PERFLODROPS
Description
CE 0476 Medical Device, class IIb, for ophthalmic use.
Sterile, protective, antioxidant, moisturising and lubricating eye drops based on Perilla extract and 0.25% hyaluronic acid.
The formula consists of a slightly hypo-osmolar, slightly viscous, sterile, preservative-free solution at physiological pH, containing a Perilla dry extract combined with hyaluronic acid (as sodium salt), in 0.5 ml single-dose containers, with high biocompatibility. Perilla extract, obtainable from both the seeds and the leaves of the plant, contains polyphenols that inhibit the action of free radicals by acting as scavengers, providing an antioxidant action. Hyaluronic acid is a highly biocompatible polysaccharide polymer with a great capacity to hydrate; in the eye it therefore proves an excellent moisturiser and lubricant, thanks also to its visco-elastic behaviour.
Indications
Thanks to its specific qualitative and quantitative composition, and in particular to the polyphenols contained in Perilla extract, the PerFlo Drops formula provides 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 the eye tissues from the consequences of oxidative stress due to unfavourable environmental factors (mechanical stress from contact lenses, sun exposure, smoke, dust, air conditioning, computer radiation).
The PerFlo Drops formulation is also refreshing, hydrating, lubricating and moisturising.
Furthermore, thanks to the slight viscosity selected, the PerFlo Drops formulation has a diluting action, increasing the volume of tear fluid and removing (through blinking) foreign bodies such as allergens, dust and mucoid thickeners.
The PerFlo Drops formula therefore protects the eye tissues by supporting the physiological antioxidant mechanisms and supplementing the aqueous component of the tear film, thus helping to maintain or restore epithelial trophism. The PerFlo Drops formula is therefore indicated to:
• relieve and counteract temporary feelings of eye discomfort (redness, dryness) due to unfavourable environmental conditions such as air conditioning, dry or very hot climates
• relieve eye fatigue, for example after long periods of driving or studying, or due to computer use and/or excessive exposure to light or prolonged contact lens wear
• relieve the feeling of occasional dry eye related to ongoing blepharitis, and help remove any secretions
• help prevent allergic conjunctivitis
For contact lens wearers: instilling PerFlo Drops before putting in contact lenses makes them easier to apply by improving their wettability; instilling after application also makes wearing them more comfortable, counteracting the feeling of dryness.
The PerFlo Drops formula is also suitable for frequent and prolonged use.
How to use
Open the protective aluminium sachet
Separate one single-dose vial from the strip of 5 containers
Twist and break off the vial cap
Gently squeeze the body of the single-dose vial and instil 2-3 drops into each eye; for contact lens wearers: if desired, instil 1 or 2 drops directly onto the lens and put it in immediately
After instillation, close the vial immediately and use the remaining contents within the following 12 hours
Keep unused vials in the aluminium sachet until the sachet's contents are finished
The vial product is for single-patient use.
Composition
Perilla dry extract (standardised to polyphenols ≥2.5%) 0.1%; hyaluronic acid sodium salt 0.25%; sodium chloride; anhydrous dibasic sodium phosphate; monobasic sodium phosphate monohydrate; purified water q.s. to 100 ml.
Warnings
The product is for ophthalmic use only.
Once opened, the single-dose vial can be closed again with its cap, but the solution it contains must be used within 12 hours.
Do not use the product if the aluminium sachet is damaged or if the vials are not perfectly intact.
Keep out of the reach of children.
Wash your hands thoroughly before opening the vial to administer the drops.
During instillation, do not touch the eye or any other surface with the tip of the vial.
Do not use the product in case of known intolerance to even one component of the formulation.
If necessary, check with your optician that the eye drops are compatible with the contact lenses you use. If any discomfort occurs during use, stop treatment and consult a doctor.
Any ophthalmic medicines should be administered at least 15 minutes apart from the eye drops, particularly products containing benzalkonium chloride or other quaternary ammonium salts, to avoid precipitation of the hyaluronic acid.
Simultaneous administration of ophthalmic medicines with the eye drops should be carried out under the supervision of a doctor, who can assess possible interactions.
Do not use the product after the expiry date shown on the pack.
Do not dispose of the container in the environment after use.
Store in a dry place, away from heat sources and direct sunlight, at a temperature not above 25°C.
Storage
Store at a temperature not above +25°C.
Shelf life with intact packaging: 24 months.
Shelf life after opening: 12 hours.
Size
The pack contains 2 sachets of 5 single-dose vials each. The 0.5 ml single-dose container is resealable.
