מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CEFTRIAXONE SODIUM
Wockhardt UK Limited
J01DD; J01DD04
CEFTRIAXONE SODIUM
2 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; ceftriaxone
Marketed
2003-03-19
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTRIAXONE 1G POWDER FOR SOLUTION FOR INJECTION CEFTRIAXONE 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION 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 further questions, ask your doctor, pharmacist or nurse. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − 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. The name of your medicine is ceftriaxone 1g powder for solution for injection and ceftriaxone 2g powder for solution for injection or infusion. In the rest of this leaflet it is called ceftriaxone for injection. WHAT IS IN THIS LEAFLET 1. What ceftriaxone for injection is and what it is used for 2. What you need to know before you take ceftriaxone for injection 3. How to take ceftriaxone for injection 4. Possible side effects 5. How to store ceftriaxone for injection 6. Contents of the pack and other information 1. WHAT CEFTRIAXONE FOR INJECTION 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 with chronic bronchitis. • קרא את המסמך השלם
Health Products Regulatory Authority 16 October 2019 CRN0093ZW Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftriaxone 2g Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains ceftriaxone sodium equivalent to 2g of ceftriaxone. Excipient with known effect Each gram of ceftriaxone contains approximately 82mg (3.6mmol) of sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion (Powder for Injection/Infusion) White to pale yellow crystalline powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftriaxone is indicated in 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 tract infections (including pyelonephritis) Infections of bones 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 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 neutropenic patients with fever that is suspected to be due to a bacterial infection In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the severity, susceptibi קרא את המסמך השלם