EFDEGE 1.0 GBq/mL, solution for injection (11ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUDEOXYGLUCOSE

Available from:

IASON GmbH Feldkirchner Str. 4, A-8054 Graz, Austria

ATC code:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUDEOXYGLUCOSE 1 gigabecquerel/millilitre

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-02-11

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFDEGE 1.0 GBQ/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 any of the side effects, talk to your nuclear medicine. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What EFDEGE is and what it is used for
2.
What you need to know before EFDEGE is used
3.
How EFDEGE is used
4.
Possible side effects
5.
How EFDEGE is stored
6.
Contents of the pack and other information
1.
WHAT EFDEGE IS AND WHAT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
The active substance contained in
EFDEGE
is fludeoxyglucose (
18
F) and is designed for the capture
of diagnostic images of some parts of your body.
Once a small amount of EFDEGE 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 EFDEGE IS USED
EFDEGE 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)
WARNINGS AND PRECAUTIONS
Talk to your nuclear medicine doctor before being administered EFDEGE:
-
if you are a 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 are pregnant or believe you may be pregnant
-
if you are breast-feeding
PAGE 3 OF 6
BEFORE ADMINISTRATION OF EFDEGE YOU SHOULD:
-
drink plenty of water before the start of the examination in order to
urinate as often as possible
during the first hours after the

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 13
1.
NAME OF THE MEDICINAL PRODUCT
EFDEGE 1.0 GBq/mL, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 1 GBq of fludeoxyglucose (
18
F) at date and time of calibration.
The activity per vial ranges from 0.2 GBq to 20.0 GBq 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 2.4 mg sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless or slight 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
PAGE 3 OF 13
Monitoring of therapeutic response
-
Malignant lymphoma
-
Head and neck cancers
Detection in case of reasonable suspicion of recurrences
-
Glioma with high grade of malignancy (III or I