Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ceftazidime pentahydrate
Sandoz Ltd
J01DD02
Ceftazidime pentahydrate
2gram
Powder for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010201; GTIN: 5000123108046
PACKAGE LEAFLET: INFORMATION FOR THE USER FORTUM® 500 MG POWDER FOR SOLUTION FOR INJECTION FORTUM® 1 G, 2 G, 3 G POWDER FOR SOLUTION FOR INJECTION OR 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 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FORTUM YOU MUST NOT BE GIVEN FORTUM: • IF YOU ARE ALLERGIC to CEFTAZIDIME or any of the other ingredients of this medicine (listed in 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 Fortum. → TELL YOUR DOCTOR BEFORE you start on Fortum if you think that this applies to you. You must not be given Fortum. TAKE SPECIAL CARE WITH FORTUM You must lo Прочитайте повний документ
OBJECT 1 FORTUM FOR INJECTION 2 G Summary of Product Characteristics Updated 15-Jun-2016 | GlaxoSmithKline UK 1. Name of the medicinal product Fortum ® 2 g powder for solution for injection or infusion Fortum ® 2 g powder for solution for infusion (Monovial) 2. Qualitative and quantitative composition Fortum 2 g Fortum 2 g (Monovial) 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 patient 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 trans-urethral 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). Ceftazidime should be co-administered with other antibacterial agents whenever the possib Прочитайте повний документ