PE-Ha-Luron hyaluronate 1% prefabricated syringes, 0.55 ml

Product features:

PE-Ha-Luron sodium hyaluronate 1%

Formula:
Each ml contains: sodium hyaluronate 10.0 mg, disodium phosphate dihydrate 1.4 mg, sodium chloride 8.3 mg, potassium dihydrogen phosphate 0.26 mg, water for injection to suffiral.

Description:
PE-Ha-Luron is a sterile, non-pyrogenic, viscoelastic preparation of highly cleaned hyaluronic acid with high molecular weight, dissolved in a physiological buffer at pH 7.0 - 7.5. It is a clear solution that is delivered in a disposable syringe.

Characteristics:
The sodium hyaluronate is produced by extraction of high molecular grinding molecules. The resulting polymer is a large, spiral module with favorable rheological properties. Since it is a native hyaluronic acid, biocompatibility is very high. The most important properties of hyaluronic acid are protective, lubrication and support of sensitive cells and tissues. PE-Ha-Luron forms a thin layer that does not compress sensitive cells and tissues.

Use:
Only for intraocular use. The product is always recommended when protecting, lubrication and support of sensitive cells and tissues are required, especially with ophthalmic interventions such as.:

• Cataract surgery and IOL implantation
• Glaucom surgery
• Cornea transplantation
• Anterior Segment Surgery.

Contraindications:
None known at the moment.

Precautions:
PE-Ha-Luron is made of material, which is gained from poultry. Since there are very small amounts of potentially immunogenic material, local reactions can occur. So that these reactions are reduced to a minimum, patients should be asked whether they react allergic to chicken egg whites. A transient increase in postoperative intraocular pressure has been detected in conjunction with the use of viscoelastic preparations. This elevated pressure reaches its climax four to eight hours after surgical procedure. The intraocular pressure should be observed in the first days after surgery.

Important:
At the end of the operation, the solution must be removed by bottling or aspiration.

Interactions:
The user should remember the possibility that medicines that can be injected or applied at the same time as injected or applied due to the structure of PE-Ha-Luron a longer residue. PE-Ha-Luron can become cloudy when mixed with benzalkonium chloride, chlorhexidine or certain detergents. When a haze occurs, the solution must be removed from the eye.

Delivery form:
PE-Ha-Luron is supplied as a sterile viscoelastic solution in a disposable glass syringe. Each syringe contains 0.55 ml or 0.85 ml of 1% or 1.4% sodium hyaluronate. A sterile 27G disposable cannula is in the packaging.

Use:
Before use, the preparation should be adapted to the room temperature for 20 minutes. To set the cannula, hold glass syringe and Luer Lock adapter with thumb and forefinger the one hand closed tightly. Take the needle protection in the other hand. Now connect both parts to each other by pressing and rotating at the same time. The preparation is intended exclusively for intraocular use as aid in eye operations. It is intraocular with the enclosed, thin, curved cannula.

Please note:
This product is intended for single use only. Upon repeated use, sterility can not be guaranteed. It must not be used if the packaging material is damaged.

Storage:
Store at 2-25 ° C. Protect against frost and light.

Durability:
3 years.

Source: Information of the leaflet
Status: 09/2016