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Manufacturers: IMMUNO-GEM, CJSC (Russia)
Active ingredients
- Normal human immunoglobulin
Disease class
- Not indicated. See instructions
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Immunostimulating
- Compensating for the deficiency of IgG antibodies
Pharmacological group
- Immunoglobulins
Solution for infusion Gabriglobin-IgG (Gabreglobine)
Instructions for medical use of the drug
Description of pharmacological action
Increases the level of antibodies in the body. With intravenous infusion, bioavailability is 100%. Redistribution of the drug occurs between the plasma and the extravascular space, and equilibrium is reached after approximately 7 days. In individuals with normal serum IgG levels, the biological half-life averages 21 days, while in patients with primary hypo- or agammaglobulinemia it is 32 days. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of missing IgG antibodies, which reduces the risk of infection.
Indications for use
Replacement therapy for the prevention of infections in primary immunodeficiency syndromes: agammaglobulinemia, common variable immunodeficiencies associated with a- or hypogammaglobulinemia; deficiency of IgG subclasses, replacement therapy to prevent infections in secondary immunodeficiency syndrome caused by chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to treatment with acetylsalicylic acid), severe bacterial infections, including sepsis (in combinations with antibiotics) and viral infections, prevention of infections in premature infants with low birth weight (less than 1500 g), Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, autoimmune neutropenia, partial red cell aplasia of hematopoiesis, thrombocytopenia of immune origin, incl. h. post-transfusion purpura, isoimmune thrombocytopenia of newborns, hemophilia caused by the formation of antibodies to coagulation factors, myasthenia gravis, prevention and treatment of infections during therapy with cytostatics and immunosuppressants, prevention of recurrent miscarriage.
Release form
solution for infusion; bottle (bottle) 25 ml cardboard pack 1; solution for infusion; bottle (bottle) 50 ml cardboard pack 1.
Pharmacodynamics
Human Ig contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. Replenishes missing IgG antibodies, reduces the risk of developing infections in patients with primary and secondary immunodeficiency.
Pharmacokinetics
With intravenous infusion, bioavailability is 100%. Redistribution of the drug occurs between the plasma and the extravascular space, and equilibrium is reached after approximately 7 days. In individuals with normal serum IgG levels, the biological half-life averages 21 days, while in patients with primary hypo- or agammaglobulinemia it is 32 days. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of missing IgG antibodies, which reduces the risk of infection.
Contraindications for use
During the first day after administration of the drug, a slight increase in body temperature and allergic reactions are possible. Sometimes headache, dizziness, dyspepsia, arterial hypo- or hypertension, tachycardia, shortness of breath occur. In extremely rare cases, with individual intolerance, anaphylactic reactions may develop. Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.
Side effects
Headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, shortness of breath, feeling of constriction or pain in the chest, allergic reactions; rarely - severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, fatigue, malaise, back pain, myalgia, numbness, hot flashes or a feeling of cold.
Directions for use and doses
V/m. Prevention of measles. From 3 months of age who have not had measles and have not been vaccinated, no later than 4 days after contact with a sick person: children - 1.5 or 3 ml (depending on health status and time since contact), adults - 3 ml once. Prevention of polio. For children who are unvaccinated or have not completed the full course of vaccination, as soon as possible after contact with a patient with paralytic polio - 3-6 ml once. Prevention of hepatitis A. Children 1-6 years old - 0.75 ml, 7-10 years old - 1.5 ml, over 10 years old and adults - 3 ml once; re-administration according to indications no earlier than after 2 months. Prevention and treatment of influenza. Children under 2 years old - 1.5 ml, 2-7 years old - 3 ml, over 7 years old and adults - 4.5-6 ml once. In severe forms of influenza, repeated administration is indicated after 24-48 hours. Prevention of whooping cough. For children who have not had whooping cough - 3 ml twice with an interval of 24 hours. Prevention of meningococcal infection. Children from 6 months to 7 years, no later than 7 days after contact with a patient with a generalized form of infection (regardless of the serogroup of the pathogen) - 1 ml (up to 3 years inclusive) or 3 ml (over 3 years). IV. Children are administered 3-4 ml/kg (no more than 25 ml) intravenously, at a rate of 8-10 drops/min daily, for 3-5 days. Immediately before administration, dilute with 0.9% NaCl solution or 5% dextrose solution. Adults are administered undiluted drug 25-50 ml intravenously, at a rate of up to 40 drops/min. The course of treatment consists of 3-10 infusions, given every 1-3 days. For primary immunodeficiency - 200-400 mg/kg (4-8 ml/kg) once a month, if necessary - 2 times a month. For idiopathic thrombocytopenic purpura - 400 mg/kg 1 time per day, if there is no adequate effect after 5 days and periodically as necessary, an additional dose in the same amount can be administered. For Kawasaki disease (as an auxiliary therapy) - 2 g/kg, once, with simultaneous administration of ASA - 100 mg/kg, daily until body temperature decreases, then - 3-5 mg/kg for 6-8 weeks at no violations of the coronary arteries.
Overdose
No data.
Interactions with other drugs
Transfusion therapy with intravenous immunoglobulin can be combined with other drugs, in particular antibiotics. The introduction of immunoglobulins can weaken (for 1.5-3 months) the effect of live vaccines against viral diseases such as measles, rubella, mumps and chicken pox (vaccinations with these vaccines should be carried out no earlier than 3 months later). After the administration of large doses of immunoglobulin, its effect can last in some cases up to one year. Do not use simultaneously with calcium gluconate in infants.
Special instructions for use
For persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis), the drug should be administered against the background of appropriate therapy. Immunoglobulin passes into breast milk and may help transfer protective antibodies to the newborn. After administration of the drug, the patient's condition should be monitored for at least 30 minutes. Antishock therapy must be available in the room where the drug is administered. When anaphylactoid reactions develop, antihistamines, glucocorticosteroids and adrenergic agonists are used. A temporary increase in the level of antibodies in the patient’s blood after the administration of immunoglobulin can cause false positive results of serological tests. The rate of intravenous administration should not be exceeded due to the possibility of developing collaptoid reactions.
Storage conditions
Store in a dry place, protected from light, at a temperature of 2 to 10° C. Transportation is carried out by any type of covered transport at a temperature of 2 to 10° C.
Best before date
24 months
ATX classification:
J Antimicrobials for systemic use
J06 Immune sera and immunoglobulins
J06B Immunoglobulins
J06BA Immunoglobulin normal human
J06BA02 Immunoglobulin normal human, for intravascular administration
Buy Gabriglobin IgG (human immunoglobulin normal) solution d/inf 50ml in pharmacies
Gabriglobin Buy Gabriglobin in pharmacies Gabriglobin in the medicine directory DOSAGE FORMS lyophilized powder for the preparation of intravenous solution 2.5g
MANUFACTURERS Ivanovo Regional Blood Transfusion Station (Russia)
GROUP Immunoglobulins
COMPOSITION Active ingredient: Normal human immunoglobulin.
INTERNATIONAL NON-PROPENTED NAME Human immunoglobulin normal
PHARMACOLOGICAL ACTION Immunostimulating. Increases the level of antibodies in the body. With intravenous infusion, bioavailability is 100%. Redistribution of the drug occurs between the plasma and the extravascular space, and equilibrium is reached after approximately 7 days. In individuals with normal serum IgG levels, the biological half-life averages 21 days, while in patients with primary hypo- or agammaglobulinemia it is 32 days. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replenishment of missing IgG antibodies, which reduces the risk of infection.
INDICATIONS FOR USE Replacement therapy for the prevention of infections in primary immunodeficiency syndromes: agammaglobulinemia, common variable immunodeficiencies associated with a- or hypogammaglobulinemia; deficiency of IgG subclasses, replacement therapy to prevent infections in secondary immunodeficiency syndrome caused by chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to treatment with acetylsalicylic acid), severe bacterial infections, including sepsis (in combinations with antibiotics) and viral infections, prevention of infections in premature infants with low birth weight (less than 1500 g), Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy, autoimmune neutropenia, partial red cell aplasia of hematopoiesis, thrombocytopenia of immune origin, incl. h. post-transfusion purpura, isoimmune thrombocytopenia of newborns, hemophilia caused by the formation of antibodies to coagulation factors, myasthenia gravis, prevention and treatment of infections during therapy with cytostatics and immunosuppressants, prevention of recurrent miscarriage.
CONTRAINDICATIONS During the first day after administration of the drug, a slight increase in body temperature and allergic reactions are possible. Sometimes headache, dizziness, dyspeptic symptoms, arterial hypo- or hypertension, tachycardia, and shortness of breath occur. In extremely rare cases, due to individual intolerance, anaphylactic reactions may develop. Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.
SIDE EFFECTS Headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, arterial hypo- or hypertension, tachycardia, cyanosis, shortness of breath, feeling of constriction or pain in the chest, allergic reactions; rarely - severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, fatigue, malaise, back pain, myalgia, numbness, hot flashes or a feeling of cold.
INTERACTION Transfusion therapy with intravenous immunoglobulin can be combined with other drugs, in particular antibiotics. The introduction of immunoglobulins can weaken (for 1.5-3 months) the effect of live vaccines against viral diseases such as measles, rubella, mumps and chicken pox (vaccinations with these vaccines should be carried out no earlier than 3 months later). After the administration of large doses of immunoglobulin, its effect can last in some cases up to one year. Do not use simultaneously with calcium gluconate in infants.
METHOD OF APPLICATION AND DOSAGE Intravenously, drip at a rate of 30-40 drops per minute. The dosage regimen is set individually depending on the indications, the severity of the disease, the state of the immune system, and individual tolerance. Immunoglobulin immediately before administration is dissolved in water for injection in the volume indicated on the label. Typically, a single dose of the drug is 0.05-0.2 g/kg body weight (2.5-10 g). The course of treatment consists of 3-10 transfusions, performed every 24 hours (depending on the severity of the disease). For systemic connective tissue diseases (systemic lupus erythematosus, vasculitis, etc.), the drug is administered in doses of 0.2 - 0.4 g/kg body weight per day daily for 3-10 days. For agamma- and hypogammaglobulinemia, the drug is administered in such doses to compensate for the deficiency of circulating IgG, controlling the level of serum immunoglobulins. Courses of treatment are repeated after 2-3 months. In some cases, in severe septicotoxemic conditions, the daily dose of the drug can be increased to 1 g/kg body weight. Immunoglobulin for intravenous administration is used only in a hospital setting, subject to all aseptic rules.
OVERDOSE No data available.
SPECIAL INSTRUCTIONS For persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis), the drug should be administered against the background of appropriate therapy. Immunoglobulin passes into breast milk and may help transfer protective antibodies to the newborn. After administration of the drug, the patient's condition should be monitored for at least 30 minutes. Antishock therapy must be available in the room where the drug is administered. When anaphylactoid reactions develop, antihistamines, glucocorticosteroids and adrenergic agonists are used. A temporary increase in the level of antibodies in the patient’s blood after the administration of immunoglobulin can cause false positive results of serological tests. The rate of intravenous administration should not be exceeded due to the possibility of developing collaptoid reactions.
STORAGE CONDITIONS At a temperature of 2-8 °C. In the refrigerator (not recommended to freeze).
Similar drugs:
- Gabriglobin (Gabreglobine) Lyophilisate for the preparation of solution for infusion
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