Technetium Tc 99m Medronate

• If you have an allergy to technetium tc 99m medronate or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding. Do not breast-feed while you take technetium tc 99m medronate.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use technetium tc 99m medronate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• Drink lots of noncaffeine liquids before the test as your doctor has told you.
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.
• You will need to empty your bladder often after the test is over as your doctor has told you. Talk with your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chills.
• Upset stomach or throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.

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.

NDC 045567-0040-1

 Pharmalucence, Inc.

Kit for the Preparation of Technetium Tc99m Medronate for Injection

Rx Only

STERILE

DIAGNOSTIC

MULTIDOSE

NON-PYROGENIC

Each 10mL multidose reaction vial contains: 20 mg medronic acid; 1 mg ascorbic acid; 0.13mg (minimum) stannous fluoride; 0.38 mg total tin (maximum, as stannous fluoride) in lyophilized form. The pH is adjusted to 6.5 (6.3 - 6.7) with NaOH and/or HCI prior to lyophilization. Sealed under nitrogen. The recommended adult dose is 370 - 740 megabecquerels (10-20 millicuries). Refer to the package insert for directions for use.

CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER LABELING WITH OXIDANT-FREE TECHNETIUM Tc99m. After labeling with Technetium Tc99m, store at 20-25°C (68-77°F), see USP. Use within 6 hours after reconstitution.

10 mL

Manufactured By:

Pharmalucence, Inc.

Billerica, MA 01821

PL-000008

Rev 0.1

Jun 2012