Hyloparin-Comod® (Solution) Instructions for Use
Marketing Authorization Holder
Ursapharm Arzneimittel, GmbH (Germany)
Dosage Form
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Hyloparin-Comod® | Moisturizing ophthalmic solution 1 mg+1300 IU/1 ml: container 10 ml 1 or 420 pcs. |
Dosage Form, Packaging, and Composition
| Moisturizing ophthalmic solution | 1 ml |
| Sodium hyaluronate | 1 mg |
| Heparin sodium | 1300 IU |
Excipients: anhydrous citric acid, sodium citrate dihydrate, glycerol, water.
10 ml – original plastic containers (1) – cardboard packs.
Properties
Moisturizing ophthalmic agent.
Sodium hyaluronate has a smaller molecular size compared to hyaluronic acid, which allows the substance to penetrate tissues more easily and ensures the formation of a uniform, stable, and durable protective layer on the cornea of the eye without affecting visual acuity.
Hyaluronic acid (in the form of a sodium salt) has the necessary viscosity and adhesive properties in relation to the cornea of the eye. Due to these properties of hyaluronic acid, when the product is instilled into the eyes, a thin film is formed on the anterior surface of the cornea, protecting the eye from drying out, relieving sensations of discomfort, dryness, fatigue, pain, and eye irritation.
It effectively moisturizes and restores the healthy condition of the eye surface – the cornea and conjunctiva.
Heparin sodium is also a natural substance, similar in chemical structure to sodium hyaluronate. Furthermore, the chemical structure of heparin sodium is very similar to the physiological mucin of the tear film, and it is also surrounded by a significant volume of water.
These properties of heparin sodium allow it to additionally support the moisturizing effect of sodium hyaluronate, thereby creating the necessary conditions for the regeneration of the ocular surface epithelium.
Sodium hyaluronate and heparin restore the normal condition of the cornea and conjunctiva; together with natural tears, these components additionally moisturize the ocular surface.
As a result, a stable tear film is formed, protecting the eye from adverse environmental influences.
Scope of Application
For additional moisturizing and protection of the ocular surface (cornea and conjunctiva), elimination of symptoms of irritation, conjunctival redness, as well as burning and itching caused by adverse environmental factors or impaired tear fluid production, including after ophthalmic surgical operations; for corneal injuries and trauma; when wearing hard and soft contact lenses.
ICD codes
| ICD-10 code | Indication |
| H04.1 | Other disorders of lacrimal gland (dry eye syndrome) |
| S05.0 | Injury of conjunctiva and corneal abrasion without mention of foreign body |
| Z97.3 | Presence of spectacles and contact lenses |
| ICD-11 code | Indication |
| 9A1Z | Diseases of the lacrimal system, unspecified |
| NA06.4 | Injury of conjunctiva or cornea without foreign body |
| QB51.Y | Presence of other specified devices other than cardiac or vascular implants |
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. |
Instill one drop into the affected eye(s) three times daily or as needed for symptom relief.
Increase application frequency to every two hours in cases of severe dryness or during prolonged exposure to adverse environmental conditions.
For use with contact lenses, instill drops 30 minutes after lens insertion to avoid potential interactions with lens care solutions.
When using other ophthalmic medications, maintain a minimum interval of 30 minutes between instillations of different products.
Apply eye ointments or gels only after the instillation of this solution.
Following corneal injury or post-operative use, adhere strictly to the dosage and frequency prescribed by your ophthalmologist.
Do not allow the container tip to contact the eye or any surface to prevent contamination.
Discard the container four weeks after first opening to ensure sterility and product efficacy.
Side Effects
Very rarely hypersensitivity reactions, such as burning or intense lacrimation (disappear immediately after discontinuation of this product); allergic skin reactions caused by heparin.
Contraindications
Hypersensitivity to the components of the medical device.
Special Instructions
It is not a medicinal product.
The product is not intended for oral administration.
In case of adverse reactions associated with the use of the product, it is necessary to discontinue the use of the medical device and consult a doctor.
When used concomitantly with ophthalmic drugs, it is recommended to maintain an interval of at least 30 minutes between the instillation of this product and other eye drops.
Eye ointments/gels should be applied after the instillation of this product.
When wearing contact lenses, it is recommended to use this product 30 minutes after inserting the contact lenses to prevent possible incompatibility reactions between contact lens care products and this product.
Drug Interactions
In case of concomitant use with eye drops containing gentamicin, it is recommended to maintain an interval of at least 1 hour between the instillations of both products, since gentamicin, upon direct contact with heparin, forms a visible precipitate in the eye tissues.
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.
Medical Disclaimer![Hyloparin-Comod® [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Hyloparin-Comod® [Solution] 2")