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DESCRIPTION
RETIBLUE is a tissue dye for use as a medical aid in ophthalmic surgery, enables
visualization of connective tissue structures. It is a sterile non-inflammatory solution
of trypan blue dissolved in sodium chloride and buffer solution.
INDICATIONS
- Used as an aid during vitreoretinal surgery in posterior eye segment.
- Used to stain and / or visualize epiretinal membrane and internal limiting membrane
facilitating removal of the tissue and reducing the risk of retinal damage.
- Used to identify and facilitate removal of posterior hyaloid remnants in traction
Diabetic Retinopathy
CONTRAINDICATIONS
No contraindications are known for the use of RETIBLUE when used as directed.
WARNINGS & PRECAUTIONS
- Take the usual precautions for surgical treatments of the posterior eye segment.
- Do not over-fill the vitreous cavity
- Avoid allowing RETIBLUE to get under the retina
- Do not apply RETIBLUE to a macular hole if the internal limiting membrane (ILM)
has already been removed
- Although no allergic reactions to RETIBLUE have been reported, this agent may trigger
allergic reactions in sensitive individuals
- Do not use on children and pregnant women
- Do not use the product after expiry date and if the package has been damaged or opened
- For single use only
- Not for IM/IV injection
ADVERSE EFFECTS
- RETIBLUE is tolerated well following injection into the vitreous cavity during ophthalmic
surgery procedures. It is recommended that RETIBLUE be removed immediately after
i njection in the vitreous space.
- Extreme care must be taken when using RETIBLUE on patients who are hypersensitive
to any of its components.
- During animal experiments, teratogenic and / or mutagenic effect has been reported after
repeated and / or high dose intraperitoneal or intravenous injections with trypan blue.
T herefore one should not use in pregnant women and children.
STORAGE
Retiblue should be stored between 20C and 350C.
SUPPLY
Available in sterile 1 ml vial in pack of five.
TECHNIQUE
Before injection of RETIBLUE perform ‘fluid-air-exchange’. i.e. filling the entire vitreous cavity
with air to prevent dilution of RETIBLUE. Then carefully apply RETIBLUE to the retinal
membrane using a blunt cannula, without allowing the cannula to contact or damage the retina.
Adequate staining is achieved as soon as RETIBLUE has come into contact with the retinal
membrane. Next, remove all excess dye from the vitreous body before performing an air-fluid
exchange, to prevent unnecessary spreading of the dye. The routine vitrectomy procedure can
be continued later.
RETIBLUE can also be injected directly in a BSS filled vitreous cavity (instead of injecting
under air). Clinical use showed that after complete vitreous and posterior hyaloid removal,
sufficient staining is achieved after 30 seconds of application under BSS.
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