TECHNETIUM TC 99M MEDRONATE- technetium tc 99m medronate injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEDRONIC ACID (UNII: 73OS0QIN3O) (MEDRONIC ACID - UNII:73OS0QIN3O)

Available from:

Jubilant DraxImage Inc., dba Jubilant Radiopharma

INN (International Name):

Medronic Acid

Composition:

Medronic Acid 25 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The kit consists of reaction vials which contain the sterile, non-pyrogenic,non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by intravenous injection. MDP-25 reaction vials are intended to be used as multidose vials. Each 10 mL MDP-25 reaction vial contains 25.0 mg medronic acid and not less than 2.0 mg of stannous chloride dihydrate (maximum total tin expressed as stannous chloride dihydrate 3.0 mg) and 5.0 mg of p-aminobenzoic acid in lyophilized form under an atmosphere of nitrogen. The pH is adjusted to 6.8 to 6.9 with HCI or NaOH prior to lyophilization. The addition of sterile, non-pyrogenic, and oxidant-free sodium pertechnetate Tc-99m sterile solution produces a rapid labeling which is essentially quantitative and which remains stable in vitro throughout the 12-hours life of the preparation. No bacteriostatic preservative is present. The structural formula of medronic acid is: Technetium Tc-99m decays by isomeric transition with a ph

Authorization status:

New Drug Application

Summary of Product characteristics

TECHNETIUM TC 99M MEDRONATE - TECHNETIUM TC 99M MEDRONATE INJECTION,
POWDER, FOR
SOLUTION
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA
---------- DRAXIMAGE MDP-25 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE INJECTION
FOR INTRAVENOUS USE
DIAGNOSTIC – FOR SKELETAL IMAGING
DESCRIPTION
The kit consists of reaction vials which contain the sterile,
non-pyrogenic,non-radioactive ingredients
necessary to produce Technetium Tc 99m Medronate Injection for
diagnostic use by intravenous
injection. MDP-25 reaction vials are intended to be used as multidose
vials.
Each 10 mL MDP-25 reaction vial contains 25.0 mg medronic acid and not
less than 2.0 mg of stannous
chloride dihydrate (maximum total tin expressed as stannous chloride
dihydrate 3.0 mg) and 5.0 mg of p-
aminobenzoic acid in lyophilized form under an atmosphere of nitrogen.
The pH is adjusted to 6.8 to 6.9 with HCI or NaOH prior to
lyophilization. The addition of sterile, non-
pyrogenic, and oxidant-free sodium pertechnetate Tc-99m sterile
solution produces a rapid labeling
which is essentially quantitative and which remains stable in vitro
throughout the 12-hours life of the
preparation. No bacteriostatic preservative is present.
The structural formula of medronic acid is:
PHYSICAL CHARACTERISTICS
Technetium Tc-99m decays by isomeric transition with a physical
half-life of 6.02 hours.
The
principal photon that is useful for detection and imaging studies is
listed in Table 1.
TABLE 1
PRINCIPAL RADIATION EMISSION DATA
Radiation
Mean % / Disintegration
Energy
(keV)
Gamma-2
89.07
140.5 EXTERNAL RADIATION
®
1
The specific gamma ray constant for Tc-99m is 0.78 R/mCi-hr at 1 cm.
The first half value layer is
0.017 cm of lead. To facilitate control of the radiation exposure from
millicurie amounts of this
radionuclide, the use of a 0.25 cm thickness of lead will attenuate
the radiation emitted by a factor of
about 1000. A range of values for the relative attenuation of the
radiation emitted by this radionuclide
that results from interposition of various t