Human normal immunoglobuline (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

J06BA01 (Normal human immunoglobulin for intramuscular administration)

Active Substance

Human normal immunoglobulin (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

Human normal immunoglobulin contains IgG antibodies present in healthy individuals. The preparation is produced from human blood plasma obtained from no fewer than 1000 donors. The distribution of immunoglobulin G subclasses in the preparation is closely proportional to their distribution in native human blood plasma. Adequate doses of human normal immunoglobulin can restore abnormally low immunoglobulin G levels to the normal range.

The mechanism of action for indications other than replacement therapy is not fully understood but includes an immunomodulatory effect.

Pharmacokinetics

C_max of antibodies in the blood is reached after 24 hours, T_1/2 of antibodies from the body is 4-5 weeks.

Indications

Prevention of hepatitis A, measles, influenza, whooping cough, meningococcal infection, poliomyelitis;
Treatment of hypo- and agammaglobulinemia;
To increase body resistance during the convalescence period of infectious diseases.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A37	Whooping cough
A39	Meningococcal infection
A80	Acute poliomyelitis
B05	Measles
B15	Acute hepatitis A
D80	Immunodeficiencies with predominant antibody deficiency
J10	Influenza due to identified seasonal influenza virus
Z29.1	Prophylactic immunotherapy (administration of immunoglobulin)

ICD-11 code	Indication
1C12.Z	Whooping cough, unspecified
1C1C.Z	Meningococcal disease, unspecified
1C81	Acute poliomyelitis
1E30	Influenza due to identified seasonal influenza virus
1E50.0	Acute hepatitis A
1F03	Measles
4A01.0Z	Immunodeficiencies with predominant antibody deficiency, unspecified
QC05.1	Prophylactic immunotherapy

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

The immunoglobulin is administered intramuscularly into the upper outer quadrant of the gluteal muscle or the outer surface of the thigh. Intravenous administration of the preparation is prohibited. Before injection, the ampoules with the preparation should be kept for 2 hours at room temperature.

Ampoule opening and the administration procedure are carried out with strict adherence to the rules of asepsis and antisepsis. To avoid foam formation, the preparation is drawn into the syringe with a needle having a wide lumen.

The preparation in an opened ampoule must not be stored. The preparation is unsuitable for use in ampoules with compromised integrity or labeling, if physical properties have changed (color change, solution turbidity, presence of non-dispersible flakes), if the expiration date has passed, or if storage conditions have not been observed.

The dose of immunoglobulin and the frequency of its administration depend on the indications for use.

Prevention of hepatitis A

The preparation is administered once in doses: children from 1 to 6 years – 0.75 ml, up to 10 years – 1.5 ml, over 10 years and adults – 3 ml. Repeated administration of immunoglobulin, if necessary for hepatitis A prevention, is indicated no earlier than 2 months later.

Prevention of measles

The preparation is administered once from 3 months of age to individuals who have not had measles and are not vaccinated against the infection, no later than 6 days after contact with a patient. The dose of the preparation for children (1.5 or 3 ml) is determined based on health status and the time elapsed since contact. For adults, as well as for children in contact with mixed infections, the preparation is administered in a dose of 3 ml.

Prevention and treatment of influenza

The preparation is administered once in doses: children under 2 years – 1.5 ml, from 2 to 7 years – 3 ml, over 7 years and adults – 4.5-6 ml. For the treatment of severe forms of influenza, repeated (after 24-48 hours) administration of immunoglobulin in the same dose is indicated.

Prevention of whooping cough

The preparation is administered twice with a 24-hour interval in a single dose of 3 ml to children who have not had whooping cough and are not vaccinated (or not fully vaccinated) against whooping cough, as early as possible after contact with a patient, but no later than 3 days.

Prevention of meningococcal infection

The preparation is administered once to children aged from 6 months to 7 years no later than 7 days after contact with a patient with a generalized form of meningococcal infection in doses of 1.5 ml (children under 3 years) and 3 ml (children over 3 years).

Prevention of poliomyelitis

The preparation is administered once in doses of 3-6 ml to children not vaccinated or inadequately vaccinated with poliomyelitis vaccine as early as possible after contact with a poliomyelitis patient.

Treatment of hypo- and agammaglobulinemia

The preparation is administered at a dose of 1 ml per 1 kg of body weight; the calculated dose can be administered in 2-3 doses with a 24-hour interval. Subsequent administrations of immunoglobulin are carried out as indicated no earlier than 1 month later.

Increasing body resistance during the convalescence period of acute infectious diseases with a protracted course and in chronic pneumonia.

The preparation is administered in a single dose of 0.15-0.2 ml per 1 kg of body weight. The frequency of administration (up to 4 injections) is determined by the doctor; the intervals between injections are 2-3 days.

Adverse Reactions

Upon administration, the following are possible: headache, dizziness, migraine pain, abdominal pain, increase or decrease in blood pressure, tachycardia, cyanosis, chills, shortness of breath, chest pain. In rare cases, reactions may develop in the form of hyperemia and an increase in body temperature to 37.5°C (99.5°F) during the first day after administration, as well as dyspeptic phenomena.

In some individuals with altered reactivity, allergic reactions of various types may develop, and in exceptional cases, anaphylactic shock.

Rarely – pronounced decrease in blood pressure, collapse, loss of consciousness, increased sweating, feeling of fatigue, malaise, back pain, myalgia, numbness, feeling of heat or cold, aseptic meningitis, acute renal tubular necrosis.

Contraindications

Allergic reactions or severe systemic reactions to human blood products in the medical history.

In cases of severe sepsis, the only contraindication for immunoglobulin administration is a history of anaphylactic shock to human blood products.

With caution in severe heart failure, diabetes mellitus, renal failure.

Use in Pregnancy and Lactation

During pregnancy or breastfeeding, use for vital indications, weighing the benefit for the mother against the risk to the fetus.

Immunoglobulin passes into breast milk and may contribute to the transfer of protective antibodies to the newborn.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

Can be used in children as indicated.

In infants, do not use together with calcium gluconate.

Special Precautions

For individuals suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, administration of antihistamines is recommended on the day of immunoglobulin administration and for the subsequent 8 days. During an exacerbation of the allergic process, administration of the preparation is carried out based on the conclusion of an allergist.

For individuals suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis, etc.), the preparation should be administered against the background of appropriate therapy.

A temporary increase in the content of administered antibodies in the patient’s blood after immunoglobulin administration may cause false-positive results in serological tests.

Information on the possible effect of the medicinal product on the ability to drive vehicles and operate machinery.

Administration of the preparation does not lead to psychomotor impairments and does not affect the ability to drive vehicles and other machinery.

Overdose

No cases of overdose have been observed.

Drug Interactions

Immunoglobulin therapy can be combined with other medicinal products, in particular, antibiotics.

In infants, do not use together with calcium gluconate.

Immunoglobulin should be administered no earlier than 3 months after immunization with live viral vaccines against measles, rubella, mumps, and chickenpox.

Storage Conditions

In a dry place, protected from light, at a temperature of 2 to 10°C (50°F). Keep out of reach of children.

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The preparation is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Human normal immunoglobuline [Vologda Regional Blood Transfusion Station No. 1 State Healthcare Institution (Russia)]
Solution for intramuscular administration 1 dose/3 ml: amp. 10 pcs.

Marketing Authorization Holder

Vologda Regional Blood Transfusion Station No. 1 State Healthcare Institution (Russia)

Dosage Form

Human normal immunoglobulin

Solution for intramuscular administration 1 dose/3 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration	1 dose
Human normal immunoglobulin	3 ml

1 dose (3 ml) – ampoules (10) – cardboard packs.

Human normal immunoglobuline [DALIOMFARMA, LLC (Republic of Belarus)]
Solution for infusion 50 mg/ml: 20 ml or 50 ml fl. 1 pc.
Solution for infusion 100 mg/ml: 20 ml or 50 ml fl. 1 pc.

Marketing Authorization Holder

DALIOMFARMA, LLC (Republic of Belarus)

Manufactured By

Belarusian-Dutch Joint Venture "FARMLAND", LLC (Republic of Belarus)

Dosage Forms

	Human normal immunoglobuline	Solution for infusion 50 mg/ml: 20 ml or 50 ml fl. 1 pc.
		Solution for infusion 100 mg/ml: 20 ml or 50 ml fl. 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion transparent or slightly opalescent, colorless or light yellow in color.

	1 ml
Human plasma proteins*, of which immunoglobulin G not less than 95%	50 mg

Excipients : glycine, water for injections, sodium hydroxide solution, hydrochloric acid solution 0.5M.

* accompanying plasma protein – maximum IgA content – 0.2 mg/ml

20 ml – glass bottles with a volume of 20 ml (1) – cardboard packs.
50 ml – glass bottles with a volume of 50 ml (1) – cardboard packs.

Solution for infusion transparent or slightly opalescent, colorless or light yellow in color.

	1 ml
Human plasma proteins*, of which immunoglobulin G not less than 95%	100 mg

Excipients : glycine, water for injections, sodium hydroxide solution, hydrochloric acid solution 0.5M.

Solution for intramuscular administration	1 dose	1 amp. (2 doses)
Human normal immunoglobulin	1.5 ml	3 ml

3 ml – ampoules (10) – cardboard packs.

Human normal immunoglobuline [Microgen NPO, JSC (Russia)]
Solution for intramuscular administration 1.5 ml/1 dose: 5, 10, or 20 amp. pcs.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Manufactured By

Yekaterinburg Bacterial Preparation Production Enterprise (Russia)

Virion NPO (Russia)

Omsk Enterprise For The Production Of Bacterial Preparations (Russia)

Biomed NPO (Russia)

Khabarovsk Enterprise For The Production Of Bacterial Preparations (Russia)

Immunopreparat (Russia)

ImBio Nizhny Novgorod State Enterprise for the Production of Bacterial Preparations (Russia)

Dosage Form

Human normal immunoglobulin

Solution for intramuscular administration 1.5 ml/1 dose: 5, 10, or 20 amp. pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration	1 dose
Human normal immunoglobulin	1.5 ml

1.5 ml – ampoules (10) – cardboard packs.
1.5 ml – ampoules (5) – plastic contour packs (1) – cardboard packs.
1.5 ml – ampoules (5) – plastic contour packs (2) – cardboard packs.
1.5 ml – ampoules (10) – plastic contour packs (1) – cardboard packs.
1.5 ml – ampoules (10) – plastic contour packs (2) – cardboard packs.

Human normal immunoglobuline [Microgen NPO, JSC (Russia)]
Solution for infusion 50 mg/1 ml: 25 ml or 50 ml vial 1 pc.

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

Dosage Form

Human normal immunoglobulin

Solution for infusion 50 mg/1 ml: 25 ml or 50 ml vial 1 pc.

Dosage Form, Packaging, and Composition

Solution for intravenous administration	1 ml
Human normal immunoglobulin	50 mg

25 ml – bottles (1) – carton packs.
50 ml – bottles (1) – carton packs.

Human normal immunoglobuline [Samara Regional Clinical Blood Transfusion Station (Russia)]
Solution for intramuscular injection 3 ml/2 doses: amp. 10 pcs.

Marketing Authorization Holder

Samara Regional Clinical Blood Transfusion Station (Russia)

Dosage Form

Human normal immunoglobulin

Solution for intramuscular injection 3 ml/2 doses: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration	1 dose
Human normal immunoglobulin	1.5 ml

3 ml (2 doses) – ampoules (10) – carton packs.

Human normal immunoglobuline [Sverdlovsk Regional Blood Transfusion Station State Healthcare Institution (Russia)]
Solution for intramuscular injection 1 dose/1 ml: amp. 10 pcs.

Marketing Authorization Holder

Sverdlovsk Regional Blood Transfusion Station State Healthcare Institution (Russia)

Dosage Form

Human normal immunoglobulin

Solution for intramuscular injection 1 dose/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration	1 dose
Human normal immunoglobulin	1 ml

Solution for intramuscular administration	1 dose
Human normal immunoglobulin	1.5 ml

1.5 ml (1 dose) – ampoules (10) – carton packs.
3 ml (2 doses) – ampoules (10) – carton packs.

Human normal immunoglobuline [Tambov Regional Blood Transfusion Station (Russia)]
Solution for intramuscular administration 100 mg/ml: 3 ml amp. 10 pcs.

Marketing Authorization Holder

Tambov Regional Blood Transfusion Station (Russia)

Dosage Form

Human normal immunoglobulin

Solution for intramuscular administration 100 mg/ml: 3 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration	1 ml	1 amp.
Human normal immunoglobulin	100 mg	300 mg

Excipients: glycine 60 mg, sodium chloride 27 mg, water for injection up to 3 ml.

3 ml – ampoules (10) – carton packs.

Human normal immunoglobuline [Chelyabinsk Regional Blood Transfusion Station SUE (Russia)]
Solution for intramuscular injection 1.5 ml/dose: amp. 10 pcs.
Solution for intramuscular injection 3 ml/2 doses: amp. 10 pcs.

Marketing Authorization Holder

Chelyabinsk Regional Blood Transfusion Station SUE (Russia)

Dosage Forms

	Human normal immunoglobulin	Solution for intramuscular injection 1.5 ml/dose: amp. 10 pcs.
		Solution for intramuscular injection 3 ml/2 doses: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration in the form of a transparent or slightly opalescent liquid, colorless or slightly yellow in color; during storage, the appearance of a slight white precipitate is allowed, which completely disappears when shaking the preparation.