Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefotaxime sodium
Wockhardt UK Ltd
J01DD01
Cefotaxime sodium
2gram
Powder for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5012727903378 5012727909219
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. Process Black Keyline (non-printing) Wockhardt UK Limited Cefotaxime common leaflet 106641/4 n-a 170 x 320mm matt.pirie-scott 4 03/03/2017 831926 n-a 7pt (Main Body) / 7pt (Variables) UK English PACKAGE LEAFLET: INFORMATION FOR THE USER Cefotaxime 500mg powder for solution for injection or infusion Cefotaxime 1g powder for solution for injection or infusion Cefotaxime 2g powder for solution for injection or infusion READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. - Keep this leaflet. You may need to read it again while you are receiving your treatment. - If you have any further questions, please ask your doctor or nurse. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is cefotaxime 500mg, 1g or 2g powder for solution for injection or infusion. In the rest of this leaflet it is called cefotaxime for injection. IN THIS LEAFLET: 1. What cefotaxime for injection is and what it is used for 2. Before you are given cefotaxime for injection 3. How cefotaxime for injection should be given 4. Possible side effects 5. How to store cefotaxime for injection 6. Further information 1. WHAT CEFOTAXIME FOR INJECTION IS AND WHAT IT IS USED FOR Cefotaxime belongs to a group of medicines called Прочитать полный документ
OBJECT 1 CEFOTAXIME 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION Summary of Product Characteristics Updated 15-Jun-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Cefotaxime 2g Powder for solution for injection or infusion 2. Qualitative and quantitative composition Each vial contains cefotaxime sodium equivalent to 2g of cefotaxime. Each gram of cefotaxime contains approximately 48mg (2.09mmol) of sodium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection or infusion (Powder for injection or infusion). White to slightly yellow powder. 4. Clinical particulars 4.1 Therapeutic indications 1. Cefotaxime is indicated in the treatment of serious infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, including osteomyelitis, septicaemia, bacterial endocarditis, meningitis, and peritonitis. and other serious bacterial infections suitable for parenteral antibiotic therapy. 2. Cefotaxime may be used for pre-operative prophylaxis in patients undergoing surgical procedures, that may be classified as contaminated or potentially so. 4.2 Posology and method of administration Cefotaxime may be administered intravenously, by bolus injection or by infusion, or by intramuscular injection. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. Adults: The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. In severe infections dosage may be increased up to 12g daily given in three or four divided doses. For infections caused by sensitive Pseudomonas species daily doses of greater than Прочитать полный документ