FDG BioM Multidose Injection

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

18F-2-FLUORO-2-DEOXY-D-GLUCOSE (18F- FDG)

から入手可能:

Bio Molecular Industries Sdn Bhd

INN（国際名）:

18F-2-FLUORO-2-DEOXY-D-GLUCOSE (18F- FDG)

パッケージ内のユニット:

1vial Vials; 10 mL; 30ml mL; 10ml mL

製:

Bio Molecular Industries Sdn Bhd

情報リーフレット

Curium
1 I 4
Bio Molecular Industries Sdn. Bhd. (691229-K) T [phone]
PT 22 Persiaran Teknologi 1, Techpark @ Enstek E [e-mail]
71760 Bandar Enstek, Negeri Sembilan, Malaysia W
www.biomolecular.com.my CURIUM - uniting BIOM Molecular and
Mallinckrodt Nuclear Medicine LLC
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FDG BIOM
® MULTIDOSE INJECTION
FLUORODEOXYGLUCOSE (
18
F)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or your pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Fluorodeoxyglucose (
18
F)-BioM
®
is and what it is used for.
2.
Before you are given Fluorodeoxyglucose (
18
F)-BioM
®
.
3.
How you will be given Fluorodeoxyglucose (
18
F)-BioM
®
.
4.
Possible side effects.
5
How to store Fluorodeoxyglucose (
18
F)-BioM
®
.
6.
Further information.
Curium
2 I 4
Bio Molecular Industries Sdn. Bhd. (691229-K) T [phone]
PT 22 Persiaran Teknologi 1, Techpark @ Enstek E [e-mail]
71760 Bandar Enstek, Negeri Sembilan, Malaysia W
www.biomolecular.com.my CURIUM - uniting BIOM Molecular and
Mallinckrodt Nuclear Medicine LLC
1. WHAT FLUORODEOXYGLUCOSE (
18
F)-BIOM
® IS AND WHAT IT IS USED FOR.
This medicine is for diagnostic use only.
It can be used for a technique called ”positron emission
tomographic” (PET) scan. With this technique it
is possible to visualise the activity of cells in your body. This
medicine is used to investigate tumor tissue,
the functioning of your heart or epilepsy in the brain.
This will give doctors more information about:

What may be wrong with you, OR

How well your treatment has worked, OR

If your disease has come back.
2. BEFORE YOU ARE GIVEN FLUORODEOXYGLUCOSE (
18
F)-BIOM
®
DO NOT USE FLUORODEOXYGLUCOSE (
18
F)-BIOM
®
:
-
If
you
are
allergic (hypersensitive)
to fluorodeoxyglucose

製品の特徴

Curium
1 I11
Bio Molecular Industries Sdn. Bhd. (691229-K) T [phone]
PT 22 Persiaran Teknologi 1, Techpark @ Enstek E [e-mail]
71760 Bandar Enstek, Negeri Sembilan, Malaysia W
www.biomolecular.com.my CURIUM - uniting BIOM Molecular and
Mallinckrodt Nuclear Medicine LLC
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FDG BioM
®
Multidose Injection – Fluorodeoxyglucose-(
18
F)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The activity per vial ranges from 37 MBq to 222000 MBq (1 to 6000 mCi)
at the date and
time of dispensing.
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.
Excipient with known effect: sodium chloride 9 mg/ml. For the full
list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Sterile Solution for injection
Clear, colourless or slightly yellow solution, with a pH between 4.5
and 8.5.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Fluorodeoxyglucose-(
18
F) is a positron emitting radiopharmaceutical used in PET
(Positron Emission Tomography) for the
-
identification of regions of abnormal glucose metabolism associated
with foci of
epileptic seizures and tumour.
-
assessment of abnormal glucose metabolism to assist in the evaluation
of malignancy
in patients with known or suspected abnormalities found by other
testing modalities,
or in patients with an existing diagnosis of cancer.
-
identification of left ventricular myocardium with residual glucose
metabolism and
reversible loss of systolic function in patients with coronary artery
disease and left
ventricular dysfunction, when used together with myocardial perfusion
imaging.
Curium
2 I11
Bio Molecular Industries Sdn. Bhd. (691229-K) T [phone]
PT 22 Persiaran Teknologi 1, Techpark @ Enstek E [e-mail]
71760 Bandar Enstek, Negeri Sembilan, Malaysia W
www.biomolecular.com.my CUR