CERETEC FREEZE DRIED

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

EXAMETAZIME

から入手可能:

GE Healthcare Limited

ATCコード:

V09AA01

INN（国際名）:

EXAMETAZIME

投薬量:

500 Microgram

医薬品形態:

Kit for radiopharmaceutical preparation

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

technetium (99mTc) exametazime

認証ステータス:

Marketed

承認日:

1988-04-19

情報リーフレット

In more serious cases reactions may include:
•
passing out (unconsciousness), feeling dizzy or
lightheaded.
If any of the side effects above happen after you
leave the hospital or clinic, you should go or be
taken straight to the casualty department of your
nearest hospital.
Other side effects include (frequency not known)
•
itchy lumpy rash
•
headache
•
feeling dizzy
•
fl ushing
•
feeling sick (nausea)
•
being sick (vomiting)
•
general feeling of being unwell, weak or tired
•
unusual feelings of numbness, tingling, prickling
burning or creeping on skin.
This radiopharmaceutical will deliver low amounts
of ionising radiation with the least risk of cancer
and hereditary abnormalities.
REPORTING OF SIDE EFFECTS
If you notice any side effects, or if you notice any
side effects not listed in this leafl et, please tell
your Nuclear medicine doctor who supervises the
procedure.
You can also report side effects directly to:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: [phone]
Fax: [phone]
Website: www.hpra.ie
e-mail: [e-mail]
By reporting side effects, you can help provide
more information on the safety of this medicine.
5. HOW CERETEC IS STORED
You will not have to store this medicine. This
medicine is stored under the responsibility of the
specialist in appropriate premises. Storage of
After injection, you will be offered a drink and
asked to urinate immediately preceding the test.
Ceretec will always be used in a hospital or clinic.
Ceretec will be given to you by a specially trained
and qualifi ed person. They will provide you with
the necessary information on the procedure.
DURATION OF THE PROCEDURE
Your nuclear medicine doctor will inform you
about the usual duration of the procedure.
AFTER ADMINISTRATION OF CERETEC YOU SHOULD:
•
urinate frequently in order to eliminate the
product from your body
The nuclear medicine doctor will inform you if
you need to take any special precautions after
receiving this medicine. Contact your nuclear
medicine doctor if

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceretec 500 micrograms kit for radiopharmaceutical preparation.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains exametazime 500 micrograms.
Ceretec is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection (not included in this kit) to prepare Technetium
(
99m
Tc) Exametazime Injection.
Excipients with known effect
The product before reconstitution contains sodium: 1.77 mg/vial. This
needs to be taken into consideration for patients
on a controlled sodium diet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
A white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (
99m
Tc) Injection, the product is indicated in adults for:
1.
Technetium (
99m
Tc) Exametazime Injection is indicated for brain scintigraphy. The
product is to be used for
the diagnosis of abnormalities of regional cerebral blood flow, such
as those occurring following stroke and other
cerebrovascular disease, epilepsy, Alzheimer’s disease and other
forms of dementia, transient ischaemic attack,
migraine and tumours of the brain.
2.
Technetium (
99m
Tc) Exametazime Injection is also indicated for_ in vitro_
technetium-99m leucocyte labelling,
the labelled leucocytes subsequently being re-injected and
scintigraphy carried out to image the sites of localisation.
This procedure may be used in the detection of sites of focal
infection (e.g. abdominal abscess), in the investigation of
pyrexia of unknown origin and in the evaluation of inflammatory
conditions not associated with infection such as
inflammatory bowel disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is direct intravenous injection for brain
scintigraphy studies and intravenous injection of
labelled leucocytes post labelling_ in vitro_.
POSOLOGY
Adults and the elderly population
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