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Trade name: Retinalamin®

Manufacturer: Geropharm

Grouping name: Cattle retinal polypeptides

Dosage form: lyophilisate for preparation of solution for intramuscular and parabulbar injections.

Composition:
Each vial contains: Drug substance – Retinalamin 5 mg (complex of water-soluble polypeptide fractions), Excipient – Glycine 17 mg (stabilizer).

Pharmacotherapeutic group: tissue regeneration stimulator.

ATC code: S01XA

Pharmacodynamics:
Retinalamin is a complex of water-soluble polypeptide fractions with molecular weight not more than 10 000 Da.

The medication has a stimulating effect on retinal photoreceptors and cellular elements. It also improves functional interactions between the pigment epithelium, exterior segments of photoreceptors, and glial cells, and it accelerates the recovery of retinal light sensitivity. It normalizes vascular permeability, reduces local inflammation, and activates reparative processes in patients with retinal diseases and traumas.

Retinalamin® improves ocular tissue metabolism, normalizes cellular membrane function, optimizes intracellular protein synthesis and energetic processes, and regulates lipid peroxidation processes.

Therapeutic Usage:
Compensated primary open-angle glaucoma, diabetic retinopathy, post-traumatic and post-inflammatory central retinal dystrophy (macular dystrophy), central retinal dystrophy (macular dystrophy), myopia (within comprehensive treatment), central and peripheral tapetoretinal abiotrophy.

Contraindications:
Individual hypersensitiveness to any of the medication components, in patients under 18 with compensated primary open-angle glaucoma, diabetic retinopathy, myopia (due to lack of efficacy and safety data); in patients under 12 months with post-traumatic and post-inflammatory central retinal dystrophy, central and peripheral tapetoretinal abiotrophy.

Administration and dosage:
In adults with diabetic retinopathy, post-traumatic and post-inflammatory central retinal dystrophy, central and peripheral tapetoretinal abiotrophy: parabulbar or intramuscular injections of 5-10 mg once a day. Treatment duration is 5-10 days; if necessary, repeated after 3-6 months.

In patients with compensated primary open-angle glaucoma: parabulbar or intramuscular injections of 5 mg once a day. Treatment duration is 10 days; if necessary, repeated after 3-6 months. In patients with myopia: parabulbar injections of 5 mg once a day. Treatment duration is 10 days. It is recommended to combine with angioprotectors and B group vitamins.

Dissolve Retinalamin® lyophilisate in 1-2 ml of water for injections, in 0.9 % solution of sodium chloride, or in 0.5 % solution of procaine (novocaine), directing the needle toward the side of the vial to avoid foaming.

In children at the age of 1 – 5 years with post-traumatic and post-inflammatory central retinal dystrophy, central and peripheral tapetoretinal abiotrophy: parabulbar or intramuscular injections of 2.5 mg once a day.

In children at the age of 6 – 18 years with retina central dystrophy of post-traumatic and post-inflammatory origin, central and peripheral tapetoretinal abiotrophy: parabulbar or intramuscular injections of 2.5 – 5.0 mg once a day.

Dissolve Retinalamin® lyophilisate in 1-2 ml of 0.9 % solution of sodium chloride, directing the needle toward the side of the vial to avoid foaming. Treatment duration is 10 days; if necessary, repeated after 3-6 months.

Potential undesirable effects:
No reported cases of adverse effects. Allergic reactions are possible in case of individual intolerance to any component of medication.

Shelf-life:
Shelf life of lyophilisate is 3 years. Do not use Retinalamin® after expiration date indicated on the package.

Storage conditions: Store in dry protected from light place, at 2–20 °C. Supplied as Lyophilisate for preparation of solution for intramuscular and parabulbar injections, 5 mg.