Label: information for the patient

Tungsten sulfide (186Re) colloid CIS bio international 148-370 MBq/ml injectable suspension

Tungsten sulfide (186Re)

Read this label carefully before starting to use this medication.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any adverse effects, consult your nuclear medicine physicianeven if they are not listed in this label.See section 4.

1. What is Tungsten sulfide (186Re) colloid CIS bio internationaland how it is used

2. What you need to know before starting to use Tungsten sulfide (186Re) colloid CIS bio international

3. How to use Tungsten sulfide (186Re) colloid CIS bio international

4. Possible adverse effects

5. Storage of Tungsten sulfide (186Re) colloid CIS bio international

6. Contents of the package and additional information

This medication is a radioisotope for therapeutic use only.

The active substance is rhenium sulfide (186Re).

Rhenium sulfide (186Re) colloidal CIS bio international is indicated for the treatment of rheumatoid disease that affects the joints of shoulders, elbows, wrists, ankles, and hips.

The administration of Rhenium Sulfide (186Re) CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk of radiation.

No use Sulfuro de renio (186Re) coloidal CIS bio international:

If you are allergic to rhenium sulfide (186Re)or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with Rhenium sulfide (186Re) CIS bio international:

• If you are pregnant or think you may be
• If you are breastfeeding.
• In children and adolescents during bone growth
• If you have septic arthritis
• If you have a joint capsule rupture.
• If you are to be treated for the hip and have been administered a prolonged-release corticosteroid.

Before administration of Rhenium sulfide (186Re) CIS bio international,

• You should avoid pregnancy by using an effective contraceptive method maintained for several months after treatment.

Children and adolescents

Consult your nuclear medicine doctor if you are under 18 years old.

Use of Rhenium sulfide (186Re) CIS bio international with other medications

Inform your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your nuclear medicine doctor before using this medication.

You must inform your nuclear medicine doctor before administration of Rhenium sulfide (186Re) CIS bio international if there is any possibility of pregnancy, if you have a missed period, or if you are breastfeeding.

If you are a fertile woman, you should use effective contraceptive methods before administration of this medication and maintain them for several months after treatment.

In case of doubt, it is essential to consult the specialist nuclear medicine doctor who will oversee the procedure.

If you are pregnant or breastfeeding, you should not receive this medication.

If you are breastfeeding, consider the possibility of reasonably delaying the test with this medication until you have stopped breastfeeding.

Driving and operating machines

No effects have been observed on the ability to drive and operate machines.

Rhenium sulfide (186Re) CIS bio international contains sodium

This medication contains 12.7 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.6% of the maximum daily sodium intake recommended for an adult. The amount of sodium administered may be higher in some cases than 23 mg. Therefore, consider if you follow a low-sodium diet.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Sulfur hexafluoride (186Re) CIS bio international will only be used in controlled special areas. This product will only be handled and administered by trained and qualified personnel to ensure safe use. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of Sulfur hexafluoride (186Re) coloidal CIS bio international to be used in your case, which will be the minimum amount necessary to achieve the desired effect. The generally recommended dose for an adult is 70 to110 MBq (Megabequerel, the unit used to express radioactivity) according to the joint to be treated.

Administration of Sulfur hexafluoride (186Re) CIS bio international and procedure performance

Sulfur hexafluoride (186Re) CIS bio international is injected directly by your nuclear medicine physician into the shoulder, elbow, wrist, ankle, or hip joints.

Multiple joints may be treated simultaneously or sequentially.

In the event of a relapse, a new injection may be considered in the joint after a 6-month break.

After administration of Sulfur hexafluoride (186Re) CIS bio international, you should:

• Have the joint immobilized for 3 days (splints or bed rest)

• Use an effective contraceptive method for several months after treatment to avoid any pregnancy.
• Avoid direct contact with small children and pregnant women.

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.

If you have been administered moreSulfur hexafluoride (186Re) CIS bio internationalthan you should:

It is unlikely that you will receive an overdose because you will receive a single, precisely controlled dose of Sulfur hexafluoride (186Re) CIS bio international administered by the nuclear medicine physician overseeing the procedure.

If you have any other questions about the use of Sulfur hexafluoride (186Re) CIS bio international, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 patients)

• Swelling due to fluid accumulation (edema)
• Pigmentation disorder

Rare (may affect up to 1 in 100 patients)

• Chromosomal anomalies

Unknown frequency (cannot be estimated from available data)

• Joint inflammation due to infection (infectious arthritis)
• Nausea
• Vomiting
• Blood flow loss in bones causing bone death (osteonecrosis)
• Joint fluid loss (joint effusion)
• Joint inflammation
• Joint pain

The most frequently observed adverse reactions after synoviorthroscopy with rhenium are:

• Brown discoloration of the wrist at the injection site and sometimes muscle infiltration and stiffness.
• Swelling due to fluid accumulation (edema) of the forearm after wrist synoviorthroscopy.
• Transient local pain or joint inflammation (dilation phenomenon) after joint puncture.
• Nausea and vomiting.
• Joint infection.
• Blood flow loss in bones causing bone death.

Reporting Adverse Effects

If you experience any type of adverse effect, consult yournuclear medicine specialist, even if it is any adverse effect not included in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of Rhenium Sulfide (186Re) CIS bio international

• The active principle is rhenium sulfide(186Re
• The other components are: ascorbic acid, gelatin, sodium hydroxide, hydrochloric acid, and water for injectable preparations.

Appearance ofRhenium Sulfide (186Re)CIS bio international and contents of the packaging

This medication is presented in the form of an injectable suspension in multi-dose vials of 15 ml of colorless glass closed with a rubber stopper and an aluminum cap. The vial is packaged with a lead-shielded container

Package size: One vial contains37 to3700 MBq of rhenium (186Re) at a concentration of 148 to 370 MBq/ml at the time and date of calibration.

Holder of the marketing authorization and responsible for manufacturing:

CIS bio international

RN 306 - Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

FRANCE

You can request more information about this medication by contacting the local representative of the Holder of the marketing authorization:

Curium Pharma Spain S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone:91 4841989

This prospectus was last reviewed in February 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

The complete technical file of Rhenium Sulfide (186Re) CIS bio internationalis includedas a separate document in the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical file.