Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cefotaxime sodium
Bowmed Ibisqus Ltd
J01DD01
Cefotaxime sodium
500mg
Powder for solution for injection
Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5060130130010
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFOTAXIME SODIUM FOR INJECTION 500MG, 1G READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. In this leaflet: 1. What Cefotaxime Injection is and what it is used for. 2. Before you are given Cefotaxime Injection. 3. How Cefotaxime Injection is given. 4. Possible side effects. 5. How to store Cefotaxime Injection 6. Further information. The name of your medicine is “Cefotaxime sodium for injection” (referred to AS CEFOTAXIME INJECTION throughout this leaflet). 1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR Cefotaxime is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin. Cefotaxime kills bacteria and it can be used to treat infections of the: • Kidneys and bladder • Blood (septicaemia) • Skin and flesh immediately under the skin • Bones • Heart valves • Brain (meningitis) • Abdomen (peritonitis) • Some sexually transmitted infections (gonorrhoea) It can also be used to prevent and treat infections following surgical operations. 2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION YOU SHOULD NOT BE GIVEN CEFOTAXIME INJECTION IF: • you are allergic (hypersensitive) to cefotaxime • you are allergic to any similar antibiotics (known as “cephalosporins”) • you have ever had a serious allergic reaction when given penicillin or similar antibiotics • you are allergic to lidocaine Tell your doctor or nurse if any of the above apply to you. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION You must tell the doctor or nurse if any of the foll Read the complete document
OBJECT 1 CEFOTAXIME 500MG POWDER FOR SOLUTION FOR INJECTION VIALS Summary of Product Characteristics Updated 26-Apr-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 Cefotaxime Sodium for Injection 500 mg/1 g 2. Qualitative and quantitative composition Cefotaxime (as cefotaxime sodium) per vial Diluent to be added Final concentration of solution 500 mg 2 ml 500 mg/2.2 ml 1 g 4 ml 1 g/4.4 ml A quantity of cefotaxime sodium equivalent to 1 g cefotaxime contains approximately 50 mg (2.2 mmol) of sodium For excipients see 6.1. 3. Pharmaceutical form Powder for solution for injection or infusion. Vials containing a white to slightly yellow powder, which when dissolved in Water for Injections forms a straw coloured solution. The intensity of the colour of the solution may vary but this does not indicate differences in potency or safety. 4. Clinical particulars 4.1 Therapeutic indications Consideration should be given to official guidance on the appr Read the complete document