-5 years of age: 20-30mg/day 6-11 years of age: 30-60mg/day Older children: 60mg/day Premature infants: 5mg elemental iron per day. Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed.Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established. Treatment of iron deficiency: Adults and elderly: Fersamal syrup two 5 ml spoonfuls twice a day Children: Full term infants and children: 3 to 6 mg elemental iron/Kg/day given in 2 to 3 divided doses. Total daily dose should not exceed 180 mg elemental iron. Administration to infants and children should take place under medical advice. Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process. 4.3 Contraindications Known hypersensitivity to any of the ingredients of the product. Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, 阅读完整的文件