CEFTAZIDIME 500 Milligram Pdr+Solv for Soln for Inj
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
20-04-2024
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Aktivna sestavina:
CEFTAZIDIME PENTAHYDRATE
Dostopno od:
Martindale Pharmaceuticals Ltd
INN (mednarodno ime):
CEFTAZIDIME PENTAHYDRATE
Odmerek:
500 Milligram
Farmacevtska oblika:
Pdr+Solv for Soln for Inj
Tip zastaranja:
Product subject to prescription which may not be renewed (A)
Status dovoljenje:
Withdrawn
Datum dovoljenje:
0000-00-00
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftazidime 500 mg Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 582 mg of ceftazidime pentahydrate, equivalent to 500 mg of ceftazidime
Excipient: each 500 mg vial of powder contains 60 mg of sodium carbonate
This medicinal product contains 1.13 mmol (or 26 mg) of sodium per vial
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 treatment of the following bacterial infections when they are caused by ceftazidime-
sensitive bacteria, and only if beta-lactam-antibiotics with a narrower spectrum cannot be used:
- Nosocomial pneumonia
- Bronchopulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
- Meningitis caused by aerobic gram-negative microorganisms
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the degree of severity of the infection, sensitivity and type of infection, and on the age, weight
and renal function of the patient.
_WITH NORMAL RENAL FUNCTION_
AGE GROUP
INFECTION
NORMAL DOSE
Adults
Most indications
1 g every 8 hours (3 g/day) or 2
g every 12 hours (4 g/day)
Nosocomial pneumonia and
infections in patients with
neutropaenia
2 g every 8 hours (6 g/day)
Bronchopulmonary infections in
cystic fibrosis caused by
Pseudomonas aeruginosa
100-150 mg/kg/day, divided
into 3 doses; 9 g/day must not
be exceeded
Infants and children aged
over two months
Most indications
30-100 mg/kg/day, divided into
2 or 3 doses
IRISH MEDICINES BOARD
_____________________________________________
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