Melavisk^® (Viscoprotector) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Melavisk®

Viscoprotector: syringes 1 ml or 2 ml 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Viscoprotector in the form of a transparent, viscous solution.

Excipients: anhydrous disodium phosphate – 2 mg, sodium dihydrogen phosphate monohydrate – 0.45 mg, water for injections – up to 1 ml.

1 ml – glass syringes (1) – packs or blister packs (1) – cardboard packs^×.
1 ml – glass syringes (1) – packs or blister packs (1) in a set with 1 or 2 cannulas* – cardboard packs^×.
1 ml – glass syringes (1) – packs or blister packs (2) – cardboard packs^×.
1 ml – glass syringes (1) – packs or blister packs (2) in a set with 2 or 4 cannulas* – cardboard packs^×.
1 ml – glass syringes (1) – packs or blister packs (5) – cardboard packs^×.
1 ml – glass syringes (1) – packs or blister packs (5) in a set with 5 or 10 cannulas* – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (1) – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (1) in a set with 1 or 2 cannulas* – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (2) – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (2) in a set with 2 or 4 cannulas* – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (5) – cardboard packs^×.
2 ml – glass syringes (1) – packs or blister packs (5) in a set with 5 or 10 cannulas* – cardboard packs^×.

^× with or without first opening control.
* The set may include a sterile ophthalmic surgical cannula 23G×7/8'' or 25G×7/8'', or 27G×7/8'' (FSZ 2012/12331 dated 13.04.2020; FSZ 2011/08973 dated 16.09.2019).
It is allowed to include 3, 6, or 15 tracking labels in the cardboard pack.

Therapeutic Category

Medical device for use in ophthalmic surgery

Properties

Viscoprotector.

Due to its viscoelastic properties, transparency, and ability to protect corneal endothelial cells, this agent provides a view of the anterior chamber of the eye, minimizes the risk of mechanical damage to any of the involved eye structures, and preserves tissue integrity during surgical manipulations.

It maintains the volume of the deep chamber during surgery on the anterior segment of the eye, thereby increasing the effectiveness of the procedure and reducing its traumatic impact on the corneal endothelium and other eye tissues.

Sodium hyaluronate is obtained by fermentation of Streptococcus equi bacteria and is thoroughly purified.

Scope of Application

For use in ophthalmology during surgical interventions on the anterior segment of the eye: cataract removal; intraocular lens implantation.

ICD codes

Dosage Regimen

The solution is for individual and single use only.

Procedures with this medical device require special training and special skills and are intended for use in medical institutions.

Side Effects

A review of clinical studies of similar devices showed that in some cases, a short-term increase in intraocular pressure was noted in the postoperative period.

In rare cases, as a result of the use of viscoelastics, postoperative inflammatory reactions (iritis, hypopyon), as well as corneal edema and decompensation, were observed.

The relationship of these conditions with the use of the devices has not been established.

Contraindications

Individual hypersensitivity to the components of the composition.

Use During Pregnancy and Breastfeeding

There are no data on the safety of use during pregnancy and breastfeeding.

Special Instructions

This is not a medicinal product.

Drug Interactions

Sodium hyaluronate is incompatible with quaternary ammonium compounds (benzalkonium chloride solutions), so contact of the device with these substances or with medical surgical instruments treated with these solutions should be avoided.

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

Over-the-Counter

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.