Histaglobulin-biolic

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HISTAGLOBULIN-BIOLIK

Composition:

Active substance: normal human immunoglobulin;

1 ampoule of the preparation contains normal human immunoglobulin (calculated as protein content) – 12 mg;

Excipients: histamine dihydrochloride – 0.2 μg; sodium thiosulfate – 16 mg.

Solvent: 1 ampoule of solvent contains sodium chloride – 18 mg; water for injections – up to 2 ml.

Medicinal form. Lyophilisate for solution for injection, supplied with solvent.

Main physico-chemical properties: the preparation is a complex of human immunoglobulin and histamine dihydrochloride, with sodium thiosulfate as a filler.

The preparation is a white porous mass. Histaglobulin dissolves easily in sodium chloride solution 9 mg/ml within 2 minutes, forming a colorless or slightly yellowish liquid, clear or slightly opalescent. The preparation does not contain preservatives or antibiotics.

Pharmacotherapeutic group. Specific immunoglobulins. ATC code J06B B30.

Immunological and biological properties.

Pharmacodynamics.

The active component of the preparation is a complex of human serum immunoglobulin and histamine dihydrochloride.

After administration of the preparation into the body, the serum's ability to inactivate free histamine increases.

Pharmacokinetics.

Assessment of pharmacokinetic data is not applicable.

Clinical characteristics.

Indications.

Treatment of allergic diseases: chronic recurrent urticaria, allergic (atopic) dermatitis, eczema, bronchial asthma (atopic form) when specific allergen therapy is not feasible, asthmatic bronchitis, pollinosis (application before the pollen season is advisable), recurrent Quincke's edema (excluding hereditary angioneurotic edema).

The drug should be used during remission periods of allergic conditions, both in children and adults.

Contraindications.

Allergic diseases in the acute phase; allergic reactions to administration of human immunoglobulin; acute infectious diseases, exacerbation of chronic infection foci (e.g., tonsillitis, sinusitis, bronchitis, cholecystitis) – treatment should not be initiated earlier than 1 month after recovery (remission); peptic ulcer of the stomach and duodenum, glomerulonephritis, rheumatism – treatment should be initiated only after achieving stable remission; severe diseases of the nervous, hematopoietic, endocrine systems, diffuse connective tissue diseases, grade II hypertension.

The use of this drug must not be combined with specific hyposensitization, corticosteroid therapy, or prophylactic vaccinations.

Administration of the drug during menstruation is not recommended (may increase bleeding).

Interaction with other medicinal products and other forms of interaction. Not studied.

Special precautions.

Open ampoules and administer the drug under strict adherence to aseptic and antiseptic rules. The diluted drug may be stored under aseptic conditions for no more than 30 minutes.

Before injection, inspect ampoules for integrity and presence of labeling. Do not use the drug in ampoules with damaged integrity or labeling, or in case of changes in its physicochemical properties (e.g., color, consistency, clarity of solution), presence of foreign particles, expired shelf life, or improper storage.

Mild dizziness may occur upon first administration in elderly patients; however, this is not a reason to discontinue treatment.

In cases of exacerbation of the underlying allergic disease, depending on the severity, reduce the dose or increase the interval between injections, and provide symptomatic treatment.

In cases of pronounced exacerbations, therapy with this drug should be discontinued.

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

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy. The possibility of using the drug during breastfeeding has not been studied.

Ability to influence reaction rate when driving or operating machinery. Not studied.

Method of Administration and Dosage

Histaglobulin-Biolyk is administered to adults at a dose of 2 ml; for children under 3 years of age – 0.1 ml, gradually increasing to 0.5 ml; for children aged 3 to 5 years – 0.25 ml, gradually increasing to 1.0 ml; for children aged 5 years and older – starting from 0.5 ml, gradually increasing to 1.5 ml.

Depending on the severity of the allergic process, the physician may establish an individual dosage regimen (initiating treatment with reduced doses – 0.1–0.2–0.3 ml).

Treatment should be administered in courses. Adults should receive 4–10 injections per course, with intervals of 3–4 days.

Children should receive 4–6 injections per course, with intervals of 4–7 days.

If necessary, treatment courses may be repeated after 1–2 months for adults and no sooner than after 2 months for children.

Method of Administration. Histaglobulin-Biolyk should be administered subcutaneously into the upper outer surface of the arm. Wipe the ampoules containing the drug and the accompanying solvent with alcohol, open them, then using a sterile syringe and a needle with a wide bore, draw 2 ml of solvent from the solvent ampoule. Using the same needle, slowly and without agitation, inject the solvent into the ampoule containing histaglobulin, and gently shake until the drug is completely dissolved. Without removing the needle from the ampoule, draw the histaglobulin solution into the syringe. Disinfect the skin before and after injection with alcohol.

Children. The drug may be used in children (see section "Method of Administration and Dosage").

Overdose. No cases of overdose have been reported.

Side effects.

Generally, adverse reactions to the drug administration are absent.

General disorders and injection site reactions: weakness; hyperemia at the injection site.

Nervous system disorders: headache; mild dizziness (see "Special precautions").

Immune system disorders: exacerbation of underlying allergic disease (see "Special precautions").

Shelf life.

Drug: 2 years. Solvent: 3 years.

Storage conditions.

Store protected from light at a temperature between 2 °C and 8 °C. Freezing and heating above 20 °C are not permitted! Keep out of reach of children.

Packaging.

Lyophilisate for solution for injection in a vial, supplied with solvent (sodium chloride solution 9 mg/mL), 2 mL in a vial, 5 sets per pack.

Prescription status.

By prescription only.

Manufacturer.

JSC "BIOLIK", Ukraine.

Manufacturer's address and place of business.

Pomirky, Kharkiv region, Ukraine.