Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Ceftriaxone sodium
AS Kalceks
J01DD; J01DD04
Ceftriaxone sodium
Powder for solution for injection/infusion
Third-generation cephalosporins; ceftriaxone
Not marketed
2023-01-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTRIAXONE 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION ceftriaxone 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 Ceftriaxone is and what it is used for 2. What you need to know before you are given Ceftriaxone 3. How Ceftriaxone is 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. This medicine 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; • to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age; • to prevent infections during surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTRIAXONE YOU MUST NOT BE GIVEN CEFTRIAXONE IF: • you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6); • you have had a sudden or se Leggi il documento completo
Health Products Regulatory Authority 13 January 2023 CRN00CJTS Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftriaxone 1 g powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium). Sodium content per vial: 83 mg (equivalent to 3.6 mmol). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. Almost white or yellowish 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 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 guidelines on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Health Products Regulatory Authority 13 January 2023 CRN00C Leggi il documento completo