Indium (In111) Chloride 370MBq/ml radiopharmaceutical precursor

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Indium (111 in)

Available from:

Curium Netherlands B.V.

ATC code:

V09AX01

INN (International Name):

Indium (111 in)

Dosage:

370 MBq/ml

Pharmaceutical form:

Radiopharmaceutical precursor, solution

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

indium (111In) pentetic acid

Authorization status:

Marketed

Authorization date:

2000-02-18

Patient Information leaflet

20-APP-4901-Ireland-PIL-15052019_clean.doc
DRN 4901 Package leaflet: Information for the user
INDIUM (IN111) CHLORIDE
370MBq per ml
radiopharmaceutical precursor
111
In as indium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE MIXED WITH
ANOTHER COMPONENT IS ADMINISTERED TO YOU 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 pharmacist.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor. See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Indium (In111) Chloride is and what it is used for
2. What you need to know before Indium (In111) Chloride is used
3. How Indium (In111) Chloride is used
4. Possible side effects
5.
How to store Indium (In111) Chloride
6. Contents of the pack and other information
1.
WHAT
INDIUM
(IN111)
CHLORIDE
IS
AND
WHAT IT IS USED FOR
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are
planning to have a baby, ask your doctor for advice.
•
PREGNANCY AND WOMEN OF CHILDBEARING POTENTIAL
Your
doctor
will
ONLY
administer
Indium
(In111)
Chloride
during
PREGNANCY OR WHEN
YOU MIGHT BE PREGNANT
IF
IT
IS ABSOLUTELY
NECESSARY, as it could harm the unborn child. Your doctor will also
give
you
advice
about
how
long
to
avoid
pregnancy
after
the
treatment.
•
BREAST-FEEDING
He/she may DELAY TREATMENT until breast-feeding is finished. He/she
may also ask you to STOP BREAST-FEEDING and discard this milk, until
the radioactivity is no longer in your body.
DRIVING AND USING MACHINES
It is not investigated whether Indium (In111) Chloride impairs the
ability
to drive and operate machinery.
This medicine is for DIAGNOSTIC USE only.
Indium (In111) Chloride is used through a scan to examine different
parts
of your body, depending on the other non-radioactive component used.
Your doctor will explain the purpose of use.
This medicine contains a radioactive

Summary of Product characteristics

Health Products Regulatory Authority
20 November 2020
CRN00C1KP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indium (In111) Chloride 370MBq/ml radiopharmaceutical precursor
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml at activity reference date:
Indium-111 370 MBq
111
In disintegrates by electron capture with a half-life of approximately
67 hours (2.8 days) and emits gamma radiation with
principal energies of 172 keV (91%) and 246 keV (94%). By internal
conversion X radiations of 23 and 26 keV are also emitted.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Radiopharmaceutical precursor.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indium [
111
In] chloride is used as an ingredient for the radiolabelling of
certain suitably derivatised proteins which are
subsequently administered intravenously for a variety of investigative
purposes using appropriate imaging procedures.
Indium [
111
In] chloride is used extensively for the radiolabelling of monoclonal
antibodies. The nature of the disease state to be
investigated will be determined by the particular monoclonal antibody
to be labelled.
Indium [
111
In] chloride has also been used as the radiolabelling ingredient in
injectable preparations such as Indium
[
111
In]-labelled proteins.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The vial contains a sterile aqueous solution for the_ in-vitro
_radiolabelling of suitable conjugated proteins such as monoclonal
antibodies, which are subsequently administered intravenously.
The quantity of Indium [
111
In] chloride required for radiolabelling and the quantity of Indium [
111
In]-labelled pharmaceutical
that is subsequently administered will depend on the pharmaceutical
being labelled and its intended use.
Information on recommended dosage and administration will be provided
by the manufacturer of the pharmaceutical to be
radiolabelled.
The activity to be administered to children may be calculated
approximately by correcting on a weig