CERETEC™ N159 Kit for the Preparation of Technetium Tc99m Exametazime Injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Technetium Tc-99m Exametazime (UNII: 3B744AG22N) (Technetium Tc-99m Exametazime - UNII:3B744AG22N)

Available from:

Medi-Physics Inc.

INN (International Name):

Technetium Tc-99m Exametazime

Composition:

Technetium Tc-99m Exametazime 0.5 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Technetium Tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. None known. The technetium Tc99m labeling reaction involved in preparing technetium Tc99m exametazime injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m employed may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. To meet the last requirement, a generator must be eluted within 24 hours prior to obtaining any elute for reconstitution with the Ceretec kit. Sodium Chloride Injection, USP must be used as the diluent. Do not use bacteriostatic sodium chloride as a diluent for sodium pertechnetate Tc99m injection because it will increase the oxidation products and adversely affect the biological distribution of Ceretec. The contents of the Ceretec vial are sterile and pyrogen free. The vial contains no bacteriostatic preservative. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical. Technetium Tc99m exametazime injection, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. Care should be taken when handling blood specimens to be labeled using this radiopharmaceutical. Even if the subject has been tested, no method can offer complete assurance that Hepatitis B Virus, Human Immuno-deficiency Virus (HIV) or other infectious agents are absent. All human blood samples should be considered potentially infectious. Precautions for handling are as those for handling radioactive materials. NOTE: DO NOT USE THIS PROCEDURE FOR LEUKOCYTE LABELING. SEE PROCEDURE FOR THE RADIOLABELING OF AUTOLOGOUS LEUKOCYTES WITH TECHNETIUM Tc99m EXAMETAZIME INJECTION. Note: Sterile technique must be used throughout. The user should wear waterproof gloves during the handling and administration procedure. Note: Sterile technique must be used throughout. The user should wear waterproof gloves during the handling and administration procedure. Note: Sterile technique must be used throughout. The user should wear waterproof gloves during the handling and administration procedure. Radiochemical purity determination must be performed before administration to the patient. Three potential radiochemical impurities may be present in the prepared injection of the lipophilic technetium Tc99m exametazime complex. These are a secondary technetium Tc99m exametazime complex, free pertechnetate, and reduced-hydrolyzed-technetium Tc99m. A combination of 3 chromatographic systems is necessary for the complete definition of the radiochemical composition of the injection. The following protocol has been designed to enable analysis of the radiochemical purity of Ceretec (99mTc-exametazime). It should be started within 2 minutes of reconstitution. The entire procedure takes approximately 15 minutes. Secondary Tc exametazime complex and reduced-hydrolyzed-Tc remain at the origin. Lipophilic Tc exametazime complex and pertechnetate migrate at Rf 0.8-1.0. Lipophilic-Tc exametazime complex, secondary Tc exametazime complex and reduced-hydrolyzed-Tc remain at the origin. Pertechnetate migrates at Rf 0.8-1.0. Reduced-hydrolyzed-Tc remains at the origin. Lipophilic Tc exametazime complex, secondary Tc exametazime complex and pertechnetate migrate at Rf 0.8-1.0.

Product summary:

The kit comprises five individual vials of sterile, non-pyrogenic, freeze-dried mixture of exametazime, stannous chloride dihydrate and sodium chloride, ten radiation labels, five radiochemical purity worksheets, five labeling efficiency worksheets, one package insert, five individual vials of Methylene Blue Injection USP 1%, five individual vials of 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP and fifteen 0.45 µM syringe filters. NDC 17156-023-05 Store the kit at 15°-25°C (59°-77°F). Store the formulated drug at 20°-25°C (68°-77°F) using appropriate radiation shielding. Do not freeze. This reagent kit is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Code Adm. Section, Section 330.260(a) and 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, or an Agreement State.

Authorization status:

New Drug Application

Summary of Product characteristics

CERETEC- EXAMETAZIME
MEDI-PHYSICS INC.
----------
CERETEC™ N159
KIT FOR THE PREPARATION OF TECHNETIUM TC99M EXAMETAZIME INJECTION
DIAGNOSTIC RADIOPHARMACEUTICAL
FOR INTRAVENOUS USE ONLY
DESCRIPTION
The Ceretec kit is supplied as five packs of three vials for use in
the preparation of a
technetium Tc99m exametazime intravenous injection as a diagnostic
radiopharmaceutical for use as an adjunct in the detection of altered
regional cerebral
perfusion and for the radiolabeling of autologous leukocytes. Each
vial of Ceretec
contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture
of 0.5 mg
exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione
bisoxime], 7.6
µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum
total stannous
and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed
under nitrogen
atmosphere with a rubber closure. The product contains no
antimicrobial preservative.
In addition, each package contains five 1 mL vials of Methylene Blue
Injection USP 1%
containing 10 mg methylene blue USP in Water for Injection q.s. pH
adjusted with
sodium hydroxide and/or hydrochloric acid, when necessary. Methylene
Blue Injection
USP is a sterile, non-pyrogenic solution of phenothiazin-5-ium,3,7-bis
(dimethylamino)-
chloride, trihydrate. Each package also contains five 4.5 mL vials of
0.003 M Monobasic
Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium
Chloride
Injection USP. The solution is sterile and non-pyrogenic. Each mL
contains 0.276 mg
monobasic sodium phosphate monohydrate (equivalent to 0.312 mg
monobasic sodium
phosphate dihydrate), 0.142 mg dibasic sodium phosphate anhydrous
(equivalent to
0.178 mg dibasic sodium phosphate dihydrate) and 9 mg sodium chloride
in Water for
Injection q.s. The total calculated osmolarity of the 0.003 M
Monobasic Sodium
Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride
Injection
USP is 317 mOsmol/L. Each mL provides 0.285 mg (3mM) of phosphate,
0.157 mEq of
sodium and 0.154 mEq of chl