Ceftazidime-AFT

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Ceftazidime pentahydrate 2.33 g equivalent to ceftazidime 2g

Dostopno od:

AFT Pharmaceuticals Ltd

Odmerek:

2 g

Farmacevtska oblika:

Powder for injection

Sestava:

Active: Ceftazidime pentahydrate 2.33 g equivalent to ceftazidime 2g Excipient: Sodium carbonate

Tip zastaranja:

Prescription

Terapevtske indikacije:

Indicated for the treatment of adults and children including neonates with single or multiple infections caused by susceptible organisms. May be used alone as first choice medicine before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other beta-lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected. Susceptibility to ceftazidime will vary with geography and time and local susceptibility data should be consulted where available. Indications include: - Severe infections: for example: · septicaemia, bacteraemia, peritonitis, meningitis. · infections in immunosuppressed patients. · infections in patients in intensive care, e.g. infected burns. - Respiratory tract infections including lung infections in cystic fibrosis. - Ear, nose and throat infections. - Urinary tract infections. - Skin and soft tissue infections. - Gastrointestinal, biliary, and abdominal infections. - Bone and joint infections. - Infections associated with haemo- and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)

Povzetek izdelek:

Package - Contents - Shelf Life: Vial, glass, single dose, Type III Soda-lime, 1x2g vial - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, Type III Soda-lime, 5x2g vial - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, Type III Soda-lime, 10x2g vial - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Datum dovoljenje:

2018-01-08

Lastnosti izdelka

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CEFTAZIDIME-AFT ceftazidime (as pentahydrate) 1 g or 2 g powder for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFTAZIDIME-AFT powder for injection contains either 1 g or 2 g of
ceftazidime (as
pentahydrate).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
A white or almost white crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CEFTAZIDIME-AFT is indicated for the treatment of adults and children
including neonates
with single or multiple infections caused by susceptible organisms.
May be used alone as first choice medicine before the results of
sensitivity tests are
available.
May be used in combination with an aminoglycoside or most other
beta-lactam antibiotics.
May be used with an antibiotic against anaerobes when the presence of
_Bacteroides fragilis _
is suspected.
Susceptibility to ceftazidime will vary with geography and time and
local susceptibility data
should be consulted where available (see section 5.1 Pharmacodynamic
properties).
Indications include:
•
Severe infections e.g.
•
-
septicaemia, bacteraemia, peritonitis, meningitis.
•
- infections in immunosuppressed patients.
•
- infections in patients in intensive care, e.g. infected burns.
•
Respiratory tract infections including lung infections in cystic
fibrosis.
•
Ear, nose and throat infections.
•
Urinary tract infections.
•
Skin and soft tissue infections.
•
Gastrointestinal, biliary and abdominal infections.
•
Bone and joint infections.
•
Infections associated with haemo- and peritoneal dialysis and with
continuous
ambulatory peritoneal dialysis (CAPD).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dose
Dosage depends upon the severity, sensitivity, site and type of
infection and upon the age
and renal function of the patient.
ADULTS:
1-6 g/day in 2 or 3 divided doses by intravenous (i.v.) or
intramuscular (i.m.) injection.
Urinary tract and less severe infections:
•
500 mg or 1 g every 12 ho