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Normosang

  • Brand Name – Normosang
  • Active Ingredient – Human Hemin
  • Packaging – 4 Ampules of 250 mg/10ml each in Single Pack
  • Strength – One ampoule of 10 ml contains 250 mg human hemin
  • Originator Name/Marketing-authorisation Holder – Recordati Rare Diseases 

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What Normosang is and what it is used for?

Normosang contains human hemin, which is a substance derived from Human blood, It is used for the treatment of patients with acute attacks of hepatic porphyria.

Normosang for three main Hepatic Porphyria :

1. Acute Intermittent Porphyria

2. Porphyria variegata

3. Hereditary coproporphyria

Symptoms of Hepatic porphyria are Pain (mainly abdomen, back and thighs), Nausea, Vomiting, Constipation.

For more details read Prescribing Information

Dosage
  • Before taking the dosage of Normosang consult the doctor for the proper dosage and acknowledge the doctor about the patient’s medical history and allergic reactions.
  • The standard strength of this human hemin injection is 250 mg. It is administered to the patient in the hospital by a healthcare professional.
  • The dose of medicine will be according to the patient’s body weight. The dosage of Normosang is about 3 mg per kg of body weight per day, do not take more than 250 mg ampoule every day. Dilute the calculated amount with a saline solution (0.9 % sodium chloride). It will result in a dark coloured solution.
  • The solution will be administered by injecting the Normosang 250 mg ampoule in a large vein of a blood vessel of the patient’s arm or a vein in the patient’s chest for at least 30 minutes. The injected solution can give a patient’s blood an unusual colour.
  • After injecting, one shall rinse the vein with a saline solution.
  • Generally, the patient is given an infusion every day for four days.
  • Even after the first course of treatment, if the symptoms are not relieved, the doctor may decide to start a second course of the treatment.
Side effects

There are numerous side effects of Normosang injection. These side effects are categorized as:
Very common
After continuous treatments, access to veins in the patient’s arm may become difficult, which may mean the need of placing a tube in a chest vein.
Common
If administered in too small amount in a vein, pain and inflammation could happen.
Uncommon
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.
Less frequent

  • 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

Rare
Fever and serious allergic reactions, 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, the infusion must be stopped and the doctor must be contacted immediately.
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.

NOTE: It is not necessary for every patient to experience the above-mentioned side effects. If the patient experiences any kind of common or severe side-effects, health professionals will treat the symptoms simultaneously.

Precautions and Warnings
  • It is essential to confirm an attack of hepatic porphyria by medical history or clinical check-ups run by the doctor.
  • The sooner treatment with this medicine is started after an attack, the greater its efficacy.
  • Abdominal pain and other gastrointestinal symptoms usually disappear within 2 – 4 days after Normosang infusion. Neurological complications like paralysis and psychological problems are less affected by the treatment.
  • Doctors should monitor the patient appropriately as porphyric attacks are often associated with various cardiovascular and neurological manifestations.
  • It is essential to acknowledge the patient the risk of attacks being worsened or triggered by fasting or taking certain medicinal products such as oestrogens, steroids etc. Because by increasing the haem demand of the liver, they can indirectly induce the delta-aminolevulinic acid synthase activity.
  • As the diluted solution is hypertonic, administer it slowly intravenously. To prevent vein irritation, administer the infusion in at least 30 minutes in a large forearm vein or a central vein.
    Venous thrombosis in the vein used for injecting may occur after taking Normosang. There are some cases describing thrombosis at the caval vessels and the major tributaries. The risk of thrombosis at caval vessels cannot be unseen.There are reports on Peripheral venous alterations after repeated infusions and can prevent the use of the affected veins for further infusions, necessitating a central venous line. Healthcare professionals advise rinsing the vein with 100 ml of 0.9 % NaCl after the injecting medicine.
  • Suppose an intravenous cannula is in place for very long. Due to mechanical irritation and irritation by the injection fluid, vascular damage may occur, which may lead to extravasation.
    Test the cannula before infusion and also check it regularly during infusion.
  • In case of extravasation, skin discoloration can occur.
  • After continuous infusions, there are reports of increased serum ferritin concentrations. Therefore, Professionals recommend measuring serum ferritin at regular intervals to monitor body iron stores; doctors should take necessary other investigation methods and therapeutic measures.
  • Standard measures to prevent infections resulting from using medicinal products prepared from human blood or plasma include selecting donors, screening of individual donations for specific markers of disorders, and the inclusion of effective manufacturing steps for the inactivation or removal of viruses. In spite of this, when medicinal products are administered, prepared from human blood/plasma, one cannot exclude the possibility of transmitting infective agents, unknown or emerging viruses, and other pathogens.
  • The measures taken are considered adequate for viruses such as HIV, HBV, and HCV.
  • Professionals advise that while administering Normosang to any patient, the name and batch number of the product are recorded. It is to maintain a link between patients and the batch of the product.
  • Normosang contains 1 g of ethanol (96 %) per 10 ml ampoule. Ethanol can be harmful to those suffering from liver disease, alcoholism, epilepsy, brain injury or illness, pregnant women, and children.
  • Do not use Normosang as a preventive treatment since available data is too limited, and long-term administration of regular infusions carries the risk of iron overload.
  • In addition to treatment with Normosang injection and other necessary measures such as eliminating triggering factors, ensure a sufficient supply of carbohydrates.
How Supplied/Storage and Handling:
  • Store in a refrigerator (2C – 8C). To protect it from light, keep the ampoule in the outer carton.
    After dilution, use the solution within 1 hour.
  • Do not throw away any medicines through wastewater or household waste. Ask the pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
  • One should not use the medicine after the expiry date, stated on the ampoule label and carton after expiry. The expiry date means the last day of the month.
  • Keep the medicine out of sight and reach of children.

Frequently asked questions (FAQs)

Normosang is a dark coloured concentrate solution for infusion. It is approved to treat acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria).

Normosang’s active ingredient is human hemin. Inactive ingredients are arginine, ethanol, propylene glycol and water for injections.

The solution will be administered by injecting the Normosang in a large vein of a blood vessel of the patient’s arm or a vein in the patient’s chest for at least 30 minutes for 4 days.

Ikris Pharma Network  is an authorized partner of “Recordati”, and can help in accessing this medicine in India for the patient through legal procedure. For more information contact Ikris at toll-free no. 18008891064 or write at info@ikrispharmanetwork.com.

In India you can buy Normosang by contacting Ikris Pharma Network , an authorised partner of “Recordati” for Normosang medicine.