Ultra-Technekow Fm
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ultra-TechneKow FM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours to technetium (99Tc) which, in view of its long half-life of 2.13 x 105 years can be regarded as quasi stable. A sterile generator containing the parent isotope 99Mo, adsorbed to an aluminium oxide column. The 99Mo on the column is in equilibrium with the formed daughter isotope 99mTc. The generators are supplied with the following 99Mo activity amounts at activity reference time:
|
GBq |
GBq |
|
2.15 |
17.20 |
|
4.30 |
21.50 |
|
6.45 |
25.80 |
|
8.60 |
30.10 |
|
10.75 |
34.40 |
|
12.90 |
43.00 |
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Radionuclide generator.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
The eluate from the generator (Sodium Pertechnetate (99mTc) Injection Ph. Eur.) may be used as a reagent for labelling of various carrier compounds supplied as kits or administered directly in-vivo.
A When administered intravenously, the sterile sodium pertechnetate (99mTc) solution is used as a diagnostic aid in the following:
• Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease.
• Salivary gland scintigraphy: to assess salivary gland function
and duct patency.
• Location of ectopic gastric mucosa: Meckel's diverticulum.
• Cerebral scintigraphy: to identify breaches in the blood-brain barrier caused by tumour, infarction, haemorrhage and oedema, when no other methods are available.
B When used in conjunction with pre-treatment with a reducing agent to effect technetium (99mTc)-labelling of red blood cells:
• Cardiac and vascular scintigraphy
- angiocardioscintigraphy for:
* evaluation of ventricular ejection fraction
* evaluation of global and regional cardiac wall motion
* myocardial phase imaging
- organ perfusion or vascular abnormalities imaging
• Diagnosis and localisation of occult gastrointestinal bleeding.
C Following instillation of sterile sodium pertechnetate (99mTc) solution into the eye:
• Lacrimal duct scintigraphy: to assess patency of tear ducts
4.2 Posology and method of administration
Sodium pertechnetate (99mTc) is normally administered intravenously at activities which vary widely according to the clinical information required and the equipment employed. Other activities may be justifiable. It should be noted that in each country physicians should follow the Diagnostic Reference Levels and the rules set out by local law. Pre-treatment of patients with thyroid blocking agents or reducing agents may be necessary for certain indications. Recommended activities are as follows:
Adults and the elderly:
• Thyroid scintigraphy: 18.5-80 MBq
Scintigraphy performed 20 minutes after intravenous injection.
• Salivary gland scintigraphy: 40 MBq
Scintigraphy performed immediately after intravenous injection and at regular intervals up to 15 minutes.
• Meckel's diverticulum scintigraphy: 400 MBq Scintigraphy performed immediately after intravenous injection and at regular intervals up to 30 minutes.
• Brain scintigraphy: 370-800 MBq
Rapid sequential images are taken immediately within the first minute after intravenous administration; static images 1 to 4 hours later. Thyroid and choroid plexus should be blocked to avoid nonspecific 99mTc uptake.
• Cardiac and vascular scintigraphy: 740-925 MBq
Red cells are labelled in-vivo or in-vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images over 30 minutes.
• Gastrointestinal bleeding: 740-925 MBq
Red cells are labelled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images at appropriate intervals for up to 24 hours.
• Lacrimal duct scintigraphy: 2-4 MBq each eye
Drops are instilled into the eye and dynamic images are taken over 2 minutes, followed by static images at appropriate intervals over 20 minutes.
Children:
The activity for administration to children may be calculated from the recommended range of adult activity and adjusted according to body weight or surface area. However, the Paediatric Task Group of EANM recommends that the activity to be administered to a child should be calculated from the body weight according to the following table:
Fraction of adult dose:
|
3 kg = 0.1 4 kg = 0.14 kg = 0.27 |
6 kg = 0.19 |
8 kg = 0.23 |
10 |
|
12 kg = 0.32 kg = 0.44 20 kg = 0.46 |
14 kg = 0.36 |
16 kg = 0.40 |
18 |
|
22 kg = 0.50 kg = 0.58 30 kg = 0.62 |
24 kg = 0.53 |
26 kg = 0.56 |
28 |
|
32 kg = 0.65 kg = 0.73 40 kg = 0.76 |
34 kg = 0.68 |
36 kg = 0.71 |
38 |
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 6466 kg = 0.98 68 kg = 0.99
In very young children (up to 1 year) a minimum dose of 20 MBq (10 MBq in thyroid scintigraphy) for direct administration or 80 MBq for red blood cell labelling is necessary in order to obtain images of sufficient quality.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
4.4 Special warnings and precautions for use
This radiopharmaceutical may be received, used and administered only by authorized persons. Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organizations. Radiopharmaceuticals intended for administration to patients should be prepared by the user in a manner that satisfies both radiological safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken, that comply with the requirements of Good Pharmaceutical Manufacturing Practice for pharmaceuticals.
During brain scintigraphy, pertechnetate uptake may occur in the plexus choroideus which might be misinterpreted as a damage of the blood brain barrier (false positive). To avoid such false positives and to minimize irradiation by reduction of pertechnetate accumulation in the thyroid and salivary glands, potassium perchlorate should be given prior to brain scintigraphy; (see also section 5.2). Potassium perchlorate blockade of thyroid and salivary glands should also be performed in lacrimal duct scintigraphy.
4.5 Interaction with other medicinal products and other forms of interaction
Drug interactions have been reported in brain scintigraphy where there can be increased uptake of (99mTc) pertechnetate in the walls of cerebral ventricles as a result of methotrexate-induced ventriculitis. In abdominal imaging drugs, such as atropine, isoprenaline and analgesics, can result in a delay in gastric emptying and redistribution of (99mTc) pertechnetate.
4.6 Fertility, Pregnancy and lactation
Pregnancy
99mTc (as free pertechnetate) has been shown to cross the placental barrier.
When it is necessary to administer radioactive medicinal products to a woman 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 particularly important that the radiation exposure should be the minimum consistent with achieving the desired clinical information. Alternative techniques which do not involve ionising radiation should be considered.
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 the foetus.
Direct administration of 800 MBq sodium pertechnetate (99mTc) to a patient results in an absorbed dose to the uterus of 6.5 mGy. Following pretreatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (99mTc) results in an absorbed dose to the uterus of 4.8 mGy. Administration of 925 MBq 99mTc labelled red blood cells results in an absorbed dose to the uterus of 3.6 mGy. Doses above 0.5 mGy should be regarded as a potential risk to the foetus.
Lactation
Before administering a radioactive medicinal product to a woman 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. If the administration is considered necessary, breast-feeding should be interrupted for at least 12 hours and the expressed feeds discarded. Breastfeeding can be restarted when the activity level in the milk will not result in a radiation dose to the child greater than 1 mSv.
4.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Information on adverse reactions is available from spontaneous reporting. The reported reaction types are anaphylactoid reactions, vegetative reactions, as well as different kinds of injection site reactions. 99mTc-perchtechnetate from the UltraTechnekow FM generator is used for radioactive labeling of a variety of compounds. These pharmaceuticals generally have a higher potential for side effects than 99mTc, and therefore the reported side effects are rather related to the labelled compounds than to 99mTc. The possible types of side effects following intravenous administration of a 99mTc-labelled pharmaceutical preparation will be dependent on the specific compound being used. Such information should be available from the manufacturer of the pharmaceutical which is to be radiolabelled.
Anaphylactoid reactions:
Anaphylactoid reactions have been reported following intravenous injection of 99mTc-perchtechnetate and include various skin or respiratory symptoms like skin irritations, oedema, or dyspnoea.
Vegetative reactions (nervous system and gastrointestinal disorders):
Single cases of severe vegetative reactions have been reported, however, most of the reported vegetative effects include gastrointestinal reactions like nausea or vomiting. Other reports include vasovagal reactions like headache or dizziness. Vegetative effects are rather considered to be related to the examinational setting than to technetium (99mTc), especially in anxious patients.
General disorders and administration site conditions
Other reports describe local injection site reactions. Such reactions are related to extravasation of the radioactive material during the injection, and the reported reactions rank from local swelling up to cellulitis. Depending on the administered radioactivity and the labeled compound, extended extravasation may necessitate surgical treatment.
The following table subsumes the observed reaction types and symptoms. Due to the fact that only spontaneous reports could be analysed, no frequency indications could be provided.
Adverse Reactions sorted by System Organ Class
Immune system disorders
Frequency unknown1: Anaphylactoid reactions (e.g. Dyspnoea, coma, urticaria erythema, rash, pruritus, oedema at various location e.g. face oedema)
Nervous system disorders
Frequency unknown1: Vasovagal reactions (e.g. Syncope, tachycardia, bradycardia dizziness, headache, vision blurred, flushing)
Gastrointestinal disorders
Frequency unknown1: Vomiting, nausea, diarrhoea General disorders and administration site conditions
Frequency unknown1: Injection site reactions (e.g. Cellulitis, pain, erythema swelling)
For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic or therapeutic 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 with low frequency because of the low radiation doses incurred. For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered is less than 20 mSv (EDE). Higher doses may be justified in some clinical circumstances.
This product contains no ingredients that have a recognised action or effect, or knowledge of which is important for safe and effective use of the product.
4.9 Overdose
In the event of the administration of a radiation overdose with sodium pertechnetate (99mTc), the absorbed dose should be reduced where possible by increasing the elimination of the radionuclide from the body. Measures to reduce possible harmful effects include frequent voiding of urine and promotion of diuresis and faecal excretion. Very little supportive treatment can be undertaken in the event of an overdose of 99mTc-labelled red blood cells since elimination is dependent on the normal haemolytic process.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Various thyroid diagnostic radiopharmaceuticals ATC code: V09F X01
No pharmacological activity has been observed in the range of doses administered for diagnostic purposes
5.2 Pharmacokinetic properties
The pertechnetate ion has similar biological distribution to iodide and perchlorate ions, concentrating temporarily in salivary glands, choroid plexus, stomach (gastric mucosa) and in the thyroid gland, from which it is released unchanged. The pertechnetate ion also tends to concentrate in areas with increased vascularisation or with abnormal vascular permeability, particularly when pre-treatment with blocking agents inhibits uptake in glandular structures.99mTc is selectively excluded from the cerebrospinal fluid.
Following intravenous administration, pertechnetate (99mTc) is distributed throughout the vascular system from which it is cleared by three main mechanisms:
• Rapid removal, depending on the diffusion equilibrium with interstitial fluid
• Intermediate rate of removal, depending on the concentration of the pertechnetate in glandular tissues, mainly thyroid, salivary and gastric fundus glands which have an ionic pump mechanism
• Slow removal, by glomerular filtration by the kidneys, dependent on rate of urinary excretion.
Plasma clearance has a half-life of approximately 3 hours. Excretion during the first 24 hours following administration is mainly urinary (approximately 25%) with faecal excretion occurring over the next 48 hours. Approximately 50% of the administered activity is excreted within the first 50 hours. When selective uptake of pertechnetate (99mTc) in glandular structures is inhibited by the preadministration of blocking agents, excretion follows the same pathways but there is a higher rate of renal clearance. When pertechnetate (99mTc) is administered in association with pre-treatment with reducing agents such as stannous/medronate which cause a "stannous loading" of red blood cells, up to approximately 95% of the administered activity is taken up by the red blood cells where it becomes bound within the cells. Any unbound pertechnetate (99mTc) is cleared by the kidneys; radioactivity in the plasma normally constitutes less than 5% of the intravascular activity. The fate of the technetium-99m follows that of the labelled erythrocytes themselves and the activity is cleared very slowly. A small level of elution of activity from the circulating red cells is thought to occur.
5.3 Preclinical safety data
There is no information on acute, subacute and chronic toxicity from single or repeated dose administration. The quantity of sodium pertechnetate (99mTc) administered during clinical diagnostic procedures is very small and apart from allergic reactions, no other adverse reactions have been reported.
Reproductive Toxicity: Placental transfer of 99mTc from intravenously administered sodium pertechnetate (99mTc) has been studied in mice. The pregnant uterus was found to contain as much as 60% of the injected 99mTc when administered without perchlorate pre-administration. Studies performed on pregnant mice during gestation, gestation and lactation, and lactation alone showed changes in progeny which included weight reduction, hairlessness and sterility.
6.1 List of excipients
• Sodium chloride
• Water for injections
6.2 Incompatibilities
To date no incompatibilities are known.
6.3 Shelf life
The expiry date for this product is 9 days after activity reference time.
The eluate can be used for 8 hours. Expiry date for the eluent is 3 years after manufacture; expiry date for both TechneVials and sterile vial is 1 year after manufacture.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate.
Generators must be kept in an Ultra-TechneKow Safe (with sufficient lead protection) or behind an adequate laboratory shield.
The eluate should be stored at 2-8°C. TechneVials and sterile vial must be stored below 25 °C. Storage should be in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
Generator
The generator consists of a cartridge containing an aluminiumoxide column charged with 99Mo and locked between two filters. One side of the cartridge is connected to the shielded, sterile supply needle in the eluent holder. The other side is connected to the similarly shielded, sterile outlet needle in the elution station. A second sterile needle in the eluent holder serves to eliminate the underpressure in the eluent vial under sterile conditions. The generator column is shielded by sufficient lead, depending on the 99Mo activity. The shielded
generator with the built-in station and the eluent holder are packed in an hermetically sealed tin, which is also the package. Elution occurs by placing the eluent vial on the needles in the eluent holder, followed by complete or partial filling of evacuated vials.
Accessories
The first time an Ultra-Technekow FM is supplied, it comes with:
• 1 TechneVial shield or UltraVial Shield
• 1 Sterile vial shielding, unless supplied with the Ultra-Technekow Safe.
Each Ultra-Technekow FM is supplied with:
• 7 TechneVials, sterile, evacuated vials of 5, 11 or 25 ml
• 1 Sterile vial is provided with the elution set.
• 1 Eluent vial, 100 ml of sterile, physiological salt solution
• 7 Disinfection swabs
• 7 Labels with the radioactivity symbol.
6.6 Special precautions for disposal
Radiopharmaceutical agents should be used only by qualified personnel with the appropriate government authorizations for the use and manipulations of radionuclides. This radiopharmaceutical may be received, used and administered only by authorised personnel in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of 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 Pharmaceutical Manufacturing Practice for radiopharmaceuticals.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Mallinckrodt Medical B.V.
Westerduinweg 3 1755 LE Petten Netherlands
8
MARKETING AUTHORISATION NUMBER(S)
PL 12288/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/06/1996
21/03/2001
10 DATE OF REVISION OF THE TEXT
27/02/2015
11 DOSIMETRY (IF APPLICABLE)
According to ICRP 53, the radiation doses absorbed by a patient following direct administration of sodium pertechnetate (99mTc) are as follows:
(I) Without pre-treatment with blocking agent:
Absorbed dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 Year |
10 Year |
5 Year |
1 Year |
|
Adrenals |
3.6E-03 |
4.7E-03 |
7.1E-03 |
1.1E-02 |
1.9E-02 |
|
Bladder wall |
1.9E-02 |
2.3E-02 |
3.4E-02 |
5.1E-02 |
9.1E-02 |
|
Bone surfaces |
3.9E-03 |
4.7E-03 |
6.9E-03 |
1.0E-02 |
1.9E-02 |
|
Breast |
2.3E-03 |
2.3E-03 |
3.5E-03 |
5.7E-03 |
1.1E-02 |
|
Gl tract Stomach wall |
2.9E-02 |
3.6E-02 |
5.0E-02 |
8.1E-02 |
1.5E-01 |
|
Small intestine |
1.8E-02 |
2.2E-02 |
3.4E-02 |
5.2E-02 |
9.0E-02 |
|
ULI wall |
6.2E-02 |
7.7E-02 |
1.3E-01 |
2.1E-01 |
3.9E-01 |
|
LLI wall |
2.2E-02 |
2.8E-02 |
4.6E-02 |
7.4E-02 |
1.4E-01 |
|
Kidneys |
5.0E-03 |
6.0E-03 |
8.7E-03 |
1.3E-02 |
2.1E-02 |
|
Liver |
3.9E-03 |
4.8E-03 |
8.0E-03 |
1.3E-02 |
2.2E-02 |
|
Lungs |
2.7E-03 |
3.4E-03 |
5.1E-03 |
7.9E-03 |
1.4E-02 |
|
Ovaries |
1.0E-02 |
1.3E-02 |
1.9E-02 |
2.7E-02 |
4.5E-02 |
|
Pancreas |
5.9E-03 |
7.2E-03 |
1.1E-02 |
1.6E-02 |
2.7E-02 |
|
Salivary glands |
9.3E-03 |
1.2E-02 |
1.7E-02 |
2.4E-02 |
3.9E-02 |
|
Red marrow |
6.1E-03 |
7.1E-03 |
9.8E-03 |
1.3E-02 |
2.0E-02 |
|
Spleen |
4.4E-03 |
5.3E-03 |
7.9E-03 |
1.2E-02 |
2.1E-02 |
|
Testes |
2.7E-03 |
3.7E-03 |
5.9E-03 |
9.3E-03 |
1.7E-02 |
|
Thyroid |
2.3E-02 |
3.7E-02 |
5.6E-02 |
1.2E-01 |
2.3E-01 |
|
Uterus |
8.1E-03 |
1.0E-02 |
1.6E-02 |
2.4E-02 |
4.0E-02 |
|
Other tissue |
3.4E-03 |
4.0E-03 |
6.0E-03 |
9.3E-03 |
1.7E-02 |
|
Effective Dose Equivalent (mSv/MBq) |
1.3E-02 |
1.6E-02 |
2.5E-02 |
4.0E-02 |
7.3E-02 |
(II) With pre-treatment with blocking agent:
Absorbed dose per unit activity (mGy/MBq) when blocking agents are given
|
Organ |
Adult |
15 Year |
10 Year |
5 Year |
1 Year |
|
Adrenals |
3.3E-03 |
4.1E-03 |
6.3E-03 |
9.5E-03 |
1.7E-02 |
|
Bladder wall |
3.2E-02 |
3.9E-02 |
5.7E-02 |
8.4E-02 |
1.5E-01 |
|
Bone surfaces |
3.8E-03 |
4.5E-03 |
6.7E-03 |
1.0E-02 |
1.8E-02 |
|
Breast |
2.5E-03 |
2.5E-03 |
3.6E-03 |
5.7E-03 |
1.1E-02 |
|
Gl tract Stomach wall |
3.2E-03 |
4.1E-03 |
6.6E-03 |
9.3E-03 |
1.7E-02 |
|
Small intestine |
4.1E-03 |
4.9E-03 |
7.6E-03 |
1.1E-02 |
2.0E-02 |
|
Ull wall |
3.8E-03 |
4.9E-03 |
7.1E-03 |
1.1E-02 |
1.9E-02 |
|
LLI wall |
4.5E-03 |
5.9E-03 |
9.2E-03 |
1.3E-02 |
2.3E-02 |
|
Kidneys |
4.7E-03 |
5.7E-03 |
8.2E-03 |
1.2E-02 |
2.1E-02 |
|
Liver |
3.1E-03 |
3.8E-03 |
5.9E-03 |
9.0E-03 |
1.6E-02 |
|
Lungs |
2.8E-03 |
3.5E-03 |
5.2E-03 |
7.9E-03 |
1.4E-02 |
|
Ovaries |
4.7E-03 |
6.0E-03 |
8.9E-03 |
1.3E-02 |
2.3E-02 |
|
Pancreas |
3.5E-03 |
4.4E-03 |
6.7E-03 |
1.0E-02 |
1.8E-02 |
|
Red Marrow |
4.5E-03 |
5.4E-03 |
7.8E-03 |
1.1E-02 |
1.8E-02 |
|
Spleen |
3.2E-03 |
3.9E-03 |
5.9E-03 |
9.0E-03 |
1.6E-02 |
|
Testes |
3.2E-03 |
4.4E-03 |
6.8E-03 |
1.1E-02 |
1.9E-02 |
|
Thyroid |
2.1E-03 |
3.5E-02 |
5.7E-03 |
9.0E-03 |
1.6E-02 |
|
Uterus |
6.6E-03 |
7.9E-03 |
1.2E-02 |
1.8E-02 |
3.0E-02 |
|
Other tissue |
2.9E-03 |
3.5E-03 |
5.3E-03 |
8.2E-03 |
1.5E-02 |
|
Effective Dose Equivalent (mSv/MBq) |
5.3E-03 |
6.6E-03 |
9.8E-02 |
1.5E-02 |
2.6E-02 |
The effective dose equivalent resulting from an administered activity of 800 MBq sodium pertechnetate (99mTc) is 10.4 mSv. Following pretreatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (99mTc) results in an effective dose equivalent of 4.24 mSv.
(III) The radiation doses absorbed by a patient following intravenous injection of 99mTc labelled red blood cells are as follows:
Absorbed dose per unit activity administered (mGy/MBq)
|
Organ |
Adult |
15 Year |
10 Year |
5 Year |
1 Year |
|
Adrenals |
8.7E-03 |
1.1E-02 |
1.7E-02 |
2.7E-02 |
4.9E-02 |
|
Bladder wall |
9.2E-03 |
1.2E-02 |
1.7E-02 |
2.5E-02 |
4.6E-02 |
|
Bone surfaces |
9.2E-03 |
1.3E-02 |
2.3E-02 |
3.9E-02 |
7.8E-02 |
|
Breast |
4.3E-03 |
4.5E-03 |
7.2E-03 |
1.1E-02 |
1.9E-02 |
|
Gl tract Stomach wall |
4.8E-03 |
6.1E-03 |
9.5E-03 |
1.4E-02 |
2.4E-02 |
|
Small intest |
4.4E-03 |
5.3E-03 |
8.1E-03 |
1.2E-02 |
2.2E-02 |
|
ULI wall |
4.3E-03 |
5.5E-03 |
7.9E-03 |
1.3E-02 |
2.1E-02 |
|
LLI wall |
3.9E-03 |
5.3E-03 |
8.0E-03 |
1.1E-02 |
2.1E-02 |
|
Heart |
2.3E-02 |
2.8E-02 |
4.1E-02 |
6.2E-02 |
1.1E-01 |
|
Kidneys |
1.0E-02 |
1.2E-02 |
1.9E-02 |
3.0E-02 |
5.5E-02 |
|
Liver |
7.5E-03 |
8.8E-03 |
1.4E-02 |
2.1E-02 |
3.8E-02 |
|
Lungs |
1.4E-02 |
1.8E-02 |
2.9E-02 |
4.5E-02 |
8.5E-02 |
|
Ovaries |
4.2E-03 |
5.4E-03 |
7.9E-03 |
1.2E-02 |
2.1E-02 |
|
Pancreas |
6.2E-03 |
7.5E-03 |
1.1E-02 |
1.7E-02 |
2.9E-02 |
|
Red marrow |
7.3E-03 |
8.8E-03 |
1.3E-02 |
2.0E-02 |
3.5E-02 |
|
Spleen |
1.5E-02 |
1.8E-02 |
2.8E-02 |
4.4E-02 |
8.4E-02 |
|
Testes |
2.7E-03 |
3.7E-03 |
5.4E-03 |
8.3E-03 |
1.5E-02 |
|
Thyroid |
4.9E-03 |
7.1E-03 |
1.2E-02 |
1.9E-02 |
3.5E-02 |
|
Uterus |
4.7E-03 |
5.7E-03 |
8.5E-03 |
1.3E-02 |
2.2E-02 |
|
Other tissue |
3.7E-03 |
4.4E-03 |
6.4E-03 |
9.8E-03 |
1.8E-02 |
|
Effective Dose Equivalent (mSv/MBq) |
8.5E-03 |
1.1E-02 |
1.6E-02 |
2.5E-02 |
4.6E-02 |
The effective dose equivalent resulting from an administration of 925 MBq 99mTc-labelled red blood cells is 7.86 mSv.
(IV) The radiation dose absorbed by the lens of the eye following administration of sodium pertechnetate (99mTc) for lacrimal duct scintigraphy is estimated to be 0.038 mGy/MBq. This results in an effective dose equivalent of less than 0.01 mSv for an administered activity of 4 MBq.
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)
Adverse reactions derived from spontaneous reporting