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DESCRIPTION
AUROSIL is fractionated, purified, sterile and apyrogenic silicone oil designed for prolonged
tamponade after surgical treatment for severe retinal detachment.
CHARACTERISTICS
Viscosity (at 25°C) : 1000 cSt ± 50 cSt
Refractive index (at 25°C) : 1.4013 – 1.4053
Specific Gravity (at 30°C) : 0.9740 ± 0.001
Average Molecular Weight (daltons) : 44,000 ±1000
Poly Dispersion Index : 2.5
Toxic Residue : Nil
Content of -OH-end groups : <70 ppm
INDICATIONS
Retinal detachment with giant tear, retinal detachment with proliferative vitreo retinopathy
(PVR), proliferative diabetic retinopathy (PDR) and traumatic retinal detachment.
CONTRAINDICATION
Pseudophakic patients with silicone intraocular lens (silicone oil can chemically interact and
opacify silicone elastomers).
PRECAUTIONS
As with any surgical procedure, posterior segment surgery using AUROSIL presents risks
which the surgeon must evaluate.
Do not resterilize. Single use product only. Do not use if packaging that ensures sterility is
damaged. Do not use after expiry date.
DIRECTIONS
In aseptic conditions decant 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 is removed from the patient's eye it should be treated as any human
biological product.
ADVERSE REACTIONS
The most common adverse reactions include cataract, anterior chamber oil migration,
keratopathy and glaucoma. Other adverse reactions include optic nerve atrophy,
rubeosis iritis, temporary IOP increase, macular pucker, vitreous hemorrhage, phthisis,
traction detachment, angle block, subretinal strands, retinal rupture, endophthalmitis,
subretinal silicone oil, choroidal detachment, aniridia and cystoid macular edema.
Opacification of silicone IOL has been reported (in-vitro).
ADMIXTURE INCOMPATIBILITY
Do not admix with any other substance prior to injection
STORAGE
Store between 2ºC and 35ºC.
SUPPLY
10 ml vial in a sterile pouch |
