OCTREOSCAN injection composite pack with needle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

indium (111In) chloride,pentetreotide

Tilgjengelig fra:

Landauer Radiopharmaceuticals Pty Ltd

INN (International Name):

indium (111In) chloride,Pentetreotide

Autorisasjon status:

Registered

Informasjon til brukeren

Australia CMI 201808
1
OCTREOSCAN
®
_OctreoScan (Kit for the preparation of _
_111_
_In Pentetreotide) _
CONSUMER MEDICINE INFORMATION
_______________ __________________________________
_WHAT IS IN THIS _
_LEAFLET _
This leaflet answers some of
the common questions about
OctreoScan. It does not
contain all of the available
information about
OctreoScan. It does not
replace talking to your doctor.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you or
your child receiving
OctreoScan against the
benefits he or she expects it
will have.
If you have any concerns
about receiving this medicine,
ask your doctor.
Keep this leaflet. You may
need to read it again.
_WHAT IS _
_OCTREOSCAN_
_ _
OctreoScan is a kit that
consists of two components,
OctreoScan 10 mL Reaction
Vial containing pentetreotide
and 10 mL vial of Indium
(
111
In) Chloride Sterile
Solution. These two
components are combined on
the day of intended use to
form a single, sterile solution
of the diagnostic agent
Indium (
111
In) Pentetreotide.
_WHAT OCTREOSCAN _
_IS USED FOR_
_ _
OctreoScan is used to
diagnose tumours containing
somatostatin receptors.
These tumours are commonly
found in the pituitary gland,
pancreas and gastrointestinal
system
Your doctor may have
prescribed OctreoScan for
another purpose. Ask your
doctor if you have any
questions about why
OctreoScan has been
prescribed for you. If you
have any concerns, you
should discuss these with
your doctor.
This medicine is only
available with a doctor's
prescription.
_BEFORE YOU ARE _
_GIVEN OCTREOSCAN_
_ _
Before you are given
OctreoScan your doctor will
explain to you the procedure
you are about to undergo,
and the radioactive medicine
you will be given. You must
discuss any concerns you
have with your doctor.
OctreoScan is not
recommended for patients
less than 18 years of age. If
your doctor believes it is
necessary to give
OctreoScan to a patient
under 18, he or she will
discuss the benefits and risks
with you.
YOU MUST TELL YOUR DOCTOR IF
YOU HAVE ALLERGIES TO:
•

Preparatomtale

1
PRODUCT INFORMATION
NAME OF THE MEDICINE
OctreoScan®
(Curium Netherlands catalogue number: DRN 4920)
Kit for the preparation of Indium (
111
In) Pentetreotide.
DESCRIPTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
OctreoScan is supplied as two vials which cannot be
used separately.
•
1 vial 4920/A with 1.1 ml solution contains at
activity reference time: Indium (
111
In) chloride 122
MBq
•
1 vial 4920/B contains: Pentetreotide 10 μg
After reconstitution and labelling the solution contains
(
111
In)-pentetreotide.
Physical characteristics of
111
In:
111
In is cyclotron produced and decays with a half-life
of 2.83 days to stable cadmium.
Emission characteristics:
γ-rays 172 keV (90 % abundance)
g-rays 247 keV (94 % abundance)
X-rays 23-26 keV
Radionuclidic purity:
111
In ≥ 99%, other γ-emitting
nuclides ≤ 0.1%.
114m
In: max. 500 Bq per 1 MBq of
111
In at activity reference time/date.
Half-life of
114m
In: 49.51 days
LIST OF EXCIPIENTS:
Vial 4920/A
Hydrochloric acid
Water for injections
Ferric chloride hexahydrate
Vial 4920/B
Sodium citrate dihydrate
Citric acid monhydrate
Inositol
Gentisic acid
After reconstitution and labelling the pH of the
aqueous solution is 3.8 - 4.3. The ready to use
solution does not contain a preservative agent.
CAS numbers: 10025-82-8 (Vial A); 138661-02-6 (Vial
B)
MOLECULAR FORMULA: C
65
H
95
N
16
O
12
S
2
PHARMACEUTICAL FORMVial A: Radiopharmaceutical
precursor.
Vial B: Powder for solution for injection.
Vial A is a glass vial shielded with lead, containing a
clear and colourless solution.
Vial B is a glass vial with grey rubber stopper and an
aluminium crimp cap with orange flip off. It contains a
white lyophilised powder.
PHARMACOLOGY
PHARMACOKINETIC
Approximately 80% (resp. 90%) of intravenously
administered radiolabelled pentetreotide is eliminated
through the urinary system in 24 (resp. 48) hours.
111
In-pentetreotide is taken up by the following organs:
liver (approx. 2% at 24 hours) and spleen (approx.
2.5% at 24 hours). Uptake in thyroid and pituitary
occurs but not