Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ceftriaxone sodium
Bowmed Ibisqus Ltd
J01DD04
Ceftriaxone sodium
250mg
Powder for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5060130130126
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFTRIAXONE 250 MG, 1G, 2G POWDER FOR SOLUTION FOR INJECTION OR 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 Ceftriaxone injection is and what it is used for 2. What you need to know before you are given Ceftriaxone injection 3. How Ceftriaxone injection is given 4. Possible side effects 5. How to store Ceftriaxone injection 6. Contents of the pack and other information The name of your medicine is “Ceftriaxone Powder for Solution for Injection or Infusion” (referred to as Ceftriaxone injection throughout this leaflet). 1. WHAT CEFTRIAXONE 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 injection 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 adu Læs hele dokumentet
OBJECT 1 CEFTRIAXONE 250MG POWDER FOR SOLUTION FOR INJECTION VIALS Summary of Product Characteristics Updated 21-Jun-2022 | Bowmed Ibisqus Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Ceftriaxone 250mg powder for solution for injection 2. Qualitative and quantitative composition Each vial contains 298.25mg Ceftriaxone sodium equivalent to 250mg Ceftriaxone Also contains approximately 21 mg (0.9 mmol) sodium. 3. Pharmaceutical form Powder for solution for injection A white or almost white 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 infect Læs hele dokumentet