HELICAP 14C-urea 37kBq hard capsule bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

urea (14C), Quantity: 37 kBq

Tersedia dari:

Vitramed Pty Ltd

INN (Nama Internasional):

urea (14C)

Bentuk farmasi:

Capsule, hard

Komposisi:

Excipient Ingredients: citric acid; titanium dioxide; indigo carmine; Gelatin

Rute administrasi :

Oral

Unit dalam paket:

Bottle of 10 capsules

Jenis Resep:

Not scheduled. Not considered by committee

Indikasi Terapi:

HeliCap (Urea[14C], 37kBq capsule) breath test is indicated for use in the detection of gastric urease as an aid in the diagnosis of H.pylori infection in the human stomach

Ringkasan produk:

Visual Identification: Blue capsule 6 x 16mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2010-04-30

Selebaran informasi

1
HELICAP 37 KBQ,
14
C UREA CAPSULE
,
HARD
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about HELICAP.
i.
What HeliCap
®
is and what it is used for
ii.
Before you take HeliCap
®
iii.
How to take HeliCap
®
iv.
Possible side effects
v.
How to store HeliCap
®
vi.
Further information
It does not contain all the information that is known about HELICAP.
It does not take the place of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of taking
HELICAP against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET - YOU MAY NEED TO READ IT AGAIN.
_WHAT HELICAP IS AND WHAT IT IS USED FOR _
HELICAP
®
is for diagnostic use only. The capsule is a part of a breath test
examination that
can be used to determine whether or not you have a primary or
remaining infection in the
stomach caused by the bacterium _Helicobacter Pylori_.
HeliCap
®
contains
14
C -urea, which is mildly radioactive. The test uses the bacterium’s
ability
to break down urea into carbon dioxide. Following the intake of
HeliCap
T®
your breath is
collected and analysed. You are infected with
_Helicobacter Pylori _
if traces of radioactivity
are found in your breath.
_HOW HELICAP WORKS _
1.
HELICAP is swallowed with a glass of water on an empty stomach.
2.
Helicap containing
14
C –labelled urea
disintegrates rapidly in the stomach area
and the
14
C –urea is dissolved.
3.
In the presence of
_Helicobacter Pylori _, the
14
C –urea is metabolized to carbon
dioxide and ammonia by the enzyme urease which is produced by the
bacteria.
4.
The available
14
C isotopes, now in the form of carbon dioxide (
14
CO
2
), diffuse into
the blood to be transported to the lungs, where it is exhaled in the
breath and
2
captured
during
sampling.
A
positive
sample
is
conclusive
evidence
of
_Helicobacter Pylori _ infection.
5.
In the absence of _Helicobacter Pylori_ the administered
14
C –urea is absorbed in the
gastr

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION – HELICAP (UREA 14C)
CAPSULE
1
NAME OF THE MEDICINE
Urea [
14
C]
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active: 37 kBq, urea[
14
C]
Each capsule contains 1 - 2 µg of urea[
14
C] equivalent to 37 kBq radioactivity. Not less than
99.9% of the radioactivity is due to
14
C.
The radiation is emitted as low energy beta particles 49 keV (mean),
156 keV (max).
Maximum range in plastic is 0.25 mm. Physical half-life for
14
C is 5730 years.
Inactive: Citric acid, gelatin, indigo carmine, titanium dioxide
3
PHARMACEUTICAL FORM
The HeliCap capsule is a blue hard-shell gelatine capsule, 6 x 16mm,
for oral administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
HeliCap (urea[
14
C], 37 kBq capsule) breath test is indicated for use in the
detection of gastric urease as an aid in the diagnosis of _H.pylori
_infection in the
human stomach.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The medicinal product is for diagnostic use only.
_Adults _(> 18 years): One capsule (37 kBq, urea[
14
C]) should be swallowed together with
water as a single administration at the time of the test. Prior to
taking the test the patient
should have been fasting for at least 6 hours, preferably overnight.
The capsule should be swallowed whole and must not be chewed on.
The HeliCap capsule should be used together with the HeliProbe test
system which
includes a single-use breath-collecting unit called BreathCard and a
14
CO
2
analyser, called
HeliProbe.
It is necessary for the patient to fast for at least six hours,
preferably overnight before the
test. The patient should also be off antibiotics and bismuth for 1
month and proton pump
inhibitors and sucralfate for 2 weeks prior to the test.
2
Instruct the patient not to handle the capsule directly as this may
interfere with the test
result. The capsule should be swallowed intact, and must not be
chewed.
HELIPROBE SYSTEM – DESCRIPTION AND INSTRUCTIONS FOR USE
HeliProbe: The analyser contains two shielded Geiger-Muller counters
mounted face to
face. An openin