)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_14.04.10_______ ‫תאריך‬
_________Cubicin__________‫שם תכשיר באנגלית‬
_____________131 21 30994 00___________‫מספר רישום‬
Medison Pharma Ltd.______‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
(Table 2) Renal Function
Hemodialysis
and
CAPD,
continuous
ambulatory (Table 2)Renal Function
Hemodialysis
peritoneal dialysis
‫פרק בעלון‬
Clinical
Pharmacology
Obesity : No dosage adjustment
of CUBICIN is warranted in
obese patients.
Immune System Disorders:
anaphylaxis; hypersensitivity
reactions, including pruritus,
hives, shortness of breath,
difficulty swallowing, truncal
erythema, and pulmonary
eosinophilia
Infections and Infestations:
Clostridium difficile–
associated diarrhea
Staphylococcus aureus
Bloodstream Infections
(Bacteremia), Including
Those with Right-Sided
Infective Endocarditis,
Caused by Methicillin-
Obesity : No dosage
adjustment of CUBICIN is
warranted in moderately or
extremely obese patients.
Immune System
Disorders: anaphylaxis;
hypersensitivity
reactions, including
pruritus, hives, shortness
Post marketing
of breath, difficulty
swallowing, truncal
erythema, and pulmonary Experience
eosinophilia
Staphylococcus aureus
Bloodstream Infections
(Bacteremia), Including
Those with Right-Sided
Endocarditis, Caused by
Methicillin-Susceptible
Dosage and
Administration
Susceptible and MethicillinResistant Isolates
and MethicillinResistant Isolates
CUBICIN should not be used in
conjunction with ReadyMED®
elastomeric infusion pumps
(Cardinal Health, Inc.). Stability
studies of CUBICIN solutions
stored in ReadyMED®
elastomeric infusion pumps
identified an impurity (2mercaptobenzothiazole) leaching
from this pump system into the
CUBICIN solution.
CUBICIN should not be
used in conjunction with
ReadyMED® elastomeric
infusion pumps (Cardinal
Health, Inc.). because of
incompatibility due to an
impurity leaching from this
pump system into the
CUBICIN solution.
The definition of right-sided
infective endocarditis (RIE) used
in the clinical trial was Definite
or
Possible
Endocarditis
according to the modified Duke
criteria and no echocardiographic
evidence
of
predisposing
pathology or active involvement
of either the mitral or aortic
valve.
The definition of right-sided
endocarditis (RIE) used in
the clinical trial was
Definite
or
Possible Clinical Studies
Endocarditis according to
the modified Duke criteria S. Aureus
and no echocardiographic
Bacteremia/Endocarditis
evidence of predisposing
pathology
or
active
involvement of either the
mitral or aortic valve.
Preparation and
Administration