Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

INDICATIONS & USAGE MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.

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Advisory information

contraindications
CONTRAINDICATIONS None known at present.
Special warnings and precautions

PRECAUTIONS Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Medronate and are NOT to be administered directly to the patient.

To minimize the radiation dose to the bladder, the patient should be encouraged to increase fluid intake and to void as often as possible after the injection of Technetium Tc 99m Medronate, and for 4 to 6 hours after the imaging procedure.

The preparation contains no bacteriostatic preservative.

Both the powdered and reconstituted forms of MDP-25 should be stored at 25°C (77°F); excursions permitted between 15° and 30°C (59° to 86°F).

The reconstituted product should be stored in a suitable lead shield.

The solution should not be used if it is cloudy.

Optimal imaging results are obtained 1 to 4 hours after administration.

The image quality may be adversely affected by obesity, old age and impaired renal function.

General The components of the kit are sterile and non-pyrogenic.

It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.

Technetium Tc 99m Medronate as well as other radioactive drugs must be handled with care.

Once sodium pertechnetate Tc-99 m is added to the vial, appropriate safety measures should be used to minimize external radiation to clinical occupational personnel.

Care should also be taken to minimize radiation exposure to patients in a manner consistent with proper patient management.

The technetium Tc-99 m labeling reactions involved depend on maintaining the stannous ion in the reduced state.

Hence, sodium pertechnetate Tc-99 m containing oxidants should not be employed.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether Technetium Tc 99m Medronate affects fertility in males or females.

Pregnancy Category C Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Medronate.

It is also not known whether Technetium Tc-99 m Medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

There have been no studies in pregnant women.

Technetium Tc-99 m should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers Technetium Tc-99 m is excreted in human milk during lactation.

Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Adverse reactions

ADVERSE REACTIONS Several cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate.

Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate.

These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting.

One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported.

In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION The recommended adult dose, after reconstitution with oxidant-free sodium pertechnetate Tc-99 m, is 370 to 740 megabecquerels (10 to 20 millicuries [200 µCi/kg]) by slow intravenous injection over a period of 30 seconds.

Optimum scanning time is 1 to 4 hours post-injection.

To minimize the contribution of the bladder content to the image, the patient should void immediately before imaging is started.

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.

The solution should not be used if cloudy.

RADIATION DOSIMETRY The estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate are shown in Table 4.

The effective half-life was assumed to be the physical half-life for all calculated values.

Table 4 Radiation Doses2 2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975 Tissue Absorbed Radiation Dose mGy/740 MBq rads/20 mCi Total Body Total Bone Red Marrow Kidneys Liver Bladder Wall 2 hr. void 4.8 hr. void Ovaries 2 hr. void 4.8 hr. void Testes 2 hr. void 4.8 hr. void 1.3 7.0 5.6 8.0 0.6 26.0 62.0 2.4 3.4 1.6 2.2 0.13 0.70 0.56 0.80 0.06 2.60 6.20 0.24 0.34 0.16 0.22 HOW SUPPLIED MDP-25, Kit for the Preparation of Technetium Tc 99m Medronate Injection Product No. 500661 (30 vials) Available in boxes consisting of 30 reaction vials, each vial containing in lyophilized form

sterile and non-pyrogenic: Medronic Acid 25.0 mg Stannous Chloride Dihydrate (minimum) 2.0 mg (Maximum tin as stannous chloride dihydrate) 3.0 mg p-Aminobenzoic Acid 5.0 mg The pH is adjusted to 6.8 to 6.9 with HCI or NaOH prior to lyophilization.

The vials are sealed under an atmosphere of nitrogen.

Radioassay information labels with radiation warning symbol and a package insert are supplied in each box.

STORAGE Store the unreconstituted reaction vials at 25?C (77?F); excursions permitted between 15° and 30?C (59° to 86?F).

After labeling with Technetium Tc-99 m, the reconstituted product should be stored at 25?C (77?F) in the original vial, and be placed in a suitable lead shield.

Excursions permitted between 15° and 30?C (59° to 86?F).

Discard the reconstituted solution after 12 hours.

DIRECTIONS NOTE: Use aseptic procedures throughout and take precautions to minimize radiation exposure by use of suitable shielding.

Use waterproof gloves during the following preparation procedure.

MDP-25 reaction vials are intended for the preparation of multiple doses of Technetium Tc 99 Medronate and the entire contents of the vial should not be used as a single dose.

Before reconstituting a vial, it should be inspected for cracks and/or a melted plug or any other indication that the integrity of the vacuum seal has been compromised.

To prepare Technetium Tc 99m Medronate: Remove the central metal disc from a reaction vial and swab the closure with either an alcohol swab or a suitable bacteriostatic agent.

Place the reaction vial in a suitable lead vial shield (minimum wall thickness 1/8 inch) which has a fitted lead cap.

Obtain 2 to 10 mL of sterile, non-pyrogenic sodium pertechnetate Tc-99 m, using a shielded syringe.

The recommended maximum amount of Technetium Tc-99 m to be added to a reaction vial is 37.0 gigabecquerels (1000 mCi).

Sufficient sodium pertechnetate is to be used for the reconstitution of a reaction vial to ensure that the dose of medronate administered does not exceed 10 mg.

Sodium pertechnetate Tc-99 m solutions containing an oxidizing agent are not suitable for use.

Using a shielded syringe, add the sodium pertechnetate Tc-99 m solution to the reaction vial aseptically.

Place the lead cap on the reaction vial shield and agitate the shielded reaction vial until the contents are completely dissolved.

The solution must be clear and free of particulate matter before proceeding.

Assay the product in a suitable calibrator, record the radioassay information on the label with radiation warning symbol, and apply it to the reaction vial.

Withdrawals for administration must be made aseptically using a shielded sterile syringe and needle.

Since the reaction vials contain nitrogen to prevent oxidation of the complex, they should not be vented.

If repeated withdrawals are made, minimize the replacement of contents with room air.

The following steps should be followed to ensure that each reconstituted of Technetium Tc 99m Medronate contains between 1 and 10 mg of medronic acid.

Where: Vr = Final volume of in the vial in mL after reconstitution.

C = Concentration of Medronic Acid in mg/mL. Max.

V = Maximum volume to be used for one dose in mL. Min.

V = Minimum volume to be used for one dose in mL.

Prior to reconstitution, determine the radioactive concentration of the sodium pertechnetate Tc-99 m.

Note the volume and activity added to the vial.

It should be between 1.85 - 37.0 GBq (50 - 1000 mCi) in 1 to 10 mL. Calculate the concentration (C) of Medronic acid in the vial after reconstitution.

C (mg/mL) = 25 mg?

Vr (mL) To ensure that the dose contains a maximum of 10 mg, the following formula should be used to calculate the maximum volume (Max.

V) to be dispensed as one dose.

Max.

V (mL) = 10 mg?

C (mg/mL) To ensure that a minimum dose of 1 mg is dispensed, the following formula should be used to calculate the minimum volume (Min.

V) to be dispensed as one dose Min.

V = 1 mg?

C (mg/mL) 7.

The finished preparation should be stored at 25?C (77?F);excursions permitted between 15° and 30?C (59° to 86?F) when not in use and discarded after 12 hours.

It should also be stored during its life in a suitable lead shield.

This reagent kit is approved by the

U.S. Nuclear Regulatory Commission for distribution to persons licensed to use by-product material identified in §35.200 to 10 CFR Part 35, to persons who have a similar authorization issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Manufactured by: Jubilant DraxImage Inc.

Kirkland Quebec, H9H 4J4 Canada.

Revised: October 2011

More information

Category Value
Authorisation number NDA018035
Orphan designation No
Product NDC 65174-660
Date Last Revised 01-10-2011
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Jubilant DraxImage Inc