Presentation of MONOBLUE NafX 0.15%

Monoblue NafX is a high-density purified trypan blue for staining of the Inner Limiting and Epiretinal Membranes.trypan-blue

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Improves tolerance thanks to its purification

To provide maximum tolerance, the exclusive Arcadophta purification process guarantees the extraction of toxic components such as o-toluidine – violet – and monoazoic by-products, thereby improving MonoBlue NafX tolerance.

ultra pure trypan blue

Improves tolerance thanks to the addition of mannitol

The addition of mannitol, known for its antioxidant properties, combined with already purified trypan blue, increases tolerance of Monoblue NafX.

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Reduces operating times

Monoblue NafX, heavier than water, makes it possible to avoid fluid-air exchange and reduce the operating time needed for staining.

save-time-operation

Improves contact with ILMs and ERMs

Thanks to its higher density than water, MonoBlue NafX improves dye/membrane contact.

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Testimony

In its new formulation the dye is quite remarkable with enhanced staining properties and a sufficiently high weight to spread to the posterior pole (rather than dispersing in the vitreous cavity).

We can thus identify the posterior hyaloids, the epimacular membrane, the inner limiting and PVR (Proliferative Vitreoretinopathy) membranes, which makes it a choice instrument for guiding and identifying these thin structures and improving the quality of dissection and certainly facilitating their identification.

Dr Babak Mashhour, Paris, France
Surgeon Babak Mashhour

Indications

For the POSTERIOR segment.

  • Staining of the ILMs and ERMs
  • Facilitates manipulations of vitreoretinal operations
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Technical specifications

MONOBLUE NAFX: Sterile and apyrogenic Trypan blue solution

Composition – Properties

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Purified trypan blue 0.15%, isotonic buffered vehicle

  • monopotassic phosphate
  • disodic phosphate
  • sodium chloride
  • mannitol 2.5%
  • deuterium oxide
  • water for injection
  • pH 7.25±0.25, osmolarity 300±50 mOsm/Kg H2O, density adapted.

Description

 MONOBLUE NAFX is a purified trypan blue isotonic sterile and apyrogenic solution presented in single dose syringe containing 0.75ml of 0.15% solution. The syringe together with a connector is packaged in a pouch. It is externally sterile. Each box contains 5 syringes MONOBLUE NAFX and 5 tuberculin syringes 1 ml. A set of patient labels is provided to allow traceability. MONOBLUE NAFX does not contain latex, phtalates or preservatives.

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Indications

MONOBLUE NAFX is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes and internal limiting membrane during the surgical vitrectomy procedures, facilitating removal of the membranes.
MONOBLUE NAFX is intended to be applied directly on areas where membranes could be present, staining any portion of the membrane which comes into contact with the dye. The dye does not penetrate the membrane.

Contraindications – Precautions

MONOBLUE NAFX is well tolerated by the ocular tissues.
The intraocular tissues integrity should be taken in consideration to control the staining of the target tissue and to avoid non expected staining of other tissues.
Avoid subretinal injection.
MONOBLUE NAFX should be used only for the retinal surgery application.
Do not use in pregnant women or with presumption of pregnancy. Do not use in nursing women or infants. Do not use in patients with known hypersensitivity.
Use MONOBLUE NAFX with caution when a hydrophilic acrylic intraocular lens is planned to be inserted into the eye, the hydrated material having shown potential reversible absorption of the dye.
MONOBLUE NAFX is contraindicated when a non-hydrated (dry state) hydrophilic acrylic intraocular lens is planned to be inserted into the eye, the dye may be absorbed by the lens and stain it.
Thoroughly rinse the excess product with a saline solution immediately after application.
Single use medical device, do not resterilize.
Multiple use of MONOBLUE NAFX syringe will not allow guarantying the sterility of the solution any more.
The integrity of the device is guaranteed if the packaging is not damaged. Do not use if the pouch is compromised.
Do not use after expiration date.
Only use cannula between 20g and 25g.

Storage conditions

Store in the original packaging, at ambient temperature, protected from light, in a clean dry place. Do not refrigerate. Do not freeze.

Instructions for use

Prepare the injection syringe: adapt the connector onto the glass syringe. Then connect the tuberculin syringe to the other end of the connector, slowly transfer the total volume of MONOBLUE NAFX into the tuberculin syringe by pushing the glass syringe plunger, disconnect the connector and replace by the injection cannula.
Verify the good mobility of the plunger before use, to avoid an unexpected jet which may lead to a subretinal passage of the solution. Protection of the retina may be achieved with the interposition of an instrument between the retina and the cannula output.
Before injection of MONOBLUE NAFX a fluid-air exchange is not required, however it may be performed by filling the entire vitreous cavity with air, to prevent aqueous dilution of MONOBLUE NAFX. Carefully apply MONOBLUE NAFX using a blunt cannula onto the retinal membrane by gently pushing the syringe plunger. Make sure the cannula does not contact the retina to prevent damage. Remove all excess dye from the vitreous cavity before performing air-fluid exchange to prevent the spreading of the dye. MONOBLUE NAFX can also be injected in a BSS filled vitreous cavity; 30 to 60 seconds of application under BSS is usually sufficient to achieve appropriate staining.

Method of sterilization

Autoclave

Bibliography

Staining for internal limiting membrane peeling

Ultrastructure and retinal imaging of internal limiting membrane: a clinicopathologic correlation of trypan blue stain inmacular hole surgery. Retina. 2010 Apr;30(4):655-61.
Mackenzie SE, Gandorfer A, Rohleder M, Schumann R, Schlottmann PG, Bunce C, Xing W, Gregor Z, Charteris DG.

Trypan blue-assisted peeling of the internal limiting membrane during macular hole surgery.Am J Ophthalmol. 2003 Jun; 135(6):903-5.
Perrier M, SĂ©bag M.

Staining for epiretinal membrane peeling.

Role of trypan blue in epiretinal membrane surgery J Fr Ophtalmol. 2005 Mar;28(3):290-7.
Balayre S, Boissonnot M, Curutchet L, Dighiero P.

Trypan blue staining ofepiretinal membranes in proliferative vitreoretinopathy. Arch Ophthalmol 2002 Feb;120(2):141-4.
Feron EJ, Veckeneer M, Parys-Van Ginderdeuren R, Van Lommel A, Melles GR, Stalmans P.

N-acetylcysteine suppresses retinal detachment in an experimental model of proliferative vitreoretinopathy. Am J Pathol. 2010 Jul; 177(1):132-40
Lei H, Velez G, Cui J, Samad A, Maberley D, Matsubara J, Kazlauskas A.

Improved tolerance of trypan blue associated with Mannitol.

1. Therapeutic effects and mechanisms of action of mannitol during H2O2-induced oxidative stress in human retinal pigment epithelium cells. J Ocul Pharmacol Ther. 2010 Jun;26(3):249-57.
Liu JH and a.

2. Mannitol, dextromethorphan, and catalase minimize ischemic damage to retinal pigment epithelium and retina. Arch Ophthalmol. 1993 Mar;111(3):384-8.
Gupta LY, Marmor MF.