Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Clavulanic acid; Amoxicillin
McDermott Laboratories Ltd., T/A Gerard Laboratories
J01CR; J01CR02
Clavulanic acid; Amoxicillin
125 mg/31.25 mg/5ml
Powder for oral suspension
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor
Marketed
2004-03-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GERMENTIN 125 MG/31.25 MG PER 5 ML POWDER FOR ORAL SUSPENSION (amoxicillin and clavulanic acid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. IF YOU ARE AN ADULT WHO HAS BEEN GIVEN THIS MEDICINE, THIS INFORMATION APPLIES TO YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their signs 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 Germentin is and what it is used for 2. What you need to know before you give Germentin 3. How to give Germentin 4. Possible side effects 5. How to store Germentin 6. Contents of the pack and other information. 1. WHAT GERMENTIN IS AND WHAT IT IS USED FOR Germentin 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. Germentin is used in adults, 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. You must talk to a doctor if your child does not feel better or if your child feels worse after 14 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE GERMENTIN DO NOT GIVE YOUR CHILD GERMENTIN: • if they are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medici Soma hati kamili
Health Products Regulatory Authority 27 February 2023 CRN00DFMX Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germentin 125 mg/31.25 mg per 5 ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5 ml reconstituted suspension contains: Amoxicillin trihydrate equivalent to 125 mg amoxicillin Potassium clavulanate equivalent to 31.25 mg clavulanic acid Excipients with known effect: each 5 ml reconstituted suspension contains 8.5 mg aspartame (E951), less than 0.15 mg sorbitol and less than 0.7 mg glucose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. Off-white granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Germentin 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 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 Germentin 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. Health Products Regulatory Authority 27 February 2023 CRN00DFMX Page 2 of 15 The use of alternative presentations of Germentin (e.g_. _those that provide higher doses of amoxicillin an Soma hati kamili