, /, 10 x 500 mg

, /, 10 x 1 g

PharmaSwiss d.o.o.

:

:
:

ul. Batajnicki drum 5A, Beograd, Srbija

19/III/6,

1.

INN: meropenem
2.
i.v.

500 mg 1g

:
meropenem trihidrat

570 mg

1140 mg

meropenem

500 mg

1000 mg

6.1.
3.
/.
.
4.
4.1.

meropenem:
- ,
- ,
- - ,
- ( ),
- ,
- ,
- ,
- , ,
.

.
, meropenem
, .
.

.
4.2.

.
:
500 mg i.v. 8 , ,
(), .
- 1g i.v. 8 , ,
, .
- , 2 g 8 ;
2 g 8 .
- , 2 g 8 .
, meropenem

 , Pseudomonas aeruginosa.
Pseudomonas aeruginosa
.

51ml/,
1.
1
(ml/)

(
500 mg, 1 g, 2 g)

26 o50

12

10 o25

12

<10

24

Meropenem ; ,
( )
.
.

( 4.4).


50 ml/.

3 12 , 10 o 20 mg/kg
8 , ,
. 50 kg , .
4 18 , ,
25 o 40 mg/kg 8 .
40 mg/kg 8 .
.

5
15 30 , .
- ,
(5 ml a 250 mg meropenem). 50 mg/ml.
.
-
(50 o 200 ml) ( 6.2 6.4).
4.3.
.
4.4.

- , . , ( 4.8).
meropenem
-

 . ,
.
,
.
,
, .
.
,
, .
- ,
.
.
Clostridium difficile
, .

. 4.2.
.
.

3 ;
.
.
4.5.
meropenem ,

meropenem .
meropenem , ,
. meropenem
. Meropenem
( 2%),
. Meropenem .
.
Meropenem .
, .
4.6.

meropenem .
.
, ,
13 . Meropenem
.
, .

Meropenem .
Meropenem
.
4.7.

.
4.8.

MedDRA

, , ,

,
,

Meropenem
.

.
.
( 1% < 10%)

( 0.1% <1 %)

( 0.01% <0.1%)

, ,
,

,
, Steven-Johnson-
,

Coombs- ;
.
2
,
.
4.9.

 ,
.
4.8.
.
; , meropenem
.
5.
5.1.
:
:

J01DH02

Meropenem ,
dehidropeptidaz-1 (DHP-1) DHP-1.
Meropenem
. meropenem
,
-
(PBP). (MBC)
(MIC). 76% , MBC:MIC
2 .
Meropenem
. In vitro meropenem
. meropenem - in vitro in vivo.

(MIC)
, meropenem.
2

(mm)

MIC (mg/L)

14
12 13
11

4
8
16

In vitro meropenem
, :
:
Bacillus spp., Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus liquifaciens, Enterococcus
avium, Listeria monocytogenes, Lactobacillus spp., Nocardia asteroides, Staphylococcus aureus (
), Staphylococci-coagulase-negative; Staphylococcus epidermidis,
Staphylococcus saprophyticus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus xylosus,
Staphylococcus warneri, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus intermedius,
Staphylococcus sciuri, Staphylococcus lugdunensis, Streptococcus pneumoniae (
), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus equi, Streptococcus bovis,
Streptococcus mitis, Streptococcus mitior, Streptococcus milleri, Streptococcus sanguis, Streptococcus viridans,
Streptococcus salivarius, Streptococcus morbillorum, Streptococcus Group G, Streptococcus Group F,
Rhodococcus equi.

 :
Achromobacter xylosoxidans, Acinetobacter anitratus, Acinetobacter lwoffii, Acinetobacter baumannii,
Aeromonas hydrophila, Aeromonas sorbria, Aeromonas caviae, Alcaligenes faecalis, Bordetella bronchiseptica,
Brucella melitensis, Campylobacter coli, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus,
Citrobacter koseri, Citrobacter amalonaticus, Enterobacter aerogenes, Enterobacter (Pantoea) agglomerans,
Enterobacter cloacae, Enterobacter sakazakii, Escherichia coli, Escherichia hermannii, Gardnerella vaginalis,
Haemophilus influenzae ( - ),
Haemophilus parainfluenzae, Haemophilus ducreyi, Helicobacter pylori, Neisseria meningitidis, Neisseria
gonorrhoeae ( -
), Hafnia alvei, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella ozaenae, Klebsiella
oxytoca, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Proteus vulgaris,
Proteus penneri, Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, Pasteurella multocida,
Plesiomonas shigelloides, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas alcaligenes,
Burkholderia (Pseudomonas) cepacia, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas
pseudomallei, Pseudomonas acidovorans, Salmonella spp. Salmonella enteritidis/typhi, Serratia
marcescens, Serratia liquefaciens, Serratia rubidaea, Shigella sonnei, Shigella flexneri, Shigella boydii, Shigella
dysenteriae, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica.
:
Actinomyces odontolyticus, Actinomyces meyeri, Bacteroides-Prevotella-Porphyromonas spp., Bacteroides
fragilis, Bacteroides vulgatus, Bacteroides variabilis, Bacteroides pneumosintes, Bacteroides coagulans,
Bacteroides uniformis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides
eggerthii, Bacteroides capsillosis, Prevotella buccalis, Prevotella corporis, Bacteroides gracilis, Prevotella
melaninogenica, Prevotella intermedia, Prevotella bivia, Prevotella splanchnicus, Prevotella oralis, Prevotella
disiens, Prevotella rumenicola, Bacteroides ureolyticus, Prevotella oris, Prevotella buccae, Prevotella denticola,
Bacteroides levii, Porphyromonas asaccharolytica, Bifidobacterium spp., Bilophila wadsworthia, Clostridium
perfringens, Clostridium bifermentans, Clostridium ramosum, Clostridium sporogenes, Clostridium cadaveris,
Clostridium sordellii, Clostridium butyricum, Clostridium clostridiiformis, Clostridium innocuum, Clostridium
subterminale, Clostridium tertium, Eubacterium lentum, Eubacterium aerofaciens, Fusobacterium mortiferum,
Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium, Mobiluncus curtisii,
Mobiluncus mulieris, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptostreptococcus
saccharolyticus, Peptococcus saccharolyticus, Peptostreptococcus asaccharolyticus, Peptostreptococcus magnus,
Peptostreptococcus prevotii, Propionibacterium acnes, Propionibacterium avidum, Propionibacterium
granulosum.
Stenotrophomonas maltophilia, Enterococcus faecium
meropenem.
5.2.
meropenem 30
11 /ml 1g.

Cmax PIK. , 287 a 205 ml/min
250 mg o 2 g.
meropenem 5
, 52 /ml
500 mg 112 /ml 1g.
1g 2, 3 5
. 110, 91
94 /ml.
i.v. 500 mg, meropenem 1
/ml , 6 .
8 ,
meropenem 1 .
meropenem 2%.
70% 12 ,
. meropenem 10
/ml 5 500 mg. 500

mg 8 1g 6 ,
meropenem . meropenem
.
Meropenem

.
meropenem .
meropenem 1,5 o 2,3 2
10 o 40 mg/kg.

meropenem .
, .
meropenem
.

meropenem.
5.3.
meropenem .
meropenem (500 mg/kg).
:
(>2000 mg/kg).
i.v. LD50 2000 mg/kg.
( 6 ),
500 mg/kg.
5

;
120mg/kg.
500 mg/kg.
meropenem .
.
meropenem .
6.
6.1.

6.2.
.
:
0.9% ,
5% ili 10% ,
5% 0.02% ,
5% 0.9%
5% 0.225% ,
5% 0.15% ,
5% -
5% Normosol-M
1/6 N
5%
2.5% 10%
6.3.
2 .

6.4.

.

.
25

2-8

* 0.9% ( i.v. )

18

* ( i.v. )

12

* 5% ( i.v. )

* 5% 0.9%

* 5% 0.02%

* 5% 0.15%

* 5% -

*5% Normosol-M M

* 2.5%

16

* 5%

* 10%

*1/6N

24

( 20 o 50 mg/ml) :

- 2
25 18 2-8.
, .
, ,
24 2-8,
.
6.5.
(20 ml) III, .
: 10 .
6.6.
4.2 .
.
.
.
7.
, . 19/III/6,
8.
Merocid 500mg
Merocid 1000mg

15-4999/10
15-5000/10

9.

24.02.2011
10.
, 2009.