País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
CEFTAZIDIME
Clonmel Healthcare Ltd
1 Grams
Pdr for Soln for Injection
2009-03-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceftazidime 1000 mg powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1165 mg ceftazidime pentahydrate corresponding to 1000 mg ceftazidime Excipients: 51.2 mg (2.23 mmol) of sodium/vial of powder for solution for injection For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection The powder is white or off-white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceftazidime is indicated for the parenteral treatment of the following bacterial infections when caused by pathogens susceptible to ceftazidime (see section 5.1) only if penicillin or a penicillin derivative with a narrower spectrum cannot be used: Nosocomial pneumonia Lower respiratory tract infections in patients with cystic fibrosis. Meningitis owing to aerobic Gram-negative organisms. It is recommended that the results of bacterial cultures and susceptibility tests are known before commencing treatment. This is especially important if ceftazidime is to be used as monotherapy. Ceftazidime should be used in combination with an additional antibacterial agent(s) when treating infections that are likely to be due to a mixture of susceptible and resistant bacterial species. For example, combination therapy with an antibacterial agent that is active against anaerobic bacteria should be considered when the infection is thought to be due to aerobic and anaerobic bacteria. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Routes of administration:_ 250 mg, 500 mg and 1000 mg Powder solution for injection: Intravenous use Intramuscular use (only exceptional clinical situations) 1 g, 2 g Leer el documento completo