MDP Kit for preparation of Technetium(99mTc) medronate injection

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

medronic acid, Quantity: 5 mg

可用日期:

Australian Nuclear Science and Technology Organisation T/A ANSTO

药物剂型:

Injection, powder for

组成:

Excipient Ingredients: ascorbic acid; stannous chloride dihydrate; hydrochloric acid; sodium hydroxide

给药途径:

Intravenous

每包单位数:

6 vials

处方类型:

Not scheduled. Not considered by committee

疗效迹象:

A bone imaging agent to delineate areas of altered osteogenesis.

產品總結:

Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 8 degrees Celsius (refrigerate)

授权状态:

Registered

授权日期:

2017-12-15

产品特点

20234-MDP Kit for preparation of Technetium (
99m
Tc) Medronate injection - ANSTO-pi
1
AUSTRALIAN PRODUCT INFORMATION
MDP KIT (MEDRONIC ACID) FOR INJECTION
1
NAME OF THE MEDICINE
MDP Kit for preparation of Technetium (
99m
Tc) Medronate injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 5.00 mg Methylene Diphosphonic Acid (Medronic Acid,
equivalent to 6.25 mg of
Sodium salt of Methylene Diphosphonic Acid), 0.417 mg Stannous
Chloride Dihydrate, 2.0 mg of
Ascorbic Acid, Hydrochloric Acid (QS) and Sodium Hydroxide (QS).
Before lyophilisation the pH is adjusted to 6.0 with Sodium Hydroxide
or Hydrochloric Acid solutions.
The contents the vial is lyophilized and stored under nitrogen.
As supplied the product is sterile and pyrogen free; it contains no
antimicrobial preservative.
The product is for diagnostic use only, for intravenous administration
after reconstitution with sterile
sodium pertechnetate (
99m
Tc) solution.
For the full list of excipients, see Section 6.1 List of Excipients.
PHYSICAL CHARACTERISTICS OF
99M
TC
Technetium-99m, with a physical half-life of six hours, decays by
isomeric transition to
99
Tc. Photons
associated with this transition that are useful for detection and
imaging studies are listed in Table 1.
Decay profile of
99m
Tc is given in Table 2.
TABLE 1: PRINCIPAL RADIATION EMISSION DATA FOR
99M
TC.
PRINCIPAL RADIATION
MEAN % PER
DISINTEGRATION
MEAN ENERGY (KEV)
Gamma-2
89.1
140.5
Reference: “D A Weber, K F Eckerman, LT Dillman and JC Ryan. MIRD:
Radionuclide and Decay Schemes.” The society of
Nuclear Medicine Inc. New York, 1989.
TABLE 2: PHYSICAL DECAY CHART OF
99M
TC.
HOURS
FRACTION REMAINING
HOURS
FRACTION REMAINING
0
1.000
7
0.445
1
0.891
8
0.397
2
0.794
9
0.354
3
0.707
10
0.315
4
0.630
11
0.281
5
0.561
12
0.250
6
0.500
20234-MDP Kit for preparation of Technetium (
99m
Tc) Medronate injection - ANSTO-pi
2
EXTERNAL RADIATION
The specific gamma ray constant for
99m
Tc is 0.19mGy per MBq
-h
at 1cm. The first half value thickness
of lead (Pb) for
99m
Tc is 0.2mm.