Patient leaflet - Adreview 74 MBq/ml solution for injection
1. What AdreView is and what it is used for
AdreView contains the active substance called ‘iobenguane’.
This medicine is a radiopharmaceutical product for diagnostic use only. It is used only to help identify illness.
AdreView is given before a scan and helps a special camera see inside a part of your body.
Once injected it can be seen from outside your body by a special
camera used in the scan.
The scan can help your doctor see certain types of tumour in
the adrenal or thyroid glands, and to see how well a tumour is responding to treatment.
Some other people are given this medicine before a scan to see
how well the heart is working.
Your nuclear medicine doctor will explain which part of your body will be scanned.
When AdreView is used, you are exposed to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to these small amounts of radiation.
2. What you need to know before AdreView is used
AdreView must not be used:
if you are allergic (hypersensitive) to the active ingredient or any of
the other ingredients of this medicine (listed in section 6).
AdreView must not be given to premature babies or newborn
babies (neonates).
Do not use AdreView if the above mentioned applies to you. Talk to your nuclear medicine doctor before you are given AdreView or if you are not sure.
Warnings and precautions
Talk to your doctor or nurse before using AdreView if you:
- are pregnant or think you may be pregnant.
- are brest-feeding.
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and AdreView
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines. Some medicines may affect the way AdreView works.
These include:
Certain products used to treat hypertension such as diltiazem,
nifedipine or verapamil.
Antidepressants such as amitryptiline or imipramine. • ‘Sympathomimetic agents’ (used as decongestants in cough
or cold remedies) such as phenylephrine, ephedrine or phenylpropanolamine.
- Reserpine (used to treat mental problems or high blood pressure). • Labetalol (used to treat high blood pressure).
- Phenothiazine (used to treat mental problems).
- Cocaine.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before having AdreView.
Pregnancy and breast-feeding
You must inform the nuclear medicine doctor before you are given AdreView 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 the nuclear medicine doctor who will supervise the procedure.
If you are pregnant
The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
If you are breastfeeding
Do not breast-feed if you are given AdreView. This is because small amounts of ‘radioactivity’ may pass into the mother’s milk. If you are breast-feeding, your nuclear medicine doctor may wait until you have finished breast-feeding before using AdreView. If it is not possible to wait your nuclear medicine doctor will ask you to:
stop breast-feeding for 3 days after AdreView is given • instead use formula feed for your child.
express (remove) the breast milk regularly during this period and throw away any breast milk you have expressed. Your doctor will let you know when you can start breast-feeding again.
Driving and using machines
Ask your nuclear medicine doctor if you can drive or use machines after you have been given AdreView.
AdreView contains
Benzyl alcohol 10.4 mg/ml. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
- 4.23 mg sodium per ml. This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. this medicinal product is essentially sodium free.
Important information about AdreView
When AdreView is used you are exposed to radioactivity.
- Your doctor will always consider the possible risks and benefits before you are given the medicine.
3. How AdreView is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. AdreView will only be used in special controlled areas. This product will only be handled and given to you by professionals who are trained and qualified to use it safely. They will take special care for the safe use of this product and will keep you informed of their actions.
Administration of AdreView and conduct of the procedure
The nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine at least one hour before you are given AdreView. This medicine is to stop radioactivity building up in your thyroid gland.
Your nuclear medicine doctor may ask you to drink plenty of water before the start of the examination and the 24 hours after the study in order to urinate as often as possible to help remove it from your body faster.
Dose
The nuclear medicine doctor supervising the procedure will decide on the amount of AdreView to be used in your case. The doctor will choose the smallest amount necessary.
PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
SUMMARY OF PRODUCT CHARACTERISTICS
- 1. NAME OF THE MEDICINAL PRODUCT
AdreView 74 MBq/ml solution for injection
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Iobenguane (123I), 37 to 740 MBq, 74 MBq/ml at calibration date and hour.
At calibration time, the radionuclidic purity is at least 99.95% iodine-123 and the main radionuclidic impurities being iodine-125 and tellurium-121 occur for less than 0.05%. The radiochemical purity is at least 97% [123I]iobenguane and the main radiochemical impurity is iodine-123 which is present for less than 3% during the shelf-life (see section 6.3).
The specific activity is greater than 0.15 and less than 1.5 TBq/mmol (0.46-4.6 GBq/mg iobenguane sulphate).
Iodine-123 is a cyclotron produced radionuclide with a physical half-life of 13.2 h, which decays to tellurium- 123 by electron capture while transmitting pure gamma radiation, with the main emission taking place at 159 keV (Energy level Abundance 83.6 %).
This medicinal product contains:
- Benzyl alcohol: 10.4 mg/ml
Sodium: 4.23 mg/ml. This needs to be taken into consideration for patients on a controlled sodium
diet.
For the full list of excipients, see section 6.1.
The contents of the vial may be used for one or more administrations until time of expiry.
- 3. PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution.
- 4. CLINICAL PARTICULARS
4.1. Therapeutic indications
This medicinal product is for diagnostic use only.
Diagnostic scintigraphic localisation of tumours originating in tissue that embryologically stems from the neural crest. These are pheochromocytomas, paragangliomas, chemodectomas and ganglioneuromas. Detection, staging and follow-up on therapy of neuroblastomas.
Evaluation of the uptake of iobenguane. The sensitivity to diagnostic visualisation is different for the listed pathological entities.
Pheochromocytomas and neuroblastomas are sensitive in approx. 90% of patients, carcinoids in 70% and medullary carcinoma of the thyroid (MCT) in only 35%.
Functional studies of the adrenal medulla (hyperplasia) and the myocardium (sympathetic innervation). 4.2. Posology and method of administration
Posology
Iobenguane (123I) is administered according to the following dosage scheme:
Paediatric population
Children under 6 months (must not be given to premature babies or neonates - see section 4.4):
4 MBq per kg body weight (max. 40 MBq)
Children between 6 months and 2 years: 4 MBq per kg body weight (min. 40 MBq). • Children over 2 years: a fraction of the adult dosage should be chosen, dependent on body weight. The recommended dosages are as follows:
weight activity weight activity weight activity
3 kg
4 kg
6 kg
8 kg
10 kg
20 MBq
28 MBq
38 MBq
46 MBq
54 MBq
15 kg
20 kg
25 kg
30 kg
76 MBq 92 MBq 110 MBq 124 MBq
35 kg
40 kg
45 kg
50 kg
140 MBq 152 MBq 162 MBq 176 MBq
Adults
The recommended dosage is 80-200 MBq, higher activities may be justifiable. Elderly
No special dosage scheme is required for the elderly patient.
Method of administration
Iobenguane (123I) is administered by slow intravenous injection or infusion. If desired the administration volume can be increased by dilution.
The instructions for preparation of radiopharmaceuticals are given in section 12. 4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Must not be given to premature babies or neonates
4.4. Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions.
The possibility of hypersensitivity including anaphylactic/anaphylactoid reactions should always be considered. If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Individual benefit/risk justification
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Renal impairment and hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Paediatric population
For information on the use in paediatric population, see section 4.2. Administered activity for children should be determined based on body weight and should be as low as reasonably achievable for diagnostic image quality.
This medicinal product contains benzyl alcohol (10.4 mg/ml). Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Patient preparation
The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hour after the examination in order to reduce radiation. Before administration of AdreView, administer Potassium Iodide Oral Solution or Lugol’s Solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine-123 by the patient’s thyroid. Administer the blocking agent at least one hour before the dose of AdreView. The dose is slowly administered intravenously over several minutes.
Whole body anterior and posterior scintigraphic images and/or relevant spot images and/or SPECT images are obtained 24 hours after the [123I]iobenguane administration. These views are eventually repeated at 48 hours.
The uptake of iobenguane (123I) in the chromaffin granules might, in theory, cause rapid noradrenalin secretion which can induce a hypertensive crisis, although the likelihood of such an occurrence is believed to be extremely low. This necessitates constant monitoring of the patient during administration. Iobenguane (123I) must be administered slowly (take at least one minute for the administration of a patient dose).
Drugs known or expected to reduce the Iobenguane uptake should be stopped before administration of AdreView (usually 4 biological half-lives). Whether a particular medication is to be stopped may depend on which type of investigation with iobenguane (123I) is intended. Consultation with the responsible physician for treatment of the patient will be useful. For details please refer to section 4.5. Specific warnings
This medicinal product contains 10.4 mg/ml benzyl alcohol. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
4.5. Interaction with other medicinal products and other forms of interaction
The following drugs are known or may be expected to prolong or to reduce the uptake of iobenguane in neural crest tumours.
Nifedipine (a Ca-channel blocker) is reported to prolong retention of iobenguane. • Decreased uptake was observed under therapeutic regimens involving the administration
of antihypertensives that deplete norepinephrine stores or reuptake (reserpine, labetalol), calcium- channel blockers (diltiazem, nifedipine, verapamil), tricyclic antidepressives that inhibit norepinephrine transporter function (amitryptiline, imipramine and derivatives), sympathomimetic agents (present in nasal decongestants, such as phenylephrine, ephedrine, pseudoephedrine or phenylpropanolamine), cocaine, and phenothiazine. These drugs should be stopped before administration of iobenguane (123I) (usually for four biological half-lives to allow complete washout). 4.6. Fertility, pregnancy and lactation
Women of childbearing potential
When an administration of radiopharmaceuticals to women of childbearing potential is intended, it is important to determine whether or not she is pregnant. 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 not using radiation (if there are any) should be offerend to the patient.
Pregnancy
No data are available on the use of this product in human 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 likely benefit exceeds the risks incurred by mother and foetus.
Breastfeeding
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should be given as to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast-feeding should be interrupted for three days and the expressed feeds discarded.
Breast-feeding can be restarted when the level in the milk will not result in a radiation dose to a child greater than 1 mSv.
4.7. Effects on the 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 the 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 determined with the data available).
Cardiac disorders Frequency not known (cannot be estimated from the available data) | Palpitations. |
Congenital, familial and genetic disorders Frequency not known (cannot be estimated from the available data) | Hereditary defects. |
Respiratory, thoracic and mediastinal disorders Frequency not known (cannot be estimated from the available data) | Dyspnoea. |
Gastrointestinal disorders Frequency not known (cannot be estimated from the available data) | Abdominal cramps. |
Neoplasms benign, malignant and unspecified (including cysts and polyps) Frequency not known (cannot be estimated from the available data) | Cancer induction. |
Vascular disorders Frequency not known (cannot be estimated from the available data) | Transient hypertension. |
General disorders and administration site conditions Frequency not known (cannot be estimated from the available data) | Heat sensations. |
Immune system disorders Frequency not known (cannot be estimated from the available data) | Blushes, urticaria, nausea, cold chills and other symptoms of anaphylactoid reactions, hypersensitivity. |
When the drug is administered too fast palpitations, dyspnoea, heat sensations, transient hypertension and abdominal cramps may occur during or immediately after administration. Within one hour these symptoms disappear.
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 reasonable 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 effective dose is less than 20 mSv. Higher doses may be justified in some clinical circumstances.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/
4.9. Overdose
The effect of an overdose of iobenguane is due to the release of adrenaline. This effect is of short duration and requires supportive measures aimed at lowering the blood pressure: Prompt injection of a rapidly acting alpha-adrenergic blocking agent (phentolamine) followed by a beta-blocker (propanolol). Because of the renal elimination pathway, maintaining the highest possible urine flow is essential to reduce the influence of radiation. The nature of the radioisotope and the amount of iobenguane present make overdosing improbable.
- 5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Diagnostic radiopharmaceuticals, tumour detection, iobenguane (123I), ATC code: V09IX01
Iobenguane is a radioiodinated aralkylguanidine. Its structure contains the guanidine-group from guanethidine linked to a benzyl-group into which iodine is introduced. Like guanethidine the aralkylguanidines are adrenergic neuron blocking agents. As a consequence of a functional similarity between adrenergic neurons and the chromaffin cells of the adrenal medulla iobenguane is able to localise preferentially in the medulla of the adrenal glands. In addition, localisation in the myocardium occurs. Of the various aralkylguanidines iobenguane is the preferred substance because of its lowest liver uptake and its best in vivo stability, resulting in the lowest achievable thyroid uptake of liberated iodide. Transport of iobenguane across the cell membranes of cells originating from the neural crest is an active process when the concentration of the drug is low (as in diagnostic dosages). The uptake mechanism can be inhibited by uptake inhibitors such as cocaine or desmethylimipramine. After uptake an active mechanism transfers at least part of the intracellular iobenguane into the storage granules within the cells.
5.2. Pharmacokinetic properties
Distribution/Organ uptake
The distribution pattern of iobenguane includes rapid initial uptake in liver (33% of the administered dose) and much less in lungs (3%), myocardium (0.8%), spleen (0.6%), and salivary glands (0.4%). Uptake in normal adrenals (adrenal medulla) can lead to visualisation with [123I]iobenguane. Hyperplastic adrenals show a high uptake.
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In children and adolescents, the quantity to be administered will be adapted to the child’s weight.
AdreView is given as an injection into your vein (intravenous injection). One injection given over several minutes is sufficient to conduct the scan that your doctor needs. You will usually have your scan the day after the injection and it may be repeated.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
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 received more AdreView that you should
An overdose is unlikely because you will receive AdreView precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you would receive the appropriate treatment.
If you have any further questions on the use of AdreView, ask your nuclear medicine doctor who supervises the procedure.
4. Possible side effects
Like all medicines, AdreView can cause side effects, although not everybody gets them.
Allergic reactions
Tell your doctor straight away, if you have an allergic reaction when you are in hospital or a clinic having the scan. The signs may include:
- skin rash or itching or flushing
- swelling of the face
- difficulty breathing
In more serious cases reactions may include:
- passing out (unconsciousness), feeling dizzy or lightheaded • nausea (feeling sick)
- cold chills
If any of the side effects above happen after you leave the hospital or clinic, you should go or be taken straight to the casualty department of your nearest hospital.
The frequency of allergic reactions cannot be estimated from the available data
Other side effects include
If AdreView is injected too quickly you may experience the following:
- fast or irregular heart beat
- difficulty breathing
- feeling warmer than usual
- stomach cramps
transient high blood pressure. Signs of this may be headache and
changes in your eyesight (visual disturbance).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
The radiopharmaceutical product will release low amounts of ionizing radiation, which is associated with a very small risk of cancer and hereditary defects.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/
By reporting side effects you can help provide more information on the safety of this medicine.
5. How AdreView 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.
Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the label.
The following information is intended for the specialist only:
- Do not use this medicine after the expiry date which is stated on the container and vial after’EXP’.
- Store below 25ºC, do not freeze.
- Once opened, store in a refrigerator at 2ºC-8ºC and use within one working day. Storage should be in the original container or equivalent lead shielding.
6. Contents of the pack and further information
What AdreView contains
- The active ingredient is [123I]iobenguane. Each ml of AdreView contains 74 MBq (Megabecquerel – the unit in which radioactivity is measured) of [123I]iobenguane at a fixed time.
- The other ingredients are benzyl alcohol, 3-iodobenzylguanidine, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate and water for injections.
What AdreView looks like and contents of the pack
AdreView is supplied as a single glass vial containing a solution for injection.
Marketing Authorisation Holder
GE Healthcare Limited
Pollards Wood
Nightingales Lane
Chalfont St Giles
Buckinghamshire HP8 4SP
United Kingdom
Manufacturer
GE Healthcare B.V.
De Rondom 8
5612 AP Eindhoven
The Netherlands
This leaflet was last revised in 12/2020.
Marketing Authorisation
UK: PL 00221/0140
Elimination
Iobenguane is to a large extent excreted unaltered by the kidneys. Of the administered doses 70 to 90% are recovered in urine within 4 days. The following metabolic breakdown products were recovered in urine: radioiodide, radioiodinated meta-iodohippuric acid, radioiodinated hydroxyiodobenzylguanidine and radioiodinated meta-iodobenzoic acid. These substances account for approximately 5 to 15% of the administered dose.
5.3. Preclinical safety data
In dogs 20 mg/kg is a lethal dose. Lower dose levels (14 mg/kg) cause transient clinical signs of toxic effect. Repeated intravenous administrations in rats of 20 to 40 mg/kg induce signs of serious clinical toxicity. Repeated intravenous administrations of 5 to 20 mg/kg do induce effects, including respiratory distress, but long term effects are only a slight increase in weight of liver and heart. Repeated administration in dogs of 2.5 to 10 mg/kg do induce clinical effects, including increased blood pressure and abnormalities in heart rate and in cardiac pulse propagation, but all signs were of a transient nature.
In the test systems used no mutagenic effect could be demonstrated.
Studies of carcinogenic effects of iobenguane have not been published.
- 6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Benzyl alcohol
3-iodobenzylguanidine
Sodium dihydrogen phosphate dihydrate
Disodium hydrogen phosphate dihydrate
Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
Can be used up to 36 hours post calibration time indicated on the label.
Once opened, store in a refrigerator (2°C-8°C) and use within one working day. 6.4. Special precautions for storage
Store below 25°C. Do not freeze.
For storage conditions of the opened medicinal product, see section 6.3. Store either in original lead container or in equivalent shielding.
Storage should take place in accordance with national regulations for radioactive materials. 6.5. Nature and contents of container
10 ml medicinal glass vial, closed with a Teflon coated rubber stopper and sealed with an aluminium cap. Each vial is enclosed in a lead container of appropriate thickness.
The contents of the vial may be used for one or more administrations until time of expiry. Pack size: 37 to 740 MBq.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
General warning
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and siposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. If at any time in the preparation of this product the integrity of this vial is compromised it should not be used.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory. The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.
Disposal
After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with local requirements.
- 7. MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Pollards Wood
Nightingales Lane
Chalfont St Giles
Buckinghamshire HP8 4SP
United Kingdom
- 8. MARKETING AUTHORISATION NUMBER
UK: PL 00221/0140
- 9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation: 01 December 1998
Date of last renewal: 18 June 2002
- 10. DATE OF REVISION OF THE TEXT
- 11. DOSIMETRY
The table below shows the dosimetry as calculated according to Publication 80 of the ICRP (International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon Press 1998).
| Organ | Absorbed dose per unit activity administered (mGy/MBq) | ||||
| Adult | 15 years | 10 years | 5 years | 1 year | |
Adrenals Bladder Bone surfaces Brain Breast Gall bladder GI-tract Stomach SI Colon (ULI (LLI Heart Kidneys Liver Lungs Muscles Oesophagus Ovaries Pancreas Red marrow Skin Spleen Testes Thymus Thyroid Uterus | 1.7E-02 4.8E-02 1.1E-02 4.7E-03 5.3E-03 2.1E-02 8.4E-03 8.4E-03 8.6E-03 9.1E-03 7.9E-03 1.8E-02 1.4E-02 6.7E-02 1.6E-02 6.6E-03 6.8E-03 8.2E-03 1.3E-02 6.4E-03 4.2E-03 2.0E-02 5.7E-03 6.8E-03 5.6E-03 1.0E-02 | 2.2E-02 6.1E-02 1.4E-02 6.0E-03 6.8E-03 2.5E-02 1.1E-02 1.1E-02 1.1E-02 1.2E-02 1.0E-02 2.4E-02 1.7E-02 8.7E-02 2.3E-02 8.4E-03 8.8E-03 1.1E-02 1.7E-02 7.9E-03 5.1E-03 2.8E-02 7.5E-03 8.8E-03 7.3E-03 1.3E-02 | 3.2E-02 7.8E-02 2.2E-02 9.9E-03 1.1E-02 3.6E-02 1.9E-02 1.8E-02 1.8E-02 2.0E-02 1.6E-02 3.6E-02 2.5E-02 1.3E-01 3.3E-02 1.3E-02 1.3E-02 1.6E-02 2.6E-02 1.2E-02 8.2E-03 4.3E-02 1.2E-02 1.3E-02 1.2E-02 2.0E-02 | 4.5E-02 8.4E-02 3.4E-02 1.6E-02 1.7E-02 5.4E-02 3.0E-02 2.8E-02 2.9E-02 3.3E-02 2.3E-02 5.5E-02 3.6E-02 1.8E-01 4.9E-02 2.0E-02 2.1E-02 2.5E-02 4.2E-02 1.8E-02 1.3E-02 6.6E-02 1.8E-02 2.1E-02 1.9E-02 2.9E-02 | 7.1E-02 1.5E-01 6.8E-02 2.9E-02 3.2E-02 1.0E-01 5.6E-02 5.1E-02 5.2E-02 5.8E-02) 4.3E-02) 9.7E-02 6.1E-02 3.3E-01 9.2E-02 3.7E-02 3.7E-02 4.6E-02 7.4E-02 3.2E-02 2.5E-02 1.2E-01 3.3E-02 3.7E-02 3.6E-02 5.3E-02 |
| Remaining organs | 6.7E-03 | 8.5E-03 | 1.3E-02 | 2.0E-02 | 3.7E-02 |
| Effective dose (mSv/MBq) | 1.3E-02 | 1.7E-02 | 2.6E-02 | 3.7E-02 | 6.8E-02 |
The effective dose resulting from an administered activity amount of 200 MBq is 2.6 mSv in the adult. The above data are valid in normal pharmacokinetic behaviour. When renal function is impaired due to disease or due to previous therapy, the effective dose delivered to organs might be increased.
- 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Solution for intravenous injection, ready to use.
Aseptic conditions must be observed during withdrawal of a patient dose from the vial, including microbial decontamination of the rubber stopper with a suitable disinfectant before removal of a dose. This product is not preserved. After removal of a dose from the vial, store at 2°C-8°C and use within one working day.
AdreView is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company
GBR
GE Healthcare
AdreViewTM
74 MBq/ml solution for injection
[123 I] iobenguane
D_GGBRTP.05
GE Healthcare
1 1 9 9 5 0 6
SV-REG-046375, 1-3-2-hcpl-pil-adv-uk-proposed-Feb2021, 1.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1~ -e Package leaflet: Information for the patient