Ultratag™ RBC

Ultratag RBC (Kit for the Preparation of Technetium (99mTc)-Labelled Red Blood Cells)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions about Ultratag RBC. It does not contain all of the available information about Ultratag RBC. It does not replace talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you or your child receiving Ultratag RBC against the benefits he or she expects it will have.

If you have any concerns about having this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What is Ultratag RBC

Ultratag RBC is a kit consisting of 3 separate components which are used in combination to prepare radiolabeled red blood cells. Ultratag RBC belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive.

Ultratag RBC comes as a kit containing a 10 mL reaction vial and 2 syringes. There are 5 units in a multi-dose kit.

What is Ultratag RBC used for

Ultratag RBC is an imaging agent that is used primarily in cardiac function studies. Ultratag RBC is also used in detecting sites of gastrointestinal bleeding.

Your doctor may have prescribed Ultratag RBC for another purpose. Ask your doctor if you have any questions about why Ultratag RBC has been prescribed for you. If you have any concerns, you should discuss these with your doctor.

This medicine is only available with a doctor’s prescription.

Before you are given Ultratag RBC

Before you are given Ultratag RBC, your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be given. You must discuss any concerns you have with your doctor.

Ultratag RBC is recommended for patients 18 years of age and older. If your doctor believes it is necessary to give Ultratag RBC to a patient under 18, he or she will discuss the benefits and risks with you.

You must tell your doctor if you have allergies to:

  • any other medicines
  • any other substances such as foods, preservatives or dyes

Tell your doctor if you are or plan to become pregnant. Like most medicines, Ultratag RBC is not recommended for use during pregnancy. If there is a need to consider Ultratag RBC during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.

Tell your doctor if you are breast feeding or plan to breast feed. Like most medicines, Ultratag RBC is not recommended while you are breast feeding. However if you are breast feeding, formula feedings should be substituted for breast feeding for 24 hours following the administration of Ultratag RBC. Breast milk produced within that time should be discarded.

Tell your doctor if you have any other medical conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

How Ultratag RBC is given

How much is given

Your doctor will decide how much you will be given. This depends on your condition and other factors, such as weight.

How it is given

Ultratag RBC is given as an injection into a vein. UltraTag RBC should only be given by a doctor or a nurse.

When you are given Ultratag RBC

Things you must do

There is nothing in particular you must do once given Ultratag RBC.

Things you must not do

Do not take any other medicines unless advised by your doctor.

Things to be careful of

To minimise the radiation dose to the bladder, drink fluids and void immediately before the examination and as often thereafter as possible for the next 4 to 6 hours.

Side effects

Tell your doctor as soon as possible if you do not feel well after being given Ultratag RBC. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

Tell your doctor if you experience any side effects which worry you.

Product description

What it looks like

Ultratag RBC is supplied as a kit containing a 10 mL reaction vial and 2 syringes. An injection is prepared from withdrawing a sample of the patient’s blood, transferring the sample to the 10 mL reaction vial, adding the contents of syringe I and syringe II to the reaction vial and dispensing technetium (99mTc). The contents in the reaction vial will be mixed for approximately 20 minutes.

Ingredients

Active ingredients:

10 mL Reaction Vial:

  • stannous chloride dihydrate – 50 μg minimum (96 μg theoretical)

Inactive ingredients:

10 mL Reaction Vial:

  • sodium citrate dihydrate – 3.67 mg
  • Glucose – 5.5 mg

Syringe I (0.6 mL):

  • sodium hypochlorite – 0.6 mg
  • water for injection – qs

Syringe II (10 mL):

  • citric acid monohydrate – 8.7 mg
    sodium citrate dihydrate – 32.5mg
    glucose – 12 mg
    water for injection – qs

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Landauer Radiopharmaceuticals Pty Ltd
Level 3/69 Phillip Street
Parramatta NSW 2015
Australia

Manufactured by Mallinckrodt Nuclear Medicines LLC
Made in USA

Registration Number: AUST R 47860

This leaflet was prepared in December 2016.

Published by MIMS June 2018