CATARACT SURGICAL PRODUCTS

APPAVISC

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

Preservative Free Sterile Solution

DESCRIPTION:

APPAVISC (Hydroxypropyl Methylcellulose Opthalmic Solution USP) is sterile, a pyrogen free clear & transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2-hydroxypropyl methyl ether. Each mL contains: Hydroxyp ropyl Methylcellulose USP 2% w/v & Sterile isotonic base q.s.

MODE OF ACTION (Mechanism Of Action)

HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues. The HPMC also shows to decrease the damage of corneal endothelial surgery.
It is routinely used as an adjuvant in cataract surgery, IOL, corneal transplantation and surgery of glaucoma.HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INTENDED USE

Appavisc is indicated as a surgical aid (medical device ) in anterior segment surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk o f damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.

WARNING

Do not use if the solution becomes dark brown or any floating particles are observed If pouch is damaged should not be reused. In-case of any serious accident in relation to the device, inform to the manufacturer and to the regulatory authority.

PRECAUTIONS

GENERAL: Overfilling of APPAVISC in anterior chamber should be avoided as it may raise lOP cause glaucoma. APPAVISC is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISC should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Vials and cannula once used should be discarded.

DRUG INTERACTIONS

Since HPMC is an inert substance and does not have any pharmacological action, no evidence suggests that the drug in intraocular millieu bind to APPAVISC solution to any significant degree. There is no evidence of drug binding established so far.

SIDE EFFECTS

APPAVISC has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any significant degree when in the anterior chamber. It obstructs the outflow mainly trabucular meshwork into schlemms canal. A spike of IOP is more likely to occur in early hours of surgery (maximum 4-7 hours and often returns to baseline 24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema. Severe corneal edema may occur due to thiomersal residues of reused Viscoelastic cannulas. There is a significant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the viscoelastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

DOSAGE AND ADMINISTRATION

APPAVISC (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula supplied along with the pack. It may be injected into the chamber prior to or following delivery of intraocular lens (IOL). It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure.

PREPARATION & ADMINISTRATION GUIDE

Appavisc should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use.
1. Remove the vial from its packging in a sterile environment
2. Open the vial, withdraw the solution using sterile disposable syringe
3. Open the cannula and firmly screw it into the lock fitting
4. Depress the pluger and discard the first 0.1 to 0.3 ml of fluid
5. Do not overfill the eye chamber with Appavisc.
6. At the closing of procedure, irrigate the Appavisc out of the anterior chamber with Balanced Salt Solution (BSS).

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation.
Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation & aspiration of solution leads to reversible eye infection.

HOW SUPPLIED

APPAVISC is a sterile , single use viscoelastic device supplied in a non-pyrogenic glass vial containing 3mL or 5mL with single use sterile angular cannula 23 G.

STORAGE

Store in dry Place. Store away from sunlight. Store between 15°C to 25°C.

PACKING

APPAVISC 3mL or 5mL packed in 5mL glass vial with one sterilized disposable cannula.
Waste Disposal Method:
Dispose in accordance with local, state and federal regulations.

APPAVISC PFS

Pack : 2ml, 3ml

DESCRIPTION:

Appavisc is a viscoelastic solution of optimum viscosity It contains highly purified grade of HPMC 2% w/v. It is clear isotonic sterile, non inflammatory used as a lubricant and protector in IOL surgery.
GENERIC NAME: Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP

COMPOSITION:

Each ML Contains :

• Hydroxy Propyl Methyl Cellulose USP.... 2% w/v.

PRODUCT  FEATURES:

• Clear Visualization.
• Preservative free sterile solution.
• Optimum Viscosity.
• Better chamber maintenance.
• Friendly with corneal endothelium.
• Provide excellent Lubrication.
• Simple to remove from the anterior chamber.

VISCOSITY:

Appavisc   PFS - NLT 5000 cps

PACKAGING

Primary packing - 2 & 3 mL plastic syringes, plunger stopper, plunger rod & pouch.
Secondary Packing - Carton box with 23G Sterile Cannula.

AVAILABILITY

Appavisc   PFS - 2 mL and 3 mL pre-filled plastic syringe in double pouch.

SHELF LIFE:

24 months from the date of manufacturing.

APPAVISC HV PFS

Pack : 2ml

Composition

Hydroxy Propyl Methyl Cellulose USP 2% w/v

Product Description

Appavisc HVPFS(Hydroxy Propyl Methyl CelluloseOpthalmic Solution USP) is a sterile, a pyrogen free clear & transparent solution of higher viscosity. It contains highly purified grade of HPMC 2% having higher viscosity.It is isotonic and non-inflammatory.Used as lubricant and protector in IOL surgery.

Product Features

• Clear Visualization
• reservative free sterile solution
• Optimum ciscasity• Better chamber maintainance
• Provide excellent Lubrication
• Simple to remove from the the anterior chamber

Indications

As a surgical aid (Medical device) during cataract surgery. Maintains the depth of the anterior chamber with out the risk of the damaging the abstacle of the cornea or other with occular tissue.

Contraindication:

No contraindications known when used as per instruction.

Supply

Available in Sterile 2ml pre-filled syringes.

STORAGE:

Store between 15ºC-25ºC.

INDICATIONS:

As a surgical aid (Medical device) during cataract surgery. Maintains the depth of the anterior chamber without the risk of the damaging the endothelium of the cornea or other intra-ocular tissues.

CONTRAINDICATION:

Contraindicated in patients with known history hypersensitivity to its ingredients.

USES:

Appavisc-PFS 2%w/v injection is used to relieve burning, irritation and discomfort of dry eye conditions associated with-deficient tear production, infrequent blinking, smoke, wind, pollution, extended use of computer screen or television, medical treatment, dry atmospheric conditions (air-conditioning, central heating). It may also be used to aid insertion of hard contact lenses and increase comfort during wear. It is also indicated to aid certain eye examinations and surgeries.

HOW IT WORKS:

Appavisc-PFS 2%w/v injection belongs to a class of medicines called eye lubricants or artificial tears. It reduces dryness and irritation by wetting and lubricating the surface of eye.

COMMON SIDE EFFECTS:

Blurred vision, eye pain, eye irritation.

SUPPLY:

Available in 2mL & 3mL Sterile pre-filled syringes & 23 Gauge Cannula. one syringe & 23 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

COHEVISC 1.0

Pack : 1ml Pack

DESCRIPTION:

Cohevisc Ophthalmic Solution (Sodium Hyaluronate 1.0, 1.4 & 1.8) is a cohesive high quality viscoelastic formulation. It has high molecular weight, high pseudoplasticity, and high surface tension. Facilitates IOL implantation can be easily removed.
GENERIC NAME: Sodium hyaluronate ophthalmic Solution

COMPOSITION:

1. COHEVISC 1.0:

Each ML Contains :

  • Sodium Hyaluronate BP....10 mg
  • Sterile Isotonic Solution....q.s.

2. COHEVISC 1.4:

Each ML Contains :

  • Sodium Hyaluronate BP....14 mg
  • Sterile Isotonic Solution....q.s

3. COHEVISC 1.8:

Each ML Contains :

  • Sodium hyaluronate BP....18mg
  • Sterile Isotonic Solution...q.s.

PRODUCT FEATURES:

  • Easy implementation.
  • Protects against mechanical damage.
  • Better Increased protection to corneal endothelium.
  • Good maintenance of the anterior chamber and capsules.

PACKAGING:

Primary packing- 2.25 mL glass syringe & pouch
Secondary Packing - Carton box, 27G Sterile Cannula.

INDICATIONS:

  • Cataract extraction.
  • IOL implementation.
  • Vitrectomy.
  • Surgical procedure detach the retina.

VISCOSITY:

1. Cohevisc 1.0

:

40,000 to 1.5 lakh cps

2.Cohevisc 1.4

:

60,000 to 2.0 lakh cps

3. Cohevisc 1.8

:

NLT 1,00,000 cps

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 80C-250C.

AVAILABILITY:

1. Cohevisc 1.0

:

1ml in Pre filled glass syringes

2. Cohevisc 1.4

:

1ml in Pre filled glass syringes

3. Cohevisc 1.8

:

1ml in Pre filled glass syringes

INTENDED USE:

Cohevisc, visco ophthalmic surgical device is indicated as an aid for ophthalmic surgical and anterior segment during cataract extraction and IOL implantation. Cohevisc helps to maintain a deep anterior chamber during anterior segment surgery reduce trauma to the corneal endothelium and surrounding ocular tissue. It helps to push back the vitreous face and prevent formation of a flat chamber during the surgery.

DIRECTION OF USE:

Cataract surgery and intraocular lens (IOL) implantation: Instill Cohevisc slowly in to the artificially created opening in the eye through the blunt cannula into the anterior chamber. The use of Cohevisc is most effective when the Instill is made before phacoemulsification, removal of the cataract and before insertion of the IOL. Cohevisc can also be applied to the IOL before placement. During the procedure, more Cohevisc can be infused for anterior chamber maintenance or to replace viscoelastic lost during surgery. At the end of the surgical procedure

CONTRAINDICATION:

No contraindications known when used as per instruction.

SUPPLY:

Available in 1mL Sterile pre-filled glass syringes & 27 Gauge Cannula. one syringe & 27 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

COHEVISC 1.4

Pack : 1ml Pack

DESCRIPTION:

Cohevisc Ophthalmic Solution (Sodium Hyaluronate 1.0, 1.4 & 1.8) is a cohesive high quality viscoelastic formulation. It has high molecular weight, high pseudoplasticity, and high surface tension. Facilitates IOL implantation can be easily removed.
GENERIC NAME: Sodium hyaluronate ophthalmic Solution

COMPOSITION:

1. COHEVISC 1.0:
Each ML Contains :

  • Sodium Hyaluronate BP....10 mg
  • Sterile Isotonic Solution....q.s.

2. COHEVISC 1.4:
Each ML Contains :

  • Sodium hyaluronate BP.....14mg
  • Sterile Isotonic Solution....q.s.

3. COHEVISC 1.8:
Each ML Contains :

  • Sodium hyaluronate BP....18mg
  • Sterile Isotonic Solution...q.s.

PRODUCT FEATURES:

  • Easy implementation.
  • Protects against mechanical damage.
  • Better Increased protection to corneal endothelium.
  • Good maintenance of the anterior chamber and capsules.

PACKAGING:

Primary packing- 2.25 mL glass syringe & pouch
Secondary Packing - Carton box, 27G Sterile Cannula.

INDICATIONS:

  • Cataract extraction.
  • IOL implementation.
  • Vitrectomy.
  • Surgical procedure detach the retina.

VISCOSITY:

1. Cohevisc 1.0

:

40,000 to 1.5 lakh cps

2.Cohevisc 1.4

:

60,000 to 2.0 lakh cps

3. Cohevisc 1.8

:

NLT 1,00,000 cps

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 80C-250C.

AVAILABILITY:

1. Cohevisc 1.0

:

1ml in Pre filled glass syringes

2. Cohevisc 1.4

:

1ml in Pre filled glass syringes

3. Cohevisc 1.8

:

1ml in Pre filled glass syringes

INTENDED USE:

Cohevisc, visco ophthalmic surgical device is indicated as an aid for ophthalmic surgical and anterior segment during cataract extraction and IOL implantation. Cohevisc helps to maintain a deep anterior chamber during anterior segment surgery reduce trauma to the corneal endothelium and surrounding ocular tissue. It helps to push back the vitreous face and prevent formation of a flat chamber during the surgery.

DIRECTION OF USE:

Cataract surgery and intraocular lens (IOL) implantation: Instill Cohevisc slowly in to the artificially created opening in the eye through the blunt cannula into the anterior chamber. The use of Cohevisc is most effective when the Instill is made before phacoemulsification, removal of the cataract and before insertion of the IOL. Cohevisc can also be applied to the IOL before placement. During the procedure, more Cohevisc can be infused for anterior chamber maintenance or to replace viscoelastic lost during surgery. At the end of the surgical procedure

CONTRAINDICATION:

No contraindications known when used as per instruction.

SUPPLY:

Available in 1mL Sterile pre-filled glass syringes & 27 Gauge Cannula. one syringe & 27 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

COHEVISC 1.8

Pack : 1ml Pack

DESCRIPTION

Cohevisc Ophthalmic Solution (Sodium Hyaluronate 1.0, 1.4 & 1.8) is a cohesive high quality viscoelastic formulation. It has high molecular weight, high pseudoplasticity, and high surface tension. Facilitates IOL implantation can be easily removed.GENERIC NAME: Sodium hyaluronate ophthalmic Solution

COMPOSITION:

1. COHEVISC 1.0:
Each ML Contains :

  • Sodium Hyaluronate BP....10 mg
  • Sterile Isotonic Solution....q.s.

2. COHEVISC 1.4:
Each ML Contains :

  • Sodium hyaluronate BP.....14mg
  • Sterile Isotonic Solution....q.s.

3. COHEVISC 1.8:
Each ML Contains :

  • Sodium hyaluronate BP....18mg
  • Sterile Isotonic Solution...q.s.

PRODUCT FEATURES

  • Easy implementation.
  • Protects against mechanical damage.
  • Better Increased protection to corneal endothelium.
  • Good maintenance of the anterior chamber and capsules.

PACKAGING

Primary packing- 2.25 mL glass syringe & pouch
Secondary Packing - Carton box, 27G Sterile Cannula.

INDICATIONS:

  • Cataract extraction.
  • IOL implementation.
  • Vitrectomy.
  • Surgical procedure detach the retina.

VISCOSITY:

1. Cohevisc 1.0

:

40,000 to 1.5 lakh cps

2.Cohevisc 1.4

:

60,000 to 2.0 lakh cps

3. Cohevisc 1.8

:

NLT 1,00,000 cps

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 80C-250C.

AVAILABILITY:

1. Cohevisc 1.0

:

1ml in Pre filled glass syringes

2.Cohevisc 1.4

:

1ml in Pre filled glass syringes

3. Cohevisc 1.8

:

1ml in Pre filled glass syringes

INTENDED USE

Cohevisc, visco ophthalmic surgical device is indicated as an aid for ophthalmic surgical and anterior segment during cataract extraction and IOL implantation. Cohevisc helps to maintain a deep anterior chamber during anterior segment surgery reduce trauma to the corneal endothelium and surrounding ocular tissue. It helps to push back the vitreous face and prevent formation of a flat chamber during the surgery.

DIRECTION OF USE

Cataract surgery and intraocular lens (IOL) implantation: Instill Cohevisc slowly in to the artificially created opening in the eye through the blunt cannula into the anterior chamber. The use of Cohevisc is most effective when the Instill is made before phacoemulsification, removal of the cataract and before insertion of the IOL. Cohevisc can also be applied to the IOL before placement. During the procedure, more Cohevisc can be infused for anterior chamber maintenance or to replace viscoelastic lost during surgery. At the end of the surgical procedure

CONTRAINDICATION:

No contraindications known when used as per instruction.

SUPPLY:

Available in 1mL Sterile pre-filled glass syringes & 27 Gauge Cannula. one syringe & 27 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

RHEX-ID

Pack : Each Ml Contains

DESCRIPTION:

Rhex ID (Trypan Blue sterile solution preservative free) 0.8 mg is a sterile solution of Trypan Blue solution (an acid di-azo group dye).
Rhex ID (Trypan Blue solution) is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Each mL of Rhex ID (Trypan Blue solution) sterile solution contains not more than 0.8 mg of Trypan Blue and 8.2 mg of Sodium Chloride in a aqueous buffered.It is a blue dye (Sodium ditolyldisazobis-8-amino-1-naphthol-3,6-disulfonate) used to stain capsules and has very low toxicity profile. It is available as a 0.1% solution.GENERIC NAME: Trypan Blue Sterile Solutions

COMPOSITION:

Each ML Contains:

● Trypan Blue ............0.8mg
● Sodium Chloride USP.......8.2mg
● Aqueous Buffered Vehicle......q.s.

PACKAGING

Primary packing - 5ml Clear Poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 150C-250C.

CLINICAL PHARMACOLOGY:

Rhex ID (Trypan Blue Solution) selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens.
Rhex ID (Trypan Blue Solution) is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.

CONTRA-INDICATIONS:

Rhex ID (Trypan Blue Solution) is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye because the dye may be absorbed by the IOL and stain the IOL.

INDICATION:

To stain the anterior capsule during capulorrhexis and in macular hole surgery capsule for muculorrhexis (it stains the internal limiting membrane)

ADVERSE EFFECTS:

It is well tolerated though rare reports of post surgical inflammatory reactions and bullous keratopathy are reported.

WARNING & PRECAUTION:

It is harmful if used systemically as it has been used as an experimental teratogen and may cause liver damage.
General: It is recommended that after injection all excess Rhex ID be immediately removed from the eye by thorough irrigation of the anterior chamber. Carcinogenesis, mutagenesis, impairment of fertility.
Rhex ID is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 1,250,000-fold the maximum recommended human dose of 0.8 mg per injection in a 60 kg person, assuming total absorption).
Rhex ID was mutagenic in the Ames test and caused DNA strand breaks in vitro.
● Do not use the products after the expiry date.
● Do not use on children.
● For single use only
● Not for injection

DOSAGE AND ADMINISTRATION:

It is available as 1 mg single use vials. Each ml contains 0.8mg trypan blue. It can be injected in the anterior chamber ideally under air bubble and is allowed to stay for a minute to allow staining before removal.

CATARACT SURGERY:

Rhex ID is packaged in a 2.0 mL glass vial in sterile pouch. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of Rhex ID by the aqueous.
Rhex ID
is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.

SUPPLY:

1 ml solution (TRYPAN-BLUE SOLUTION) filled in 2 ml glass vial packed with printed labelled pouch & cartons And Such Carton Packed in a corrugated shipper box.

SUPRACOAT

Sodium Chondroitin Sulphate & Sodium Hyaluronate Ophthalmic Solution

DESCRIPTION:

SUPRACOAT is a sterile, non-pyrogenic, viscoelastic solution of a highly purified non- inflammatory medium molecular weight fraction of sodium chondroitin sulphate and sodium hyaluronate. SUPRACOAT solution is formulated to a viscosity of 20000 to 60000 cps (at shear rate of 2 sec.-1 25°C). Each mL of SUPRACOAT Solution contains not more than 40 mg sodium chondroitin sulphate and 17 mg sodium hyaluronate in a physiological buffer.
Sodium chondroitin sulphate and sodium hyaluronate are quite similar in regard to chemical and physical composition, as each occurs as a large, unbranched chain structure of medium to high molecular weight.

COMPOSITION:

Each ML Contains:

  • Sodium chondroitin sulphate   USP ............40 mg
  • Sodium hyaluronate     BP ............17 mg
  • Aqueous Buffered Solution .............q.s.

INDICATION:

Viscoelastic Solution is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction. Ophthalmic viscoelastic solutions serve to maintain a deep anterior chamber during anterior segment surgery, thereby reducing trauma to the corneal endothelium and surrounding ocular tissues. They help to push back the vitreous face and prevent formation of a flat chamber postoperatively.

PHARMACOLOGICAL ACTION:

SUPRACOAT solution maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face, thus preventing formation of a postoperative flat chamber. The sugar moieties of these two compounds occur as repeating disaccharide subunits consisting of glucuronic acid in B 1-3 linkage with Nacetylglucosamine for sodium chondroitin sulphate and Nacetylglucosamine for sodium hyaluronate. The subunits are then combined by B 1-4 linkage of the amino sugar residue to the glucuronic residue of the next subunit to form large polymers. The two compounds differ in that sodium chondroitin sulphate possesses a sulphate group and a double, rather than a single, negative charge (as in the case of sodium hyaluronate) per repeating disaccharide subunit. Sodium chondroitin sulphate and sodium hyaluronate are biological polymers centered in the extra-cellular matrix of animals and humans. The cornea is the ocular tissue having the greatest concentration of sodium chondroitin sulphate, while the vitreous and aqueous humor contain the greatest concentration of sodium hyaluronate. SUPRACOAT solution is completely transparent and exhibits flow properties.

CONTRA-INDICATIONS:

There are no contra-Indications recorded on using SUPRACOAT, If Used as recommended. CLINICAL APPLICATIONS: In surgery involving the anterior segment, SUPRACOAT should be carefully and slowly injected into the anterior chamber using a sterile single-use Luer lock canula (in no case a reusable cannula should be used, even if it is well cleaned, rinsed and re-sterilized since it could release particles during injection) SUPRACOAT is injected before the capsulorhexis procedure, so that its protective effect will be optimized. At this stage of the surgery, SUPRACOAT protects the endothelium of the cornea from potential damage by surgical instruments. SUPRACOAT may be injected into the anterior chamber several times during surgery to replace the product lost during the surgical procedure. At the end of the surgery, SUPRACOAT should be aspiration with sterile irrigating solution.

DOSAGE AND DIRECTIONS FOR USE:

FOR INTRAOCULAR USE ONLY
FOR SINGLE USE ONLY
NOT FOR IV/IM INJECTION

SUPRACOAT should be allowed to attain room temperature prior to use. The syringe assembly is designed only for the injection of the SUPRACOAT viscoelastic solution it contains. Use of the syringe assembly for aspiration is not advised. When left in the eye, endothelial loss can be expected to be lower. For cataract surgery and intraocular lens implantation SUPRACOAT solution should be carefully introduced (using a 27-gauge cannula) into the anterior chamber. SUPRACOAT solution may be injected into the chamber prior to or following delivery of the crystalline lens. Instillation of SUPRACOAT solution prior to lens delivery will provide additional protection to the corneal endothelium. Instillation of the solution at this point is significant in that a coating of SUPRACOAT solution may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery. SUPRACOAT solution may also be used to coat an intraocular lens as well as the tips of surgical instruments prior to implantation surgery. Additional solution may be injected during anterior segment surgery to fully maintain the chamber or replace any solution lost during the surgical procedure. At the end of the surgical procedure SUPRACOAT solution may be removed from the eye by thoroughly irrigating and aspirating with a balanced salt solution. Alternatively SUPRACOAT solution may be left in the eye, when used as directed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Atransient rise in intraocular pressure may be expected due to the presence of sodium hyaluronate which has been shown to effect such a rise. The intraocular pressure should be carefully monitored and appropriate therapy instituted if significant increases occur. In high risk patients tonometry should be performed on the first and second post-operative days. Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium chondroitin sulphate and sodium hyaluronate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

WARNINGS:

Do not use if package is damaged. Do not resterilize. Resterilization on this product has not been validated. Discard remaining solution after single use. Do not freeze. Physical, chemical and microbiological parameters may not be guaranteed if SUPRACOAT is reused

PRESENTATION:

SUPRACOAT solution is a sterile, non-pyrogenic, 1 mL, viscoelastic preparation supplied in a disposable syringe with a threaded luer. Lock. A sterile 27-gauge, disposable, bent, blunt-tip cannula is provided separately.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

Store between 10°C-25°C. Protect from light. The contents are sterile unless the package is opened or broken. Do Not Freeze. Keep Out of the Reach of Children.

NOTE:

For Use during surgery Do not exert more pressure on the plunger prior to removing the cannula from the eye. This is to avoid aspiration of air Bubbles into the cannula.