Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ceftriaxone sodium
Roche Products (Ireland) Ltd
J01DD04
Ceftriaxone sodium
1 gram(s)
Powder for solution for injection/infusion
ceftriaxone
Marketed
2021-06-18
1 IE-PIL-Rocephin_IM/IV-1g_01 March 2023_Clean PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROCEPHIN ® 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION ceftriaxone (as ceftriaxone sodium) 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. - 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. WHAT IS IN THIS LEAFLET 1. What Rocephin is and what it is used for 2. What you need to know before you are given Rocephin 3. How Rocephin is given 4. Possible side effects 5. How to store Rocephin 6. Contents of the pack and other information 1. WHAT ROCEPHIN IS AND WHAT IT IS USED FOR Rocephin 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 _. _ Rocephin 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. 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 ROCEPHIN YOU MUST NOT BE GIVEN ROCEPHIN IF: You are allergi Read the complete document
Health Products Regulatory Authority 06 April 2023 CRN00DHHJ Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rocephin 1 g powder for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 g ceftriaxone as ceftriaxone sodium. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion. White to yellowish-orange crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rocephin 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 Rocephin 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. Rocephin 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 The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient. The doses recommended in the tables below are the generally recommended doses in these indications. In particularl Read the complete document