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Treść ulotki
- What is Fluodesossiglucosio (F) ITEL and what is it used for
- What you need to know before you are given Fluodesossiglucosio (F) ITEL
- How Fluodesoxyglucose (F) ITEL is used
- Possible side effects
- How Fluodesoxyglucose (F) ITEL is stored
- Contents of the pack and other information
FLUODESOSSIGLUCOSIO (F) ITEL 250 MBq/mL, injectable solution
Fluodeossiglucosio ( F)
Read this leaflet carefully before this medicine is administered to youbecause
it contains important information for you
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask the nuclear medicine doctor who is supervising the procedure.
- If any side effects occur, even if not listed in this leaflet, ask the nuclear medicine doctor.
Contents of this leaflet:
- 1. What Fluodesossiglucosio ( F) ITEL is and what it is used for
- 2. What you need to know before Fluodesossiglucosio ( F) ITEL is administered to you
- 3. How Fluodesossiglucosio ( F) ITEL is used
- 4. Possible side effects
- 5. How Fluodesossiglucosio ( F) ITEL is stored
- 6. Contents of the pack and other information
1. What is Fluodesossiglucosio (F) ITEL and what is it used for
This medicine is a radiopharmaceutical used only for diagnostic purposes.
The active substance contained in Fluodesossiglucosio (F) ITEL is fluorodeoxyglucose (F) and it is
indicated for the acquisition of diagnostic images of some parts of the body.
Once a small amount of Fluodesossiglucosio (F) ITEL is injected, the images obtained with
a special machine allow the doctor to observe the location and evolution of the disease.
2. What you need to know before you are given Fluodesossiglucosio (F) ITEL
Do not use Fluodesossiglucosio (F) ITEL
- if you are allergic to fluodeoxyglucose (F) or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Consult your nuclear medicine doctor before you are given Fluodesossiglucosio (F)
ITEL
- if you are a diabetic and your diabetes is not currently under control
- if you have an infection or an inflammatory disease
- if you have kidney problems.
Inform your nuclear medicine doctor in the following cases:
- if you are pregnant or suspect you may be
- if you are breastfeeding
Before the administration of Fluodesossiglucosio (F) ITEL you must:
- drink plenty of water before the examination begins so that you urinate as often as possible during the first few hours after the study.
- avoid all strenuous physical activity
- fast for at least 4 hours
Children and adolescents
Inform your nuclear medicine doctor if you are under 18 years of age.
Other medicines and Fluodesossiglucosio (F) ITEL
Inform your nuclear medicine doctor if you are taking, have recently taken or might
take any other medicines, because they may interfere with the interpretation of the images by
the doctor:
- any medicine that may induce a change in blood sugar levels (glycemia), such as medicines that act on inflammation (corticosteroids), anti-convulsant medicines (valproate, carbamazepine, phenytoin, phenobarbital), medicines that act on the nervous system (adrenaline, noradrenaline, dopamine, etc.),
- glucose,
- insulin,
- medicines used to increase the production of red blood cells. Fluodesossiglucosio (F) ITEL with food and drinkBefore the administration of the product you must fast for at least 4 hours. You should drink plenty of water and avoid drinks containing sugars. Before the administration of the product, your nuclear medicine doctor will measure your blood sugar levels, as a high concentration of glucose in the blood (hyperglycemia) may make it more difficult for the doctor to interpret the results.
Pregnancy and breastfeeding
If there is a possibility that you may be pregnant, if you have missed a menstrual period or if you
are breastfeeding, inform your nuclear medicine doctor before the administration of
Fluodesossiglucosio (F) ITEL.
If in doubt, it is important that you consult your nuclear medicine doctor who is supervising the
procedure.
If you are pregnant
Your nuclear medicine doctor will administer this product during pregnancy if the expected benefit
outweighs the risks.
If you are breastfeeding
You should stop breastfeeding for 12 hours after the injection and the expressed breast milk must
be discarded.
Resumption of breastfeeding should be agreed with your nuclear medicine doctor who
supervises the procedure.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your nuclear medicine doctor for advice before you are given this medicine.
Driving and using machines
It is unlikely that Fluodesossiglucosio (F) ITEL will impair your ability to drive vehicles or
use machines.
Fluodesossiglucosio (F) ITEL contains sodium
This product may contain more than 1 mmol of sodium (23 mg). This should be taken into
consideration if you are on a low-sodium diet.
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3. How Fluodesoxyglucose (F) ITEL is used
There are strict regulations regarding the use, handling and disposal of radiopharmaceuticals.
Fluodesoxyglucose (F) ITEL will only be used in specially controlled areas. The product must be
handled and administered only by trained and qualified personnel to use it safely.
These people will take particular care to ensure the safe use of the product and will keep you informed of
what they are doing.
The nuclear medicine physician supervising the procedure will determine the amount of
Fluodesoxyglucose (F) ITEL to be used in your case, which will correspond to the minimum amount
necessary to obtain the desired information.
The amount normally recommended for administration to an adult is between 100 and 400 MBq
(depending on the patient's body mass, the type of camera used for image acquisition and the acquisition mode). Megabecquerel (MBq) is the unit of measure used for
radioactivity.
Use in children and adolescents
In the case of use in children and adolescents, the amount to be administered will be adjusted to the child's weight.
Administration of Fluodesoxyglucose (F) ITEL and performance of the procedure
Fluodesoxyglucose (F) ITEL is administered intravenously.
One injection is sufficient to perform the examination necessary for the doctor.
After the injection, you must remain completely at rest, you will not be able to read or speak. In addition, you will be
asked to drink and urinate immediately before the procedure.
During image acquisition, you must remain completely at rest.
You must not move or speak.
Duration of the procedure
The nuclear medicine physician will inform you of the normal duration of the procedure.
Fluodesoxyglucose (F) ITEL is administered as a single injection into a vein 45-60 minutes before
the start of image acquisition. Image acquisition with a camera takes 30 to 60 minutes.
After administration of Fluodesoxyglucose (F) ITEL, you must:
- avoid close contact with young children and pregnant women for the 12 hours following the injection
- urinate frequently to eliminate the product from the body
If you take more Fluodesoxyglucose (F) ITEL than you should
An overdose is unlikely as you will receive a single dose of Fluodesoxyglucose (F)
ITEL under strict control of the nuclear medicine physician supervising the procedure. However,
in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine
physician in charge of the procedure may recommend that you drink plenty of fluids to facilitate
the elimination of Fluodesoxyglucose (F) ITEL from the body (in fact, the main route of
elimination of the product is renal, through the urine).
If you have any doubts about the use of Fluodesoxyglucose (F) ITEL, please contact the nuclear medicine
physician supervising the procedure.
4. Possible side effects
Like all medicines, Fluodesossiglucosio (F) ITEL can cause side effects, although not
everyone gets them.
The radiopharmaceutical emits a small amount of ionizing radiation, which carries a very
low risk of cancer and hereditary defects.
Your doctor has determined that the clinical benefit obtained from the procedure performed with the
radiopharmaceutical outweighs the risk due to radiation.
Post-marketing data with frequency not known:
Immune system disorders
Hypersensitivity reactions (e.g. itching, edema and skin rash)
Cardiovascular effects
transient hypotension
Endocrine/metabolic effects
Abnormal blood glucose levels (e.g. hypoglycemia or hyperglycemia)
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
your nuclear medicine physician. You can also report side effects directly through the
national reporting system ( https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse ).
By reporting side effects you can help provide more information on the safety
of this medicine.
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5. How Fluodesoxyglucose (F) ITEL is stored
You must not store this medicine. The storage of the product is the responsibility of the
specialist in appropriate facilities. Radiopharmaceuticals must be stored in accordance with
national regulations relating to radioactive products.
The following information is intended for the specialist only.
The product must not be used after the expiry date stated on the label after {DD MM
YYYY at hh:mm}
6. Contents of the pack and other information
What Fluodesossiglucosio (F) ITEL contains
- The active substance is fluodeoxyglucose ( F). 1 mL of injectable solution contains 250 MBq of fluodeoxyglucose ( F) at the date and time of calibration.
- The other components are disodium phosphate monobasic dihydrate, sodium hydroxide and water for injections. Description of the appearance of Fluodesossiglucosio (F) ITEL and contents of the packFluodesossiglucosio ( F) ITEL is supplied in a single multi-dose glass vial containing a variable amount of injectable solution between 1 mL and 10 mL.
Marketing Authorisation Holder
ITEL Telecomunicazioni S.r.l.
Via A. Labriola, lotto 39 (Z.I.)
70037 Ruvo Di Puglia (BA)
Italy
Manufacturer
ITEL Telecomunicazioni S.r.l.
Via A. Labriola, lotto 40 (Z.I.)
70037 Ruvo Di Puglia (BA)
Italy
More detailed information on this medicine is available on the website of the Italian Medicines Agency
(AIFA): http://www.agenziafarmaco.gov.it .
The following information is intended exclusively for doctors or healthcare professionals:
The Summary of Product Characteristics of Fluodesossiglucosio ( F) ITEL is included
as a separate document in the product packaging, with the aim of providing healthcare
professionals with further scientific and practical information on the administration and use of this
radiopharmaceutical.
Refer to the Summary of Product Characteristics included in the packaging
- Kraj rejestracji
- Postać farmaceutycznaInjectable suspension, 80 mg/ml
- Kod ATCS01BA05
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TAIOFTALPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: clobetasoneProducent: OMNIVISION ITALIA SRLBez receptyPostać farmaceutyczna: Eye drops, solution, 0.3 MLSubstancja czynna: hydrocortisoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 1,5 MG/MLSubstancja czynna: dexamethasoneProducent: DOC GENERICI SRLWymaga recepty
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