Composition, form of production and packaging
Solution for intravenous administration of 1 ml
human immunoglobulin normal 50 mg
25 ml - bottles (1) - packs of cardboard.
50 ml - bottles (1) - packs of cardboard.
100 ml - bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
A highly purified IgG preparation isolated from human blood plasma from healthy donors, individually tested for the absence of the surface antigen of the hepatitis B virus (HBsAg) and antibodies to the hepatitis C virus and human immunodeficiency viruses HIV-1 and HIV-2. Has low anticomplementary activity as a result of additional purification of Ig from aggregated proteins and impurities. Does not contain preservatives and antibiotics.
Increases the body's antibodies. Contains a wide range of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients suffering from primary or secondary immunodeficiency syndrome, provides the replacement of missing IgG antibodies, which reduces the risk of infection.
It has antibodies of various specificity, as well as nonspecific activity, which manifests itself in increasing the resistance of the organism.
With iv infusion bioavailability is 100%. Between the plasma and extravascular space there is a redistribution of the drug, and the equilibrium is reached in about 7 days. In individuals with normal IgG levels in the serum, the biological half-life period averages 21 days, while in patients with primary hypo- or agammaglobulinemia, 32 days.
- Substitution therapy for the prevention of infections in primary immunodeficiency syndromes: agammaglobulinemia, conventional variable immunodeficiencies associated with a- or hypogammaglobulinemia; deficiency of subclasses of IgG;
- Substitution therapy for the prevention of infections in the syndrome of secondary immunodeficiency caused by chronic lymphocytic leukemia, AIDS in children or bone marrow transplantation,
- idiopathic thrombocytopenic purpura;
- Kawasaki syndrome (in addition to treatment with acetylsalicylic acid preparations);
- severe bacterial, including sepsis (in combination with antibiotics), viral infections, infection prevention in preterm infants with low birth weight (less than 1500 g);
- Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuropathy;
- autoimmune neutropenia, partial red cell aplasia of hematopoiesis;
- Thrombocytopenia of immune origin, incl. posttransfusion purpura, isoimmune thrombocytopenia of newborns, hemophilia caused by the formation of antibodies to coagulation factors;
- myasthenia gravis;
- prevention and treatment of infections in the treatment of cytostatics and immunosuppressants;
- Prevention of a habitual miscarriage.
In / in the drip. The rate of administration for children is 0.08-0.5 ml / min, depending on the body weight, for adults - 1-1.5 ml / min. A faster injection can cause the development of collapse.
In the treatment of bacterial and viral infections, a single dose in children - 4 ml (200 mg) per 1 kg of body weight administered 1-2 times in adults - 2 ml (100 mg) per 1 kg of body weight for 4 days.
At primary immunodeficiency in patients with congenital agammaglobulinemia and hypogammaglobulinemia - 4-6 ml (200-300 mg) per 1 kg of body weight.Repeated course - after 3-4 weeks.
In secondary immunodeficiency in patients with chronic lymphocytic leukemia - 4-10 ml (200 to 500 mg) per 1 kg of body weight. Repeated course - after 3-4 weeks.
During the first day after the administration of the drug, slight increase in body temperature, allergic reactions are possible.
Sometimes there is a headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, dyspepsia, arterial hypo- or hypertension, tachycardia, cyanosis, dyspnea, a feeling of constriction or pain in the chest; rarely severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, tired feeling, malaise, back pain, myalgia, numbness, hot flashes or cold sensation. 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.
PREGNANCY AND LACTATION
Immunoglobulin penetrates into breast milk and can facilitate the transfer of protective antibodies to the newborn.
Imbioglobulin is used only in a hospital setting while observing aseptic rules.
In connection with the possibility of developing allergic reactions, those who received the drug should be under medical supervision. In the room where the drug is administered, there should be antishock therapy.
Persons with 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 introduction within 8 days after the end of the course of treatment.
Persons with diseases in which the leading are immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis), the drug is appointed after consultation of the relevant specialist.
During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.
A temporary increase in antibody levels in the patient's blood following immunoglobulin administration may result in false positive serological test results.
Do not exceed the speed of intravenous injection due to the possibility of developing collapoid reactions.
Before administration, the vials are kept at a temperature of 20 В± 2 В° C for at least 2 hours. A muddy and sediment-bearing preparation is not subject to application.
Introduction Imbioglobulin is registered in the prescribed registration forms with the serial number, date of manufacture, expiration date, manufacturer, dose and nature of the reaction to the administration of the drug.
On cases of increased reactogenicity should be reported by phone (fax) or telegraph to the State Scientific Research Institute for Standardization and Control of Medical Biological Preparations them. L.A. Tarasevich (LA Tarasevich), followed by the presentation of medical documentation.
Transfusion therapy with immunoglobulin for intravenous administration can be combined with other drugs, in particular, antibiotics.
The introduction of immunoglobulins can weaken (during 1.5-3 months) the action of live vaccines against such viral diseases as measles, rubella, mumps and chickenpox (vaccinations with these vaccines should be given no earlier than 3 months).
After the administration of large doses of immunoglobulin, its effect can last in individual cases up to one year.
Do not use concomitantly with calcium gluconate in infants.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry, dark place at a temperature of no higher than 2-8 В° C. Shelf life - 2 years.