国: マルタ
言語: 英語
ソース: Medicines Authority
A, S
Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia
J01CR01
Ampicillin Sodium 1 g Sulbactam Sodium 0.5 g
SOLUTION FOR INJECTION/INFUSION
Ampicillin Sodium 1 g Sulbactam Sodium 0.5 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-07-16
PACKAGE LEAFLET Page 1 of 11 Page 2 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER AMPICILLIN/SULBACTAM APTAPHARMA 1 G/0.5 G POWDER FOR SOLUTION FOR INJECTION/INFUSION AMPICILLIN/SULBACTAM APTAPHARMA 2 G/1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION ampicillin and sulbactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ampicillin/sulbactam AptaPharma is and what it is used for 2. What you need to know before you use Ampicillin/sulbactam AptaPharma 3. How to use Ampicillin/sulbactam AptaPharma 4. Possible side effects 5. How to store Ampicillin/sulbactam AptaPharma 6. Contents of the pack and other information 1. WHAT AMPICILLIN/SULBACTAM APTAPHARMA IS AND WHAT IT IS USED FOR Ampicillin/sulbactam AptaPharma is a broad-spectrum antibiotic. It treats infections caused by bacteria, which are susceptible to ampicillin and sulbactam. Ampicillin belongs to a group of medicines called ‘penicillins’ (type of beta-lactam antibiotics). It works by inhibiting the formation of the bacterial cell wall during the stage of bacterial multiplication (biosysnthesis). Sulbactam’s antibacterial activity is effective on bacterial strains which are not sensitive to ampicillin. Your doctor can give you Ampicillin/sulbactam AptaPharma injection to treat the following bacterial infections: • upper respiratory tract infections including sinusitis, inflammation of middle ear (otitis media) or of larynx (epiglottitis) • lower respiratory tract infections including inflammation of the lung (pneumonia) • urinary tract infections including inflammation of the kidney (pyelonephritis) • intra-abdominal infections (including peritonitis), inflammation of the gall bladder 完全なドキュメントを読む
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 12 1. NAME OF THE MEDICINAL PRODUCT Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for solution for injection/infusion Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for solution for injection/infusion _ Each vial contains 1.0 g of ampicillin (as ampicillin sodium) and 0.5 g of sulbactam (as sulbactam sodium). _Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for injection/infusion _ Each vial contains 2.0 g of ampicillin (as ampicillin sodium) and 1 g sulbactam (as sulbactam sodium). Excipients with known effect: Each vial of Ampicillin/sulbactam AptaPharma 1 g/0.5 g powder for solution for injection/infusion contains 115 mg (5 mmol) sodium. Each vial of Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for injection/infusion contains 230 mg (10 mmol) sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to off-white crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infections caused by susceptible microorganisms, in the following conditions: • upper and lower respiratory tract infections (including sinusitis, otitis media, epiglottitis; bacterial pneumonias); • urinary tract infections and pyelonephritis; • intra-abdominal infections (including peritonitis), gynaecological infections (cholecystitis, endometritis and pelvic cellulitis); • skin and soft tissue infections; • bone and joint infections; • gonococcal infections; • pre-or post-operatively to reduce the incidence of wound infections in patients undergoing abdominal or pelvic surgery; • treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with any of infections stated above. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY 完全なドキュメントを読む