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Ceretec Drug Description
CERETEC™
Kit for the Preparation of Technetium Tc99m Exametazime Injection
Diagnostic Radiopharmaceutical
For intravenous use only
DRUG 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, 0.142 mg dibasic
sodium phosphate anhydrous 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 chloride. When used according to the preparation instructions
(see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium
Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:








When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is
added to the vial of Ceretec, aTc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Physical Characteristics
Technetium Tc99m decays by isomeric transition with a physical half-life of
6.03 hours.(1) Photons that are useful for imaging studies are listed
in Table 1.
Table 1. Principal Radiation Emission Data-technetium Tc99m



Radiation
Mean %/ Disintegration
Mean Energy (keV)


Gamma 2
87.87
140.5


(1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay
schemes and nuclear parameters for use in radiation-dose estimation. MIRD
Phamphlet No. 10, p. 62,1975.



External radiation
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37
MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead
(Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from interposition
of various thicknesses of Pb is shown in Table 2. For example, the use of a
2.7 mm thickness of Pb will decrease the external radiation exposure by a factor
of 1,000.
Table 2. Radiation Attenuation by Lead Shielding



Shield Thickness (Pb) mm
Coefficient of Attenuation


0.2
0.5


0.95
10-1


1.8
10-2


2.7
10-3


3.6
10-4


4.5
10-5



To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart - Tc99m half-life 6.03 hours



Hours
Fraction Remaining
Hours
Fraction Remaining


0*
1.000
7
0.447


1
0.891
8
0.399


2
0.795
9
0.355


3
0.708
10
0.317


4
0.631
11
0.282


5
0.563
12
0.252


6
0.502
24
0.063


*Calibration time (time of preparation)


Last reviewed on RxList: 1/21/2009




Ceretec Drug Description
CERETEC™
Kit for the Preparation of Technetium Tc99m Exametazime Injection
Diagnostic Radiopharmaceutical
For intravenous use only
DRUG 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, 0.142 mg dibasic
sodium phosphate anhydrous 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 chloride. When used according to the preparation instructions
(see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium
Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:








When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is
added to the vial of Ceretec, aTc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Physical Characteristics
Technetium Tc99m decays by isomeric transition with a physical half-life of
6.03 hours.(1) Photons that are useful for imaging studies are listed
in Table 1.
Table 1. Principal Radiation Emission Data-technetium Tc99m



Radiation
Mean %/ Disintegration
Mean Energy (keV)


Gamma 2
87.87
140.5


(1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay
schemes and nuclear parameters for use in radiation-dose estimation. MIRD
Phamphlet No. 10, p. 62,1975.



External radiation
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37
MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead
(Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from interposition
of various thicknesses of Pb is shown in Table 2. For example, the use of a
2.7 mm thickness of Pb will decrease the external radiation exposure by a factor
of 1,000.
Table 2. Radiation Attenuation by Lead Shielding



Shield Thickness (Pb) mm
Coefficient of Attenuation


0.2
0.5


0.95
10-1


1.8
10-2


2.7
10-3


3.6
10-4


4.5
10-5



To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart - Tc99m half-life 6.03 hours



Hours
Fraction Remaining
Hours
Fraction Remaining


0*
1.000
7
0.447


1
0.891
8
0.399


2
0.795
9
0.355


3
0.708
10
0.317


4
0.631
11
0.282


5
0.563
12
0.252


6
0.502
24
0.063


*Calibration time (time of preparation)


Last reviewed on RxList: 1/21/2009




Ceretec Drug Description
CERETEC™
Kit for the Preparation of Technetium Tc99m Exametazime Injection
Diagnostic Radiopharmaceutical
For intravenous use only
DRUG 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, 0.142 mg dibasic
sodium phosphate anhydrous 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 chloride. When used according to the preparation instructions
(see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium
Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:








When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is
added to the vial of Ceretec, aTc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Physical Characteristics
Technetium Tc99m decays by isomeric transition with a physical half-life of
6.03 hours.(1) Photons that are useful for imaging studies are listed
in Table 1.
Table 1. Principal Radiation Emission Data-technetium Tc99m



Radiation
Mean %/ Disintegration
Mean Energy (keV)


Gamma 2
87.87
140.5


(1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay
schemes and nuclear parameters for use in radiation-dose estimation. MIRD
Phamphlet No. 10, p. 62,1975.



External radiation
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37
MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead
(Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from interposition
of various thicknesses of Pb is shown in Table 2. For example, the use of a
2.7 mm thickness of Pb will decrease the external radiation exposure by a factor
of 1,000.
Table 2. Radiation Attenuation by Lead Shielding



Shield Thickness (Pb) mm
Coefficient of Attenuation


0.2
0.5


0.95
10-1


1.8
10-2


2.7
10-3


3.6
10-4


4.5
10-5



To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart - Tc99m half-life 6.03 hours



Hours
Fraction Remaining
Hours
Fraction Remaining


0*
1.000
7
0.447


1
0.891
8
0.399


2
0.795
9
0.355


3
0.708
10
0.317


4
0.631
11
0.282


5
0.563
12
0.252


6
0.502
24
0.063


*Calibration time (time of preparation)


Last reviewed on RxList: 1/21/2009




Ceretec Drug Description
CERETEC™
Kit for the Preparation of Technetium Tc99m Exametazime Injection
Diagnostic Radiopharmaceutical
For intravenous use only
DRUG 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, 0.142 mg dibasic
sodium phosphate anhydrous 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 chloride. When used according to the preparation instructions
(see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium
Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:








When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is
added to the vial of Ceretec, aTc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Physical Characteristics
Technetium Tc99m decays by isomeric transition with a physical half-life of
6.03 hours.(1) Photons that are useful for imaging studies are listed
in Table 1.
Table 1. Principal Radiation Emission Data-technetium Tc99m



Radiation
Mean %/ Disintegration
Mean Energy (keV)


Gamma 2
87.87
140.5


(1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay
schemes and nuclear parameters for use in radiation-dose estimation. MIRD
Phamphlet No. 10, p. 62,1975.



External radiation
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37
MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead
(Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from interposition
of various thicknesses of Pb is shown in Table 2. For example, the use of a
2.7 mm thickness of Pb will decrease the external radiation exposure by a factor
of 1,000.
Table 2. Radiation Attenuation by Lead Shielding



Shield Thickness (Pb) mm
Coefficient of Attenuation


0.2
0.5


0.95
10-1


1.8
10-2


2.7
10-3


3.6
10-4


4.5
10-5



To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart - Tc99m half-life 6.03 hours



Hours
Fraction Remaining
Hours
Fraction Remaining


0*
1.000
7
0.447


1
0.891
8
0.399


2
0.795
9
0.355


3
0.708
10
0.317


4
0.631
11
0.282


5
0.563
12
0.252


6
0.502
24
0.063


*Calibration time (time of preparation)


Last reviewed on RxList: 1/21/2009




Ceretec Drug Description
CERETEC™
Kit for the Preparation of Technetium Tc99m Exametazime Injection
Diagnostic Radiopharmaceutical
For intravenous use only
DRUG 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, 0.142 mg dibasic
sodium phosphate anhydrous 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 chloride. When used according to the preparation instructions
(see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium
Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:








When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is
added to the vial of Ceretec, aTc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Physical Characteristics
Technetium Tc99m decays by isomeric transition with a physical half-life of
6.03 hours.(1) Photons that are useful for imaging studies are listed
in Table 1.
Table 1. Principal Radiation Emission Data-technetium Tc99m



Radiation
Mean %/ Disintegration
Mean Energy (keV)


Gamma 2
87.87
140.5


(1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay
schemes and nuclear parameters for use in radiation-dose estimation. MIRD
Phamphlet No. 10, p. 62,1975.



External radiation
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37
MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead
(Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from interposition
of various thicknesses of Pb is shown in Table 2. For example, the use of a
2.7 mm thickness of Pb will decrease the external radiation exposure by a factor
of 1,000.
Table 2. Radiation Attenuation by Lead Shielding



Shield Thickness (Pb) mm
Coefficient of Attenuation


0.2
0.5


0.95
10-1


1.8
10-2


2.7
10-3


3.6
10-4


4.5
10-5



To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
Table 3. Physical Decay Chart - Tc99m half-life 6.03 hours



Hours
Fraction Remaining
Hours
Fraction Remaining


0*
1.000
7
0.447


1
0.891
8
0.399


2
0.795
9
0.355


3
0.708
10
0.317


4
0.631
11
0.282


5
0.563
12
0.252


6
0.502
24
0.063


*Calibration time (time of preparation)


Last reviewed on RxList: 1/21/2009





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Accurate, FDA approved Ceretec information for healthcare professionals and patients - brought to you by Drugs.com. Ceretec Official FDA information, side effects and uses.


Learn about the prescription medication Ceretec (Technetium Tc99m Exametazime Injection), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling Ceretec (Technetium Tc99m Exametazime Injection) Drug Information ...


Technetium (99m Tc) exametazime (trade name Ceretec) is a drug used for the detection of altered regional cerebral perfusion in stroke and other cerebrovascular diseases, and for the ... Technetium (99mTc) exametazime - Wikipedia, the free encyclopedia


Ceretec is a medicine available in a number of countries worldwide. A list of US medications equivalent to Ceretec is available on the Drugs.com website. Ceretec Information from Drugs.com - Drugs.com


Ceretec® Imaging Technetium 99m– 99m Tc imaging agent commonly used with SPECT imaging to detect CVAs, which may be useful for diagnosing Alzheimer's disease. Ceretec - definition of Ceretec in the Medical dictionary - by the ...


CERETEC SUMMARY CERETEC ™ Kit for the Preparation of Technetium Tc99m Exametazime Injection. The Ceretec kit is supplied as five packs of three vials for use in the preparation ... Ceretec (Exametazime) - Drug Info, Side Effects, Research ...


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nuclear medicine department nuclear medicine white blood scan (ceretec) nuclear medicine white blood scan (ceretec) NUCLEAR MEDICINE WHITE BLOOD SCAN (CERETEC)


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