Monfh

Package Leaflet: Information for the Patient

MonFCH, 910-3415 MBq/ml, Solution for Injection

Fluorocholine Chloride[18F]

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a nuclear medicine specialist supervising the examination.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, inform the nuclear medicine specialist supervising the examination. See section 4.

Table of Contents of the Package Leaflet

• 1. What is MonFCH and what is it used for
• 2. Important information before using MonFCH
• 3. How to use MonFCH
• 4. Possible side effects
• 5. How to store MonFCH
• 6. Package contents and other information

1. What is MonFCH and what is it used for

MonFCH is a radiopharmaceutical product intended exclusively for diagnostic purposes.
MonFCH is used for diagnostic purposes in examinations using positron emission tomography (PET) and is administered before the examination.
The active substance of the MonFCH product enables imaging of increased uptake of natural substances, choline, by specific organs or tissues and is detected in the PET examination and displayed in the form of an image.
Positron emission tomography is an imaging technique used in nuclear medicine, which provides cross-sectional images of living organisms. A very small amount of radiopharmaceutical is used to obtain quantitative and precise images of specific metabolic processes in the body. The examination is intended to help make decisions about the treatment of a diagnosed or suspected disease.

2. Important information before using MonFCH

When not to use MonFCH:

• if the patient is allergic (hypersensitive) to the active substance, fluorocholine chloride [18F], or any of the other ingredients of this product (listed in section 6);
• if the patient is pregnant.

Warnings and precautions

When to exercise special caution when using MonFCH:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding;
• if the patient's kidneys do not function properly; in such cases, very careful consideration of the indication for the examination is required, as the patient may be exposed to increased radiation;
• in case of contact with small children: it is recommended to avoid close contact between the patient and small children for 12 hours after injection.

Before administering MonFCH:

• drink a large amount of water before the examination to urinate as often as possible in the first hours after its completion;
• do not eat for at least 4 hours.

Children and adolescents

Tell the nuclear medicine specialist if the patient is under 18 years old.

MonFCH and other medicines

Tell the nuclear medicine specialist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, as they may affect the assessment of the examination results. This is especially true for current or previous treatment with androgen receptor antagonists.
In case of doubts, consult the nuclear medicine specialist performing the PET examination, who will provide further information.

MonFCH with food and drink

Do not take any food for at least 4 hours before administering MonFCH.
However, drink plenty of water.

Pregnancy and breastfeeding

If the patient is pregnant, has not had her period, or is breastfeeding, inform the nuclear medicine specialist before using this medicinal product.
In case of doubts, it is essential to consult the nuclear medicine specialist who will supervise the examination.
If the patient is pregnant
Do not administer MonFCH if the patient is pregnant.
The nuclear medicine specialist will administer the product to a pregnant woman only if the expected benefits of its use outweigh the risks.
If the patient is breastfeeding
If MonFCH needs to be administered during breastfeeding, express milk before injection and store it for later use. Stop breastfeeding for at least 12 hours. Discard the breast milk obtained during this time.
Ask the nuclear medicine specialist when you can resume breastfeeding.

Driving and using machines

No studies have been conducted on the effects of MonFCH on the ability to drive and use machines.

MonFCH contains sodium

According to the conditioning time for the patient, the sodium content may be greater than 1 mmol (23 mg) in some cases. This fact should be considered in patients on a low-sodium diet.

3. How to use MonFCH

The use, handling, and disposal of radiopharmaceutical products are subject to strict regulations. The MonFCH product will be used in specially prepared rooms. The product will be prepared and administered only by trained and qualified medical personnel in accordance with safety principles and strict regulations governing the preparation, use, and disposal of radiopharmaceutical products.
The personnel will strictly follow the rules for safe use of the product and inform the patient about the procedures being performed.
The nuclear medicine specialist supervising the examination will decide on the amount of MonFCH to be used in individual cases. This will be the smallest amount necessary to obtain the desired information.
The recommended dose for an adult is usually between 200 and 500 MBq (megabecquerel [MBq] is a unit of radioactivity).

Administration of MonFCH and performance of the examination

MonFCH is administered in a single intravenous injection.
A single injection is sufficient to perform the entire examination. After administering the product, the patient will be given a liquid to drink and will be asked to urinate just before the examination begins.

Duration of the examination

The nuclear medicine specialist will inform the patient about the usual duration of the examination.

After administering MonFCH:

• avoid close contact with small children for 12 hours after injection;
• urinate frequently to accelerate the elimination of the product from the patient's body.

The nuclear medicine specialist will tell the patient if any special precautions should be taken after receiving the product. In case of questions, consult the nuclear medicine specialist.

Use of a higher than recommended dose of MonFCH

Overdose is unlikely, as the patient will receive a single dose of MonFCH under the strict control of the nuclear medicine specialist supervising the examination. However, in case of overdose, the patient will receive appropriate treatment. The nuclear medicine specialist supervising the examination may recommend that the patient drink plenty of fluids to facilitate the elimination of MonFCH from the body (the main route of elimination of this medicinal product is through the kidneys, with urine). It may be necessary to take diuretics.
In case of any further doubts related to the use of MonFCH, consult the nuclear medicine specialist supervising the examination.

4. Possible side effects

Like all medicines, MonFCH can cause side effects, although not everybody gets them.
No side effects have been observed so far.
The radiopharmaceutical product emits a small amount of radioactive radiation and may cause tumors and genetic diseases, but the risk of their occurrence is very small.
The doctor has decided that the clinical benefit of the examination using the radiopharmaceutical product outweighs the risk associated with radiation.
If any side effects occur, including those not listed in this package leaflet, consult the nuclear medicine specialist.

Reporting side effects

If any side effects occur, including any side effects not listed in this package leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorization Holder.
Reporting side effects will allow for more information to be collected on the safety of the medicinal product.

5. How to store MonFCH

The product will not be stored by patients. MonFCH is stored by qualified personnel in a special room. Radiopharmaceutical products are stored in accordance with national regulations on radioactive materials.
The following information is intended exclusively for medical personnel.
MonFCH should be stored at a temperature below 25°C, in the original lead container.
Do not store in the refrigerator or freeze. The shelf life is 15 hours from the date and time of production (at the end of synthesis).
13 hours from the first use, without exceeding the shelf life. After the first use, store at a temperature below 25°C.
Do not use the product after the expiration date stated on the label.

6. Package contents and other information

What MonFCH contains

• The active substance is fluoromethyl-[18F]-dimethyl-2-hydroxyethyl-ammonium chloride (fluorocholine chloride [18F]).

1 ml of the solution for injection contains from 910 MBq to 3415 MBq of fluorocholine chloride [18F] on the date and time of calibration after its production.

• The other ingredients are: sodium chloride.

What MonFCH looks like and what the package contains

The patient does not need to purchase this product themselves, nor is it necessary to handle the packaging or vial. The following information is provided for informational purposes only.
MonFCH is a clear and colorless solution supplied in a 10 ml glass vial of colorless glass type I (Ph.Eur), closed with a rubber stopper and an aluminum cap. As a result of the manufacturing process, the MonFCH product may be supplied with a punctured rubber stopper. The vial is packed in a lead container with a lead cap.
One vial contains 0.2 to 10.0 ml of solution, corresponding to 182 to 34150 MBq at the end of the synthesis process.

Marketing Authorization Holder

Synektik Pharma Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 3,
Warsaw 00-728
Poland
Tel: +48 22 327 09 00

Manufacturer

Synektik Pharma Sp. z o.o.
Mszczonów 96-320
ul. Keramzytowa 16
Poland
Tel: +48 46 857 14 25/26/27
Fax: +48 46 857 14 28

Date of the last update of the package leaflet: ------------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

Information intended exclusively for medical personnel or healthcare professionals:
The full Summary of Product Characteristics of MonFCH is provided as a separate document in the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the Summary of Product Characteristics (the Summary of Product Characteristics should be attached to the packaging).