CELLUVISC * COLL30F 0.4ML10MG / ML

CELLUVISC * COLL30F 0.4ML10MG / ML

Therapeutic indications

Symptomatic treatment of ocular dryness due to alterations in the stability of the tear film.

Dosage and method of use

Instill 1-2 drops of the product directly into the conjunctival sac.Pediatric population: The safety and efficacy of CELLUVISC 10 mg / ml eye drops, solution in pediatric patients has not yet been established.Elderly patients: No significant age-related differences were observed, therefore no dose adjustment is required in elderly patients.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Adverse reactions observed with CELLUVISC 10 mg / ml eye drops, solution, documented from clinical studies, are classified by system organ and listed below as: Very common (≥1 / 10); Common (≥1 / 100, Eye disorders.Common: eye irritation including burning and discomfort.Post-marketing data:The following adverse reactions have been reported since CELLUVISC 10 mg / ml eye drops, solution was marketed; frequency is 'Not known' as it cannot be estimated from the available data:Immune System Disorders:Hypersensitivity, including eye allergy with symptoms of eye swelling or eyelid edema.Eye disorders:Ocular discharge, eye pain, eye itching, scabs and / or residue of medicine on the lid margin, foreign body sensation in the eye, ocular hyperaemia, blurred vision and / or visual impairment, increased tearing of the eye.Injury, poisoning and procedural complications:Superficial eye injury (resulting from the vial tip touching the eye during administration) and / or corneal abrasion.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

For external use only. The prolonged use of topical medicines can give rise to sensitization phenomena (for example, irritation, pain, redness, change in vision). If so or if the condition worsens, stop treatment and consult your doctor. Since CELLUVISC 10 mg / ml eye drops, solution is a sterile preparation, in order to avoid contamination or possible injury to the eye, the tip of the single-dose vial should not touch the eye or any other surface. Once opened, the medicine must not be reused. Before each application, remove contact lenses and reapply after 15 minutes.

Pregnancy and breastfeeding

No specific clinical studies have been conducted on the use of CELLUVISC 10 mg / ml eye drops, solution during pregnancy and lactation. However, non-clinical studies have not shown harmful effects in pregnancy. Due to poor systemic absorption it is unlikely that CELLUVISC 10 mg / ml eye drops, solution will be excreted in human milk.

Expiration and retention

Keep the single-dose vials in the sachet and return the sachet to the box to protect the medicine from light and moisture. Do not store above 25 ° C

Interactions with other drugs

No interactions with other medicinal products have been observed. CELLUVISC 10 mg / ml eye drops, solution may prolong the contact time of topical medicinal products commonly used in ophthalmology. In case of concomitant treatment with other eye dressings, you should wait 5 minutes before instilling CELLUVISC 10 mg / ml eye drops, solution.

Overdose

No data on overdose are available due to poor systemic absorption. Accidental overdoses do not pose any risk.

Active principles

CELLUVISC 10 mg / ml 1 ml contains 10 mg of Carmellose sodium; 1 drop (≈ 0.05 ml) contains 0.5 mg of Carmellose sodium For a full list of excipients, see section 6.1.

Excipients

Sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, purified water.