9,25 – 18,50 MBq/ml injektions-/infusionsvätska, lösning
jobenguan[131I]
What MIBG (I-131) GE Healthcare is and what it is used for
This radioactive medicine is used for diagnostic examination (imaging), to identify disease.
MIBG (I-131) GE Healthcare contains the active substance jobenguan [ 131 I] and is used to examine by imaging whether a tumor in the adrenal glands or thyroid gland is suitable for treatment, and what treatment is required.
Your doctor will tell you how MIBG (I-131) GE Healthcare works.
When you receive MIBG (I-131) GE Healthcare, 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 MIBG (I-131) GE Healthcare
Do not use MIBG (I-131) GE Healthcare
- if you are allergic to jobenguan [ 131 I] or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant
- this product contains benzyl alcohol and must not be used in premature babies and infants.
MIBG (I-131) GE Healthcare should not be used in any of the above applies to you. If you are not sure, talk to your doctor.
Warnings and cautions
Talk to your doctor before using MIBG (I-131) GE Healthcare about:
- your last period has not been missed (pregnancy must be excluded)
- you have impaired kidney function
- you breastfeed
Before you receive MIBG (I-131) 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.
Children and young people
Talk to your doctor if you are under 18 years of age.
Other medicines and MIBG (I-131) GE Healthcare
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You should do this as some medicines may affect the way MIBG (I-131) GE Healthcare works.
Before you receive MIBG (I-131) GE Healthcare tell your doctor or nurse if you are taking the following types of medicines below:
- antihypertensive drugs (such as reserpine, labetalol, betanidine, debrisoquine, bretylium and guanetidine) and calcium channel blockers ( diltiazem , nifedipine and verapamil).
- antidepressants such as amitryptiline, imipramine, doxepine, amoxapine, loxapine, maprotiline and trazolone.
- medicines used in coughs or colds, e.g. phenylephrine , ephedrine or phenylpropanolamine.
- cocaine (sometimes used as an anesthetic for nasal surgery, also an addictive drug)
If you are not sure if any of the above applies to you, talk to your doctor or nurse before giving MIBG (I-131) 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 MIBG (I-131) GE Healthcare if you are pregnant or think you may be pregnant. This is because the medicine can affect the child.
Breast-feeding
You should not breastfeed if you are given MIBG (I-131) GE Healthcare as small amounts of radioactivity will pass into breast milk. If you are breastfeeding, your doctor may postpone the examination with MIBG (I-131) 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
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.
MIBG (I-131) GE Healthcare contains benzyl alcohol and sodium
This product contains benzyl alcohol which may cause poisoning or allergic reactions in children under 3 years of age. This product contains 3.54 mg of sodium per ml, which you should keep in mind if you are prescribed a low-salt diet.
How to use MIBG (I-131) GE Healthcare
There are strict regulations on how radioactive drugs should be used, handled, and disposed of. MIBG (I-131) GE Healthcare will only be used at designated controlled locations.
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 MIBG (I-131) 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 20 MBq – 40 MBq (megabecquerel, a device used to express radioactivity).
Use for children and adolescents
The recommended doses apply to both adults and children.
Use of MIBG (I-131) GE Healthcare and how the study is performed
The dose is given as a slow injection into a vein.
Your doctor will inform you if you need to take any special measures after receiving this medicine. Consult a doctor if you are unsure.
Duration of the survey
Your doctor will tell you how long the examination is expected to take.
If you use more MIBG (I-131) GE Healthcare than you should
You are unlikely to receive an overdose as you are only receiving a dose of MIBG (I-131) 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 who is monitoring the study.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- high blood pressure including acute episodes of high blood pressure (hypertensive crisis) which can be serious.
This radioactive drug emits small amounts of ionizing radiation with very little risk of cancer and hereditary defects.
How to store MIBG (I-131) GE Healthcare
You do not need to store this medicine. Healthcare professionals are responsible for storing the medicine in suitable premises. The storage of radioactive medicines takes place by national regulations on radioactive materials.
The following information is intended for healthcare professionals only:
Do not store above 25 ° C. Do not freeze. Do not use this medicine after the expiry date which is stated on the label after EXP.
Keep this medicine out of the sight and reach of children.
Contents of the package and other information
Content declaration
- The active substance is jobenguan [ 131 I]. Each vial contains between 9.25 – 18.50 MBq / ml (the MBq unit in which radioactivity is measured) jobenguan [ 131 I] at a reference time.
- The other ingredients are sodium chloride, benzyl alcohol and water for injections.
What the medicine looks like and contents of the pack
The drug is delivered in a clear glass bottle (10 ml) with a butyl rubber stopper that has a surface layer consisting of PTCF.
Pack size : 1 vial with 9.25-18.5 MBq / ml.
Marketing Authorization Holder and Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunsweig
Germany
Contact your local marketing authorization holder for more information on this medicine:
GE Healthcare AB, Box 90, 182 11 Danderyd