Consumer medicine information

Thallous(TI201) Chloride injection

Thallous chloride Tl 201

BRAND INFORMATION

Brand name

Thallous (Tl 201) Chloride Injection

Active ingredient

Thallous chloride Tl 201

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Thallous(TI201) Chloride injection.

What is in this leaflet

This leaflet answers some of the common questions about Thallous(TI201) Chloride Injection. It does not contain all of the available information about Thallous(TI201) Chloride Injection. 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 Thallous(TI201) Chloride Injection 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 Thallous(TI201) Chloride Injection

Thallous(TI201) Chloride Injection contains the active ingredient called Thallous Chloride and belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive.

The radioactivity can be detected from outside of the body by using special cameras.

The image produced is known as a scan. This scan will show the accumulation of radioactivity within the body, within an organ or within a mass or lump. This can give the doctor valuable information about the structure and the function of an organ or the location of e.g., a tumour.

Thallous(TI201) Chloride Injection comes in a 10 mL vial and is available in five different radioactivities. It is ready for intravenous injection as packaged.

What Thallous (TI201) Chloride Injection is used for

Thallous(TI201) Chloride Injection is used to show the blood flow inside your heart during exercise and rest.

Thallous(TI201) Chloride Injection can also be used to image the thyroid for abnormalities as well as the parathyroid and the brain for signs of tumours.

Thallous(TI201) Chloride has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

Your doctor may have prescribed Thallous(TI201) Chloride Injection for another purpose. Ask your doctor if you have any questions about why Thallous(TI201) Chloride Injection 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 Thallous (TI201) Chloride Injection

Before you are given Thallous(TI201) Chloride Injection 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.

Thallous(TI201) Chloride Injection is recommended for patients less than 18 years of age. If your doctor believes it is necessary to give Thallous(TI201) Chloride Injection 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 Thallous(TI201) Chloride Injection is not recommended for use during pregnancy. If there is a need to consider Thallous(TI201) Chloride Injection during your pregnancy, your doctor will discuss the benefits and risks of giving it to you.

Tell your doctor if you are breastfeeding or plan to breastfeed. Like most medicines Thallous(TI201) Chloride Injection is not recommended while you are breastfeeding. However if you are breastfeeding, formula feedings should be substituted for breastfeeding for 24 hours following the administration of Thallous(TI201) Chloride Injection. Breast milk produced within that time should be discarded. If administration during lactation is considered necessary, breast feeding has to be discontinued and the expressed milk has to be discarded.

Tell your doctor if you have any other medical conditions especially if you suffer from heart disease.

Taking other medicines

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

How Thallous (TI201) Chloride Injection 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 and depending on the investigation to be performed.

If you are being given Thallous(TI201) Chloride Injection for heart imaging you may be given two injections, one at rest and one with exercise. You may be asked to fast for 4 hours before the procedure, and may be given a light meal after the injection.

If you are being given Thallous(TI201) Chloride Injection for thyroid or brain imaging you will be given one injection.

How it is given

Thallous(TI201) Chloride Injection is given as an injection into a vein. Thallous(TI201) Chloride Injection should only be given by a doctor or a nurse.

When you are given Thallous (TI201) Chloride Injection

Things you must do

There is nothing in particular you must do once given Thallous(TI201) Chloride Injection.

Things you must not do

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

Things to be careful of

Thallium is excreted in the faeces and urine.

Do not drive or operate machinery until you know how Thallous(TI201) Chloride Injection affects you. Thallous(TI201) Chloride Injection may cause dizziness some people. Make sure you know how you react to Thallous(TI201) Chloride before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Side Effects

Tell your doctor as soon as possible if you do not feel well after being given Thallous(TI201) Chloride for Injection.

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 of the following and they worry you

  • nausea
  • diarrhoea
  • headache
  • warmth or redness of skin (Flushing)
  • retaining fluid (Oedema)
  • injection site inflammation

These side effects are usually mild.

Tell your doctor or a nurse immediately if you notice any of the following:

  • Severe chest pain (Myocardial Infarction)
  • Abnormal hearth rhythm (Arrhythmia)
  • Low blood pressure (Hypotension)
  • Feel like you cannot breathe (Bronchoconstriction)
  • Cerebrovascular event

These are serious side effects for which you may need urgent medical treatment.

Do not be alarmed by this list of side effects. You may not experience any of them.

Product Description

What it looks like

Thallous(TI201) Chloride Injection is supplied in a glass vial. An injection is prepared from the vial immediately before it is injected.

Not all presenations are avaialble.

Ingredients

Active ingredient:

Thallous Chloride

Inactive Ingredients:

Sodium Chloride

Sodium hydroxide

Hydrochloric acid

Water for injections.

Sponsor

Landauer Radiopharmaceuticals Pty Ltd
Level 3/69 Phillip Street
Parramatta NSW 2150
AUSTRALIA

Registration Numbers:

AUST R 20026

AUST R 20039

AUST R 49415

AUST R 49416

AUST R 49417

Date of Preparation: November 2015.

Published by MIMS October 2017

BRAND INFORMATION

Brand name

Thallous (Tl 201) Chloride Injection

Active ingredient

Thallous chloride Tl 201

Schedule

Unscheduled

 

Name of the medicine

Thallous chloride (Tl201).

Excipients.

Sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

Description

Curium Netherlands catalogue number: DRN 8103. CAS number: 7791-12-0. Molecular formula: ThCl.

Qualitative and quantitative composition.

201Tl-Thallium as thallous chloride 37 MBq. The specific activity is more than 18.5 GBq (500 mCi)/mg thallium. 201Tl decays to 201Hg by electron capture with a half-life of 73.1 hours.
Most important radiation emitted energy level abundance (%): 69 keV-X-rays 27.4; 80 keV-X-rays 20.5; 135 keV-γ-rays 2.7; 166 keV-γ-rays 1.6; 167 keV-γ-rays 10.0.

List of excipients.

Sodium chloride; sodium hydroxide; hydrochloric acid; water for injections.
The pH of the product is 5.0-7.0.

Pharmaceutical form.

Solution for injection.

Pharmacology

Pharmacodynamic properties.

Pharmacotherapeutic group: other cardiovascular system, diagnostic radiopharmaceutical.
ATC code: V09GX01.
At the chemical concentrations and activities used for diagnostic procedures thallous (Tl201) chloride does not appear to exert any pharmacodynamic effects.

Pharmacokinetic properties.

After intravenous injection of thallous (Tl201) chloride, the thallium rapidly leaves the blood as approximately 90% is cleared after the first pass. The relative uptake depends on regional perfusion and on the cell extraction efficacy of different organs. The myocardial extraction fraction of (201Tl) is about 85% during the first pass and the peak myocardial activity is 4-5% of the injected dose, relatively constant for about 20-25 minutes.
The precise cellular uptake process is still uncertain but the sodium-potassium ATPase pump is probably involved, at least in part. The muscular uptake depends on workload and compared with the resting condition, the uptake in skeletal muscle and myocardium is increased 2-3 fold during exercise with consequently reduction in other organs. Thallium is mainly excreted in the faeces (80%) and in the urine (20%). The effective half-life is about 60 hours and its biological half-life about 10 days.

Preclinical safety data.

Thallium is one of the most toxic chemical elements with a lethal dose in man of about 500 mg. Toxicological studies in animals with thallous salts using intravenous administration show lethal doses ranging from 8-45 mg/kg of body weight. The doses used in man for scintigraphy are ten thousand times smaller than these toxic doses. Studies in the mouse and the rat demonstrated considerable transplacental passage of thallium.

Indications

Thallous (Tl201) chloride may be useful in myocardial perfusion imaging using either planar or SPECT (single photon emission computed tomography) techniques for the diagnosis and localization of myocardial infarction. It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect. Thallous (Tl201) chloride may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease). It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate exactly between recent myocardial infarction and ischemia. Thallous (Tl201) chloride is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels. It may also be useful in preoperative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for postsurgical reexamination. Thallous (Tl201) chloride has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

a) Myocardial scintigraphy.

Fasting during 4 hours before the examination is recommended.
Thallous (Tl201) Chloride Injection can be done either at rest or during intervention tests: conventional stress test or a similar test like electrostimulation or pharmacological test.
The first set of images can be acquired a few minutes after injection.
Thallium redistribution can be studied with a new set of images obtained between 3 to 24 hours after injection. In some cases, instead of the redistribution study (or after it), reinjection of 37 MBq of thallium can be done to evaluate myocardium viability.

b) Nonmyocardial indications.

Image acquisitions can be started during/or few minutes after injection ("flow images") and/or later ("cell uptake images").

Contraindications

Thallous (Tl201) Chloride Injection must not be administered to pregnant women and breastfeeding mothers.
The specific contraindications of associated interventional tests should be considered.

Precautions

Special warnings and special precautions for use.

This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the local competent official organisations.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken, complying with the requirements of good manufacturing practice for pharmaceuticals.

Paediatric use.

In young children the use of 99mTc-labelled myocardial perfusion agents should be preferred because of their lower radiation burden. Strict cardiological monitoring and the material required for emergency treatment are essential when performing interventional tests (exercise, pharmacological, electrical). Injection should be strictly intravenous to avoid 201Tl-thallous chloride local deposit and irradiation.

Use in the elderly, genotoxicity, effects on fertility, carcinogenicity.

No data available.

Use in pregnancy.

No data are available on the use of thallous (Tl201) chloride in pregnancy. Due to the high uterus radiation doses, Thallous (Tl201) Chloride Injection is contraindicated during pregnancy.
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information. Alternative techniques which do not involve ionising radiation should be considered.

Use in lactation.

Before administering a radioactive medicinal product to a mother who is breastfeeding consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breastfeeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the lack of data concerning the secretion of (201Tl) in the milk. If the administration is considered necessary, breastfeeding should be discontinued.

Effects on the ability to drive and use machines.

Effects on the ability to drive vehicles or to operate machines have not been described.

Interactions

Some drugs are responsible for interferences modifying the 201Tl-thallium myocardial uptake. Three processes could be implied:
direct or indirect variations of the coronary blood flow (dipyridamole, adenosine, isoprenaline, dobutamine, nitrates);
interferences with the interventional tests (beta blockers and stress tests, methylxanthines (i.e. theophylline) and dipyridamole);
thallium cell uptake modifications, although no definitive data are available (digitalis analogues and insulin have been mentioned as examples).

Incompatibilities.

Incompatibilities are not known to exist.

Adverse Effects

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
For diagnostic nuclear medicine investigations the current evidence suggests that these adverse effects will occur in low frequency because of the low radiation doses incurred. For most diagnostic investigations using a nuclear procedure the radiation dose delivered (EDE) is less than 20 mSv. Higher doses may be justified in some clinical circumstances.
Rare allergic reactions and vasovagal effects have been reported without more precise information about the frequency of these effects.
Local radiation necrosis has been reported after paravenous injection.

Dosage and Administration

Posology and method of administration.

Injection of 0.74 to 1.11 MBq/kg in adults and the elderly of thallous (Tl201) chloride solution via the intravenous route. This activity can be increased by 50% if SPECT-imaging is considered until a maximum activity of 110 MBq.
The dose to be administered to a child should be a fraction of the adult dose calculated from the body weight according to Table 1.
In very young children (under 1 month) a minimum dose of 18.5 MBq is necessary in order to obtain images of sufficient quality.

Radiation dosimetry.

For thallous (Tl201) chloride, the effective dose equivalent resulting from an administered activity of 78 MBq is typically 18 mSv (per 70 kg individual). For this administered activity of 78 MBq, the typical radiation dose to the target organ (myocardium) is 18 mGy and the typical radiation doses to the critical organs (kidneys and descending colon) are 42 mGy and 28 mGy respectively.
According to ICRP 53 (International Commission for Radiological Protection) the radiation doses absorbed by the patients are presented in Table 2.

Impurities.

See Table 3.

Instructions for use and handling and disposal.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Therefore, radiation protection precautions in accordance with national regulations must be taken. The disposal of waste should be in accordance with national guidelines.

Overdosage

In the event of the administration of a radiation overdose with thallous (Tl201) chloride the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis with frequent voiding and stimulation of the gastro-intestinal passage.

Presentation

10 mL glass vial (type 1 Ph.Eur.) closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap.
Thallous (Tl201) Chloride Injection is supplied in the following amounts at activity reference date and time:
63 MBq in 1.7 mL, TGA number AUST R 49415;
85 MBq in 2.3 mL, TGA number AUST R 20026;
122 MBq in 3.3 mL, TGA number AUST R 49416;
213 MBq in 5.8 mL, TGA number AUST R 20039;
370 MBq in 10.0 mL, TGA number AUST R 49417.
Not all presentations are available.

Storage

Shelf-life.

Thallous (Tl201) Chloride Injection expires 7 days after activity reference date and time. Activity reference date and time and expiry date are stated on the label of the outer shielding and in the shipping papers accompanying each shipment.

Special precautions for storage.

Do not store Thallous (Tl201) Chloride Injection above 25°C. The product is unpreserved. If multi-dose use is intended, each aliquot should be removed under aseptic conditions, and within one working day. The vial should be stored between 2°C-8°C after removal of the first aliquot.

Poison Schedule

Unscheduled.