MESPORIN-1000 I.V. VIALS

Country: Malaysia

Language: English

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

Active ingredient:

CEFTRIAXONE SODIUM

Available from:

MEPHARM (MALAYSIA) SDN BHD

INN (International Name):

CEFTRIAXONE SODIUM

Units in package:

1Units Units

Manufactured by:

LABESFAL-LABORATORIOS, ALMIRO, S.A.

Summary of Product characteristics

Mesporin
®
-1000 I.M./I.V.
Mesporin
®
-250/500 I.M.
Long-acting, parenteral, broad-spectrum
bactericidal antibiotic
Composition
Mesporin
®
-1000 I.V.
Each vial contains:
Ceftriaxone 1000 mg in the form of disodium salt.
Each ampoule of solvent contains 10 ml of sterile
water for injection.
Mesporin
®
-1000 I.M.
Each vial contains:
Ceftriaxone 1000 mg in the form of disodium salt.
Each ampoule of solvent contains 3.5 ml of lidocaine
HCI 1%.
Mesporin
®
-500 I.M.
Each vial contains:
Ceftriaxone 500 mg in the form of disodium salt.
Each ampoule of solvent contains 2 ml of lidocaine
HCI 1%.
Mesporin
®
-250 I.M.
Each vial contains:
Ceftriaxone 250 mg in the form of disodium salt.
Each ampoule of solvent contains 25 ml of lidocaine
HCI 1%.
Mesporin
®
contains approximately 83 mg (3.6 mEq)
of sodium per gram of ceftriaxone.
Properties, effects
The bactericidal activity of ceftriaxone results from
inhibition of cell wall synthesis. Ceftriaxone exerts in
vitro activity against a wide range of gram-negative
and gram positive microorganisms. Ceftriaxone is
highly stable to most -lactamases, both penicilli-
nases and cephalosporinases, of gram-negative and
gram-positive bacteria. Ceftriaxone is usually active
against the following microorganisms in vitro and in
clinical infections:
Gram-positive aerobes
median values
MlC
50*
MlC
90**
(in mg/I)
(in mg/I)
Staphylococcus aureus
(methicillin-sensitive)
4
4
Staphylococci,
Coagulase-negative
4
16
Streptococcus pyogenes
(beta-haemolytic, group A)
0.03
0.03
Streptococcus agalactiae
(beta-haemolytic, group B)
0.06
0.06
Streptococci,
beta-haemolytic
(not group A or B)
0.06
0.06
Streptococcus viridans
0.125
0.5
Streptococcus pneumoniae
0.06
0.06
* MIC
50
=
minimal inhibitory concentration for 50%
of the tested strains.
**MIC
90
=
minimal inhibitory concentration for 90%
of the tested strains.
Gram-negative aerobes
median values
MIC
50
MIC
90
(in mg/I)
(in mg/I)
Acinetobacter Iwoffi
2
8
Acinetobacter anitratus
1)
(mainly A baumanii)
8
32
Aeromonas hydrophila
0.25
4
Alc