Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Cefuroxime Sodium
Laboratoires Thea
S01AA; S01AA27
Cefuroxime Sodium
50 milligram(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Antibiotics; cefuroxime
Marketed
2012-09-07
1 APROK 50 MG POWDER FOR SOLUTION FOR INJECTION Cefuroxime READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What APROK is and what it is used for 2. What you need to know before you are given APROK 3. How APROK is used 4. Possible side effects 5. How to store APROK 6. Contents of the pack and other information 1. WHAT APROK IS AND WHAT IT IS USED FOR The full name of your medicine is Aprok 50 mg, powder for solution for injection. It is called Aprok in this leaflet. This medicine contains cefuroxime (as cefuroxime sodium) which belongs to a group of antibiotics called cephalosporins. Antibiotics are used to kill the bacteria or germs that cause infections. You will be given this medicine if you are having eye surgery because of cataract (cloudy lens). Your ophthalmic surgeon will give you this medicine by injection into the eye at the end of the surgery to prevent eye infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN APROK DO NOT USE APROK • If you are allergic (hypersensitive) to cefuroxime or to any of the cephalosporin type of antibiotics. WARNINGS AND PRECAUTIONS Talk to your doctor, or pharmacist or nurse before you are given APROK: • if you are allergic to other antibiotics such as penicillin, • if you are at risk of an infection due to bacteria called MRSA (Methicillin-resistant _Staphylococcus aureus_), • if you have a high risk of infection, • if you have been told you have a complicated cataract, • if a combined eye surgery is planned, • if you Aqra d-dokument sħiħ
Health Products Regulatory Authority 09 October 2019 CRN0092JK Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aprok 50mg 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 0.1 ml of reconstituted solution (see section 6.6), i.e. 1 mg of cefuroxime. DO NOT INJECT MORE THAN THE RECOMMENDED DOSE (see section 4.9). _Paediatric population:_ The optimal dose and the safety of APROK 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 APROK, no dose adjustment is necessary. _METHOD OF ADMINISTRATION_ APROK 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 APROK (see section 6.6). After reconstitution, APROK should be inspected visually for particulate matter and discoloration prior to administration. Slowly inject 0.1 ml of the reconstituted solution into the anter Aqra d-dokument sħiħ