KryptoScan, [81m Kr] Radionuclide generator

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Krypton (81m kr)

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09EX01

INN (International Name):

Krypton (81m kr)

Dosering :

74 - 740 megabecquerel(s)

Legemiddelform:

Radionuclide generator

Resept typen:

Product subject to Restricted Prescription (C)

Terapeutisk område:

krypton (81mKr) gas

Autorisasjon status:

Not marketed

Autorisasjon dato:

2006-05-26

Informasjon til brukeren

11-APP-3633-Ireland-PIL-15052019_clean.doc
DRN 3633 Package leaflet: Information for the patient
KRYPTOSCAN [81MKR]
radionuclide generator
Active substance:
81
Rb Rubidium /
81m
Kr Krypton
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 nuclear medicine doctor
who will supervise the procedure.
•
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What KryptoScan is and what it is used for
2. What you need to know before KryptoScan is used
3. How KryptoScan is used
4. Possible side effects
5. How KryptoScan is stored
6. Contents of the pack and other information
1.
WHAT KRYPTOSCAN IS AND WHAT IT IS USED FOR
PREGNANCY AND BREAST-FEEDING
You must inform the nuclear medicine doctor before the administration
of
KryptoScan if there is a possibility:
•
you might be pregnant
•
if you have missed your period or
•
if you are breast-feeding
When in doubt, it is important to consult your nuclear medicine doctor
who
will supervise the procedure.
•
If you are PREGNANT
The nuclear medicine doctor will ONLY administer this product during
pregnancy IF A BENEFIT IS EXPECTED WHICH WOULD OUTWEIGH THE RISKS.
•
If you are BREAST-FEEDING
Your
doctor
may
DELAY
TREATMENT
until
breast-feeding
is
finished.
However,
if
your
doctor
considers
administration
of
KryptoScan
is
absolutely necessary, breast-feeding need not be interrupted.
DRIVING AND USING MACHINES
It is considered unlikely that KryptoScan will affect your ability to
drive or
to use machines.
This medicine is a radiopharmaceutical product for diagnostic use
only.
KryptoScan is used through a scan to examine the
•
LUNG FUNCTION and
•
BLOOD CIRCULATION IN THE LUNGS
This medicine contains a radioactive substance, from which another
radioactive
substance called
81m
Kr Krypton can be rece

Preparatomtale

Health Products Regulatory Authority
20 November 2020
CRN00C1KP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
KryptoScan, [81m Kr] Radionuclide generator
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rubidium (
81
Rb) bound as ion to a cation exchange resin is in equilibrium with the
daughter-product Krypton (
81m
Kr) and serves
as a generator for Krypton (
81m
Kr) gas.
The generator is available with activities ranging between 74-740 MBq
(DRN 3633).
PHYSICAL CHARACTERISTICS
Rubidium (
81
Rb) decays with a physical half-life of 4.58 hours to its metastable
daughter-product Krypton (
81m
Kr) thus
generating the short-lived radionuclide with a half life of 13
seconds. Krypton (
81m
Kr) decays by isometric transition to Krypton
(
81
Kr), emitting pure gamma radiation of 0.190 MeV which is internally
converted.
81
Kr decays to stable
81
Br with a half life of t
1/2
= 2.1 x 10
5
years.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Radionuclide generator.
The product is a shielded Radionuclide generator producing a
colourless, odourless, inert gas for inhalation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Investigation of pulmonary ventilation. This product can be especially
recommended for paediatric examination
because of the low radiation dose.

Combined with a pulmonary perfusion scintigraphy for diagnosis of
pulmonary embolism.

Pulmonary ventilation (
81m
Kr)/perfusion (
99m
Tc-macroaggregation) studies are possible because of the different
spectrometric windows of
81m
Kr and
99m
Tc.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Krypton images are acquired during the continuous inhalation of the
short lived and otherwise inert radioactive gas, krypton
[
81m
Kr]. This is eluted with humidified air from a rubidium generator and
administered to the patient through a face mask or
airway.
In general adequate imaging is achieved when 200,000-350,000 counts
are accumulated per gamma camera image. This
corresponds to approx. 18 MBq/kg body weight.
Most in