Sodium Iodide (123i) Injection 37 Mbq/Ml Solution For Injection
If any of the side effects gets serious, of if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Sodium Iodide Injection is kept out of the reach and sight of children.
The product label includes the correct storage conditions and the expiry date for the batch. Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the label.
What Sodium Iodide Injection contains
• The active ingredient is sodium [123l]iodide. Each ml of Sodium Iodide (123l) Injection contains 37 MBq (Megabecquerel - the unit in which radioactivity is measured) of sodium [123l]iodide at a fixed time.
• The other ingredients are acetic acid, sodium hydroxide, sodium thiosulphate, sodium bicarbonate, sodium chloride and water for injections.
What Sodium Iodide Injection looks like and contents of the pack
Sodium Iodide Injection is supplied as a single glass vial containing a solution for injection.
Marketing Authorisation Holder
GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom
Manufacturer
GE Healthcare B.V.
Den Dolech 2 5612 AZ Eindhoven The Netherlands
This leaflet was last approved in 05/2011
Marketing Authorisation
UK: PL 00221/0138
Incomplete blockage:
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
|
uptake |
0.5% |
1.6E-02 |
2.0E-02 |
3.1E-02 |
5.2E-02 |
9.6E-02 | |
|
uptake |
1.0% |
1.9E-02 |
2.5E-02 |
3.8E-02 |
6.7E-02 |
1.3E-01 | |
|
uptake |
2.0% |
2.5E-02 |
3.4E-02 |
5.2E-02 |
9.9E-02 |
1.8E-01 |
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.5% at calibration time and 3% at expiration time
Thyroid blocked, uptake 15%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 55%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 yeqr |
1 yeqr | |
|
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 |
|
Gl-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 |
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.
13. OTHER INFORMATION Manufacturer
GE Healthcare B.V.
Den Dolech 2 5612 AZ Eindhoven The Netherlands
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
Thyroid blocked, uptake 35%
|
Orgqn |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 |
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may 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 local competent official organisations (see section 6.6).
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.
GE and the GE Monogram are trademarks of General Electric Company
GE Healthcare B.V.
P.O. Box 746 NL-5600 AS Eindhoven T +31(0)40 299 1000 F +31(0)40 299 1299
1 1 7 3 6 2 4
Sodium Iodide (123l) Injection 37 MBq/ml solution for injection
(called Sodium Iodide Injection in this leaflet)
Sodium [123l]iodide
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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.
In this leaflet:
1. What Sodium Iodide Injection is and what it is used for
2. Before you are given Sodium Iodide Injection
3. How Sodium Iodide Injection is given
4. Possible side effects
5. How to store Sodium Iodide Injection
6. Further information
This medicine is for diagnostic use only. It is used only to help identify illness.
Sodium Iodide Injection is a 'radiopharmaceutical' medicine. It is given before a scan and helps a special camera see inside a part of your body.
• It contains an active ingredient called 'sodium iodide'.
• 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 the thyroid gland and how well it is working.
You should not be given Sodium Iodide Injection:
• If you are allergic (hypersensitive) to the active ingredient or any other ingredient. (Listed in Section 6).
Do not have Sodium Iodide Injection if the above applies to you. If you are not sure talk to your doctor or nurse.
Take special care with Sodium Iodide Injection
Check with your doctor or nurse before having Sodium Iodide Injection:
• If you are pregnant or think you might be pregnant.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because some medicines can affect the way Sodium Iodide Injection works.
Before your scan tell your doctor or nurse if you are taking any of the types of medicine below. This is because they may affect the results of your scan:
• Anti-inflammatory medicines, such as phenylbutazone.
• Antithyroid medicines, such as propylthiouracil or thiamazole.
• Expectorants, such as certain cough medicines (used to loosen mucus from the respiratory tract).
• Salicylates, such as aspirin (used to treat pain or heart disease).
• Steroids, such as hydrocortisone, prednisolone or dexamathasone.
• Medicines used to treat thyroid disorders, such as levothyroxine sodium or liothyronine sodium.
• Medicines taken before some types of scan, such as perchlorate.
• Medicines to treat infections, such as antiparasitics, penicillins, sulfonamides.
• Amiodarone, and antiarrythmic agents (used to treat an irregular heartbeat).
• Lithium (used to treat certain conditions such as depression or mental problems.
• Sodium nitroprusside (used to treat very high blood pressure).
• Sulfobromophthalein sodium (used to test how the liver is working).
• Topical iodides (used to clean the skin before surgery).
• Anticoagulants (used to thin the blood).
• Antihistamines (used to treat or prevent allergic reactions).
• Tolbutamide (used for people with diabetes to lower blood sugar levels).
• Thiopental (used as a general anaesthetic).
• Medicines given in hospital for x-rays or scans (intravenous contrast media).
• Vitamins.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Sodium Iodide Injection.
Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or think you might be pregnant. Your doctor will only use this product if it is considered that the benefit outweighs the risk.
Do not breast-feed if you are given Sodium Iodide Injection.
This is because small amounts of 'radioactivity' may pass into the mother's milk. If you are breast-feeding, your doctor may wait until you have finished breast-feeding before using Sodium Iodide
Injection. If it is not possible to wait your doctor will ask you to:
• stop breast-feeding for 1.5 to 3 days, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.
Your doctor will let you know when you can start breast-feeding again.
Driving and using machines
Ask your doctor if you can drive or use machines after you have been given Sodium Iodide Injection.
Important information about Sodium Iodide Injection
When Sodium Iodide Injection is used you are exposed to radioactivity.
• Your doctor will always consider the possible risks and benefits before you are given the medicine.
Ask your doctor if you have any questions.
This medicinal product contains less than lmmol sodium 23 mg) per dose, i.e. essentially 'sodium -free'.
Sodium Iodide Injection will be given to you by a specially trained and qualified person.
• Sodium Iodide Injection will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe use.
Your doctor will decide on the dose that is best for you.
The usual dose is:
• One single injection.
The scan is usually taken 3 to 6 hours after the injection.
Like all medicines, Sodium Iodide Injection can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction when you are in hospital or a clinic having the scan, tell the doctor or nurse straight away. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty breathing.
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.
PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
1. NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (12!l) Injection 37 MBq/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium [12!l]iodide, 37 MBq/ml at reference date and hour.
At calibration time, the radionuclidic purity is at least 99.9% and the main radionuclidic impurities (iodine-125 and tellurium-121) occurfor less than 0.05%.
Iodine-123 is a cyclotron product with a physical half-life of 13.2 hours. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV.
This medicinal product contains:
Sodium: 3.99 mg/ml. This needs to be taken into consideration for patients on a controlled sodium diet.
Fora full list of excipients, see section 6.1.
The content 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.
Sodium Iodide (12!l) Injection 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 activity for an adult patient (70 kg) is between 3.7 and 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 is decided by the specialist concerned.
Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well established standard procedures.
The activities for children may be calculated from the recommended range of adult activities and adjusted according to the following equation:
_activity adult (MBq) x body weight (kg)_
Activity child (MBq) = 70 (kg)
In young children the activity of 14.8 MBq should be used in the equation to calculate the activity for children in order to obtain images of sufficient quality.
Sodium Iodide (12!l) Injection must be given as an intravenous injection; as a routine check, the activity in the injection should be measured immediately prior to administration. Imaging is performed 3-6 hours after administration.
The instructions for preparation of radiopharmaceuticals are given in section 12.
4.3 Contra-indications
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, storages, use, transfer and diposal 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 meidicnal 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 [12!l] iodide maybe decreased by recent administration of iodinated contrast materials, by intake of stable iodine in any form, or by thyroid, antithyroid, and certain otherdrugs.
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 [12!l] iodide.
Active substances: Withdrawal period prior to administration of sodium [12!l]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): 1-3 weeks.
Amiodoarone, 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 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer 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 not using ionising radiation (if there are any) should be 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 breastfeeding and to what is the most appropriate choice of radiopharmaceutical has been made, 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 iodine-123 that contains iodine-125 and/or iodine-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 defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered these adverse events are expected to occur with a low probability.
4.9 Overdose
In the event of the administration of an overdose of [123l] iodide, 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
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (12!l), ATC code: V09FX02.
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 hour after dosing.
The half-time of iodide elimination from the thyroid is estimated at 80 days so that the physical half-life of iodine-123 of 13 hours governs the temporal opportunity for imaging.
Without considering the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (37-75%), while faecal excretion is low (about 1%).
5.3 Preclinical safety data
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to image the thyroid for diagnostic purposes.
No data are available from animal models about toxicity with repeated dose administration or about reproduction toxicity.
Sodium Iodide (12!l) Injection has not been investigated for mutagenicity and carcinogenic/oncogenic potential.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acetic acid Sodium hydroxide Sodium thiosulphate Sodium bicarbonate Sodium chloride 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.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be observed. 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 the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via an authorised route.
7. MARKETING AUTHORISATION HOLDER
GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom
8. MARKETING AUTHORISATION NUMBER
UK: PL00221/0138
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
|
Date of first authorisation |
Date of last renewal | |
|
UK |
01 December 1998 |
23 May 2003 |
10. DATE OF REVISION OF THE TEXT
xx/xxxx
11. DOSIMETRY
Depending on the production procedure of iodine -123, impurities like iodine-125 and/or iodine-124 may be present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP model refers to intravenous administration.
For this product the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be 2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.
The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose (marked with *).
The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon Press 1987).
Thyroid blocked, uptake 0%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 |
If any of the side effects gets serious, of if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Sodium Iodide Injection is kept out of the reach and sight of children.
The product label includes the correct storage conditions and the expiry date for the batch. Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the label.
What Sodium Iodide Injection contains
• The active ingredient is sodium [123l]iodide. Each ml of Sodium Iodide (123l) Injection contains 37 MBq (Megabecquerel - the unit in which radioactivity is measured) of sodium [123l]iodide at a fixed time.
• The other ingredients are acetic acid, sodium hydroxide, sodium thiosulphate, sodium bicarbonate, sodium chloride and water for injections.
What Sodium Iodide Injection looks like and contents of the pack
Sodium Iodide Injection is supplied as a single glass vial containing a solution for injection.
Marketing Authorisation Holder
GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom
Manufacturer
GE Healthcare B.V.
Den Dolech 2 5612 AZ Eindhoven The Netherlands
This leaflet was last approved in XX/XXXX
Marketing Authorisation
UK: PL 00221/0138
Incomplete blockage:
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
|
uptake |
0.5% |
1.6E-02 |
2.0E-02 |
3.1E-02 |
5.2E-02 |
9.6E-02 | |
|
uptake |
1.0% |
1.9E-02 |
2.5E-02 |
3.8E-02 |
6.7E-02 |
1.3E-01 | |
|
uptake |
2.0% |
2.5E-02 |
3.4E-02 |
5.2E-02 |
9.9E-02 |
1.8E-01 |
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.5% at calibration time and 3% at expiration time
Thyroid blocked, uptake 15%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 55%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 yeqr |
1 yeqr | |
|
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 |
|
Gl-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 |
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.
13. OTHER INFORMATION Manufacturer
GE Healthcare B.V.
Den Dolech 2 5612 AZ Eindhoven The Netherlands
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
Thyroid blocked, uptake 35%
|
Orgqn |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 |
Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with approximately 0.6% at calibration time and 4% at expiration time.
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may 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 local competent official organisations (see section 6.6).
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.
GE and the GE Monogram are trademarks of General Electric Company
GE Healthcare B.V.
P.O. Box 746 NL-5600 AS Eindhoven T +31(0)40 299 1000 F +31(0)40 299 1299
1 1 7 3 6 2 4
Sodium Iodide (123l) Injection 37 MBq/ml solution for injection
(called Sodium Iodide Injection in this leaflet)
Sodium [123l]iodide
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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.
In this leaflet:
1. What Sodium Iodide Injection is and what it is used for
2. Before you are given Sodium Iodide Injection
3. How Sodium Iodide Injection is given
4. Possible side effects
5. How to store Sodium Iodide Injection
6. Further information
This medicine is for diagnostic use only. It is used only to help identify illness.
Sodium Iodide Injection is a 'radiopharmaceutical' medicine. It is given before a scan and helps a special camera see inside a part of your body.
• It contains an active ingredient called 'sodium iodide'.
• 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 the thyroid gland and how well it is working.
You should not be given Sodium Iodide Injection:
• If you are allergic (hypersensitive) to the active ingredient or any other ingredient. (Listed in Section 6).
Do not have Sodium Iodide Injection if the above applies to you. If you are not sure talk to your doctor or nurse.
Take special care with Sodium Iodide Injection
Check with your doctor or nurse before having Sodium Iodide Injection:
• If you are pregnant or thinkyou might be pregnant.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because some medicines can affect the way Sodium Iodide Injection works.
Before your scan tell your doctor or nurse if you are taking any of the types of medicine below. This is because they may affect the results of your scan:
• Anti-inflammatory medicines, such as phenylbutazone.
• Antithyroid medicines, such as propylthiouracil or thiamazole.
• Expectorants, such as certain cough medicines (used to loosen mucus from the respiratory tract).
• Salicylates, such as aspirin (used to treat pain or heart disease).
• Steroids, such as hydrocortisone, prednisolone or dexamathasone.
• Medicines used to treat thyroid disorders, such as levothyroxine sodium or liothyronine sodium.
• Medicines taken before some types of scan, such as perchlorate.
• Medicines to treat infections, such as antiparasitics, penicillins, sulfonamides.
• Amiodarone, and antiarrythmic agents (used to treat an irregular heartbeat).
• Lithium (used to treat certain conditions such as depression or mental problems.
• Sodium nitroprusside (used to treat very high blood pressure).
• Sulfobromophthalein sodium (used to test how the liver is working).
• Topical iodides (used to clean the skin before surgery).
• Anticoagulants (used to thin the blood).
• Antihistamines (used to treat or prevent allergic reactions).
• Tolbutamide (used for people with diabetes to lower blood sugar levels).
• Thiopental (used as a general anaesthetic).
• Medicines given in hospital for x-rays or scans (intravenous contrast media).
• Vitamins.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Sodium Iodide Injection.
Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or think you might be pregnant. Your doctor will only use this product if it is considered that the benefit outweighs the risk.
Do not breast-feed if you are given Sodium Iodide Injection.
This is because small amounts of 'radioactivity' may pass into the mother's milk. If you are breast-feeding, your doctor may wait until you have finished breast-feeding before using Sodium Iodide
Injection. If it is not possible to wait your doctor will ask you to:
• stop breast-feeding for 1.5 to 3 days, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.
Your doctor will let you know when you can start breast-feeding again.
Driving and using machines
Ask your doctor if you can drive or use machines after you have been given Sodium Iodide Injection.
Important information about Sodium Iodide Injection
When Sodium Iodide Injection is used you are exposed to radioactivity.
• Your doctor will always consider the possible risks and benefits before you are given the medicine.
Ask your doctor if you have any questions.
This medicinal product contains less than lmmol sodium 23 mg) per dose, i.e. essentially 'sodium -free'.
Sodium Iodide Injection will be given to you by a specially trained and qualified person.
• Sodium Iodide Injection will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe use.
Your doctor will decide on the dose that is best for you.
The usual dose is:
• One single injection.
The scan is usually taken 3 to 6 hours after the injection.
Like all medicines, Sodium Iodide Injection can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction when you are in hospital or a clinic having the scan, tell the doctor or nurse straight away. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty breathing.
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.
PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
1. NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (12!l) Injection 37 MBq/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium [12!l]iodide, 37 MBq/ml at reference date and hour.
At calibration time, the radionuclidic purity is at least 99.9% and the main radionuclidic impurities (iodine-125 and tellurium-121) occurfor less than 0.05%.
Iodine-123 is a cyclotron product with a physical half-life of 13.2 hours. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV.
This medicinal product contains:
Sodium: 3.99 mg/ml. This needs to be taken into consideration for patients on a controlled sodium diet.
Fora full list of excipients, see section 6.1.
The content 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.
Sodium Iodide (12!l) Injection 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 activity for an adult patient (70 kg) is between 3.7 and 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 is decided by the specialist concerned.
Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well established standard procedures.
The activities for children may be calculated from the recommended range of adult activities and adjusted according to the following equation:
_activity adult (MBq) x body weight (kg)_
Activity child (MBq) = 70 (kg)
In young children the activity of 14.8 MBq should be used in the equation to calculate the activity for children in order to obtain images of sufficient quality.
Sodium Iodide (12!l) Injection must be given as an intravenous injection; as a routine check, the activity in the injection should be measured immediately prior to administration. Imaging is performed 3-6 hours after administration.
The instructions for preparation of radiopharmaceuticals are given in section 12.
4.3 Contra-indications
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, storages, use, transfer and diposal 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 meidicnal 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 [12!l] iodide maybe decreased by recent administration of iodinated contrast materials, by intake of stable 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 [12!l] iodide.
Active substances: Withdrawal period prior to administration of sodium [12!l]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): 1-3 weeks.
Amiodoarone, 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 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer 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 not using ionising radiation (if there are any) should be 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 breastfeeding and to what is the most appropriate choice of radiopharmaceutical has been made, 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 iodine-123 that contains iodine-125 and/or iodine-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 defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered these adverse events are expected to occur with a low probability.
4.9 Overdose
In the event of the administration of an overdose of [123l] iodide, 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
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (12!l), ATC code: V09FX02.
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 hour after dosing.
The half-time of iodide elimination from the thyroid is estimated at 80 days so that the physical half-life of iodine-123 of 13 hours governs the temporal opportunity for imaging.
Without considering the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (37-75%), while faecal excretion is low (about 1%).
5.3 Preclinical safety data
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to image the thyroid for diagnostic purposes.
No data are available from animal models about toxicity with repeated dose administration or about reproduction toxicity.
Sodium Iodide (12!l) Injection has not been investigated for mutagenicity and carcinogenic/oncogenic potential.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acetic acid Sodium hydroxide Sodium thiosulphate Sodium bicarbonate Sodium chloride 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.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be observed. 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 the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via an authorised route.
7. MARKETING AUTHORISATION HOLDER
GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom
8. MARKETING AUTHORISATION NUMBER
UK: PL00221/0138
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
|
Date of first authorisation |
Date of last renewal | |
|
UK |
01 December 1998 |
23 May 2003 |
10. DATE OF REVISION OF THE TEXT
xx/xxxx
11. DOSIMETRY
Depending on the production procedure of iodine -123, impurities like iodine-125 and/or iodine-124 may be present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP model refers to intravenous administration.
For this product the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be 2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.
The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose (marked with *).
The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon Press 1987).
Thyroid blocked, uptake 0%
|
Organ |
Absorbed dose per unit activity adm |
inistered (mGy/MBq) | |||
|
Adult |
15 year |
10 year |
5 year |
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 |
|
Gl-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 |
|
* LU 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 |