Adgevisk^® (Solvent) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Adgevisk^®

Ophthalmic viscoelastic solution: syringes 0.5 ml or 0.8 ml 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Ophthalmic viscoelastic solution transparent, viscous.

	1 ml
Chondroitin sulfate sodium	≤40 mg (≤4%)
Sodium hyaluronate	30 mg (3%)
Dynamic viscosity 20000-100000 mPa·s (at a temperature of 25°C (77°F) and a shear rate of 1 s^-1) Osmolality 325±60 mOsm/kg PH 7.0-7.6

Excipients : sodium chloride – 5.5 mg, sodium hydrogen phosphate anhydrous – 2 mg, sodium dihydrogen phosphate monohydrate – 0.45 mg, sodium hydroxide or hydrochloric acid – to adjust pH 7.0-7.6, water for injections – to 1 ml.

0.5 ml – glass syringes (1) – bags or contour cell packaging (1) – cardboard packs^×.
0.5 ml – glass syringes (1) – bags or contour cell packaging (2) – cardboard packs^×.
0.5 ml – glass syringes (1) – bags or contour cell packaging (1) in a set with 1 or 2 sterile ophthalmic surgical cannulas – cardboard packs^×.
0.5 ml – glass syringes (1) – bags or contour cell packaging (2) in a set with 2 or 4 sterile ophthalmic surgical cannulas – cardboard packs^×.
0.8 ml – glass syringes (1) – bags or contour cell packaging (1) – cardboard packs^×.
0.8 ml – glass syringes (1) – bags or contour cell packaging (2) – cardboard packs^×.
0.8 ml – glass syringes (1) – bags or contour cell packaging (1) in a set with 1 or 2 sterile ophthalmic surgical cannulas – cardboard packs^×.
0.8 ml – glass syringes (1) – bags or contour cell packaging (2) in a set with 2 or 4 sterile ophthalmic surgical cannulas – cardboard packs^×.

^× with or without first opening control.
* The set may include a sterile ophthalmic surgical cannula 27G×7/8'' ((0.4×22 mm) angle 35° (±5°)) and 25G×7/8'' ((0.5×22 mm) angle 25° (±5°)) or 27G×7/8'' ((0.4×22 mm) angle 35° (-3°)) and 25G×7/8'' ((0.5×22 mm) angle 35° (-3°)).
It is allowed to include cannulas of the same or different sizes in the cardboard pack. Information about the size of the included cannula(s) is indicated on the consumer packaging.
It is allowed to include 3, or 5, or 10 tracking labels in the cardboard pack.

Therapeutic Category

Medical device for use in ophthalmic surgery

Properties

Adgevisk^® is a specific combination of chondroitin sulfate sodium and sodium hyaluronate, created for use in ophthalmic surgery during operations on the anterior segment of the eye.

Chondroitin sulfate sodium and Sodium hyaluronate are similar in chemical and physical composition, as the molecule of each of them is a long, unbranched chain with a molecular weight from medium to high. The molecular weight of chondroitin sulfate sodium averages 22500 daltons, the molecular weight of sodium hyaluronate is over 500000 daltons.

The saccharide residues of these two molecules are repeating disaccharide subunits consisting of D-glucuronic acid in a β 1→3 linkage with D-galactosamine (for chondroitin sulfate sodium) and N-acetyl-D-glucosamine (for sodium hyaluronate). The subunits then form long polymers by forming a β 1→4 linkage of the amino sugar residue with the glucuronic residue. The molecules differ in that Chondroitin sulfate sodium has a sulfo group and more often a double, rather than a single, negative charge per repeating disaccharide subunit. Sodium hyaluronate is characterized by a single negative charge.

Chondroitin sulfate sodium and Sodium hyaluronate are biological polymers concentrated in the extracellular matrix of animals and humans.

Chondroitin sulfate sodium is found in the highest concentration in the cornea, Sodium hyaluronate is found in the aqueous humor and vitreous body.

Adgevisk^® is absolutely transparent and has excellent flow properties.

The ophthalmic viscoelastic solution Adgevisk^® maintains the depth of the anterior chamber and improves visualization throughout the operation, provides protection for the corneal endothelium and other intraocular tissues. Adgevisk^® helps to keep the vitreous body in a normal position, which prevents the collapse of the anterior chamber in the postoperative period.

Scope of Application

During operations on the anterior segment of the eye, including cataract extraction and intraocular lens implantation.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Before starting use, the cooled Adgevisk^® solution should be kept at room temperature (for 20-60 minutes depending on the volume).

Cataract extraction and intraocular lens implantation surgery

During cataract extraction and intraocular lens implantation, Adgevisk^® is carefully introduced (using a 27-gauge cannula) into the anterior chamber. The period the solution remains at the injection site can range from 10 minutes to 2.5 hours (the duration of the operation).

Adgevisk^® can be introduced before or after the insertion of the intraocular lens. Introducing the Adgevisk^® solution before inserting the intraocular lens provides additional protection for the corneal endothelium.

Injection of the viscoelastic at this stage is important because Adgevisk^® coats the endothelium and thus protects it from possible damage by surgical instruments during the operation. Also, Adgevisk^® can be used to coat intraocular lenses and the tips of surgical instruments before implantation. Additionally, the viscoelastic can be introduced during the operation to maintain the depth of the anterior chamber or to replace any fluids lost during surgical manipulations. At the end of the operation, Adgevisk^® is thoroughly removed from the eye by irrigation/aspiration using a balanced irrigation solution.

Instructions for using the syringe

Open the contour cell packaging/bag under aseptic conditions.
Unscrew the cap from the syringe tip (the cap is fitted tightly).
Fill the cannula hub to the top with ophthalmic irrigation solution.
Expel air through the syringe tip, holding the barrel with one hand and smoothly pressing the plunger rod with the other. Be careful not to expel the solution.
Screw the cannula onto the syringe until it passes the thread path and sits tightly.
Ensure the cannula hub is screwed on completely.
Remove the plastic sheath from the cannula with a straight motion. Be careful not to unscrew the cannula.
Expel the remaining air from the system, holding the syringe barrel with one hand and smoothly pressing the plunger rod with the other, until Adgevisk^® solution appears at the needle tip.

Side Effects

The ophthalmic viscoelastic solution Adgevisk^® is well tolerated during ophthalmic surgical procedures.

Possible transient increase in intraocular pressure in the postoperative period due to the presence of sodium hyaluronate in the composition; development of allergic reactions.

Contraindications

Individual hypersensitivity to the components of the composition.

Use during Pregnancy and Breastfeeding

There are no data on the safety of using the Adgevisk^® solution during pregnancy and breastfeeding. Use during pregnancy and breastfeeding is at the discretion of the ophthalmologist.

Special Instructions

Precautions necessary for surgical interventions on the anterior segment of the eye should be taken.

A transient increase in intraocular pressure in the postoperative period is possible. If intraocular pressure exceeds the permissible level after surgery, appropriate treatment should be carried out.

It is recommended to remove the Adgevisk^® solution by irrigation/aspiration at the end of the operation.

The composition includes highly purified biological polymers. The possibility of developing an allergic reaction must be considered.

In addition to the above, the following precautions should be observed:

Do not reuse the cannula;
Use only a transparent solution;
Avoid getting bubbles;
Do not use the Adgevisk^® solution with damaged or opened packaging.

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

The solution is intended for intraocular use only.

The supplied syringe is intended only for injection of the contained Adgevisk^® solution. It is not recommended to use this syringe for aspiration.

It is necessary to pay attention to the expiration date of the cannula indicated on its packaging.

For safe use and disposal, national and regional rules and regulations must be observed.

Requirements for the use and operation of the medical device

The solution is for individual and single use.

Performing procedures with this medical device requires special training and special skills and is intended for use in medical institutions.

Disposal procedure

The medical device (including unused solution, syringe, cannula) must be disposed of in accordance with SanPiN 2.1.7.2790-2010 as class B waste (epidemiologically hazardous waste). Packaging materials, cardboard pack are subject to disposal in accordance with SanPiN 2.1.7.2790-2010 as class A waste (epidemiologically safe waste, similar in composition to municipal solid waste).

Drug Interactions

No data.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.

Medical Disclaimer