Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID (IN THE FORM OF POTASSIUM CLAVULANATE)
PCO Manufacturing
J01CR02
AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID (IN THE FORM OF POTASSIUM CLAVULANATE)
400/57 MG/5ml
Powder for Oral Suspension
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors
Authorised
2012-04-05
PACKAGE LEAFLET: INFORMATION FOR THE USER AUGMENTIN-DUO ® 400MG/57 MG/5ML POWDER FOR ORAL SUSPENSION Amoxicillin/clavulanic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR THEM. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their si gns of illness are the same as your child’s. If your child gets 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 give Augmentin 3. How to give Augmentin 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 babies and children to treat the following infections: middle ear and sinus infections respiratory tract infections urinary tract infections skin and soft tissue infections including dental infections bone and joint infections. 2. WHAT YOU NEED TO KN Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin – Duo 400 mg/57 mg/5ml Powder for oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 80mg amoxicillin and potassium clavulanate equivalent to 11.4 mg clavulanic acid. Excipients: Contains aspartame (E951) and maltodextrin. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral suspension. _Product imported from Greece and Romania:_ Dry white powder for reconstitution with yellowish grains & a characteristic odour. 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): Acute bacterial sinusitis (adequately diagnosed) Acute otitis media 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 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 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 The age, weight and renal function of the patient as shown below. The use of alternative presentations of Augmentin (e.g. those that Přečtěte si celý dokument