1. Name Of The Medicinal Product
LlQUlVISC 2.5 mg/g, eye gel
2. Qualitative And Quantitative Composition
Carbomer 974P 2.5 mg/g.
Excipient: benzalkonium chloride (0.06 mg/g).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye gel
Slightly yellow and opalescent gel.
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic treatment of dry eye syndrome.
4.2 Posology And Method Of Administration
Ocular use.
Adults (including the elderly):
Instil one drop of the gel into the inferior conjunctival cul-de-sac 1 to 4 times daily according to the degree of ocular trouble.
Children:
No specific studies with LIQUIVISC 2.5 mg/g, eye gel have been performed in children. It is recommended that LlQUlVISC 2.5 mg/g, eye gel should not be used in children until further data becomes available.
After instillation, the bottle should be stored vertically with the dropper downwards to facilitate the formation of drops when next used.
Do not touch the eye with the dropper tip. Replace the cap after use.
4.3 Contraindications
Hypersensitivity to any of the components of the product.
4.4 Special Warnings And Precautions For Use
Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or ulcerative keratopathy.
Contact lenses :
Benzalkonium chloride may be absorbed by and discolour contact lenses and therefore the patients should be instructed to wait until 30 minutes after instillation of LIQUIVISC 2.5 mg/g, eye gel before inserting contact lenses.
If symptoms continue or worsen, the patient should be reviewed by a physician.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In case of concomitant use with other eye drops, wait for 15 minutes between instillations.
LIQUIVISC 2.5 mg/g, eye gel should be the last medication instilled.
4.6 Pregnancy And Lactation
LIQUIVISC 2.5 mg/g, eye gel was not studied in pregnant and breast-feeding women.
Caution should be exercised when prescribing to pregnant or breast-feeding women.
4.7 Effects On Ability To Drive And Use Machines
Vision may be blurred for a few minutes after the instillation.
If affected, the patient should be advised not to drive or operate hazardous machinery until normal vision is restored.
4.8 Undesirable Effects
As for other eye drops, possibility of mild transient stinging or burning upon instillation.
Blurred vision may occur briefly after instillation until the gel is evenly distributed over the eye surface.
4.9 Overdose
Any ocular overdose or oral intake that could occur is of no clinical relevance.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
TEAR SUBSTITUTE
(S : Sensory organ (eye))
- Fluid eye gel based on a high molecular weight hydrophilic polymer (carbomer 974P).
- Due to its physical properties, this gel forms a transparent lubricating and wetting film on the surface of the eye, temporarily compensating for tear insufficiency.
- Its pH (7.3) and osmolality are similar to those of the normal tear film.
- Its viscosity (700 mPas) is greater than that of artificial tears, allowing less frequent administration.
5.2 Pharmacokinetic Properties
Because of the relatively large size of the carbomer molecule, penetration through the cornea is unlikely.
The persistence time of the gel on the eye surface is about 30 minutes.
5.3 Preclinical Safety Data
Data from subacute toxicity and local tolerance studies do not show any relevant findings.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Benzalkonium chloride
Sorbitol
Lysine monohydrate
Sodium acetate
Polyvinyl alcohol
Water for injections
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Shelf life prior to opening:
30 months.
In-use shelf life:
4 weeks.
6.4 Special Precautions For Storage
Do not store above 25°C. Store container in the outer carton, in order to protect from light.
6.5 Nature And Contents Of Container
10 g in 10 m1 bottle (PE) with dropper (PE).
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Laboratoires Thea
12 rue Louis Blériot
Z.I.du Brézet
63017 Clermont-Ferrand Cedex 2
France
8. Marketing Authorisation Number(S)
PL 20162/0009
9. Date Of First Authorisation/Renewal Of The Authorisation
10/06/2008
10. Date Of Revision Of The Text
10/06/2008
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