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IELMAG3 0.2 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): MERTIATIDE / NO ACTIVES PRESENT

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
IELMAG3 0.2 mg kit for radiopharmaceutical preparation
Mertiatide (mercaptoacetyltriglycine)

Read all of this leaflet carefully before you will be
administered this medicine.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your referring doctor or
the specialist physician in Nuclear Medicine who will supervise
the procedure.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your referring
doctor or the specialist physician in Nuclear Medicine who has
supervised the procedure.

In this leaflet:
1.
2.
3.
4.
5.
6.

What IELMAG3 is and what it is used for
Before IELMAG3 is administered
How IELMAG3 will be used
Possible side effects
How IELMAG3 is stored
Contents of the pack and other information

1. WHAT IELMAG3 IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic
use only.
IELMAG3 is used to study the function and structure and
blood flow of the kidneys as well as function of the urinary
tract, by making an image of these organs. After the medicine
is injected, it temporarily collects in certain parts of the body.
This radiopharmaceutical substance contains a small amount
of radioactivity, which can be detected from outside of the
body by using special cameras. Your nuclear medicine doctor
will then take an image (scintigraphy) of the concerned
organs which can give your doctor valuable information about
the about the structure and the function of these organs. The
use of IELMAG3 does involve exposure to small amounts of
radioactivity. Your doctor and the nuclear medicine doctor
have considered that the clinical benefit that you will obtain
from the procedure with the radiopharmaceutical outweighs
the risk due to radiation.
2. BEFORE IELMAG3 IS ADMINISTERED
IELMAG3 must never be used
- if you are allergic (hypersensitive) to mertiatide
(mercaptoacetyltriglycine) or any of the other ingredients of
IELMAG3 or to any of the components of the labelled
radiopharmaceutical.

Taking IELMAG3 with food and drink
Drink plenty of water before the examination starts.
Pregnancy and breast-feeding
You must inform the specialist physician in Nuclear Medicine
before the administration of IELMAG3 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 physician or the specialist physician in Nuclear Medicine
who will supervise the procedure.
If you are pregnant
Your physician will only consider this examination during your
pregnancy in case of absolute necessity.
If you are breast-feeding
Resuming breast-feeding should be in agreement with the
specialist in Nuclear Medicine. Please ask your doctor or the
specialist physician in Nuclear Medicine who will supervise the
procedure before taking any medicines.
Before IELMAG3 administration you should:
- drink plenty of water before the start of the examination in
order to allow optimal results of the investigation.
After administration of IELMAG3 has been performed, you
should:
- avoid any close contact with young children for the 12 hours
following the injection
- urinate frequently in order to eliminate the product from your
body
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. IELMAG3 will only be used in a
hospital. This product will only be handled and given to you by
people who are trained and qualified to use it safely. These
persons will take special care for the safe use of this product
and will keep you informed of their actions.
Driving and using machines
It is considered unlikely that IELMAG3 will affect your ability to
drive or to operate machinery.

3. HOW WILL IELMAG3 BE USED?
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. IELMAG3 will only be used in
special controlled areas. This product will only be handled and
given to you by people who are trained and qualified to use it
safely. These persons will take special care for the safe use of
this product and will keep you informed of their actions. The
nuclear medicine doctor supervising the procedure will decide
on the quantity of IELMAG3 to be used in your case. It will be
the smallest quantity necessary to get the desired information.
The quantity usually recommended to be administered for an
adult ranges, depending on the test to perform between 40
and 200 MBq (megabequerel, the unit to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will
be adapted to the child’s weight.

Take special care with IELMAG3
Inform the specialist in Nuclear Medicine in the following
cases:
- if you are pregnant or believe you may be pregnant
- if you are breast-feeding
- if you are under 18 years old

Administration of IELMAG3 and conduct of the procedure
You will be asked to drink plenty of water and empty your
bladder immediately before the examination starts. IELMAG3 is
administered by intravenous administration. The scintigraphy is
usually started immediately after administration.

Your nuclear medicine doctor will inform you if you need to
take any special precautions after using this medicine. Talk to
your nuclear medicine doctor if you have any questions.

Duration of the procedure
Your physician will inform you about the usual duration of the
procedure.

Taking other medicines
Please tell your doctor or the specialist physician in Nuclear
Medicine who will supervise the procedure if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.

If you have been administered more IELMAG3 than you
should
An overdose is almost impossible because you will only
receive a single dose of IELMAG3 precisely controlled by the
nuclear medicine doctor supervising the procedure. However,

in the case of an overdose, you will receive the appropriate
treatment. In particular, the nuclear medicine doctor in charge
of the procedure may recommend that you drink abundantly
to facilitate the elimination of IELMAG3 from your body.
Should you have any further question on the use of IELMAG3,
please ask your doctor or the specialist physician in Nuclear
Medicine who supervises the procedure.

4. POSSIBLE SIDE EFFECTS
Like all medicines, IELMAG3 can cause side effects, although
not everybody gets them.
This administered radiopharmaceutical will deliver low amount
of ionising radiation with very low risk of cancer and hereditary
abnormalities. Mild allergic reactions, characterised by hives,
rash, swelling of the eyelids and coughing have been reported
very rarely in less than 1 out of 10,000 patients. Occasionally a
circulatory disorder of a mild nature (characterized by sudden
dizziness or fainting) has been reported. Your doctor has
considered that the clinical benefit that you will obtain from the
procedure with the radiopharmaceutical overcomes the risk
due to radiation. If you notice any side effects, or if you notice
any side effects not listed in this leaflet, please tell your doctor
or the specialist physician in Nuclear Medicine who supervises
the procedure.
Reporting of side effects
If you get any side effects talk to your nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national
reporting system to:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Vial 2:
Sodium monohydrogenphosphate dihydrate,
Sodium dihydrogenphosphate dihydrate,
Hydrochloric acid,
Water for injection
What IELMAG3 looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation.
It consists of 2 different vials, 5 of each kind in one box.
Vial (1) contains a powder with 0.2 mg of the active substance
mertiatide; vial (2) contains 2.5 ml of phosphate buffer
solution.
Marketing Authorisation Holder
Imaging Equipment Limited
The Barn, Manor Farm, Church Lane, Chilcompton,
RADSTOCK BA3 4HP, United Kingdom
Phone:
Fax:
E-Mail:

+44 (0) 1761 417402
+44 (0) 1761 413600
nick@imagingequipment.co.uk

Manufacturer
ROTOP Pharmaka AG
Bautzner Landstrasse 400,
01328 Dresden, Germany
Phone:
Fax:
E-Mail:

+49 (0) 351 26 310-0
+49 (0) 351 26 310-300
info@rotop-pharmaka.de

This medicinal product is authorised in the
MemberStates of the EEA under the following names:
United Kingdom:

By reporting side effects you can help to provide more
information on the safety of this medicine.

Ireland:
Austria:

5. HOW IELMAG3 IS STORED
Bulgaria:
You will not have to store this medicine. This medicine is
stored under the responsibility of the specialist in appropriate
premises. Storage of radiopharmaceuticals will be in
accordance with national regulation on radioactive materials.

IELMAG3 0.2 mg
kit for radiopharmaceutical preparation
IELMAG3 0.2 mg
kit for radiopharmaceutical preparation
Mertioscan 0,2 mg
Kit für ein radioaktives Arzneimittel
IELMAG3 0.2 mg
Кит за радиофармацевтичен препарат

This leaflet was last approved in 07/2013.

The following information is intended for the specialist only.
IELMAG3 must not be used after the expiry date which is
stated on the label. The expiry date refers to the last day of
that month.
Storage conditions:
Store in a refrigerator (2 – 8 C).
Store in the original package in order to protect from light.
Shelf life after first opening and radiolabelling:
After radiolabelling: 6 hours.
Store the radiolabelled preparation at 2 – 8 °C.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance is 0.2 mg mertiatide (mercaptoacetyltriglycine) in vial (1).
The other ingredients are:
Vial 1:
Stannous chloride dihydrate,
Disodium (R,R)-tartrate dihydrate,
Sodium hydroxide,
Hydrochloric acid,
Nitrogen as protective gas

PL-MAG3-UK-eng-01-mockupfinal3

What IELMAG3 contains

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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