Immunoglobulin-biolic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Immunoglobulin-Biolik

Composition:

Active substance: human normal immunoglobulin;

1.5 mL (1 dose) of the medicinal product contains: human normal immunoglobulin (calculated as protein content) – 150 mg;

Excipients: sodium chloride – 14 mg, glycine – 30 mg, water for injections – up to 1.5 mL.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: the product is a clear or slightly opalescent, colorless or slightly yellow liquid. A slight sediment may appear during storage, which disappears upon shaking.

Pharmacotherapeutic group. Immunoglobulins. Normal human immunoglobulins for extravascular use.

ATC code J06B A01.

Immunological and biological properties.

Pharmacodynamics.

The medicinal product increases the nonspecific resistance of the body.

Pharmacokinetics.

The active component of the product is immunoglobulins – antibodies of various specificities. After administration of immunoglobulin, the concentration of antibodies in the blood reaches its maximum within 24 hours. The half-life of antibodies in the body is 4–5 weeks.

Clinical characteristics.

Indications.

Infection prophylaxis: hepatitis A, measles. The drug is also recommended for the treatment of hypo- and agammaglobulinemia, and for increasing the body's resistance during the convalescence period after prolonged acute infections.

Contraindications.

Hypersensitivity to the components of the drug.

Severe allergic reactions to administration of blood protein products in medical history.

Severe thrombocytopenia and other coagulation disorders.

Interaction with other medicinal products and other forms of interaction.

Administration of immunoglobulin reduces the efficacy of live vaccines against measles, rubella, mumps, and varicella (for 1.5–3 months). After administration of Immunglobulin-Biolik, live attenuated viral vaccinations should not be administered earlier than 3 months thereafter. For measles, this period may last up to 1 year; therefore, it is necessary to check antibody status prior to immunization.

If the interval between vaccination against measles, mumps, rubella and administration of immunoglobulin for prophylactic or therapeutic purposes is less than 14 days, revaccination against these infections should be performed.

Vaccinations against other infections can be administered at any time before or after Immunglobulin-Biolik administration.

Special precautions for use.

Patients suffering from allergic diseases or with a history of severe allergic reactions should be administered antihistamine agents on the day of drug administration and for the following 3 days.

Immunoglobulin-Biolic should be administered against the background of appropriate therapy in patients with immunopathological systemic diseases (hematological disorders, connective tissue diseases, nephritis).

Patients who have received the drug must remain under medical supervision for 30 minutes.

Rooms where Immunoglobulin-Biolic is administered must be equipped with equipment for anti-shock therapy.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e. practically sodium-free.

Use during pregnancy or breastfeeding.

Not studied.

Ability to influence reaction rate when driving or operating machinery.

Data not available.

Administration and Dosage

Administer intramuscularly.

INTRAVENOUS ADMINISTRATION OF THE DRUG IS PROHIBITED!

For hepatitis A prophylaxis: administer a single dose of 3 mL to adults.

In case of urgent necessity, repeat administration of immunoglobulin is indicated no sooner than 2 months after the first dose.

Upon contact with patients suffering from mixed infections: administer 3 mL of the drug to adults.

To enhance body resistance during the convalescence period following prolonged acute infectious diseases and in chronic or protracted pneumonias: administer to adults a single dose of 0.15–0.2 mL per 1 kg body weight. The frequency of administration (up to 4 injections) is determined by the physician; intervals between injections are 2–3 days.

Children.

For hepatitis A prophylaxis: administer 0.75 mL to children aged 1–6 years; 1.5 mL to children aged 7–10 years; 3 mL to children aged 10 years and older. In case of urgent necessity, repeat administration of immunoglobulin is indicated no sooner than 2 months after the first dose.

For measles prophylaxis: administer a single dose to children aged 3 months and older who have not had measles and have not been vaccinated against this infection, no later than 6 days after contact with an infected person. The dose of the drug, depending on health status and time elapsed since contact, is either 1.5 mL or 3 mL.

Upon contact with patients suffering from mixed infections: administer 3 mL of the drug to children.

For treatment of hypo- and agammaglobulinemia: administer the drug to children at a dose of 1 mL per 1 kg body weight. The calculated dose may be administered in 2–3 portions with 24-hour intervals. Further administrations should be performed based on clinical indications, no sooner than 1 month after the previous dose.

To enhance body resistance during the convalescence period following prolonged acute infectious diseases and in chronic or protracted pneumonias: administer to children a single dose of 0.15–0.2 mL per 1 kg body weight. The frequency of administration (up to 4 injections) is determined by the physician; intervals between injections are 2–3 days.

Children. Administer to children based on clinical indications (see section "Administration and Dosage").

Overdose.

No cases of overdose have been reported.

Side effects.

Side effects following administration of immunoglobulin are very rare and depend on individual characteristics of the organism. Frequency of adverse reactions is unknown (cannot be estimated from available data):

General disorders and administration site reactions: chills, fever, mild back pain; local pain and sensitivity at the injection site.

Gastrointestinal disorders: vomiting, nausea.

Immune system disorders: allergic reactions, anaphylactic shock, even in patients who did not experience hypersensitivity during previous administrations.

Musculoskeletal and connective tissue disorders: arthralgia.

Nervous system disorders: headache.

Vascular disorders: decreased blood pressure, sudden drop in blood pressure.

Shelf life. 2 years.

Storage conditions.

Store in a protected from light place at a temperature from 2 °C to 8 °C. Do not freeze!

Keep out of reach of children.

Incompatibility.

The product should not be mixed with other medicinal products.

Packaging.

1.5 mL (1 dose) or 3 mL (2 doses) in vials; 10 vials per pack.

Prescription status. Prescription only.

Manufacturer.

JSC «BIOLIK», Ukraine.

Manufacturer's address and location of its business activity.

Pomirky, Kharkiv region, Ukraine.