Poltehmibi

PATIENT INFORMATION LEAFLET: USER INFORMATION

PoltechMIBI, 1 mg, kit for the preparation of a radiopharmaceutical preparation

Tetra(2-methoxy-2-methylpropyl-1-isocyanide)]-tetrafluoroborate of copper (I)

You should read the contents of the leaflet before using the preparation.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult your doctor or a specialist in nuclear medicine who supervises the examination if you have any further doubts.
• If any of the side effects worsen or if you experience any side effects not mentioned in this leaflet, you should inform your doctor or a specialist in nuclear medicine who supervises the examination.

Table of contents of the leaflet

• 1. What is PoltechMIBI and what is it used for
• 2. Important information before using PoltechMIBI
• 3. How to use PoltechMIBI
• 4. Possible side effects
• 5. How to store PoltechMIBI
• 6. Contents of the packaging and other information

1. WHAT IS PoltechMIBI AND WHAT IS IT USED FOR

PoltechMIBI is a radiopharmaceutical product intended exclusively for diagnostic purposes.
PoltechMIBI is used to examine heart function and blood flow through the heart muscle
(myocardial perfusion) by means of heart imaging (scintigraphy), for example, to detect
heart attack or when the disease causes a reduction in blood flow to part of the heart muscle
(ischemia).
Scintigraphy with PoltechMIBI is used:

• in the diagnosis of ischemic heart disease,
• to detect and localize myocardial infarction,
• to examine heart function as a pump (total heart function and/or local wall motion),
• to examine the breast in case of suspected breast cancer in patients with non-conclusive mammography results or palpable breast tumor and negative or non-conclusive mammography results,
• to examine the parathyroid glands in case of their hyperfunction.

The use of PoltechMIBI results in exposure to a small dose of radiation. Your doctor
and the specialist in nuclear medicine have decided that the benefits of the examination outweigh the potential risks associated with ionizing radiation.

2. IMPORTANT INFORMATION BEFORE USING PoltechMIBI

When not to use PoltechMIBI

PoltechMIBI must not be administered if the patient is allergic to the active substance or any of the other components of the medicinal product.

Warnings and precautions

You should inform the specialist in nuclear medicine in the following cases:

• if the patient has kidney or liver function disorders,
• if the woman is pregnant or suspected to be pregnant,
• if the woman is breastfeeding,
• if the patient is under 18 years of age.

The administration of radiopharmaceuticals poses a risk of exposure to external ionizing radiation or contamination caused by urine stains, vomiting, etc. to other people. Therefore, you should follow basic hygiene rules in accordance with local regulations.
You should exercise particular caution when using radiopharmaceuticals to avoid unnecessary exposure of staff and patients.
To reduce the radiation dose absorbed by the bladder, it is recommended to drink plenty of fluids after injection to frequently empty the bladder.

Before administering PoltechMIBI:

• you should drink plenty of water and ensure good hydration before the examination to urinate as frequently as possible in the first hours after the examination,
• you should fast for at least four hours if a heart examination is to be performed.

Other medicines and PoltechMIBI

You should tell your doctor or the specialist in nuclear medicine supervising the examination about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take.

PoltechMIBI with food and drink

If the product is to be used for a heart examination, you should fast for at least four hours before the examination. The doctor may ask you to eat a light fatty meal or drink one or two glasses of milk after injection and before the examination.

Pregnancy and breastfeeding

Before administering the product, you should inform the specialist in nuclear medicine if:

• the woman is suspected to be pregnant
• menstruation has not occurred at the expected time
• the woman is breastfeeding. In case of doubt, consultation with the doctor or specialist in nuclear medicine who will supervise the examination is necessary. If the patient is pregnant, it is essential to inform the doctor. The use of radiopharmaceuticals during pregnancy should be carefully considered. The doctor will refer for an examination using radiopharmaceuticals during pregnancy only if absolutely necessary.

In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may ask to stop breastfeeding and discard breast milk.
Breastfeeding should be stopped for 24 hours after injection, and the expressed breast milk should be discarded. The possibility of returning to breastfeeding should be agreed upon with the specialist in nuclear medicine who supervises the examination.

Driving and using machines

It is considered unlikely that the Tc-MIBI product will affect the ability to drive vehicles and operate machines.

PoltechMIBI contains sodium

This product contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially "sodium-free".

3. HOW TO USE PoltechMIBI

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. PoltechMIBI is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the product and will keep the patient informed about their actions.
The product is intended for intravenous administration.
Before administration, PoltechMIBI should be dissolved in sodium pertechnetate [Tc]. The specialist in nuclear medicine supervising the procedure decides on the dose of the product to be used in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information.
Depending on the type of examination, the recommended dose will be in the range of 200 to 2000 MBq (MBq = megabecquerel, a unit of measurement of radioactivity).

Use in children and adolescents

The use of PoltechMIBI in children and adolescents must be carefully analyzed by the specialist in nuclear medicine supervising the examination, taking into account clinical indications and the risk-benefit assessment in this patient group. Safety and efficacy in children and adolescents under 18 years of age have not been fully established.
In the pediatric population, the dose of the product will be adjusted according to the child's body weight.

Administration of the product and performance of the examination

The ready-to-use solution for injection will be administered intravenously before scintigraphy. The examination, depending on its type, may be performed within 5-10 minutes or up to 6 hours after injection.
In the case of a heart examination, two injections may be necessary: at rest and after a stress test (e.g., after physical exertion). These two injections are performed at an interval of at least two hours, and the total activity will not exceed 2000 MBq (one-day examination). It is also possible to perform the examination over two days.
The radiopharmaceutical Tc-MIBI is intended for intravenous administration only under the strict supervision of qualified personnel. When preparing and administering the radiopharmaceutical, the regulations regarding safety at work in conditions of exposure to ionizing radiation must be strictly followed.

Duration of the procedure

The doctor will inform you about the standard duration of the procedure.

After administering PoltechMIBI:

• you should avoid close contact with small children for 24 hours after injection,
• you should urinate frequently to remove the product from the body,
• if a heart examination is to be performed, you should eat a light fatty meal or drink one or two glasses of milk after each injection and before the examination.

Use of a higher than recommended dose of PoltechMIBI

Overdose is impossible because the dose of the product administered to the patient is strictly controlled by the specialist in nuclear medicine supervising the examination. However, in case of overdose, the doctor may recommend drinking more fluids to remove the radiopharmaceutical from the body.
In case of any further doubts regarding the use of the medicinal product, you should consult your doctor or the specialist in nuclear medicine supervising the examination.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PoltechMIBI can cause side effects, although they may not occur in everyone.
Common side effects (observed in 1 to 10 out of 100 patients) include metallic or bitter taste in the mouth, change in smell, and dryness in the mouth shortly after injection.
Uncommon side effects (observed in 1 to 10 out of 1000 patients) include headache, chest pain, ECG changes, and nausea.
Rare side effects (observed in 1 to 10 out of 10,000 patients) include hypersensitivity reactions, arrhythmias, edema (swelling), local reactions at the injection site, abdominal pain, indigestion, vomiting, itching, hives, fever, fainting, seizures, dizziness, skin redness, rash, feeling of numbness or tingling of the skin, feeling of fatigue, feeling of shortness of breath (dyspnea), decreased blood pressure, vasodilation, and joint pain.
One case of erythema multiforme has been reported in the literature, characterized by widespread rash on the skin and mucous membranes.
The administration of radiopharmaceuticals results in exposure to a small dose of ionizing radiation, which is associated with the risk of inducing cancer and congenital anomalies.
Reporting of side effects
If you experience any side effects, including any side effects not mentioned in this leaflet, you should inform your doctor or the specialist in nuclear medicine.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. HOW TO STORE PoltechMIBI

The patient will not need to store this medicinal product.
Radiopharmaceutical products are stored exclusively by authorized personnel in appropriate clinical conditions. The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
The product should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What PoltechMIBI contains

The active substance of the medicinal product is:
[tetra(2-methoxy-2-methylpropyl-1-isocyanide)]-tetrafluoroborate of copper (I) (1.0 mg/vial)
The other ingredients are:
Copper (II) chloride dihydrate
L-cysteine hydrochloride monohydrate
Sodium citrate dihydrate
D-mannitol

What PoltechMIBI looks like and what the packaging contains

Kit for the preparation of a radiopharmaceutical preparation.
White powder.
The kit is supplied in 10 ml glass vials.
The vial is closed with a rubber stopper and an aluminum cap.
The vials are packed in cardboard boxes.
The kits are offered in packaging containing 3 or 6 vials.
Each vial contains powder for the preparation of a solution for injection.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel.: 22 718 07 00
Fax: 22 718 03 50
e-mail: polatom@polatom.pl
To obtain more detailed information, you should consult your doctor or a representative of the marketing authorization holder.

Date of last revision of the leaflet: April 2016

The full Summary of Product Characteristics (SmPC) of PoltechMIBI is attached as a separate document to the product packaging to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.