Ceftazidime Mylan

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Ceftazidime pentahydrate 582mg equivalent to 500 mg ceftazidime;  ;  

Disponible depuis:

Viatris Limited

DCI (Dénomination commune internationale):

Ceftazidime pentahydrate 582 mg (equivalent to 500 mg ceftazidime)

Dosage:

500 mg

forme pharmaceutique:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 582mg equivalent to 500 mg ceftazidime     Excipient: Sodium carbonate

Unités en paquet:

Vial, Type III glass with chlorobutyl rubber (EP) (1 vial pack) (not marketed), 500 mg

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Orchid Chemicals and Pharmaceuticals Limited

indications thérapeutiques:

Indicated for the treatment of single and mixed 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 ?- 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

Descriptif du produit:

Package - Contents - Shelf Life: Vial, Type III glass with chlorobutyl rubber (EP) or bromobutyl (EP) - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Date de l'autorisation:

2007-05-07

Résumé des caractéristiques du produit

Page 1 of 12
NEW ZEALAND DATA SHEET
CEFTAZIDIME MYLAN
1. PRODUCT NAME
Ceftazidime Mylan, 250 mg, 500 mg, 1 g & 2 g, powder for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg, 500 mg, 1 g or 2 g of ceftazidime (as
pentahydrate).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Ceftazidime Mylan Powder for Injection is supplied as a white or
almost white, crystalline powder,
containing 116.4 mg sodium carbonate per gram of ceftazidime.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Treatment of 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 β-
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).
INDICATIONS INCLUDE:
•
Severe infections e.g.
-
Septicaemia, bacteraemia, peritonitis, meningitis
-
Infections of 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).
Page 2 of 12
_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 IV or IM injection.
URINARY TRACT AND LESS SEVERE INFECTIONS
- 500 mg or 1g every 12 hours._ _
MOST INFECTIONS
- 1 g every 8 hours or 2 g every 12 ho