SODIO IODURO (123I) JE EALTKARE 37 MBq/ml Инъекционный раствор

Содержание инструкции

1. Sodium Iodide (I) GE Healthcare 37 MBq/mL injectable solution
   1. What is Sodium Iodide injectable solution and what is it used for
   2. What you need to know before you are given Sodium Iodide (I) GE Healthcare 37 MBq/ml
2. Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution must not be used:
   1. How Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution is used
   2. Possible side effects
   3. How to store Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution
   4. Contents of the pack and other information

Sodium Iodide (I) GE Healthcare 37 MBq/mL injectable solution

Sodium Iodide (I)

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the specialist doctor in nuclear medicine, responsible for performing the examination.

ask the specialist doctor in nuclear medicine.

Contents of this leaflet:

• 1. What Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution is and what it is used for
• 2. What you need to know before you are given Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution
• 3. How Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution is used
• 4. Possible side effects
• 5. How Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution is stored
• 6. Contents of the pack and other information

1. What is Sodium Iodide injectable solution and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only. It is only used to help
identify any presence of disease.
Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution is a radiopharmaceutical. It is given
before a scan and helps a special device to visualize the inside of a part of your
body.

• Contains an active ingredient called ‘sodium iodide’.
• Once administered, it can be seen from outside your body via the device that acquires images, used for the diagnostic examination.
• The scan can help your doctor to see the thyroid and how it is functioning. Your nuclear medicine doctor will explain which part of your body will undergo the examination. The use of Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have assessed that the clinical benefit you will obtain from the diagnostic procedure with the radiopharmaceutical is greater than the risk due to radiation.

2. What you need to know before you are given Sodium Iodide (I) GE Healthcare 37 MBq/ml

injectable solution

Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution must not be used:

• If you are allergic (hypersensitive) to sodium iodide (I) or any of the excipients of this medicine (listed in section 6). Do not take Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution if the above cases apply to you. If you have any doubts, talk to your nuclear medicine doctor or nurse.

Warnings and precautions
Take special care with Sodium Iodide (I) GE Healthcare 37 MBq/ml solution
injectable
Check with your nuclear medicine doctor or nurse before you are given Sodium Iodide
( I) GE Healthcare 37 MBq/ml injectable solution

• if you are pregnant or think you might be pregnant
• if you have reduced kidney function
• if you are breastfeeding

Before the administration of Sodium Iodide (I) GE Healthcare 37 MBq/ml solution
injectable you must:
Drink plenty of fluids before undergoing the examination, so as to urinate as often as possible in the first
few hours after the examination.

Children and adolescents
Tell the nuclear medicine specialist if you are under 18 years of age.

Other medicines and Sodium Iodide (I) GE Healthcare 37 MBq/ml solution injectable
Tell the nuclear medicine specialist or nurse if you are taking, have recently
taken or might take any other medicines, including over-the-counter medicines, including herbal medicines.
This is because some medicines may interfere with Sodium Iodide (123I) GE Healthcare 37
MBq/ml injectable solution.
Before undergoing the investigation, tell the nuclear medicine specialist if you are taking
any of the types of medicines listed below because these medicines may
interfere with the results of your examination:

• anti-inflammatory drugs, such as phenylbutazone
• anti-thyroid drugs, such as carbimazole, propylthiouracil or methimazole
• expectorants, such as some cough medicines
• salicylates, such as aspirin
• steroids (such as hydrocortisone, prednisolone or dexamethasone).
• benzodiazepines (such as diazepam, temazepam and nitrazepam).
• medicines used to treat thyroid disorders, such as sodium levothyroxine or sodium liothyronine.
• medicines taken before some types of scans, such as perchlorate.
• medicines used to treat infections, such as antiparasitics, penicillins, sulfonamides.
• Amiodarone and antiarrhythmic drugs (used to treat irregular heartbeat).
• Lithium (used in the treatment of some conditions, such as depression or mental problems).
• Sodium nitroprusside (used to treat very high blood pressure).
• Sodium sulfobromophthalein (used to test how the liver works).
• Topical iodides (used to disinfect the skin before surgery).
• Anticoagulants (used to thin the blood).
• Antihistamines (used to treat or prevent allergic reactions)
• Tolbutamide (used in people with diabetes to lower blood sugar levels).
• Thiopental (used as a general anesthetic).
• medicines administered in hospital for X-rays or scans (intravenous contrast agents, with or without iodine).
• vitamins If you are not sure whether any of the above cases apply to you, tell your doctor, the nuclear medicine specialist or the nurse before taking Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy
or if you are breastfeeding
ask your nuclear medicine specialist for advice before you are
given this medicine.
You must inform the nuclear medicine specialist before the administration of Sodium Iodide
(123I) GE Healthcare 37 MBq/ml injectable solution if there is a possibility that you may be
pregnant, if you have missed a menstrual period or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist, responsible for
performing the examination.

If you are pregnant
The nuclear medicine specialist will only give you this medicine during pregnancy
if they assess that the expected benefit outweighs the risk.

If you are breastfeeding
Do not breastfeed if you have been given Sodium Iodide (123I) GE Healthcare 37 MBq/ml
injectable solution
This is because small amounts of ‘radioactivity can pass into breast milk.
If you are breastfeeding, the nuclear medicine specialist should wait until the end
of breastfeeding, before using Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable
solution.
If it is not possible to wait, the nuclear medicine specialist will ask you:

• to stop breastfeeding for 1.5-3 days, and
• to use formula milk for your baby, and
• to collect (express) breast milk and throw it away. Your doctor will tell you when you can resume breastfeeding.

Driving and using machines
No effects on the ability to drive and use machines are known.

Important information about Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution
When Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution is used, you are
exposed to radioactivity.

• Your doctor will always weigh the possible risks and benefits before giving you the medicine. Ask your doctor if you have any questions.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it can be
considered ‘essentially’ sodium-free.

3. How Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution is used

There are strict regulations regarding the use, handling and disposal of radiopharmaceuticals.
Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution will only be used in designated
controlled areas.
This product will be handled and administered exclusively by trained and
qualified personnel for its safe use.

• Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution will always be used in hospital or clinic. Staff will ensure that the product is used safely and will inform you about the measures taken. The nuclear medicine specialist responsible for performing the examination will decide the amount of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution to be used in your case. The minimum dose necessary to obtain the desired information will be used. The usual amount to be administered to an adult is between 3.7 MBq and 14.8 MBq. (The megabecquerel is the unit of measure for radioactivity).

Use in children and adolescents
In children and adolescents, the amount to be administered will be adjusted to the child's weight.

Administration of Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution and
performance of the procedure:
Sodio Ioduro injectable solution is administered intravenously.

The usual dose is:

• A single injection. The scan is usually performed between 3 and 6 hours after the injection.

Duration of the procedure
The nuclear medicine specialist will inform you about the duration of the procedure.

After the administration of Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution
you must:

• Avoid close contact with infants and pregnant women.
• Urinate as often as possible to eliminate the product from the body.

The nuclear medicine specialist will inform you about the need to take special precautions
to be observed after receiving this medicine. If you have any questions, contact the nuclear
medicine specialist.

If you have been given too much Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable
solution:
It is unlikely that cases of overdose will occur, as you will receive a single dose of
Sodio Ioduro ( I) GE Healthcare 37 MBq/ml injectable solution controlled by the specialist doctor
responsible for performing the examination. However, in case of overdose, you will receive
appropriate treatment.
If you have questions about the use of Sodio Ioduro (123I) GE Healthcare 37 MBq/ml injectable solution,
ask the nuclear medicine specialist, responsible for performing the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If you experience an allergic reaction while in hospital or in a clinic during the examination, inform your doctor or nurse immediately.
The signs may include:

• skin rash, itching or flushing
• swelling of the face
• difficulty breathing.

Other side effects include
Not known – frequency cannot be estimated based on available data

• nausea, vomiting
• itching, rash and hives.

If any of the side effects described above occur after you have left
hospital or clinic, go directly to the emergency room of the nearest hospital.
This radiopharmaceutical will release a small amount of ionizing radiation, with a minimal risk
of developing cancer or hereditary abnormalities.
If any side effect occurs, consult your nuclear medicine doctor.
This also applies to any possible side effect not listed in this leaflet.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your nuclear medicine specialist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects
can help provide more information on the safety of this medicine.

5. How to store Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution

Do not store this medicine. This medicine is stored under the
responsibility of a specialist in suitable premises. Storage will occur in accordance with
current regulations regarding radioactive material.
Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution must not be used
after the expiry date reported on the packaging
The following information is intended for the specialist only.
This medicine can be used for up to 36 hours from the calibration time reported on
the label.
Store this medicine at a temperature below 25°C. Do not freeze. Store in the
original lead container or in an equivalent shielding container.
After opening, store in a refrigerator (2°C-8°C) and use within one working day.
Sodio Ioduro injectable solution must not be used after the expiry date which is reported
on the box after SCAD.
Keep Sodio Ioduro (I) GE Healthcare 37 MBq/ml injectable solution out of the reach and
sight of children.
The product label includes the correct storage conditions and the expiry date of the
batch.
Hospital staff will ensure that the product is stored and disposed of correctly
and that it is not used after the expiry date reported on the label.

6. Contents of the pack and other information

What contains Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution

• The active ingredient is Sodium Iodide ( I). Each ml of Sodium Iodide ( I) injectable solution contains 37 MBq (The Megabecquerel is the unit used to measure radioactivity) of Sodium Iodide [( I)]
• The other components are: glacial acetic acid, sodium hydroxide, sodium thiosulfate, sodium bicarbonate, sodium chloride and water for injections.

Description of the appearance of Sodium Iodide (I) GE Healthcare 37 MBq/ml injectable solution and
contents of the pack
Sodium Iodide injectable solution is supplied in a single glass vial containing a variable amount
of injectable solution from 0.5 mL to 10 mL.

Marketing Authorisation Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano
Italy

Manufacturer
GE Healthcare B.V.
De Rondom 8
5612 AZ Eindhoven
Netherlands
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The following information is intended exclusively for the doctor or healthcare professional:
The Summary of Product Characteristics complete of Sodium Iodide (123I) GE Healthcare 37
MBq/ml injectable solution is provided as a separate document within the pack,
with the aim of providing healthcare professionals with further scientific and practical information on the
administration, dosage and use of this medicine.
Please refer to the SmPC (the SmPC must be included in the pack).