Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE ; CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1))
DSM Sinochem Pharmaceuticals Netherlands B.V.
J01CR02
AMOXICILLIN TRIHYDRATE ; CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE (1:1))
875/125 Milligram
Film Coated Tablet
oral use
4/5/6/10/12/14/15/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500 film-coated tablets.
Product subject to prescription which may not be renewed (A)
PenCef Pharma GmbH
: Combination of penicillins, incl. beta-lactamase inhibitors
amoxicillin and enzyme inhibitor
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 and severe dental abscess with spreading cellulitis. Bone and joint infections, in particular osteomyelitis.
Not Marketed
2015-09-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMOXICILLIN/CLAVULANIC ACID875 MG/125 MG FILM-COATED TABLETS Amoxicillin Clavulanic acid 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 or pharmacist. • This medicine has been prescribed for you (or for your child). Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1. What Amoxicillin/Clavulanic acid Perskaitykite visą dokumentąis and what it is used for 2. What you need to know before you take Amoxicillin/Clavulanic acid 3. How to take Amoxicillin/Clavulanic acid 4. Possible side effects 5. How to store Amoxicillin/Clavulanic acid 6. Contents of the pack and other information 1. WHAT AMOXICILLIN/CLAVULANIC ACID IS AND WHAT IT IS USED FOR Amoxicillin/Clavulanic acid 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 is used in adults 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 KNOW BEFORE YOU TAKE AMOXICILLIN/CLAVULANIC ACID DO NOT TAKE AMOXICILLIN/CLAVULANIC ACID : • if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (lis
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin/Clavulanic acid DSM-Sinochem 875 mg/125 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white 22 mm by 10 mm oblong film-coated tablet with score line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxicillin/clavulanic acid 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 and 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 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 DSM-Sinochem 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 amoxicillin/clavulanic acid (e.g. those that provide higher doses of amoxicillin H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ Perskaitykite visą dokumentą