Citrato de ytrio (90 y) coloidal cis bio international 37-370 mbq/ml suspension inyectable

Label: information for the patient

Yttrium citrate (90Y) colloid CIS bio international 37-370 MBq/ml injectable suspension

Yttrium citrate (90Y)

Read this label carefully before this medication is administered to you,because it contains important information for you.

• 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 physician, even if they are not listed in this label. See section 4.

1. What isYttrium citrate (90Y) colloid CIS bio internationaland how is it used

2. What you need to know before starting to useYttrium citrate (90Y) colloid CIS bio international

3. How to useYttrium citrate (90Y) colloid CIS bio international

4. Possible adverse effects

5.Storage ofYttrium citrate (90Y) colloid CIS bio international

6. Contents of the package and additional information

This medication is a radioisotope solely for therapeutic use.

Colloidal Yttrium Citrate (90Y) CIS bio international is indicated for the treatment of the knee in case of synovial hypertrophy (radioisotopic synoviorthesis) mainly for monoarthritis or oligoarthritis in chronic inflammatory rheumatic diseases, especially rheumatoid polyarthritis.

The administration of Colloidal Yttrium Citrate (90Y) 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 the procedure with the radiopharmaceutical outweighs the risk of radiation.

Yttrium Citrate (90Y) Colloidal CIS Bio International Should Not Be Used

• If you are allergic to Yttrium Citrate (90Y) or any of the other components of this medication (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• If you suffer from septic arthritis of the knee.
• If you have a broken synovial cyst.
• If you have localized infections or skin conditions present in the injection area.

Warnings and Precautions

Be Especially Careful with Yttrium Citrate (90Y) Colloidal CIS Bio International

Inform your nuclear medicine doctor in the following cases:

• If you have an unstable knee joint,
• If you have had a knee X-ray in the last 8 days
• If you have severe bone tissue destruction or
• Ankylosed joints.
• If you have significant cartilage articular loss. Insofar as possible, your doctor should avoid administering Yttrium Citrate (90Y) Colloidal CIS Bio International to individuals of fertile age with reproductive potential.
• If you are a fertile woman, before starting treatment, you should begin effective contraception and continue it for several months afterwards.

Children and Adolescents

Inform your nuclear medicine doctor if you are under 18 years old because, insofar as possible, its administration should be avoided in children during bone growth.

Use of Yttrium Citrate (90Y) Colloidal CIS Bio International with Other Medications:

Inform your doctor or your nuclear medicine doctor who will oversee the procedure if you are taking, have taken recently, or may have to take any other medication, including those acquired without a prescription, as they may affect the quality of the results obtained with Yttrium-90 treatment.

Inform your nuclear medicine doctor if you have recently been administered an X-ray contrast agent. It is recommended to wait at least 8 days after the local use of an EDTA-containing contrast agent or other chelating agents.

Pregnancy, Lactation, and Fertility

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 administeringYttrium Citrate (90Y) Colloidal CIS Bio International if there is any possibility of pregnancy, if you have missed your period, or if you are breastfeeding.

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

If you are pregnant or breastfeedingyou should not receive this medication.

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

Insofar as possible, you should avoid administering this medication during fertile age.

Driving and Using Machines

The intra-articular injection of Yttrium (90Y) should be followed by immobilization of the knee, with bed rest for 2 or 3 days to reduce extra-articular migration of the radiopharmaceutical.

Yttrium Citrate (90Y) Colloidal CIS Bio International Contains 7.4 mg/mL of Sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose; it is essentially “sodium-free”.

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.Yttrium citrate (90Y) coloidal CIS bio internationalwill be used exclusively in special controlled areas.This medication will only be handled and administered by personnel with training and qualification to use it safely. These individuals will take special care in the safe use of this medication and will inform you of their actions.

The nuclear medicine physician who supervises the procedure will decide on the amount ofYttrium citrate (90Y) coloidalCIS bio internationalto be used in your case. This will be the minimum amount necessary to achieve the desired effect.

The recommended dose to administer is normally between 185 to 222 MBq per joint. (Megabecquerel, the unit of measurement used to express radioactivity).

Multiple joints can be treated simultaneously. In the case of a relapse, re-injection of radioactive colloid into a joint can be performed after a period of 6 months.

The recommended range of activity for re-treatment is 111-222 MBq.

After two unsuccessful radio synoviorthesis in the same joint, this treatment should not be repeated.

The annual activity should not exceed 444 MBq per knee.

Administration ofYttrium citrate (90Y) coloidalCIS bio international and procedure performance

The doseis administereddirectly into the joint being treated by injection.

Before injection, most of the liquid present in the cavity being treated should be removed by aspiration.

Procedure duration

Your nuclear medicine physician will inform you of the normal duration of the procedure.

After administration ofYttrium citrate (90Y) coloidalCIS bio international you should:

• absolute immobilization of the knee, with bed rest for 2 or 3 days is recommended.This is to reduce extra-articular migration of the radiofarmacon.
• use effective contraception for several months after treatment.

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

If you have been administered moreYttrium citrate (90Y) coloidalCIS bio internationalthan you should

It is unlikely to have an overdose because you will receive a single, controlled dose ofYttrium citrate (90Y) coloidalCIS bio internationalprecisely controlled by the nuclear medicine physician who supervises the procedure.However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use ofYttrium citrate (90Y) coloidalCIS bio international, ask the nuclear medicine physician who supervises the procedure.

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

In approximately 2% of cases, a transient reaction of fever may occur within 24 hours of the injection.

Allergic reactions have been observed rarely.

In some cases, the injection of radioactive colloid may be painful.

Swelling in the joint may appear several hours or days after arthroscopy. Your doctor may treat this inflammation with nonsteroidal anti-inflammatory drugs and analgesics.

There are infrequent cases in which skin necrosis and dark discoloration of the skin occur as a result of the administration method.

In rare instances, secondary joint infection may occur after radiation synovectomy.

Cases of bone tissue destruction in the knee have been reported.

Carcinogenic and leukemogenic risk (cancer and leukemia; blood cancer affecting white blood cells)

Exposure to ionizing radiation is linked to cancer induction and potential development of hereditary defects.

In very rare instances, chronic myeloid leukemia (one case) and malignant inguinal lymphoma (one case) have occurred. However, the relationship of these pathologies to radiation synovectomy has not been determined with certainty.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nuclear medicine physician, even if it is a possible adverse effect not listed in this prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: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.This medication will be 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 ofCitrate of Yttrium (90Y) colloid CIS bio international

• The active principle is Citrate of Yttrium (90Y). Each ml of injectable suspension contains between 37-370 MBq/ml of Citrate of Yttrium (90Y) at the date and time of calibration.

• The other components are: sodium chloride solution and sodium hydroxide (to adjust the pH).

Aspect of the product and content of the packaging

This medicine is presented in a glass vial in the form of a white milky injectable suspension. A vial contains between 1 ml and 10 ml of injectable suspension.

Holder of the marketing authorization and responsible for the manufacture:

CIS bio international

BP 32 - 91192 Gif sur Yvette Cedex

FRANCE

Further information about this medicine can be requested by contacting the local representative of the holder of the marketing authorization.

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tel.: 91 4841989

Registration number of the AEMPS: 75966

This medicine is authorized in the following countries:

Date of the last review of this prospectus: 06/2018

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

This information is intended solely for healthcare professionals:

The complete technical file of Citrate of Yttrium (90Y) colloid CIS bio international is included as a separate document in the packaging of the product, in order to facilitate healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please, consult the technical file.