Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Fresenius Kabi Deutschland GmbH
J01CR; J01CR02
Amoxicillin; Clavulanic acid
1000 mg/200 milligram(s)
Powder for solution for injection/infusion
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Marketed
2014-02-28
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMOXICLAV 1000 MG/200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. Includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Co-amoxiclav is and what it is used for 2. What you need to know before you have Co-amoxiclav 3. How Co-amoxiclav is given 4. Possible side effects 5. How to store Co-amoxiclav 6. Content of the pack and other information 1. WHAT CO·AMOXICLAV IS AND WHAT IT IS USED FOR Co-amoxiclav, 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 "penicillin’s" that can sometimes be stopped from working (Made inactive). The other active component (clavulanic acid) stops this from happening. Co-amoxiclav, 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. Co-amoxiclav, is used in adults and children to prevent infections associated with major surgical procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE CO·AMOXICLAV You should not have Co-amoxiclav • if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav (listed in section 6) • if you have ever had a severe allergic (hypersensitive) reaction to any other antibiot Przeczytaj cały dokument
Health Products Regulatory Authority 04 September 2023 CRN00DFVN Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav 1000mg/200mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg of amoxicillin as amoxicillin sodium and 200 mg clavulanic acid as potassium clavulanate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion Vials containing a white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-Amoxiclav 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 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 Co-amoxiclav 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 The age, weight and renal funct Przeczytaj cały dokument