SESTAMIBI injection, powder, lyophilized, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE (UNII: N6OU7HJ70P) (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE - UNII:N6OU7HJ70P)

זמין מ:

AnazaoHealth Corporation

INN (שם בינלאומי):

TETRAKISCOPPER TETRAFLUOROBORATE COPPER TETRAFLUOROBORATE - UNII:N6OU7HJ70P)

הרכב:

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1.5 mg

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Sestamibi is a diagnostic agent used to assess areas of reversible myocardial ischemia in the presence or absence of infracted myocardium. Evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques.

מצב אישור:

unapproved drug other

מאפייני מוצר

SESTAMIBI - SESTAMIBI 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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SES TAMIBI
(FOR THE PREPARATION OF TC99M SESTAMIBI INJECTION)
Dear Medical Professional,
Per your order, we have compounded Sestamibi as a sterile,
freeze-dried preparation in a 10 mL vial.
The characteristics of this preparation are described below.
DESCRIPTION
AnazaoHealth’s compounded Sestamibi vial is a sterile, non-pyrogenic
preparation that consists of a
lyophilized mixture of 1.5mg of Copper (1) tetrafluoroborate, 3.9 mg
of Sodium Citrate Dihydrate, 1.5
mg of L-Cysteine HCL Monohydrate, 30 mg Mannitol and 0.112 mg of Tin
Chloride. It is maintained
under an inert nitrogen atmosphere. Prior to lyophilization the pH is
5.3 to 5.9. The pH of the final
reconstituted product is 5.5 to 6.0. It contains no antimicrobrial
preservative.
CLINICAL PHARMACOLOGY
When Sestamibi is reconstituted with Tc99m pertechnetate, a complex of
Tc99m Sestamibi is formed
and is the active ingredient of the reconstituted product. When
administered intravenously, Tc99m
Sestamibi shows rapid myocardial uptake and its distribution follows a
linear relationship with coronary
blood flow.
Tc99m Sestamibi is a lipophilic agent that is taken up by the
mitochondria of myocardial cells by
passive diffusion and appears to accumulate in viable myocardial
tissue.
INDICATIONS AND USAGE
Sestamibi is a diagnostic agent used to assess areas of reversible
myocardial ischemia in the presence
or absence of infracted myocardium. Evaluation of myocardial ischemia
can be accomplished with rest
and cardiovascular stress techniques.
PREPARATION
INSTRUCTIONS FOR THE PREPARATION OF TC99M SESTAMIBI
1. Inspect vial to ensure there are no cracks in the glass.
2. Reconstitute with 1- 3ml of non-pyrogenic, oxidant free Sodium
Pertechnetate Tc99m injection.
3. Remove equal amount o