Retinalamin^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Geropharm, LLC (Russia)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substance

Polypeptides of cattle retina (Grouping name)

Dosage Form

Retinalamin®

Lyophilisate for preparation of solution for intramuscular and parabulbar administration 5 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intramuscular and parabulbar administration in the form of a powder or porous mass of white or white with a yellowish tint color.

Excipients: glycine – 17 mg.

22 mg – vials of colorless glass with a capacity of 5 ml (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Drug improving regeneration of retinal tissues, for systemic use in ophthalmology

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A complex of water-soluble polypeptide fractions of cattle retina.

It has a stimulating effect on photoreceptors and cellular elements of the retina, promotes improvement of the functional interaction between the pigment epithelium and the outer segments of photoreceptors, and glial cells in dystrophic changes, accelerates the recovery of light sensitivity of the retina.

It normalizes vascular permeability, reduces the manifestations of local inflammatory reaction, and stimulates reparative processes in diseases and injuries of the retina.

The mechanism of action is determined by the metabolic activity of the agent: it improves the metabolism of eye tissues and normalizes the functions of cell membranes, improves intracellular protein synthesis, regulates lipid peroxidation processes, and contributes to the optimization of energy processes.

Indications

Compensated primary open-angle glaucoma, diabetic retinopathy, central retinal dystrophy of inflammatory and traumatic genesis, central retinal dystrophy, myopic disease (as part of complex therapy), central and peripheral tapetoretinal abiotrophy, rhegmatogenous and traumatic retinal detachment (rehabilitation postoperative period as part of complex therapy).

ICD codes

Dosage Regimen

Administer Retinalamin^® via parabulbar injection.

Reconstitute the 5 mg lyophilisate immediately before use with 1-2 mL of water for injection or a 0.5% procaine solution.

Establish the dose, frequency, and duration of therapy individually based on the specific retinal pathology and the patient’s age.

A typical course consists of 5-10 mg administered once daily for 5 to 10 days.

Repeat courses may be prescribed after 3 to 6 months, as determined by the treating physician.

Do not mix the reconstituted solution with other medicinal products in the same syringe.

Perform injections under aseptic conditions.

If a scheduled injection is missed, administer the next dose at the standard time; do not administer a double dose.

Adverse Reactions

Immune system disorders: anaphylactic shock, angioneurotic edema of the larynx.

Local reactions: pain, hyperemia, and swelling at the injection site.

Contraindications

Hypersensitivity to the components of the agent; age under 18 years (for compensated primary open-angle glaucoma, diabetic retinopathy, myopic disease, rhegmatogenous and traumatic retinal detachment – due to lack of data on efficacy and safety); age under 1 year (for central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral tapetoretinal abiotrophy).

Use in Pregnancy and Lactation

The agent is contraindicated for use during pregnancy (no data on efficacy and safety).

If it is necessary to prescribe the agent during lactation, breastfeeding should be discontinued.

Pediatric Use

The agent is contraindicated for use in children under 18 years of age with compensated primary open-angle glaucoma, diabetic retinopathy, myopic disease, rhegmatogenous and traumatic retinal detachment (due to lack of data on efficacy and safety); in children under 1 year of age with central retinal dystrophy of inflammatory and traumatic genesis, central and peripheral tapetoretinal abiotrophy.

Special Precautions

If an injection is missed, it is not recommended to administer a double dose, but to perform the next injection as usual on the scheduled day.

Effect on ability to drive vehicles and mechanisms

Caution should be exercised when driving vehicles and operating machinery, as in the case of parabulbar injections of this agent and concomitant vision examination, temporary visual disturbances are possible, which may affect the performance of potentially hazardous activities requiring special attention and quick reactions (driving vehicles, working with moving mechanisms).

Drug Interactions

It is not recommended to mix the agent with other solutions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.