Kit For the Preparation of Technetium Tc99m Mertiatide (Page 2 of 4)

CONTRAINDICATIONS

None known.

WARNINGS

None known.

PRECAUTIONS

General

1. The contents of this kit are not radioactive. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.

2. Contents of the reaction vial are intended only for use in the preparation of technetium Tc 99m mertiatide and are NOT to be administered directly to the patient.

3. To help reduce the radiation dose to the bladder, as well as other target organs, the patient should increase his or her fluid intake (unless medically contraindicated) and void as often as possible after the injection of technetium Tc 99m mertiatide for six hours after the imaging procedure.

4. Technetium Tc 99m mertiatide should not be used more than six hours after preparation.

5. The components of the kit are sterile and nonpyrogenic. It is essential that the user follow the directions carefully and use aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers during the addition of pertechnetate solution and the withdrawal of doses for patient administration.

6. The technetium Tc 99m labeling reactions involved in preparing technetium Tc 99m mertiatide depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m may adversely affect the quality of the radiopharmaceutical. Therefore, sodium pertechnetate Tc 99m containing oxidants should not be employed.

7. As in the use of any other radioactive material, care should be taken to insure minimum radiation exposure to the patient and to occupational workers.

8. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 30 days have not been established.

ADVERSE REACTIONS

The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

DOSAGE AND ADMINISTRATION

The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi).

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

RADIATION DOSIMETRY

The estimated absorbed radiation doses from an intravenous administration of technetium Tc 99m mertiatide are presented in Table 4.

Table 4: Radiation Dose Estimates for Tc 99m Mertiatide
8-day Old 1-year Old * 5-year Old * 10-year Old * 15-year Old Adult
Assumed Weight (kg) 3.4 9.8 19 32 57 70
Tc 99m Mertiatide Dose 37 MBq (1 mCi) 72.52 MBq (1.96 mCi) 140.6 MBq (3.8 mCi) 236.8 MBq (6.4 mCi) 370 MBq (10 mCi) 370 MBq (10 mCi)
Organ mSv rem mSv rem mSv rem mSv rem mSv rem mSv rem
*Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories. The adult radiation absorbed doses were calculated based on data from ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema.
*
Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200 μCi/kg).

Gallbladder Wall

2.701

0.27

2.466

0.235

1.547

0.160

1.658

0.166

1.961

0.200

1.628

0.160

Lower Large Intestine Wall

1.739

0.17

1.595

0.161

2.250

0.220

2.368

0.237

4.070

0.400

3.256

0.330

Small Intestine

0.518

0.052

0.5439

0.055

1.195

0.122

1.397

0.141

2.035

0.200

1.628

0.160

Upper Large Intestine Wall

0.962

0.096

0.943

0.096

1.828

0.186

2.0365

0.205

2.442

0.250

1.887

0.190

Kidneys

1.406

0.14

1.088

0.112

1.308

0.129

1.5155

0.154

1.739

0.180

1.443

0.140

Liver

0.3219

0.032

0.3046

0.031

0.394

0.038

0.4262

0.0435

0.481

0.048

0.3626

0.036

Ovaries

0.592

0.058

0.6164

0.061

1.322

0.133

1.5392

0.154

3.330

0.330

2.5900

0.260

Red Marrow

0.1628

0.016

0.1595

0.0161

0.281

0.0277

0.3552

0.0352

0.629

0.063

0.4810

0.050

Testes

0.518

0.051

0.5294

0.053

1.0826

0.110

1.1840

0.122

2.368

0.240

1.628

0.160

Urinary Bladder Wall

11.470

1.1

9.428

0.921

21.090

2.090

23.680

2.368

59.20

6.00

48.1000

4.80

Total Body

0.2405

0.024

0.2176

0.022

0.3656

0.0365

0.4026

0.0410

0.814

0.081

0.6660

0.065

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