Normosang 25 mg/ml, concentrate for solution for infusion

• 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.

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

• if you are allergic to human hemin or any of the other ingredients of this medicine (listed in section 6).

• 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.
• 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

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.

It is not known if there is a risk in using the medicine during pregnancy. However, mothers treated with have delivered normal babies.

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”.

Your medicine should not affect your ability to drive or to use machines.

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.

If you have received more NORMOSANG than you should have, your doctor will treat you to prevent harmful 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

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

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.

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