OCUGEL

Hydroxypropyl Methylcellulose 2%
Sterile Eye Solution

Description:

Ocugel is a sterile, isotonic, non-pyrogenic, viscoelastic solution of highly purified, non-inflammatory Hydroxypropyl Methylcellulose.

Composition:

Each ml contains Hydroxypropyl Methylcellulose USP 20 mg.

Indication:

Ocugel is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation.

Pharmacological action:

Ocugel maintains a deep anterior chamber during anterior segment surgery and protects the corneal endothelium and other ocular tissues. Ocugel helps to push back the vitreous face, thus preventing formation of a flat chamber during surgery.

Dosage and administration:

Cataract surgery-IOL implantation

For cataract surgery and intraocular lens implantation, Ocugel should be carefully injected into the anterior chamber prior to capsulotomy using standard aseptic techniques and only the cannula provided with the product. Ocugel may be injected into the chamber prior to or following removal of the crystalline lens.

Ocugel may also be used to coat an intraocular lens prior to implantation as well as the tips of surgical instruments. Additional Ocugel may be injected during anterior segment surgery to fully maintain the chamber or replace any volume lost during the surgical procedure.

Contraindication:

Patients with known hypersensitivity to any component of the drug should not use the drug. 

Side effects:

After injection into the human eye, Ocugel has been extremely well tolerated. Occasionally a transient rise in intra-ocular pressure postoperatively has been reported in some cases. Rarely postoperative inflammatory reactions (iritis, hypopyon) as well as incidence of corneal edema and corneal decompensation may occur.

Precaution:

Ocugel is guaranteed sterile inside the aseptic transfer peel pouch until the sterility expiration date printed on the package label. There may be transient increased intraocular pressure following surgery because of pre-existing glaucoma or due to the surgery itself. For these reasons, the following precautions should be considered:

·   Ocugel should be removed from the anterior chamber at the end of surgery.

·   If the postoperative intraocular pressure increases above expected values, appropriate therapy should be provided.

Warning

·        For intraocular use only.

·        For single use only. 

Storage:

·        Store at room temperature below 25⁰ C.

·        Protect from freezing and light.

·        Keep out of the reach of children.

Ocugel is a sterile, non-pyrogenic, viscoelastic fluid supplied in a 3.0 ml single use disposable syringe with a sterile, disposable blunt-tipped cannula. Ocugel syringes are aseptically packaged and terminally sterilized by autoclave. The sterility expiration date is printed on the outer package label.