FORTUM INJECTION 2GVIAL

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFTAZIDIME

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

CEFTAZIDIME

Units in package:

77ml mL; 77 ml mL

Manufactured by:

ACS Dobfar S.p.A.

Summary of Product characteristics

FORTUM
CEFTAZIDIME
QUALITATIVE AND QUANTITATIVE COMPOSITION
_FORTUM_
injection contains 250 mg, 500 mg, 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).
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 by 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 into the vein or introduced into the
tubing of a giving set if the
patient is receiving parenteral fluids.
•
ADULTS
1 to 6 g/day in two