APROKAM POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL [SIN17391P]

Product Info

APROKAM POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL

[SIN17391P]

Indication

4.1 Therapeutic indications

Antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Consideration should be given to official guidance on the appropriate use of antibacterial agents, including guidance on the antibiotic prophylaxis on eye surgery.

Dosing

4.2 Posology and method of administration

Intracameral use. One vial for single-use only.

Posology

Adults:

The recommended dose is 0.1 ml of reconstituted solution (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), i.e. 1 mg of cefuroxime.

DO NOT INJECT MORE THAN THE RECOMMENDED DOSE (see section 4.9 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population:

The optimal dose and the safety of APROKAM have not been established in the paediatric population.

Elderly:

No dose adjustment is necessary.

Patients with hepatic and renal impairment:

Considering the low dose and the expected negligible systemic exposure to cefuroxime using APROKAM, no dose adjustment is necessary.

Method of administration

APROKAM must be administered after reconstitution by intraocular injection in the anterior chamber of the eye (intracameral use), by an ophthalmic surgeon, in the recommended aseptic conditions of cataract surgery. Only sodium chloride 9 mg/ml (0.9 %) solution for injection must be used when reconstituting APROKAM (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

After reconstitution, APROKAM should be inspected visually for particulate matter and discoloration prior to administration.

Slowly inject 0.1 ml of the reconstituted solution into the anterior chamber of the eye at the end of the cataract surgery.

For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

Hypersensitivity to cefuroxime or to the cephalosporin group of antibiotics.