CUBICIN 500 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

DAPTOMYCIN

Dostopno od:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Koda artikla:

J01XX09

Farmacevtska oblika:

LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION

Sestava:

DAPTOMYCIN 500 MG/VIAL

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

MERCK SHARP & DOHME LLC, USA

Terapevtsko območje:

DAPTOMYCIN

Terapevtske indikacije:

Cubicin is indicated for the treatment of the infections listed below. * Complicated Skin and Skin Structure InfectionsComplicated 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 IsolatesStaphylococcus 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

Datum dovoljenje:

2014-06-30

Navodilo za uporabo

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_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ _
_ _
_ _
_ ןכדועמ(_
_ ןכדועמ(_
_ ןכדועמ(_
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_.102.50_
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_ _
_ _
ךיראת :ןולעה רושיא
61.
11
םושירה רפסמו תילגנאב רישכת םש
131 21 30994 01
:
CUBICIN REG.NO
םושירה לעב םש
ISRAEL LTD.
MERCK SHARP & DOHME
פוט
! דבלב תורמחהה טורפל דעוימ הז ס
תושקובמה תורמחהה
ןולעב קרפ
נ טסקט
יחכו
שדח טסקט 6.2 POST –MARKETING
EXPERIENCE
The following adverse reactions have been
identified during postapproval use of CUBICIN.
Because these reactions are reported voluntarily
from a population of uncertain size, it is not
always possible to estimate their frequency
reliably or establish a causal relationship to drug
exposure.
_Immune System Disorders:_ anaphylaxis;
hypersensitivity reactions, including
angioedema, drug rash with eosinophilia and
systemic symptoms (DRESS), pruritus, hives,
shortness of breath, difficulty swallowing, truncal
erythema, and pulmonary eosinophilia [see
_Contraindications (4), Warnings and Precautions _
_(5.1)_]
_Infections and Infestations: Clostridium difficile_–
associated diarrhea [see _Warnings and _
_Precautions (5.6)_]
_Musculoskeletal Disorders:_ myoglobin
increased; rhabdomyolysis (some reports
involved patients treated concurrently with
CUBICIN and HMG-CoA reductase inhibitors)
[see _Warnings and Precautions (5.2), Drug _
_Interactions (7.1),_ and _Clinical Pharmacology _
_(12.3)_]
_Respiratory, Thoracic, and Mediastinal _
_Disorders:_ cough, eosinophilic pneumonia [see
_Warnings and Precautions (5.3)_]
_Nervous System Disorders:_ peripheral
neuropathy [see _Warnings and Precautions _
_(5.4)_]
_Skin and Subcutaneous Tissue Disorders:_
serious skin reactions, including Stevens-
Johnson syndrome and

Lastnosti izdelka

1
PRESCRIBING INFORMATION
Name of the medicinal p
roduct
:
CUBICIN
® 500 MG
Qualitative and qua
ntitative composition
:
Cubicin 500 mg lyophilized powder for solution for injection
.
Each vial contains 500 mg da
p
tomycin as a sterile, lyophilized powder.
1
INDIC
ATIONS
AND USAGE
CUBICIN
is indicated for the t
reatment of t
he
infections listed below
.
1.1
COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
Complicated skin and skin structure infections (cSSSI) caused
b
y susceptible isolates of the following
Gram-positive bacteria:
Staphylococcus aureus
(including m
ethicillin-re
sistant isolates),
Streptococc
us
pyogenes,
Streptococcus agalactiae,
Streptococcus dysgalactiae
subsp.
equisimilis,
and
Enterococcus
faecalis
(vancomycin-
susceptible isolates only).
1.2
STAPHYLO
COCCUS AUREUS
BLOODSTREAM INFECTIONS (BACTEREMIA
), INCLUDING
THOSE WITH
RIGHT-
SIDED INFECTI
VE ENDOCARDITIS, CAUSED BY METHICILLIN
-
SUSCEPTIBLE AND METHICILLIN
-
RESISTANT ISOLATES
Staphylococcus aureus
bloods
tream infections (bacteremia), including those wi
th right-
sided infective
endocarditis, caused by
methicillin-s
usceptible and methicillin
-res
istant isolates.
Combination
therapy may be clinically indicated if the documented or presumed
pathogens include
G
ram negative or anaerobic organism
.
1.3
LIMITATI
ONS OF USE
CUBICIN
is not indicated for the tre
atment of pn
eumonia.
CUBICIN
is not indic
ated for the treatment of left
-
sided infective endocarditis due to
S. aureus
. The
clinical trial of
CUBICIN
in adult
patients with
S. aureus
bloodstream infections
in
cluded limited data
from patients with left
-sided infective
endocarditis; outcomes in the
se patients were poor
[see Clinical
Studies (14.2)]
.
CUBICIN
has not been studied in patients with prosthetic valve
endocarditis.
1.4
USAGE
Appropriate spe
cimens for
microbi
ological examination should be obtained
in order to isolate and
identify t
he causative pathogens and to determine their susceptibility to
daptomycin.
To reduce the development of drug
-resistant b
acteria and maint