Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amoxicillin sodium
Wockhardt UK Ltd
J01CA04
Amoxicillin sodium
500mg
Powder for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010103; GTIN: 5012727902555
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN SODIUM 250 MG, 500 MG AND 1000 MG POWDER FOR SOLUTION FOR INJECTION Sodium Amoxicillin (referred to as Amoxicillin in the remainder of the leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Amoxicillin is and what it is used for 2. What you need to know before you are given Amoxicillin 3. How Amoxicillin is given 4. Possible side effects 5. How to store Amoxicillin 6. Contents of the pack and other information 1. WHAT AMOXICILLIN IS AND WHAT IT IS USED FOR The name of your medicine is Amoxicillin Sodium Powder for Solution for Injection. The vials contain a medicine called sodium amoxicillin. This belongs to a group of medicines called ‘penicillin’. WHAT AMOXICILLIN IS USED FOR Amoxicillin is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Powder for Solution for Injection is usually used for urgent treatment of severe infection or if patients cannot take Amoxicillin by mouth. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMOXICILLIN INJECTION YOU SHOULD NOT BE GIVEN AMOXICILLIN • if you are allergic to amoxicillin or penicillin. There are no other ingredients in this medicine (see section 6). • if you have had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. • if you have previously been told that your infection cannot be treated with amoxicillin or ampicillin. You should not be given Amoxicillin if any of the above applies to you. If you are not sure speak to your doctor, nurse or pharmacist. WARNINGS AND PRECAUTIONS Talk to you doctor , pharmacist or nurse before you Perskaitykite visą dokumentą
OBJECT 1 AMOXICILLIN SODIUM FOR INJECTION Summary of Product Characteristics Updated 10-Jan-2018 | Wockhardt UK Ltd 1. Name of the medicinal product Amoxicillin Sodium 250mg Powder for Solution for Injection Amoxicillin Sodium 500mg Powder for Solution for Injection Amoxicillin Sodium 1g Powder for Solution for Injection 2. Qualitative and quantitative composition Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 250mg Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 1g 3. Pharmaceutical form Powder for solution for injection. 4. Clinical particulars 4.1 Therapeutic indications Amoxicillin 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 • Community acquired pneumonia • Acute cystitis • Acute pyelonephritis • Severe dental abscess with spreading cellulitis • Prosthetic joint infections • Lyme disease • Bacterial meningitis • Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above Amoxicillin is also indicated for the treatment and prophylaxis of endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration POSOLOGY The dose of Amoxicillin 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 duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections requir Perskaitykite visą dokumentą