Celluvisc Eye Drops 30 vials 0.4ml10mgm,Celluvisc Collirio 30 flaconcini 0,4ml10mgm,ALLERGAN PLC

“Dosage: The drug should be taken according to the following doses and methods: instill 1-2 drops of the drug directly into the conjunctival sac.
The safety and effectiveness of Celluvisc 10 mg/ml eye drop solution in pediatric patients has not yet been established. No significant age differences were observed, so there is no need to change the dose in elderly patients.
Overdose: There is no evidence of overdose due to poor systemic absorption. Accidental overdose does not pose any risk.ContraindicationsHypersensitivity to the active substance or to any of the excipients.Side effectsAdverse reactions observed with the use of Celluvisc eye drops 10 mg/ml, solution, confirmed by clinical studies, are classified by organ system and are listed below as: Very often (≥1/10); Often (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); Rarely (≥1/10000, <1/1000); Very rare (<1/10,000) and unknown (frequency cannot be estimated from available data):
– Eye pathologies:
Common: eye irritation, including burning and discomfort.
Since the marketing of Celluvisc 10 mg/ml eye drop solution, the following adverse reactions have been reported; frequency “”Unknown”” because it cannot be determined from the available data:
Immune system disorders: hypersensitivity, including eye allergies with symptoms of ocular swelling or swelling of the eyelids.
From the eyes: discharge from the eyes, eye pain, itching of the eyes, formation of crusts and/or drug residues on the edges of the eyelids, sensation of a foreign body in the eye, eye hyperemia, blurred vision and/or blurred vision, increased lacrimation.
Pregnancy and breastfeeding: No special clinical studies have been conducted on the use of Celluvisc eye drops 10 mg/ml during pregnancy and breastfeeding. However, preclinical studies have not shown any harmful effects on pregnancy. Due to poor systemic absorption, Celluvisc 10 mg/ml eye drops are unlikely to pass into breast milk.
Special Warnings: For external use only.
The use, especially long-term, of local medications can cause sensitization phenomena (for example, irritation, pain, redness, changes in vision). In this case or if the condition worsens, stop treatment and consult a doctor. Because Celluvisc 10 mg/ml eye drop solution is a sterile preparation, to avoid contamination or possible damage to the eyes, the tip of the single dose vial should not touch the eye or any other surface. Once opened, the medicine cannot be reused. Before each use, remove contact lenses and reinsert them after 15 minutes.
Expiration date and preservation: Check the expiration date indicated on the package. The expiration date indicated on the packaging refers to the product in undamaged packaging and properly stored. Do not store at temperatures above 25°C.
Warning: Do not use the drug after the expiration date indicated on the package.
Composition: 1 ml Celluvisk contains:
Active principle
10 mg carmellose sodium
Excipients
Sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, purified water.”