Medical Device CE 0476, class IIb, for ophthalmic use.
Characteristics
PerFlo Drops sterile, protective, antioxidant, humectant, lubricating eye drops, based on Perilla extract and 0.25% hyaluronic acid.
The formula consists of a slightly hypo-osmolal, slightly viscous, sterile solution, at physiological pH, free of preservatives, comprising a dry Perilla extract in combination with hyaluronic acid (in the form of sodium salt), in a 0.5 ml single-dose package, with high biocompatibility. Perilla extract, obtained from both the seeds and leaves of the plant, contains polyphenols that inhibit the action of free radicals by acting as scavengers, and have an antioxidant effect.
Hyaluronic acid is a polysaccharide polymer with high biocompatibility and has a great capacity for hydration; At the ocular level, it therefore proves to be an excellent humectant and lubricant thanks also to its visco-elastic behavior.
The PerFlo Drops formula, thanks to its specific qualitative-quantitative composition and in particular thanks to the polyphenols contained in the Perilla extract, is able to determine an antioxidant action by counteracting free radicals (such as superoxide radicals) and chelating metals.
Thanks to the antioxidant and anti-free radical properties of its components, the device protects ocular tissues from the consequences of oxidative stress due to unfavorable environmental factors (mechanical stress from contact lenses, solar radiation, smoke, dust, air conditioning, computer radiation).
The PerFlo Drops formulation is also refreshing, hydrating, lubricating and humectant.
The PerFlo Drops formula is therefore indicated for:
- relieve and counteract temporary sensations of eye discomfort (redness, dryness) due to unfavorable environmental conditions such as air conditioning, dry or very hot climates;
- alleviate states of fatigue such as long periods of driving, or studying, or due to computer use and/or excessive exposure to light or prolonged use of contact lenses;
- alleviate the occasional sensation of dry eyes related to ongoing blepharitis, and promote the removal and removal of any secretions;
- prevent states of allergic conjunctivitis.
For contact lens wearers: instilling PerFlo Drops eye drops before putting in contact lenses makes them easier to apply as it improves their wettability; furthermore, instilling them after application makes them more absorbent. comfortable to use, counteracting the sensation of dryness.
The PerFlo Drops formula is also suitable for frequent and prolonged use.
Composition
Perilla dry extract (titrated in polyphenols ≥2.5%) 0.1%; hyaluronic acid sodium salt 0.25%; sodium chloride; sodium phosphate dibasic anhydrous; sodium phosphate monobasic monohydrate; purified water to 100 ml.
Directions for use
Open the protective aluminum pouch
Separate a single-dose vial from the bar of 5 containers
Rotate and break the cap of the vial
Gently press the body of the single-dose vial and instill 2/3 drops in each eye; For contact lens wearers: if desired, instill 1 or 2 drops directly onto the lens and put it on immediately.
After instillation, immediately close the vial and reuse the remaining contents within the next 12 hours.
Keep unused vials in the aluminum pouch until the contents of the pouch are used up.
The product in the vial is for single-patient use.
Warnings
The product is for ophthalmic use only.
Once opened, the single-dose vial can be used again. The container should be closed with the appropriate cap, but the solution contained must be used within 12 hours.
Do not use the product if the aluminum pouch is damaged or if the vials are not perfectly intact.
Keep out of reach of children.
Before opening the vial to administer the drops, it is advisable to thoroughly clean your hands.
During instillation, do not touch the eye or other surfaces with the dispensing end of the vial.
Do not use the product in case of known incompatibility with even just one component of the formulation.
If necessary, check with your optician to ensure the compatibility of the eye drops with the contact lenses used.
In case of discomfort during use, discontinue treatment and consult a doctor.
Any administration of ophthalmic drugs should be carried out at least 15 minutes after instilling the eye drops, especially if they contain benzalkonium chloride or other quaternary ammonium salts, to avoid precipitation of hyaluronic acid.
The administration of ophthalmic drugs at the same time as the eye drops must be carried out under the supervision of a doctor who may evaluate possible interactions.
Do not use the product after the expiry date indicated on the package.
Do not dispose of the container in the environment after use.
Store in a dry place, away from heat sources and direct exposure to sunlight, at a temperature not exceeding 25°C.
Storage
24 months.
Format
The package consists of 2 sachets of 5 single-dose vials each.
The 0.5 ml single-dose container is resealable.
Product Code:FRCM124447
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