Scintimun
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
13-12-2022
Valmisteyhteenveto
(SPC)
13-12-2022
Julkisesta arviointikertomuksesta
(PAR)
30-09-2014
Aktiivinen ainesosa:
besilesomab
Saatavilla:
CIS bio international
ATC-koodi:
V09HA03
INN (Kansainvälinen yleisnimi):
besilesomab
Terapeuttinen ryhmä:
Diagnostic radiopharmaceuticals
Terapeuttinen alue:
Osteomyelitis; Radionuclide Imaging
Käyttöaiheet:
This medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.
Tuoteyhteenveto:
Revision: 6
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2010-01-11
Pakkausseloste
24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SCINTIMUN 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION
besilesomab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 doctor or the nuclear
medicine specialist who will
supervise the procedure.
-
If you get any side effects, talk to your nuclear medicine doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Scintimun is and what it is used for
2.
What you need to know before you are given Scintimun
3.
How Scintimun is given
4.
Possible side effects
5.
How Scintimun is stored
6.
Contents of the pack and other information
1.
WHAT SCINTIMUN IS AND WHAT IT IS USED FOR
Scintimun is a medicine containing an antibody (besilesomab) used to
target specific cells called
granulocytes (a type of white blood cells involved in the inflammation
process) in your body.
Scintimun
is used for the preparation of a radioactive solution for injection of
technetium(
99m
Tc)-
besilesomab. Technetium(
99m
Tc) is a radioactive element allowing the organs where besilesomab
accumulates to be seen using a special camera.
This medicine is a radiopharmaceutical product for diagnostic use only
in adults.
After injection into your vein, your doctor can obtain pictures
(scans) of your organs that give more
information about the detection of sites of inflammation and/or
infection. However Scintimun should
not be used for the diagnosis of diabetic foot infection.
The use of Scintimun does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit that
you will obtain from the
procedure with the radiopharmaceutical outweights the risk due to
radiation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SCINTIMUN
_ _
SCINTIMUN MUST NOT BE USED:
-
if you are aller
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Scintimun 1 mg kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Scintimun contains 1 mg of besilesomab.
Besilesomab is an anti-granulocyte monoclonal antibody (BW 250/183),
produced in murine cells.
The radionuclide is not part of the kit.
Excipient(s) with known effect
Each vial of Scintimun contains 2 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Kit for radiopharmaceutical preparation.
Scintimun: white powder
Solvent for Scintimun: white powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the technetium (
99m
Tc) besilesomab
solution obtained is indicated in adults for scintigraphic imaging, in
conjunction with other appropriate
imaging modalities, for determining the location of
inflammation/infection in peripheral bone in adults
with suspected osteomyelitis.
Scintimun should not be used for the diagnosis of diabetic foot
infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is for use in designated nuclear medicine
facilities only, and should only be
handled by authorised personnel.
Posology
_Adults _
The recommended activity of technetium (
99m
Tc) besilesomab should be between 400 MBq and
800 MBq.
This corresponds to the administration of 0.25 to 1 mg of besilesomab.
For repeated use, see section 4.4.
_Elderly _
No dose adjustment is required.
3
_Renal impairment / Hepatic impairment _
Formal studies have not been performed in patients with renal or
hepatic impairment. However, due to
the nature of the molecule and the short half-life of technetium (
99m
Tc) besilesomab, dose adjustment
is not necessary in such patients.
_Paediatric population _
The safety and efficacy of Scintimun in children and adolescents have
not yet been established.
No data are available.
Method of administration
The rad
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