Savior Lifetec Corporation 衛部藥製字第 · °1 ±除了Tes-Tape 外之臨床檢查，以...

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



Dextrose Injection 5.01 mgml 1 hour 4 hours



Dextrose Injection 101 mgml 1 hour 2 hours



Dextrose and Sodium Chloride Injection 5.00.9

1 mgml 1 hour 2 hours











Potassium Chloride in Dextrose Injection 0.155.0






Dextrose Injection 5.0 in Normosol -M*1 mgml 1 hour 8 hours




1 mgml 3 hours 12 hours





Mannitol Injection 2.51 mgml 2 hours 16 hours



Ringers Injection 1 mgml 4 hours 24 hours



Ringers Lactate Injection 1 mgml 4 hours 12 hours



Sodium Bicarbonate Injection 5.0 1 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: [email protected]

mailto:[email protected]

Savior Lifetec Corporation 衛部藥製字第 · °1 ±除了Tes-Tape 外之臨床檢查，以...

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