Sammibi

Document: Sammibi kit for radiopharmaceutical preparation ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 3.4

Sammibi1 mgkit for radiopharmaceutical preparation

[Tetrakis (1 isocyanide- 2-methoxy-2 methylpropyl-)copper (I)] tetrafluoroborate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Sammibiis and what it is used for

2. What you need to know before Sammibiis used.

3. How Sammibi is used.

4. Possible side effects

5. How Sammibi is stored

6. Contents of the pack and other information

What Sammibi is and what it is used for

This medicine is aradiopharmaceutical product for diagnostic use only.

Sammibicontains a substance called [tetrakis(1-isocyanide-2-methoxy-2-methylpropyl)copper(I)] tetrafluoroborate which is used to studythe heart function and blood flow(myocardial perfusion) by making an image of the heart (scintigraphy), for example in the detection of heart attacks (myocardial infarctions) or when a disease causes reduced blood supply to (a part of) the heart muscle(ischaemia).

Sammibi is also used in the diagnosis of breast abnormalities in addition to other diagnostic methods when the results are unclear. Sammibi can also be used to find the position of overactive parathyroid glands (glands that secrete the hormone that controls blood calcium levels).

After Sammibi is injected, it temporarily collects in certain parts of the body. This radiopharmaceutical substance contains a small amount of radioactivity, which can be detected from outside of the body by using special cameras. You nuclear medicine doctor will then take an image (scintigraphy) of the concerned organ which can give your doctor valuable information about the structure and the function of this organ or the location of e.g., a tumour.

The use of Sammibi does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

What you need to know before Sammibi is used

Sammibimust not be used

if you are allergic to tetrakis (1 isocyanide-2-methoxy-2-methylpropyl) copper(I)] tetrafluoroborate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with Sammibi

if you are pregnant or believe you may be pregnant
if you are breastfeeding
if you have a kidney or liver disease.

You should inform your nuclear medicine doctor in case those apply to you. You nuclear medicine doctor will inform you if you need to take any special precautions after using this medicine. Talk to your nuclear medicine doctor if you have any questions.

Before administration of Sammibi you should

be fasting for at least 4 hours if the product is going to be used to perform images of your heart,
drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.

Children and adolescents

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

Other medicines and Sammibi

A number of medicines, foods and beverages can adversely affect the outcome of the planned investigation. It is therefore recommended to discuss with the referring physician, which intake should be discontinued before the investigation and when the medicines should be taken again. Tell also your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, since they may interfere with the interpretation of the images.

Especially tell your nuclear medicine doctor if you are taking medicines which affect heart function and/or blood flow.

Please ask your nuclear medicine doctor before taking any medicines.

Pregnancy and breastfeeding

You must inform the nuclear medicine doctor before the administration of Sammibi if there is possibility you might be pregnant, if you have missed your period or if you are breastfeeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant,

your nuclear medicine doctorwill only administer this medicine during pregnancy if a benefit is expected which would outweigh the risks.

If you are breastfeeding,

please tell your nuclear medicine doctor, as he/she will advise you to stop doing so until the radioactivity has left your body. This takes about 24 hours. The expressed milk should be discarded. Please ask your nuclear medicine doctor when you can resume breast-feeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before taking this medicine.

Driving and using machines

It is considered unlikely that Sammibi will affect your ability to drive or to use machines.

Sammibi contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

How Sammibi is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Sammibi will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.

The nuclear medicine doctorsupervising the procedure will decide on the quantity of Sammibi to be used in your case. It will be the smallestquantity necessary to get the desired information.

The quantity usually recommended to be administered for an adult ranges depending on the test to be performed, and ranges between 200 and 2000 MBq (Megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the quantity to be administered will be adapted to the child’s weight.

Administration of Sammibi and conduct of the procedure

Sammibiis administered in a vein of the arm or the foot (intravenous administration).

One to two injections is sufficient to conduct the test that your doctor needs.

After injection, you will be offered a drink and asked to urinate immediately preceding the test.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

The ready-to-use solution will be injected to you in a vein before the scintigraphy is taken. The scanning may take place within 5 to 10 minutes or up to 6 hours after injection, depending on the test.

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 pharmacological stress). 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 scintigraphy of breast abnormalities, an injection of 750 to 1100 MBq is administered into a vein of your arm opposite to the breast concerned, or into a vein of your foot.

To find the position of overactive parathyroid glands, the activity administered is between 185 and 1100 MBq, depending on the methods used.

If the medicine 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 test. After the injection, but before the image (scintigraphy) 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 liver and to improve the image.

Duration of the procedure

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

After administration of Sammibi has been performed, you should:

avoid any close contact with young children and pregnant women for the 24 hours following the injection,
urinate frequently in order to eliminate the product from your body.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Sammibi than you should

An overdose is almost impossible, because you will only receive a dose of Sammibi precisely controlled by the nuclear medicine doctor supervising the procedure. However in the case of an overdose,you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink abundantly in order to facilitate the elimination of Sammibi from your body.

Should you have any further questions on the use of this medicine, please ask the 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.

Allergic reactions possibly with shortness of breath, extreme tiredness, being sick (usually within 2 hours after administration), swelling beneath the skin that can occur in areas such as the face and limbs (angioedema), and obstruct the airway, or leading to a dangerous decrease of blood pressure (hypotension) and slow heart beat (bradycardia) have been seen rarely. Doctors are aware of this possibility and have emergency treatment available for use in such cases. Local skin reactions have also been seen rarely with itching, hives, rash, swelling and redness. If you experience any of those, please refer immediately to your nuclear medicine doctor.

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

Frequency	Possible side effects
common: may affect up to 1 in 10 people	Metallic or bitter taste, smell alteration, and dry mouth immediately after injection.
uncommon: may affect up to 1 in 100 people	Headache, chest pain, abnormal ECG and feeling sick.
rare: may affect up to 1 in 1,000 people	abnormal heart rhythm, local reactions at the injection site, stomach ache, fever, fainting, seizures, dizziness, flushing, skin numbness or tingling, tiredness, joint pains and stomach upset (dyspepsia).
not known: frequency cannot be estimated from the available data	Erythema multiforme, a widespread rash of skin and mucosa.

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

How Sammibi is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

This medicine must not be used after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Contents of the pack and other information

What Sammibi contains

The active substance is: [tetrakis (1 isocyanide- 2-methoxy-2 methylpropyl) copper (I)] tetrafluoroborate
One vial contains 1.0 mg [tetrakis (1 isocyanide- 2-methoxy-2 methylpropyl) copper (I)] tetrafluoroborate

The other ingredients are:

stannous chloride dihydrate

L-cysteine hydrochloride monohydrate

sodium citrate dihydrate

D-mannitol.

What Sammibi looks like and contents of the pack

The product is a kit for radiopharmaceutical preparation.

Sammibi consists of lyophilisate (white powder) which has to be dissolved in a solution and combined with radioactive technetium before use as an injection. Once the radioactive substance sodium pertechnetate (^99mTc) is added to the vial, technetium (^99mTc) sestamibi is formed. This solution is ready for injection..

Pack size

10 ml glass vials sealed with a chlorobutyl rubber stopper and an aluminium crimp cap.

Vials are packed in cardboard boxes.

Pack size: 3 or 6 vials.

Marketing Authorisation Holder

S Ahlén Medical Nordic AB

Cylindervägen 18, 5tr

131 52 Nacka Strand, Sweden

e-mail: info@samnordic.com

Manufacturer

National Centre for Nuclear Research

Andrzej Sołtan 7

05-400 Otwock, Polen

phone: + 48 22 718 07 00

fax: + 48 22 718 03 50

e-mail:polatom@polatom.pl

This leaflet was last revised in

2016-11-09

The following information is intended for healthcare professionals only:

The complete SmPC of Sammibi is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please refer to the SmPC (SmPC should be included in the box).