KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN injection, powder, lyophilized, for solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

MEBROFENIN (UNII: 7PV0B6ED98) (MEBROFENIN - UNII:7PV0B6ED98)

Pieejams no:

Sun Pharmaceutical Industries, Inc.

SNN (starptautisko nepatentēto nosaukumu):

MEBROFENIN

Kompozīcija:

MEBROFENIN 45 mg in 10 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent. Hypersensitivity to this compound.

Produktu pārskats:

Kit for the Preparation of Technetium Tc 99m Mebrofenin is supplied in kits of 5 or 30 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate SnF2 •2H2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate SnF2 •2H2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. Sun Pharmaceutical Industries, Inc. 29 Dunham Rd. 781-275-7120 Kit Contents 5 or 30 sterile multidose reaction vials. 12 or 72 radiation labels for Technetium Tc 99m Mebrofenin (for 5 or 30 vial kits, respectively). 1 package insert. Preparation Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure: 1. Waterproof gloves should be worn during the preparation procedure. 2. Place reaction vial in an appropriate lead shield. 3. Swab the rubber closure of the reaction vial with a germicide. 4. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution. NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Kit for the Preparation of Technetium Tc 99m Mebrofenin, only preservative free Sodium Chloride Injection USP should be used. 5. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. 6. Record the date and time of preparation on radiation label. 7. Affix radiation label to shield. 8. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. 9. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. 10. Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage Store the kit as supplied at 20-25ºC (68-77ºF) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution. Rx only NDC-45567-0455-1 (5 Vial Kit) NDC-45567-0455-2 (30 Vial Kit) This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 1-800-221-7554 (For International call 781-275-7120) Mar 2020

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN- KIT FOR THE
PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN
DESCRIPTION
Each multidose reaction vial contains a nonradioactive, sterile,
nonpyrogenic mixture of 45 mg
mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF •2H O
and 1.03 mg total tin, maximum
(as stannous fluoride dihydrate, SnF •2H O), not more than 5.2 mg
methylparaben, and 0.58 mg
propylparaben. The pH is adjusted with sodium hydroxide or
hydrochloric acid prior to lyophilization.
The contents of the vial are lyophilized and sealed under nitrogen at
the time of manufacture.
The pH of the reconstituted product is 4.2 to 5.7.
The structure of mebrofenin
(2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino]
bisacetic acid) is shown below:
MOLECULAR WEIG HT = 387.23
Molecular Weight = 387.23
When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is
added to the vial, the diagnostic
agent Technetium Tc 99m Mebrofenin is formed for administration by
intravenous injection.
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 % per Disintegration
Mean Energy (keV)
Gamma-2
89.07
140.5
Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026,
(1981) p. 108.
EXTERNAL RADIATION
2
2
2
2
1
1
The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie
at 1 cm. The first half value
layer is 0.017 cm of lead (Pb). 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. To
facilitate control of the radiation exposure from millicurie amounts
of this radionuclide, the use of a
0.25 cm thickne