Pays: Malte
Langue: anglais
Source: Medicines Authority
CEFTRIAXONE
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
J01DD04
CEFTRIAXONE 1 g
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
CEFTRIAXONE 1 g
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2014-03-05
Page 1 of 14 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFTRIAXONE 500 MG POWDER FOR SOLUTION FOR INJECTION (IM, IV) CEFTRIAXONE 1 G POWDER FOR SOLUTION FOR INJECTION (IM, IV) CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INFUSION (IV) Ceftriaxone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. WHAT IS IN THIS LEAFLET 1. What Ceftriaxone is and what it is used for 2. What you need to know before you are given Ceftriaxone 3. How Ceftriaxone will be given 4. Possible side effects 5. How to store Ceftriaxone 6. Contents of the pack and other information 1. WHAT CEFTRIAXONE IS AND WHAT IT IS USED FOR Ceftriaxone is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins_. _ _ _ Ceftriaxone is used to treat infections of: • the brain (meningitis). • the lungs. • the middle ear. • the abdomen and abdominal wall (peritonitis). • the urinary tract and kidneys. • bones and joints. • the skin or soft tissues. • the blood. • the heart. It can be given: • to treat specific sexually transmitted infections (gonorrhoea and syphilis). • to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection. • to treat infections of the chest in adults wi Lire le document complet
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ceftriaxone 500 mg Powder for Solution for Injection (IM, IV) Ceftriaxone 1 g Powder for Solution for Injection (IM, IV) Ceftriaxone 2 g Powder for Solution for Infusion ( IV) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg ceftriaxone as 596 mg ceftriaxone sodium. Each vial contains 1 g ceftriaxone as 1.193 g ceftriaxone sodium. Each vial contains 2 g ceftriaxone as 2.386 g ceftriaxone sodium. Ceftriaxone 500 mg contains approximately 1.8 mmol (41.4 mg) sodium. Ceftriaxone 1 g contains approximately 3.6 mmol (82.8 mg) sodium. Ceftriaxone 2 g contains approximately 7.2 mmol (165.6 mg) sodium. 3. PHARMACEUTICAL FORM Powder for Solution for Injection Powder for Solution for Infusion Almost white or yellowish, slightly hygroscopic, crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth): Bacterial Meningitis. Community acquired pneumonia. Hospital acquired pneumonia. Acute otitis media. Intra-abdominal infections. Complicated urinary track infections (including pyelonephritis). Infections of bone and joints. Complicated skin and soft tissue infections. Gonorrhoea. Syphilis. Bacterial Endocarditis. Ceftriaxone may be used: For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults. Page 2 of 21 For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age. For Pre-operative prophylaxis of surgical site infections. In the management of neutro Lire le document complet