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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
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