Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ceftazidime pentahydrate
Bowmed Ibisqus Ltd
J01DD02
Ceftazidime pentahydrate
2gram
Powder for solution for injection
Intramuscular; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5060130130256
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTAZIDIME 500, 1G, POWDER FOR SOLUTION FOR INJECTION CEFTAZIDIME 2G, POWDER FOR SOLUTION FOR INJECTION/INFUSION Ceftazidime READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. • 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 Ceftazidime Injection is and what it is used for 2. What you need to know before you are given Ceftazidime Injection 3. How Ceftazidime Injection is given 4. Possible side effects 5. How to store Ceftazidime Injection 6. Contents of the pack and other information The name of your medicine is “Ceftazidime powder for solution for injection or infusion” (referred to as CEFTAZIDIME INJECTION throughout this leaflet). 1. WHAT CEFTAZIDIME INJECTION IS AND WHAT IT IS USED FOR Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins _. _ CEFTAZIDIME IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF : • the lungs or chest • the lungs and bronchi in patients suffering from cystic fibrosis • the brain (meningitis) • the ear • the urinary tract • the skin and soft tissues • the abdomen and abdominal wall (peritonitis) • the bones and joints. Ceftazidime can also be used: • to prevent infections during prostate surgery in men • to treat patients with low white blood cell counts (neutropenia) who have a fever due to a bacterial infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME INJECTION YOU MUST NOT BE GIVEN CEFTAZIDIME INJECTION: • IF YOU ARE ALLERGIC to CEFTAZIDIME or the other ingredient of this medicine (see section 6). • if you have had a SEVERE ALLERGIC REACTIO Lestu allt skjalið
OBJECT 1 CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION VIALS Summary of Product Characteristics Updated 11-Dec-2017 | 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 Ceftazidime 2g Powder for Solution for Injection or Infusion 2. Qualitative and quantitative composition Each vial contains 2g Ceftazidime (as pentahydrate) Also contains sodium carbonate anhydrous (equivalent to 104mg sodium) For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection or infusion A white to cream-coloured powder. 4. Clinical particulars 4.1 Therapeutic indications Ceftazidime is indicated for the treatment of the infections listed below in adults and children including neonates (from birth). • Nosocomial pneumonia • Broncho-pulmonary infections in cystic fibrosis • Bacterial meningitis • Chronic suppurative otitis media • Malignant otitis externa • Complicated urinary tract infections • Complicated skin and Lestu allt skjalið