Post on 04-Apr-2019
Savior Lifetec Corporation
058266
Carbapenem
Merocure Powder for I.V. Injection SLC
Each Vial Contains
Meropenem trihydrate equivalent to Meropenem 500mg1gpotency
with excipient sodium carbonate
Meropenem
Meropenem Staphylococcus sp.Streptococcus sp.Enterococcus
sp.Neisseria meningitidisBranhamella catarrhalisE.coli Citrobacter sp.Klebsiella sp.
Enterobacter sp.Serratia sp.Proteus sp.Pseudomonas sp.Haemophilus influenzae and
Bacteroides sp.
14
1 0.51g Meropenem 23 30
2g
3060mgkg 3 30
120mgkg
2g
0.25g 0.5g 100mL
1. Creatinine clearance 30mL
2.
Meropenem
1.
2. Sodium Valproate
2683 471.8 200.7
130.5 40.1 40.139914.9
ASTGOT 6.91782573
ALTGPT 7.92032573Al-p 2.5612444
3.5822345
52 2344.2
703 10715.2
167552.18 755 1.1
ASTGOT237543.1ALTGPT
297543.8187542.410
7541.3
1 0.1Anaphylaxis*1
2 0.1
3 0.1
4 PIE syndrome0.1
X
5 0.1
6 Lyell syndrome0.1Stevens-Johnson syndrome
7
8 0.150.1
1
Carbapenem
2
Carbapenem
0.5 0.10.5 0.1 *1
*2 ,
*2
ASTGOT
ALTGPT
LDHAl-PLAP
-GTPbiliru-bin
urinary robilinogen
cholintesterase
2-
microglobulin
BUNcreatinine
Candidiasis
K
Hypoprothrombinemia
B
Myoclonus *1 *2,
(1) CarbapenemPenicillin Cephem
(2)
(3)
(4)
(5)
(6) K
(7)
(1) Skin test
(2)
(3)
(4) 3
(5)
(6) 7
(7) ASTGOTALTGPT
1
2 K
1
2
ASTGOT ALTGPT
1 Tes-Tape Benedicts solutionFehlings solutionClini test
2 Coombs test
3 Urobilinogen test
1.
2.
a.
6 5 24
25 2 0.5gVial
90
b.
1.
2. Ped. Inf. Dis. J 1999 Meropenem 30
Cefotaxime 20
3. 14 500mgkg
1000mgkg 7
180mgkg 500mgkg ALP-GTPNAG
500mgkg
4. 3 120mgkg
ASTGOT 6
240mgkg ASTGOT ALTGPT
Sodium valproate Valproic Acid
1.
30
30 2-compartmental model
Clearance Logarithmic normal distribution
0.444Lhrkg Central
compartment 0.291Lkg Peripheral compartment 0.112L
kg Compartment Transfer 0.160Lhrkg
8.77 CV 47.7 CV
Cmax
gmL T12
hr AUC
ghrmL CLt *1
Lhr CLr *2
Lhr
0.25g 15.8 0.98 16.3 16.27 9.60
0.5g 26.9 1.03 33.9 14.88 9.44
0.1g 53.1 1.02 58.0 17.46 10.50 *1 Clearance *2 Clearance
Parameter S.E. CV
Clearance LhrKg 0.444 0.0224
compartment LKg 0.291 0.0225
Compartment Clearance LhrKg 0.160 0.0598
compartment LKg 0.112 0.0341
Clearance 0.00770 0.00366 8.77
0.228 0.0915 47.7
Meropenem
Meropenem
2.
308
6065 61
3.
4.
0.5g 30
Ccr1
mLmin
T12
hr
AUC ghrmL
CLt2
Lhr
CLr3
Lhr
50Ccr 4 1.54 36.6 14.64 7.61
30Ccr50 4
3.36 74.6 7.67 2.78
Ccr30 5 5.00 186.8 2.99 0.92 1 Creatinine clearance
2 clearance 3 clearance
82.715011816
78118 66.1
3132
1313
96.9
100
2533
1114
3845
1317
75.8
78.6
84.4
76.5
2123
5766
5973
5366
412471
1720
58
91.3
86.4
80.8
80.3
87.5
85.0
62.5
122158
222278
77.2
79.9
1920
3438
59
95.0
89.5
55.6
89113 78.8
1920
4444
46
66
95.0
100
66.7
100
23 66.7
3646
2729
78.3
93.1
2525
1422
100
63.6
15011816 82.7
95.94749
22 -
44 -
45 -
2525
01
100
-
33 -
55 -
33 -
11 -
4749 95.9
98.6290294
97.3109122
3737 100
3738 97.4
22 -
9596
11
99.0
-
7172 98.6
66 100
4142 97.6
290294 98.6
Meropenem
non-glucose-fermenting G(-)-P. aeruginosa
-lactamase
Carbapemen -I (DHP-I
PBPs peptidoglycan
MeropenemMeropenem trihydrate
MEPM
(4R, 5S, 6S)-3-{[(3S, 5S)-5-(Dimethylcarbamoyl)pyrrolidin-3-ylsulfanyl]thio}
-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic
acid trihydrate
C17H25N3O5S3H2O 437.51
Meropenem trihydrate
170 230
n-octanol n-octanol
90
INJECTION VIALS
Stability Period
15-25C
Stability Period
2-8C
Water for Injections50 mgmL 2 hours 12 hours
INFUSION VIALS
Stability Period
15-25C
Stability Period
2-8C
0.9 Sodium Chloride2.5 mgmL 2 hours 18 hours
0.9 Sodium Chloride50 mgmL 2 hours 18 hours
5 Dextrose2.5 mgmL 1 hour 8 hours
5 Dextrose50 mgmL 1 hour 8 hours
PLASTIC IV BAGS
Stability Period
15-25C
Stability Period
2-8C
Sodium Chloride Injection 0.91 mgml 4 hours 24 hours
Sodium Chloride Injection 0.95 mgml 4 hours 24 hours
Sodium Chloride Injection 0.920 mgml 4 hours 24 hours
Dextrose Injection 5.01 mgml 1 hour 4 hours
Dextrose Injection 5.05 mgml 1 hour 4 hours
Dextrose Injection 5.020 mgml 1 hour 4 hours
Dextrose Injection 101 mgml 1 hour 2 hours
Dextrose Injection 105 mgml 1 hour 2 hours
Dextrose Injection 1020 mgml 1 hour 2 hours
Dextrose and Sodium Chloride Injection 5.00.9
1 mgml 1 hour 2 hours
Dextrose and Sodium Chloride Injection 5.00.9
5 mgml 1 hour 2 hours
Dextrose and Sodium Chloride Injection 5.00.9
20 mgml 1 hour 2 hours
Dextrose and Sodium Chloride Injection 5.00.2
1 mgml 1 hour 4 hours
Dextrose and Sodium Chloride Injection 5.00.2
5 mgml 1 hour 4 hours
Dextrose and Sodium Chloride Injection 5.00.2
20 mgml 1 hour 4 hours
Potassium Chloride in Dextrose Injection 0.155.0
1 mgml 1 hour 6 hours
Potassium Chloride in Dextrose Injection 0.155.0
5 mgml 1 hour 6 hours
Potassium Chloride in Dextrose Injection 0.155.0
20 mgml 1 hour 6 hours
Dextrose Injection 5.0 in Normosol -M*1 mgml 1 hour 8 hours
Dextrose Injection 5.0 in Normosol -M*5 mgml 1 hour 8 hours
Dextrose Injection 5.0 in Normosol -M*20 mgml 1 hour 8 hours
Dextrose and Sodium Chloride Injection 2.50.45
1 mgml 3 hours 12 hours
Dextrose and Sodium Chloride Injection 2.50.45
5 mgml 3 hours 12 hours
Dextrose and Sodium Chloride Injection 2.50.45
20 mgml 3 hours 12 hours
Mannitol Injection 2.51 mgml 2 hours 16 hours
Mannitol Injection 2.55 mgml 2 hours 16 hours
Mannitol Injection 2.520 mgml 2 hours 16 hours
Ringers Injection 1 mgml 4 hours 24 hours
Ringers Injection 5 mgml 4 hours 24 hours
Ringers Injection 20 mgml 4 hours 24 hours
Ringers Lactate Injection 1 mgml 4 hours 12 hours
Ringers Lactate Injection 5 mgml 4 hours 12 hours
Ringers Lactate Injection 20 mgml 4 hours 12 hours
Sodium Bicarbonate Injection 5.0 1 mgml 1 hour 4 hours
Sodium Bicarbonate Injection 5.0 5 mgml 1 hour 4 hours
Sodium Bicarbonate Injection 5.0 20 mgml 1 hour 4 hours
2025
500 500 mg100 1 1 g100
74144 12 4F16 4F8 4F & 12 5F
Tel+886-6-505-6351
Fax+886-6-505-2600
E-mail: sales@saviorlifetec.com.tw
mailto:sales@saviorlifetec.com.tw