Imunorix (Solution) Instructions for Use

Marketing Authorization Holder

Polichem, S.A. (Luxembourg)

Manufactured By

Doppel Farmaceutici, S.r.l. (Italy)

ATC Code

L03AX05 (Pidotimod)

Active Substance

Pidotimod (Rec.INN registered by WHO)

Dosage Form

Imunorix

Oral solution 400 mg/7 ml: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Oral solution red-violet in color, transparent, with a wild berry scent.

Excipients : sodium chloride – 5.6 mg, sodium saccharin – 5 mg, disodium edetate – 3.5 mg, trometamol – q.s. to pH 6.5, sodium methylparaben – 10.3 mg, sodium propylparaben – 1.6 mg, sorbitol 70% – 2500 mg, fruit flavor (wild berry scent) – 21 mg, anthocyanin colorant – 5.6 mg, ponceau 4R colorant – 0.5 mg, purified water – up to 7 ml.

7 ml – single-dose vials made of type III transparent glass (10) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Immunostimulating agent. Pidotimod stimulates and regulates cellular and humoral immunity in conditions of immunodeficiency.

Action on T-cell immunity: enhances the activity of natural killer cells and activates phagocytosis. Action on humoral immunity: increases cytokine production.

Pharmacokinetics

When taken orally, the bioavailability is 45%. T_1/2 – 4 hours.

Indications

As part of complex therapy: immunocorrection for bacterial, fungal, and viral infections of the upper and lower respiratory tracts; immunocorrection for bacterial, fungal, and viral infections of the urinary tract.

ICD codes

Dosage Regimen

Administer the oral solution twice daily, in the morning and evening, maintaining a consistent schedule.

Take each dose away from meals, at least one hour before or two hours after eating, to ensure optimal absorption.

For adults and adolescents, the dosage is 800 mg per administration, equivalent to the contents of two single-dose vials (2 x 7 ml).

For children over 3 years of age, the dosage is 400 mg per administration, equivalent to the contents of one single-dose vial (7 ml).

Continue this treatment for an initial period of 15 days as part of the immunocorrective therapy.

Do not exceed the maximum daily dose of 1.6 grams for adults or 800 mg for children.

For recurrent or chronic conditions, a maintenance therapy of 800 mg once daily for 60 days may be considered for adults, following medical evaluation.

Open the single-dose vial immediately before use; do not store the opened solution for later administration.

Discard any unused solution from an opened vial.

Adverse Reactions

Possible allergic reactions.

Contraindications

Children under 3 years of age, hypersensitivity to pidotimod.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and lactation (breastfeeding).

In experimental studies on animals, no embryotoxic or teratogenic effects were identified.

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

Use with caution in patients with hyperimmunoglobulinemia E syndrome, history of allergic reactions.

Drug Interactions

Pidotimod may affect the efficacy of drugs that suppress or stimulate the functional activity of lymphocytes.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.