Instructions for use

Solatum™ Ophthalmic Viscoelastic Device Sodium Hyaluronate

Indication: Solatum™ gel is intended to aid anterior or posterior segment ophthalmic surgery: Cataract extraction with/without implantation of intraocular lens; Corneal transplant surgery; Glaucoma filtering surgery; Secondary lens implantation.

Contraindications: Not suitable for the following patient groups: with known hypersensitivity to the individual components of the product.

Description: Hyaluronic acid is a substance naturally present in the body including in fluids in the eye and has viscoelastic properties. Sodium Hyaluronate Viscoelastic device (VED) for ophthalmic surgery when injected into the eye can help lubricate and protect the ocular structures during surgical eye procedures. The active substance is a highly purified sodium salt of hyaluronic acid. Sodium Hyaluronate Viscoelastic device for ophthalmic surgery is terminally sterilised by moist heat. The product is for single use only. Its final packaging includes a 27G blunt cannula (Rycroft Cannula) which is terminally sterilised by ethylene oxide.

Contents: Each Solatum™ VED gel prefilled syringe contains sodium hyaluronate in a phosphate buffered saline for a single surgical procedure. The following volumes and concentration of HA are available: 1ml and 2ml of 1Smg/ml and 1ml of23mg/ml and 30mg/ml.

Warnings: Do not use if sterile packaging has been damaged, or if there is damage to the pre-filled syringe. Avoid contact with drugs containing benzalkonium chloride due to interaction. Never overfill the eye chamber (except in glaucoma surgery). Do not use for intravenous injection. Do not use if solution is cloudy. The pre-filled syringe is intended for single procedure use only. The contents of the syringe must be used immediately after the packaging is opened. Discard any unused gel. Reuse may cause infection. Strict aseptic administration technique must be followed to minimise danger of cross infection. Only for injection into the eye cavity. Overfilling the eye anterior or posterior segment with gel may lead to increased intraocular pressure, glaucoma, or other ocular damage. Postoperative intraocular pressure may also be elevated as result of pre-existing glaucoma, compromised outflow and by operative procedure and events following, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. In posterior segment procedures in the aphakic diabetic patient, special care should be exercised to avoid using large amounts of Solatum™ VED gel. Remove all remaining gel by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery).

Precautions: Avoid trapping any air bubbles. Avoid contact with instruments sterilized with quarternary ammonium salts solution or disinfectant containing quaternary ammonium salts. Do not use after the expiry date printed on the package. Carefully monitor the intraocular pressure especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy. Rarely, viscoelastic Solatum™ VED gel has been observed to become slightly opaque or to form a slight precipitate upon instillation into the eye. Should this be observed, the cloudy or precipitated material should be removed by irrigation and/or aspiration. Product should be stored in its original packaging at a temperature between 2 ̊C – 25 ̊C. Do not freeze.

Directions for Use: Clean the skin around the injection site with antiseptic and allow to dry before giving injection. If joint effusion is present it should be aspirated before injection of HA. Discard the syringe and needle after single use. A suggested dosage regimen is injection into the affected joint space once a week for up to four injections depending on the severity of degenerative change to the knee joint. Alternatively, ad hoc injections may be given. The therapeutic effect of Solatum™ HA Intra-articular Joint Injection Gel may last for up to three months. Transient pain and a feeling of heat may occur with intra-articular injections. These will disappear spontaneously in 2 to 3 days. If there is no improvement, then stop using and use appropriate symptomatic treatment.

Applications:

• Cataract surgery and Intra Ocular Lens (OCL) implantation: The required amount of Solatum™ VED gel is slowly infused through the cannula into the anterior chamber. The protective effect of Solatum™ VED gel as an aid is optimised when the injection is performed prior to cataract extraction and insertion of the IOL and is effective for both intra and extra capsular cataract procedures. Solatum™ VED gel may be applied to IOL prior to insertion. Additional gel can be injected as required to facilitate the surgical procedure.
• Corneal transplant surgery: The corneal button is removed and the anterior chamber filled with Solatum™ VED gel to a level with the surface of the cornea. The donor graft is then placed on top of the gel and sutured into place. Additional Solatum™ VED gel can be used as required as an aid during the operation.
• Glaucoma filtration surgery: Solatum™ VED gel is injected through a corneal paracentesis to restore and maintain anterior chamber volume during the performance of the trabulectomy. Additional gel can be used as required to aid the surgical procedure.

Storage Conditions: Store between 2 ̊C and 25 ̊C in a well ventilated and clean area with relative humidity below 80%. Do not freeze. Protect from light. Poor storage conditions will affect the products performance or could lead to produce contamination.

Disposal: Dispose after use in a sharps bin or appropriate container.

Date of preparation: June 2019