Label: information for the patient

Erbium citrate (169Er) colloid CIS bio international 111 MBq/ml injectable suspension

erbium citrate (169Er)

Read this label carefully before starting to use this medication because it contains important information for you..

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

1.What isErbium citrate (169Er) colloid CIS bio internationaland how it is used

2.Before usingErbium citrate (169Er) colloid CIS bio international

3.How to useErbium citrate (169Er) colloid CIS bio international

4.Possible adverse effects

5.Conservation ofErbium citrate (169Er) colloid CIS bio international

6.Content of the package and additional information

This medication is a radioisotope for therapeutic use only.

Erbium Citrate (169Er) coloidal CIS bio international is indicated for adults in the treatment of arthritis during inflammatory episodes of small joints in the hand and foot, when intra-articular treatment with corticosteroids fails, or when it is contraindicated.

The administration of Erbium Citrate (169Er) coloidal CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician consider that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

Erbium Citrate (169Er) Colloidal CIS Bio International Should Not Be Used:

• If you are allergic (hypersensitive) to erbium citrate (169Er) or to 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 your child.
• In children and young patients under 20 years old.
• If you have an infection in the joint being treated.
• If you have local infections or skin alterations in the injection area.
• If you have a recent rupture of a synovial cyst.

Warnings and Precautions

Be especially careful withErbium Citrate (169Er)Colloidal CIS Bio International and consult a nuclear medicine specialist:

• If you have undergone a procedure with X-ray contrast media in the last 3 days
• If you are a fertile woman

Before Administration ofErbium Citrate (169Er) Colloidal CIS Bio InternationalYou Must Avoid Pregnancy Using an Effective Contraceptive Method Maintained for Several MonthsAfter Treatment.

Children and Adolescents

Inform yournuclear medicine specialist if you are under 20 years old.

Use of Erbium Citrate (169Er) Colloidal CIS Bio International with Other Medications:

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

Inform your nuclear medicine specialist if you have undergone a procedure with X-ray contrast media in the last 3 days, as it may interfere with the treatment results.

Pregnancy and Lactation

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

You must inform your nuclear medicine specialist before the administration ofErbium Citrate (169Er) ColloidalCIS Bio International if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding. In fact, erbium citrate (169Er)should not be administered to pregnant women or breastfeeding women. If you are a fertile woman, you must use effective contraceptive methods before administering this medication and maintain them for several months after treatment.

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

Driving and Using Machines

It is not recommended to drive vehicles or use machines due to joint immobilization after administration.

Erbium Citrate (169Er) Colloidal CIS Bio International contains less than 23 mg of sodium (1mmol) per dose; this is, essentially “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radioactive substances.Erbium citrate (169Er) colloidCIS bio international will only be used in specially controlled facilities.This product will only be handled and administered by trained and qualified personnel to use it safely. 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 ofErbium citrate (169Er) colloidCIS bio internationalto be used in your case. This will be the minimum amount necessary to achieve the desired effect. The generally recommended dose for an adult is between10 to80 MBq (Megabequerel, the unit used to express radioactivity) depending on the joint being treated.

Administration ofErbium citrate (169Er) colloidCIS bio international and procedure performance

The nuclear medicine physician will injectErbium citrate (169Er) colloidCIS bio international directly into the small joints of the hands and feet.

Multiple joints may be treated simultaneously or sequentially.

The product will not be injected into the same joint again until at least six months have passed.

After administration of Erbium citrate (169Er) colloid CIS bio international, you should:

• Have the treated joint immobilized for 2 days (splints or bed rest)
• Use an effective contraceptive method for several months after treatment to avoid pregnancy.

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

If you have received moreErbium citrate (169Er)colloid CIS bio international than you should have:

A overdose is unlikely because you will receive a single, precisely controlled dose ofErbium citrate (169Er) colloidCIS bio international per joint by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive appropriate treatment.

If you have any doubts about the use of Erbium citrate (169Er) colloidCIS bio international, ask the nuclear medicine physician overseeing the procedure.

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

The most frequently observed adverse effects after synoviorhexis with Erbium Citrate (169Er) colloid CIS bio international are:

• Very frequent (may affect more than 1 in 10 people): pain, inflammation at the injection site, acute arthritis (reappearance of inflammation during the first week after administration).
• Frequent (may affect up to 1 in 10 people): fever, joint mobility dysfunction, skin pigmentation.
• Very rare (may affect up to 1 in 10,000 people):redness, severe skin alteration with blisters.
• Unknown frequency (cannot be estimated from available data):secondary joint infection, joint inflammation, skin necrosis, rash, and itching.

This radiopharmaceutical will release small amounts of ionizing radiation associated with a minimal risk of cancer or hereditary defects.

Reporting Adverse Effects

If you experience any type ofadverse effect, inform your nuclear medicine specialist doctor,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. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of Erbium Citrate ( 169Er colloidal CIS bio international

• The active principle is Erbium Citrate ( 169Er ).

• Other components are: nitric acid, sodium hydroxide, sodium chloride, and water for injectable preparations.

Appearance of Erbium Citrate ( 169Er colloidal CIS bio international and contents of the packaging

Erbium Citrate (169Er) colloidal CIS bio international is presented in the form of an injectable suspension, in a multidose vial.

Packaging size: Glass vials of 15 ml, sealed with rubber stopper and aluminum capsule. Contains between 0.1 and 10.0 ml, corresponding to an activity between 11 and 1110 MBq at the date and time 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 leaflet was last reviewed in June 2020

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

The following information is intended only for medical professionals or healthcare professionals:

The complete technical file of Erbium Citrate ( 169Er colloidal CIS bio international is included as a separate document, in the packaging of the product for the purpose of providing additional information to healthcare professionals

Please consult the Technical File.