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Package Leaflet: Information for the Patient
Rhenium sulfide (186Re) CIS bio international 148-370 MBq/ml injectable suspension
Rhenium sulfide (186Re)
Read this package leaflet carefully before you start using this medicine.
Contents of the package leaflet:
This medicine is a radiopharmaceutical for therapeutic use only.
The active substance is rhenium sulfide (186Re).
Rhenium sulfide (186Re) CIS bio international is indicated for the treatment of rheumatoid disease affecting the shoulder, elbow, wrist, ankle, and hip joints.
Administration of Rhenium sulfide (186Re) CIS bio international involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from this procedure with the radiopharmaceutical outweighs the risk of radiation.
Do not use Rhenium sulfide (186Re) CIS bio international:
If you are allergic to rhenium sulfide (186Re) or any of the other components of this medicine (listed in section 6).
Warnings and precautions
Be careful with Rhenium sulfide (186Re) CIS bio international:
Before administration of Rhenium sulfide (186Re) CIS bio international,
Children and adolescents
Consult your nuclear medicine doctor if you are under 18 years old.
Using Rhenium sulfide (186Re) CIS bio international with other medicines
Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before using this medicine.
You should tell your nuclear medicine doctor before administration of Rhenium sulfide (186Re) CIS bio international if there is any possibility that you are pregnant, if you have a delayed menstrual period, or if you are breast-feeding.
If you are a woman of childbearing age, you should use effective contraceptive measures before administration of this medicine and for several months after treatment.
In case of doubt, it is important that you consult your specialist nuclear medicine doctor who will supervise the procedure.
If you are pregnant or breast-feeding, you should not receive this medicine.
If you are breast-feeding, you should consider delaying the test with this medicine until you have stopped breast-feeding.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Rhenium sulfide (186Re) CIS bio international contains sodium
This medicine contains 12.7 mg of sodium (a major component of cooking/table salt) per ml. This is equivalent to 0.6% of the maximum recommended daily sodium intake for an adult. The amount of sodium administered may be higher than 23 mg in some cases. Therefore, this should be taken into account if you are on a low-sodium diet.
There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Rhenium sulfide (186Re) CIS bio international will only be used in controlled areas. This product will only be handled and administered by trained and qualified personnel. These people will take special care in the safe use of this product and will inform you of their actions.
The nuclear medicine doctor who supervises the procedure will decide the amount of Rhenium sulfide (186Re) CIS bio international to be used in your case, which will be the minimum amount necessary to achieve the desired effect. The recommended amount for administration to an adult is 70 to 110 MBq (Megabecquerel, the unit used to express radioactivity) depending on the joint to be treated.
Administration of Rhenium sulfide (186Re) CIS bio international and performance of the procedure
Rhenium sulfide (186Re) CIS bio international is injected directly by your nuclear medicine doctor into the shoulder, elbow, wrist, ankle, or hip joints.
Several joints can be treated simultaneously or successively.
In case of relapse, a new injection into the joint may be considered after a 6-month break.
After administration of Rhenium sulfide (186Re) CIS bio international, you should:
Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine doctor if you have any doubts.
If you have been given more Rhenium sulfide (186Re) CIS bio international than you should:
It is unlikely that you will be given an overdose because you will receive a single, precisely controlled dose of Rhenium sulfide (186Re) CIS bio international by the nuclear medicine doctor who supervises the procedure.
If you have any further questions on the use of Rhenium sulfide (186Re) CIS bio international, ask your nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (may affect up to 1 in 10 patients)
Uncommon (may affect up to 1 in 100 patients)
Frequency not known (cannot be estimated from the available data)
The most frequently observed adverse reactions after synovectomy with rhenium are:
Reporting of side effects
If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es
By reporting side effects, you can help provide more information on the safety of this medicine.
You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.
Composition of Rhenium sulfide (186Re) CIS bio international
Appearance of Rhenium sulfide (186Re) CIS bio international and contents of the pack
This medicine is presented as an injectable suspension in 15 ml glass vials closed with a rubber stopper and an aluminum cap. The vial is packaged with a lead shielded container
Pack size: One vial contains 37 to 3700 MBq of rhenium (186Re) at a concentration of 148 to 370 MBq/ml on the calibration date and time.
Marketing authorization holder and manufacturer:
CIS bio international
RN 306 - Saclay
B.P. 32
F-91192 Gif-sur-Yvette Cedex
FRANCE
You can request more information about this medicine from the local representative of the Marketing Authorization Holder:
Curium Pharma Spain S.A.
Avda. Dr. Severo Ochoa, 29
28100-Alcobendas
Phone: 91 4841989
This package leaflet was last revised in February 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
This information is intended only for healthcare professionals:
The complete technical data sheet for Rhenium sulfide (186Re) CIS bio international is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the technical data sheet.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension – subject to medical assessment and local rules.