Meropenem Sandoz

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
16-09-2011

ingredients actius:

Meropenem trihydrate 1.14155 g equivalent to of Meroopenem 1 g;  

Disponible des:

Novartis New Zealand Ltd

Designació comuna internacional (DCI):

Meropenem trihydrate 1.14155 g (equivalent to of Meroopenem 1 g)

Dosis:

1 g

formulario farmacéutico:

Powder for injection

Composición:

Active: Meropenem trihydrate 1.14155 g equivalent to of Meroopenem 1 g   Excipient: Nitrogen Sodium carbonate

Unidades en paquete:

Vial, glass, single dose, 30 ml clear type 1 glass, grey rubber bung , Al crimp seal, 10 dose units

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Sandoz Private Limited

indicaciones terapéuticas:

Indicated for treatment, in adults and children, of lower respiratory tract infections.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, single dose, 30 ml clear type 1 glass, grey rubber bung , Al crimp seal - 10 dose units - 24 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Shelf life reduced with alternate reconstituting solutions

Data d'autorització:

2011-09-16

Fitxa tècnica

                                NEW
MERO
_MEROPE_
NAME
Active In
Chemica
hydroxye
Chemica
CAS Nu
Empirica
PRESE
Meropen
yellow  c
blended 
anhydro
 
Merop
_Active_
Merop
Equiv
_Excip_
Sodiu
 
PHARM
Meropen
(DHP-1)
_PHARM_
Meropen
with whic
its high 
meropen
concentr
W ZEALA
OPENEM 
_ENEM TRIHY_
E OF THE M
ngredient: Me
al name: (4R
ethyl]-4-meth
al structure: 
mber: 11947
al formula: 
ENTATION 
nem Sandoz 
crystalline po
with sodium
us for each g
penem Sand
_e ingredient  _
penem (as tr
valent to mer
_pient  _
um carbonate
MACOLOGY
nem is a carb
. It is structu
_MACODYNAM_
nem exerts it
ch it penetra
affinity for t
nem agains
rations are g
AND DA
SANDOZ
_YDRATE, 50_
MEDICINE 
eropenem tri
R,5S,6S)-3-[[(
hyl-7-oxo-1-a
78-56-7 
C
17
H
25
N
 powder for 
owder contai
m carbonate 
gram of mero
doz 
rihydrate)  
ropenem  
e anhydrous 
Y 
bapenem an
rally similar t
_MICS _
ts bactericida
ates bacteria
the Penicillin
st a broad 
generally wi
ATA SHE
Z
_®_
 
_00MG, 1G P_
hydrate 
(3S,5S)-5-(D
azabicyclo[3.
3
O
5
S·3H
2
O
intravenous 
ning merope
anhydrous. 
openem.  
500mg
571mg
500mg
104mg
tibiotic for pa
to imipenem
al action by i
al cell walls, 
n Binding Pr
spectrum 
thin one do
EET 
_POWDER FO_
Dimethylcarba
.2.0]hept-2-e
MW:
injection or i
enem trihydr
Meropenem
g 1g 
 
g 1.14g 
 
g 1g 
 
g 208mg 
arenteral use
. 
interfering w
its high leve
roteins (PBP
of aerobic 
ubling dilutio
_OR INJECTION_
amoyl)-3-pyr
ene-carboxyli
 
437.52 
infusion is pr
rate equivale
m Sandoz co
e, that is stab
ith vital bacte
l of stability 
PS) explain 
and anaer
on of the m
_N  _
rrolidinyl]thio]
ic acid, trihyd
resented as a
ent to merop
ontains 208m
ble to human
erial cell wal
to most seri
the potent b
obic bacter
minimum inhi
]-6-[(1R)-1-
drate 
a sterile whit
penem, 500m
mg sodium c
n dehydrope
l synthesis. T
ne β-lactam
bactericidal 
ria. The ba
bitory conce
te to pale 
mg or 1g, 
carbonate 
ptidase-1 
The ease 
ases and 
action of 
actericidal 

                                
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