APROKAM Powder for solution for injection Ref.[27679] Active ingredients: Cefuroxime

Intracameral use. One vial for single-use only.

Posology

Adults

The recommended dose is 0.1ml of reconstituted solution (see section 6.6), i.e. 1mg of cefuroxime.

DO NOT INJECT MORE THAN THE RECOMMENDED DOSE (see section 4.9).

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).

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

Slowly inject 0.1ml 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.

The reported cases of overdose are those described in the literature after incorrect dilution and non-authorised use of cefuroxime intended for systemic administration.

Inadvertent high-dose (3-fold the recommended dose) intracameral cefuroxime was administered to 6 patients following an incorrect dilution due to homemade cefuroxime dilution protocol. These injections did not cause any detectable adverse effect in any patient even on ocular tissues.

Toxicity data were available following intracameral injection, during cataract surgery, of 40 to 50-fold the recommended dose of cefuroxime in 6 patients after a dilution error. Initial mean visual acuity was 20/200. Severe anterior segment inflammation was present, and retinal optical coherence tomography showed extensive macular oedema. Six weeks after surgery, mean visual acuity reached 20/25. Macular optical coherence tomography profile returned to normal. A 30% decrease of scotopic electroretinography was, however, observed in all patients.

Administration of incorrectly diluted cefuroxime (10-100mg per eye) to 16 patients resulted in ocular toxicity including corneal oedema resolving in weeks, transient raised intraocular pressure, loss of corneal endothelial cells and changes in the electroretinography. A number of these patients had permanent and severe vision loss.

18 months.

After reconstitution: the product should be used immediately after reconstitution and not reused.

Store below 25°C.

Keep the vial in the outer carton, in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

8ml type I glass vial, stoppered with bromobutyl stopper and sealed with flip-off cap. Box of 1×50mg, 10×50mg or 20×50mg vials.

Box of 10×50mg vials together with 10 5-micron sterile filter needles.

Not all pack sizes may be marketed.

APROKAM must be administered by intracameral injection, by an ophthalmic surgeon in the recommended aseptic conditions of cataract surgery.

VIAL IS FOR SINGLE USE ONLY.

USE ONE VIAL FOR ONE PATIENT. Stick the flag label of the vial on the patient’s file.

To prepare the product for intracameral administration, please adhere to the following instructions:

1. Withdraw flip-off cap
2. Before inserting a sterile needle, the outer part of the rubber stopper of the vial should be disinfected.
3. Push the needle vertically into the centre of the vial stopper, keeping the vial in an upright position. Then, inject into the vial 5ml of sodium chloride 9mg/ml (0.9%) solution for injection using aseptic technique.
4. Shake gently until the solution is free from visible particles.
5. Assemble a sterile needle (18G x 1½", 1.2mm x 40mm) with 5-micron filter (acrylic copolymer membrane on a non-woven nylon) onto a 1ml sterile syringe. Push this syringe vertically into the centre of the vial stopper, keeping the vial in an upright position.
6. Aseptically aspire at least 0.1ml of the solution.
7. Disconnect the 5-micron filter needle from the syringe and assemble the syringe with an appropriate anterior chamber cannula.
8. Carefully expel the air from the syringe and adjust the dose to the 0.1ml mark on the syringe. The syringe is ready for injection.

The reconstituted solution should be visually inspected and should only be used if it is a colourless to yellowish solution free from visible particles. It has a pH and osmolality close to the physiological values (pH about 7.3 and osmolality about 335mosmol/kg).

After use, discard the remaining of the reconstituted solution. Do not keep it for subsequent use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Discard used needles in a sharps container.