Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Potassium clavulanate; Amoxicillin trihydrate
Viatris UK Healthcare Ltd
J01CR02
Potassium clavulanate; Amoxicillin trihydrate
6.25mg/1ml ; 25mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010103
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CO-AMOXICLAV 125 MG/31.25 MG/5 ML POWDER FOR ORAL SUSPENSION CO-AMOXICLAV 250 MG/62.5 MG/5 ML POWDER FOR ORAL SUSPENSION 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 is usually 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If you are an adult who has been given this medicine, this information applies to you. WHAT IS IN THIS LEAFLET 1. What Co-amoxiclav is and what it is used for 2. What you need to know before you give Co-amoxiclav 3. How to give Co-amoxiclav to your child 4. Possible side effects 5. How to store Co-amoxiclav 6. Contents of the pack and other information 1. WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR Co-amoxiclav 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 is used in adults, babies and children to treat the following infections: • middle ear and sinus infections • respiratory tract infections • urinary tract and kidney infections • skin and soft tissue infections including animal bites and 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 CO-AMOXICLAV DO NOT GIVE CO-AMOXICLAV TO YOUR CHILD IF: • your chi Pročitajte cijeli dokument
OBJECT 1 CO-AMOXICLAV 125 MG/31.25 MG/5 ML POWDER FOR ORAL SUSPENSION Summary of Product Characteristics Updated 03-Jan-2018 | Generics UK T/A Mylan 1. Name of the medicinal product Co-amoxiclav 125 mg/31.25 mg/5 ml Powder for Oral Suspension 2. Qualitative and quantitative composition 5 ml reconstituted suspension contains: Amoxicillin trihydrate 143.50 mg corresponding to 125 mg amoxicillin Potassium clavulanate 37.2 mg corresponding to 31.25 mg clavulanic acid Excipients with known effect: Each 5 ml reconstituted suspension contains 8.5 mg aspartame (E951), small amounts of sorbitol (E420), dextrose and maltodextrin (glucose). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for oral suspension Off-white powder or off-white suspension once reconstituted. 4. Clinical particulars 4.1 Therapeutic indications Co-amoxiclav 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 Co-amoxiclav 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 Co-amoxiclav (_e.g._ Pročitajte cijeli dokument