AUROSIL PLUS-(5000 cSt) is a (Purified Polydimethyl siloxane) highly purified long chain Polydimethyl siloxane trimethyl siloxy terminated silicone oil designed for prolonged tamponade after surgical treatment for severe retinal detachment. CHARACTERISTICS Viscosity (at 25°C) Refractive index (at 25°C) Specific gravity (at 25°C) Average Molecular Weight (Daltons) Toxic Residue Content of –OH end groups INDICATIONS : 5000 cSt ± 250 cSt : 1. 4013- 1. 4053 : 0. 967 – 0.
975 : 50,000 ± 1000 : Nil : < 70 ppm AUROSIL PLUS is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments like proliferative vitreoretinopathy (PVR), traumatic retinopathy, Proliferative diabetic retinopathy (PDR), Cytomegalovirus (CMV) retinitis, Giant tears, primary use in AIDS – related CMV retinitis and other viral infections affecting the retina. CONTRAINDICATION ? stability Greater ? emulsification due to a Reduced.
AUROSIL PLUS is contraindicated in patients with known hypersensitivity to silicone oil. In Pseudophakic patients with silicone intraocular lens (silicone oil can chemically interact and opacify silicone elastomers). PRECAUTIONS high degree of purification and low level of reactive -OH end groups ? impregnation Less tissue ? to all physical and Subject As with any surgical procedure posterior segment surgery using AUROSIL PLUS presents risks which the surgeon must evaluate.
Do not resterilize. Single use product only. Do not use if packaging that ensure sterility is damaged. Do not use after the expiry date. DIRECTIONS chemical analysis (H-NMR spectral test, gel permeation chromatography study and gas chromatography) to ensure purity level ? of catalyst impurities Low level In aseptic conditions transfer the contents of the bottle into a sterile syringe. Place the syringe in a syringe driver in order to facilitate the injection.
Plug in the infusion terminal to the tip of the syringe. Inject slowly. During withdrawal avoid leaving silicone bubbles in the vitreo-retinal cavity. Once AUROSIL PLUS is removed from the patient’s eye it should be treated as any human biological product. ADVERSE REACTIONS minimize the risks of interactions with the ocular environment ? High quality product The most common adverse reactions include cataract, anterior chamber oil migration, keratopathy and glaucoma.
Other adverse reactions include cornea band-shaped degeneration, corneal opacity, silicone oil emulsification, angle blockade, macular pucker, optic nerve atrophy, traction detachment, phthisis, redetachment of retina, vitreous hemorrhage, rubeosis iridis, temporary IOP increase, hypotony, endophthalmitis, aniridia, choroidal detachment, subretinal infusion, cystoid macular edema, proliferative vitreoretinopathy reproliferation, subretinal silicone oil, and Corneal decompensation.
ADMIXTURE INCOMPATIBILITY 0197 Do not admix with any other substance prior to injection STORAGE Store between 20C and 350C SUPPLY 10ml vial in a sterile pouch Information published in this catalogue is subject to change without notification aurolab Excellence . . . in sight A R A V I N No 1, Sivagangai Main Road, Veerapanjan, Madurai 625 020, India. Phone: 91 452 2446100 Fax: 91 452 2446200 E-mail: [email protected] com Web: www. aurolab. com D E Y E C A R E S Y S T E M Issue 2 – 08/10.