Država: Malta
Jezik: angleščina
Source: Medicines Authority
HUMAN HEMIN
Recordati Rare Disease Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800 Puteaux, France
B06AB
HUMAN HEMIN 25 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
HUMAN HEMIN 25 mg/ml
POM
OTHER HEMATOLOGICAL AGENTS
Authorised
2006-11-10
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER NORMOSANG 25 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION Human hemin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NORMOSANG is and what it is used for 2. What you need to know before you use NORMOSANG 3. How to use NORMOSANG 4. Possible side effects 5. How to store NORMOSANG 6. Contents of the pack and other information 1. WHAT NORMOSANG IS AND WHAT IT IS USED FOR NORMOSANG contains human hemin, which is a substance derived from human blood. NORMOSANG is used to treat sudden attacks that occur in patients suffering from acute hepatic porphyria; the disease is characterized by liver accumulation of compounds (including porphyrins and its toxic precursors). There are three types of hepatic porphyria whose medical names are: acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. This accumulation leads to symptoms of the disease including pain (mainly abdomen, back and thighs), nausea, vomiting and constipation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORMOSANG DO NOT USE NORMOSANG: - if you are allergic to human hemin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Before treatment with NORMOSANG, your doctor should confirm an attack of hepatic porphyria by series of clinical and biological criteria : suggestive family or personal history; suggestive clinical signs; quantitative determination of delta-amino-laevulinic acid and porphobilinogen (specific markers of the disease) in urines. The sooner NORMOSANG treatment is started after the onset of an attack, the greater its efficacy. Page 2 of 6 As a Preberite celoten dokument
Page 1 of 8 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. Page 2 of 8 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 to flush the vein initially with 3 to 4 bolus injections of 10 ml 0.9 % NaCl Preberite celoten dokument