Octreoscan 111 MBq/ml radiopharmaceutical preparation kit
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Octreoscan 111 MBq/ml radiopharmaceutical kit for radiopharmaceutical preparation
Indium (111In) labelled pentetreotide
Read the entire leaflet carefully before you are given this medicine because it contains important information for you.
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Package leaflet:
- What Octreoscan is and what it is used for
- What you need to know before using Octreoscan
- How to use Octreoscan
- Possible side effects
- How to store Octreoscan
- Contents of the pack and other information
1. What Octreoscan is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
Octreoscan is used in scanning to locate specific cells of the stomach, intestine, and pancreas, such as:
- abnormal tissues or
- tumours
This medicine consists of a powder for injectable solution 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 may provide your doctor with valuable information regarding the structure and function of a specific part of the body.
Administration of Octreoscan involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the procedure with this radiopharmaceutical outweighs the radiation risk.
2. What you need to know before using Octreoscan
Octreoscan must not be used:
- if you are allergic (hypersensitive) to pentetate or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Exercise special caution with Octreoscan:
- if you have renal insufficiency, your nuclear medicine physician will only administer Octreoscan if absolutely necessary
- if you are pregnant or think you might be
- if you are breastfeeding
Before administration of Octreoscan you must:
- drink at least 2 liters of fluid, for example water, and urinate as frequently as possible before and during the 2–3 days following treatment. This will prevent the active substance from accumulating in the kidneys and bladder.
- Your physician may additionally prescribe a laxative.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Octreoscan should only be administered to a child when alternative radiopharmaceuticals are not available or when results obtained with alternative radiopharmaceuticals in the child's clinical context are unsatisfactory.
Use of Octreoscan with other medicines
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with the interpretation of images.
The following medicines may influence or be influenced by Octreoscan:
- Octreotide, a medicine used for symptomatic treatment of certain tumors. Your physician may temporarily discontinue octreotide. In such cases, this should be done for a period of three days to prevent side effects.
- Insulin: Using Octreoscan in patients receiving high doses of insulin may cause a severe decrease in blood sugar levels.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before administration of Octreoscan if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding. If in doubt, it is important to consult your nuclear medicine physician who supervises the procedure.
If you are pregnant
The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
If you are breastfeeding
Inform your physician if you are breastfeeding. If administration is considered necessary, it is not necessary to interrupt breastfeeding. However, contact with small children should be restricted during the first 36 hours after administration.
Ask your nuclear medicine physician before taking any medicine.
Driving and use of machines
It is considered unlikely that Octreoscan will affect your ability to drive or operate machinery.
This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.
3. How to use Octreoscan
There are strict regulations regarding 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 who are skilled in its safe use. These individuals will take special care in ensuring the safe use of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Octreoscan to be used in your case. This will be the minimum quantity necessary to obtain the required information.
The normally recommended administered activity 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 administer Octreoscan to this age group only when absolutely necessary. Octreoscan should be given to a child only when alternative radiopharmaceuticals are not available or when results obtained with alternative radiopharmaceuticals in the child's clinical context are unsatisfactory.
Administration of Octreoscan and performance of the procedure
Octreoscan is administered intravenously.
A single injection is sufficient to perform the procedure required by your physician.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
Typically, images are obtained within 1 to 2 days after the injection. This timing depends on the information required from the images.
On some occasions, images are repeated several days after the initial scan to clarify the results.
After receiving Octreoscan, you should:
- Avoid close contact with young children and pregnant women during the first 36 hours after injection.
- Drink at least 2 liters of fluid (e.g., water) and urinate frequently for 2 or 3 days after administration to help eliminate the product from your body.
- The nuclear medicine physician will inform you if any special precautions are needed after administration of this medicine. Consult your nuclear medicine physician if you have any doubts.
If you have been given more Octreoscan than you should have
An overdose is unlikely, as you will receive a single, precisely controlled dose of Octreoscan determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided.
Drinking as much as possible (e.g., water) will help eliminate the radioactive substance more quickly.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 5620420.
If you have any further questions about the use of Octreoscan, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Adverse effects that may occur with the following frequencies:
Uncommon, occurring in 1 to 10 per 1,000 patients
- Allergic reactions may occur, with symptoms such as:
- Warm flushing
- Skin redness
- Itching
- Nausea or
- Difficulty breathing
Hospital staff will treat these reactions if they occur.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Octreoscan
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for the specialist only.
Do not use Octreoscan after the expiry date stated on the label following EXP.
Do not use Octreoscan if you observe that the integrity of the can has been broken and/or if one of the vials shows any damage.
6. Pack contents and other information
Composition of Octreoscan
Octreoscan consists of a kit containing two vials (A and B). Vial A contains 1.1 ml of solution, vial B contains powder for injectable solution.
The active substances are:
- Vial A: each vial contains 122 MBq of indium chloride (111In) in 1.1 ml (111 MBq/ml) at the time of calibration.
- Vial B: 10 micrograms of pentetreotide.
Mixed solution (A plus B): 111 MBq/ml of indium (111In)-labelled pentetreotide at the time of calibration.
The other components are:
- Vial A: hydrochloric acid, water for injections, and iron(III) chloride hexahydrate.
- Vial B: sodium citrate dihydrate, citric acid monohydrate, inositol, gentisic acid.
Presentation of the product and contents of the pack
Octreoscan is supplied in a sealed can containing two vials and a Luer Lock Sterican connector.
Vial A is a lead-shielded glass vial containing a clear, colourless solution.
Vial B is a vial closed with a grey bromobutyl rubber stopper and an aluminium seal with an orange flip-off cap. It contains a white lyophilised powder.
The vials must not be used separately.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
The Netherlands
This medicinal product is authorised 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 the most recent review of this summary: November 2016
This information is intended for healthcare professionals only:
The complete summary of product characteristics for Octreoscan is included as a separate document within the product pack, to provide healthcare professionals with scientific information as well as practical guidance on the administration and use of this radiopharmaceutical.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/