IELMAG3 0.2 mg kit for radiopharmaceutical preparation

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Mertiatide

Tilgjengelig fra:

ROTOP Pharmaka GmbH

ATC-kode:

V09CA; V09CA03

INN (International Name):

Mertiatide

Dosering :

0.2 milligram(s)

Legemiddelform:

Kit for radiopharmaceutical preparation

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Technetium (99mTc) compounds; technetium (99mTc) mertiatide

Autorisasjon status:

Marketed

Autorisasjon dato:

2013-08-09

Informasjon til brukeren

1
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. What IELMAG3 is and what it is used for
2. Before IELMAG3 is administered
3. How IELMAG3 will be used
4. Possible side effects
5.
How
IELMAG3 is stored
6. 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
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 compo

Preparatomtale

Health Products Regulatory Authority
01 February 2021
CRN00C4TM
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IELMAG3 0.2 mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The kit contains two different vials: (1) and (2).
Vial (1) contains 0.2 mg of the mertiatide (mercaptoacetyltriglycine).
Vial (2) contains 2.5 mL phosphate buffer solution.
For a full list of excipients, see section 6.1.
The radionuclide is not part of the kit. The kit contains all non
radioactive components required for the reconstitution of
technetium-(
99m
Tc) mertiatide solution for injection.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Vial 1: white to off-white powder
Vial 2: clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. This is indicated
for adults. For paediatric population see section 4.2.
After radiolabelling with sodium pertechnetate(
99m
Tc) solution, the solution of technetium-(
99m
Tc) mertiatide, is used for the
evaluation of nephrological and urological disorders in particular for
the study of function, morphology and perfusion of the
kidneys and characterisation of urinary outflow.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly population_
40 - 200 MBq, depending on the pathology to be studied and the method
to be used.
_Population aged less than 18 years_
Although IELMAG3 0.2 mg kit for radiopharmaceutical preparation may be
used in paediatric patients, formal studies have not
been performed. Clinical experience indicates that, for paediatric
use, the activity should be reduced. Because of the variable
relationship between the size and body weight of patients, it is
sometimes more satisfactory to adjust activities to body surface
area.
The use in children and adolescents has to be considered carefully,
based upon clinical needs and assessing the risk/benefit
ratio in this patient group. The activities to be administered to
children a