Ultrapure heavy silicone oil
DENSIRON® 68 is a colourless, homogenous liquid composed of a mixture of ultrapure polydimethylsiloxane (CH3)3SiO-(Si(CH3)2O)n-Si(CH3)3 and ultrapure perfluorohexyloctane (F6H8®). DENSIRON® 68 is chemically and physiologically inert and has a viscosity of 1400 mPas. Heavy silicone oils produced by FLUORON are characterised by their consistently high quality. They contain no low molecular siloxanes, particularly cyclical siloxanes, are free of ionic compounds, and contain no cleavable fluoride. DENSIRON® 68 is used as a temporary retinal tamponade following successful retinal attachment and is removed dependent on the clinical findings. DENSIRON® 68 is used particularly in severe cases of retinal detachment for which conventional treatments would fail.
DENSIRON® 68 is used as a temporary tamponade after operative treatment of severe retinal detachment, particularly for:
• Inferior and posterior retinal holes
• Retinal detachment with giant tears
• Retinal detachment with vitreoretinal proliferation (PVR)
• Retinal detachment in cases of proliferative diabetic retinopathy (PDR)
• Traumatic retinal detachment
Composition 69.5% polydimethylsiloxane and 30.5% perfluorohexyloctane
Physical properties Viscosity (mPas at 25 °C) 1200-1600
Density (g/cm3 at 25 °C) 1.06
Solubility in water immiscible
Refractive index 1.3870
Instructions for use DENSIRON® 68 is used as an agent for temporary retinal tamponades after retinal reattachment. When removing DENSIRON® 68 from the eye it must be ensured that the heavy silicone oil is completely removed from the eye. The treating doctor must determine how long the DENSIRON® 68 will remain in the eye. Experience has shown that if the silicone oil is removed in the post-operative phase, during which the visual acuity neither continues to increase nor drops again, the final result of the surgery can be improved. Apart from eyes where the initial situation was complex, the retention time of DENSIRON® 68 must be kept as short as possible and restricted to a maximum of 3 months.
Any droplets of heavy silicone oil remaining in the eye or adhering to an IOL can be dissolved with a semifluorinated alkane from Fluoron GmbH, e.g. F6H8®, and subsequently removed.
Side effects Use of silicone oils can lead to the formation of cataracts and secondary glaucoma. In isolated cases corneal nubeculae and emulsification have been observed. Interactions with other agents are not known.
Posology instructions Vial: Draw the contents of the vial into a sterile 10 ml syringe and use a 20 G cannula.
The sterile glass syringe can be used immediately.
Attention: DENSIRON® 68 must be visually checked for homogeneity and transparency prior to use. Products with phase separation or cloudiness must not be used!
Packaging DENSIRON® 68 is available in 10 ml units in vials and syringes.
Sterilisation Heat sterilisation with subsequent autoclaving.
Storage conditions DENSIRON® 68 must not be stored below 2°C as this can cause phase separation, rendering the product unusable. After storage for a week at room temperature the phase separation reverses and DENSIRON® 68 can be used once again.
Warnings Do not use this product after the expiry date. The expiry date is shown on the packaging. Only use undamaged packages. Vials and syringes are only intended for a single use.