STERIPET 250 MBq/ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Steripet, 250 MBq/ml, solution for injection
   1. You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Steripet and what is it used for
4. Important information before using Steripet
   1. When not to use Steripet
   2. Warnings and precautions
   3. Children and adolescents
   4. Steripet and other medicines
   5. Steripet with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Steripet contains sodium.
5. How to use Steripet
   1. Use in children and adolescents
   2. Administration of Steripet and performance of the examination
   3. Duration of the examination
   4. After administering Steripet
   5. Use of a higher than recommended dose of Steripet
6. Possible side effects
   1. Reporting side effects
7. How to store Steripet
8. Package contents and other information
   1. What Steripet contains
   2. What Steripet looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: October 2019

Leaflet attached to the packaging: patient information

Steripet, 250 MBq/ml, solution for injection

Fludeoxyglucose (F)

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult the doctor who will be supervising the examination.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the doctor. See section 4.

Table of contents of the leaflet

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

1. What is Steripet and what is it used for

This medicine is a radiopharmaceutical product intended exclusively for diagnostic purposes.
It is used only for the purpose of diagnosing diseases.
The active substance contained in Steripet is called fludeoxyglucose. The medicine is administered before
an examination performed using a special camera, for the purpose of imaging the inside of a part of the body.
After injecting a small amount of Steripet, the images obtained during the examination will help
the doctor to locate the disease or assess its progression.

2. Important information before using Steripet

When not to use Steripet

• if the patient is allergic to fludeoxyglucose (F) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before administering Steripet, you should consult a doctor if:

• the patient has diabetes and it is not currently controlled
• the patient has an infection or inflammatory disease
• the patient has kidney disease
• the patient is pregnant or suspects she may be pregnant
• the patient is breastfeeding

Before administering Steripetyou should avoid any intense physical exertion.

Children and adolescents

Patients who are under 18 years old should inform their doctor.

Steripet and other medicines

You should tell your doctor about all medicines that the patient is currently taking or
has recently taken, as well as any medicines that the patient plans to take. Some medicines may interfere with the proper
evaluation of the images, in particular:

• all medicines that may cause a change in blood sugar levels, such as medicines: that reduce inflammation (e.g. corticosteroids), that prevent seizures (e.g. valproic acid, carbamazepine, phenytoin, phenobarbital), that affect the nervous system (e.g. adrenaline, noradrenaline, dopamine),
• glucose,
• insulin,
• medicines used to increase blood cell production.

Steripet with food and drink

Before the examination:

• The patient should avoid drinking beverages containing a type of sugar called glucose.
• The patient should drink plenty of water (or other glucose-free fluids) in any amount.
• The patient should fast (for at least 4 hours) before injecting Steripet.
• The doctor will measure the patient's blood glucose level before administering Steripet.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
In case of doubts, the patient should consult the doctor performing the examination.
Pregnancy
The doctor will consider performing this examination on a pregnant patient only if absolutely necessary.
Breastfeeding

• The patient must stop breastfeeding for 12 hours after injecting Steripet.
• The patient should give the baby a milk substitute, and discard the expressed breast milk. The patient should discuss with her doctor when to resume breastfeeding.

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, the patient should consult her doctor before using this medicine.

Driving and using machines

It is unlikely that Steripet will affect the patient's ability to drive or use machines.

Steripet contains sodium.

This medicine may contain more than 1 mmol of sodium (23 mg).
This should be taken into account if the patient is on a low-sodium diet.

3. How to use Steripet

There are strict regulations regarding the use of radiopharmaceuticals, their handling, and disposal. Steripet will only be used in authorized medical facilities. The medicine can only be prepared and administered by personnel with the appropriate training and qualifications in the safe use of this medicine. These personnel will ensure that the medicine is used safely and will inform the patient how the medicine is administered.
The doctor supervising the examination will choose the appropriate dose of Steripet to be administered. This will be the smallest amount necessary to obtain the required information.
The usual recommended dose for an adult is between 100 and 400 MBq. Megabecquerel (MBq) is a unit of measurement of radioactivity in the metric system.

Use in children and adolescents

The amount administered to children and adolescents will depend on their body weight.

Administration of Steripet and performance of the examination

Steripet is administered in a single intravenous injection.
A single injection is sufficient to perform the examination ordered by the doctor. The medicine is administered 45-60 minutes before the start of the examination.
After injecting the medicine, the patient will be asked to drink water, and then, immediately before the start of the examination, to urinate.
During the examination, the patient should rest in a comfortable lying position. The patient should not read or talk.

Duration of the examination

The doctor will inform the patient about the exact duration of the examination.
The examination usually lasts between 30 and 60 minutes.

After administering Steripet

• the patient should avoid close contact with small children and pregnant women for 12 hours after the injection.
• the patient should urinate frequently to remove Steripet from the body.

Use of a higher than recommended dose of Steripet

Overdose is unlikely, as the patient receives only one dose of Steripet, carefully prepared under the control of the doctor performing the examination. However, in the event of an overdose, the doctor will initiate appropriate treatment. The doctor supervising the procedure may recommend drinking plenty of fluids, which will help to remove Steripet from the body.
If you have any further questions about the use of Steripet, you should consult your doctor.

4. Possible side effects

Like all medicines, Steripet can cause side effects, although not everybody gets them.
With Steripet, a small dose of ionizing radiation is administered, which carries a very small risk of developing cancer and genetic disorders.
The doctor has evaluated that the benefits of using Steripet outweigh the risk of exposure to ionizing radiation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
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 this medicine.

5. How to store Steripet

The patient does not need to store this medicine. The medicine is stored in a medical facility under the supervision of a specialist. Steripet should be stored in accordance with national regulations regarding the handling of radioactive products.
The following information is intended for healthcare professionals only. Do not use this medicine after the expiry date stated on the label, i.e. the day and hour after EXP.

6. Package contents and other information

What Steripet contains

• The active substance of Steripet is fludeoxyglucose (F). 1 ml of Steripet contains 250 MBq of fludeoxyglucose (F) on the day and hour of calibration.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium hydroxide, water for injections.

What Steripet looks like and what the package contains

Steripet is supplied as one multidose vial made of colorless glass containing from 1 to 10 ml of solution for injection.

Marketing authorization holder and manufacturer

Marketing authorization holder

GE Healthcare B.V.
De Rondom 8
5612 AP, Eindhoven
Netherlands

Manufacturer

GE Healthcare B.V.
De Rondom 8
5612 AP Eindhoven
Netherlands
Norsk medisinsk syklotronsenter AS
Sognsvannsveien 20
Oslo NO-0372
Norway
Centrum Produkcji Radiofarmaceutyków Voxel SA,
ul. Wrocławska 1-3,
30-006 Kraków,
Poland

Date of last revision of the leaflet: October 2019

Information intended exclusively for healthcare professionals:
The full Summary of Product Characteristics of Steripet is provided as a separate document in the package of medicinal product documentation. Its purpose is to provide healthcare professionals with additional scientific and practical information on the administration and use of Steripet.
Steripet is a trademark of GE Healthcare
GE and GE Monogram are trademarks of General Electric Company