Sodium Iodide (I131) Capsules T
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I131) Capsules T (Mallinckrodt Medical catalogue number: DRN 5302)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 Active ingredient
Sodium Iodide (I-131), with activity from 37-7400 MBq / capsule at activity reference date and time.
2.2 Physical characteristics
Iodine-131 is produced by fission of uranium-235 or by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.04 days. It decays by emission of gamma radiations of 365 keV (81%), 637 keV (7.3%) and 284 keV (6.0%) and beta radiations of maximal energy of 606 keV to stable Xenon-131.
3 PHARMACEUTICAL FORM
Capsule.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Radioiodine thyroid therapy is indicated for:
• Treatment of Graves disease, toxic multinodular goitre or autonomous nodules.
• Treatment of papillary and follicular thyroid carcinoma including metastatic disease.
Sodium iodide 131I therapy is often combined with surgical intervention and with antithyroid medications.
4.2 Posology and method of administration
The activity administered is a matter for clinical judgement. The therapeutic effect is only achieved after several months.
For the treatment of hyperthyroidism
The activity administered is usually in the range of 200 - 800 MBq but repeated treatment may be necessary. The dose required depends on the diagnosis, the size of the gland, thyroid uptake and iodine clearance. Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism.
For thyroid ablation and treatment of metastases
The administered activities following total or subtotal thyroidectomy to ablate remaining thyroid tissue are in the range of 1850 - 3700 MBq. It depends on the remnant size and radioiodine uptake. In subsequent treatment for metastases, administered activity is in the range 3700 - 11100 MBq.
The activity to be administered in children and adolescent should be a fraction of the adult dose calculated from the body weight/surface area methods according to the following equations:
Adult dose (MBq) x child weight (kg)
Paediatric dose (MBq) = 70 kg
2
Adult dose (MBq) x child surface (m ) Paediatric dose (MBq) = 1.73
Correction factors given for guidance are proposed below.
|
3 kg = 0.1 |
4 kg = 0.14 |
6 kg = 0.19 |
8 kg = 0.23 |
10 kg = 0.27 |
|
12 kg = 0.32 |
14 kg = 0.36 |
16 kg = 0.49 |
18 kg = 0.44 |
20 kg = 0.46 |
|
22 kg = 0.50 |
24 kg = 0.53 |
26 kg = 0.56 |
28 kg = 0.58 |
30 kg = 0.62 |
|
32 kg = 0.65 |
34 kg = 0.68 |
36 kg = 0.71 |
38 kg = 0.73 |
40 kg = 0.76 |
|
42 kg = 0.78 |
44 kg = 0.80 |
46 kg = 0.82 |
48 kg = 0.85 |
50 kg = 0.88 |
|
52-54 kg = 0.90 |
56-58 kg = 0.92 |
60-62 kg = 0.96 |
64-66 kg = 0.98 |
68 kg = 0.99 |
(Paediatric Task Group, EANM)
The capsule is administered orally together with a drink. It should be swallowed whole.
In patients with suspected gastrointestinal disease, great care should be taken when administering 131I capsules. The capsules should be swallowed whole with sufficient fluid to ensure clear passage into the stomach and upper small intestine. Concomitant use of H2 antagonists or proton pump inhibitors is advised. After high doses used e.g. for the treatment of thyroid carcinoma, patients should be encouraged to increase oral fluids to have frequent bladder emptying to reduce bladder radiation.
4.3 Contraindications
• Pregnancy.
• For diagnostic purpose children under 10 years of age.
123
• Thyroid scanning except in the follow-up of malignant disease or when I or 99mTc are not available.
• Patients with dysphagia, oesophageal stricture, active gastritis, gastric erosions and peptic ulcer.
• Patients with suspected reduced gastrointestinal motility.
4.4 Special warnings and precautions for use
Radiopharmaceuticals may be received, used and administered only by authorised persons, in designated clinical setting. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the local competent official organisation.
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiological and pharmaceutical quality requirements. This preparation is likely to result in relatively a high radiation dose to most patients (see section 4.8 and 5.4). The administration of high dose radioiodine may result in significant environmental hazard. These may be of concern to the immediate family of those individual undergoing treatment or the general public depending on the level of activity administered. Suitable precautions should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
There is little evidence of an increased incidence of cancer, leukaemia or mutations in man with respect to patients treated for benign thyroid disease with radioiodine, despite extensive use. In the treatment of children and young people however, account must be taken of the greater sensitivity of child tissue and the greater life expectancy of such patients. The risks must also be weighed up against those of other possible treatments. In the treatment of malignant thyroid disease, a higher incidence of bladder cancer has been reported in one study of patients receiving greater than 3,700 MBq 131I. Another study has reported a small excess leukemia in patients receiving very high doses. A cumulative total activity higher than 26000 MBq is therefore not advisable.
The therapeutic administration of I capsules in patients with significant renal impairment, in which an activity adjustment is necessary, requires special attention. To avoid sialadenitis which may complicate high dose radioiodine administration, the patient may be advised to take sweets or drinks containing citric acid which will stimulate saliva excretion. A low iodine diet prior to therapy will enhance uptake into functioning thyroid tissue.
Thyroid replacement should be stopped prior to radioiodine administration for thyroid carcinoma to ensure adequate uptake. A period of ten days is recommended for triiodothyronine and six weeks for thyroxine. They should be restarted two weeks after treatment. Similarly carbimazole and propythiouracil should be stopped five days prior to treatment of hyperthyroidism and restarted several days later.
4.5 Interaction with other medicinal products and other forms of interaction
Many pharmacological agents are known to interact with radioiodide. These may do so by a variety of mechanisms which can affect the protein binding, the pharmacokinetics or influence the dynamic effects of labelled iodide. It is therefore necessary to take a full drug history and ascertain whether any medications are required to be withheld prior to the administration of sodium iodide I-131. For example antithyroid agents, carbimazole (or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophtalein, perchlorate, miscellaneous agents (anticoagulants, anti-histamines, antiparasitics, penicillins, sulphonamides, tolbutamide, thiopentone), are normally withheld for 1 week; phenylbutazone for 1 - 2 weeks; expectorants, vitamins for 2 weeks; natural or synthetic thyroid preparations (sodium thyroxine, sodium liothyronine, thyroid extract) for 2 - 3 weeks; amiodarone, benzodiazepines, lithium for 4 weeks; topical iodides for 1 - 9 months; and for intravenous contrast agents, oral cholecystographic agents, iodine containing contrast media for a period up to 1 year.
4.6 Fertility, Pregnancy and lactation
Sodium iodide I-131 is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to transplacental passage of sodium iodide I-131 which can cause severe and possibly irreversible hypothyroidism in neonates (the absorbed dose to the uterus for this agent is likely to be in the range 11 - 511 mGy, and the foetal thyroid gland avidly concentrates iodine during the second and third trimesters). 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. Alternative techniques which do not involve ionizing radiation should be considered. Women receiving sodium iodide I-131 should be advised NOT to become pregnant within four months of administration. 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 as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of
activity in breast milk. Breast-feeding should be discontinued indefinitely after sodium iodide I-131 administration.
4.7 Effects on ability to drive and use machines
No effects on the ability to drive or to operate machinery are to be expected after use of the drug.
4.8 Undesirable effects
For each patient, exposure to ionizing 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 or therapeutic result. Exposure to ionizing radiation is linked with cancer induction and a potential for development of hereditary effects. The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. In all cases it is necessary to ensure that the risks of the radiation are less than those of the disease itself. The radiation dose delivered (EDE) after therapeutic doses of Sodium Iodide I-131 is higher than 20 mSv.
Some cases of adverse reactions have been reported following the administration of sodium iodide I-131, including nausea, vomiting, iodo acne, local swelling and unspecified possible allergic phenomena. Nausea and vomiting are more frequent after administration by oral route especially after therapeutic doses and the risks of contamination following the occurrence of vomiting have to be considered.
Early consequences
Therapeutic quantities of I-131 may worsen existing hyperthyroidism temporarily. High levels of radioactivity may lead to gastrointestinal disturbance, usually within the first hours or days after administration. The incidence of gastrointestinal upset can be as high as 67%. This can easily be prevented or counteracted by means of symptomatic treatment.
With high dose radioiodine treatment, 1 - 3 days after administration, the patient may experience transient inflammatory thyroiditis and tracheitis, with a possibility of severe trachaeal constriction, especially where there is existing tracheal stenosis. Sialadenitis may occur, with swelling and pain in the salivary glands, partial loss of taste and dry mouth. Incidence varies from 10% (with precautions) and 60%
(without precautions). Sialadenitis is usually reversible spontaneously or with antiinflammatory treatment but cases have occasionally been described of dose-dependent persistent loss of taste and dry mouth, followed by loss of teeth. The radiation exposure of the salivary glands should be reduced by stimulating saliva excretion with acidic
substances.
High levels of uptake of radioiodine given to the patients can be associated with local pain, discomfort and oedema in the tissue taking up the radionuclide. In the treatment of metastasizing thyroid carcinomas with CNS involvement, the possibility of local cerabral oedema and/or an increasing existing cerebral oedema must also be born in mind.
Late consequences
Dose dependent hypothyroidism may occur as a late consequence of radioiodine treatment of hyperthyroidism. This may manifest itself weeks or years after treatment, requiring suitable timed measurement of thyroid function and appropriate thyroid replacement. The incidence of hypothyroidism, generally not seen until 6 - 12 weeks, following radioiodine has been variously reported as between 2 - 70%. Occasionally cases of transient hypoparathyroidism have been observed after radioiodine, they must be monitored accordingly and treated with replacement therapy. As a late consequence a single administration of over 5000 MBq or in interval of below 6 months are more likely to be associated with reversible or in very rare cases irreversible bone marrow depression may develop, with isolated thrombocytopenia or erythrocytopenia, which may be fatal. Transient leucocytosis is frequently observed. After higher activities, typically those used in the treatment of thyroid malignancies, an increased incidence of leukaemia has been observed.. There is also evidence for an increased incidence of secondary solid cancers at high activities (more than 7.4 GBq).
The product contains no excipients that have a recognised action or effect, or knowledge of which is important for safe and effective use of the product.
4.9 Overdose
This agent is intended for use by competent personnel within a hospital setting. As such the risk of overdose is theoretical. The risks relate to the inadvertent administration of excess radioactivity. High radiation exposure through overdose can be reduced by means of administration of thyroid blocking agents, such as potassium iodide or potassium perchlorate, immediately following suspected overexposure, the use of emetics and promoting a diuresis with frequent voiding of urine.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Iodide in the amount used for therapeutic indications, is not known to have any pharmacological effect. More than 90% of the radiation effects result from beta radiation which has a mean range of 0.5 mm.
5.2 Pharmacokinetic properties
After oral administration sodium iodide I-131 is absorbed rapidly from the upper gastrointestinal tract (90% in 60 minutes). The pharmacokinetics follow that of unlabelled iodide. After entering the blood stream it is distributed in the extra thyroidal compartment. From here it is predominantly taken up by the thyroid or excreted renally. Small amounts of iodide I-131 are taken up by salivary glands, gastric mucosa and would also be localised in breast milk, the placenta and choroid plexus. The effective half-life of radioiodine in plasma is in the order of 12 hours whereas that for radioiodine taken up by the thyroid gland is about 6 days. Thus after administration of sodium iodide I-131 approximately 40% of the activity has an effective half-life of 0.4 days and the remaining 60% 8 days. Urinary excretion is 37 - 75%, faecal excretion is about 10% with almost negligible excretion in sweat.
5.3 Preclinical safety data
Because of the small quantities of substance administered compared with the normal food intake of iodine (40 - 500mcg/day) no acute toxicity is to be expected or observed. There are no data available on the toxicity of repeated doses of sodium iodide nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium hydrogen phosphate dihydrate, sodium thiosulphate pentahydrate, sodium hydrogen carbonate, sodium hydroxide, saccharose, sodium chloride, water for injections and gelatin.
6.2 Incompatibilities
None known.
6.3 Shelf life
Sodium Iodide (I131) Capsules T expires 2-6 weeks after activity reference date and time. Activity reference date and time and expiry date are printed on the label on the outer package.
6.4 Special precautions for storage
The preparation should be stored at 15-25 °C (room temperature) either within its original lead shield or within shielding of appropriate thickness. Storage should be in accordance with national regulations for radioactive material.
6.5 Nature and contents of container
1 Capsule in a plastic screwcap vial. Sodium Iodide (1131) Capsules T is supplied in amounts of radioactivity ranging between 37 - 7400 MBq at activity reference time.
6.6 Special precautions for disposal
The capsules are ready to use.
Administration protocol
1. Remove the tin from the package and take out the leadpot.
2. Turn the lid gently clockwise until you meet with slight resistance, then lift the lid from the leadpot leaving the inner vial in the base.
3. Place the vial, containing the capsule, into your measuring device to determine the activity.
4. Replace the vial in the leadpot and mount the lid on leadpot without turning.
5. Ask your patient to unscrew the lid of the leadpot and the vial cap simultaneously by turning it three times counterclockwise.
6. The patient removes the lid, lifts the leadpot, and swallows the capsule.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc.
Radiation protection precautions in accordance with national regulations must therefore be taken.
7 MARKETING AUTHORISATION HOLDER
Mallinckrodt Medical B.V.
Westerduinweg 3 1755 LE Petten Netherlands
8 MARKETING AUTHORISATION NUMBER(S)
PL 12288/0010
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)
Tabulated radiation dosimetry as reported in ICRP publication no 53 (1987) are reported. The ICRP model refers to intravenous administration. Since absorption of radioiodide is rapid and complete, this model is applicable in case of oral administration also but there is a further radiation dose to the stomach wall in addition to that due to gastric and salivary excretion. Assuming that the mean residence time in the stomach is 0.5 hr, the absorbed dose to the stomach increase by about 30% for I-131.
Radiation dose to specific organs, which may not be the target organ of therapy, can be influenced significantly by pathophysiological changes induced by the disease process. As part of the risk-benefit assessment it is advised that the EDE and likely radiation doses to individual target organ(s) be calculated prior to administration. The activity might then be adjusted according to thyroid mass, biological half-life and the “re-cycling” factor which takes into account the physiological status of the patient (including iodine depletion) and the underlying pathology.
IODIDE
Thyroid blocked, uptake 0%
131I 8.04 days
Absorbed dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
3.7E-02 |
4.2E-02 |
6.7E-02 |
1.1E-01 |
2.0E-01 |
|
* Bladder wall |
6.1E-01 |
7.5E-01 |
1.1E+00 |
1.8E+00 |
3.4E+00 |
|
Bone surfaces |
3.2E-02 |
3.8E-02 |
6.1E-02 |
9.7E-02 |
1.9E-01 |
|
Breast |
3.3E-02 |
3.3E-02 |
5.2E-02 |
8.5E-02 |
1.7E-01 |
|
GI-tract | |||||
|
Stomach wall |
3.4E-02 |
4.0E-02 |
6.4E-02 |
1.0E-01 |
1.9E-01 |
|
* Small intest |
3.8E-02 |
4.7E-02 |
7.5E-02 |
1.2E-01 |
2.2E-01 |
|
* ULI wall |
3.7E-02 |
4.5E-02 |
7.0E-02 |
1.2E-01 |
2.1E-01 |
|
* LLI wall |
4.3E-02 |
5.2E-02 |
8.2E-02 |
1.3E-01 |
2.3E-01 |
|
* Kidneys |
6.5E-02 |
8.0E-02 |
1.2E-01 |
1.7E-01 |
3.1E-01 |
|
Liver |
3.3E-02 |
4.0E-02 |
6.5E-02 |
1.0E-01 |
2.0E-01 |
|
Lungs |
3.1E-02 |
3.8E-02 |
6.0E-02 |
9.6E-02 |
1.9E-01 |
|
Ovaries |
4.2E-02 |
5.4E-02 |
8.4E-02 |
1.3E-01 |
2.4E-01 |
|
Pancreas |
3.5E-02 |
4.3E-02 |
6.9E-02 |
1.1E-01 |
2.1E-01 |
|
Red marrow |
3.5E-02 |
4.2E-02 |
6.5E-02 |
1.0E-01 |
1.9E-01 |
|
Spleen |
3.4E-02 |
4.0E-02 |
6.5E-02 |
1.0E-01 |
2.0E-01 |
|
Testes |
3.7E-02 |
4.5E-02 |
7.5E-02 |
1.2E-01 |
2.3E-01 |
|
Thyroid |
2.9E-02 |
3.8E-02 |
6.3E-02 |
1.0E-01 |
2.0E-01 |
|
Uterus |
5.4E-02 |
6.7E-02 |
1.1E-01 |
1.7E-01 |
3.0E-01 |
|
Other tissue |
3.2E-02 |
3.9E-02 |
6.2E-02 |
1.0E-01 |
1.9E-01 |
|
Effective | |||||
|
dose equivalent (mSv/MBq) |
7.2E-02 |
8.8E-02 |
1.4E-01 |
2.1E-01 |
4.0E-01 |
Bladder wall contributes to 50.8% of the effective dose equivalent.
Incomplete blockage:
Effective dose equivalent (mSv/MBq) at small uptake in the thyroid:
|
uptake 0.5%: |
3.0E-01 |
4.5E-01 |
6.9E-01 |
1.5E+00 |
2.8E+00 |
|
uptake 1%: |
5.2E-01 |
8.1E-01 |
1.2E+00 |
2.7E+00 |
5.3E+00 |
|
uptake 2%: |
9.7E-01 |
1.5E+00 |
2.4E+00 |
5.3E+00 |
1.0E+01 |
Thyroid uptake 15%
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
3.6E-02 |
4.3E-02 |
7.1E-02 |
1.1E-01 |
2.2E-01 |
|
* Bladder wall |
5.2E-01 |
6.4E-01 |
9.8E-01 |
1.5E+00 |
2.9E+00 |
|
Bone surfaces |
4.7E-02 |
6.7E-02 |
9.4E-02 |
1.4E-01 |
2.4E-01 |
|
Breast |
4.3E-02 |
4.3E-02 |
8.1E-02 |
1.3E-01 |
2.5E-01 |
|
Gl-tract | |||||
|
Stomach wall |
4.6E-01 |
5.8E-01 |
8.4E-01 |
1.5E+00 |
2.9E+00 |
|
* Small intest |
2.8E-01 |
3.5E-01 |
6.2E-01 |
1.0E+00 |
2.0E+00 |
|
* ULI wall |
5.9E-02 |
6.5E-02 |
1.0E-01 |
1.6E-01 |
2.8E-01 |
|
* LLI wall |
4.2E-02 |
5.3E-02 |
8.2E-02 |
1.3E-01 |
2.3E-01 |
|
* Kidney |
6.0E-02 |
7.5E-0 |
1.1E-01 |
1.7E-0 |
2.9E-01 |
|
Liver |
3.2E-02 |
4.1E-02 |
6.8E-02 |
1.1E-01 |
2.2E-01 |
|
Lungs |
5.3E-02 |
7.1E-02 |
1.2E-01 |
1.9E 01 |
3.3E-01 |
|
Ovaries |
4.3E-02 |
5.9E-02 |
9.2E-02 |
1.4E-01 |
2.6E-01 |
|
Pancreas |
5.2E-02 |
6.2E-02 |
1.0E-01 |
1.5E-01 |
2.7E-01 |
|
Red marrow |
5.4E-02 |
7.4E-02 |
9.9E-02 |
1.4E-01 |
2.4E-01 |
|
Spleen |
4.2E-02 |
5.1E-02 |
8.1E-02 |
1.2E-01 |
2.3E-01 |
|
Testes |
2.8E-02 |
3.5E-02 |
5.8E-02 |
9.4E-02 |
1.8E-01 |
|
Thyroid |
2.1E+02 |
3.4E+02 |
5.1E+02 |
1.1E+03 |
2.0E+03 |
|
Uterus |
5.4E-02 |
6.8E-02 |
1.1E-01 |
1.7E-01 |
3.1E-01 |
|
Other tissue |
6.5E-02 |
8.9E-02 |
1.4E-01 |
2.2E-01 |
4.0E-01 |
|
Effective | |||||
|
dose equivalent (mSv/MBq) |
6.6E+00 |
1.0E+01 |
1.5E+01 |
3.4E+01 |
6.2E+01 |
Thyroid uptake 35%
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
4.2E-02 |
5.0E-02 |
8.7E-02 |
1.4E-01 |
2.8E-01 |
|
* Bladder wall |
4.0E-01 |
5.0E-01 |
7.6E-01 |
1.2E+00 |
2.3E+00 |
|
Bone surfaces |
7.6E-02 |
1.2E-01 |
1.6E-01 |
2.3E-01 |
3.5E-01 |
|
Breast |
6.7E-02 |
6.6E-02 |
1.3E-01 |
2.2E-01 |
4.0E-01 |
|
GI-tract | |||||
|
Stomach wall |
4.6E-01 |
5.9E-01 |
8.5E-01 |
1.5E+00 |
3.0E+00 |
|
* Small intest |
2.8E-01 |
3.5E-01 |
6.2E-01 |
1.0E+00 |
2.0E+00 |
|
* ULI wall |
5.8E-02 |
6.5E-02 |
1.0E-01 |
1.7E-01 |
3.0E-01 |
|
* LLI wall |
4.0E-02 |
5.1E-02 |
8.0E-02 |
1.3E-01 |
2.4E-01 |
|
* Kidneys |
5.6E-02 |
7.2E-02 |
1.1E-01 |
1.7E-01 |
2.9E-01 |
|
Liver |
3.7E-02 |
4.9E-02 |
8.2E-02 |
1.4E-01 |
2.7E-01 |
|
Lungs |
9.0E-02 |
1.2E-01 |
2.1E-01 |
3.3E-01 |
5.6E-01 |
|
Ovaries |
4.2E-02 |
5.7E-02 |
9.0E-02 |
1.4E-01 |
2.7E101 |
|
Pancreas |
5.4E-02 |
6.9E-02 |
1.1E-01 |
1.8E-01 |
3.2E-01 |
|
Red marrow |
8.6E-02 |
1.2E-01 |
1.6E-01 |
2.2E-01 |
3.5E-01 |
|
Spleen |
4.6E-02 |
5.9E-02 |
9.6E-02 |
1.5E-01 |
2.8E-01 |
|
Testes |
2.6E-02 |
3.2E-02 |
5.4E-02 |
8.9E-02 |
1.8E-01 |
|
Thyroid |
5.0E+02 |
7.9E+02 |
1.2E+03 |
2.6E+03 |
4.7E+03 |
|
Uterus |
5.0E-02 |
6.3E-02 |
1.0E-01 |
1.6E-01 |
3.0E-01 |
|
Other tissue |
1.1E-01 |
1.6E-01 |
2.6E-01 |
4.1E-01 |
7.1E-01 |
|
Effective | |||||
|
dose equivalent (mSv/MBq) |
1.5E+01 |
2.4E+01 |
3.6E+01 |
7.8E+01 |
1.4E+02 |
Thyroid uptake 55%
|
Organ |
Adult |
15 years |
10 years |
5 years |
1 year |
|
Adrenals |
4.9E-02 |
5.8E-02 |
1.1E-01 |
1.7E-01 |
3.4E-01 |
|
* Bladder wall |
2.9E-01 |
3.6E-01 |
5.4E-01 |
8.5E-01 |
1.6E+00 |
|
Bone surfaces |
1.1E-01 |
1.7E-01 |
2.2E-01 |
3.2E-01 |
4.8E-01 |
|
Breast |
9.1E-02 |
8.9E-02 |
1.9E-01 |
3.1E-01 |
5.6E-01 |
|
GI-tract | |||||
|
Stomach wall |
4.6E-01 |
5.9E-01 |
8.6E-01 |
1.5E+00 |
3.0E+00 |
|
* Small intest |
2.8E-01 |
3.5E-01 |
6.2E-01 |
1.0E+00 |
2.0E+00 |
|
* ULI wall |
5.8E-02 |
6.7E-02 |
1.1E-01 |
1.8E-01 |
3.2E-01 |
|
* LLI wall |
3.9E-02 |
4.9E-02 |
7.8E-02 |
1.3E-01 |
2.4E-01 |
|
* Kidneys |
5.1E-02 |
6.8E-02 |
1.0E-0 |
1.7E-01 |
2.9E-01 |
|
Liver |
4.3E-02 |
5.8E-02 |
9.7E-02 |
1.7E-0 |
3.3E-01 |
|
Lungs |
1.3E-01 |
1.8E-01 |
3.0E-0 |
4.8E-01 |
8.0E-01 |
|
Ovaries |
4.1E-02 |
5.6E-02 |
9.0E-02 |
1.5E-01 |
2.7E-01 |
|
Pancreas |
5.8E-02 |
7.6E-02 |
1.3E-01 |
2.1E-0 |
3.8E-01 |
|
Red marrow |
1.2E-01 |
1.8E-01 |
2.2E-01 |
2.9E-01 |
4.6E-01 |
|
Spleen |
5.1E-02 |
6.8E-02 |
1.1E-01 |
1.7E-01 |
3.3E-01 |
|
Testes |
2.6E-02 |
3.1E-02 |
5.2E-02 |
8.7E-02 |
1.7E-01 |
|
Thyroid |
7.9E+02 |
1.2E+03 |
1.9E+03 |
4.1E+03 |
7.4E+03 |
|
Uterus |
4.6E-02 |
6.0E-02 |
9.9E-02 |
1.6E-01 |
3.0E-01 |
|
Other tissue |
1.6E-01 |
2.4E-01 |
3.7E-01 |
5.9E-01 |
1.0E+00 |
|
Effective dose equivalent (mSv/MBq) |
2.4E+01 |
3.7E+01 |
5.6E+01 |
1.2E+2 |
2.2E+02 |
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)