Silicone Oil

Silicone Oils 1000cSt/2000cSt/5000cSt in syringes

 

Features

The D.O.R.C. Silicone oil is a purified silicone oil which allows for a maximum interfacial tension and
minimizes interactions between tissues, cells and endo-tamponades media. The physical properties
include a combination of specific gravity, refractive index and surface tension. The choice of viscosity
offers an optimum balance between easy injection and a stable temporary tamponade.

 

Viscosity: 1000-1500 / 5000-5900 mPas.
Specific Gravity: 0,97 g/cm3 at 25°C.
Surface tension: 21 mN/m against air.
Interfacial tension: 40 mN/m against water.

27G High Infusion Line Silicon oil removal

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EFTIAR Decalin

PFCL in vials and in prefilled syringes

 

Features

EFTIAR offers the vitreoretinal surgeon a temporary tamponade for efficient re-attachment of the retina, release of subretinal fluid, dissection of fibro-vascular proliferation and controlling retinal bleeding.

Maximized purity.
> 99.999 % fluorinated.
Chemically inert liquid.
Transparent, colorless and optically clear.
Low refractive index.
High specific gravity.
Flattening of a detached retina. 

EFTIAR Decalin in prefilled syringe:

Easy-to-use syringe format with flange extender for easy handling.
Avoids requirement for transfer from vial to syringe.
Available in 5ml and 7ml format.

D.O.R.C. PFCL Purity Standards

D.O.R.C.s PFCL manufacturing method uses a proprietary and stringent production and purification process. • These ensure removal of critical impurities • Verification of purity levels is confirmed using analytical methods specifically developed to detect critical impurities. • Using independent analytical methods – sourcing of raw materials is continuously controlled. • Deploying a multi-step purification process.

Indications for use

EFTIAR Decalin liquid is indicated for use as an intra-operative tool for temporary flattening and manipulation of the retina during surgical treatment of retinal detachment, in particular : • Retinal detachment with giant tears. • Retinal detachment with proliferative vitreoretinopathy. • Traumatic Retinal Detachment. • Luxated Lenses. • Intraocular haemorrhage.

EFTIAR Decalin

• High interfacial tension to silicone oil. • Specific gravity: 1,93 g/cm3 at 20°C. • Refractive index: 1,31 at 20°C. • Viscosity: 5,53 mPas at 25°C. • Boiling point: 140,4-142,4°C. • Packaging: 1 vial/syringe of 5ml or 7ml.

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MEMBRANEBLUE-DUAL®

Effective ILM & ERM staining

MEMBRANEBLUE-DUAL®

Effective ILM & ERM staining, high purification – minimum 97% purity

Features

MembraneBlue-Dual® is a dye to stain both the ILM as well as the ERM and PVR membrane, without compromising the staining effect within one injection.

By injecting MembraneBlue-Dual® in the vitreous cavity the membrane will be clearly stained and easily distinguished 
from the underlying, unstained retina and can be removed selectively.

MembraneBlue-Dual® is a stable mix and stains the ILM at the same level as ILM-Blue® and stains the ERM and PVR at a higher level than the classic MembraneBlue.

Due to an integrated carrier 4% PEG solution, MembraneBlue-Dual® can be injected in a BSS filled eye and sinks immediately as a cohesive ball to the fundus of  the eye and only stains the targeted tissue without diffusion throughout the whole globe.

 

Effective ILM & ERM staining due to high purification – minimum 97% purity
MEMBRANEBLUE-DUAL®: Dye for staining ILM, ERM & PVR membranes consists of: 

Combination of TrypanBlue 0,15% + BBG 0,025% + 4% PEG

Highly purified TB + BBG – minimum 97% purity

 

Advanced injection characteristics due “carrier” 4% PEG solution
Creates better injection characteristics under BSS.
Sinks immediately to posterior pole as a cohesive ball. 
Stains only target tissue and no diffusion throughout the eye.

 

Specifications MEMBRANEBLUE-DUAL® 
Composition of one 0.5ml syringe

Brilliant Blue G: 0.125 mg

Trypan Blue: 0.75 mg

PEG: 4% PEG 3350

Concentration: 1.75 g/l

pH-value: 7.3 – 7.6

Osmolality: 301-369 mOsm/kg H2O

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MembraneBlue-Dual®

Purity & safety


MembraneBlue-Dual®is produced according to Current Good Manufacturing Practice (CGMP). MembraneBlue-Dual® is produced with highly purified BBG + Trypanblue at a drug substance level.

Safety tests

Toxicity tests on ARPE-19 human retinal pigment epithelium cells showed an advantageous safety profile of the new products MembraneBlue-Dual®. Increased purity of the dyes as well as the addition of PEG3350 results in even safer products. Safety testing was complemented by electron microscopy ultrastructural analysis and in vitro cytotoxicity tests according to ISO-10993.

Patent protected

USA (6,696,430B1, 6,372,449, 20080090914A1), Australia (75731 8), Japan (4200222), Europe (EP 1 819 366, B1). Technology licensed from D.Western Therapeutics Institute, Inc., Japan.
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