País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
GlaxoSmithKline (Ireland) Limited
J01CR; J01CR02
Amoxicillin; Clavulanic acid
1000 mg/200 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Not marketed
1985-07-01
Reason for update: Type IB variation to align to the EU excipient guidelines and other admin updates (updated post submission of Brexit CMC change) Market: IE Agency Approval Date: TBC Text Date: 29/03/2019 Text Issue and Draft No.: Issue 7 Draft 2 (combines issues 5 and 6) PACKAGE LEAFLET: INFORMATION FOR THE USER AUGMENTIN INTRAVENOUS 500 MG/100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION AUGMENTIN INTRAVENOUS 1000 MG/200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION amoxicillin/clavulanic acid 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Augmentin is and what it is used for 2. What you need to know before you have Augmentin 3. How Augmentin is given 4. Possible side effects 5. How to store Augmentin 6. Contents of the pack and other information 1. WHAT AUGMENTIN IS AND WHAT IT IS USED FOR Augmentin is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. Augmentin is used in adults and children to treat the following infections: • severe ear, nose and throat infections • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental infections • bone and joint infections • intra-abdominal infections • genital organ infections in women. Augmentin is used in adults and children to prevent infections associated with major surgical procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE A Leia o documento completo
Health Products Regulatory Authority 16 January 2020 CRN009DRL Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin Intravenous 1000mg/200mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid. The sodium content of each vial or bottle is 62.9 mg (2.7 mmol). The potassium content of each vial or bottle is 39.3 mg (1.0 mmol). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. Vials or bottles containing a white to off-white sterile powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) Acute exacerbations of chronic bronchitis (adequately diagnosed) Community acquired pneumonia Cystitis Pyelonephritis Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis Bone and joint infections, in particular osteomyelitis Intra-abdominal infections Female genital infections. Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the: Gastrointestinal tract Pelvic cavity Head and neck Biliary tract surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of Augmentin that is selected to treat an individual infection should take Leia o documento completo