Immunomaxe (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Contact Information

IMMAPHARMA LLC (Russia)

ATC Code

L03AX (Other immunostimulants)

Dosage Forms

	Immunomaxe	Lyophilisate for preparation of solution for intramuscular administration 100 IU: amp.
		Lyophilisate for preparation of solution for intramuscular administration 100 IU: vial.
		Lyophilisate for preparation of solution for intramuscular administration 200 IU: vial.
		Lyophilisate for preparation of solution for intramuscular administration 200 IU: amp.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intramuscular administration as a white powder.

Ampoules in a kit with solvent (water for injection 2 ml – amp.), syringes and pre-injection wipes – cardboard packs.

Lyophilisate for preparation of solution for intramuscular administration as a white powder.

Vials in a kit with solvent (water for injection 2 ml – amp.), syringes and pre-injection wipes – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Immunomodulator.

It enhances immune defense against viral and bacterial infections.

The immunopharmacological mechanisms of action of the drug consist in the fact that Immunomaxe activates the following links of the immune system.

• NK cells, which 2-3 hours after administration of Immunomaxe intensively express activation molecules CD69. The cytolytic activity of NK cells increases 3 times;
• Circulating monocytes 2-4 hours after activation by Immunomaxe begin to secrete cytokines: interleukin-8, interleukin-1β and tumor necrosis factor alpha;
• Neutrophilic granulocytes are activated through monocytes; the drug does not have a direct effect on neutrophilic granulocytes. Interleukin-8 secreted by monocytes causes activation of neutrophilic granulocytes, which is clearly manifested 24 hours after exposure to Immunomaxe;
• Tissue macrophages, which is manifested by changes in the morphology of these cells, increased production of bactericidal substances, and changes in 5′-nucleotidase activity;
• Formation of antibodies against foreign antigens, both soluble and corpuscular.

Immunomaxe enhances immunological defense mechanisms in infections caused by viruses (human papillomavirus, herpes simplex virus, parvovirus, canine distemper virus) or bacteria (Escherichia coli, Salmonella, Staphylococcus, Chlamydia, Mycoplasma, Ureaplasma).

This action of the drug is manifested in adults and newborns when Immunomaxe is administered by various routes: intramuscularly, intravenously, intraperitoneally, orally.

Pharmacokinetics

The pharmacokinetics of the drug have not been studied due to its peptidoglycan nature and very low active doses.

Indications

• Correction of weakened immunity;
• Treatment of pathological conditions (condylomas, warts, dysplasias) caused by human papillomavirus;
• Infections caused by Herpes simplex, Chlamydia spp., Mycoplasma spp., Ureaplasma spp., other bacteria and viruses.

ICD codes

Dosage Regimen

The recommended dose for adults and children aged 12 years and older is 100-200 IU intramuscularly once daily.

Before use, the contents of the vial (ampoule) are dissolved in 1 ml of water for injection, administered intramuscularly at 100-200 IU depending on the severity of the disease.

The course of treatment is 6 injections on days 1, 2, 3, 8, 9, 10 of treatment.

For recurrent anogenital warts, a course of 6 injections of 200 IU Immunomaxe is combined with wart destruction (cryodestruction, electrocoagulation, laser destruction or application of the drug Solcoderm).

For infections caused by bacteria or viruses, a course of 6 injections of 100-200 IU Immunomaxe is carried out.

For correction of weakened immunity, a course of 3-6 injections of 100-200 IU Immunomaxe is carried out.

Adverse Reactions

When used according to the indications and in recommended doses, no adverse effects have been identified.

Contraindications

• Children under 12 years of age;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

There are no data on the effects of Immunomaxe on pregnant women.

As with other medicines, Immunomaxe should not be used during pregnancy unless the benefits to the patient outweigh the possible risk to the fetus.

Immunomaxe is not recommended for use by nursing mothers.

Pediatric Use

The drug is contraindicated in children under 12 years of age.

Special Precautions

The drug can be used as part of combination therapy according to indications.

Overdose

To date, no cases of overdose with Immunomaxe have been reported.

Drug Interactions

Drug interactions of Immunomaxe have not been described.

Storage Conditions

The drug should be stored at a temperature from 4°C (39.2°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Pharmacy dispensing terms

The drug is dispensed by prescription.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.