Superlymph^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Immunohelp Immunotherapy Center LLC (Russia)

Manufactured By

Altpharm LLC (Russia)

Contact Information

IMMUNOHELP IMMUNOTHERAPY CENTER LLC (Russia)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Natural peptides and cytokines peptide-protein complex (Group name)

Dosage Forms

	Superlymph®	Rectal and vaginal suppositories 10 units: 10 or 20 pcs.
		Rectal and vaginal suppositories 25 units: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Rectal and vaginal suppositories of whitish-cream color, conical or cylindrical in shape, with a diameter of 8.0±0.5 mm; heterogeneity in the form of inclusions or marbling is allowed.

* the Superlymph^® substance is a peptide-protein complex with a molecular weight of less than 40000 Da and activity of a number of cytokines, including the macrophage migration inhibitory factor, obtained in a continuous production cycle from cultures of porcine blood leukocytes, which are cultured in colorless medium 199; auxiliary substances are not used in the lyophilization process.

Excipients: cocoa butter, anhydrous lanolin.

5 pcs. – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Immunomodulator with antiviral, antimicrobial, and antifungal action for topical use

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Superlymph^® is an immunomodulator, representing a natural complex of natural antimicrobial peptides and cytokines – universal stimulators of the immune system with the activity of the macrophage migration inhibitory factor, interleukin-1 (IL-1), IL-6, tumor necrosis factor (TNF), transforming growth factor, secreted by porcine peripheral blood leukocytes.

It has antiviral, antimicrobial, and antifungal action.

The drug stimulates the functional activity of phagocytic cells (monocytes and neutrophils): it activates phagocytosis, the production of cytokines (IL-1, TNF), induces antitumor cytotoxicity of macrophages, regulates cell migration to the inflammation site, and increases the activity of natural killer cells. The drug has antioxidant activity, reduces the development of inflammatory reactions, and stimulates the regeneration and epithelialization of wound defects.

Pharmacokinetics

With intravaginal administration, systemic bioavailability is minimal.

Indications

• Complex treatment of herpetic diseases of the urogenital tract, including those complicated by bacterial and other viral infections;
• Complex treatment of chronic recurrent uncomplicated cystitis to prolong the remission period.

ICD codes

Dosage Regimen

Before administration, remove the packaging material from the suppository.

For treatment of viral infection in the acute stage, the drug Superlymph^® 10 units/25 units is used vaginally or rectally depending on the patient’s sex, alternating the route of administration if necessary, Superlymph^® 25 units as 1 suppository 1 time/day or Superlymph^® 10 units as 1 suppository 2 times/day in the morning and evening.

The course duration is from 10 to 20 days.

For prevention of viral infection relapse, the drug Superlymph^® 10 units is used as 1 suppository 1 time/day, alternating rectal and vaginal administration is possible.

The course duration is 10 days.

Repeated courses sequentially or after 1-2 months are allowed for the purpose of preventing possible relapses.

In complex therapy of chronic recurrent uncomplicated cystitis to prolong the remission period, the drug Superlymph^® 25 units is used rectally as 1 suppository 1 time/day for 10 days. The course of therapy with Superlymph^® 25 units is started simultaneously with antibacterial and symptomatic therapy for the cystitis episode in patients.

The drug should be used according to the method of application and in the doses indicated in the instructions. If necessary, consult a doctor before using the medicinal product.

Adverse Reactions

The adverse reactions listed below are presented according to the affected organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000), very rare (<1/10000, including isolated cases), frequency unknown (cannot be estimated from the available data). Frequency categories were formed based on clinical studies of the drug and post-registration surveillance.

Immune system disorders frequency unknown – allergic reactions.

If any of the side effects mentioned in the instructions get worse, or the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Body temperature above 38°C (100.4°F);
• Hypersensitivity to proteins of porcine origin and excipients;
• Severe allergic reactions in history;
• Malignant neoplasms in the active stage;
• Breastfeeding period;
• Age under 18 years (due to lack of data on efficacy and safety).

Use in Pregnancy and Lactation

Pregnancy

Use of Superlymph^® during pregnancy is possible after consultation with a doctor.

Breastfeeding period

Due to the lack of data on the penetration of Superlymph^® into breast milk, the use of the drug during breastfeeding is contraindicated.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years (due to lack of data on efficacy and safety).

Special Precautions

The drug is unsuitable for use if the packaging integrity is compromised; labeling is absent; the physical properties of the drug have changed (change in color, appearance of a rancid fat odor, deformation of the suppository).

Effect on ability to drive vehicles and machinery

Special studies on the effect of Superlymph^® on the ability to drive a car and moving mechanisms have not been conducted. Given the pharmacological properties of the drug, such an effect is unlikely.

Overdose

Cases of drug overdose have not been described.

Drug Interactions

If the patient is taking other medicinal products (including over-the-counter), it is necessary to consult a doctor before using Superlymph^® 10 units/25 units.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

The drug is transported in accordance with SP 3.3.2.3332-16 at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a 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.