Steripet

Package leaflet: Information for the patient

Steripet, 250 MBq/ml, solution for injection
Fludeoxyglucosum ( F)
Please read all of this leaflet before the medicine is administered, as it contains important
information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult the doctor supervising your examination.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents

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

1. What Steripet is and what it is used for

This medicine is a radiopharmaceutical product intended solely for diagnostic use.
It is used exclusively for the diagnosis of diseases.
The active substance in Steripet is called fludeoxyglucose. The medicine is administered prior
to an examination performed using a special camera to produce images of the inside of a body part.
After injection of a small amount of Steripet, the images obtained during the examination will help
the doctor 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, consult a doctor if:

• the patient has diabetes and currently has uncontrolled blood sugar levels
• if the patient has an infection or inflammatory disease
• if the patient has kidney disease
• if the patient is pregnant or suspects she may be pregnant
• if the patient is breastfeeding

Before administration of Steripet, avoid any intense physical exertion.
Children and adolescents
Patients under 18 years of age should inform their doctor.
Interaction of Steripet with other medicines
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to use. Some medicines may interfere with proper image interpretation, especially:

• all medicines that may alter blood glucose levels, such as: anti-inflammatory drugs (e.g. corticosteroids), anticonvulsants (e.g. valproic acid, carbamazepine, phenytoin, phenobarbital), drugs affecting the nervous system (e.g. adrenaline, noradrenaline, dopamine),
• glucose,
• insulin,
• medicines used to stimulate blood cell production.

Steripet with food and drink
In the period preceding the examination:

• The patient should avoid drinking beverages containing glucose.
• The patient should drink large amounts of water (or other fluids not containing glucose) without restriction.
• The patient must remain fasting (for at least 4 hours) before injection of Steripet.
• The doctor will measure blood glucose concentration before administering Steripet.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, has missed a menstrual period, or is planning pregnancy, she should consult a doctor before using this medicine.
In case of doubt, consult the doctor performing the examination.
Pregnancy
The doctor will consider performing this examination in a pregnant patient only if absolutely necessary.
Breastfeeding

• The patient must interrupt breastfeeding for 12 hours after administration of the medicine.
• Feed the infant with infant formula during this time; breast milk expressed during this period must be discarded. Resuming breastfeeding should be discussed with the doctor.

During pregnancy, breastfeeding, or if there is suspicion of pregnancy, or when planning pregnancy, consult a doctor before using this medicine.
Driving and operating machinery
It is unlikely that Steripet will affect the ability to drive or operate machinery.
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 sodium-restricted diet.

3. How to use Steripet

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Steripet will be administered only in authorized medical facilities. Only trained and qualified personnel with appropriate expertise in the safe use of this medicinal product may prepare and administer the drug. These individuals will ensure that the medicine is used safely and will inform the patient how the medicine is administered.

The physician supervising the procedure will determine the appropriate dose of Steripet to be administered. This will be the smallest amount necessary to obtain the required diagnostic information.

The usual recommended dose for an adult is 100 to 400 MBq. Megabecquerel (MBq) is a metric unit of measurement for radioactivity.

Use in children and adolescents
The dose administered to children and adolescents will depend on body weight.

Administration of Steripet and performance of the examination
Steripet is administered as a single intravenous injection.

One injection is sufficient to perform the examination ordered by the physician. The medicine is administered 45–60 minutes before the start of the examination.

After injection, the patient will be asked to drink water and then, immediately before the start of the examination, to empty the bladder.

During the examination, the patient should rest in a comfortable lying position. Reading or talking is not allowed.

Duration of the examination
The physician will inform the patient of the exact duration of the examination.
The examination usually lasts from 30 to 60 minutes.

After administration of Steripet, the patient should

• avoid close contact with young children and pregnant women for 12 hours after injection.
• urinate frequently to help eliminate Steripet from the body.

Administration of a higher than recommended dose of Steripet
Overdose is unlikely, as the patient receives only a single dose of Steripet, carefully prepared under the supervision of the physician performing the procedure. However, in the event of an overdose, the physician will initiate appropriate treatment. The supervising physician may recommend drinking large amounts of fluids to facilitate elimination of Steripet from the body.

If you have any further questions regarding the use of Steripet, please consult your physician.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everyone will experience them.
The administration of Steripet involves a small dose of ionizing radiation, which carries a very low risk of developing cancer and hereditary defects.
Your treating physician has assessed that the benefits of using Steripet outweigh the risks associated with exposure to ionizing radiation.
Reporting adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Steripet

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

6. Contents of the package and other information

What Steripet contains

• The active substance is fluorodeoxyglucose (F). 1 ml of Steripet contains 250 MBq of fluorodeoxyglucose (F) at the date and time of calibration.
• The other ingredients are: disodium hydrogen phosphate dihydrate, sodium hydroxide, water for injections.

What Steripet looks like and contents of the pack
Steripet is supplied as a single multi-dose vial made of colourless glass containing
1 to 10 ml of solution for injection.
Marketing Authorisation Holder
Marketing Authorisation Holder
GE Healthcare B.V.
De Rondom 8
5612 AP, Eindhoven
The Netherlands
Manufacturer
GE Healthcare B.V.
De Rondom 8
5612 AP Eindhoven
The Netherlands
Norsk medisinsk syklotronsenter AS
Sognsvannsveien 20
Oslo NO-0372
Norway
Centrum Produkcji Radiofarmaceutyków Voxel SA,
ul. Wrocławska 1-3,
30-006 Kraków,
Poland

Information intended exclusively for healthcare professionals:

The complete Product Information for Steripet is provided as a separate document
within the medicinal product documentation package. Its purpose is to provide healthcare
professionals with additional scientific and practical information regarding the administration and use of the medicinal product
Steripet.
Steripet is a trademark of GE Healthcare
GE and GE Monogram are trademarks of General Electric Company