Fortum powder for solution for injection/infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ceftazidime (ceftazidime pentahydrate)

Available from:

GlaxoSmithKline Manufacturing S.p.A.

ATC code:

J01DD02

INN (International Name):

ceftazidime (ceftazidime pentahydrate)

Dosage:

1000mg

Pharmaceutical form:

powder for solution for injection/infusion

Units in package:

(1) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-08-31

Patient Information leaflet

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

Summary of Product characteristics

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