Bioven (Human normal immunoglobulin), infusions, 10%, 50 ml. bottle №1

Description

Bioven (Human normal immunoglobulin) solution for infusions 10% 50 ml bottle №1

Composition:

active substance: Human normal immunoglobulin for intravenous administration;

1 ml of the drug contains normal human immunoglobulin 0.1 g;

Excipients: glycine (amino acetic acid); water for injections.

Bioven Dosage form

Solution for infusions.

Main physical and chemical properties: clear or slightly opalescent, colorless or slightly yellowish liquid.

Bioven Pharmacotherapeutic group

Human immunoglobulin is normal for intravenous administration.

ATX code J06B A02.

Pharmacological properties

The drug Bioven is an immunologically active protein fraction (distribution of immunoglobulin G subclasses in the drug: IgG1: 65.6%, IgG2: 22.1%, IgG3: 10.8%, IgG4: 1.5%), the maximum content of immunoglobulin A in the drug is 50 μg / ml.

The active ingredient of the drug is antibodies with specific activity against various pathogens – viruses and bacteria, including hepatitis A and B, cytomegalovirus, human herpes virus type 1, type 2 and type 6, Epstein-Barr virus, chickenpox , influenza, measles, mumps, polio, rubella, pertussis, staphylococcus, Escherichia coli, pneumococcus, tetanus and diphtheria toxin. It also has non-specific activity, which is manifested in increasing the body’s resistance.

The drug has low spontaneous anticomplementary activity.

The drug is a native immunoglobulin G, retains all biological properties: complement activation, effector and opsono-phagocytic function.

The drug is an immunologically active protein fraction isolated from human serum or plasma, tested for the absence of antibodies to HIV-1, HIV-2, hepatitis C virus and hepatitis B virus surface antigen, purified and concentrated by fractionation, which passed through alcohol fractions. stage of viral inactivation by solvent-detergent method.

Bioven Indication

The drug should be used in adult patients for replacement immunotherapy in the treatment of primary and secondary immunodeficiency conditions and related diseases:

• primary immunodeficiency syndromes: congenital agammaglobulinemia or hypogammaglobulinemia, severe combined immunodeficiency, unclassified variable immunodeficiency, Viscott-Aldrich syndrome;
• secondary antibody deficiency syndrome: cytopenia of various origins (acute and chronic leukemia, aplastic anemia, post-treatment with cytostatics), severe bacterial-toxic and viral infections (including surgical complications accompanied by bacteremia and septic and surgical preparations) patients before surgery);
• autoimmune diseases: idiopathic thrombocytopenic purpura with a high risk of bleeding or before surgery – to correct the number of platelets; Hyena-Barre syndrome, chronic inflammatory neuropathy (demyelinating), inflammatory myopathy, Wegener’s granulomatosis, dermatomyositis, systemic connective tissue diseases (rheumatoid arthritis), Kawasaki syndrome;
  bone marrow transplantation.

Replacement therapy in children and adolescents (0-18 years) in:

• Primary immunodeficiency syndrome (PID) with impaired antibody production;
• secondary immunodeficiency (IM) in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment, or if proven deficiency of specific antibodies (DNSA *) or serum IgG <4 g / l.
  * DNSA – failure to achieve at least a twofold increase in the titer of IgG against pneumococcal polysaccharide and vaccines against polypeptide antigens.

Use in combination therapy in adult patients with severe pneumonia caused by coronavirus infection COVID-19 / SARS-CoV-2.

Precautions for drug administration

Some severe side effects may be related to the rate of infusion. The recommended infusion rate should be strictly adhered to. The patient’s condition should be closely monitored and any symptoms closely monitored throughout the infusion period.

Some side effects may be more common:

• in case of high infusion rate;
• in patients receiving normal human immunoglobulin for the first time, and rarely when switching to normal human immunoglobulin or when a long time has elapsed since the previous infusion.

Potential complications can be avoided by making sure that:

• patients are insensitive to normal human immunoglobulin at the first slow administration of the drug by infusion;
• patients are closely monitored for any symptoms throughout the infusion period. In particular, to monitor for adverse reactions during the first infusion and in the first hour after the first infusion, patients who have not previously received immunoglobulin, who have received alternative therapy and those who have had a long break since the last immunoglobulin should be monitored. Such patients require monitoring throughout the first infusion period, as well as within 1 hour after completion of the administration. All other patients should be under medical supervision for the first 20 minutes after administration.

If an adverse reaction occurs, either reduce the rate of administration or stop the infusion. The necessary treatment depends on the nature and severity of the adverse reaction. In case of shock, treatment should be carried out in accordance with the approved recommendations for anti-shock therapy.

For all patients with IgG:

• to carry out adequate hydration before the start of IgG infusion;
• control diuresis;
• monitor serum creatinine levels;
• avoid concomitant use of loop diuretics.

General information

The drug is produced from human plasma. Standard measures to prevent infection through the use of medicinal products from human or plasma blood include donor selection, testing of donor blood samples and plasma pools for specific markers of infection, and the inclusion of effective production steps to inactivate / kill viruses. Nevertheless, the risk of transmitting infections cannot be completely ruled out when administering drugs prepared from human blood or plasma. The same applies to unknown and new viruses and other pathogens.

These measures are considered effective against enveloped viruses such as HIV, hepatitis B virus and hepatitis C virus. For non-enveloped viruses such as hepatitis A virus and parvovirus B19, these measures may be of limited effectiveness. Clinical experience convincingly shows no cases of transmission of hepatitis A virus and parvovirus B19 when using human immunoglobulin drugs. In addition, it is assumed that the content of antibodies is of great importance for improving viral safety.

The drug does not contain preservatives and antibiotics.