Consumer medicine information

Pentastan DTPA Reagent

Technetium (99mTc) pentetate

BRAND INFORMATION

Brand name

Pentastan Kit

Active ingredient

Technetium (99mTc) pentetate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pentastan DTPA Reagent.

What is in this leaflet

This leaflet answers some common questions about Pentastan DTPA* Reagent (also known as Pentetic Acid). It does not contain all the available information and it does not take the place of you talking to your nuclear medicine specialist.

All medicines have potential risks and benefits associated with their use. Your nuclear medicine physician or specialist has weighed the small risk of you being treated with DTPA against the benefits it is expected you will receive from it.

If you have any concerns about being given this injection, discuss them with your nuclear medicine physician or specialist.

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

What DTPA is used for

DTPA Reagent is used with an imaging agent (radiotracer) to study renal (kidney) function and blood flow surrounding the brain.

The imaging agent

The imaging agent used is a radiotracer called Technetium-99m. Technetium-99m emits small amounts of radiation similar to X-rays. This radiation can be detected by a special camera, called a gamma camera, and produces an image known as a scan. A nuclear medicine physician or specialist interprets these scans and provides you and your doctor with information related to your referral that otherwise may not be known.

Your nuclear medicine physician or specialist may be giving you DTPA to help diagnose other conditions. Ask your nuclear medicine physician or specialist if you have any questions about why DTPA is being given to you or why you have been referred for a scan.

For more information, ask for a copy of the booklet “Nuclear Medicine – Answering your Questions” available from the hospital, clinic or the supplier.

Before you receive the injection

Tell your nuclear medicine physician or specialist if:

  1. You are pregnant
It is not known whether the injection is harmful to an unborn baby when administered to a pregnant woman. If you are pregnant, the nuclear medicine specialist will need to talk to your referring doctor before deciding whether you should have the injection.
  1. You are breast-feeding
It is normal practice to suspend breast-feeding for at least 12 hours after the injection. It is known that Technetium-99m DTPA passes into breast milk.
  1. You are taking other medicines
These medicines include vitamins, cough medicines and nasal congestants that you buy from a pharmacy, supermarket or health food shop, without a prescription.
Some medication may interfere with the expected results; you will be advised what to do.

If you have not told your nuclear medicine physician or specialist about any of the above, tell them BEFORE you are given a DTPA injection.

For a renal study you will often be asked to:

  1. drink water a short time before your scan.
  2. pass urine just prior to your scan.

How a DTPA injection is used

A DTPA injection can only be administered by qualified staff with specific training in the safe use and handling of radiopharmaceuticals.

How a DTPA injection is given

DTPA may be given as an injection into a vein in your arm. You may feel a slight pinprick from the needle when it is injected. DTPA may be given to you by other means. Ask your nuclear medicine physician or specialist to explain why you are being given DTPA in this way.

After being given a DTPA Injection

For most studies your scan will be performed almost immediately. The scan is painless and will take from 30 minutes to 2 hours, depending on the type of scan. In some cases you may be asked to have another scan at a later time to confirm the results.

Returning home

Continue your day-to-day activities with members of your family and friends as you would normally.

You may be advised to drink plenty of fluids and pass urine frequently over the 6-hour period following the scan. This will help flush the agent from your body.

Side effects

Tell your nuclear medicine physician or specialist as soon as possible if you do not feel well after having a DTPA injection.

No side effects directly related to DTPA have been reported. Safety and efficacy in children have not been established.

Storage

After delivery, DTPA is stored in a refrigerator by the hospital or clinic. Technetium-99m is produced fresh every day. Your nuclear medicine specialist or technologist will check the expiry date and time before giving you the DTPA injection.

Product description

What it looks like:

DTPA is is a freeze-dried white powder. It comes in a 3 mL (single dose) and 10 mL (multi dose) glass vial. Technetium-99m is added to the DTPA to produce a clear, colourless liquid. DTPA is sterilised by gamma irradiation and is pyrogen free.

Ingredients

Active:

  • Pentetic acid
  • Technetium-99m.

Inactive:

  • Sodium chloride
  • Stannous chloride dihydrate.

AUST R 22926 and AUST R 22790

Supplier

ANSTO Health
Locked Bag 2001
Kirrawee DC, NSW 2232

Telephone: 1800 251 572
Facsimile: 02 9543 6511

ANSTO Health is a commercial enterprise of the Australian Nuclear Science and Technology Organization (ANSTO), which is located at Lucas Heights, in Sydney, NSW.

Amended Format: January 2012
Date of Printing: January 2012

* 1 diethylenetriamine penta-acetic acid

Published by MIMS December 2017

BRAND INFORMATION

Brand name

Pentastan Kit

Active ingredient

Technetium (99mTc) pentetate

Schedule

Unscheduled

 

1 Name of Medicine

Pentastan Kit for preparation of technetium (99mTc) pentetate injection.

2 Qualitative and Quantitative Composition

Each vial contains 13.25 mg of Na-DTPA i.e. sodium diethylenetriaminepentaacetate monohydrate (equivalent to 10 mg of pentetic acid), 800 micrograms of stannous chloride di-hydrate and 7.10 mg of sodium chloride.
The contents of the vial are freeze-dried solid and sealed in nitrogen atmosphere.
As supplied, the product is sterile and pyrogen free; it contains no antimicrobial preservative.
The product is designed for diagnostic use only. Administration after reconstitution with sterile sodium pertechnetate solution is by intravenous injection.

Physical characteristics of 99mTc.

Technetium-99m, with a physical half-life of six hours, decays by isomeric transition to technetium-99. Photons associated with this transition, useful for detection and imaging studies are listed in Table 1. Decay profile of 99mTc is given in Table 2.

External radiation.

The specific gamma ray constant for 99mTc is 0.19 mGy per MBq-h at 1 cm. The first half value thickness of lead for 99mTc is 0.2 mm. A range of values for the relative attenuation of the radiation emitted by 99mTc resulting from the interposition of various thicknesses of lead is given in Table 3.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Kit for radiopharmaceutical preparation.
Sterile, pyrogen free, freeze-dried solid, powder for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Pentastan Kit, after radiolabelling to produce 99mTc-Pentetate, may be used to perform kidney imaging, brain imaging, to assess renal perfusion and to estimate glomerular filtration rate.

4.2 Dose and Method of Administration

Each vial contains pentetic acid intended for 2 or more doses.
(a) Pentastan Kit is designed for labelling with technetium-99m (as sodium pertechnetate, 99mTc) obtained from Mo-99/Tc-99m sterile generators (such as ANSTO's Gentech generator or equivalent generators from other manufacturers). The labelling procedure should be performed in the workstation providing protection against ionizing radiation and using aseptic techniques that ensures sterility of the preparation.
Radiolabelling procedure for the preparation of 99mTc-Pentetate Injection solution using the Pentastan Kit product is prepared for clinical use is given below:

Labelling procedure.

Place the kit vial containing the lyophilisate in an appropriate radioprotective shield.
Using a syringe inject (by piercing the rubber stopper) about 5 mL of eluate of sodium pertechnetate (eluate with desired activity pre-diluted with sterile saline) into freeze-dried Pentastan Kit vial.
Using the same syringe relieve the excess pressure in the vial by withdrawing the volume of gas equivalent to the volume of sodium pertechnetate 99mTc solution added.
Shake the contents of the vial until complete dissolution of the freeze-dried solid (about 2 min.). Keep the vial in the shield all the time.
The resultant solution is a ready for use as 99mTc-Pentetate solution for injection.
It is recommended that reconstituted 99mTc-Pentetate Injection solution should be used within 6 hours after completion of the labelling procedure.
(b) Recommended activity: the suggested dose for a normal (70 kg) adult is:
Brain scan: 400-800 MBq;
Renal scan: 200 MBq.
For children, the dose should be reduced to that appropriate to the patient's weight.
The patient dose should be measured with a suitable radioactivity calibrator immediately before administration. Radiochemical purity should be checked prior to administration. Shielding should be used when preparing 99mTc-Pentetate solution.
(c) Determination of radiochemical purity:
The radiochemical purity should be checked prior to administration. It can be measured by thin layer chromatography - using two chromatographic systems according to Ph. Eur. Monograph 0642.

Impurity A: [99mTc] technetium in colloidal form.

(i) TLC silica gel plate: use silica gel as the coating substance on a glass-fibre sheet, previously heated at 110°C for 10 min.
(ii) Mobile phase: 9 g/L solution of sodium chloride.
(iii) Application: 5-10 microL of the examined solution about 1.5 cm from the bottom of a 1.5 cm x 12 cm chromatographic plate.
(iv) Development: immediately, until the solvent front moves to about 4/5 of the plate in about 10 min.
(v) Drying: in the air.
(vi) Detection: suitable detector to determine the distribution of radioactivity.
(vii) Retardation factors: impurity A = 0.0 to 0.1 (Rf value); [99mTc] technetium pentetate and impurity B = 0.9 to 1.0 (Rf value).

Impurity B: [99mTc] pertechnetate ion.

(i) TLC silica gel plate: use silica gel as the coating substance on a glass-fibre sheet, previously heated at 110°C for 10 min.
(ii) Mobile phase: methyl ethyl ketone.
(iii) Application: 5-10 microL of the examined solution about 1.5 cm from the bottom of a 1.5 cm x 12 cm chromatographic plate.
(iv) Development: immediately, until the solvent front moves to about 4/5 of the plate in about 10 min.
(v) Drying: in the air.
(vi) Detection: suitable detector to determine the distribution of radioactivity.
(vii) Retardation factors: [99mTc] technetium pentetate and Impurity A = 0.0 to 0.1 (Rf value); impurity B = 0.9 to 1.0 (Rf value).

Limit - sum of impurities A and B.

Maximum 5.0 per cent of the radioactivity due to technetium-99m in the chromatograms obtained in tests for Impurity A and B.

Radiation dosimetry.

The estimated radiation absorbed dose to various organs from an intravenous injection of 99mTc-Pentetate in patients with normal and abnormal renal function is given in Tables 4 and Table 5 respectively. This data have been taken from "ICRP publication 128, Radiation Dose to Patients from Radiopharmaceuticals: a Compendium of Current Information Related to Frequently Used Substances"; p.154-157.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed, see Section 6.1.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Radiopharmaceuticals should only be used by physicians who are qualified and licensed to handle radioactive. Contents of the kit are intended only for use in the preparation of technetium 99mTc pentetate injection. They should not be administered directly to the patient. Solutions containing sodium pertechnetate with antioxidants should not be used. At time of administration the solution should be crystal clear.

Dose handling.

Radiation exposure to clinical personnel must be minimised. Care and appropriate safety measures should always be used.
The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration.
Pentastan Kit vial contains no bactericide. Aseptic techniques must be used at all times when handling the product.

Patient care.

Care should be taken to minimise unwanted radiation exposure to patients, consistent with proper patient management.
In order to reduce radiation dose to the bladder the patient should be encouraged to drink fluids and to void (empty bladder) as frequently as possible following the administration of the radiopharmaceutical for a period of four to six hours.

Patients with renal impairment.

Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Use in the elderly.

No specific data in elderly are available.

Paediatric use.

This radiopharmaceutical should generally not be administered to persons under 18 years of age unless the benefits to be gained outweigh the potential hazards. See Section 4.2, (b).
For children, the dose should be reduced to that appropriate to the patient's weight.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data was available at time of registration of this product.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Adequate reproduction studies have not been performed in animals to determine whether this drug affects fertility in males or females, has teratogenic potential, or has other adverse effects on the foetus.
This radiopharmaceutical should not be administered to pregnant or nursing women unless the benefits to be gained outweigh the potential hazards. Ideally, examination of a woman of childbearing capabilities should be performed only during the 10 days following the onset of menses.
Technetium (99mTc) is excreted in human milk. If administered to a nursing mother, formula feeding must be substituted.

4.7 Effects on Ability to Drive and Use Machines

Effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

No adverse reactions have been reported.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

In the event of the administration of a radiation overdose with Technetium (99mTc) pentetate injection, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Following intravenous injection, 99mTc-Pentetate is rapidly distributed throughout the extracellular fluid space, where it is promptly cleared from the body by glomerular filtration. There is minimal binding to the renal parenchyma.
99mTc-Pentetate tends to accumulate in intracranial lesions with excessive neovascularity or an altered blood-brain barrier. The agent does not accumulate in the choroid plexus.
Since medicine is excreted by glomerular filtration, the images of the kidneys obtained during the first few minutes after injection show the vascular pool within the kidney. Subsequent images represent radioactivity in both the collecting system and the renal pelvis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data was available at time of registration of this product.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, BP; stannous chloride dihydrate, BP.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned, see Section 4.2.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the ARTG. The expiry date can be found on the packaging under this heading.

6.4 Special Precautions for Storage

Pentastan Kit should be stored between 2-8°C (Refrigerate. Do not freeze).
The reconstituted 99mTc-Pentetate should be stored below 8°C and is to be used within 6 hours of reconstitution.
During transportation, Pentastan Kit can be handled/ stored at up to up to 35°C (for not longer than 7 days).

6.5 Nature and Contents of Container

(i) Primary (vial).

The primary container is a labelled 10 mL colourless glass vial with a grey rubber bung and white centre tear crimp cap.

(ii) Secondary (outer carton).

The glass vial is packed in a carton. Each carton box contains: 6 x labelled vials.

6.6 Special Precautions for Disposal

Disposal of all radioactive wastes should be carried out in accordance with the ARPANSA's "Code for the Disposal of Radioactive Waste by the User - Radiation Protection Series, C-6, September 2018".
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Name: sodium; 2-[bis[2[bis (carboxylatomethyl) amino]ethyl]amino] acetate; technetium-99m.
Molecular Formula: C14H18N3NaO1099mTc.
Structure:

CAS number.

65454-61-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes