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Tc 99M Medronate

Prescription

Tên thương mại: Kit for the Preparation of Technetium Tc 99M Medronate

Dạng bào chế
Injection
Đường dùng
INTRAVENOUS

About This Medication

Description Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection. Each 10mL multidose vial contains: Medronic acid: 20 mg Ascorbic acid: 1 mg Stannous fluoride, SnF 2 : 0.13 mg (minimum) Total tin (maximum, as stannous fluoride, SnF 2 ): 0.38 mg The pH is adjusted to 6.5 (6.3 to 6.7) with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present in the vial. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The structural formula is: When a solution of sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection is added to the vial, the diagnostic agent, Technetium Tc 99m Medronate is formed for administration by intravenous injection. The pH of the reconstituted product is 5.4 to 6.8. The precise structure of Technetium Tc 99m Medronate Injection is not known at this time. Structural Formula PHYSICAL CHARACTERISTICS: Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours 1 . 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 1 Kocher, DC: Radioactive Decay Data Tables, DOE/TIC-11026, 108, 1981 . EXTERNAL RADIATION: The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr 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 the 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 thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. TABLE 2 Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3. TABLE 3 Physical Decay Chart: Tc 99m, Half-Life 6.02 Hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 * Calibration Time

Hoạt chất

Thành phần Hàm lượng
Technetium Tc-99M Medronate -

Chỉ định & Cách dùng

INDICATIONS AND USAGE: Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Liều dùng & Cách dùng

DOSAGES AND ADMINISTRATION: Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection. After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is: 370-740 megabecquerels: (10-20 millicuries) given intravenously. Imaging is optimal at 1 to 4 hours post Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Radiation Dosimetry The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4. TABLE 4 Estimated Absorbed Radiation Dose 2 Technetium Tc 99m Medronate Organ (MGy/740 MBq) (Rads / 20 mCi) Total Body 1.3 0.13 Bone Total 7.0 0.70 Red Marrow 5.6 0.56 Kidneys 8.0 0.80 Liver 0.6 0.06 Bladder Wall 2 hour void 26 2.60 4.8 hour void 62 6.20 Ovaries 2 hour void 2.4 0.24 4.8 hour void 3.4 0.34 Testes 2 hour void 1.6 0.16 4.8 hour void 2.2 0.22 2 Method of calculation: "S" Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)

Side Effects Overview

ADVERSE REACTIONS: Several adverse reactions due to Technetium Tc 99m Medronate Injection have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of Technetium Tc 99m Medronate.

Cảnh báo & Thận trọng

Chống chỉ định

Frequently Asked Questions

INDICATIONS AND USAGE: Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.

DOSAGES AND ADMINISTRATION: Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection. After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is: 370-740 megabecquerels: (10-20 millicuries) given intravenously. Imaging is optimal at 1 to 4 hours post Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The patient dose …

WARNINGS: This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis). Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, …

CONTRAINDICATIONS: None known.

Tc 99M Medronate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

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Nguồn dữ liệu: DailyMed (NLM), openFDA, MFDS

Medical Disclaimer

This content is for educational and informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making medication decisions.

Data sources: ChEMBL, PubChem, DailyMed.