Generic drug of the therapeutic class: Ophthalmology
active ingredients: Cefuroxime
Powder for solution for injection
Box of 10 vials of 50 mg
Antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery (see section 5.1 ).
Official recommendations for the appropriate use of antibacterials, including those for antibiotic prophylaxis in eye surgery, should be taken into account.
Dosage APROKAM 50 mg Powder for solution for injection Box of 10 vials of 50 mg
Intra-camerular pathway. One vial for single use only.
The recommended dose is 1 mg of cefuroxime, ie 0.1 ml of reconstituted solution (see section Instructions for use, handling and disposal ).
DO NOT INJECT A DOSE HIGHER THAN THAT RECOMMENDED (see section Overdose ).
The optimal dosage and safety of use of APROKAM have not been established in the pediatric population.
Dosage adjustment is not necessary.
Renal and hepatic impairment:
Considering the low dose and negligible systemic passage of cefuroxime expected after APROKAM use, no dosage adjustment is necessary.
APROKAM should be administered after reconstitution, by intraocular injection into the anterior chamber of the eye (intra-camerular route), by an ophthalmic surgeon, under aseptic conditions recommended for cataract surgery.
After reconstitution, APROKAM should be visually inspected for particulate matter or abnormal discoloration prior to administration.
Slowly inject 0.1 ml of reconstituted solution into the anterior chamber of the eye at the end of cataract surgery.
For instructions on reconstitution of APROKAM prior to administration, see section Instructions for use, handling and disposal .
Hypersensitivity to cefuroxime or antibiotics in the cephalosporin group.
Aprokam side effects
Immune system disorders
Very rare (<1 / 10, 000): Anaphylactic reaction.
No other specific adverse events have been reported in the literature when cefuroxime is given by intraocular injection.