Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Haem arginate
Recordati Rare Diseases UK Ltd
n/a
Haem arginate
25mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09080200; GTIN: 3663502000649
OBJECT 1 NORMOSANG Summary of Product Characteristics Updated 26-Sep-2017 | Orphan Europe (UK) Limited 1. Name of the medicinal product NORMOSANG 25 mg/ml, concentrate for solution for infusion. 2. Qualitative and quantitative composition Human hemin ...........................................................................................................................25 mg/ml. One ampoule of 10 ml contains 250 mg of human hemin. After dilution of one 10 ml ampoule in 100 ml of 0.9% Na Cl solution, the diluted solution contains 2273 micrograms per ml of human hemin. Excipient with known effect: ethanol 96% (1 g / 10 ml) (see section 4.4). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion. NORMOSANG is a dark coloured concentrate for solution for infusion. 4. Clinical particulars 4.1 Therapeutic indications Treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria). 4.2 Posology and method of administration Posology The recommended daily dose is 3 mg/kg once daily for four days, diluted in 100 ml of 0.9% sodium chloride in a glass bottle and infused intravenously over at least 30 minutes into a large antebrachial or central vein using an inline filter. The dose should not exceed 250 mg (1 ampoule) per day. Exceptionally, the course of the treatment may be repeated under strict biochemical surveillance if there is inadequate response after the first course of treatment. _Elderly patients_ No dose adjustment is required. _Children and adolescents_ Attacks of porphyria are rare in children but limited experience in tyrosinaemia suggests that it is safe to use a dose of not more than 3 mg/kg daily for 4 days, administered with the same precautions as for adults. Method of administration The infusions should be administered in a large antebrachial or central vein over a period of at least 30 minutes. After the infusion, the vein should be rinsed with 100 ml of 0.9 % NaCl. It is recommended Olvassa el a teljes dokumentumot