Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
Istituto Biochimico Italiano G. Lorenzini S.p.A Via Fossignano 2, Aprilia (LT), Italy
J01CR02
AMOXICILLIN SODIUM 1000 mg CLAVULANATE POTASSIUM 200 mg
POWDER FOR SOLUTION FOR INJECTION/INFUSION
AMOXICILLIN SODIUM 1000 mg CLAVULANATE POTASSIUM 200 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-05-24
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMOXICLAV IBISQUS 500 MG/100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION CO-AMOXICLAV IBISQUS 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 Co-amoxiclav Ibisqus is and what it is used for 2. What you need to know before you are given Co-amoxiclav Ibisqus 3. How Co-amoxiclav Ibisqus is given 4. Possible side effects 5. How to store Co-amoxiclav Ibisqus 6. Contents of the pack and other information 1. WHAT CO-AMOXICLAV IBISQUS IS AND WHAT IT IS USED FOR Co-amoxiclav Ibisqus 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. Co-amoxiclav Ibisqus 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 Ibisqus 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 CO-AMOXICLAV IBISQUS YOU SHOULD NOT HAVE CO-AMOXICLAV IBISQUS: • if you are allergic to amoxicillin, clavulanic acid or penicillin • if you have ever had a severe alle Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-amoxiclav Ibisqus 500 mg/100 mg powder for solution for injection/infusion Co-amoxiclav Ibisqus 1000 mg/200 mg powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg amoxicillin (as amoxicillin sodium) and 100 mg clavulanic acid (as clavulanate potassium) Each vial contains 1000 mg amoxicillin (as amoxicillin sodium) and 200 mg clavulanic acid (as potassium clavulanate) Each vial contains 1.4 mmol (31.4 mg) of sodium Each vial contains 0.5 mmol (19.6 mg) of potassium 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 Co-amoxiclav Ibisqus 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 Co-amoxiclav Ibisq Lue koko asiakirja