Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Ceftazidime
GlaxoSmithKline (Ireland) Limited
J01DD; J01DD02
Ceftazidime
2 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; ceftazidime
Marketed
1984-09-24
Reason for update: Type IAin Divestment of GSK Verona manufacturing site to ACS Dobfar – Project Chestnut Agency Approval Date: TBC Text Date: 20/01/2020 Text Issue and Draft No.: issue6draft2 SPC Issue and Draft No.: issue5draft3 (No change in SPC with this submission) [GSK Logo] PACKAGE LEAFLET: INFORMATION FOR THE USER FORTUM ® 500 MG POWDER FOR SOLUTION FOR INJECTION FORTUM ® 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION, VIAL FORTUM ® 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION, VIAL FORTUM ® 2 G POWDER FOR SOLUTION FOR INFUSION, MONOVIAL TM 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 or nurse. - If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Fortum is and what it is used for 2. What you need to know before you are given Fortum 3. How Fortum is given 4. Possible side effects 5. How to store Fortum 6. Contents of the pack and other information 1. WHAT FORTUM IS AND WHAT IT IS USED FOR Fortum 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._ FORTUM 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. Fortum 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. Reason for update: Type IAin Divestment of GSK Verona manufacturing site to ACS Dobfar Les hele dokumentet
Health Products Regulatory Authority 09 October 2019 CRN009D2L Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fortum 2 g powder for solution - for injection or infusion, vial - for infusion, monovial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2 g ceftazidime (as pentahydrate) with sodium carbonate (118 mg per gram of ceftazidime). Excipient with known effect Each vial contains 104 mg (4.6 mmol) of sodium per vial. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion Vials containing white to cream sterile powder. Powder for solution for infusion Monovial containing white to cream sterile powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fortum 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 infections · Complicated intra-abdominal infections · Bone and joint infections · Peritonitis associated with dialysis in patients on CAPD. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing transurethral resection of the prostate (TURP). The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria (see sections 4.4 and 5.1). Health Products Regulatory Authority 09 October 2019 CRN009D2L Page 2 of 17 Ceftazidime should be co-administered with other antibacterial agents whenever the possi Les hele dokumentet