Aprokam 50mg powder for solution for injection vials

Summary of Product characteristics

                                OBJECT 1
APROKAM CEFUROXIME 50MG POWDER FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 18-Nov-2016 | Thea
Pharmaceuticals Ltd
1. Name of the medicinal product
APROKAM 50 mg powder for solution for injection
2. Qualitative and quantitative composition
Each vial contains 50 mg of cefuroxime (as 52.6 mg of cefuroxime
sodium).
After reconstitution with 5 ml of solvent (see section 6.6), 0.1 ml
solution contains 1 mg of cefuroxime.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection [powder for injection].
White to almost white powder.
4. Clinical particulars
4.1 Therapeutic indications
Antibiotic prophylaxis of postoperative endophthalmitis after cataract
surgery (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents,
including guidance on the antibiotic prophylaxis on eye surgery.
4.2 Posology and method of administration
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.
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 in
                                
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