DAPTOMYCIN S.K. 350 MG

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

DAPTOMYCIN

Հասանելի է:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC կոդը:

J01XX09

Դեղագործական ձեւ:

LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Կազմը:

DAPTOMYCIN 350 MG/VIAL

Կառավարման երթուղին:

I.V

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

ANFARM HELLAS S.A., GREECE

Թերապեւտիկ տարածք:

DAPTOMYCIN

Թերապեւտիկ ցուցումներ:

Daptomycin S.K. is indicated for the treatment of the infections listed below. • Complicated Skin and Skin Structure Infections Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).• Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.• Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram negative or anaerobic organisms.

Հաստատման ամսաթիվը:

2023-02-07

Ապրանքի հատկությունները

1
PRESCRIBING INFORMATION
Name of the medicinal product
:
DAPTOMYCIN S.K 350MG, DAPTOMYCIN S.K 500 MG
Qualitative and quantitative composition:
DAPTOMYCIN S.K 350MG powder for solution for injection Each vial
contains 350 mg daptomycin as
a sterile, lyophilized powder
DAPTOMYCIN S.K 500 mg powder for solution for injection. Each vial
contains 500 mg daptomycin
as a sterile, lyophilized powder.
1
INDICATIONS AND USAGE
DAPTOMYCIN S.K is indicated for the treatment of the infections listed
below.
1.1
COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
Complicated skin and skin structure infections (cSSSI) caused by
susceptible isolates of the following
Gram-positive bacteria: _Staphylococcus aureus _(including
methicillin-resistant isolates), _Streptococcus _
_pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae
_subsp. _equisimilis, _and _Enterococcus _
_faecalis _(vancomycin-susceptible isolates only).
1.2
_STAPHYLOCOCCUS AUREUS _BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING
THOSE WITH
RIGHT-SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE
AND METHICILLIN-
RESISTANT ISOLATES
_Staphylococcus aureus _bloodstream infections (bacteremia), including
those with right-sided infective
endocarditis, caused by methicillin-susceptible and
methicillin-resistant isolates.
Combination therapy may be clinically indicated if the documented or
presumed pathogens include
Gram negative or anaerobic organism.
1.3
LIMITATIONS OF USE
DAPTOMYCIN S.K is not indicated for the treatment of pneumonia.
DAPTOMYCIN S.K is not indicated for the treatment of left-sided
infective endocarditis due to _S. _
_aureus_. The clinical trial of daptomycin in adult patients with _S.
aureus _bloodstream infections included
limited data from patients with left-sided infective endocarditis;
outcomes in these patients were poor
_[see Clinical Studies (14.2)]_. Daptomycin has not been studied in
patients with prosthetic valve
endocarditis.
1.4
USAGE
Appropriate specimens for microbiological examination should be
obtained in order to isolat