NEUROLITE- bicisate dihydrochloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BICISATE DIHYDROCHLORIDE (UNII: B005P07V07) (BICISATE - UNII:3JXF0Z0XOI)

Available from:

Lantheus Medical Imaging, Inc.

INN (International Name):

BICISATE DIHYDROCHLORIDE

Composition:

BICISATE DIHYDROCHLORIDE 0.9 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions. None known.

Product summary:

Lantheus Medical Imaging, Inc. Neurolite® Kit for the Preparation of Technetium Tc99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 11994-006-02); and five (5) vials of A and five (5) vials of B (NDC 11994-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels. Prior to reconstitution, vial A and vial B are stored 15-25°C. Protect vial A from light. Store at controlled room temperature after preparation. Use within 6 hours of preparation. This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.

Authorization status:

New Drug Application

Summary of Product characteristics

NEUROLITE- BICISATE DIHYDROCHLORIDE
LANTHEUS MEDICAL IMAGING, INC.
----------
NEUROLITE
KIT FOR THE PREPARATION OF TECHNETIUM TC99M BICISATE FOR INJECTION
FOR DIAGNOSTIC USE
DESCRIPTION
This kit formulation consists of two nonradioactive vials: Vial A
contains bicisate
dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester
dihydrochloride) and a
reducing agent as a lyophilized solid and vial B contains a buffer
solution. Both vials are
sterile and non-pyrogenic.
VIAL A –
Bicisate dihydrochloride (ECD•2HCl)
0.9 mg
Edetate disodium, dihydrate
0.36 mg
Mannitol
24 mg
Stannous chloride, dihydrate,
theoretical
(SnCl
•2H O)
72 µg
Stannous chloride, dihydrate,
minimum (SnCl
•2H O)
12 µg
Total Tin, (stannous and stannic),
dihydrate
(as SnCl
•2H O)
83 µg
The contents of vial A are lyophilized and stored under nitrogen. The
pH of the solution
before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C.
Protect from light.
VIAL B –
Sodium phosphate dibasic
heptahydrate
4.1 mg
Sodium phosphate monobasic
monohydrate
0.46 mg
Water for Injection
qs
1 mL
The contents of vial B are stored under air. The pH of the solution is
7.6 ± 0.4. This vial
is stored at 15-25°C.
This drug is administered by intravenous injection for diagnostic use
after reconstitution
with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m
Injection. The
precise structure of the Technetium complex is [N,
N'-ethylenedi-L-cysteinato(3-
)]oxo[
Tc] technetium (V), diethyl ester.
®
2
2
2
2
2
2
99m
PHYSICAL CHARACTERISTICS
Technetium Tc99m decays by isomeric transition with a physical
half-life of 6.02 hrs .
Photons useful for the detection and imaging studies are listed in
Table 1.
TABLE 1. PRINCIPLE RADIATION EMISSION DATA
RADIATION
MEAN % / DISINTEGRATION
MEAN ENERGY (KEV)
Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC 11026, 108
(1981).
Gamma-2
89.07
140.5
EXTERNAL RADIATION
The specific gamma ray constant for Tc99m is 5.4
microcoulombs/kg-MBq-hr
(0.78R/mCi-hr) at 1cm. The first half value layer