TIENAM 500 MG 500 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CILASTATIN SODIUM; IMIPENEM AS MONOHYDRATE

Available from:

MERCK SHARP & DOHME ISRAEL LTD

ATC code:

J01DH51

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

CILASTATIN SODIUM 500 MG/VIAL; IMIPENEM AS MONOHYDRATE 500 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORIES MSD-CHIBRET (MIRABEL),FRANCE

Therapeutic group:

IMIPENEM AND ENZYME INHIBITOR

Therapeutic area:

IMIPENEM AND ENZYME INHIBITOR

Therapeutic indications:

1.1 Lower Respiratory Tract InfectionsTIENAM for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of Staphylococcus aureus (penicillinase-producing isolates), Acinetobacter species, Enterobacter species, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella species, Serratia marcescens.1.2 Urinary Tract Infections (complicated and uncomplicated) TIENAM is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing isolates), Enterobacter species, Escherichia coli, Klebsiella species, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa.1.3 Intra-Abdominal Infections TIENAM is indicated for the treatment of intra-abdominal infections caused by susceptible strains of Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing isolates), Staphylococcu

Authorization date:

2014-07-31

Patient Information leaflet

)תוחיטב עדימ ( הרמחה לע העדוה
ןכדועמ(
05.2013
)
__ ןולעה תקידב ךיראת
06
-
NOV-2016
____ תילגנאב רישכת םש
TIENAM 500 MG/ 500 MG םושירה רפסמ
141
50
25222
25 םושירה לעב םש
MERCK SHARP & DOHME (ISRAEL – 1996) COMPANY LTD
.
! דבלב תורמחהה טורפל דעוימ הז ספוט אפורל ןולעב
תושקובמה תורמחהה
ןולעב קרפ טסקט
יחכונ
שדח טסקט
ADVERSE
REACTIONS
_Adults_
_CNS _— encephalopathy, tremor, confusion, myoclonus, paresthesia,
vertigo,
headache,
psychic
disturbances
including
hallucinations,
dyskinesia, agitation;

Summary of Product characteristics

________________________________________________________
TIENAM
®
500 MG/500 MG
(IMIPENEM AND CILASTATIN)
POWDER FOR SOLUTION FOR INFUSION, IV
Each vial contains:
Imipenem (monohydrate) equivalent to 500 mg Imipenem anhydrous
Cilastatin Sodium equivalent to 500 mg Cilastatin free acid
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of TIENAM I.V. and
other antibacterial drugs, TIENAM I.V. should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
FOR INTRAVENOUS INJECTION ONLY
DESCRIPTION
TIENAM
†
I.V. (Imipenem and Cilastatin for Injection) is a sterile formulation
of imipenem (a thienamycin
antibiotic) and cilastatin sodium (the inhibitor of the renal
dipeptidase, dehydropeptidase l), with sodium
bicarbonate added as a buffer. TIENAM I.V. is a potent broad spectrum
antibacterial agent for intravenous
administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline
derivative of thienamycin, which is
produced by _Streptomyces cattleya_. Its chemical name is (5_R_,
6_S_)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-
1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic
acid
monohydrate.
It
is
an
off-white,
nonhygroscopic crystalline compound with a molecular weight of 317.37.
It is sparingly soluble in water, and
slightly soluble in methanol. Its empirical formula is C
12
H
17
N
3
O
4
S•H
2
O, and its structural formula is:
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid.
Its chemical name is sodium _(Z_)-7-[[(_R_)-
2-amino-2-carboxyethyl]thio]-2-[(_S_)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate.
It is an off-white to
yellowish-white, hygroscopic, amorphous compound with a molecular
weight of 380.43. It is very soluble in
water and in methanol. Its empirical formula is C
16
H
25
N
2
O
5
SNa, and its structural formula is:
TIENAM I.V. is buffered to provide solutions in the pH range of 6.5 to
8.5. There is no significant change in
pH when solutions are prepared and u