74 MBq / ml solution for injection
sodium [ 131 L] iodide
What Sodium Iodide (131I) GE Healthcare is and what it is used for
This medicine is a radioactive medicine that is used for diagnostic examination (imaging), to identify disease.
Sodium iodide ( 131 L) GE Healthcare contains the active substance sodium [ 131 L] iodide. When the drug is injected, it can be seen from outside the body through a special camera used in the examination. The imaging can help your doctor see your tumor in the thyroid gland, show how well a tumor responds to the treatment or if the tumor has spread to other parts of the body.
Your doctor or nurse will tell you what you need to know about how Sodium Iodide ( 131 I) GE Healthcare works.
When you get sodium iodide you are exposed to radioactivity. Your doctor believes that the clinical benefit you will get from the medicine outweighs the risk of radiation. If you have any further questions, ask your doctor.
What You Need to Know Before Using Sodium Iodide (131I) GE Healthcare
Do not use Sodium Iodide (131I) GE Healthcare
- if you are allergic to sodium [ 131 I] iodide or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or think you may be pregnant.
Warnings and cautions
Talk to your doctor or nurse before receiving Sodium Iodide ( 131 I) GE Healthcare:
- if your last period has been missed
- if you are breast-feeding.
- if you have kidney problems
Before you get Sodium Iodide ( 131 I) GE Healthcare
Drink plenty of water before the test to be able to urinate as often as possible during the first hours after the test.
Your doctor may recommend a low-iodine diet.
Children and young people
Talk to your doctor if you are under 18 years of age.
Other Medicines and Sodium Iodide (131I) GE Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You should do this because some medicines may affect the effect of Sodium Iodide ( 131 I) GE Healthcare.
Before you receive Sodium Iodide ( 131 I) GE Healthcare, tell your doctor or nurse if you are taking the following types of medicines:
- Drugs used for an overactive or underactive thyroid gland such as carbimazole, propylthiouracil, levothyroxine, sodium liotyronine or thyroid extract. Acetylsalicylic acid , e.g. aspirin.
- Steroids are, e.g. prednisolone or methylprednisolone.
- Blood-thinning drugs, e.g. warfarin or heparin .
- Antihistamines are, e.g. chlorpheniramine or cetirizine.
- Drugs used in parasitic infections e.g. thiabendazole, rifampicin or amphotericin B.
- Penicillin
- “Sulfonamides” e.g. sulfasalazine (used to treat rheumatoid arthritis and certain intestinal problems), sumitriptan (used to treat migraines ) or probenicide (used to treat gout ).
- “Benzodiazepines”, a sedative e.g. temazepam, nitrazepam, diazepam .
- Expectorants used in coughs or colds, e.g. guaifenesin
- Vitamin is
- Lithium, used for mental health problems
- Tolbutamide, used for diabetes .
- Thiopental, an anesthetic used in hospitals
- Phenylbutazone, used for pain and arthritis .
- Amiodarone , used against irregular heartbeats
- Liquid or ointments containing iodine.
- Sodium nitroprusside, a blood pressure lowering agent used in hospitals.
- Sodium sulfobromophthalein, is used in hospitals to examine how well your liver is functioning.
- Perchlorate, given before certain pictures.
- Medicines used in hospitals for X-rays or imaging of the gallbladder.
- Drugs containing iodine used in hospitals for X-rays or imaging.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Sodium Iodide ( 131 I) GE Healthcare.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
You should not be given Sodium Iodide ( 131 I) GE Healthcare if you are pregnant, think you may be pregnant, or are planning to have a baby. This is because the medicine can affect the child.
Breast-feeding
You should not breastfeed if you are given Sodium Iodide ( 131 I) GE Healthcare as small amounts of radioactivity will pass into breast milk. If you are breastfeeding, your doctor may postpone the examination with Sodium Iodide ( 131 I) GE Healthcare until you stop breastfeeding. If waiting is not possible, your doctor may ask you to stop breastfeeding and give the baby breast milk substitute and pump out the milk and discard it. Your doctor will tell you when you can resume breastfeeding.
Driving and using machines
Sodium Iodide Treatment ( 131 I) GE Healthcare is not expected to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sodium iodide (131I) GE Healthcare contains sodium
This medicine contains 5.92 mg sodium per ml, which you should keep in mind if you have been prescribed a low-salt diet.
How to use Sodium Iodide (131I) GE Healthcare
There are strict regulations on how radioactive drugs should be used, handled, and disposed of. Sodium iodide ( 131 I) GE Healthcare will only be used at specially controlled sites.
This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These people make sure that the medicine is used in a risk-free way and keep you informed of what is happening.
The doctor supervising the examination will decide which dose of Sodium Iodide ( 131 I) GE Healthcare to use in your case. It will be the minimum amount required to get the desired effect.
The amount usually recommended for an adult is between 0.2 MBq – 400 MBq (megabecquerel, a device used to express radioactivity).
Use for children and adolescents
Dose one for children and adolescents is calculated by the doctor and depends, among other things, on the child’s body weight.
Use of Sodium Iodide ( 131 I) GE Healthcare and how the study is performed
Sodium iodide ( 131 L) GE Healthcare is given in a vein ( intravenous injection ).
During the survey
Your doctor will tell you how long the examination is expected to take.
For diagnostic use, the usual dose is one injection before a CT scan. Imaging can be taken after 4 hours and up to 72 hours after injection.
After receiving Sodium Iodide ( 131 I) GE Healthcare:
- you should urinate frequently for the medicine to leave the body.
- you may be asked to drink more fluids
Your doctor will inform you if you need to take any special measures after receiving this medicine. Contact your doctor if you have any questions.
If you use more Sodium Iodide (131I) GE Healthcare than you should
It is unlikely that you will receive an overdose as you will only receive a dose of Sodium Iodide ( 131 I) GE Healthcare which is closely monitored by the doctor supervising the examination. If you still receive an overdose, you will receive appropriate treatment.
If you have any further questions on the use of this product, ask your doctor
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Allergic reactions
Has been reported (occurs in an unknown number of users):
If you have an allergic reaction when you are in the hospital or clinic, tell your doctor or nurse immediately. The symptoms can be:
- skin rash, itching or hot flashes
- swelling of the face
- breathing difficulties
If any of the above side effects happen after you leave the hospital or clinic, go directly to the nearest emergency department.
Other side effects have
been reported (affects an unknown number of users):
- nausea
- vomiting
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
This radioactive drug emits small amounts of ionizing radiation with very little risk of cancer and hereditary defects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How to store Sodium Iodide (131I) GE Healthcare
You do not need to store this medicine. Healthcare professionals are responsible for storing the medicine in suitable premises. Storage of radioactive medicines takes place per national regulations on radioactive materials.
The following information is intended for healthcare professionals only:
Do not use this medicine after the expiry date which is stated on the label after EXP. Store at a maximum of 25 o C. Do not freeze. Store in the original lead protection or lead protection of a suitable thickness. Broken packaging is stored in a refrigerator (2 o C-8 o C) and used within 8 hours.
As the product does not contain preservatives and is marketed as a multi-dose pack, all doses from the same bottle should be taken during one working day and the bottle should be stored at 2 o C-8 o C after the first withdrawal. Keep this medicine out of the sight and reach of children.
Contents of the pack and other information
Content declaration
- The active substance is sodium [ 131 L] iodide.
- The other ingredients are sodium thiosulphate, sodium dihydrogen phosphate, disodium phosphate, sodium chloride, sodium hydroxide, water for injections.
What the medicine looks like and contents of the pack
Sodium iodide ( 131 L) GE Healthcare is supplied in a clear glass bottle containing a clear, colorless solution.
Marketing Authorization Holder and Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany
Contact your local marketing authorization holder for more information on this medicine:
GE Healthcare AB
Box 90
182 11 Danderyd
Tel: 08-559 504 00