TIENAM 500 FOR INJECTION

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

şimdi satın al

Ürün özellikleri Ürün özellikleri (SPC)
06-01-2022

Aktif bileşen:

CILASTATIN SODIUM EQV CILASTATIN; IMIPENEM

Mevcut itibaren:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC kodu:

J01DH51

Doz:

500 mg/vial

Farmasötik formu:

INJECTION, POWDER, FOR SOLUTION

Kompozisyon:

CILASTATIN SODIUM EQV CILASTATIN 500 mg/vial; IMIPENEM 500 mg/vial

Uygulama yolu:

INTRAVENOUS

Reçete türü:

Prescription Only

Tarafından üretildi:

MERCK SHARP & DOHME CORP.

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

1988-05-03

Bilgilendirme broşürü

                                SG-TEN-IV-102014
 
 
 
____________________ 
*Registered trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey, USA 
 
PHYSICIANS CIRCULAR 
 
 
I.V. Infusion  Trademark 
 
TIENAM

 
(imipenem and cilastatin sodium, MSD) 
 
 
WORLDWIDE PRODUCT LABELING 
 
MRL 
 
 
TIENAM* (imipenem and cilastatin sodium, MSD) is a broad spectrum beta -lactam antibiotic 
supplied as  an intravenous infusion only formulation.  TIENAM consists of two components: 
(1)  imipenem,  the  first  of  a  new class of beta-lactam antibiotics, the thienamycins; and (2) 
cilastatin sodium, a specific enzyme inhibitor that blocks the metabolism of imipenem in the 
kidney, and substantially increases the concentration of intact imipenem in the urinary tract.  
Imipenem and cilastatin sodium are present in TIENAM in a 1:1 ratio by weight.  
 
The  thienamycin  class  of  antibiotics,  to  which  imipenem  belongs,  is  characterized  by  a 
spectrum  of  potent  bactericidal  activity  broader  than  that  provided  by  any other antibiotic 
studied. 
 
M ICROBIOLOGY 
 
TIENAM  is  a  potent  inhibitor  of  bacterial  cell  wall  synthesis  and  is  bactericidal  against  a 
broad spectrum of pathogens
—gram-positive and gram-negative, aerobic and anaerobic. 
 
TIENAM  shares  with  the  newer  cephalosporins and penicillins a broad spectrum of activity 
against  gram-negative  species,  but  is  unique  in  retaining  the  high  potency  against gram-
positive  species,  previously  associated  only  with  earlier  narrow-spectrum  beta-lactam 
antibiotics.    The  spectrum  of  activity  of  TIENAM  includes  _Pseudomonas  aeruginosa, _
_Staphylococcus  aureus,_
_ _
_Enterococcus_
 
_faecalis_ and _Bacteroides fragilis_, a 
                                
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Ürün özellikleri

                                SG-MK0787B-IV-122020
PHYSICIANS CIRCULAR
TIENAM®
(imipenem and cilastatin sodium, MSD)
I.V. Infusion
TIENAM (imipenem and cilastatin sodium, MSD) is a broad-spectrum
beta-lactam antibiotic
supplied as an intravenous infusion only formulation. TIENAM consists
of two components: (1)
imipenem, the first of a new class of beta-lactam antibiotics, the
thienamycins; and (2) cilastatin
sodium, a specific enzyme inhibitor that blocks the metabolism of
imipenem in the kidney, and
substantially increases the concentration of intact imipenem in the
urinary tract. Imipenem and
cilastatin sodium are present in TIENAM in a 1:1 ratio by weight.
The thienamycin class of antibiotics, to which imipenem belongs, is
characterized by a
spectrum of potent bactericidal activity broader than that provided by
any other antibiotic
studied.
MICROBIOLOGY
TIENAM is a potent inhibitor of bacterial cell-wall synthesis and is
bactericidal against a broad
spectrum of pathogens— gram-positive and gram-negative, aerobic and
anaerobic.
TIENAM shares with the newer cephalosporins and penicillins a broad
spectrum of activity
against gram-negative species but is unique in retaining the high
potency against gram-positive
species, previously associated only with earlier narrow-spectrum
beta-lactam antibiotics. The
spectrum of activity of TIENAM includes
Pseudomonas aeruginosa, Staphylococcus aureus,
Enterococcus
faecalis,
and
Bacteroides
fragilis
,
a
diverse
group
of
problem
pathogens
commonly resistant to other antibiotics.
TIENAM is resistant to degradation by bacterial beta-lactamases, which
makes it active against
a
high
percentage
of
organisms
such
as
Pseudomonas
aeruginosa,
Serratia
spp.,
and
Enterobacter
spp., which are inherently resistant to most beta-lactam antibiotics.
The antibacterial spectrum of TIENAM is broader than that of any other
antibiotic studied and
includes virtually all clinically significant pathogens. Organisms
against which TIENAM is
usually active
in vitro
include:
Gram-Negative Aerobes
Achromobacter
spp.
Acinetobacter
sp
                                
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