INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CELLUGEL®

Rev. 0208

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CELLUGEL®
Ophthalmic viscosurgical device

COMPOSITION
CELLUGELOphthalmic viscosurgical device is a sterile, nonpyrogenic, non-inflammatory, non-proteinaceous, viscoelastic solution of purified 2% (m/v)
hydroxypropyl methylcellulose (HPMC) with an average molecular weight of 400 000 Daltons, dissolved in an isotonic physiological buffer.
Each ml of CELLUGEL contains 2% (m/v) HPMC, 0.525% (m/v) sodium chloride, 0.075% (m/v) potassium chloride, 0.048% (m/v) calcium chloride, 0.03% (m/v) magnesium chloride, 0.39% (m/v) sodium acetate, 0.17% (m/v) sodium citrate and water for injection.

PHARMACOLOGICAL CLASSIFICATION
A.3 Connective Tissue Medicine

PHARMACOLOGICAL ACTION.
CELLUGEL maintains a deep anterior chamber during anterior segment surgery, and protects the corneal endothelium and other ocular tissues. CELLUGEL helps to push back the vitreous face, thus preventing formation of a flat chamber during surgery. CELLUGELis completely transparent, acts as a space-occupying fluid, having an osmolality of 315 +35 mOsM, pH 7.2 and a viscosity of 30 000 +10 000 mPa.s (at 0.2 sec-1, 25°C).

INDICATIONS
CELLUGEL is indicated for use as a surgical aid in anterior segment surgical procedures including cataract extraction and intraocular lens (IOL) implantation.

CONTRA-INDICATIONS
Hypersensitivity to any of the components in this preparation.

WARNINGS
For intraocular use only
For single use only

DOSAGE AND DIRECTIONS FOR USE
Cataract surgery - IOL implantation
For cataract surgery and intraocular lens implantation, CELLUGEL Ophthalmic viscosurgical device should be carefully injected into the anterior chamber prior to capsulotomy using standard aseptic techniques and only the cannula provided with the product. CELLUGELmay be injected into the chamber prior to or following removal of the crystalline lens. Instillation of CELLUGEL prior to lens removal will provide protection to the corneal endothelium from possible damage due to surgical instrumentation during cataract surgery.
CELLUGELmay also be used to coat an intraocular lens prior to implantation as well as the tips of surgical instruments. Additional CELLUGELmay be injected during anterior segment surgery to fully maintain the chamber or replace any volume lost during the surgical procedure. At the end of the surgical procedure it is recommended that CELLUGEL be removed from the eye as completely as possible by irrigation and/or aspiration.
Directions For Use
FOR INTRAOCULAR USE ONLY.
BOTH CELLUGEL AND CANNULA ARE FOR SINGLE USE ONLY.
The syringe assembly is designed only for the injection of the CELLUGELOphthalmic viscosurgical device it contains. Use of the syringe assembly for aspiration is not advised.
1. Using sterile technique, peel open the pouch containing the sterile syringe or cannula and drop the contents onto a sterile field.
2. Remove cap from syringe tip.
3. It is recommended that the cannula hub be filled with balanced salt solution prior to attaching the cannula to the syringe in order to minimize the introduction of air bubbles into the anterior chamber.
4. Firmly attach the cannula to the tip of the syringe.
5. Remove plastic cartridge from cannula.
6. Purge the remaining air from the system by holding the syringe barrel with one hand and gently depressing the plunger rod with the other hand until CELLUGEL appears at the cannula tip.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
A transient rise in intraocular pressure has been reported. For this reason, IOP should be monitored and appropriate therapy instituted if significant increases occur.
Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscosurgical preparations, as well as incidents of corneal oedema and corneal decompensation.
PRECAUTIONS
Precautions normally associated with the surgical procedure should be observed.
It is recommended that CELLUGEL be removed from the anterior chamber by irrigation and/or aspiration at the end of surgery. Do not overfill the anterior chamber.
In addition, the following precautions should be observed
- Do not re-use cannulas
- Use only if material is clear
- Avoid trapping air bubbles within CELLUGEL before injection
- This Product Contains Dry Natural Rubber

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
None known

IDENTIFICATION
CELLUGELis a clear, colourless viscoelastic solution.

PRESENTATION
Supplied in a sterile disposable glass syringe delivering 1.0 ml of CELLUGELintraocular viscoelastic solution, packaged in a sterile peel pouch. A sterile, disposable blunt-tipped cannula is provided.

STORAGE INSTRUCTIONS
Store at room temperature below 25°C.
PROTECT FROM FREEZING AND LIGHT.
The contents are sterile unless the package is opened or broken.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
35/3/0326

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Alcon Laboratories (SA)(Pty) Ltd
261 Surrey Avenue
Randburg 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT
27 June 2001

Rev. 0208

New to this site: March 2003
Source: Pharmaceutical Industry

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