CELLUVISC COLL 30F 0,4ML5MG/ML

CELLUVISC 5 MG/ML COLLECTION

active ingredients

CELLUVISC 5 mg/ml 1 ml contains 5 mg of sodium Carmellosa 1 drop (≈0.05 ml) contains 0.25 mg of sodium Carmellosa For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

Syntomatic treatment of mild irritation or 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 5 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

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. irritations, pain, redness, vision changes). In such case or if the condition worsens, stop treatment and consult your doctor. Because CELLUVISC 5 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 the eye or come in contact with other surface. The medicinal product, once opened, should not be reused.

Interactions

No interactions with other medicines have been observed. CELLUVISC 5 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 5 mg/ml colliery, solution.

Effects

The adverse reactions observed with CELLUVISC 5 mg/ml colliary, solution documented by clinical studies, are classified for systems and organs and listed below as: Very common (?1/10); Common (?1/100, Eye pathologies. Town: eye irritation including burning and discomfort, eye pain, eye itching, visual ailments. Post-marketing data: The following adverse reactions have been reported since CELLUVISC 5 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. Eye pathologies: Offused vision, increased tearing, eye secretion, eye hyperemia and foreign body sensation in the eyes. 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 5 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 5 mg/ml colliery, solution is excreted in breast milk.

Source: Farmadati