PACKAGE LEAFLET: INFORMATION FOR THE USER

STAMICIS1 mg

Kit for radiopharmaceutical preparation

Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or the specialist in nuclear medicine who will perform the investigation.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the specialist in nuclear medicine who will perform the investigation.

In this leaflet:

1. What STAMICIS,is and what it is used for

2. Before you use STAMICIS

3. How to use STAMICIS

4. Possible side effects

6. Further information

STAMICIS is a powder used for the preparation of a radioactive solution for injection of technetium (^99mTc) sestamibi. Technetium (^99mTc) is a radioactive element allowing the visualisation of organs which bind sestamibi. The solution is injected into a vein of your arm or of your foot and the product can be easily traced in your body.

This medicine is for diagnostic use only.

The product is used to take pictures (scintigraphy) of your heart, breast or parathyroid tissue, which give doctors more information about :

• the blood flow and workings of your heart ,

• the finding of possible breast abnormalities, in addition to routine check-up, or

• the finding of overactive parathyroid glands.

Do not use STAMICIS

Take special care with STAMICIS

- if you have a kidney or liver disease

- if there is a possibility that you are pregnant

If any of the above mentioned conditions are applicable to you, you should inform your doctor or the specialist in nuclear medicine who will perform the investigation.

The use of STAMICIS does involve exposure to small amounts of radioactivity; however, your doctor should always consider the possible risks and benefits before using this product.

To minimise the dose of radiation absorbed by the bladder, it is recommended that you should drink plenty of water after the injection in order to help frequent voiding.

Your doctor will inform you if you need to take any special precautions after using medicine. Contact your doctor if you have any questions.

Using other medicines

Please tell your doctor or the specialist in nuclear medicine who will perform the investigation if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using STAMICIS with food and drink

If the product is going to be used to perform images of your heart, then you will be asked not to eat anything for at least 4 hours before the investigation. After the injection, but before the image (scan) is made, you will be asked to eat a light fatty meal, if possible, or to drink one or two glasses of milk in order to decrease the radioactivity in your body and to improve the image.

Pregnancy and breast-feeding

Ask your doctor and /or the specialist in nuclear medicine who will perform the investigation for advice before taking any medicine.

It is important to tell your doctor whether there is a chance you may be pregnant. The use of radiopharmaceuticals during pregnancy should be considered carefully. Your doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.

If you are breastfeeding and if the administration of a radioactive medicine is necessary, you may be told to express your breast milk before the injection. Breastfeeding should be stopped for 24 hours after injection and the expressed milk within this period of time should be discarded.

Driving and using machines

STAMICIS has no influence on the ability to drive and use machines.

STAMICIS must be reconstituted with a sodium pertechnetate (^99mTc) solution before it can be administered. Your doctor will decide what quantity of radioactive STAMICIS should be used. Depending on the investigation to be performed, the recommended dosage will range between 200 and 2000 MBq (Mega Bequerel, the unit used to express radioactivity).

After the non-radioactive STAMICIS is combined with the radioactive sodium pertechnetate (^99mTc), the finished solution for injection will be injected to you in a vein before the scan is taken. The scanning may take place within 5 to 10 minutes or up to 6 hours after injection, depending on the investigation.

In the case of a heart investigation, two injections may be necessary, one at rest and one at stress (e.g., during a physical exercise or administration of medicine). The two injections will be done at least two hours apart and not more than 2000 MBq in total (1 day protocol) will be administered. A two day protocol is feasible, also.

For the scans of breast abnormalities, an injection of 750 to 1000 MBq is administered into a vein of your arm opposite to the breast concerned, or into a vein of your foot.

For the localisation of hyperfunctioning parathyroid glands, the activity administered is between 185 and 1000 MBq, depending on the methods used.

Because there are strict laws covering the use, handling and disposal of radioactivity, STAMICIS will always be used in a hospital or in similar settings. It will only be handled and administered by people who have been trained and are qualified in the safe handling of radioactive material.

This medicine is not intended to be administered on a regular basis or continuously. However, the usual protocol can include a second injection during the investigation.

If more radioactive STAMICIS is given to you than necessary

In the unlikely event of an overdose, your doctor may recommend that you drink plenty of fluids to remove the traces of radioactivity from your body.

If you have any further questions on the use of this product, ask your doctor or specialist in nuclear medicine who will perform the investigation.

4. POSSIBLE SIDE EFFECTS

Like all medicines, STAMICIScan cause side effects, although not everybody gets them.

Possible side effects are listed in the order of their frequency below:

Frequency	Possible side effects
common: affects 1 to 10 users in 100	Metallic or bitter taste, smell alteration, and dry mouth immediately after injection.
uncommon: affects 1 to 10 users in 1,000	Headache, chest pain, and feeling sick.
rare: affects 1 to 10 users in 10,000	Dizziness, swelling (oedema), irritation around the injection site, nausea, vomiting, diarrhoea, fall in blood pressure, itching, urticaria or hives, fever, flushing and non itching rash, fatigue, difficulty in catching your breath.
not known: frequency cannot be estimated from the available data	One case has been discovered in literature describing the occurrence of Erythema multiforme, a widespread rash of skin and mucosa.

Any radioactive medicine may cause cancer or hereditary defects, but because the dose of radiation received with technetium (^99mTc) sestamibi is low, it is very unlikely to cause these effects.

Reporting of side effects

If you get any side effects, talk to your doctor or specialist in nuclear medicine. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Läkemedelsverket

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE STAMICIS

You will not have to get or store this medicine for diagnostic. The qualified staff of the nuclear medicine center where is performed this investigation, will do this.

Keep out of the reach and sight of children.

Do not use STAMICIS after the expiry date which is stated on the labels after EXP. The expiry date refers to the last day of that month.

Do not store above 25C°C. Keep the vial in the outer carton, in order to protect from light.

Do not store the reconstituted and radiolabelled product above 25°C and use within 10 hours after labelling.

6. FURTHER INFORMATION

What STAMICIScontains

• The active substance is tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

• 1 vial contains 1 mg Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

• The other ingredients are : stannous chloride dihydrate, cysteine hydrochloride monohydrate, sodium citrate, mannitol.

What STAMICISlooks like and contents of the pack

STAMICIS is a kit for radiopharmaceutical preparation which should be dissolved and labeled with radioactive technetium before use. When this powder is mixed with a solution of sodium pertechnetate (^99mTc), a solution of technetium (^99mTc) sestamibi is formed.

This solution is ready to be injected intravenously.

Packsize : 5 vials.

Marketing Authorisation Holder and Manufacturer

CIS bio international

B.P. 32

91192 GIF-SUR-YVETTE CEDEX

FRANCE

This leaflet was last approved in 2014-04-09

Swedish summary of product characteristics for this medicine is available on the web site of Medical Products Agency.