Cefazolin-AFT Powder for Injection 1g

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

CEPHAZOLIN SODIUM

Tillgänglig från:

AFT PHARMACEUTICALS (SE ASIA) SDN BHD

INN (International namn):

CEPHAZOLIN SODIUM

Enheter i paketet:

1vial Vials; 5vial Vials; 10vial Vials; 10 Vials; 5 Vials; 1 Vials

Tillverkad av:

Qilu Pharmaceutical Co.,Ltd

Bipacksedel

Not Applicable

Produktens egenskaper

CEFA INJ_PI_MY_rev12.2017(v2)
CEFAZOLIN-AFT
AFT Pharmaceuticals Ltd.
NAME OF THE MEDICINE
Cefazolin-AFT Powder for Injection 500mg
Cefazolin-AFT Powder for Injection 1g
(Cephazolin sodium 524mg and 1.048g equivalent to Cephazolin 500mg and
1g)
Cephazolin
sodium
has
the
chemical
name
sodium
(6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-
yl)sulphanyl]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-
carboxylate. It has the chemical formula C
14
H
13
N
8
NaO
4
S
3
with a molecular weight of 476.5. The
CAS number is 27164-46-1.
DESCRIPTION
Cephazolin sodium is a white or almost white powder which is freely
soluble in water but only very
slightly soluble in ethanol. When reconstituted with Water for
Injections or other compatible solutions,
a pale yellow to amber solution is formed depending on the
concentration and storage time.
PHARMACOLOGY
_MICROBIOLOGY _
In vitro tests demonstrate that the bactericidal action of
cephalosporins results from inhibition of cell
wall synthesis. Cephazolin has been found to be active against the
following organisms in vitro:

_Staphylococcus aureus_ (penicillin sensitive and penicillin
resistant)

Group A β-haemolytic streptococci and other strains of streptococci
(many strains of
enterobacter are resistant)

_Streptococci pneumoniae _

_Escherichia coli _

_Proteus mirabilis_

_Klebsiella_ sp

_Enterobacter aerogenes_

_Haemophilus influenzae_
Most strains of _Enterobacter cloacae_ and indole-positive proteus
(_P. vulgaris, P. morganii, P. rettgeri_)
are resistant.
Methicillin resistant staphylococci, serratia, pseudomonas,
_Acinetobacter calcoaceticus _(previously
Mima and Herellea sp.) are almost uniformly resistant to Cephazolin.
Susceptibility tests
Dilution or diffusion techniques (either quantitative (MIC) or
breakpoint) should be used following a
recognised and standardised method e.g. NCCLS.
A report of “susceptible” indicates that the infecting organism is
likely to respond to therapy. A report
of “resistant” in