Features and Characteristics
Features Provided
Sterile
Primary Container Type
Bottle
Primary Container Content Quantity
500.000 milliliters or 515.000 milliliters
Total Primary Container Quantity
6
Administration
Ophthalmic irrigation
Part Name Assigned By Controlling Agency
Ophthalmic irrigating solution 500ml bottle 6s
Special Features
For intraocular use; shall consist of two parts (part i and part ii), such that when mixed together, each ml of the reconstituted product contains 7.14 mg sodium chloride, 0.38 mg potassium chloride, 0.154 mg calcium chloride dihydrate, 0.42 mgdibasic sodium phosphate (anhydrous), 0.20 mg magnesium chloride hexahydrate, 2.1 mg sodium bicarbonate, 0.92 mg dextrose, 0.184 mg glutathione disulfide (oxidized glutathione), hydrochloric acid and/or sodium hydroxide (to adjust ph), in water for injection; the reconstituted product has approximate ph of 7.4 and osmolarity of appoximateley 305 mosmol per liter; the unit of issue shall be either six 500 ml bts containing part i with six 20 ml bts containing part ii concentrate or six 515 ml bts containing part i with six vials containing lyopilized powder for part ii, together with six sterile transfer spikes
Therapeutic Equivalent
Bss plus by alcon
FSC
6505 Drugs And Biologicals