SPHERO^® oko (Protector) Instructions for Use

Marketing Authorization Holder

Biomir Service, JSC (Russia)

Contact Information

BIOMIR Service JSC (Russia)

Dosage Form

SPHERO^® oko

Corneal epithelium protector gel: syringes 0.5 ml or 1 ml 1 pc., bottle 0.5 ml or 1 ml 5 pcs.

Dosage Form, Packaging, and Product Composition

Corneal epithelium protector gel in the form of a transparent, homogeneous, colorless, viscous, sterile, odorless hydrogel.

	1 ml
Collagen-containing extract (of animal origin)	12.422 mg
Polyethylene glycol 400	0.621 mg
Sodium chloride	0.696 mg
Potassium chloride	0.017 mg
Sodium phosphate dibasic dodecahydrate	0.17 mg
Potassium dihydrogen phosphate dihydrate	0.017 mg
Dynamic viscosity 7-12 mPa·s (at a temperature of 25°C (77°F)) PH 6.2-7.0

Excipients : purified water – up to 1 ml.

0.5 ml – syringes (1) – bags (1) – cardboard boxes.
1 ml – syringes (1) – bags (1) – cardboard boxes.
0.5 ml – monodose vials "Strip monodose" (5) – bags (1) – cardboard boxes.
1 ml – monodose vials "Strip monodose" (5) – bags (1) – cardboard boxes.

The protector is supplied sterile. The sterilization method is radiation.

Therapeutic Category

Medical device for moisturizing and protecting the mucous membrane of the eye

Properties

SPHERO^® oko is used as a corneal epithelium protector for patients suffering from superficial lesions of the cornea.

The protector has wound-healing properties, as it belongs to the class of biopolymer hydrogels with regenerative properties.

The use of the SPHERO^® oko protector can significantly reduce the time of epithelialization of defects, prolong the remission period and prevent the recurrence of chronic corneal epithelial defects.

Scope of Application

Of the SPHERO^® oko product

Restoration of chronic and recurrent defects of the corneal epithelium (including when used with therapeutic contact lenses)

Recurrent corneal erosions;
Filamentary keratitis;
Toxic erosion;
Dry keratoconjunctivitis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
H16.2	Keratoconjunctivitis (including that caused by external influence)
H16.8	Other forms of keratitis
H18.8	Other specified disorders of cornea

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.

The SPHERO^® oko protector is intended for single use in clinics, ophthalmology departments of hospitals and for use at home.

The SPHERO^® oko protector is applied to the surface of the cornea or to a therapeutic silicone-hydrogel soft contact lens (previously used or unused lens), which is placed on the surface of the cornea.

The duration of wearing the therapeutic contact lens is no more than 2 days, after which the contact lens with the protector should be changed.

The duration of application of the protector depends on the severity and form of the pathology, so it is necessary to repeat the course of treatment at least one more time, until the symptoms of the disease completely disappear, that is, until the cornea is completely epithelialized.

After application, the protector is evenly distributed, forming a protective film on the damaged surface, which retains its properties for 2 days.

After this period, the protector degrades under the influence of a group of tissue enzymes into decomposition products – amino acids, which are further broken down.

Method of application of the monodose vial

Side effects

Symptoms rarely – local pain, swelling, heat and redness (these symptoms are mild and transient), septic conjunctivitis (when general precautions during application are not observed).

Contraindications

Established individual hypersensitivity to the components of the protector;
Infectious eye diseases.

Special instructions

When applying the protector, general ophthalmological precautions must be observed to avoid the occurrence of septic conjunctivitis.

It is not allowed to use the protector if the integrity of the packaging is compromised.

Do not touch the tip of the opened monodose vial "Strip monodose", as this may lead to contamination of the solution. Do not use the first drop.

The contents of the opened monodose vial "Strip monodose" should be used within 24 hours.

It is necessary to observe the storage conditions and the expiration date of the protector indicated on the packaging.

Procedure for disposal

Dispose of the protector (including unused, together with used and unused therapeutic lens) in accordance with SanPiN 2.1.3684-21 as class B waste (epidemiologically hazardous waste).

Packaging materials, cardboard box are subject to disposal in accordance with SanPiN 2.1.3684-21 as class A waste (epidemiologically safe waste, similar in composition to municipal solid waste).

Storage Conditions

Transportation and storage conditions of the protector according to group 1 GOST 15150, but at a temperature from 0°C (32°F) to 25°C (77°F).

Avoid exposure to direct sunlight.

The manufacturer guarantees the conformity of the protector to the requirements of the technical specifications subject to the rules of operation, transportation and storage.

The guaranteed shelf life of the protector in the packaging is 2 years from the date of manufacture.

Do not use after the expiration date indicated on the packaging.

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