Package Leaflet: Information for the user NephroMAG 0.2 mg Kit for ...

treat or prevent organ transplant rejection).
Using NephroMAG with food and drink
In this leaflet
Package Leaflet: Information for the user
NephroMAG 0.2 mg
Kit for radiopharmaceutical preparation
Mercaptoacetyltriglycine (Mertiatide)
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
1. What NephroMAG is and what it is used for
2. Before you use NephroMAG
3. How to use NephroMAG
4. Possible side effects
5. How to store NephroMAG
6. Further information
1. WHAT NephroMAG IS AND WHAT IT IS USED FOR
NephroMAG is a diagnostic radiopharmaceutical for the renal system.
This medicine is a kit to prepare a radioactive solution for injection.
Therefore the preparation takes place in a specialized radio-pharmacy
unit. The final solution for injection serves to apply a diagnostic
imaging procedure of your kidneys and urinary tract.
Together with a suitable radioactive substance technetium-(99mTc)
mertiatide solution is prepared. This is indicated in babies, children
and adults for diagnostic investigations of the kidneys, the urinary
tract and the urinary flow.
Using a special camera your doctor will obtain images which allow to
watch your kidneys work and to diagnose form and function of your
kidneys and entire urinary tract. Regarded is how well your kidneys
are able to clear your blood (clearance) from the substance injected
and your urinary system is able to excrete it afterwards.
2. BEFORE YOU USE NephroMAG
Do not use NephroMAG
Do not use NephroMAG if you are allergic (hypersensitive) to
mertiatide or any of the other ingredients of NephroMAG. If the allergic
symptoms, such as urticaria, pruritus, nausea or difficulty in breathing
were developed during the previous examination, the necessity of the
intervention should be considered.
Take special care with NephroMAG
You should know that you may create risks for others from external
radiation or contamination from spills of urine, vomiting, etc. for some
hours once you have been injected with the pharmaceutical. Vice
versa you could be subjected to risks from other patients. Particular
care you should take when you get in close contact with children.
Taking other medicines
Technetium-(99mTc) mertiatide is not known to interfere with agents
commonly prescribed to patients requiring the above mentioned
investigations (e.g. antihypertensives and medicinal agents used to
Drink plenty of water before the examination starts to allow optimal
results of the investigation. Empty your bladder as often as possible
during the first hours after the examination in order to reduce
radiation.
Pregnancy and breast-feeding
So-called radionuclide procedures on pregnant women also involve
radiation doses to the foetus which could endanger the healthy
development. Only imperative investigations should be carried out
during pregnancy, when the likely benefit exceeds the risk incurred by
mother and foetus. There must be urgent and important medical
reasons to justify the investigation during pregnancy.
You should be assumed pregnant if you are missing a period.
Alternative techniques which do not involve ionising radiation should
be considered then.
If you are a breast-feeding mother you should interrupt breast-feeding
for 24 hours and discard the expressed feeds. Moreover, to protect
from radioactivity transmission, the mother is recommended to avoid
close contact to the baby during the initial 24 hours following
injection. Ask your doctor for specific advice.
Driving and using machines
You may drive and use machines after the investigation.
3. HOW TO USE NephroMAG
Your doctor will prepare the radioactive solution for injection and will
inject it intravenously as a single shot immediately before the
diagnostic examination starts.
If you get more NephroMAG than you should
Your medicinal product will be administered by doctor in strictly
defined conditions, so there is hardly anything to be expected from
that side. The risk of a radiation overdose is hardly to happen. You can
always reduce radiation to your body if you drink plenty of water and
void your bladder frequently. If necessary, your doctor may support
excretion with some other medicine (forced diuresis).
If you have any further questions on the use of this product, ask your
doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, technetium-(99mTc) mertiatide can cause side
effects, although not everybody gets them.
Mostly mild anaphylactoid reactions characterised by uriticarial rash,
swelling of eyelids and coughing have been reported very rarely in less
than 1 out of 10,000 patients. Occasionally circulatory disorders of a
mild nature (characterized by sudden dizziness or fainting) have been
reported.
Your doctor is aware to treat these immediately if necessary.
Exposure to ionisation radiation is linked with cancer induction and a
potential for development of hereditary defects. However, the
absorbed radiation dose is probably much lesser than that
radioactivity you are naturally exposed to during a year in your normal
environment. For diagnostic nuclear medicine procedures these
adverse effects will occur with low frequency because of the low
radiation doses incurred.
If you suffer from reduced kidney function an increased radiation
exposure can be the consequence. If any of the side effects gets
serious, or if you notice any side effects not listed in this leaflet, tell
your doctor at once.
5. HOW TO STORE NephroMAG
Generally this medicine is stored at your doctor’s place since there are
special requirements.

Store in a refrigerator at 2 – 8 °C.
Store in the original package in order to protect from light.
The labelled preparation must be stored at 2 – 8 °C for aseptic
reasons.
Storage should be in accordance with national regulations for
radioactive material.
6. FURTHER INFORMATION
What NephroMAG contains
The active substance is 0.2 mg mercaptoacetyltriglycine (mertiatide)
in vial (1). The other ingredients are stannous chloride dihydrate,
disodium (R,R)-tartrate dihydrate, sodium hydroxide, hydrochloric
acid, sodium monohydrogenphosphate dihydrate, sodium
dihydrogenphosphate dihydrate.
What NephroMAG looks like and content of the pack
NephroMAG 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 and Manufacturer
ROTOP Pharmaka AG
Bautzner Landstrasse 45
01454 Radeberg
Federal Republic of Germany
Fon +49 351 26 95 395
Fax +49 351 26 95 311
E-Mail: info@rotop-pharmaka.de
Local Representative
N.N.
This medicinal product is authorised in the Member States of the
EEA under the following names:
Germany
Spain
Hungary
The Netherlands
Finland
Greece
France
Portugal
Sweden
Belgium
Norway
Italy
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Reduction of radioactivity to less than 10 % of the activity adults
receive will generally result in technically unsatisfactory procedures.
3 kg = 0.1 22 kg = 0.5 42 kg = 0.78
4 kg = 0.14 24 kg = 0.53 44 kg = 0.80
6 kg = 0.19 26 kg = 0.56 46 kg = 0.82
8 kg = 0.23 28 kg = 0.58 48 kg = 0.85
10 kg = 0.27 30 kg = 0.62 50 kg = 0.88
12 kg = 0.32 32 kg = 0.65 52 - 54 kg = 0.90
14 kg = 0.36 34 kg = 0.68 56 - 58 kg = 0.92
16 kg = 0.40 36 kg = 0.71 60 - 62 kg = 0.96
18 kg = 0.44 38 kg = 0.73 64 - 66 kg = 0.98
20 kg = 0.46 40 kg = 0.76 68 kg = 0.99
Fraction of adult activity (Paediatric Task Group EANM, 1990).
Method of Administration
The radiopharmaceutical is prepared according to the following
labelling instructions immediately before use: The labelling procedure
has to be carried out under aseptic conditions.
Place vial (1) into an adequate lead shielding. Swab the rubber
septum with an appropriate disinfectant and let it dry.
Inject 2 ml of sodium pertechnetate (99mTc) solution into vial (1) using a
syringe. Then withdraw the same volume of nitrogen from the vial with
the same syringe for pressure compensation.
Shake the vial carefully in order to moisten the entire vial for complete
dissolution of any powder.
After 15 minutes reaction time transfer a volume of 2 ml buffer solution
from vial (2) into vial (1) using a new syringe. Then withdraw the same
volume of nitrogen from the vial with the same syringe for pressure
compensation.
Shake carefully for good mixing. Determine the total radioactivity and
calculate the volume to be injected.
If necessary, dilute with sterile isotonic saline up to a final total volume
of 10 ml. Shake again for good mixing.
The prepared solution for injection is administrated intravenously.
The technetium-(99mTc) mertiatide should be injected within 6 hours
after preparation.
This leaflet was last approved in March 2011.
The following information is intended for medical or healthcare
professionals only:
Dosage
Adults usually receive 40 - 200 MBq depending on the pathology to
be studied and the method to be used. Studies of renal blood flow or
transport through the ureters generally require a larger dose than
studies of intrarenal transport, whereas renography requires smaller
activities than sequential scintigraphy.
Children and adolescents (aged less than 18 years)
Although NephroMAG may be used in paediatric patients, formal
studies have not been performed. Clinical experience indicates that
for paediatric use the activity should be reduced.
A practical approach is to adopt the recommendations of the
Paediatric Task Group of the European Association of Nuclear
Medicine (EANM). See table below.
PL-MAG3-FI-eng-05