Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals
ATC code: S0lXA20
Vidisic Gel is a substitute for lacrimal fluid. The gel structure has high water-binding capability and forms a stable hydrophilic film that adheres to the ocular surface.
In pharmacokinetic studies, radioactive carbomer was administered to rats. It could be shown that only a small amount of carbomer is absorbed.
As systemic absorption of ocular administration is low, this is not of relevance to the prescriber.
Following single administration, 0.75% of the administered dose was detected as carbon dioxide in the expired air, and 0.63% in the urine. The major proportion of carbomer (92%) was detected unchanged in the faeces 24 hours after intake.
The LD50 value could not be ascertained due to the low toxicity. In studies on rats, no deaths were observed at a concentration of 625 mg/kg carbomer.
Oral doses of 0.5, 1.0 and 3.0 g/kg bodyweight were administered to pregnant rats during a period between days 6 and 13 of gestation. No pathological alterations were seen in the embryos.
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