Normal Human Immunoglobulin - Instructions For Use, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Human immunoglobulin normal

Human immunoglobulin is normal: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Drug interactions
10. Analogs
11. Terms and conditions of storage
12. Terms of dispensing from pharmacies
13. Reviews
14. Price

Latin name: Immunoglobulinum humanum normale

ATX code: J06BA02

Active ingredient: normal human immunoglobulin (immunoglobulin human normal)

Producer: NPO FSUE MZ RF "Microgen" (Russia)

Description and photo update: 2019-13-08

Prices in pharmacies: from 990 rubles.

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Normal human immunoglobulin - an immunological agent.

Release form and composition

Dosage forms of normal human immunoglobulin:

Solution for intramuscular (i / m) administration (in ampoules: 1 ml / 1 dose, in a cardboard box 10 pcs.; 1.5 ml / 1 dose, in a cardboard box 10 pcs. Or in a contour plastic package of 5 or 10 ampoules, in a cardboard box 1 or 2 packs; 3 ml / 2 doses, 10 pcs in a cardboard box; 3 ml / 1 dose, 10 pcs in a cardboard box);
Solution for intravenous (IV) administration (25 or 50 ml in bottles, in a cardboard box 1 bottle);
Solution for infusion (25, 50 or 100 ml in bottles, in a cardboard box 1 bottle).

The active substance is normal human immunoglobulin:

Solution for intramuscular injection: in 1 ml - 100 mg;
Solution for intravenous administration: in 1 ml - 50 mg;
Solution for infusion: 1 ml - 50 mg.

Pharmacological properties

Pharmacodynamics

Normal human immunoglobulin contains approximately 90% of monomeric IgG and a small amount of degradation products fraction, dimeric and polymeric IgG and IgA, as well as IgM in trace concentrations. The IgG subclasses are fractionated in the same way as in human serum.

The preparation contains a wide range of neutralizing and opsonizing antibodies that can fight viruses, bacteria and other pathogens. In patients with primary or secondary immunodeficiency, human normal immunoglobulin replenishes the deficiency of antibodies belonging to the IgG class, which reduces the risk of developing infectious diseases.

Pharmacokinetics

After intravenous infusion, normal human Immunoglobulin is redistributed between the extravascular space and blood plasma, and the equilibrium state is reached in about 7 days.

The substance crosses the placental and blood-brain barriers, and is also determined in breast milk. The half-life of immunoglobulin is 21 days. In patients with primary hypogammaglobulinemia (agammaglobulinemia), it increases to 32 days.

Indications for use

The use of normal human immunoglobulin is shown:

Solution for i / m administration: for the treatment of agamma and hypoglobulinemia; for the prevention of: whooping cough, measles, hepatitis A, meningococcal infection, influenza, poliomyelitis; to increase the body's resistance to infectious diseases during the period of convalescence;
Solution for IV administration: therapy of severe forms of viral and bacterial infections; with postoperative complications in adults and children associated with septicemia;
Solution for infusion: idiopathic thrombocytopenic purpura (especially in acute forms in children), treatment and prevention of infectious diseases, immunodeficiency congenital conditions (partial, complete or variable immunodeficiency, severe forms of combined immunodeficiency, Wiskott-Aldrich syndrome), as well as acquired immunodeficiency as a result of bone marrow transplantation and other types of transplantation, with chronic lymphocytic leukemia, with AIDS in children, Kawasaki syndrome (as concomitant therapy with acetylsalicylic acid).

Contraindications

According to the instructions, normal human immunoglobulin in the form of solutions for intramuscular and intravenous administration is contraindicated in the following cases:

A history of severe allergic reactions to the administration of blood products;
Allergic diseases, including bronchial asthma, atopic dermatitis, recurrent urticaria, as well as a history of allergic reactions (patients in this category may be administered the drug with the simultaneous use of antihistamines, which continue to be administered for 3 days with i / m and 8 with / in the introduction of immunoglobulin);
Systemic immunopathological diseases, including nephritis, diseases of the blood, connective tissue (if it is necessary to use immunoglobulin, the introduction should be made only after consultation with the appropriate specialist and against the background of the appointment of concomitant therapy).

Do not use a solution for intramuscular administration in infants at the same time as calcium gluconate.

The use of the solution for infusion is contraindicated in patients with selective deficiency of immunoglobulin A (IgA) in the presence of antibodies against IgA and with hypersensitivity to the drug.

The solution for infusion should be prescribed with caution during pregnancy and breastfeeding.

Instructions for the use of normal human immunoglobulin: method and dosage

The solution for intramuscular injections is injected into the outer surface of the thigh or the upper outer quadrant of the gluteus muscle (intravenous administration of the drug is prohibited!) Do not store the drug in an opened ampoule, use ampoules with broken labeling or tightness, if the color of the solution changes, it becomes cloudy or the presence of unbreakable flakes, if the storage conditions are violated and the expiration date has expired. Within 2 hours before administration, ampoules with the drug should be kept at room temperature. The procedure is carried out in compliance with the rules of antiseptics and asepsis. The solution is drawn into a syringe with a wide-bore needle to prevent the formation of foam. The dose and frequency of administration of immunoglobulin are prescribed by the doctor based on clinical indications.

Recommended dosage of normal human immunoglobulin for prevention:

Hepatitis A: once, for children from 1 to 6 years old at a dose of 0.75 ml, up to 10 years old - 1.5 ml, for patients over 10 years old - 3 ml (if necessary, repeated administration is possible only after 2 months);
Measles prophylaxis: once, the dose for children depends on the time elapsed since contact with the patient and the child's condition, and can be 1.5 or 3 ml, in case of contact with mixed infections - 3 ml, for adults - 3 ml (shown to patients from the age of 3 months, who did not have measles and was not vaccinated against it, no later than 6 days from the moment of contact with the patient);
Prevention of whooping cough: for children who are not sick and not vaccinated or not fully vaccinated against whooping cough - 3 ml twice with a break of 24 hours for the shortest time, but not later than 3 days from the moment of contact with the patient;
Prevention of meningococcal infection: once, for children from 6 months to 3 years at a dose of 1.5 ml, from 3 to 7 years - 3 ml, within the first 7 days after contact with a patient with generalized meningococcal infection;
Prevention of poliomyelitis: once in doses of 3-6 ml, children who are not fully or not vaccinated with poliomyelitis vaccine, at an earlier date after contact with a patient with poliomyelitis;
For the treatment and prevention of influenza, the solution is administered once: children under 2 years old at a dose of 1.5 ml, from 2 to 7 years old - 3 ml, patients over 7 years old - 4.5-6 ml, with a severe form of the disease, it is shown again (after 24 -48 hours) administration of a dose of the drug;
In the treatment of agamma and hypoglobulinemia, the appointment is made in a dose of 1 ml per 1 kg of the patient's weight (it can be administered in 2-3 doses with a break of 24 hours). Carrying out subsequent prescriptions of the drug according to indications is possible only after 1 month;
To increase the body's resistance in chronic pneumonia and during the period of convalescence with a protracted course of acute infectious diseases, the introduction of a single dose of 0.15-0.2 ml per 1 kg of patient weight is indicated. The frequency of administration is prescribed by the doctor, but no more than 4 injections with an interval of 2-3 days.

The solution for intravenous administration is diluted immediately before use with 0.9% sodium chloride solution with isotonic or 5% glucose solution in a ratio of 1: 4. The prepared solution of immunoglobulin is injected intravenously at a rate of 8-10 drops per minute, daily for 3-5 days. Without additional dilution, immunoglobulin can be injected intravenously at a rate of 30-40 drops per minute, the course of treatment is 3-10 transfusions, carried out with an interval of 24-72 hours. This method of administration can cause the patient to collapse. Transfusion therapy can be combined with other drugs. A single dose for children is 3-4 ml per 1 kg of body weight (but not more than 25 ml), for adults - 25-50 ml. The use of the drug should be carried out only in stationary conditions in compliance with the rules of asepsis. Before the introduction, it is necessary to keep the bottles with the drug for 2 hours at room temperature. Solutions containing sediment or cloudy should not be used.

The solution for infusion is administered by intravenous drip, it is recommended to warm the drug to body temperature or room temperature before use. You can enter only a clear solution. The initial infusion rate is 30 drops per minute, after 10 minutes the rate is adjusted to 40 drops per minute. Apply:

Substitution therapy for congenital and secondary immunodeficiency, including children with AIDS: 2-8 ml per 1 kg of patient weight 1 time per month until the level of immunoglobulin increases (in the absence of sufficient dynamics of growth in the level or a very rapid decrease in it, the intervals between administration should be shortened or increase the dose to 16 ml per 1 kg of body weight);
With allogeneic bone marrow transplantation, the patient is prescribed 10 ml per 1 kg of body weight for 7 days;
With Kawasaki syndrome - 32-40 ml per 1 kg of body weight for 2-5 days, or 40 ml per 1 kg - once;
With idiopathic thrombocytopenic purpura - 16-20 ml per 1 kg of body weight, once (if necessary, it can be repeated after 2-3 days), or 8 ml per 1 kg of patient's weight for 2-5 days (if necessary, the course can be repeated);
For severe viral and bacterial infections, including sepsis - 8-10 ml per 1 kg of body weight, daily for 1 to 4 days;
For premature babies (with low birth weight), for the prevention of infections, the administration of the drug is prescribed with a break of 1-2 weeks, 10-20 ml per 1 kg of the infant's weight;
For chronic inflammatory demyelinating neuropathy, Guillain-Barré syndrome: 8 ml per 1 kg of body weight for 5 days (it is allowed to repeat the course with an interval of 4 weeks);
Patients with cerebral ischemia and ischemic heart disease: 8 ml per 1 kg, daily.

Side effects

Reactions to intramuscular and intravenous administration of immunoglobulin are usually absent.

In some cases, the development of allergic reactions of various types up to anaphylactic shock is possible. Therefore, after administration of the drug, patients should be under the supervision of medical personnel for 30 minutes; the room where the drug is administered must be provided with anti-shock therapy means.

In rare cases, with intramuscular injection, local reactions can develop in the form of hyperemia and an increase in temperature during the first day up to 37.5 ° C.

With infusion, side effects may develop in the form of chills, headaches, nausea, fever, vomiting, back pain, joint aches, and allergic reactions. Rarely - a decrease in blood pressure, in isolated cases - symptoms of aseptic meningitis (nausea, severe headache, vomiting, stiff neck muscles, fever, photosensitivity and impaired consciousness), anaphylactic shock, aggravation of existing renal dysfunction.

Overdose

Cases of an overdose of normal human immunoglobulin have not been described at the moment. If too high doses are introduced into the body, symptomatic therapy is recommended.

special instructions

Normal human immunoglobulin should be used only as directed by a physician.

Each procedure is registered in the established registration forms indicating the date of issue, batch number, manufacturer, expiration date, date of administration and dose, and the nature of the patient's reaction to drug administration.

After the introduction of immunoglobulin, vaccinations against mumps and measles should be carried out no earlier than 3 months later. After vaccination against these diseases, immunoglobulin can be administered no earlier than 2 weeks later. If it is necessary to use immunoglobulin earlier than the specified period, the vaccination should be repeated. All other vaccinations are allowed at any time, regardless of the time of drug administration.

Normal human immunoglobulin can cause false positive serological test results.

The recommended infusion rate must not be exceeded, as this can cause the development of severe side effects. The entire period of infusion and 20 minutes after it, the patient should be under medical supervision.

Drug interactions

Clinically significant drug interactions of the solution for intramuscular or intravenous administration have not been established.

Solution for infusion reduces the activity of attenuated live vaccines against rubella, measles, chickenpox, mumps. If it is necessary to administer immunoglobulin during the first 2 weeks after vaccination against mumps, measles or rubella, vaccination against these diseases must be repeated after 3 months. The infusion solution can only be mixed with 0.9% sodium chloride solution.

Analogs

Analogues of normal human immunoglobulin are: Intratect, Intraglobin, Gamimun N, Gamunex, Immunovenin, Pentaglobin, Gabriglobin, Endobulin.

Terms and conditions of storage

Store at 2 to 8 ° C, do not freeze. Keep out of the reach of children.

Shelf life: solution for intramuscular injection - 2 years, solution for intravenous administration - 1 year.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of normal human immunoglobulin

According to reviews, Human Immunoglobulin is normal when administered both intramuscularly and intravenously, it is considered a fairly effective drug. However, serious side effects associated with its use are often mentioned. Among them, cases of malaise, weakness, chills are often reported.

Many pregnant women believe that even with vital indications, it is not worth taking the risk and undergoing treatment with normal human immunoglobulin. However, doctors say that with strict control of the patient's condition, such therapy will not do harm.

The price of human immunoglobulin is normal

The price for normal human immunoglobulin in the form of a solution for intramuscular administration is approximately 948–1168 rubles (the package includes 10 ampoules of 1.5 ml). The solution for intravenous administration will cost 2947–3523 rubles (for a 25 ml bottle) or 5708 rubles (for a 50 ml bottle). The cost of the solution for infusion ranges from 2897 to 3181 rubles (for a 25 ml bottle).

Human immunoglobulin normal: prices in online pharmacies

Drug name

Price

Pharmacy

Human immunoglobulin normal 1.5 ml / dose solution for intramuscular administration 1.5 ml 10 pcs.

990 RUB

Buy

Human immunoglobulin normal solution for intravenous administration 25 ml 1 pc.

3667 RUB

Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!