Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ceftazidime pentahydrate
Bowmed Ibisqus Ltd
J01DD02
Ceftazidime pentahydrate
500mg
Powder for solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5060130130232
PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTAZIDIME 500 MG POWDER FOR SOLUTION FOR INJECTION 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET : 1. What Ceftazidime Injection is and what it is used for 2. Before you are given Ceftazidime Injection 3. How Ceftazidime Injection is given 4. Possible side effects 5. How to store Ceftazidime Injection 6. Further information The name of your medicine is “Ceftazidime powder for solution for injection” (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 (hypersensitive) to CEFTAZIDIME or the other ingredients of this medicine (see section 6). • if you have had a SEVERE ALLERGIC REACTION to any OTHER ANTIBIOTIC (penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidime. TELL YOUR DOCTOR BEFOR Lugege kogu dokumenti
OBJECT 1 CEFTAZIDIME 500MG POWDER FOR SOLUTION FOR INJECTION VIALS Summary of Product Characteristics Updated 21-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 Ceftazidime 500mg Powder for Solution for Injection 2. Qualitative and quantitative composition Each vial contains 500mg Ceftazidime (as pentahydrate) Also contains sodium carbonate anhydrous (equivalent to 26mg sodium) For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection 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 soft tissue inf Lugege kogu dokumenti