Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
SODIUM STIBOGLUCONATE
GLAXO SMITH KLINE (ISRAEL) LTD
P01CB02
SOLUTION FOR INJECTION
SODIUM STIBOGLUCONATE 10 G / 100 ML
I.M, I.V
Required
GLAXO OPERATIONS (UK) LIMITED
SODIUM STIBOGLUCONATE
SODIUM STIBOGLUCONATE
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.
2011-08-31
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 . Lue koko asiakirja
_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 Lue koko asiakirja