Ceftazidime Mylan

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Ceftazidime pentahydrate 582mg equivalent to 500 mg ceftazidime;  ;  

제공처:

Viatris Limited

INN (International Name):

Ceftazidime pentahydrate 582 mg (equivalent to 500 mg ceftazidime)

복용량:

500 mg

약제 형태:

Powder for injection

구성:

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

패키지 단위:

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

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Orchid Chemicals and Pharmaceuticals Limited

치료 징후:

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

제품 요약:

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)

승인 날짜:

2007-05-07

제품 특성 요약

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