Edit the instructions. Dexamethasone and tobramycin in the dosage form of eye drops

April 17, 2017
ICD-10:
VII.H00-H06.H01.0    Blepharitis
VII.H10-H13.H10.2    Other acute conjunctivitis
VII.H10-H13.H10.4    Chronic conjunctivitis
VII.H10-H13.H10.5    Blepharoconjunctivitis
VII.H15-H22.H16    Keratite
XXI.Z20-Z29.Z29.2    Another type of preventive chemotherapy

Tobramycin, dexamethasone, eye drops, blepharitis, conjunctivitis, keratitis

The need to supplement the instructions for the use of appropriate medications with the following information has been identified.

Instructions for the use of a reference medication containing dexamethasone and tobramycin, registered in the Russian Federation, was revised in 2016. According to the current information, the combination of dexamethasone and tobramycin in the form of eye drops can be used in patients of child age from 2 years.

In the civil turnover of the Russian Federation there are medicinal preparations of dexamethasone and tobramycin in the form of eye drops, the instructions for their use contain information that does not correspond to the current information on the clinical experience of the clinical use of dexamethasone and tobramycin in this dosage form.

We consider it advisable to give instructions on the use of preparations containing as active substances dexamethasone and tobramycin, in the form of eye drops, in accordance with current information on the experience of their clinical use.