Kit for the Preparation of Technetium Tc99m

Mertiatide - Now Available!

Betiatide injection, powder, lyophilized, for solution.

Product Information and Features

  • Competitively priced first to market generic of the RLD (Reference Listed Drug)
  • Room temperature storage (15° to 30° C) both before and after reconstitution for use up to 6 hours
  • Available in 5 vial kits (MER05)

Indications and Usage

Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See PEDIATRIC USE details in full package insert) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

IMPORTANT SAFETY INFORMATION

Warnings and 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.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Technetium Tc 99m Mertiatide as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.