Immunovac-VP-4^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Sphere-Pharm, LLC (Russia)

Manufactured By

Microgen NPO, JSC (Russia)

ATC Code

L03AX (Other immunostimulants)

Dosage Forms

	Immunovac-VP-4®	Lyophilisate for preparation of solution for subcutaneous administration 0.5 mg: amp. 5 pcs. in a kit with solvent
		Lyophilisate for preparation of solution for intranasal administration and for oral administration 4.3 mg/1 dose: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intranasal administration and for oral administration as a porous or crystalline mass of white or white with a yellowish tint color.

Excipients: lactose – 100±10 mg (stabilizer).
No preservative.

1 dose – vials (10) – cardboard packs.

Lyophilisate for preparation of solution for s/c administration as a porous or crystalline mass of white or white with a yellowish tint color.

Excipients: lactose – 12.5±1.3 mg (stabilizer).
No preservative.

Solvent: sodium chloride injection 0.9%.

0.5 mg – ampoules (5) in a kit with solvent – cardboard packs.
0.5 mg – ampoules (5) in a kit with solvent – cardboard boxes.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Immunostimulating drug of bacterial origin. The mechanism of action of the drug is based on the activation of key effectors of innate and adaptive immunity.

The drug activates the phagocytic activity of macrophages, corrects the number and functional activity of lymphocyte subpopulations (CD3, CD4, CD8, CD16, CD72), programs the proliferation and activation of CD4 T-lymphocytes along the Th1 pathway, increases the production of IFNγ and IFNα, corrects the synthesis of immunoglobulin isotypes towards a decrease in IgE and an increase in IgG, IgA, sIgA.

It induces the production of antibodies to 4 types of opportunistic microorganisms, the antigens of which are part of the drug, as well as to other types (Streptococcus pneumoniae, Haemophilus influenzae, etc.) due to the presence of broad cross-protective activity in the antigens used.

The clinical effect is manifested in a decrease in the frequency of acute infections, a reduction in their duration, a decrease in the severity of symptoms, as well as a decrease in the likelihood of exacerbation of chronic diseases, and a reduction in the volume of medications taken.

Indications

Immunotherapy and immunoprophylaxis in children from 3 to 18 years of age and adults.

Children from 3 to 15 years:

• Inflammatory diseases of the respiratory organs (including chronic ones) 5-7 days after the start of basic therapy, as well as during the pre-seasonal increase in the number of respiratory infections;
• Prevention of respiratory infections in children who frequently suffer from acute respiratory infections (more than 4 times a year), including in children who have not previously attended institutions with organized children’s groups (before admission to children’s institutions – preschools, schools);
• Allergic diseases (bronchial asthma, obstructive bronchitis, atopic dermatitis, hay fever) during remission against the background of basic therapy, preferably during the pre-seasonal rise in morbidity or immediately after relief of exacerbation against the background of basic therapy;
• Dysbiosis caused by opportunistic microflora, in atopic dermatitis.

Children over 15 years and adults

• Chronic recurrent inflammatory diseases of the respiratory organs in the acute stage 5-7 days after the start of basic therapy, during remission, as well as during the pre-seasonal increase in the number of respiratory infections;
• Allergic diseases (including bronchial asthma of mixed and infectious-allergic types, atopic dermatitis) during remission against the background of basic therapy or after relief of exacerbations against the background of basic therapy;
• Prevention of respiratory infections in individuals who frequently suffer from acute respiratory infections (more than 4 times a year), during the pre-seasonal rise in morbidity.

ICD codes

Dosage Regimen

The drug is taken according to a combined scheme intranasally, then orally.

Add 4 ml of solvent (sodium chloride injection 0.9% or boiled water) at a temperature of 18-25°C (64-77°F) into the vial with the drug immediately before use using a syringe and mix.

The dissolution time should not exceed 2 minutes. The dissolved drug can be stored at a temperature from 2°C (36°F) to 8°C (46°F) for 3 days and used if there is no cloudiness.

The drug is administered intranasally with a medical pipette.

For oral administration, the required volume of the drug is drawn up with a syringe and the contents of the syringe are transferred to a spoon.

The use of the drug begins with intranasal administration. They switch to oral administration of the drug only if the patient tolerates intranasal administration without significant reactions (increase in body temperature by no more than 0.5°C (33°F), absence of bronchospasm).

Administration scheme for children over 3 years of age and adults

When administering the next dose for oral administration, it is necessary to take into account the intensity of the reaction to the previous oral administration of the drug.

The dose of the drug is not increased during subsequent administration if the body temperature increases by more than 0.5°C (33°F).

If the effect is insufficiently pronounced, provided there is no reaction to the 7th-8th oral administration of the drug (if the patient’s temperature is not more than 37.5°C (99.5°F)), it is recommended for adults to extend the course of taking the drug with the same administration interval at a dose of 4 ml.

The maximum number of oral administrations for adults is 10; for children – 8.

Repeated courses of immunotherapy are carried out no earlier than after 1 year if there are indications.

Adverse Reactions

Short-term (12-24 hours) increase in body temperature to subfebrile values (37.1-37.6°C (99-100°F)), nasal congestion, cough, skin itching are possible.

These adverse reactions resolve on their own within 1-2 days.

If the patient’s body temperature rises to 38.5°C (101°F), if it persists 36 hours after drug administration at a level of 37.6°C (100°F) and above, as well as if other side effects occur, the administration of the drug is stopped.

In patients with bronchial asthma, in rare cases, exacerbation of the underlying disease is possible.

In case of bronchospasm or an attack of bronchial asthma, anti-attack therapy is carried out, and the issue of further administration of the drug is decided by an allergist.

Considering the possibility of anaphylactic shock, in rare cases in particularly sensitive individuals, it is necessary to provide medical observation of the vaccinated for 30 minutes after administration of the drug.

Places where immunotherapy and immunoprophylaxis are carried out must be equipped with anti-shock therapy means.

Contraindications

• Mental illnesses during the period of exacerbation;
• Collagenoses;
• Tuberculous process of any localization during the period of exacerbation;
• Chronic diseases in the stage of decompensation;
• Acute febrile conditions with hyperthermia (>38°C (100°F));
• Age under 3 years (efficacy and safety not established);
• Pregnancy;
• Breastfeeding period;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 3 years of age (efficacy and safety not established).

Special Precautions

Before use, it is necessary to perform a visual inspection of the drug: the dissolved drug should be a yellowish, slightly opalescent liquid without suspended particles.

The drug in vials with damaged integrity, lack of labeling, changes in physical properties (color, transparency, etc.), expired shelf life, or improper storage is not suitable for use.

Immunotherapy with the drug is carried out against the background of basic drug therapy.

Discontinuation of basic therapy drugs is possible by the doctor’s decision after a course of immunotherapy with the drug Immunovac-VP-4^®.

Drug Interactions

It is used in complex therapy with other medications.

It is compatible with antibiotics, antiviral, antifungal and antihistamine drugs, bronchodilators, corticosteroids, and beta-adrenergic agonists.

When conducting immunotherapy or immunoprophylaxis, the use of other immunomodulators is not recommended for 1 month before the start of the course and for 3 months after the course of immunotherapy or immunoprophylaxis with the drug Immunovac-VP-4^®.

Storage Conditions

The drug is stored and transported at a temperature from 2°C (36°F) to 8°C (46°F).

Transportation at a temperature from 9°C (48°F) to 25°C (77°F) for a duration of no more than 10 days is allowed.

Keep out of reach of children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.