Fortum powder for solution for injection/infusion

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

ceftazidime (ceftazidime pentahydrate)

Sẵn có từ:

GlaxoSmithKline Manufacturing SpA

Mã ATC:

J01DD02

INN (Tên quốc tế):

ceftazidime (ceftazidime pentahydrate)

Liều dùng:

500mg

Dạng dược phẩm:

powder for solution for injection/infusion

Các đơn vị trong gói:

(1) glass vial

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-08-31

Tờ rơi thông tin

FORTUM™
CEFTAZIDIME
QUALITATIVE AND QUANTITATIVE COMPOSITION
_FORTUM_ injection contains 250 mg, 500 mg, 1 g, 2 g or 3 g of
ceftazidime (as pentahydrate).
_FORTUM MONOVIAL_
™
contains 1 g or 2 g of ceftazidime (as pentahydrate).
Ceftazidime pentahydrate is formulated in a mixture with sodium
carbonate. When constituted, this mixture provides a
solution of ceftazidime sodium.
PHARMACEUTICAL FORM
Powder for injection/infusion
CLINICAL PARTICULARS
INDICATIONS
Treatment of single or multiple infections caused by susceptible
organisms.
May be used alone as first choice drug 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 _FORTUM _will vary with geography and time and local
susceptibility data should be consulted
where available (_see Pharmacological properties, Pharmacodynamic
effects_).
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)
-
prophylaxis: prostatic surgery (transurethral resection).
DOSAGE AND ADMINISTRATION
Dosage depends upon the severity, sensitivity, site and type of
infection and upon the age and renal function of the patient.
Use _FORTUM_ injection by intravenous (i.v.) or deep intramuscular
(i.m.) injection. Recommended i.m. injection sites are the
upper outer quadrant of the gluteus maximus or lateral part of the
thigh.
_FORTUM_ solutions may be given directly in

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FORTUM ™, CEFTAZIDIME
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_FORTUM_ injection contains 250 mg, 500 mg, 1 g, 2 g or 3 g of
ceftazidime (as
pentahydrate).
_FORTUM_ _MONOVIAL_™ contains 1 g or 2 g of ceftazidime (as
pentahydrate).
Cetftazidime pentahydrate is formulated in a mixture with sodium
carbonate. When
constituted, this mixture provides a solution of ceftazidime sodium.
3. PHARMACEUTICAL FORM
Powder for injection/infusion
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of single or multiple infections caused by susceptible
organisms.
May be used alone as first choice drug 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 _FORTUM _will vary with geography and time and local
susceptibility
data should be consulted where available (_see Pharmacological
properties, _
_Pharmacodynamic effects_).
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)
-
prophylaxis: prostatic surgery (transurethral resection).
4.2 DOSAGE AND ADMINISTRATION
Dosage depends upon the severity, sensitivity, site and type of
infection and upon the age
and renal function of the patient.
Use _FORTUM_ injection by intravenous (i.v.) or deep intramuscular
(i.m.) injection.
Recommended i.m. injection sites are the upper oute