Patient leaflet - Ielmag3 0.2 mg kit for Radiopharmaceutical Preparation
1. What IELMAG3 is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only. IELMAG3 is used to study the function and structure and blood flow of the kidneys as well as function of the urinary tract, by making an image of these organs.
After the medicine is injected, it temporarily collects in certain parts of the body. This radiopharmaceutical substance contains a small amount of radioactivity, which can be detected from outside of the
body by using special cameras. Your nuclear medicine doctor will then take an image (scintigraphy) of the concerned organs which can give your doctor valuable information about the structure and the function of these organs.
The use of IELMAG3 does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
2. What you need to know before IELMAG3 is used
IELMAG3 must not be used
if you are allergic (hypersensitive) to mertiatide (mercaptoacetyltriglycine) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with IELMAG3
- if you are pregnant or believe you may be pregnant • if you are breast-feeding
- if you are under 18 years old
Before administration of IELMAG3 you should
drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study. Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old. Other medicines and IELMAG3
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines.
IELMAG3 with drink
Please see section 2 „Before administration of IELMAG3 you should“.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
You must inform the nuclear medicine doctor before the administration of IELMAG3 if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
If you are pregnant
The nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks. If you are breast-feeding
The doctor may delay the examination until you stop breast-feeding. If this not possible, your doctor will ask you to stop breast-feeding for 4 hours and discard the expressed breastmilk during this period. You do not need to avoid close contact with your baby after the procedure.
Driving and using machines
It is considered unlikely that IELMAG3 will affect your ability to drive and use machines after the investigation.
IELMAG3 contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per kit [vial (1) and vial (2)], that is to say essentially ‘sodium-free’.
3. How IELMAG3 is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
IELMAG3 will only be used in special controlled areas. This product Package Leaflet: Information for the Patient
SUMMARY OF PRODUCT CHARACTERISTICS
UK/PL+SmPC
IELMAG3 0.2 mg
kit for radiopharmaceutical preparation
Package Leaflet: Information for the Patient &
SUMMARY OF PRODUCT CHARACTERISTICS
Any unused product or waste material should be disposed of in accordance with local requirements.
- 7. MARKETING AUTHORISATION HOLDER
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany
- 8. MARKETING AUTHORISATION NUMBER(S)
PL 45925/0005
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12 July 2013 / 30 January 2018
- 10. DATE OF REVISION OF THE TEXT
MM/2025
- 11. DOSIMETRY
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 141 keV and a half-life of 6.01 hours to technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable. The data listed below are from ICRP 128 published in 2015 and are calculated according to the following assumptions:
In the normal case, following intravenous administration of
technetium (99mTc) mertiatide, the substance is rapidly distributed in the extracellular fluid and excreted entirely by the renal system according to the kidney-bladder model. Total body retention is described by a tri-exponential function (Stabin et al., 1992). The renal transit time is assumed to be 4 minutes, as for Hippuran. • When renal function is bilaterally impaired, it is assumed that the
clearance rate of the substance is one-tenth of that of the normal case, that the renal transit time is increased to 20 minutes, and that a fraction of 0.04 is taken up in the liver.
As an example of acute unilateral renal blockage, it is assumed that
a fraction of 0.5 of the administered radiopharmaceutical is taken up by one kidney, slowly released to the blood with a half-time of 5 days and subsequently excreted by the other kidney, which is assumed to function normally.
Normal renal function
Absorbed doses: Technetium (99mTc) mertiatide
Dose absorbed per activity administered [mGy/MBq]
Organ Adults 15-year-olds 10-year-olds 5-year-olds 1-year-olds Adrenals 0.00039 0.00051 0.00082 0.00120 0.00250 Bladder 0.11000 0.14000 0.17000 0.18000 0.32000 Bone surfaces 0.00130 0.00160 0.00210 0.00240 0.00430 Brain 0.00010 0.00013 0.00022 0.00035 0.00061 Breast 0.00010 0.00014 0.00024 0.00039 0.00082 Gall bladder 0.00057 0.00087 0.00200 0.00170 0.00280 GI-tract Stomach 0.00039 0.00049 0.00097 0.00130 0.00250 SI 0.00230 0.00300 0.00420 0.00460 0.00780 Colon 0.00340 0.00430 0.00590 0.00600 0.00980 ULI 0.00170 0.00230 0.00340 0.00400 0.00670 LLI 0.00570 0.00700 0.00920 0.00870 0.01400 Heart 0.00018 0.00024 0.00037 0.00057 0.00120 Kidneys 0.00340 0.00420 0.00590 0.00840 0.01500 Liver 0.00031 0.00043 0.00075 0.00110 0.00210 Lungs 0.00015 0.00021 0.00033 0.00050 0.00100 Muscles 0.00140 0.00170 0.00220 0.00240 0.00410 Oesophagus 0.00013 0.00018 0.00028 0.00044 0.00082 Ovaries 0.00540 0.00690 0.00870 0.00870 0.01400 Pancreas 0.00040 0.00050 0.00093 0.00130 0.00250 Red marrow 0.00093 0.00120 0.00160 0.00150 0.00210 Skin 0.00046 0.00057 0.00083 0.00097 0.00180 Spleen 0.00036 0.00049 0.00079 0.00120 0.00230 Testes 0.00370 0.00530 0.00810 0.00870 0.01600 Thymus 0.00013 0.00018 0.00028 0.00044 0.00082 Thyroid 0.00013 0.00016 0.00027 0.00044 0.00082 Uterus 0.01200 0.01400 0.01900 0.01900 0.03100 Remaining
organs 0.00130 0.00160 0.00210 0.00220 0.00360
Effective dose
[mSv/MBq] 0.00700 0.00900 0.01200 0.01200 0.02200
Bladder wall contributes up to 80 % of the effective dose.
Effective dose if the bladder is emptied 1 or 0.5 hours after administration: 1 hour 0.00250 0.00310 0.00450 0.00640 0.00640 30 min 0.00170 0.00210 0.00290 0.00390 0.00680
The effective dose resulting from the administration of the maximum recommended activity of 200 MBq for an adult weighing 70 kg is about 1.4 mSv.
For an administered activity of 200 MBq the typical radiation dose to the target organ (kidneys) is 0.68 mGy and the typical radiation dose to the critical organ (urinary bladder wall) is 21.6 mGy.
Abnormal renal function
Absorbed doses: Technetium (99mTc) mertiatide
Dose absorbed per activity administered [mGy/MBq] Organ Adults 15-year-olds 10-year-olds 5-year-olds 1-year-olds Adrenals 0.00160 0.00210 0.00320 0.00480 0.00860 Bladder 0.08300 0.11000 0.13000 0.13000 0.23000 Bone surfaces 0.00220 0.00270 0.00380 0.00500 0.00910 Brain 0.00061 0.00077 0.00130 0.00200 0.00360 Breast 0.00054 0.00070 0.00110 0.00170 0.00320 Gall bladder 0.00160 0.00220 0.00380 0.00460 0.00640
GI-tract Stomach 0.00120 0.00150 0.00260 0.00350 0.00610 SI 0.00270 0.00350 0.00500 0.00600 0.01000 Colon 0.00350 0.00440 0.00610 0.00690 0.01100 ULI 0.00220 0.00300 0.00430 0.00560 0.00930 LLI 0.00510 0.00630 0.00850 0.00860 0.01400 Heart 0.00091 0.00120 0.00180 0.00270 0.00480 Kidneys 0.01400 0.01700 0.02400 0.03400 0.05900 Liver 0.00140 0.00180 0.00270 0.00380 0.00660 Lungs 0.00079 0.00110 0.00160 0.00240 0.00450 Muscles 0.00170 0.00210 0.00290 0.00360 0.00640 Oesophagus 0.00074 0.00097 0.00150 0.00230 0.00410 Ovaries 0.00490 0.00630 0.00810 0.00870 0.01400 Pancreas 0.00150 0.00190 0.00290 0.00430 0.00740 Red marrow 0.00150 0.00190 0.26000 0.00310 0.00500 Skin 0.00078 0.00096 0.00150 0.00200 0.00380 Spleen 0.00150 0.00190 0.00290 0.00430 0.00740 Testes 0.00340 0.00470 0.00710 0.00780 0.01400 Thymus 0.00074 0.00097 0.00150 0.00230 0.00410 Thyroid 0.00073 0.00095 0.00150 0.00240 0.00440 Uterus 0.01000 0.01200 0.01600 0.01600 0.02700 Remaining
organs 0.00170 0.00210 0.00280 0.00340 0.00600
Effective dose
[mSv/MBq] 0.00610 0.00780 0.01000 0.01100 0.19000
The effective dose resulting from the administration of the maximum recommended activity of 200 MBq for an adult weighing 70 kg is about 1.22 mSv.
For an administered activity of 200 MBq the typical radiation dose to the target organ (kidneys) is 2.8 mGy and the typical radiation dose to the critical organ (urinary bladder wall) is 16.6 mGy.
Acute unilateral renal blockage
Absorbed doses: Technetium (99mTc) mertiatide
Dose absorbed per activity administered [mGy/MBq] Organ Adults 15-year-olds 10-year-olds 5-year-olds 1-year-olds Adrenals 0.01100 0.01400 0.02200 0.03200 0.05500 Bladder 0.05600 0.07100 0.09100 0.09300 0.17000 Bone surfaces 0.00310 0.00400 0.00580 0.00840 0.01700 Brain 0.00011 0.00014 0.00023 0.00039 0.00075 Breast 0.00038 0.00051 0.00100 0.00160 0.00300 Gall bladder 0.00620 0.00730 0.01000 0.01600 0.02300 GI-tract Stomach 0.00390 0.00440 0.00700 0.00930 0.01200 SI 0.00430 0.00550 0.00850 0.01200 0.01900 Colon 0.00390 0.00500 0.00720 0.00920 0.00150 ULI 0.00400 0.00510 0.00760 0.01000 0.01600 LLI 0.00380 0.00480 0.00670 0.00820 0.01300 Heart 0.00130 0.00160 0.00270 0.00400 0.00610 Kidneys 0.20000 0.24000 0.33000 0.47000 0.81000 Liver 0.00440 0.00540 0.00810 0.01100 0.01700 Lungs 0.00110 0.00160 0.00250 0.00390 0.00720 Muscles 0.00220 0.00270 0.00370 0.00510 0.00890 Oesophagus 0.00038 0.00054 0.00085 0.00150 0.00230 Ovaries 0.00380 0.00510 0.00710 0.00920 0.01500 Pancreas 0.00740 0.00900 0.01300 0.01800 0.02900 Red marrow 0.00300 0.00360 0.00500 0.00600 0.00830 Skin 0.00082 0.00100 0.00150 0.00220 0.00420 Spleen 0.00980 0.01200 0.01800 0.02600 0.04000 Testes 0.00200 0.00290 0.00450 0.00500 0.00980 Thymus 0.00038 0.00054 0.00085 0.00150 0.00230 Thyroid 0.00017 0.00023 0.00045 0.00092 0.00160 Uterus 0.00720 0.00870 0.01200 0.01300 0.02200 Remaining
organs 0.00210 0.00260 0.00360 0.00470 0.00800
Effective dose
[mSv/MBq] 0.01000 0.01200 0.01700 0.02200 0.03800
The effective dose resulting from the administration of the maximum recommended activity of 200 MBq for an adult weighing 70 kg is about 2.0 mSv.
For an administered activity of 200 MBq the typical radiation dose to the target organ (kidneys) is 40 mGy and the typical radiation dose to the critical organ (urinary bladder wall) is 11.2 mGy.
- 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Radiolabelling should be done using an eluate with a radioactive concentration between 40 and 500 MBq/ml. Only eluates obtained from a generator, which has been eluted once in the preceding 24 hours, should be used.
The content of vial (1) is labelled with sodium pertechnetate (99mTc) solution at room temperature. The radiolabelling reaction is stopped after 15 minutes by adding the buffer solution.
Withdrawals should be performed under aseptic conditions. The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorized automated application system.
If the integrity of a vial is compromised, the product should not be used. Method of preparation
The radiopharmaceutical is prepared according to the following labelling instructions immediately before use:
The radiolabelling procedure has to be carried out under aseptic
conditions.
Place vial (1) into an adequate lead shielding. Swab the rubber
septum with an appropriate disinfectant and let it dry. • Inject 8 ml of sodium pertechnetate (99mTc) solution into vial (1) using
a syringe. Then withdraw the same volume of nitrogen from the vial with the same syringe for pressure compensation. • Shake the vial carefully in order to moisten. The complete content of
the vial is for complete dissolution of any powder.
After 15 minutes reaction time transfer a volume of 2 ml buffer
solution from vial (2) into vial (1) using a new syringe. Then withdraw the same volume of nitrogen from the vial with the same syringe for pressure compensation.
Shake carefully for good mixing. Determine the total radioactivity and
calculate the volume to be injected.
Properties of the product after radiolabelling:
Appearance: clear to slightly opalescent, colourless, aqueous solution.
pH: 7.1 - 7.5
Quality control
The following methods may be used:
HPLC method
The radiochemical purity of the labelled substance is examined by high-performance liquid chromatography (HPLC) using a suitable detector of radioactivity, on a 25 cm RP18 column, flow rate 1.0 ml/min. Mobile phase A is a 93:7 mixture of phosphate solution (1.36 g KH2PO4, adjusted with 0.1 M NaOH to pH 6) and ethanol.
Mobile phase B is a 1:9 mixture of water and methanol.
Use a gradient elution program with the following parameters:
Time (min): Flow (ml/min): % A % B
10 1 100 0 15 1 0 100 The technetium (99mTc) mertiatide peak appears at the end of the passage of mobile phase A.
The injection volume is 10 μl and the total count rate per channel must not exceed 30,000.
Specification:
t = 0 after 8 hours Technetium (99mTc) mertiatide ≥ 94 % ≥ 94 %
hydrophilic impurities ≤ 3.0 % ≤ 3.0 % lipophilic impurities ≤ 4.0 % ≤ 4.0 %
Simplified rapid procedure (Sep-Pak)
This method is based on cartridges, which are widely used as sample pre-treatment of aqueous solutions for chromatography.
Stepwise process
The cartridge (e.g. Sep-Pak Plus C 18, Waters) is washed with 10 ml absolute ethanol, followed by 10 ml 0.001 M hydrochloric acid. Remaining residues of the solutions are removed by 5 ml of air.
0.05 ml technetium (99mTc) mertiatide solution is applied on the cartridge. Elute with 10 ml of 0.001 M hydrochloric acid and collect this first eluate A (hydrophilic impurities).
will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions. The nuclear medicine doctor supervising the procedure will decide on the quantity of IELMAG3 to be used in your case. It will be the smallest quantity necessary to get the desired information.
The quantity to be administered usually recommended for an adult ranges from 40 to 200 MBq (megabecquerel, the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to the child’s weight.
Administration of IELMAG3 and conduct of the procedure
You will be asked to drink plenty of water and empty your bladder immediately before the examination starts.
IELMAG3 is administered by intravenous administration. The scintigraphy is usually started immediately after administration.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of IELMAG3, you should:
urinate frequently in order to eliminate the product from your body. The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.
If you have been given more IELMAG3 than you should
An overdose is unlikely because you will only receive a single dose of IELMAG3 precisely controlled by the nuclear medicine doctor
supervising the procedure.
However, in the case of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink abundantly to facilitate the elimination of IELMAG3 from your body.
Should you have any further question on the use of IELMAG3, please ask the nuclear medicine doctor who supervises the procedure.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with frequency very rare (less than 1 out of 10,000 patients):
Allergic reactions including sudden, serve allergic reactions, with
symptoms such as hives, rash, swelling of the eyelids, coughing, feeling sick, vomiting.
Side effects with frequency not known (cannot be estimated from the available data):
Circulatory reactions with symptoms such as seizure, difficulty
in breathing, reddening of the skin, headache, facial swelling, pain, abnormal sensation, sensation of unsteadiness, low blood pressure, rapid heartbeat.
Injection site reactions with symptoms such as skin rash, pain,
swelling.
This administered radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities. Your doctor has considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the risk due to radiation.
Reporting of side effects
If you get any side effects talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.
5. How IELMAG3 is stored
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
The following information is intended for the specialist only. IELMAG3 must not be used after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Storage conditions:
Kit: Store in a refrigerator (2 - 8 °C).
Store in the original package in order to protect from light. Shelf life after first opening and radiolabelling: 8 hours when stored below 25 °C.
6. Contents of the pack and other information
What IELMAG3 contains
The active substance is 0.2 mg mertiatide (mercaptoacetyltriglycine) in vial (1).
The other ingredients are:
Vial (1): Stannous chloride dihydrate,
Disodium (R,R)-tartrate dihydrate, Sodium hydroxide, Hydrochloric acid, Nitrogen as protective gas Vial (2): Sodium monohydrogenphosphate dihydrate, Sodium dihydrogenphosphate dihydrate,
Hydrochloric acid, Water for injection
What IELMAG3 looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation. IELMAG3 consists of two different 10 ml glass vials which cannot be used separately.
Vial (1) contains IELMAG3 powder and vial (2) contains IELMAG3 solution. Pack size: 5 Kits [vial (1) and vial (2)]
Marketing Authorisation Holder and Manufacturer
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden, Germany
This leaflet was last revised in MM/2025.
The following information is intended for medical or healthcare professionals only:
The complete Summary of Product Characteristics (SmPC) of IELMAG3 is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical. Please refer to the SmPC.
Next, elute the cartridge with ethanol/ 9 g/l sodium chloride solution in a ratio of 1:1. This second eluate B contains technetium (99mTc) mertiatide. The cartridge C contains the lipophilic impurities.
Measure the radioactivity of each portion. Sum up the radioactivity of the eluates and the cartridge as 100 % and calculate the respective percentages. Be aware to elute slowly (drop-wise).
Calculation:
Radiochemical purity [%] = radioactivity of second eluate (B) [MBq] x 100 % sum of radioactivity (A+B+C) [MBq] Specification:
Technetium (99mTc) mertiatide ≥ 94 %
Sum of impurities: ≤ 6.5 %
Simplified TLC procedure
This method is used for:
- a) Determination of technetium (99mTc) pertechnetate (impurity A) Chromatographic system:
TLC plate: ITLC-SA
Solvent: Methyl ethyl ketone (MEK)
Sample: 1 - 2 µl
Start: 1.0 cm from lower end
Running distance: 6 - 8 cm
Development time: approx. 10 minutes, immediately after sample application
Detector: a suitable detector
Evaluation:
Detection by radio activity counters without spatial resolution Technetium (99mTc) pertechnetate migrates with the solvent front (Rf = 0.8 to 1.0). If you do not have a scanner, you cut the strip 5 cm from the bottom. Measure separately the radioactivity of both parts. Put the activity of the upper part in relation to the total activity.
Detection by radio-TLC scanner
The activity distribution is measured and plotted as a chromatogram. Calculate the percentages of the individual peaks.
Technetium (99mTc) pertechnetate [%] =
Activity upper part [MBq] x 100 % Total activity [MBq]
Specification for technetium (99mTc) pertechnetate (impurity A): ≤ 5.0 %
- b) Determination of colloidal technetium (99mTc) (impurity B) Chromatographic system:
TLC plate: ITLC-SA
Solvent: Water for injection (WfI)
Sample: 1 - 2 µl
Start: 1.0 cm from lower end
Running distance: 6 - 8 cm
Development time: approx. 10 minutes, immediately after sample application
Detector: a suitable detector
Evaluation:
Detection by radio activity counters without spatial resolution Colloidal technetium (99mTc) (hydrolysed reduced technetium (99mTc)) remains at the starting point (Rf = 0.0 to 0.1). If you do not have a scanner, you cut the strip 1.5 cm from the bottom. Measure separately the radioactivity of both parts.
Put the activity of the lower part in relation to the total activity.
Detection by radio-TLC scanner
The activity distribution is measured and plotted as a chromatogram. Calculate the percentages of the individual peaks.
Colloidal technetium(99mTc) [%] = Activity lower part [MBq] x 100 %
Total Activity [MBq]
Specification for colloidal technetium (99mTc) (impurity B): ≤ 2.0 %
Calculation of radiochemical purity (specification ≥ 94 %) Radiochemical Purity = 100 % - (A [%] + B [%])
colloidal technetium 1.5 cm W | ||
| W |
Pertechnetate 5 cm M | ||
| M |