Pays: Royaume-Uni
Langue: anglais
Source: myHealthbox
ceftazidime
Glaxo Operations UK Ltd
J01DD02
ceftazidime
2g
Powder for solution for injection or infusion
intravenous injection or infusion
packs of 1 or 5
POM - Prescription Only Medicine
GlaxoSmithKline Manufacturing
Anti-bacterials for systemic use. Third-generation cephalosporins
It 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.
Authorised
2015-03-06
INFORMATION FOR THE HEALTHCARE PROFESSIONAL FORTUM ® FOR INJECTION 3 G, 2 G, 1 G AND 500 MG CEFTAZIDIME DOSAGE AND ADMINISTRATION INFORMATION ONLY Please refer to the Summary of Product Characteristics for further information DON’T STOP TAKING FORTUM Don’t stop taking Fortum unless your doctor tells you to. If you have any further questions on the use of this medicine ask your doctor or nurse. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. CONDITIONS YOU NEED TO LOOK OUT FOR The following serious side effects have occurred in a small number of people but their exact frequency is unknown: • SEVERE ALLERGIC REACTION. Signs include RAISED AND ITCHY RASH, SWELLING, sometimes of the face or mouth causing DIFFICULTY IN BREATHING. • SKIN RASH, which may BLISTER, and looks like SMALL TARGETS (central dark spot surrounded by a paler area, with a dark ring around the edge). • A WIDESPREAD RASH with BLISTERS and PEELING SKIN. (These may be signs of _Stevens-Johnson syndrome _or_ _ _toxic epidermal necrolysis)._ • NERVOUS SYSTEM DISORDERS: tremors, fits and, in some cases coma. These have occurred in people when the dose they are given is too high, particularly in people with kidney disease. • There have been rare reports of severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS). ➔ CONTACT A DOCTOR OR NURSE IMMEDIATELY IF YOU GET ANY OF THESE SYMPTOMS. COMMON SIDE EFFECTS These may affect UP TO 1 IN 10 people: • diarrhoea • swelling and redness along a vein • red raised skin rash which may be itchy • pain, burning, swelling or inflammation at the injection site. ➔ TELL YOUR DOCTOR if any of these are troubling you. Common side effects Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fortum for Injection 2g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fortum for Injection: Vials contain 2g ceftazidime (as pentahydrate) with sodium carbonate (118mg per gram of ceftazidime). Fortum Monovial in a vial containing 2g ceftazidime pentahydrate. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion 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 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 possible range of causative bacteria would not fall within its spectrum of activity. Consideration should be given to official guidelines on the a Lire le document complet