Gabriglobin (human immunoglobulin normal) - instructions for use, dose, side effects, contraindications

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 the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and the hepatitis B surface antigen.

The active component of the drug is immunoglobulin G, possessing the activity of antibodies of different specificity.

Pharmacokinetics:

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:

Heavy 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.

Diseases of the blood, the consequences of immunosuppressive therapy, acquired immunodeficiency (AIDS), especially when infecting children with human immunodeficiency virus.

Contraindications:

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

Anaphylactic shock on human blood products in anamnesis in cases of severe sepsis.

Hypersensitivity (including maltose), immunodeficiency IgA.

Carefully:

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.

Immunoglobulin penetrates into breast milk and can facilitate the transfer of protective antibodies to the newborn.

Dosing and Administration:

Immunoglobulin for intravenous administration is used only in hospital settings. Before administration, the vials are kept at a temperature of (20±2) ° 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 speed of 15-20 drops per minute, then at a speed 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 effects:

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.

Interaction:

Transfusion therapy with immunoglobulin for intravenous administration can be combined with other drugs, in particular antibiotics.

The introduction of immunoglobulins can weaken 1,5-3 months), the action of live vaccines against such viral diseases as measles, rubella, mumps and chickenpox (vaccinations with these vaccines should not be earlier than, than in 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.

Special instructions:

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

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 collapoid reactions.

Form release / dosage:Lyophilizate for solution for infusion.

Packaging:

2.5 grams of immunoglobulin in bottles with a capacity of 100 ml.

For 50 or 100 ml of solvent in bottles with a capacity of 50 or 100 ml.

A bottle of the drug and a bottle of thinner are placed in a pack together with instructions for use.

Storage conditions:

The drug is stored in a dry, dark place at a temperature of 2 to 10 ° C. Keep out of the reach of children.

Transportation is made by any kind of covered transport at a temperature of 2 to 10 ° C.

Shelf life:

2 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001529 / 01

Date of registration:04.07.2008

Expiration Date:Unlimited

The owner of the registration certificate:IVANOV REGIONAL STATION OF BLOOD TRANSFUSION IVANOV REGIONAL STATION OF BLOOD TRANSFUSION Russia

Manufacturer: & nbsp

IVANOV REGIONAL STATION OF BLOOD TRANSFUSION Russia

Information update date: & nbsp11.03.2017

Illustrated instructions

Instructions

Gabriglobin (human immunoglobulin is normal) (Gabreglobine (Immunoglobulinum humanum normale))