Composition, form of production and packaging
Lyophilizate for solution for infusion 1 bt.
human immunoglobulin 2.5 g
Solvent: water d / and.
2.5 g - bottles (1) complete with a solvent - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Gabriglobin is an immunologically active protein fraction containing a broad spectrum of antibodies isolated from human plasma or donor sera tested for the absence of antibodies to human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and surface antigen of hepatitis B virus.
The active component of the drug is immunoglobulin G, which has antibodies of various specificity.
PHARMACOKINETICS
The drug is not subjected to chemical or enzymatic treatment, does not contain preservatives and antibiotics. The stabilizer is maltose.
With intravenous infusion, bioavailability is 100%. Immunoglobulin G passes through the placenta and penetrates into breast milk. The maximum concentration of antibodies in the blood is maintained for 21 days. In patients with primary hypo- or agammaglobulinemia, the elimination half-life is more than 32 days.
INDICATIONS
- severe forms of bacterial and viral infections;
- Postoperative complications accompanying bacteremia and septicopyemic conditions;
- primary syndrome of antibody deficiency: agamma or hypogammaglobulinemia (congenital form, period of physiological deficit in newborns);
- secondary antibody deficiency syndrome;
- blood diseases, consequences of immunosuppressive therapy, acquired immunodeficiency (AIDS), especially when infecting children with human immunodeficiency virus.
DOSING MODE
Immunoglobulin for intravenous administration is used only in hospital settings. Before administration, the vials are kept at a temperature of (20 + 2) В° C for at least 2 hours. Immediately prior to administration, the immunoglobulin is dissolved in water for injection in the volume indicated on the label. Contaminant medication is not applicable.
The dose and the frequency of administration of the drug depend on the indications for use. Single dose is 0.05-0.2 g / kg body weight. Diluted immunoglobulin is administered intravenously drip in the first 10-15 minutes at a rate of 15-20 drops per minute, then at a rate of 30-40 drops per minute. A faster injection can cause the development of a collapoid reaction. The course of treatment consists of 3-10 transfusions, conducted in 24 - 72 hours (depending on the severity of the disease).
SIDE EFFECT
During the first day after the administration of the drug, slight increase in body temperature, allergic reactions are possible.
Sometimes there is a headache, dizziness, dyspepsia, arterial hypo- or hypertension, tachycardia, dyspnea. In extremely rare cases with individual intolerance, the development of anaphylactic reactions is possible.
CONTRAINDICATIONS
- Allergic reactions or severe systemic reactions to blood products of a person in the anamnesis;
- Anaphylactic shock on human blood products in anamnesis in cases of severe sepsis;
- hypersensitivity (including maltose), immunodeficiency IgA.
With caution: severe heart failure, diabetes, kidney failure.
PREGNANCY AND LACTATION
When pregnancy and lactation are administered only on strict indications, when the intended benefit for the mother exceeds the potential risk for the child.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in kidney failure.
SPECIAL INSTRUCTIONS
Persons suffering from autoimmune diseases (blood diseases, connective tissue, nephritis, etc.), the drug should be administered against the background of appropriate therapy.
Immunoglobulin penetrates into breast milk and can facilitate the transfer of protective antibodies to the newborn.
After the administration of the drug, the patient should be monitored for at least 30 minutes. In the room where the drug is administered, there should be antishock therapy. With the development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.
Temporary increase of the content of introduced antibodies in the blood of the patient after the administration of immunoglobulin can cause false positive results of serological tests.
Do not exceed the speed of intravenous injection due to the possibility of developing collaptoid reactions.
DRUG INTERACTION
Transfusion therapy with immunoglobulin for intravenous administration 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 such viral diseases as measles, rubella, mumps and chicken pox (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
On prescription.
TERMS AND CONDITIONS OF STORAGE
The drug is stored in a dry, protected from light at a temperature of 2 to 10 В° C. Keep out of the reach of children. Shelf life - 2 years.
