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ORAL SODIUM IODIDE 131 I SOLUTION

Active substance(s): SODIUM IODIDE I 131 SOLUTION / SODIUM IODIDE I 131 SOLUTION / SODIUM IODIDE I 131 SOLUTION

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PATIENT INFORMATION LEAFLET

1.

IDENTIFICATION OF THE MEDICINAL PRODUCT
Name of the Medicinal Product
I-131-S-1
Oral sodium iodide [131I] solution, CIS bio international.
Qualitative Composition
Sodium iodide [131I]
Quantitative Composition
Sodium iodide [131I]: 1110 MBq/mL at the date of calibration.
Pharmaceutical Form
Oral solution
Pharmaco-Therapeutic Group
Sodium iodide [131I] is a diagnostic and therapeutic radiopharmaceutical. When orally
administered, the radiopharmaceutical is distributed in the extra thyroidal compartment.
Name and Address of the Marketing Authorisation Holder
CIS bio international
B.P. 32
91192 Gif-sur-Yvette Cedex
FRANCE
Marketing authorisation n°: PL/11876/0014
Name and Address of the Manufacturer
CIS bio international
B.P. 32
91192 Gif-sur-Yvette Cedex
FRANCE

VAR GB_P4509pD
09/2007

2.

WHEN IS THE PRODUCT USED ?
Sodium iodide [131I] is indicated for the study and the management of thyroid diseases
therapy. It is sometimes combined with surgical intervention and with antithyroid
medications.

3. WARNINGS
When should this Product not be used ?
Sodium iodide [131I] IS NOT TO BE USED by pregnant women. You should tell your
physician if there is any possibility that you are pregnant, or if you are breast-feeding.
Sodium iodide [131I] IS NOT TO BE USED for diagnostic in children under 10 years of
age.
Sodium iodide [131I] IS NOT TO BE USED in patients with gastrointestinal disorders.
IN CASE OF DOUBT IT IS ESSENTIAL TO CONSULT YOUR PHYSICIAN
Special Warnings
The use of sodium iodide [131I] does involve administration of radioactivity. The risk this
involves is very small and your physician will not consider carrying out the administration
unless he believes that the risk is outweighed by the potential benefit of the treatment.
Precautions for Use
To prevent accumulation of sodium iodide [131I] in the bladder, you will be asked to drink
plenty of fluids during at least the first day after administration and to have frequent
bladder emptying.
To avoid sialadenitis, you will be advised to take sweets or drinks containing citric acid
which stimulate saliva excretion.
In men, high doses of sodium iodide [131I] may affect temporary sperm production. If you
would ever like to father a child, speak to your doctor about wether saving your sperm in
a sperm bank should be considered.
Because sodium iodide [131I] is administered by trained personnel there are no additional
precautions which are your responsibility. Because there are strict laws covering the
use, handling and disposal of radioactivity, sodium iodide [131I] will always be used in a
hospital or a similar setting. It will only be handled and administered by people who are
trained and qualified in the safe handling of radioactive material.
Your physician will inform you if you need to take any other special precautions after use
of this product.
IN CASE OF DOUBT DO NOT HESITATE TO CONSULT YOUR PHYSICIAN

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09/2007

Interactions with other Medicinal Products and other Forms of Interaction
Several medicines may interfere with this treatment.
Particular examples are antithyroid agents, carbimazole (or other imidazole derivatives
such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium
sulfobromophthalein, perchlorate, miscellaneous agents (anticoagulants, antihistamines, anti-parasitics, penicillins, sulphonamides, tolbutamide, thiopentone),
phenylbutazone, expectorants, vitamins, natural or synthetic thyroid preparations,
amiodarone, benzodiazepines, lithium, topical iodides, contrast agents.
IN ORDER TO AVOID POSSIBLE INTERACTIONS WITH OTHER MEDICINAL
PRODUCTS, ANY OTHER CURRENT MEDICATION MUST BE NOTIFIED TO YOUR
PHYSICIAN.
Pregnancy-Lactation
As mentioned above, sodium iodide [131I] should not be administered to pregnant
women. Any possibility of pregnancy must be ruled out before use of this product.
Women receiving sodium iodide [131I] should not became pregnant within four months of
administration.
Tell your physician if you are breast-feeding as he may delay treatment until breastfeeding is completed or, alternatively, he may ask you to stop breast-feeding.
Effects on Ability to Drive or to Operate Machinery
Sodium iodide [131I] has no effect on your fitness to drive or to operate machinery.
Sportsmen and Sportswomen
There are no particular precautions for the use of sodium iodide [131I] by people engaged
in active sport.
List of those Excipients, Knowledge of which is Important for the Safe Use of the
Medicinal Product in certain Patients
This product contains no ingredients which might necessitate special consideration
being given to its use for particular types of patients.
4.

HOW IS THIS PRODUCT USED ?
Dosage
Your physician will decide on the amount of sodium iodide [131I] to be used.
Doses required depend on the indication : for diagnostic use, the dose may be from
0.1 MBq for small children, up to a maximum of 11 MBq (Megabecquerel - the unit in
which radioactivity is measured); for therapeutic use, the dose may be from 20 MBq for
small children, up to a maximum of 11100 MBq.

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09/2007

Method and Route of Administration
Sodium iodide [131I] is administered orally in a drink through a straw.
Frequency of Administration and Appropriate time of Administration
The treatment may be repeated.
Duration of treatment
Images of your thyroid, known as scans, are performed at 4 hours, and then again
between 18 and 24 hours after administration and sometimes at 72 hours.
In therapeutic indications, you should be asked to stay in hospital during a few days after
administration.
The therapeutic effect is only achieved after several months.
Action to be taken in the case of an Overdose
Since sodium iodide [131I] is administered by a physician under strictly controlled
conditions there is little chance of possible overdose. However, should this occur, you
will receive appropriate treatment from your physician.
Action to be taken when one or more doses have not been taken
Not applicable in the case of this medicinal product.
Risk of withdrawal effects
No such risks occur with this product.
5.

INDESIRABLE EFFECTS
Some allergic type reactions have been notified following the administration of sodium
iodide [131I]. On rare occasions, nausea and vomiting have been reported.

The part of the eye that makes tears may not work properly. This may cause dry eyes or
block tear ducts, for example. Normally these side effects are short lasting, but they may
last longer in some patients.
In men, high doses of sodium iodide [131I], may affect temporary sperm production. If you
would ever like to father a child, speak to your doctor about wether saving your sperm in
a sperm bank should be considered.
INFORM YOUR PHYSICIAN IF YOU EXPERIENCE ANY ILL-EFFECTS

6.

STORAGE
The product label includes the appropriate storage conditions and the expiry date for the
batch of product. Hospital personnel will ensure that the product is stored correctly and
not administered to you after the stated expiry date.

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09/2007

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7.

DATE OF LAST REVISION OF THE PACKAGE LEAFLET
09/2007

VAR GB_P4509pD
09/2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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