Sodium Iodide (I123) Injection
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I-123) Injection
(Mallinckrodt Medical catalogue number: DRN 5375)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Sodium Iodide (I-123), 37 MBq/ml at activity reference date and hour. Physical characteristics
Iodine-123 is a cyclotron product with a physical half-life of 13.21 h. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV.
123
I is obtained by proton irradiation of enriched Xenon. The radionuclidic
123
purity of the product at expiry date and time is: I > 99.9%. The only
121 125
detectable radionuclidic impurities are Te < 900 Bq/MBq and I < 1500 Bq/MBq at expiry date and time.
3 PHARMACEUTICAL FORM
Solution for injections.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium iodide (I-123) is used as a diagnostic agent in the functional or morphological study of the thyroid gland by means of:
• Scintigraphy
• Radioactive iodine uptake test
The 24 hours uptake data are generally used in calculating the therapeutic dose.
4.2 Posology and method of administration
The recommended activities for an adult patient (70 kg) lies between 3.7 to 14.8 MBq. The lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for thyroid scintigraphy. However, for each individual case, the dose prescribed must be determined by the attending specialist.
Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well established standard procedures.
The activity dosages for children may be calculated from the recommended range of adult dosages, adjusted according to the following equation:
Paediatric dosage (MBq) = Adult dosage (MBq) x Child weight (kg)
70
In very young children the maximal adult dosage of 14.8 MBq should be used in the equation in order to obtain images of sufficient quality.
123I must be given as an intravenous injection: as a routine check, the activity in the syringe should be measured immediately prior to administration. Imaging is performed 3 - 6 hours after administration.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
4.4 Special warnings and precautions for use Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Paediatric population
Paediatric population, see section 4.2.
General warnings:
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
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.
Specific warnings
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium - free”.
4.5 Interaction with other medicinal products and other forms of interaction
The uptake of I-iodide may be decreased by recent administration of iodinated contrast materials, by intake of stabile iodine in any form, or by thyroid, antithyroid, and certain other drugs. Accordingly, the patient should be questioned carefully regarding diet, previous medication, and procedures involving radiographic contrast media. Relevant medication including the ones mentioned below should be withheld prior to the administration of sodium I-iodide
Active substances: Withdrawal period to administration of sodium 123I-iodide Antithyroid agents (e.g.) carbimazole, methimazole, propyluracil), perchlorate: 1 week.
Salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, anticoagulants, antihistamines, antiparasitics, penicillins, sulfonamides, tolbutamide, thiopental: 1 week.
Phenylbutazone: 1-2 weeks.
Expectorants and vitamins: 2 weeks.
Natural or synthetic thyroid preparations (levothyroxine sodium, liothyronine sodium: 2-3 weeks.
Amiodarone, benzodiazepines, lithium: approx. 4 weeks.
Iodine-containing preparations for topical use: 1-9 months.
Intravenous contrast agents: 1-2 months.
Iodine containing contrast agent: up to 1 year.
4.6 Fertility, Pregnancy and lactation
Woman of childbearing potential
When it is necessary to administer a radioactive medicinal product 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. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques using ionising radiation should offered to the patient.
Pregnancy
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk incurred by the mother and foetus.
Breast-feeding
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and to what is the most appropriate choice of radiopharmaceutical, bearing in mind the secretion activity in breast milk. If the administration is found necessary the breast-feeding should be interrupted for 1.5-3 days following the administration of I-123 that contains I-125 and/or I-124 as radio contaminant. Expressed milk should be discarded.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:
Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Immune system disorders
Not known: hypersensitivity
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered, these adverse effects are expected to occur with a low probability.
4.9 Overdose
In the event of the administration of an overdose of Iodine I-123, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by diuresis and frequent voiding of urine. A blocking agent such as potassium perchlorate should be used to minimise irradiation to the thyroid.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
At doses used in diagnostic investigations, sodium iodide has not been observed to exert any pharmacodynamic effects.
5.2 Pharmacokinetic properties
Intravenously administered iodide is taken by the thyroid - about 20 % of the available radioactivity enters the thyroid in one pass of the blood volume. Normal thyroid clearance of blood iodide is 20 - 50 ml/min with an increase to 100 ml/min in thyroid deficiency. Peak levels of iodide occur in thyroid gland within a few hours so that diagnostic imaging can take place from one hours after dosing.
The half-time of iodide elimination from the thyroid is estimated at 80 days so that the physical half-life of I-123 governs the temporal opportunity for imaging.
- Without considering the thyroid uptake, the iodide leaves the blood stream chiefly by urinary excretion (37 - 75 %), while faecal excretion is low (about 1 %).
5.3 Preclinical safety data
Known toxic effects of relatively very high dose of sodium iodide are not relevant to this use of I-123 to image the thyroid for diagnostic purposes.
No data are available from animal models about toxicity with repeated dose administration and about reproduction toxicity.
Sodium iodide I-123 was not investigated for mutagenicity and carcinogenic/oncogeni c potential.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride, sodium hydrogencarbonate, water for injections.
6.2 Incompatibilities
None known.
6.3 Shelf life
The expiry time for this product is 20 hours after the activity reference date/time as stated on the label.
6.4 Special precautions for storage
The preparation should be stored at 15 - 25 °C (room temperature).
However, if multi-dose use is intended, each aliquot should be removed under aseptic conditions and then the vial should be stored at 2 - 8 °C after removal of the first aliquot and for no longer than 24 hours or up to end of shelf life, whichever comes first.
Storage should be in accordance with national regulations for radioactive material.
6.5 Nature and contents of container
Sodium Iodide (I123) injection is supplied in a glass bottle (Type I Ph.Eur.) closed with a rubber stopper sealed with an aluminium crimp cap. Each bottle is enclosed in a lead container of appropriate thickness.
Available pack size: 37, 74, 185 and 370 MBq.
6.6 Special precautions for disposal
The sodium iodide (I-123) solution is ready for use.
Adequate precautions must be taken to prevent contamination concerning the radioactivity eliminated by the patients. All residues must be considered as radioactive waste and must be disposed in accordance with the relevant national regulations.
7 MARKETING AUTHORISATION HOLDER
Mallinckrodt Medical B.V.
Westerduinweg 3 1755 LE Petten Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
PL 12288/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/10/2002
10 DATE OF REVISION OF THE TEXT
27/02/2015
11 DOSIMETRY (IF APPLICABLE)
As a consequence of the production procedure of I-123, I-125 is present as impurity. This increases the radiation dose delivered.
Also the production procedure leads to the formation of Te-121. This impurity also must be taken into consideration as source of radiation to the patient.
The ICRP model used for the dosimetry calculations relates to intravenous administrations.
For the maximum recommended dose of 14.8 MBq I the EDE in patients with 35% thyroid uptake is calculated as 2.2 mSv.
Radiation dosimetry for respectively I-123 and I-125 is reported in ICRP publication 53 n° (1987) and is as follows:
|
T23^- |
13.2 hours |
|
Thyroid blocked, uptake 0 % Absorbed Dose per unit activity administered (mGy/MBq) |
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
7.0E-03 |
8.7E-03 |
1.4E-02 |
2.1E-02 |
3.9E-02 |
|
*Bladder wall |
9.0E-02 |
1.1E-01 |
1.6E-01 |
2.4E-01 |
4.5E-01 |
|
Bone surfaces |
8.1E-03 |
9.7E-03 |
1.5E-02 |
2.4E-02 |
4.6E-02 |
|
Breast |
5.6E-03 |
5.6E-03 |
8.1E-03 |
1.3E-02 |
2.5E-02 |
|
GI-Tract | |||||
|
Stomach wall |
6.9E-03 |
8.5E-03 |
1.4E-02 |
2.1E-02 |
3.7E-02 |
|
*Small intest |
8.5E-03 |
1.0E-02 |
1.6E-02 |
2.5E-02 |
4.6E-02 |
|
*ULI wall |
8.0E-03 |
9.9E-03 |
1.5E-02 |
2.4E-02 |
4.3E-02 |
|
*LLI wall |
9.7E-03 |
1.2E-02 |
1.9E-02 |
2.9E-02 |
5.4E-02 |
|
Kidneys |
1.1E-02 |
1.4E-02 |
2.0E-02 |
2.9E-02 |
5.1E-02 |
|
Liver |
6.7E-03 |
8.2E-03 |
1.3E-02 |
2.0E-02 |
3.7E-02 |
|
Lungs |
6.1E-03 |
7.8E-03 |
1.2E-02 |
1.9E-02 |
3.5E-02 |
|
Ovaries |
9.8E-03 |
1.2E-02 |
1.9E-02 |
3.0E-02 |
5.3E-02 |
|
Pancreas |
7.6E-03 |
9.1E-03 |
1.4E-02 |
2.2E-02 |
4.1E-02 |
|
Red marrow |
9.4E-03 |
1.1E-02 |
1.7E-02 |
2.6E-02 |
4.7E-02 |
|
Spleen |
7.0E-03 |
8.3E-03 |
1.3E-02 |
2.0E-02 |
3.7E-02 |
|
Testes |
6.9E-03 |
9.4E-03 |
1.5E-02 |
2.5E-02 |
4.8E-02 |
|
Thyroid |
5.1E-03 |
7.7E-03 |
1.2E-02 |
2.0E-02 |
3.7E-02 |
|
Uterus |
1.4E-02 |
1.7E-02 |
2.8E-02 |
4.3E-02 |
7.6E-02 |
|
Other tissue |
6.4E-03 |
7.7E-03 |
1.2E-02 |
1.9E-02 |
3.5E-02 |
|
Effective dose equivalent | |||||
|
(mSv/MBq) |
1.3E-02 |
1.6E-02 |
2.4E-02 |
3.7E-02 |
6.7E-02 |
Incomplete blockage:
Effective dose equivalent (mSv/MBq) at small uptake in the thyroid:
|
Adult |
15 years |
10 years |
5 years |
1 year | |
|
Uptake: 0.5 % |
1.6E-02 |
2.0E-02 |
3.1E-02 |
5.2E-02 |
9.6E-02 |
|
Uptake: 1 % |
1.9E-02 |
2.5E-02 |
3.8E-02 |
6.7E-02 |
1.3E-01 |
|
Uptake: 2 % |
2.5E-02 |
3.4E-02 |
5.2E-02 |
9.9E-02 |
1.8E-01 |
Thyroid blocked, uptake 15 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
6.3E-03 |
8.3E-03 |
1.3E-02 |
2.0E-02 |
3.7E-02 |
|
*Bladder wall |
7.6E-02 |
9.5E-02 |
1.4E-01 |
2.1E-01 |
3.8E-01 |
|
Bone surfaces |
7.1E-03 |
9.1E-03 |
1.4E-02 |
2.2E-02 |
4.1E-02 |
|
Breast |
4.7E-03 |
4.7E-03 |
7.3E-03 |
1.2E-02 |
2.3E-02 |
|
GI-Tract | |||||
|
Stomach wall |
6.8E-02 |
8.5E-02 |
1.2E-01 |
2.0E-01 |
3.8E-01 |
|
*Small intest |
4.3E-02 |
5.4E-02 |
9.1E-02 |
1.4E-01 |
2.7E-01 |
|
*ULI wall |
1.8E-02 |
1.9E-02 |
2.9E-02 |
4.5E-02 |
7.7E-02 |
|
*LLI wall |
1.1E-02 |
1.4E-02 |
2.2E-02 |
3.3E-02 |
6.0E-02 |
|
Kidneys |
1.0E-02 |
1.3E-02 |
1.8E-02 |
2.7E-02 |
4.6E-02 |
|
Liver |
6.2E-03 |
7.6E-03 |
1.3E-02 |
2.1E-02 |
3.8E-02 |
|
Lungs |
5.7E-03 |
7.2E-03 |
1.1E-02 |
1.8E-02 |
3.4E-02 |
|
Ovaries |
1.2E-02 |
1.6E-02 |
2.5E-02 |
3.8E-02 |
6.8E-02 |
|
Pancreas |
1.4E-02 |
1.6E-02 |
2.4E-02 |
3.5E-02 |
6.1E-02 |
|
Red marrow |
9.4E-03 |
1.2E-02 |
1.7E-02 |
2.5E-02 |
4.3E-02 |
|
Spleen |
9.5E-03 |
1.1E-02 |
1.7E-02 |
2.5E-02 |
4.4E-02 |
|
Testes |
5.3E-03 |
7.2E-03 |
1.2E-02 |
2.0E-02 |
3.8E-02 |
|
Thyroid |
1.9E+00 |
3.0E+00 |
4.5E+00 |
9.8E+00 |
1.9E+01 |
|
Uterus |
1.5E-02 |
1.9E-02 |
3.1E-02 |
4.9E-02 |
8.6E-02 |
|
Other tissue |
6.8E-03 |
8.5E-03 |
1.3E-02 |
2.1E-02 |
3.9E-02 |
Effective dose equivalent
|
(mSv/MBq) |
7.5E-02 |
1.1E-01 |
1.7E-01 |
3.5E-01 |
6.5E-01 |
Thyroid blocked, uptake 35 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
6.5E-03 |
8.4E-03 |
1.3E-02 |
2.1E-02 |
3.8E-02 |
|
*Bladder wall |
6.0E-02 |
7.4E-02 |
1.1E-01 |
1.6E-01 |
3.0E-01 |
|
Bone surfaces |
7.9E-03 |
1.1E-02 |
1.6E-02 |
2.5E-02 |
4.6E-02 |
|
Breast |
5.2E-03 |
5.2E-03 |
8.5E-03 |
1.5E-02 |
2.7E-02 |
|
GI-Tract | |||||
|
Stomach wall |
6.8E-02 |
8.5E-02 |
1.2E-01 |
2.0E-01 |
3.8E-01 |
|
*Small intest |
4.2E-02 |
5.4E-02 |
9.0E-02 |
1.4E-01 |
2.7E-01 |
|
*ULI wall |
1.8E-02 |
1.9E-02 |
2.9E-02 |
4.5E-02 |
7.6E-02 |
|
*LLI wall |
1.0E-02 |
1.4E-02 |
2.1E-02 |
3.2E-02 |
5.8E-02 |
|
Kidneys |
9.1E-03 |
1.1E-02 |
1.6E-02 |
2.4E-02 |
4.1E-02 |
|
Liver |
6.3E-03 |
7.8E-03 |
1.3E-02 |
2.1E-02 |
4.0E-02 |
|
Lungs |
6.5E-03 |
8.6E-03 |
1.4E-02 |
2.2E-02 |
4.2E-02 |
|
Ovaries |
1.1E-02 |
1.5E-02 |
2.4E-02 |
3.7E-02 |
6.6E-02 |
|
Pancreas |
1.4E-02 |
1.6E-02 |
2.4E-02 |
3.6E-02 |
6.2E-02 |
|
Red marrow |
1.0E-02 |
1.3E-02 |
1.9E-02 |
2.8E-02 |
4.8E-02 |
|
Spleen |
9.6E-03 |
1.1E-02 |
1.7E-02 |
2.5E-02 |
4.5E-02 |
|
Testes |
5.0E-03 |
6.8E-03 |
1.1E-02 |
1.8E-02 |
3.5E-02 |
|
Thyroid |
4.5E+00 |
7.0E+00 |
1.1E+01 |
2.3E+01 |
4.3E+01 |
|
Uterus |
1.4E-02 |
1.7E-02 |
2.9E-02 |
4.4E-02 |
7.9E-02 |
|
Other tissue |
8.0E-03 |
1.0E-02 |
1.6E-02 |
2.6E-02 |
4.9E-02 |
|
Effective dose equivalent | |||||
|
(mSv/MBq) |
1.5E-01 |
2.3E-01 |
3.5E-01 |
7.4E-01 |
1.4E+00 |
Thyroid blocked, uptake 55 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
6.5E-03 |
8.5E-03 |
1.4E-02 |
2.1E-02 |
3.9E-02 |
|
*Bladder wall |
4.3E-02 |
5.3E-02 |
7.9E-02 |
1.2E-01 |
2.2E-01 |
|
Bone surfaces |
8.6E-03 |
1.2E-02 |
1.8E-02 |
2.8E-02 |
5.1E-02 |
|
Breast |
5.6E-03 |
5.6E-03 |
9.5E-03 |
1.7E-02 |
3.1E-02 |
|
GI-Tract | |||||
|
Stomach wall |
6.8E-02 |
8.5E-02 |
1.2E-01 |
2.0E-01 |
3.9E-01 |
|
*Small intest |
4.2E-02 |
5.4E-02 |
9.1E-02 |
1.4E-01 |
2.7E-01 |
|
*ULI wall |
1.8E-02 |
1.9E-02 |
2.9E-02 |
4.4E-02 |
7.6E-02 |
|
*LLI wall |
9.8E-03 |
1.3E-02 |
2.0E-02 |
3.0E-02 |
5.5E-02 |
|
Kidneys |
9.1E-03 |
1.1E-02 |
1.6E-02 |
2.4E-02 |
4.1E-02 |
|
Liver |
6.4E-03 |
7.9E-03 |
1.3E-02 |
2.2E-02 |
4.1E-02 |
|
Lungs |
7.2E-03 |
9.7E-03 |
1.6E-02 |
2.6E-02 |
4.8E-02 |
|
Ovaries |
1.1E-02 |
1.5E-02 |
2.3E-02 |
3.6E-02 |
6.4E-02 |
|
Pancreas |
1.4E-02 |
1.6E-02 |
2.5E-02 |
3.6E-02 |
6.3E-02 |
|
Red marrow |
1.1E-02 |
1.5E-02 |
2.1E-02 |
3.0E-02 |
5.2E-02 |
|
Spleen |
9.7E-03 |
1.1E-02 |
1.7E-02 |
2.6E-02 |
4.6E-02 |
|
Testes |
4.6E-03 |
6.2E-03 |
1.0E-02 |
1.6E-02 |
3.2E-02 |
|
Thyroid |
7.0E+00 |
1.1E+01 |
1.7E+01 |
3.6E+01 |
6.8E+01 |
|
Uterus |
1.2E-02 |
1.6E-02 |
2.6E-02 |
4.0E-02 |
7.2E-02 |
|
Other tissue |
9.2E-03 |
1.2E-02 |
1.9E-02 |
3.1E-02 |
5.8E-02 |
|
Effective dose equivalent | |||||
|
(mSv/MBq) |
2.3E-01 |
3.5E-01 |
5.3E-01 |
1.1E+00 |
2.1E+00 |
125I 60.14 days
Thyroid blocked, uptake 0 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
4.8E-03 |
6.6E-03 |
1.1E-02 |
1.9E-02 |
3.7E-02 |
|
*Bladder wall |
1.0E-01 |
1.3E-01 |
1.9E-01 |
2.9E-01 |
5.4E-01 |
|
Bone surfaces |
7.4E-03 |
9.3E-03 |
1.6E-02 |
2.7E-02 |
5.7E-02 |
|
Breast |
5.1E-03 |
5.1E-03 |
7.4E-03 |
1.2E-02 |
2.4E-02 |
|
GI-Tract | |||||
|
Stomach wall |
5.3E-03 |
6.5E-03 |
1.0E-02 |
1.8E-02 |
3.5E-02 |
|
*Small intest |
5.8E-03 |
6.8E-03 |
1.2E-02 |
2.0E-02 |
4.1E-02 |
|
*ULI wall |
5.8E-03 |
6.8E-03 |
1.2E-02 |
1.9E-02 |
3.9E-02 |
|
*LLI wall |
6.7E-03 |
8.1E-03 |
1.3E-02 |
2.3E-02 |
4.8E-02 |
|
Kidneys |
1.0E-02 |
1.3E-02 |
1.9E-02 |
2.8E-02 |
5.1E-02 |
|
Liver |
5.4E-03 |
6.4E-03 |
1.1E-02 |
1.8E-02 |
3.5E-02 |
|
Lungs |
5.5E-03 |
6.9E-03 |
1.1E-02 |
1.9E-02 |
3.7E-02 |
|
Ovaries |
6.4E-03 |
7.8E-03 |
1.4E-02 |
2.4E-02 |
4.8E-02 |
|
Pancreas |
5.6E-03 |
6.7E-03 |
1.1E-02 |
1.9E-02 |
3.7E-02 |
|
Red marrow |
8.3E-03 |
1.0E-02 |
1.7E-02 |
2.9E-02 |
5.9E-02 |
|
Spleen |
5.6E-03 |
6.5E-03 |
1.1E-02 |
1.8E-02 |
3.6E-02 |
|
Testes |
5.0E-03 |
6.5E-03 |
1.2E-02 |
2.1E-02 |
4.4E-02 |
|
Thyroid |
4.7E-03 |
6.3E-03 |
1.1E-02 |
1.8E-02 |
3.6E-02 |
|
Uterus |
9.5E-03 |
1.2E-02 |
2.2E-02 |
3.8E-02 |
7.5E-02 |
|
Other tissue |
5.2E-03 |
6.3E-03 |
1.0E-02 |
1.7E-02 |
3.4E-02 |
Effective dose equivalent
|
(mSv/MBq) |
1.2E-02 |
1.5E-02 |
2.3E-02 |
3.7E-02 |
7.3E-02 |
Incomplete blockage:
Effective dose equivalent (mSv/MBq) at small uptake in the thyroid:
|
Adult |
15 years |
10 years |
5 years |
1 year | |
|
Uptake: 0.5 % |
1.5E-01 |
2.4E-01 |
3.6E-01 |
7.7E-01 |
1.4E+00 |
|
Uptake: 1 % |
3.0E-01 |
4.6E-01 |
6.9E-01 |
1.5E+00 |
2.8E+00 |
|
Uptake: 2 % |
5.8E-01 |
9.0E-01 |
1.4E+00 |
3.0E+00 |
5.6E+00 |
Thyroid blocked, uptake 15 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
3.6E-03 |
5.1E-03 |
8.9E-03 |
1.5E-02 |
3.3E-02 |
|
*Bladder wall |
8.5E-02 |
1.1E-01 |
1.6E-01 |
2.4E-01 |
4.6E-01 |
|
Bone surfaces |
1.6E-02 |
4.1E-02 |
5.3E-02 |
8.0E-02 |
1.4E-01 |
|
Breast |
4.6E-03 |
4.5E-03 |
8.5E-03 |
1.9E-02 |
5.1E-02 |
|
GI-Tract | |||||
|
Stomach wall |
7.1E-02 |
9.0E-02 |
1.3E-01 |
2.2E-01 |
4.4E-01 |
|
*Small intest |
4.2E-02 |
5.5E-02 |
9.5E-02 |
1.6E-01 |
3.0E-01 |
|
*ULI wall |
1.6E-02 |
1.4E-02 |
2.4E-02 |
3.9E-02 |
7.6E-02 |
|
*LLI wall |
7.5E-03 |
9.5E-03 |
1.6E-02 |
2.7E-02 |
5.4E-02 |
|
Kidneys |
8.6E-03 |
1.1E-02 |
1.6E-02 |
2.4E-02 |
4.6E-02 |
|
Liver |
4.2E-03 |
4.9E-03 |
9.4E-03 |
1.7E-02 |
3.8E-02 |
|
Lungs |
8.7E-03 |
1.3E-02 |
3.1E-02 |
6.2E-02 |
1.3E-01 |
|
Ovaries |
6.9E-03 |
9.8E-03 |
1.8E-02 |
3.1E-02 |
6.2E-02 |
|
Pancreas |
9.2E-03 |
1.0E-02 |
1.8E-02 |
2.9E-02 |
5.7E-02 |
|
Red marrow |
1.7E-02 |
3.9E-02 |
5.1E-02 |
7.7E-02 |
1.4E-01 |
|
Spleen |
5.8E-03 |
6.6E-03 |
1.2E-02 |
1.9E-02 |
4.3E-02 |
|
Testes |
3.6E-03 |
4.7E-03 |
8.8E-03 |
1.6E-02 |
3.4E-02 |
|
Thyroid |
1.4E+02 |
2.0E+02 |
2.6E+02 |
5.1E+02 |
7.9E+02 |
|
Uterus |
9.2E-03 |
1.2E-02 |
2.4E-02 |
4.1E-02 |
8.2E-02 |
|
Other tissue |
5.3E-02 |
7.0E-02 |
1.1E-01 |
1.7E-01 |
2.9E-01 |
|
Effective dose equivalent | |||||
|
(mSv/MBq) |
4.3E+00 |
6.0E+00 |
8.0E+00 |
1.5E+01 |
2.4E+01 |
Thyroid blocked, uptake 35 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
3.5E-03 |
5.0E-03 |
8.9E-03 |
1.6E-02 |
3.7E-02 |
|
*Bladder wall |
6.6E-02 |
8.3E-02 |
1.2E-01 |
1.9E-01 |
3.6E-01 |
|
Bone surfaces |
3.1E-02 |
8.6E-02 |
1.1E-01 |
1.6E-01 |
2.7E-01 |
|
Breast |
5.9E-03 |
5.7E-03 |
1.3E-02 |
3.2E-02 |
9.5E-02 |
|
GI-Tract | |||||
|
Stomach wall |
7.1E-02 |
9.0E-02 |
1.3E-01 |
2.2E-01 |
4.4E-01 |
|
*Small intest |
4.2E-02 |
5.5E-02 |
9.5E-02 |
1.6E-01 |
3.0E-01 |
|
*ULI wall |
1.6E-02 |
1.4E-02 |
2.4E-02 |
3.9E-02 |
7.5E-02 |
|
*LLI wall |
7.2E-03 |
9.1E-03 |
1.5E-02 |
2.6E-02 |
5.1E-02 |
|
Kidneys |
7.6E-03 |
9.3E-03 |
1.4E-02 |
2.2E-02 |
4.4E-02 |
|
Liver |
4.2E-03 |
5.0E-03 |
1.0E-02 |
1.9E-02 |
4.5E-02 |
|
Lungs |
1.5E-02 |
2.3E-02 |
6.1E-02 |
1.2E-01 |
2.8E-01 |
|
Ovaries |
6.7E-03 |
9.6E-03 |
1.7E-02 |
3.0E-02 |
6.0E-02 |
|
Pancreas |
9.2E-03 |
1.0E-02 |
1.8E-02 |
2.9E-02 |
6.1E-02 |
|
Red marrow |
3.0E-02 |
7.9E-02 |
9.9E-02 |
1.5E-01 |
2.7E-01 |
|
Spleen |
5.8E-03 |
6.6E-03 |
1.2E-02 |
2.0E-02 |
5.1E-02 |
|
Testes |
3.5E-03 |
4.5E-03 |
8.2E-03 |
1.5E-02 |
3.1E-02 |
|
Thyroid |
3.3E+02 |
4.7E+02 |
6.2E+02 |
1.2E+03 |
1.9E+03 |
|
Uterus |
8.3E-03 |
1.1E-02 |
2.1E-02 |
3.7E-02 |
7.4E-02 |
|
Other tissue |
1.2E-01 |
1.6E-01 |
2.4E-01 |
3.8E-01 |
6.4E-01 |
|
Effective dose equivalent | |||||
|
(mSv/MBq) |
9.9E+00 |
1.4E+01 |
1.9E+01 |
3.6E+01 |
5.6E+01 |
Thyroid blocked, uptake 55 %
Absorbed Dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
3.6E-03 |
5.1E-03 |
9.2E-03 |
1.7E-02 |
4.1E-02 |
|
*Bladder wall |
4.7E-02 |
5.8E-02 |
8.8E-02 |
1.3E-01 |
2.5E-01 |
|
Bone surfaces |
4.5E-02 |
1.3E-01 |
1.6E-01 |
2.4E-01 |
4.0E-01 |
|
Breast |
7.3E-03 |
7.0E-03 |
1.7E-02 |
4.6E-02 |
1.4E-01 |
|
GI-Tract | |||||
|
Stomach wall |
7.1E-02 |
9.0E-02 |
1.3E-01 |
2.2E-01 |
4.5E-01 |
|
*Small intest |
4.2E-02 |
5.5E-02 |
9.5E-02 |
1.5E-01 |
3.0E-01 |
|
*ULI wall |
1.6E-02 |
1.4E-02 |
2.4E-02 |
3.9E-02 |
7.5E-02 |
|
*LLI wall |
7.0E-03 |
8.8E-03 |
1.5E-02 |
2.4E-02 |
4.9E-02 |
|
Kidneys |
6.4E-03 |
7.9E-03 |
1.2E-02 |
1.9E-02 |
4.3E-02 |
|
Liver |
4.2E-03 |
5.1E-03 |
1.1E-02 |
2.2E-02 |
5.2E-02 |
|
Lungs |
2.1E-02 |
3.4E-02 |
9.1E-02 |
1.9E-01 |
4.2E-01 |
|
Ovaries |
6.6E-03 |
9.4E-03 |
1.7E-02 |
2.9E-02 |
5.8E-02 |
|
Pancreas |
9.2E-03 |
1.0E-02 |
1.8E-02 |
3.0E-02 |
6.6E-02 |
|
Red marrow |
4.3E-02 |
1.2E-01 |
1.5E-01 |
2.2E-01 |
4.0E-01 |
|
Spleen |
5.8E-03 |
6.6E-03 |
1.2E-02 |
2.0E-02 |
5.9E-02 |
|
Testes |
3.4E-03 |
4.4E-03 |
7.7E-03 |
1.4E-02 |
2.8E-02 |
|
Thyroid |
5.2E+02 |
7.4E+02 |
9.7E+02 |
1.9E+03 |
2.9E+03 |
|
Uterus |
7.5E-03 |
1.0E-02 |
1.9E-02 |
3.3E-02 |
6.7E-02 |
|
Other tissue |
1.8E-01 |
2.4E-01 |
3.8E-01 |
5.9E-01 |
9.9E-01 |
Effective dose equivalent
|
(mSv/MBq) |
1.6E+01 |
2.2E+01 |
2.9E+01 |
5.6E+01 |
8.8E+01 |
121Te 16.8 days
121
The radiation dose from Te, homogeneously distributed throughout the whole body is 4.6E-02 mSv/MBq.
The calculated effective dose equivalent is 4.6E-02 mSv/MBq.