Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Normosang 25 mg/ml, concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Human hemin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 take it
e 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.
- As a result of NORMOSANG infusions, abdominal pain and other gastro-intestinal symptoms generally disappear within 2 – 4 days. Neurological complications (paralysis and psychological disorders) are less affected by the treatment.
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- You will be monitored during the whole course of the treatment, because porphyria attacks are often associated with various effects on the heart and circulation, and on the nervous system.
- Do not: make sudden changes to your normal diet, in particular, do not stop eating for long periods take drugs or substances such as oestrogens (e.g. oral contraceptives), barbiturates (drugs which help you to sleep and drugs sometimes used to treat epilepsy) or steroids (body hormone-like drugs), because this can bring on an attack or make the attack worse. Please ask your doctor or pharmacist for advice on the drugs and substances you should not take (now and in the future).
- To prevent vein irritation, the solution will be administered by infusion in a large vein (blood vessel) of your arm or in a vein in your chest over a period of at least 30 minutes. After the infusion, the vein shall be rinsed with a saline solution.
- A blood clot (known as a 'venous thrombosis') can block the vein used for infusion.
- If your cannula is in place for long time, vascular damage may occur and could lead to an unintended migration of NORMOSANG outside the vein (extravasation). This migration may cause a skin discolouration.
- In order to diminish the risk of extravasation, the nurse/doctor will test your cannula before the infusion and will check it regularly during the infusion.
- The infused solution can give your blood an unusual colour.
- To limit the risk of iron compound increase, NORMOSANG should not be used as a preventive treatment of the acute attacks.
- Human hemin contains iron. It can sometimes happen that iron builds up in the body after several years of treatment with repeated infusions of NORMOSANG. Your doctor may perform blood tests from time to time to check the level of iron in your body.
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations for specific markers of infections and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
- The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. It is strongly recommended that every time that NORMOSANG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product Other medicines and NORMOSANG Do not take drugs or substances such as oestrogens (e.g. oral contraceptives), barbiturates (drugs which help you to sleep and drugs sometimes used to treat epilepsy) or steroids (body hormone-like drugs), because they can bring on an attack or make the attack worse. Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding It is not known if there is a risk in using the medicine during pregnancy. However, mothers treated with have delivered normal babies.
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When you are pregnant, ask your doctor for advice before NORMOSANG is administered to you. Your doctor will only prescribe the medicine when absolutely necessary. NORMOSANG has not been studied during breast-feeding. However, since a lot of drugs are passed into the breast-milk, you should inform your doctor when you are breast-feeding and ask for advice before NORMOSANG is administered to you. Your doctor will only prescribe NORMOSANG treatment when absolutely necessary, or may advise you to stop breast-feeding. NORMOSANG contains ethanol (alcohol). This should be taken into account if you are pregnant or breast feeding women. See heading "Important information about some of the ingredients of NORMOSANG". Driving and using machines Your medicine should not affect your ability to drive or to use machines. Important information about some of the ingredients of NORMOSANG NORMOSANG contains 11.78 vol. % ethanol (alcohol), i.e. up to 1000 mg per daily dose (one ampoule), equivalent to 23.6ml beer or 9.8ml wine per daily dose. This can be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease, or epilepsy. Ask your doctor for advice before NORMOSANG is administered to you, if you suffer from one of the above conditions. 3.
How to take it
NORMOSANG
The medicine will only be administered to you in a hospital setting by qualified hospital personnel. The dose to be administered will be calculated from your body weight and is about 3 mg per kg of body weight per day, but not more than 250 mg (1 ampoule) per day. This calculated amount will be diluted with a saline solution (0.9 % sodium chloride) in a glass bottle and this will form a dark coloured solution. The solution will be administered by infusion in a large vein (blood vessel) of your arm or in a vein in your chest over a period of at least 30 minutes. The infused solution can give your blood an unusual colour. After the infusion, the vein shall be rinsed with a saline solution. Usually, you will receive one infusion per day during four days. If after this first course of treatment the symptoms are not relieved, your doctor can decide exceptionally to start a second course of treatment. If you have received more NORMOSANG than it should If you have received more NORMOSANG than you should have, your doctor will treat you to prevent harmful effects. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare (may affect up to 1 in 1,000 people):
- Fever and serious allergic reactions (rash, tongue swelling) including anaphylactoid reaction may rarely occur.
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Anaphylactoid reactions are sudden and potentially life-threatening reactions that may rarely occur. If you suffer symptoms such as facial oedema, dyspnoea, tightness in the chest, tachycardia, low blood pressure, urticaria, spontaneous loss of consciousness (caused by insufficient blood to the brain), the infusion must be stopped and the doctor must be contacted immediately. Very common (may affect more than 1 in 10 people):
- After repeated treatments, access to veins in your arm may become difficult, which may mean that a tube needs to be placed in a chest vein. Common (may affect up to 1 in 10 people):
- If administered in too small a vein, pain and inflammation can be caused. Uncommon (may affect up to 1 in 100 people):
- The amount of an iron compound (called ferritin) may increase in the blood following repeated treatments over several years. To limit the risk of iron compound increase, NORMOSANG should not be used as a preventive treatment of the acute attacks. Frequency not known (frequency cannot be estimated from the available data):
- Headache.
- Venous thrombosis (clots formation in the peripheral or central veins) including injection site thrombosis.
- Leakage of the infusion to the surrounding tissue (extravasation).
- Skin damage (necrosis).
- Skin redness on the site of injection (injection site erythema).
- Skin itching on the site of injection (injection site pruritus).
- Increase in the blood level of creatinine (substance excreted by the kidneys).
- Skin discoloration. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Website: www.hpra.ie By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
NORMOSANG
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Keep the ampoule in the outer carton in order to protect from light. After dilution, the solution should be used within 1 hour. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 4
throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What NORMOSANG contains The active substance is human hemin (25 mg/ml). 10 ml ampoule contains 250 mg of human hemin. After dilution of one 10 ml ampoule in 100 ml of 0.9 % NaCl solution, the diluted solution contains 2273 micrograms per ml of human hemin. The other ingredients are arginine, ethanol (96 %), propylene glycol and water for injections. What NORMOSANG looks like and contents of the pack NORMOSANG is presented as a Concentrate for solution for infusion (10 ml in ampoule – pack size of 4). NORMOSANG is a dark coloured solution even after dilution of the concentrate for solution for infusion. Marketing Authorisation Holder Recordati Rare Diseases Tour Hekla 52 avenue du Général de Gaulle F-92800 Puteaux France Manufacturer Recordati Rare Diseases Tour Hekla 52 avenue du Général de Gaulle F-92800 Puteaux France Or Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France This medicinal product is authorised in the Member States of the EEA under the following names: Normosang – Austria / Belgium / Cyprus / Czech Republic / Denmark / Estonia / Finland / France / Germany / Greece / Hungary / Iceland / Ireland / Italy / Latvia / Lithuania / Luxembourg / Malta / Netherland / Norway / Portugal / Spain / Sweden / Slovenia / Slovakia / United Kingdom Human Hemin Orphan Europe – Poland
This leaflet was last revised in 19/11/2024
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Frequently asked questions about Normosang 25 mg/ml, concentrate for solution for infusion
How do I take Normosang 25 mg/ml, concentrate for solution for infusion?
Normosang 25 mg/ml, concentrate for solution for infusion comes as infusion containing 25mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Normosang 25 mg/ml, concentrate for solution for infusion?
The active substance in Normosang 25 mg/ml, concentrate for solution for infusion is human hemin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Normosang 25 mg/ml, concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Normosang 25 mg/ml, concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: human hemin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 to flush the vein initially with 3 to 4 bolus injections of 10 ml 0.9 % NaCl after which the remaining volume of saline can be infused for 10 - 15 minutes.
For instructions for the preparation of the solution, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
• Before treatment is started, it is necessary to confirm an attack of hepatic porphyria by series of clinical and biological criteria:
- suggestive family or personal history,
- suggestive clinical signs,
- quantitative determination of urinary delta-amino-laevulinic acid and porphobilinogen (in preference to the classical WATSON-SCHWARZ or HOESCH tests, which are considered to be less reliable).
• The sooner NORMOSANG treatment is started after the onset of an attack, the greater its efficacy.
• As a result of NORMOSANG infusions, abdominal pain and other gastro-intestinal symptoms generally disappear within 2 - 4 days. Neurological complications (paralysis and psychological disorders) are less affected by the treatment.
• As porphyric attacks are often associated with various cardiovascular and neurological manifestations, appropriate monitoring should be ensured.
• It is also important to warn patients of the risk of attacks being worsened or triggered by fasting or taking certain medicinal products (particularly oestrogens, barbiturates and steroids), because by increasing the haem demand of the liver they are capable of indirectly inducing the delta-aminolaevulinic acid synthase activity.
• As the diluted solution is hypertonic, it should be administered by very slow intravenous infusion only.
To prevent vein irritation, the infusion should be administered in at least 30 minutes in a large vein of the forearm or in a central vein.
• Venous thrombosis in the vein used for infusion may potentially occur following repeated administration of NORMOSANG. There are few cases describing thrombosis at the caval vessels and their major tributaries (iliac and subclavian veins). The risk of thrombosis at the caval vessels cannot be excluded.
• Peripheral venous alterations have been reported after repeated infusions and can prevent the use of the affected veins for further infusions, necessitating the use of a central venous line. It is therefore recommended to rinse the vein with 100 ml of 0.9 % NaCl after the infusion.
• If intravenous cannula is in place for too long, due to mechanical irritation and also due to irritation by the injection fluid, vascular damage may occur which may lead to extravasation.
• Test the cannula before infusing NORMOSANG and also check it regularly during the infusion.
• In case of extravasation, skin discoloration may occur.
• Increased serum ferritin concentrations have been reported after repeated infusions. It is therefore recommended that serum ferritin be measured at regular intervals to monitor body iron stores. If necessary other investigation methods and therapeutic measures should be undertaken.
• The dark NORMOSANG colour may give the plasma an unusual colouring.
• Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations for specific markers of infections and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
• The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.
• It is strongly recommended that every time that NORMOSANG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
• NORMOSANG contains 1 g of ethanol (96 %) per ampoule of 10 ml. This may be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant woman and children. The ethanol content of NORMOSANG may modify or increase the effect of other medicines.
• NORMOSANG should not be used as a preventive treatment since available data is too limited and long term administration of regular infusions carries the risk of iron overload (see section 4.8. Undesirable effects).
• In addition to treatment with NORMOSANG and other necessary measures such as the elimination of triggering factors, ensuring a sufficient supply of carbohydrates is recommended.
4.5. Interaction with other medicinal products and other forms of interaction
During treatment with NORMOSANG the enzyme activity of the P450 enzymes increases. The metabolism of concomitantly administered drugs that are metabolised by cytochrome P450 enzymes (such as oestrogens, barbiturates and steroids) may increase during administration of NORMOSANG, leading to lower systemic exposure.
4.6. Fertility, pregnancy and lactation
Pregnancy
In the absence of specific experimental and clinical data, the risks during pregnancy are not defined; to date, however, no after-effects have been observed in new-born babies whose mothers were treated with NORMOSANG during their pregnancy.
Breast-feeding
NORMOSANG has not been studied during breast-feeding. However, since numerous substances are excreted in breast milk, it is appropriate to be cautious when administering NORMOSANG during lactation.
Due to limited data the use of NORMOSANG can not be recommended unless clearly necessary during pregnancy and breast-feeding.
4.7. Effects on ability to drive and use machines
There is no evidence to suggest that NORMOSANG affects adversely the ability to drive or use machines.
4.8. Undesirable effects
The most commonly reported ADRs are infusion site reactions especially occurring if infusion takes place into veins which are too small (see section 4.4. Special warnings and precautions for use).
Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Rare: anaphylactoid reaction, hypersensitivity (such as dermatitis medicamentosa and tongue oedema).
Nervous system disorders:
Not known: headache.
Vascular disorders
Very common: Poor venous access.
Not known: Injection site thrombosis, venous thrombosis
General disorders and administration site conditions
Common: infusion site phlebitis, Infusion site pain, infusion site swelling,
Rare: Pyrexia.
Not known: injection site erythema, injection site pruritus, extravasation, injection site necrosis
Investigations
Uncommon: Serum ferritin increased.
Not known: blood creatinine increase
Increased serum ferritin concentrations have been reported after several years of treatment with repeated infusions, which may indicate an iron overload (see section 4.4. Special warnings and precautions for use).
Skin disorders
Not known: skin discoloration
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In animal experiments with NORMOSANG the acute toxic effects after high dosage were directed to the liver. Ten times higher total doses than the recommended human posology also decreased blood pressure in rats. High doses may cause disturbances in hemostasis.
NORMOSANG contains 4000 mg of propylene glycol (per ampoule of 10 ml). Propylene glycol in high doses may cause central nervous system side-effects, lactic acidosis, kidney and liver toxicity, increase in plasma osmolarity, and haemolytic reactions.
Cases of overdosage with Normosang have been reported. For example, one patient had slight vomiting, pain and tenderness over the forearm (at the site of infusion) and made uneventful recovery. One other patient who received 10 ampoules of Normosang (2500 mg of human hemin) in a single infusion developed fulminant hepatic failure and one patient with a medical history of chronic hepatic failure who received 4 ampoules of Normosang (1000 mg of human hemin) experienced acute liver failure requiring liver transplantation. One patient received 12 ampoules of Normosang (3000 mg of human hemin) over 2 days which resulted in hyperbilirubinemia, anemia and a generalised haemorrhagic diathesis. The effects lasted for several days after administration, but the patient then improved without consequences.
Also, a high dose (1000 mg) of haematin, another form of haem, has been reported to have caused transitory renal failure in one patient.
Blood coagulation parameters, hepatic, renal and pancreatic functions should be carefully monitored until their normalisation.
Cardiovascular monitoring should also be performed (possibility of arrythmias).
Therapeutic measures
- Albumin infusions should be administered to fix the freely-circulating and potentially reactive hemin.
- The administration of activated charcoal will enable the enterohepatic recirculation of the haem to be interrupted.
- Haemodialysis is necessary to eliminate the propylene glycol.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Human Hemin Orphan EuropeHeminum humanum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
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Ask anything about Normosang 25 mg/ml, concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.