Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92800, Puteaux, France
NORMOSANG 25 mg/ml, concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. NORMOSANG is a dark coloured concentrate for solution for infusion. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Hemin |
Hemin arginate is indicated for hepatic porphyria (intermittent acute porphyria, porphyria variegata and hereditary coproporphyria). Hemin, by contributing to the re-establishment of normal levels of haemoproteins and of respiratory pigments, corrects the biological disorders observed in patients with porphyria. |
| List of Excipients |
|---|
|
Arginine |
10 ml of solution in ampoule (type I glass) - pack of 4.
Recordati Rare Diseases, Immeuble “Le Wilson”, 70 avenue du Général de Gaulle, F-92800, Puteaux, France
PL 15266/0008 (UK)
PA 0928/001/001 (Ireland)
Date of latest renewal: 5 May 2019
| Drug | Countries | |
|---|---|---|
| NORMOSANG | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Malta, Netherlands, Romania, United Kingdom, South Africa |
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