Patient leaflet - Normosang 25 mg / ml concentrate for solution for infusion
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.
- 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.
- 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.
migration of NORMOSANG outside the vein (extravasation). This migration may cause a skin discolouration.
- To limit the risk of iron compound increase, NORMOSANG should not be used as a preventive treatment
- 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
It is strongly recommended that every time that NORMOSANG is administered to a patient, the name
Other medicines and NORMOSANG
Do not take drugs or substances such as oestrogens (e.g. oral contraceptives), barbiturates (drugs which
Pregnancy and breast-feeding
When you are pregnant, ask your doctor for advice before NORMOSANG is administered to you. Your
NORMOSANG has not been studied during breast-feeding. However, since a lot of drugs are passed into
NORMOSANG is administered to you. Your doctor will only prescribe NORMOSANG treatment when
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
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),
Ask your doctor for advice before NORMOSANG is administered to you, if you suffer from one of the above
3. HOW TO USE NORMOSANG
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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.
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 the national reporting system listed in Appendix. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE 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 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 / Manufacturer
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 /