Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Amoxicillin; Clavulanic acid
Ivowen Limited
J01CR; J01CR02
Amoxicillin; Clavulanic acid
1000/200 milligram(s)
Powder for solution for injection/infusion
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
2019-11-22
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN/CLAVULANIC ACID IVOWEN 500 MG/100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION AMOXICILLIN/CLAVULANIC ACID IVOWEN 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. IN THIS LEAFLET: 1. What Amoxicillin/clavulanic acid Ivowen is and what it is used for 2. What you need to know before you are given Amoxicillin/clavulanic acid Ivowen 3. How Amoxicillin/clavulanic acid Ivowen is given 4. Possible side effects 5. How to store Amoxicillin/clavulanic acid Ivowen 6. Contents of the pack and other information 1. WHAT AMOXICILLIN/CLAVULANIC ACID IVOWEN IS AND WHAT IT IS USED FOR Amoxicillin/clavulanic acid Ivowen 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. Amoxicillin/clavulanic acid Ivowen 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 Amoxicillin/clavulanic acid Ivowen is also used in adults and children to prevent infections associated with major surgical procedures. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMOXICILLIN/CLAVULANIC ACID IVOWEN DO Soma hati kamili
Health Products Regulatory Authority 22 November 2019 CRN008LJL Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin and clavulanic acid Ivowen 1000 mg/200 mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg amoxicillin (as amoxicillin sodium) and 200 mg clavulanic acid (as potassium clavulanate) Each vial contains 2.7 mmol (62.9 mg) of sodium Each vial contains 1 mmol (39.3 mg) of potassium 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion White powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin/clavulanic acid Ivowen 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 amoxicillin/ clavulanic acid 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 infe Soma hati kamili