Retinalamine lyophilisate for the preparation of a solution for intramuscular and parabulbar administration 5 mg No. 10

Pharmacological properties

Retinalamin is a tissue repair stimulator. The mechanism of action is determined by the metabolic activity of Retinalamin: the drug activates the metabolism of eye tissue, normalizes the functions of cell membranes, improves intracellular protein synthesis, regulates lipid peroxidation, optimizes energy processes by enhancing the activity of Müller cells and inactivating glutamate. Due to this, the functional interaction of the pigment epithelium and the outer segments of photoreceptors is improved, vascular permeability is normalized, oxidative stress and excitotoxicity are prevented, metabolism in the eye tissues is improved, and blood flow in the eye vessels is improved. Pharmacokinetics The composition of Retinalamin, the active substance of which is a complex of polypeptide fractions, does not allow for conventional pharmacokinetic analysis of its individual components.

Price of the drug Retinalamin

The cost of the drug "Retinalamin" in Moscow pharmacies starts from 3,500 rubles.

In our ophthalmology center you can take courses of parabulbar (injections into the eyes) and intramuscular injections of the drug. The cost of a parabulbar injection is 700 rubles, an intramuscular injection is 300 rubles. (excluding the cost of the medicine).

In addition, all types of effective medical, physiotherapeutic and surgical treatment of retinal diseases are available at the Moscow Eye Clinic.

Directions for use and dosage

For adults. For diabetic retinopathy, central retinal dystrophy of inflammatory and traumatic origin, central and peripheral taperetinal abiotrophy, the drug Retinalamin parabulbar or IM 5-10 mg 1 time per day. The course of treatment is 5–10 days; if necessary, repeat after 3–6 months. For compensated primary open-angle glaucoma - parabulbar or intramuscular, 5 mg 1 time per day. The course of treatment is 10 days; if necessary, repeat after 3–6 months. For myopic disease - parabulbar 5 mg 1 time per day. The course of treatment is 10 days. It is recommended in combination with angioprotective agents and B vitamins. The drug is dissolved in 1-2 ml of water for injection, 0.9% sodium chloride solution or 0.5% procaine (novocaine) solution, directing the needle to the wall of the bottle to avoid foaming. Children aged 1–5 years For central retinal dystrophy of inflammatory and traumatic origin, central and peripheral taperetinal abiotrophy - parabulbar or intramuscular, 2.5 mg 1 time per day. Children aged 6–18 years For central retinal dystrophy of inflammatory and traumatic origin, central and peripheral taperetinal abiotrophy - parabulbar or IM 2.5–5 mg 1 time per day. The drug is dissolved in 1–2 ml of 0.9% sodium chloride solution, directing the needle to the wall of the bottle to avoid foaming. The course of treatment is 10 days; if necessary, repeat after 3–6 months. Precautions for use. Retinalamin should only be used as prescribed by a doctor! The bottle with the dissolved medicinal product must not be stored or used after storage. The solution of the drug Retinalamin is not recommended to be mixed with other solutions.

Composition and release form

The drug is available in the form of a powder (lyophilisate), which is used to prepare a drug solution for parabulbar or intramuscular administration. The color of this porous mass is white or with a slight yellowish tint. The total mass of the substance in each bottle is 22 mg.

One bottle contains:

• Retinalamin, which is a purified water-soluble polypeptide that is isolated from the retina of the eyeball of livestock, in an amount of 5 mg.
• Glycine, which is a stabilizer, in the amount of 17 mg.

Five bottles are placed in a package made of foil and PVC film. Next, two such packs are packed in a cardboard box along with paper instructions.

Additionally

Indication of the characteristics of the action of the drug when first taken or when discontinued. There are no specific effects of the drug when first taken or when discontinued. Description, if necessary, of the actions of a doctor (paramedic), veterinary specialist, patient, or animal owner if one or more doses of the drug are missed. If an injection is missed, it is not recommended to administer a double dose, but to administer the next injection as usual on the scheduled day. Influence on the ability to drive vehicles and machinery. Does not affect.

Contraindications

The use of Retinalamin is contraindicated for:

• individual intolerance and hypersensitivity;
• minors, since there is not enough data to confirm its effectiveness in primary compensated open-angle glaucoma, myopic disease or diabetic retinopathy;
• under the age of one year with taperetinal abiotrophy (peripheral or central) and with central retinal dystrophy caused by inflammation or injury;
• during pregnancy, since there are no results of studies of safety and effectiveness in this category of patients.

During treatment with the drug, breastfeeding should be stopped.

Parabulbar injections

When prescribing a course of parabulbar injections with Retinolamine, they are performed by a specialist with sufficient experience in such procedures in a specially equipped clinic room or in a sterile operating room. Injections of the drug do not require special preparations.

To obtain an injection solution, the leophilisate of the drug is diluted using an isotonic solution or procaine (0.5%) and water for injection. Administration is carried out with a disposable syringe with a slightly blunted needle. During the procedure, the needle enters percutaneously into the lower eyelid (outer edge) and advances approximately 1 cm in depth. The required dose of the drug is injected into the space at the back wall of the eyeball.

Retinolamine solution cannot be stored, therefore, after the injection, its remains are disposed of.

Retinalamine lyophilisate for the preparation of a solution for intramuscular and parabulbar administration 5 mg No. 10

Name

Retinalamin.

Release forms

Lyophilisate.

INN

Polypeptides of the retina of livestock eyes.

FTG

Tissue regeneration stimulator.

Compound

Each bottle contains: active substance - Retinalamin® 5 mg, (a complex of water-soluble polypeptide fractions isolated from the dry extract of Retinalamin®), excipient - glycine 17 mg (stabilizer).

Pharmacotherapeutic group

Other drugs used in ophthalmology. ATX code: S01ХА.

Description

Lyophilized powder or porous mass of white or white with a yellowish tint.

Pharmacological properties

Pharmacodynamics Retinalamin is a complex of water-soluble polypeptide fractions with a molecular weight of no more than 10,000 Da. The drug has a stimulating effect on photoreceptors and cellular elements of the retina, helps improve the functional interaction of the pigment epithelium and the outer segments of photoreceptors, glial cells during dystrophic changes, and accelerates the restoration of light sensitivity of the retina. Normalizes vascular permeability, reduces the manifestations of local inflammatory reaction, stimulates reparative processes in diseases and injuries of the retina. The mechanism of action of RETINALAMINA® is determined by its metabolic activity: the drug improves the metabolism of eye tissue and normalizes the functions of cell membranes, improves intracellular protein synthesis, regulates lipid peroxidation processes, and helps optimize energy processes. Pharmacokinetics The composition of RETINALAMINA®, the active substance of which is a complex of polypeptide fractions, does not allow for conventional pharmacokinetic analysis of its individual components.

Indications for use

Compensated primary open-angle glaucoma, diabetic retinopathy, central retinal dystrophy of inflammatory and traumatic origin, central retinal dystrophy, myopic disease (as part of complex therapy), central and peripheral taperetinal abiotrophy.

Directions for use and dosage

For adults, 5-10 mg 1 time per day is dissolved parabulbarly or intramuscularly in 1-2 ml of 0.5% solution of procaine (novocaine), water for injection or 0.9% sodium chloride solution, directing the needle to the wall of the bottle to avoid foaming. The course of treatment is 5-10 days; if necessary, repeat after 3-6 months. For myopic disease: dissolve the contents of the 5 mg bottle in 1 ml of water for injection. Administer 0.5 ml (2.5 mg) parabulbarly into both eyes once a day. The course of treatment is 10 days. Recommended in combination with vitamins B6 and B12, pentoxifylline.

Side effect

Disturbances at the injection site: in very rare cases (less than 0.01% or 1:10,000) with parabulbar administration of the drug, reactions at the injection site may occur, which may have the following clinical manifestations: pain at the injection site, hyperemia (redness) at the injection site injections, swelling at the injection site. Immune system disorders: in very rare cases (less than 0.01% or 1:10,000), hypersensitivity reactions or allergic reactions may occur, which may have the following clinical manifestations: anaphylaxis reactions (anaphylactic shock, angioedema of the larynx). If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

Individual hypersensitivity to the components of the drug, pregnancy, breastfeeding.

Overdose

No cases of drug overdose have been reported.

Precautionary measures

Use RETINALAMINE® only as prescribed by your doctor! When using a 0.5% solution of procaine (novocaine) as a solvent for the drug RETINALAMINE®, you should adhere to the information on contraindications, precautions and age restrictions set out in the instructions for use of procaine (novocaine). The bottle with the dissolved medicinal product must not be stored or used after storage. RETINALAMINE® solution is not recommended to be mixed with other solutions. If an injection is missed, it is not recommended to administer a double dose, but to administer the next injection as usual on the scheduled day.

Use in children

There is no sufficient experience of use in children. Contraindicated for use in children under 18 years of age with compensated primary open-angle glaucoma, diabetic retinopathy, myopic disease (due to the lack of data on effectiveness and safety). Contraindicated for use in children under 1 year of age with central retinal dystrophy of inflammatory and traumatic origin, central and peripheral taperetinal abiotrophy. Use in children over 1 year of age with central retinal dystrophy of inflammatory and traumatic origin, central and peripheral taperetinal abiotrophy is possible only as prescribed by a doctor, if the expected therapeutic effect exceeds the risk of side effects: for children aged 1-5 years, parabulbar or intramuscular 2.5 mg 1 time per day, for children aged 6-18 years parabulbar or intramuscular 2.5-5 mg 1 time per day. The course of treatment is 10 days.

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy (due to the lack of clinical trial data). If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped (due to the lack of clinical trial data).

The effect of the drug on the ability to drive vehicles and machinery

In the case of parabulbar injections of the drug and an accompanying vision examination, temporary visual impairment is possible, affecting the performance of potentially hazardous activities that require special attention and quick reactions (driving vehicles, working with moving mechanisms).

Interaction with other drugs

No drug interactions have been described. Indication, if necessary, of the peculiarities of the action of the medicinal product upon first administration or upon its cancellation. There are no peculiarities of the action of the medicinal product upon first administration or upon its abolition.

Storage conditions

In a place protected from light at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date indicated on the package.

Vacation conditions

By doctor's prescription.

Package

Lyophilisate for preparing a solution for intramuscular and parabulbar administration, 5 mg. Produced in flint glass bottles in accordance with ISO 8362-1: 2009 with a capacity of 5 ml, sealed with rubber medical stoppers in accordance with GOST R ISO 8871-5-2010 or in accordance with ISO 8362-5:2008 with rolled-in aluminum caps with a tear-off purple plastic lining in accordance with GOST R 51314-99, or according to ISO 8362-6:2010, or according to ISO 8362-7:2006. 5 bottles each in a blister pack made of polyvinyl chloride or polyethylene terephthalate film and aluminum foil. 2 blister packs per cardboard pack along with instructions for use.

Buy Retinalamin liof.d/prig.solution for IM and s/w injection.5mg in bottle in pack No. 10 in the pharmacy

Price for Retinalamin lyof.d/preg.solution for IM and P/W injection.5mg in flask in pack No. 10

Instructions for use for Retinalamin lyof.d/prig.solution for i.m. and p/w injection.5mg in vial in pack No. 10

Cost of treatment

• Intramuscular injection (without the cost of medicine) - 300 rubles
• Parabulbar injection (without the cost of medicine) - 700 rubles
• Introduction into the sub-Tenon's space together with revascularization of the posterior part of the eye - 23,500 rubles

ATTENTION! The exact cost of treatment can only be determined after an in-person consultation, when the condition of the patient’s eyes is determined and a treatment plan is drawn up.

List of sources

1. Instructions for use of the drug "Retinalamin"
2. Khavinson VKh, Malinin VV, Trofimova SV, Zemchikhina VN. Inductive activity of retinal peptides. Bull Exp Biol Med. 2002 Nov;134(5):482-4.
3. Erichev V.P., Petrov S.Yu. Structural and functional changes in the retina as a criterion for assessing neuroprotective therapy for glaucoma Modern technologies in ophthalmology No. 4 2020
4. Zhuravleva L.V., Peptide bioregulators and antioxidants in the treatment of patients with Stargardt abiotrophy, IX Congress of Russian Ophthalmologists. Moscow, 2010.
5. Korotkikh S.A., Knyazeva E.S., Chervyakova E.S. Peptide neuroprotection in the treatment of age-related macular degeneration of the retina. East - West 2011
6. Makashova NV, Vasil'eva AE, Morozova NE, Ronzina IA. . Vestn Oftalmol. 2014 Jul-Aug;130(4):71-6, 78-80.
7. Sabirova D.B., Tulakova G.E., Ergasheva D.S. Complex treatment of diabetic maculopathy using the peptide bioregulator “Retinalamin” and laser coagulation of the retina. East - West. No. 2 2017
8. Ivanov S.V., Mashkovtsev V.M., Cherygova E.G., First experience of using retinalamine in the complex treatment of patients with rhegmatogenous retinal detachment. Modern technologies for the treatment of vitreoretinal pathology - 2010
9. Shiveleva O.G. Results of the use of retinalamine in the treatment of age-related macular degeneration in outpatient settings East - West 2011

Material prepared by:

Ophthalmologist Dmitry Alekseevich Sagonenko