PATIENT INFORMATION LEAFLET

Octreoscan 111 MBq/ml kit for radiopharmaceutical preparation

Indium-111 labelled pentetreotide

1. What is Octreoscan and how is it used

2. What you need to know before starting to use Octreoscan

3. How to use Octreoscan

4. Possible side effects

5. Storage of Octreoscan

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Octreoscan is used in exploratory procedures to locate specific cells in the stomach, intestines, and pancreas, such as:abnormal tissues or

• tumors

This medication consists of a powder for injectable solution and a radioactive substance, which should not be used separately. When mixed by a qualified person and injected into the body, it accumulates in specific cells.

The radioactive substancecan be detected from the outside of the body using special cameras that take an image. This image shows the distribution of radioactivity in the body. This can provide valuable information to the doctor about the structure and function of a specific part of the body.

The administration of Octreoscaninvolves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Octreoscan should not be used:

• If you are allergic (hypersensitive) to pentetreotideor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with Octreoscan:

• If you have kidney insufficiency, your doctor will only administer Octreoscan in this case if it is absolutely necessary
• If you are pregnant or think you may be pregnant
• If you are breastfeeding

Before Octreoscan administration, you must:

• Drink at least2 liters, for example water, and urinate as much as possible before and during the 2-3 days after treatment. This will prevent the active substance from accumulating in the kidneys and bladder.
• Your doctor may prescribe you, in addition, a laxative.

Children and adolescents

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

Octreoscan should only be administered to a child when alternative radiopharmaceuticals are not available or when the results with alternative radiopharmaceuticals in the child's clinical context are not satisfactory.

Use of Octreoscan with other medications

Inform your nuclear medicine doctor if you are using, have used recently, or may need to use any other medication, as some medications may interfere with image interpretation.

The following medications mayinfluence or be influencedby Octreoscan:

• Octreotide, which is a medication for the symptomatic treatment of certain tumors. Your doctor may temporarily suspend octreotide. In this case, it should be for a period of three days to prevent side effects.
• Insulin: Using Octreoscan in patients who use high doses of insulin may cause severe decrease in blood sugar levels.

Pregnancy and breastfeeding

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

You must inform your nuclear medicine doctor beforeOctreoscan administration if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding. In case of doubt, it is essential to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Inform your doctor if you are breastfeeding.If administration is considered necessary, it is not necessary to stop breastfeeding. However, contact with small children should be restricted for the first 36 hours after administration.

Ask your nuclear medicine doctor before taking any medication.

Driving and operating machines

It is considered unlikely that Octreoscan will affect your ability to drive and use machines.

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

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Octreoscan will only be used in specially controlled areas. 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 of Octreoscan to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The normally recommended and standard dose for adults is in the range of 110-220 MBq (MBq is the unit used to express radioactivity).

Use in children and adolescents

The physician will only administer Octreoscan to this age group when absolutely necessary. Octreoscan should only be administered to a child when alternative radiopharmaceuticals are not available or when the results with alternative radiopharmaceuticals in the child's clinical context are not satisfactory.

Administration of Octreoscan and procedure performance

Octreoscan is administered intravenously.

One injection is sufficient to perform the procedure that your physician needs.

Procedure duration

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

Images are usually obtained within 1 or 2 days after the injection. This depends on the information needed from the images.

In some cases, images are repeated several days after the examination to clarify the results.

After Octreoscan administration, you must:

• Avoid any contact with small children and pregnant women during the first 36 hours after the injection.
• Drink at least2 liters, for example water,, and urinate frequently for 2 or 3 days after treatment to eliminate the product from your body.
• Your nuclear medicine physician will inform you if you need to take special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more Octreoscan than necessary

It is unlikely to have an overdose because you will receive a single, controlled dose of Octreoscan administered by the nuclear medicine physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment.

Drinking as much water as possible will help you eliminate the radioactive substance more quickly.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 5620420.

If you have any other questions about the use ofOctreoscan,ask the nuclear medicine physician overseeing the procedure.

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

Adverse effects that may occur with the following frequencies:

Rare,occur in1 to10 per 1,000 patients

• Allergic reactions may occur with symptoms such as:
• • flushing
  • skin redness
  • itching
  • nausea or
  • difficulty breathing

The hospital staff will treat these reactions if they occur.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive material storage will be carried out in accordance with national regulations.

The following information is intended solely for the specialist.

Do not use Octreoscan after the expiration date that appears on the label after CAD.

Do not use Octreoscan if you observe that the integrity of the canister is broken and/or if one of the vials shows any damage.

Composition of Octreoscan

Octreoscan consists of a package containing two vials (A and B). Vial A contains 1.1 ml of solution, and vial B contains powder for injectable solution.

The active principles are

• Vial A: Each vial contains 122 MBq of indium chloride (111In) in 1.1 ml (111 MBq/ml) on the calibration date.
• Vial B: 10 micrograms of pentetreotide.

Mixed solution (A plus B): 111 MBq/ml of pentetreotide labeled with indium (111In) on the calibration date.

The other components are:

• Vial A: Hydrochloric acid, water for injectable preparations, and iron (III) hexahydrate chloride.
• Vial B: Sodium citrate dihydrate, citric acid monohydrate, inositol, and gentisic acid.

Appearance of the product and contents of the packaging

Octreoscan is supplied in a closed tin with two vials and a Luer Lock Sterican connector.

Vial A is a lead-coated glass vial containing a clear and colorless solution.

Vial B is a closed vial with a gray bromobutyl rubber stopper and an aluminum crown seal with an orange tab. It contains a white lyophilized powder.

The vials cannot be used separately.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Curium Pharma Spain S.A.

Avda. Dr. Severo Ochoa, 29

28100 – Alcobendas (Madrid)

Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium, Germany, Denmark, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Sweden, United Kingdom: Octreoscan

Last review date of this leaflet: November 2016

This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet of Octreoscan is included as a separate document in the product packaging, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

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