PENTOSTAM

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

SODIUM STIBOGLUCONATE

זמין מ:

GLAXO SMITH KLINE (ISRAEL) LTD

קוד ATC:

P01CB02

טופס פרצבטיות:

SOLUTION FOR INJECTION

הרכב:

SODIUM STIBOGLUCONATE 10 G / 100 ML

מסלול נתינה (של תרופות):

I.M, I.V

סוג מרשם:

Required

תוצרת:

GLAXO OPERATIONS (UK) LIMITED

קבוצה תרפויטית:

SODIUM STIBOGLUCONATE

איזור תרפויטי:

SODIUM STIBOGLUCONATE

סממני תרפויטית:

Pentostam is indicated for the following diseases: Visceral leishmaniasis (kala azar).Cutaneous leishmaniasis.South American mucocutaneous leishmaniasis.Pentostam may also be of value in the treatment of leishmaniasis recidivans and diffuse cutaneous leishmaniasis in the new world.

תאריך אישור:

2011-08-31

עלון מידע

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת :
14/7/2013
םושירה רפסמו תילגנאב רישכת םש :
PENTOSTAM , 102-10-24710
םושירה לעב םש
GLAXOSMITHKLINE (ISRAEL) LTD :
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
אפורל ןולעב
אפורל ןולעב
תורמחהה
תושקובמה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
There have been some reports of cardiac
arrhythmias and sudden death when
amphotericin B deoxycholate is
administered soon after sodium
stibogluconate for retreatment of visceral
leishmaniasis. Electrolyte imbalances
should be corrected_ _prior to
administration of amphotericin B
deoxycholate,_ _and patients appropriately
monitored.
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
(
ונמוס תורמחה רדגב םניאש םייוניש
ןולעב
)
עבצב
קורי
.

מאפייני מוצר

_The format of this leaflet was determined by the Ministry of Health _
_and its content was checked and approved in July 2013_
PENTOSTAM
TM
TITLE
Sodium stibogluconate
SCOPE
TRADE NAME
_PENTOSTAM_
_TM_
_ _
FORMULATION AND STRENGTH
Injection solution.
Injections of sodium stibogluconate containing the equivalent of 100
mg/ml
pentavalent antimony.
EXCIPIENTS
Chlorocresol
Gluconolactone
Water for injection
CLINICAL INFORMATION
INDICATIONS
Sodium stibogluconate is indicated for the following diseases:
Visceral leishmaniasis (Kala Azar);
Cutaneous leishmaniasis;
South American mucocutaneous leishmaniasis.
Sodium stibogluconate may also be of value in the treatment of
leishmaniasis
recidivans and diffuse cutaneous leishmaniasis in the New World.
NOTE: Cutaneous and diffuse cutaneous leishmaniasis caused by
Leishmania
aethiopica infections are unresponsive to treatment with pentavalent
antimony
compounds, including sodium stibogluconate injection, at conventional
dosage, but may respond slowly at higher dosage.
DOSAGE AND ADMINISTRATION
Except where otherwise stated, all doses should be given by the
intravenous
or intramuscular route (see _Warnings and Precautions_).
Due to the presence of particulates (size range 20 to 300 microns)
sodium
stibogluconate solution should be drawn up through a sterile filter
immediately
prior to administration. These particulates are insoluble complexes
formed
by an interaction between product preservative and the antioxidant in
the
rubber stopper. Filters of pore size 5 microns or less and membrane
types
polyvinylidene difluoride, polyethersulphone, polysulphone, nylon,
surfactant-
free cellulose acetate and mixed cellulose esters have been shown to
be suitable.
Where sterile filters are not available the risks and benefits of
administering
unfiltered sodium stibogluconate therapy should be assessed by the
clinician
on an individual basis.
All dosage recommendations are based on the findings of the WHO Expert
Committee on leishmaniasis, which met in 1984. There are no special
recommendat