Fludeoxyglucose (18F)-Curium 185MBq/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUDEOXYGLUCOSE

Available from:

Curium International Boulevard Bischoffsheim 39 boîte 4 1000 Bruxelles , Belgium

ATC code:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE 185 MBq/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUDEOXYGLUCOSE 185 MBq/ml

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Authorization status:

Authorised

Authorization date:

2019-01-18

Patient Information leaflet

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1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUDEOXYGLUCOSE (
18
F)-CURIUM 185 MBQ/ML SOLUTION FOR INJECTION
Fludeoxyglucose (
18
F)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Fludeoxyglucose (
18
F)-Curium is and what it is used for
2.
What you need to know before Fludeoxyglucose (
18
F)-Curium is used
3.
How Fludeoxyglucose (
18
F)-Curium will be used
4.
Possible side effects
5
How Fludeoxyglucose (
18
F)-Curium is stored
6.
Contents of the pack and other information
1. WHAT FLUDEOXYGLUCOSE (
18
F)
-
CURIUM IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
The active substance contained in Fludeoxyglucose (
18
F)-Curium is designed for the capture of
diagnostic images of some parts of your body.
Once a small amount of Fludeoxyglucose (
18
F)-Curium has been injected, medical images that are
obtained with a special camera will enable the doctor to capture
images and to see where your illness is
or how it is progressing.
2.
WHAT YOU NEED TO KNOW BEFORE FLUDEOXYGLUCOSE (
18
F)-CURIUM IS USED
FLUDEOXYGLUCOSE (
18
F)-CURIUM MUST NOT BE USED:
-
If you are allergic to fludeoxyglucose (
18
F) or any of the other ingredients of this medicine
(listed in section 6).
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2
WARNINGS AND PRECAUTIONS
Talk to your nuclear medicine doctor before being administered
Fludeoxyglucose (
18
F)-Curium:
-
If you are diabetic and your diabetes is currently not equilibrated,
-
If you have an infection or ,an inflammatory disease,
-
If you are affected by kidney problems.
Inform your nuclear medicine doctor in the following cases:
-
If you

Summary of Product characteristics

1
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fludeoxyglucose (
18
F)-Curium 185 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 185 MBq of fludeoxyglucose (
18
F) at the date and time of calibration.
The activity per vial ranges from 90 MBq to 1850 MBq at the date and
time of calibration.
Fluorine (
18
F) decays to stable oxygen (
18
O) with a half-life of 110 minutes by emitting a positronic
radiation of maximum energy of 634 keV, followed by photonic
annihilation radiations of 511 keV.
Excipients with known effects:
Each mL of fludeoxyglucose (
18
F) contains 9 mg of sodium chloride and less than 4 mg of ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless or slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Fludeoxyglucose (
18
F) is indicated for use with positron emission tomography (PET) in
adults and
paediatric population.
_Oncology _
In
patients
undergoing
oncologic
diagnostic
procedures
describing
function
or
diseases
where
enhanced glucose influx of specific organs or tissues is the
diagnostic target. The following indications
are sufficiently documented (see also section 4.4):
_ _
Diagnosis:
•
Characterisation of solitary pulmonary nodules
•
Detection of cancer of unknown origin, revealed for example by
cervical adenopathy, liver or bones
metastases.
•
Characterisation of a pancreatic mass
Staging:
•
Head and neck cancers including assistance in guiding biopsy
•
Primary lung cancer
•
Locally advanced breast cancer
•
Oesophageal cancer
•
Carcinoma of the pancreas
•
Colorectal cancer particularly in restaging recurrences
•
Malignant lymphoma
•
Malignant melanoma, Breslow > 1.5 mm or lymph node metastasis at first
diagnosis
Monitoring of therapeutic response:
•
Malignant lymphoma
•
Head and neck cancers
2
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Detection in case of reasonable su