Land: Malta
Språk: engelsk
Kilde: Medicines Authority
AMOXICILLIN; CLAVULANIC ACID
Beecham Group PLC
J01CR02
AMOXICILLIN; CLAVULANIC ACID
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
AMOXICILLIN 500 mg; CLAVULANIC ACID 100 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-03-28
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER AUGMENTIN 500 MG/100 MG POWDER FOR SOLUTION FOR INJECTION OR 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 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 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 AUGMENTIN YOU SHOULD NOT HAVE AUGMENTIN: • if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6). • if you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat. • if you have ever had Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Augmentin 500 mg/100 mg powder for solution for injection or infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 100 mg of clavulanic acid. Excipients with known effect: Sodium 31.4 mg (1.4 mmol) per vial. Potassium 19.6 mg (0.5 mmol) per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. Vials 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 into account: The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) The severity and the site of the infection Les hele dokumentet