EXAMETAZIME HMPAO- exametazime injection, powder, lyophilized, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

EXAMETAZIME (UNII: G29272NCKL) (EXAMETAZIME - UNII:G29272NCKL)

Disponible depuis:

AnazaoHealth Corporation

DCI (Dénomination commune internationale):

EXAMETAZIME

Composition:

EXAMETAZIME 1 mg

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Exametazime is a diagnostic agent used as an adjunct in the detection of altered cerebral perfusion in stroke patients and is also indicated for white blood cell labeling as an adjunct in the localization of abdominal infections and inflammatory bowel disease There are no known contraindications for this preparation.

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

EXAMETAZIME HMPAO- EXAMETAZIME INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ANAZAOHEALTH CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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EXAMETAZIME (HMPAO)
(FOR THE PREPARATION OF TC99M EXAMETAZIME INJECTION)
Dear Medical Professional,
Per your order, we have compounded Exametazime as a sterile,
freeze-dried preparation in a 10 mL
vial. The characteristics of this preparation are described below
DESCRIPTION
AnazaoHealth’s compounded Exametazime vial is a sterile,
non-pyrogenic preparation that consists of a
lyophilized mixture of 1 mg of Exametazime, 6.75 mg of Sodium
Chloride, 11.4 µg of Stannous
Chloride Dihydrate and is maintained under an inert nitrogen
atmosphere. The kit also contains a vial of
Cobalt Chloride, which contains 0.3 mg of cobalt chloride hexahydrate,
or Methylene Blue 1%
(methylene blue 10 mg/mL) and Phosphate Buffer (monobasic sodium
phosphate, sodium chloride,
dibasic sodium phosphate This kit contains no antimicrobial
preservative
CLINICAL PHARMACOLOGY
CEREBRAL SCINTIGRAPHY
When Exametazime is reconstituted with Tc99m pertechnetate, a
lipophilic complex of Tc99m
Exametazime is formed and is the active ingredient of the
reconstituted product. The lipophilic complex
crosses the blood-brain barrier. It converts to the less lipophilic
complex 12% per hour. The
preparation is good for 30 minutes without the use of a stabilizer.
The _in vitro_ addition of cobalt
chloride helps to stabilize the complex for 6 hours.
LEUKOCYTE (WBC) LABELING
The lipophilic complex of Tc99m Exametazime is taken up by leukocytes
and selectively retained by
neutrophils. Cobalt chloride, as a stabilizer, may be used with this
procedure as well
INDICATIONS AND USAGE
Exametazime is a diagnostic agent used as an adjunct in the detection
of altered cerebral perfusion in
stroke patients and is also indicated for white blood cell labeling as
an adjunct in the loca