LeukoScan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-02-2018
Charakterystyka produktu
(SPC)
09-02-2018
Sprawozdanie z oceny publicznego
(PAR)
09-02-2018
Składnik aktywny:
sulesomab
Dostępny od:
Immunomedics GmbH
Kod ATC:
VO4D
INN (International Nazwa):
sulesomab
Grupa terapeutyczna:
Diagnostic agents
Dziedzina terapeutyczna:
Osteomyelitis; Radionuclide Imaging
Wskazania:
This medicinal product is for diagnostic use only.LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
1997-02-14
Ulotka dla pacjenta
19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEUKOSCAN (0.31 POWDER FOR SOLUTION FOR INJECTION)
(SULESOMAB)
Read all of this leaflet carefully before you start using this
medicine.
•
Keep this leaflet. You may need to read it again.
•
It does not contain all the information about your medicine that you
may need to know, so please
refer to the Summary of Product Characteristics or ask your doctor or
nurse if you have any
questions. This leaflet only applies to LeukoScan.
•
If you have any further questions, please ask your doctor.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
WHAT LEUKOSCAN IS USED FOR
2.
BEFORE YOU USE LEUKOSCAN
3.
HOW TO USE LEUKOSCAN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LEUKOSCAN
6.
FURTHER INFORMATION
1.
WHAT LEUKOSCAN IS AND WHAT IT IS USED FOR
An antibody is a natural substance made by the body which binds to
foreign substances to help remove
them from your body. You produce many different kinds of antibodies.
LeukoScan (sulesomab) is a special kind of antibody which binds to the
surface of certain kinds of blood
cells called leukocytes. It is produced in mice and purified so that
it can be used in humans. When it is
combined to the radioactive technetium isotope and injected into your
vein, it finds an abnormal
accumulation of white blood cells and attaches to them. One to eight
hours later after the injection you
will be placed on a special table and pictures will be taken with
standard nuclear cameras. This helps your
doctor make a diagnosis and evaluate the extent of your illness. The
doctor does this by using a special
imaging camera that reveals areas of radioactivity to see where the
infections are located. This medicine
is for diagnostic use only.
LeukoScan is used to determine the presence of infections in long
bones. Shortly after mixing the
LeukoScan with the radioactive technetium isotope, the doctor will
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
LeukoScan 0.31 mg, powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kit for the preparation of
99m
Tc-labelled LeukoScan.
Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab
′
-SH antigranulocyte monoclonal
antibody fragments) for the preparation of
99m
Tc labelled LeukoScan. The kit does not include the
radioisotope.
Excipients:
Sucrose (37.8 mg)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
LeukoScan is indicated for diagnostic imaging for determining the
location and extent of
infection/inflammation in bone in patients with suspected
osteomyelitis, including patients with diabetic
foot ulcers.
LeukoScan has not been employed to diagnose osteomyelitis in patients
with sickle cell anaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The radiolabelled solution should be administered as an intravenous
injection. After injection, any
remaining portion of the reconstituted solution should be discarded.
LeukoScan is not recommended for use in children.
Formal studies have not been performed in patients with renal or
hepatic impairment. However, due to the
low dose of protein administered and the short half-life of
99m
Tc, dosage adjustment is probably not
necessary in such patients.
Radiopharmaceutical agents should be used only by qualified personnel
with appropriate government
authorisation for the use and manipulation of radionuclides.
Medicinal product no longer authorised
3
This radiopharmaceutical may be received, used and administered only
by authorised persons in
designated clinical settings. Its receipt, storage, use, transfer and
disposal are subject to the regulations
and/or appropriate licenses of local competent official organisations.
Immediately prior to use, contents of the vial are re
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