Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Amoxicillin sodium
GlaxoSmithKline (Ireland) Limited
J01CA; J01CA04
Amoxicillin sodium
500 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Penicillins with extended spectrum; amoxicillin
Not marketed
1977-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXIL VIALS 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION AMOXICILLIN 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, 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 Amoxil is and what it is used for 2. What you need to know before you take Amoxil 3. How to take Amoxil 4. Possible side effects 5. How to store Amoxil 6. Contents of the pack and other information 1 WHAT AMOXIL IS AND WHAT IT IS USED FOR WHAT AMOXIL IS Amoxil is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‘penicillin’. WHAT AMOXIL IS USED FOR Amoxil is used to treat infections caused by bacteria in different parts of the body. Amoxil Powder for Solution for Injection or Infusion is usually used for urgent treatment of severe infection or if patients cannot take Amoxil by mouth. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXIL DO NOT TAKE AMOXIL: if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6). if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat. Do not take Amoxil if any of the above apply. If you are not sure, talk to your doctor, pharmacist or nurse before taking Amoxil. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Amoxil if you: have glandular fever (fever, sore throat, swollen glands and extreme tiredness) have kidney problems are not urinating regularly. If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Amoxil. BLOOD AND URINE TESTS If you are havi Læs hele dokumentet
Health Products Regulatory Authority 17 June 2021 CRN00C087 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxil Vials 500 mg, powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains amoxicillin sodium equivalent to 500 mg amoxicillin Excipient with known effect Sodium 32 mg (1.37 mmol) per vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. Vials containing a white to off-white sterile powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxil 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 Amoxil 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 Amoxil 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 require longer periods of treatment (see section 4.4 regardin Læs hele dokumentet