Immunoglobulin human normal intramuscular efficacy. Contraindications for use, side effects and overdose of normal human immunoglobulin. Indications and contraindications for the use of human immunoglobulin
Biaven V.I.; Venoglobulin; Wigam (Wigam-liquid, Wigam-S); Gabriglobin; Gabriglobin-IgG; Gamma Globulin; Gamimun N; Gamunex; I.G. Vienna N.I.V.; Imbiogam; Imbioglobulin; Immun Inject; Immunovenin; Immunoglobulin; Immunoglobulin G; Antirotavirus immunoglobulin; Immunoglobulin antistaphylococcal; ; Human immunoglobulin normal; Intraglobin; Intratekt; Octagam; Pentaglobin; Sandoglobulin; Humaglobin; Endobulin.
normal human immunoglobulin- Immunostimulating and immunomodulatory agent. Effectively opsonizes microorganisms and neutralizes toxins. Replenishes missing IgG antibodies, which reduces the risk of infection in patients with primary and secondary immunodeficiencies. It is used to replace and replenish natural antibodies in the patient's serum: agammaglobulinemia and hypogammaglobulinemia, deficiency of IgG subclasses, severe combined immunodeficiencies, chronic lymphocytic leukemia, myeloma, AIDS. As a means for immunomodulation and suppression of inflammation: idiopathic thrombocytopenic purpura, Kawasaki syndrome. It is used in combined treatment for severe infections of bacterial and viral origin, sepsis, iatrogenic immunodeficiency, bacterial meningitis, Guillain-Barré syndrome, demyelinating polyneuropathy, autoimmune neutropenia, anemia, thrombocytopenia, hemophilia, myasthenia gravis; for the prevention of opportunistic infections, infections in premature infants and children with low birth weight.
Active active ingredient:
Immunoglobulin human normal / Immunoglobulin human normal / Immunoglobulin human normal / Immunoglobulin humanum normale.
Dosage forms:
Solution for intravenous infusion (lyophilisate for solution preparation).
Solution for i / m injections.
normal human immunoglobulin
Properties / Action:
Normal human immunoglobulin is a polyvalent human immunoglobulin. It has all the properties of immunoglobulin G, found in a healthy population. Prepared from plasma from healthy donors who, on clinical examination, laboratory blood tests, and history, show no evidence of transfusion-transmitted infections or blood-derived products (particularly hepatitis B surface antigen, HIV -1, HIV-2, antibodies against hepatitis C virus, etc.).
The main component of preparations of normal human Immunoglobulin is the immunologically active protein fraction of human blood serum. About 95-96% of the total protein is represented by immunoglobulin G (IgG). According to the distribution of IgG subclasses, normal human immunoglobulin is close to the plasma of a healthy person. Normal human immunoglobulin contains small amounts of immunoglobulin M (IgM) and immunoglobulin A (IgA). Immunoglobulin solution is a colorless or light yellow, clear or slightly opalescent solution; lyophilisate - white porous hygroscopic mass.
Normal human immunoglobulin is an immunostimulating agent. Immunoglobulin has a wide range of opsonizing and neutralizing properties of antibodies against bacteria, viruses and other pathogens of infectious diseases. In patients suffering from primary or secondary immunodeficiency syndromes, Immunoglobulin ensures that the missing IgG antibodies are replenished, which reduces the risk of infection. When used in adequate doses, it is possible to restore a pathologically low level of IgG to normal.
Human normal immunoglobulin also has nonspecific and immunoregulatory activity, manifested in an increase in the body's resistance and anti-inflammatory action. In some disorders of immune function, such as idiopathic (immune origin) thrombocytopenic purpura (ITP) and Kawasaki syndrome, the mechanism of action that provides the positive effects of immunoglobulin G remains unclear.
The introduction of Immunoglobulin G to pregnant women at risk of premature birth reduces infant mortality and the risk of infection.
Pharmacokinetics:
With IV infusion, the bioavailability of Normal Human Immunoglobulin is 100%. Immunoglobulin G is relatively rapidly distributed between plasma and extravascular fluid. After 3-7 days, equilibrium is reached between the vascular and extravascular systems. The biological half-life of Immunoglobulin G averages 21-34 days. There are significant individual variations in T1 / 2 values, which may be important in determining the dose regimen for a particular patient. Individuals with normal serum IgG have a shorter biological half-life; in patients with primary hypoglobulinemia or agammaglobulinemia - longer. Immunoglobulins and immunoglobulin complexes are utilized by cells of the reticuloendothelial system.
Indications:
The indication for the use of normal human immunoglobulin is the clinical feasibility of replacing / replenishing natural antibodies in the patient's serum. The application has been tested in the following cases:
For replacement therapy to prevent infections in patients with primary immunodeficiency syndromes:
As replacement therapy for the prevention of infections in patients with secondary immunodeficiency syndrome with hypogammaglobulinemia and repeated infections:
As a means for immunomodulation and suppression of inflammation:
As a result of the studies, the positive effects of normal human immunoglobulin were found in the following conditions:
Dosage and administration:
Human normal immunoglobulin is used only as prescribed by a doctor and only in compliance with all asepsis rules. Immunoglobulins for intramuscular administration are strictly prohibited to be administered intravenously.
Immunoglobulin for intravenous administration (for infusions):
Normal human immunoglobulin is administered by slow intravenous drip infusion (over 15-30 minutes). The concentration in the solution for intravenous infusion can vary from 3 to 12% depending on the volume used. The lyophilized preparation can be dissolved in the supplied solvent or 0.9% sodium chloride a solution (isotonic solution). Avoid shaking the vial, which leads to foaming. The drug should completely dissolve within 10-12 minutes. Before administration, the solution must be warmed to body temperature. The drug should be examined for the presence of particles; you can use only a clear solution. After preparing the solution, the infusion should be carried out immediately. Immunoglobulin solution should be administered through a system with a filter; a separate dropper should always be used for administration. Partially used vials should be discarded.
Dosage regimens used for various indications depend on the state of the patient's immune system, the severity of the disease and individual tolerance.
A single dose of Immunoglobulin is 0.05-0.2 g / kg of body weight (2.5-10 g). In some cases, in severe septic-toxic conditions, the daily dose of Immunoglobulin may be increased to 1 g/kg of body weight. The course of treatment consists of 3-10 transfusions performed every 24 hours (depending on the severity of the disease).
Patients receiving immunoglobulin treatment for the first time should be given as a 3% solution, with an initial infusion rate of 0.5 to 1.0 ml/min (approximately 10 to 20 drops/min). If there are no side effects within the first 15 minutes, the infusion rate can be gradually increased to 2.5 ml/min (approximately 50 drops/min). Faster administration may cause the development of a collaptoid reaction.
Patients who regularly receive and tolerate immunoglobulin can be given higher concentrations (up to a maximum of 12%), however, the infusion should always be started at a slow rate and the patient's condition should be carefully monitored, increasing the concentration gradually.
There are no universal rules for the use of immunoglobulin, and the following are only advisory in nature:
Syndromes of primary immunodeficiency: 0.2 to 0.8 g/kg body weight (most commonly 0.4 g/kg) at intervals of 2 to 4 weeks to achieve maintenance of trough plasma IgG levels of at least 5 g/L ( achieved within 3-6 months from the start of treatment). Treatment courses are repeated after 2-3 months.
Syndromes of secondary immunodeficiency: 0.2 to 0.8 g/kg body weight at intervals of 2 to 4 weeks.
At prevention of infections in patients undergoing bone marrow allotransplantation, the recommended dose is 0.5 g/kg. It can be administered once for 7 days before transplantation and then repeated once a week for the first three months after transplantation and once a month for the next 9 months.
Idiopathic (immune origin) thrombocytopenic purpura (ITP): for initial treatment, a dose of 0.4 g/kg administered on 5 consecutive days, or 0.4 to 1 g/kg once or on two consecutive days, is used. If necessary, 0.4 g/kg can be further administered at intervals of 1 to 4 weeks to maintain a sufficient level of platelets.
Kawasaki Syndrome: 0.6 to 2.0 g/kg in divided doses over 2-5 days, usually as an adjunct to standard treatment with acetylsalicylic acid preparations.
Severe infections of bacterial origin (including sepsis) and viral infections: 0.4 to 1.0 g/kg daily for 1-4 days.
Infection prevention in low birth weight preterm infants: 0.5 to 1.0 g/kg at intervals of 1 to 2 weeks.
Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy: 0.4 g/kg for 5 consecutive days, repeated at 4 week intervals as needed.
At systemic connective tissue diseases (systemic lupus erythematosus, vasculitis, etc.) the drug is administered in doses of 0.2-0.4 g/kg of body weight per day daily for 3-10 days.
Transfusion therapy with intravenous immunoglobulin can be combined with other drugs, antibiotics, cytokines, bacteriophages.
Immunoglobulin for intramuscular administration:
Human normal immunoglobulin is administered intramuscularly, into the upper outer quadrant of the gluteal muscle or into the outer surface of the thigh, the dose and frequency of administration depend on the indications.
Measles Prevention: from 3 months without measles and unvaccinated, no later than 4 days after contact with the patient: children - 1.5 or 3 ml (depending on the state of health and time since contact), adults - 3 ml once.
Prevention of poliomyelitis: unvaccinated or not fully vaccinated children, as soon as possible after contact with a patient with a paralytic form of poliomyelitis - 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; repeated introduction according to indications not earlier than in 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.
Whooping cough prevention: children without 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).
Overdose:
Symptoms: with / in the introduction are possible: hypervolemia, increased blood viscosity (especially in patients with impaired renal function or in the elderly).
Contraindications:
In cases of severe sepsis, the only contraindication to immunoglobulin administration is a history of anaphylactic shock to blood products.
Normal human immunoglobulin is used with caution:
Use during pregnancy and lactation:
Studies on the effect of immunoglobulin on reproductive function have not been conducted, experience in pregnant women is limited. Although no fetal or reproductive adverse reactions have been reported, normal human immunoglobulin should be used in pregnant women only when clearly indicated.
Normal human immunoglobulin should be used with caution during lactation (breastfeeding). Immunoglobulins pass into breast milk and may facilitate the transfer of protective antibodies to newborns.
Side effect:
Subject to contraindications, precautions for the use of Immunoglobulin, as well as recommendations regarding dosages and administration, serious side effects in response to administration are rarely noted. Symptoms may appear within a few hours to several days after the infusion of Immunoglobulin and, as a rule, disappear after the end of therapy. Most of the effects are associated with a relatively high infusion rate and can be stopped by reducing it or temporarily suspending the infusion. If side effects persist, appropriate symptomatic therapy is advisable.
Side effects are more likely with the first infusion of Immunoglobulin, shortly after it is started, or during the first 30-60 minutes:
Flu-like syndrome: fever, chills, headache, weakness, malaise.
From the digestive system: nausea, vomiting, abdominal pain, diarrhea, increased salivation.
From the side of the central nervous system: dizziness, weakness, drowsiness; in isolated cases - symptoms of aseptic meningitis (severe headache, nausea, vomiting, fever, stiff neck, photosensitivity, impaired consciousness).
From the side of the cardiovascular system: fluctuations in blood pressure (rarely collapse with loss of consciousness), tachycardia, cyanosis, flushing of the face, a feeling of pressure or pain in the chest.
From the respiratory system: dry cough, rarely - shortness of breath.
From the side of the kidneys: in isolated cases - acute necrosis of the renal tubules, aggravation of renal failure in patients with impaired renal function (with an increase in serum creatinine, up to anuria).
Allergic reactions: skin rash, itching, bronchospasm; in isolated cases - anaphylactic shock (even if the patient did not show excessive sensitivity during the previous injection).
Local reactions: hyperemia at the site of intramuscular injection.
Other: joint pain, back pain, myalgia, cold sensation, sweating, hiccups.
Special instructions and precautions:
Normal human immunoglobulin is used only on prescription.
The drug and solvent in bottles with impaired integrity, labeling, as well as a change in the color of the drug and solvent, a change in the transparency of the solvent, the presence of flakes, an expired shelf life, and improper storage are not suitable for use. Before administration, it is necessary to visually check whether the solution contains suspended particles. Cloudy or precipitated immunoglobulin solutions should not be used. The contents of opened ampoules or vials should be used immediately; the dissolved or diluted preparation is not subject to storage. Due to the risk of bacterial contamination, any remaining solution should be discarded.
Normal human immunoglobulin can only be mixed with 0.9% sodium chloride solution or with the solvent supplied with the preparation. Other drugs should not be added to the solution, as a change in the electrolyte concentration or pH value may cause protein denaturation or precipitation.
The introduction of the drug is recorded in the established accounting forms indicating the batch number, control number, expiration date, manufacturer, date of administration, dose and nature of the reaction to the administration. Do not exceed the recommended rate of administration of the drug (most side effects are associated with a high rate of infusion). For a more accurate determination of an adequate dose and intervals between injections of normal human immunoglobulin, it is recommended to periodically measure the level of IgG in the patient's blood serum.
During the entire period of infusion and for at least 30 minutes after the end of the infusion, the patient must be under medical supervision. In the room where the drug is administered, anti-shock therapy must be available. In the event of intolerance reactions, it is necessary to either reduce the rate of administration or interrupt it until the symptoms disappear. Severe hypotension, collapse, loss of consciousness, anaphylactic reactions and shock are observed in rare cases. If such reactions develop, treatment should be carried out in accordance with the rules of shock therapy: the infusion should be stopped, administration is indicated.
Normal human immunoglobulin is not administered to persons with a history of allergic reactions to blood products. Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria), or prone to allergic reactions, are administered against the background of antihistamines (erius, xizal, telfast, kestin, zyrtek, etc.). During the period of exacerbation of the allergic process, the introduction of Immunoglobulin is carried out at the conclusion of the allergist.
Patients with agammaglobulinemia or severe hypogammaglobulinemia who have never received immunoglobulin replacement therapy or who have received more than 8 weeks after their last treatment may be at increased risk for anaphylactoid reactions, sometimes leading to anaphylactic shock. In such patients, rapid infusion should be avoided, vital signs should be continuously monitored, and close monitoring should be maintained throughout the entire infusion period. In very rare cases, normal human immunoglobulin can cause a sharp drop in blood pressure associated with clinical signs of anaphylaxis, even in patients who previously tolerated immunoglobulin preparations well.
A transient increase in creatinine levels has been reported after administration of immunoglobulin to several patients with impaired renal function (in patients with diabetes mellitus and systemic lupus erythematosus). In such patients, serum creatinine levels should be monitored for three days after infusion.
In patients with a known tendency to migraine, special care should be taken.
Persons suffering from systemic diseases (diseases of the blood, connective tissue, glomerulonephritis, etc.) and diseases of the immune system, Normal human immunoglobulin should be administered against the background of appropriate therapy and control of the function of the relevant systems.
During pregnancy, Immunoglobulin is administered only under strict indications, when the intended benefit to the mother outweighs the potential risk to the fetus.
After the administration of immunoglobulin, a passive increase in the level of antibodies in the patient's blood (for example, to erythrocyte antigens A, B, or D) may be observed, which can lead to erroneous false-positive interpretation of serological testing results, such as the Coombs test, haptoglobin test, or determination of the number of reticulocytes.
Influence on the ability to drive a car or work with mechanisms:
There is no indication that immunoglobulins can affect the ability to drive or operate machinery.
Drug interaction:
Normal human immunoglobulin should not be mixed with any other drug and should always be infused using a separate drip.
The simultaneous use of Immunoglobulin may reduce the effectiveness of active immunization against viral diseases such as measles, rubella, mumps and chicken pox. Live parenteral vaccines should not be used for at least 30 days (up to 3 months) after the last dose of Immunoglobulin infusion.
Normal human immunoglobulin should not be used concomitantly with calcium gluconate in infants, as there are suspicions that simultaneous use may cause adverse effects.
Storage conditions:
Store at a temperature of 2-10°C, protected from light. Do not freeze!
The expiration date is indicated on the packaging. An expired drug should not be used.
Conditions for dispensing from pharmacies - by prescription.
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 due to chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation, idiopathic thrombocytopenic purpura, Kawasaki syndrome (in addition to treatment with acetylsalicylic acid drugs), 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, neonatal isoimmune thrombocytopenia, 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 Human immunoglobulin normal solution for intramuscular injection 1.5ml/dose 1 dose
During the first days after the administration of the drug, a slight increase in body temperature, allergic reactions are possible. Sometimes there is a headache, dizziness, dyspeptic symptoms, arterial hypo- or hypertension, tachycardia, shortness of breath. In extremely rare cases, with individual intolerance, the development of anaphylactic reactions is possible. Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to the formation of antibodies to it.
Method of administration and dosage Human immunoglobulin normal solution for intramuscular injections 1.5ml/dose 1 dose
In / in, drip. The dosage regimen is set individually, depending on the indications, the severity of the disease, the state of the immune system, and individual tolerance. With primary and secondary immunodeficiency syndromes, a single dose is 0.2-0.8 g / kg (average - 0.4 g / kg); administered at intervals of 2-4 weeks (to maintain minimal levels of IgG in blood plasma, constituting 5 g / l). For the prevention of infections in patients undergoing bone marrow allotransplantation, 0.5 g / kg once 7 days before transplantation, and then 1 time per week for the first 3 months after transplantation, and 1 time per month for the next 9 months. With idiopathic thrombocytopenic purpura - 0.4 g / kg for 5 days in a row; in the future (if necessary) - 0.4 g / kg at intervals of 1-4 weeks to maintain a normal level of platelets. With Kawasaki syndrome - 0.6-2 g / kg in several doses for 2-4 days. In severe bacterial infections (including sepsis) and viral infections - 0.4-1 g / kg daily for 1-4 days. For the prevention of infections in premature infants with low birth weight - 0.5-1 g / kg with an interval of 1-2 weeks. With Guillain-Barré syndrome and chronic inflammatory demyelinating neuropathy - 0.4 g / kg for 5 days; if necessary, 5-day courses of treatment are repeated at intervals of 4 weeks.
The best prevention of a disease is its prevention. The cost of the procedure is negligible compared to the saved health. Especially if the disease is intractable. There are drugs to stimulate the immune natural defenses of the human body.
One of these is normal human immunoglobulin. These instructions for use are given strictly for educational and informative purposes.
Normal human immunoglobulin is a drug based on a natural component of the human body, taken from donor blood fractions. Previously, the blood goes through many stages of purification in order to reduce the presence of possible infections to zero. Therefore, normal human immunoglobulin is an absolutely safe and useful medicine for humans.
Various patient reviews confirm its effectiveness. Even during pregnancy (in rare cases), normal human immunoglobulin is used to inject into a woman's body. During pregnancy, an adapted anti-Rhesus immunoglobulin is used. Let's apply antirhesus in several cases.
Active ingredients
The main active ingredient is human immunoglobulin of normal protein origin. In a very small amount in the composition of water for injection and sodium chloride. Immunoglobulin is well known as an anti-tetanus drug for intramuscular administration. He also acquired other associations - human immunoglobulin against tick-borne encephalitis, measles, problems with the immune system.
But you can not take it as a medicine or vaccine. The drug is intended to strengthen the immune system in the fight against diseases or to develop a strong barrier against them. For example, anti-tetanus barrier. Human immunoglobulin against tick-borne encephalitis is a particularly valuable drug in spring and autumn.
Release form
On sale there is human normal immunoglobulin liquid for intravenous administration, as well as intramuscular immunoglobulin. The price of the drug is affordable, as is the possibility of acquiring human immunoglobulin. However, in domestic medicine, only immunoglobulin is used for intramuscular injection.
Liquid human immunoglobulin normal for intravenous administration is used only in the form of a dropper. You can buy normal human immunoglobulin for intramuscular injection at a pharmacy by prescription. Packaging of the drug in ampoules of 1.5 and 3 ml.
Dosage and course of intramuscular medication
Human normal immunoglobulin has no limited instructions for use. The dose is calculated based on body weight, and the number of injections is based on the severity of the patient's condition. For example, a tetanus injection for a child should not exceed a volume of 25 ml at a time. Or if human immunoglobin against tick-borne encephalitis is given to an adult, then its dose is not higher than 50 ml. The ratio of such a dosage to an injection for any type of ill health.
Indications for use
The use of normal human immunoglobulin for intramuscular injection, as the instructions say, is possible with a number of diseases:
- immune diseases, immunodeficiencies;
- postoperative periods;
- prevention of influenza diseases, measles, whooping cough, meningococci, poliomyelitis, also has an anti-tetanus effect;
- human immunoglobulin against tick-borne encephalitis is also used;
- various infectious diseases, including sepsis;
- blood diseases;
- acquired immunodeficiency syndrome - AIDS, often children's;
- other.
Immunoglobulin for humans, normal for intramuscular injection, is placed in the gluteal muscle. The injection site is the upper lateral square of the buttock. Also, the insertion site is used in the anterior outer part of the thigh.
The use of immunoglobulin during pregnancy and lactation
During pregnancy, human normal immunoglobulin should be used in strictly justified cases. Studies on the reaction of organisms during pregnancy of women have not been conducted. Therefore, it is impossible to convince about the absence of consequences at different stages of pregnancy.
During the period of breastfeeding, it is also worth being treated in a limited mode. Any medical intervention during pregnancy or lactation is best reduced to zero. Nevertheless, it is known that during pregnancy, immunoglobulin is transmitted to the child.
Immunoglobulin antirhesus during pregnancy
When the mother is Rh negative and the child is Rh positive, a serious conflict can arise. The price of which is sometimes very expensive: a miscarriage, for example. Immunoglobulin antirhesus during pregnancy, abortion, forced termination of pregnancy.
The drug immunoglobin antirhesus is useful for prophylaxis during the first pregnancy, when the rhesus of the mother and child are different. The price of such a procedure is affordable for young mothers.
Contraindications
Immunoglobulin antirhesus is contraindicated in persons with hypersensitivity. Human tetanus immunoglobulin for intramuscular injection does not leave side effects. Studies have shown that pathogenic reactions do not occur. Negative reviews and complaints after the introduction of an intramuscular drug were not received.
At the moment, no negative effects of the drug with other drugs for intramuscular injection on the human body have been found.
Conclusion
The price of human health is immeasurable. Therefore, monitor your well-being, do preventive vaccinations, even if you are far from being a child. The price of such methods is low. Use natural medicines that do not harm the health of the chemical composition. Reviews indicate the safety of this drug. Be healthy!
**** Bio Products Laboratories BIOLEK, CJSC BIOMED Biomed named after I.I. Mechnikova, JSC GKhP for the production of biological products YEKATERINBURG ENTERPRISE FOR THE PRODUCTION OF BAKPR Zelenograd immunobiological enterprise, ZA Ivanovo Regional blood transfusion station Ministry of Health and Social Development Omsk Microgen NPO FSUE (Yekaterinburskoye Prospekt for PBP) Microgen NPO FSUE Ministry of Health and Social Development Russia/PharmV MICROGEN NPO FSUE (Stavropol) MICROGEN NPO FSUE (KHABAROVSK PPPBP) Microgen NPO, FSUE of the Ministry of Health of Russia Tomsk Microgen NPO, FSUE Ministry of Health of Russia PERM MICROGEN NPO, Federal State Unitary Enterprise of the Ministry of Health of Russia Ufa MICROGEN NPO, Federal State Unitary Enterprise of the Ministry of Health of Russia Nizhny Novgorod NIIEM them. PASTER OSK, Ivanovo PKF "InterGRIM", CJSC ST. PETERSBURG BANKENTERPRISE Sanofi-Aventis S.A. Sverdl. SEC №2 Sangvis, SPbNIIVS Talekris Biotherapy Inc. Pharma Mediterrania S.L./B.Brown Medical S.A.
Country of origin
Russia UNITED STATES UkraineProduct group
Immunomodulatory drugs and immunosuppressantsMedical immunobiological preparation (MIBP) - globulin
Release forms
- 2 ml (2 doses) - ampoules (10) - cardboard packs. 1 ml (1 dose) - ampoules (10) - cardboard packs. 1.5 ml - ampoules (10) - cardboard packs 25 ml - bottles (1) - cardboard packs. 300 mg - bottles (5) - packs of cardboard. 5 vials. Bottles with a capacity of 25 ml (1) - packs of cardboard. Lyophilisate for solution for oral administration - 5 bottles Solution for intramuscular injection - 10 ampoules per pack. solution for intramuscular injection 300 mcg / ml - 1 ml - 1 ampoule Vials (5) - packs of cardboard.
Description of the dosage form
- Amorphous mass of white or bluish color Lyophilisate for solution for oral administration Transparent or slightly opalescent liquid, colorless or with a slightly yellow color. During storage, a slight precipitate may appear, which disappears after slight shaking. Clear or slightly opalescent liquid, colorless or slightly yellow. A slight precipitate may appear, which disappears on shaking. Solution for intravenous administration Solution for intravenous administration is clear or slightly opalescent, colorless Solution for intramuscular injection Solution for intramuscular injection is transparent or slightly opalescent, colorless or with a slightly yellow color; during storage, the appearance of a slight precipitate, which disappears with slight shaking, is allowed.
pharmachologic effect
Antiseptic intestinal; immunostimulating; restoring microflora; antidiarrheal; Complex immunoglobulin preparation (CIP) is an immunobiological preparation for enteral use. CIP is an immunologically active protein fraction isolated during fractionation of donor blood sera. CIP freeze-dried, has the appearance of a white amorphous mass. A complex immunoglobulin preparation (CIP) has an intestinal antiseptic, immunostimulating, antidiarrheal and microflora restoring effect. The immunobiological properties of CIP are due to the content of three classes of immunoglobulins IgA, IgM and IgG. IgM has a bactericidal effect on pathogenic microorganisms, IgA makes it difficult for them to attach to the epithelium of the mucous membrane, reproduction and ensures rapid removal from the intestine, IgG neutralizes microbial toxins and viruses, mediates the "sticking" of bacteria to macrophages with their subsequent phagocytosis. In addition to removing pathogenic and opportunistic microorganisms from the body, CIP promotes the growth of normal intestinal microflora (bifidobacteria, lactobacilli, enterococci and non-pathogenic Escherichia coli), increases the production of secretory IgA and normalizes altered indicators of systemic immunity.Pharmacokinetics
Immunoglobulins and their fragment, which retained serological activity, are found both in the contents of the large intestine and in coprofiltrates for several days after oral administration of the drug.Special conditions
Precautions for use. Considering the possibility of anaphylactic reactions in particularly sensitive individuals, it is necessary to provide medical observation of patients for 1 hour after the administration of the drug. If symptoms of an allergic reaction appear, appropriate therapy is immediately carried out. The introduction of immunoglobulin is recorded in the established accounting forms indicating the name of the drug, batch number, expiration date, manufacturer, date of administration, dose and nature of the reaction to the administration. Information about the possible effect of the drug on the ability to drive vehicles, mechanisms. The drug does not affect the ability to drive vehicles, mechanisms, as well as activities that require increased concentration of attention and speed of psychomotor reactions. Overdose Cases of overdose are not described.Compound
- 1 dose normal human immunoglobulin 1.5 ml 1 dose human immunoglobulin G with antiallergic activity, at least 97% of the total protein mass Excipients: glycine (stabilizer) 22.5±7.5 mg. 1 dose (ampoule): Active substance: -anti-alphastaphylolysin - not less than 100 IU. Auxiliary substance: - stabilizer - glycine (aminoacetic acid) - (2.25 ± 0.75)%; The drug does not contain preservatives and antibiotics. Immunoglobulin (by protein) 10%, aminoacetic acid 2%, water for injection. normal human immunoglobulin 300 mg, including IgG 50-70% IgM 15-25% IgA 15-25% lyophilized powder for solution for enteral administration, stabilizer - glycine at a concentration of 3% COMPOSITION FOR ONE DOSE Active ingredient Immunoglobulin complex drug (immunoglobulins G, A, M) - 300 mg Auxiliary substance Glycine - 100 mg
Immunoglobulin indications for use
- The drug is used only as directed by a doctor. Human immunoglobulin anti-Rh o (D) is used in Rh-negative women who are not sensitized to the Rh o (D) antigen (i.e., who have not developed Rh antibodies) under the condition of the first pregnancy and the birth of a Rh-positive child whose blood is compatible with maternal blood by ABO blood groups. The drug is used for artificial termination of pregnancy in Rh-negative women, also not sensitized to Rh o (D) antibodies, in the case of Rh-positive blood of the husband.
Immunoglobulin contraindications
- - Immunoglobulin is not administered to persons with a history of allergic reactions to blood products. (In cases of severe sepsis, the only contraindication for administration is a history of anaphylactic shock to blood products); - For persons suffering from allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, the drug is administered against the background of antihistamines. It is recommended to continue their administration within 8 days after the end of the course of treatment. In the period of exacerbation of the allergic process, the introduction of the drug is carried out at the conclusion of the allergist according to vital indications. - For persons suffering from diseases in the genesis of which immunopathological mechanisms are the leading ones (systemic connective tissue diseases, immune blood diseases, glomerulonephritis), the drug is prescribed after consulting an appropriate specialist.
Immunoglobulin dosage
- 300 mg 300 mcg/dose
Immunoglobulin side effects
- In the course of treatment, some patients may experience a slight and short-term exacerbation of the underlying disease, in rare cases, during the first day after administration, local reactions may develop in the form of hyperemia, as well as an increase in temperature to 37 ° C, which is not a reason for stopping the administration of the drug. With the appearance of pronounced general reactions (lowering blood pressure, weakness, nausea, dizziness), as well as a pronounced exacerbation of the underlying disease, treatment with the drug is stopped. Treatment with immunoglobulin is canceled with the development of intercurrent diseases (flu, acute respiratory infections). The patient should be warned about the need to inform the attending physician about all cases of adverse reactions that have developed during the course of drug treatment.
drug interaction
Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chicken pox (when administered in the first 2 weeks after vaccination against measles, mumps and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months later) Can only be mixed with 0.9% sodium solution chloride. Other drugs cannot be added to the solution, because. a change in electrolyte concentration or pH value can cause protein denaturation or precipitation.Overdose
not describedStorage conditions
- store in a dry place
- store in a cool place 5-15 degrees
- Keep cold (t 2 - 5)
- store at room temperature 15-25 degrees
- keep away from children
- store in a place protected from light
Human immunoglobulin has in its composition the main active component - the immunoglobulin fraction. Initially, it is isolated from human plasma, and then it is purified and concentrated. The drug does not contain antibodies to human immunodeficiency viruses and hepatitis C. Also, it does not contain antibiotics. The level of protein concentration reaches 5.5%. The drug has low anticomplimentary activity. It is an immunological agent.
Pharmacological forms
Medicines based on immunoglobulin are produced by the manufacturer in two pharmacological forms. This is a solution intended for intramuscular injection, and a powder from which a solution is prepared for intravenous infusion. The solution is a clear or slightly opalescent liquid.
Pharmacological effects
Human immunoglobulin is able to have an immunomodulating and immunostimulating effect. It contains a large number of neutralizing and opsonizing antibodies. Thanks to them, effective resistance to various bacteria and viruses is ensured.
Against the background of the action of this agent, the number of IgG antibodies that are in short supply is replenished. As a result, the likelihood of developing infectious diseases in patients with primary or secondary immunodeficiency is reduced. Immunoglobulin is able to replace and replenish natural antibodies in the blood serum.
Pharmacodynamics and pharmacokinetics
The bioavailability of the active substance during intravenous infusion reaches 100%. Over the next 14 days, the highest saturation of antibodies is noted in human blood. The drug is withdrawn up to 5 weeks. The drug is able to penetrate the placenta, get into breast milk.
Indications for use
Normal human immunoglobulin is used during replacement therapy if the patient requires treatment aimed at replenishing and replacing natural antibodies.
The drug can be used for prophylactic purposes in case of:
- The need to prevent diseases of infectious etymology in newborns born prematurely.
- The need to prevent miscarriage.
- Hemophilia, which was provoked by the process of synthesis of antibodies to factor P.
- Thrombocytopenia and hemolytic anemia, the origin of which is autoimmune.
- Demyelinating polyneuropathy, which is in a chronic state.
- Neutropenia of autoimmune origin.
- erythrocyte aplasia.
- Guillain-Barré syndrome.
- Kawasaki syndrome.
- Infections of viral and bacterial etymology with a severe course.
- Thrombocytopenic purpura of immune origin.
- AIDS in childhood.
- Lymphatic leukemia, which is chronic.
- Variable immunodeficiency.
- Primary and secondary immunodeficiency.
- Agammaglobulinemia.
- The need for bone marrow transplantation.
This is confirmed by the instructions for use for human immunoglobulin.
Contraindications for use
This medicinal product should not be used if the patient has:
- Anaphylactic reaction to blood products.
- Diabetes.
- Lack of kidney function.
- Hypersusceptibility to human immunoglobulins.
- Acute forms of allergic reactions.
- Deficiency in IgA against the background of the presence of antibodies to it.
When prescribing therapy using human normal immunoglobulin, it is important to take into account not only the presence of contraindications, but also conditions and diseases that should be treated with caution.
The remedy should be administered under close supervision to patients suffering from migraines, chronic decompensated heart failure, pregnant women, breastfeeding women. Caution should be exercised when using immunoglobulins in immune blood diseases, nephritis, collagenosis and other diseases associated with immunopathological mechanisms.
Side effects
When using human immunoglobulin with strict adherence to the instructions, side effects rarely develop. However, it is important to take into account that the development of undesirable effects may occur several hours or days after the drug has been administered to the patient. Most often, all side effects completely disappear after the cessation of immunoglobulin therapy.
The main reason why negative effects develop is the high rate of drug administration. Reducing the rate of administration or suspending its administration allows you to get rid of negative factors. If they do not disappear, then therapy is recommended to stop completely.
Side effects from injections of human immunoglobulin are most often observed at the first injection. Symptoms are as follows:
- Local skin reactions.
- Allergic reactions.
- Aseptic meningitis, impaired consciousness, photosensitivity, drowsiness and weakness.
- Chest pain, hot flashes, cyanosis, tachycardia.
- Pain in the stomach, increased salivation, diarrhea, vomiting.
- Shortness of breath, dry cough.
- Flu-like syndrome: body temperature rises, chills, weakness develop, headaches occur.
In addition, the patient may feel aching joints, back pain, hiccups, sweating, myalgia. In rare cases, there may be loss of consciousness, severe hypertension, collapse. In case of a serious reaction to therapy with this agent, its use should be discontinued. If necessary, the patient is administered plasma replacement solutions, adrenaline, antihistamines are provided.
Dosage and application
According to the instructions for use, human immunoglobulin can be used for intramuscular injection or intravenous infusion. The dosage should be selected by the doctor based on the severity of the disease and the patient's immune status.
Children are shown the introduction of 3-4 ml of solution for each kilogram of body weight. The total dosage cannot be more than 25 ml. Human immunoglobulin, before being administered, should be diluted with sterile sodium chloride (0.9%) or glucose solution (5%) in proportions of 1:4. The introduction is carried out intravenously, and the rate of administration should not exceed 10 drops per minute. The duration of the course of infusions is up to 5 days. Human immunoglobulin should be used especially carefully in children, as there is a high risk of developing allergies.
Adults are shown to use a dosage of 25-50 ml per application. Additional dilution of the drug is not required. Infusion is performed intravenously, and the infusion rate should not exceed 40 drops per minute. The duration of the course of therapy can be from 3 to 10 infusions, which should be carried out once a day or every three days.
Before the introduction, be sure to keep the solution at room temperature for up to 2 hours. If a precipitate appears or the solution becomes cloudy, it must be discarded.
Prevention of various ailments
The drug is also used for preventive purposes:
- For hepatitis A: at the age of 1-6 years - 0.75 ml, up to 10 years - 1.5 ml, from 10 years and older - 3 ml once.
- For the prevention of meningitis: 6 months-3 years - 1.5 ml, 3-7 years - 3 ml once.
- For the prevention of whooping cough: 3 ml twice, between doses must pass at least 24 hours, but no later than three days from the moment of contact with the patient.
- For the prevention of measles: 1.5-3 ml once.
- The solution is administered once for influenza and for its prevention: up to 2 years - 1.5 ml, from 2-7 years - 3 ml, from 7 years - 4.5-6 ml.
- For the prevention of poliomyelitis: 3-6 ml once.
Overdose
Immunoglobulin human intramuscularly is usually well tolerated. With intravenous administration of the drug, the occurrence of overdose symptoms is not excluded. They are expressed in hypervolemia and increased blood viscosity. Most often, overdose occurs in elderly patients and in those who suffer from kidney disease.
Interaction with other drugs
Pharmaceutically, the drug is incompatible with any other medications. It is strictly forbidden to mix it with other means.
The effectiveness of immunoglobulin is reduced if it is used in parallel with immunizing drugs against measles, chickenpox and rubella.
Parenteral administration of live virus vaccines should be carried out at least one month after completion of immunoglobulin therapy. The optimal break is three months.
The simultaneous use of the drug in infants with calcium gluconate is prohibited.
Does human immunoglobulin have analogues for intravenous administration, as well as for intramuscular injection?
Analogues
Currently, there are a number of similar drugs in their action. These include: Endobulin, Gabriglobin, Intratect, Pentaglobin, Intraglobin, Immunovenin, Gamunex.
The selection of an analogue should be carried out together with the doctor.
Also, analogues of the drug include:
- "Immunovenin";
- "Intratekt";
- "Immunoglobulin Sigardis";
- "Wigum-S";
- "Gabriglobin - IgG";
- "Venoglobulin";
- "Gamimun N".
All of them with the same composition of active ingredients, with the same therapeutic effect.
This group of funds is dispensed only by prescription. The doctor selects the dosage for each patient individually.
The cost of the drug
The cost of a drug intended for intramuscular injection is on average 900 rubles per package containing 10 ampoules. The average cost of a drug intended for intravenous infusion will be about 2600 rubles per 25 ml bottle.
