CELLUVISC COLL30F 0,4ML10MG/ML

CELLUVISC 10 MG/ML COLLIRIUM, DEAL

active ingredients

CELLUVISC 10 mg/ml 1 ml contains 10 mg of sodium Carmellosa; 1 drop ( 0,0≈5 ml) contains 0.5 mg of sodium Carmellosa. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Syntomatic treatment of eye dryness due to alterations in the stability of the lacrimal film.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Instill 1-2 drops of the product directly into the joint bag. Pediatric population: Security and effectiveness of CELLUVISC 10 mg/ml colliary, solution in pediatric patients has not yet been established. Senior Patients: Significant age-related differences have not been observed, so it is not necessary to change the dose in older patients.

Conservation

Keep the single-dose bottle in the bag and store the bag in the box to protect the medicine from light and moisture. Do not store at temperature above 25°C

Warnings

Only for external use. Prolonged use of topical medicines can give rise to awareness-raising phenomena (e.g. irritation, pain, redness, change of sight). In such case or if the condition worsens, stop treatment and consult your doctor. For CELLUVISC 10 mg/ml colliery, solution is a sterile preparation, in order to avoid contamination or a possible injury of the eye, the tip of the monodose bottle should not touch either the eye, or come into contact with other surface. The medicinal product, once opened, should not be reused. Before each application, remove contact lenses and reapply them again after 15 minutes.

Interactions

No interactions with other medicines have been observed. CELLUVISC 10 mg/ml colliery, solution may prolong the contact time of topical medicines commonly used in ophthalmology. In case of treatment with other eye medications, you must wait 5 minutes before instilling CELLUVISC 10 mg/ml colliary, solution.

Effects

The adverse reactions observed with CELLUVISC 10 mg/ml colliary, solution, documented by clinical studies, are classified by systems and organs and listed below as: Very common (≥1/10); Common (≥1/100, Eye pathologies. Town: eye irritation included burning and discomfort. Post-marketing data: The following adverse reactions have been reported since CELLUVISC 10 mg/ml colliery, solution is marketed; the frequency is ‘Note’ as it cannot be defined on the basis of the available data: Immunity System Disorders: Hypersensitivity, including eye allergy with symptoms of eye swelling or eyelid edema. Eye pathologies: Eye secretion, eye pain, eye itching, crusts and/or residue of medicine on the eyelid margin, feeling of foreign body in the eyes, eye hyperemia, blurred vision and/or visual disability, increased eye tearing. Traumatism, poisoning and procedure complications: Surface lesion of the eye (derived by the tip of the bottle that touches the eye during administration) and/or corneal abrasion. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose data is available due to poor systemic absorption. Excessive accidentals do not determine any risk.

No specific clinical studies have been conducted on the use of CELLUVISC 10 mg/ml colliery, pregnant and nursing solution. However, non-clinical studies have not shown harmful effects in pregnancy. Due to poor systemic absorption it is unlikely that CELLUVISC 10 mg/ml colliery, solution is excreted in breast milk.

Source: Farmadati