CEFAZOLIN SANDOZ 1G VIAL

Land: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

CEPHAZOLIN SODIUM

Fáanlegur frá:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Alþjóðlegt nafn):

CEPHAZOLIN SODIUM

Einingar í pakka:

ml50Units mL; 15ml mL

Framleitt af:

SANDOZ GMBH

Upplýsingar fylgiseðill

NOT APPLICABLE

Vara einkenni

CEFAZOLIN SANDOZ
®
1 G VIAL
1.
NAME OF THE MEDICINAL PRODUCT
Cefazolin Sandoz 1 g Vial
2.
QUALITITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Cefazolin 1,000 mg (as sodium salt)
.
3.
PHARMACEUTICAL FORM
Powder for solution for
injection/infusion. White to light yellow
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefazolin is indicated in a number of infections caused by
cefazolin-sensitive microorganisms. These
include:
-
_Infections of the respiratory tract like bronchitis and pneumonia _
-
_Infections of the urogenital tract like pyelonephritis, cystitis,
urethritis and prostatitis _
-
_Infections of the skin and soft tissues _
-
_Infections of the bile ducts _
-
_Bone and joint infections _
-
_Endocarditis _
-
_Systemic septic infections _
-
_Perioperative prophylaxis (hysterectomy, cholecystectomy, open-heart
surgery, bone and joint surgery). _
_ _
Use of cefazolin should be restricted to cases needing to be treated
parenterally.
Consideration should be given to official guidance (e.g. national
recommendations) on the appropriate use of
antibacterial agents.
Susceptibility of the causative organism to the treatment should be
tested (if possible), although therapy may be
initiated before the results are available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the susceptibility of the pathogens and the
severity of the disease.
_ADULTS _
TYPE OF INFECTION
DOSE
FREQUENCY
TOTAL DAILY DOSE
Mild infections (caused by Gram-
positive organisms)
500 mg
1 g
every 8 hours
every 12 hours
1.5 g
2 g
Uncomplicated urinary tract
infections
1 g
every 12 hours
2 g
Moderate to severe infections
(caused by Gram-negative
organisms)
_ _
1 g
_ _
every 6 to 8 hours
_ _
3 g - 4 g
Life-threatening infections
1 g - 1.5 g
every 6 hours
4 g - 6 g
_ _
Rarely, doses up on to 12 g daily were administered.
_IN ADULT PATIENTS WITH RENAL INSUFFICIENCY _
The dose schedule below should be followed:
Creatinine clearance
(ml/min x 1.73 m
2
)
Serum creatinine
(mg/100 ml)
Total daily dose
Dose inter