OCTREOSCAN 111 MBq/ml KIT FOR RADIOPHARMACEUTICAL PREPARATION

1. What is Octreoscan and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Octreoscan is used to locate specific cells in the stomach, intestine, and pancreas, such as:

• abnormal tissues or
• tumors

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

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

Administration of Octreoscan involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you are given Octreoscan

Octreoscan must not be used:

• if you are allergic (hypersensitive) to pentetreotide or any of the other components of this medicine (listed in section 6)

Warnings and precautions

Be particularly careful with Octreoscan:

• if you have kidney problems, your doctor will only give you Octreoscan if it is absolutely necessary
• if you are pregnant or think you may be pregnant
• if you are breast-feeding

Before administration of Octreoscan, you must:

• drink at least 2 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 also prescribe a laxative for you

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years old

Octreoscan should only be given to a child when no alternative radiopharmaceuticals are available or when the results with alternative radiopharmaceuticals in the clinical context of the child are not satisfactory

Using Octreoscan with other medicines

Tell your nuclear medicine doctor if you are using, have recently used, or might use any other medicines, as some medicines may interfere with the interpretation of the images

The following medicines may affect or be affected byOctreoscan:

• Octreotide, which is a medicine for the symptomatic treatment of certain tumors. Your doctor may temporarily stop the 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 a severe decrease in blood sugar levels

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine

You must inform your nuclear medicine doctor before administration of Octreoscan if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding. In case of doubt, it is important that you consult your nuclear medicine doctor who supervises the procedure

If you are pregnant

Your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risk

If you are breast-feeding

Tell your doctor if you are breast-feeding. If administration is considered necessary, it is not necessary to stop breast-feeding. However, you should restrict contact with small children during the first 36 hours after injection

Ask your nuclear medicine doctor before taking any medicine

Driving and using machines

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

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free"

3. How Octreoscan is used

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. Octreoscan will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. 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 Octreoscan to be used in your case. This will be the minimum amount necessary to obtain the desired information

The amount to be administered is normally in the range of 110-220 MBq (MBq is the unit used to express radioactivity) for adults

Use in children and adolescents

The doctor will only give Octreoscan to this age group when it is absolutely necessary. Octreoscan should only be given to a child when no alternative radiopharmaceuticals are available or when the results with alternative radiopharmaceuticals in the clinical context of the child are not satisfactory

Administration of Octreoscan and performance of the procedure

Octreoscan is administered by intravenous injection

A single injection is sufficient to perform the procedure that your doctor needs

Duration of the procedure

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

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

In some cases, images are repeated on subsequent days after the examination to clarify the results

After administration of Octreoscan, you must:

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

If you have been given more Octreoscan than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Octreoscan from your nuclear medicine doctor. However, in case of overdose, you will receive the appropriate treatment

Drinking as much as possible, for example water, will help you eliminate the radioactive substance more quickly

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420

If you have any further questions about the use of Octreoscan, ask your nuclear medicine doctor who supervises the procedure

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

Side effects that may occur with the following frequencies:

Uncommon, occur in 1 to 10 per 1,000 patients

• Allergic reactions may occur with symptoms such as:
• • hot flush
  • redness of the skin
  • itching
  • nausea or
  • difficulty breathing

Hospital staff will treat these reactions if they occur

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them 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

5. Storage of Octreoscan

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

The following information is intended only for the specialist

Do not use Octreoscan after the expiry date stated on the label after EXP

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

6. Package contents and further information

Composition of Octreoscan

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

The active ingredients are

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

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

The other ingredients are:

• Vial A: hydrochloric acid, water for injections, and iron (III) chloride hexahydrate
• Vial B: sodium citrate dihydrate, citric acid monohydrate, inositol, gentisic acid

Appearance of the product and package contents

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

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

Vial B is a vial closed with a gray bromobutyl rubber stopper and an aluminum 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 under the following names:

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

Date of last revision of this leaflet: November 2016

This information is intended only for healthcare professionals:

The full technical specifications of Octreoscan are included as a separate document in the product packaging, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical

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/