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META-IODOBENZYLGUANIDINE (131I) FOR DIAGNOSTIC USE 9.25 -18.5 MBQ/ML SOLUTION FOR INJECTION

Active substance(s): IOBENGUANE(131-I) CHLORIDE

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Transcript
Read all of this leaflet carefully
before you are given MIBG
Diagnostic.
PackaGe LeaFLeT:
InFoRMaTIon FoR The UseR

Meta-Iodobenzylguanidine
(131I) for Diagnostic Use
Meta-lodobenzylguanidine (131I)
for Diagnostic Use
9.25-18.5 MBq/ml solution for
injection
[131I]Iobenguane
Meta-lodobenzylguanidine (131I) for
Diagnostic Use 9.25-18.5 MBq/ml
solution for injection is referred to as
MIBG Diagnostic in this leaflet.

– Keep this leaflet. You may need to
read it again.
– If you have any further questions,
ask your doctor.
– If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or nurse.
In this leaflet:
1. What MIBG Diagnostic is and
what it is used for
2. Before you are given MIBG
Diagnostic
3. How MIBG Diagnostic is given
4. Possible side effects
5. How to store MIBG Diagnostic
6. Further information

2

1. What MIBG Diagnostic is and
what it is used for
This medicine is used for diagnostic
use only. It is used only to help
identify illness.
MIBG Diagnostic is a
‘radiopharmaceutical’ medicine. It is
given before a scan and helps a
special camera see inside a part of
your body.
• It contains an active ingredient
called ‘iobenguane’.
• Once injected it can be seen
from outside your body by a
special camera used in the scan.
• The scan can help your doctor
see if a tumour of the adrenal or
thyroid glands is suitable for

treatment and help decide on
the treatment required.
Your doctor or nurse will explain
which part of your body will be
scanned.
2. Before you are given MIBG
2. Diagnostic
You should not be given MIBG
Diagnostic:
• If you are allergic
(hypersensitive) to the active
ingredient or any other
ingredient. (Listed in Section 6).
• If you are pregnant or think you
might be pregnant.
Do not have MIBG Diagnostic if any
of the above apply to you. If you
are not sure talk to your doctor or
nurse.

3

Premature babies or newborn
babies (neonates) must not be given
MIBG Diagnostic. (See “Important
information about some of the
ingredients of MIBG Diagnostic”).
Take special care with MIBG
Diagnostic
Check with your doctor or nurse
before having MIBG Diagnostic:
• If you have missed your last
period.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor or nurse if
you are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription. This includes
herbal medicines. This is because

some medicines can affect the way
MIBG Diagnostic works.
Before your scan tell your doctor or
nurse if you are taking any of the
types of medicine below. This is
because they may affect the results
of your scan:
• Antihypertensive drugs such as
reserpine, labetalol or calciumchannel blockers (which include
diltiazem, nifedipine, verapamil,
betanidine, debrisoquine,
bretylium and guanethidine).
• Antidepressants such as
amitriptyline, imipramine,
doxepin, amoxepine, loxapine,
maprotiline or trazolone.
• ‘Sympathomimetic agents’ (used
as decongestants in cough and
cold remedies) such as

4

phenylephrine, ephedrine or
phenylpropanolamine.
• Cocaine
If you are not sure if any of the
above apply to you, talk to your
doctor or nurse before having MIBG
Diagnostic.
Pregnancy and breast-feeding
You should not be given MIBG
Diagnostic if you are pregnant or
think that you may be pregnant.
This is because it may affect the
baby.

Do not breast-feed if you are given
MIBG Diagnostic. This is because
small amounts of ‘radioactivity’
may pass into the mother’s milk. If
you are breast-feeding, your doctor
may wait until you have finished
breast-feeding before using MIBG
Diagnostic. If it is not possible to
wait your doctor may ask you to:
• stop breast-feeding, and
• use formula feed for your child,
and
• express (remove) breast milk
and throw away the milk.
Your doctor will let you know when
you can start breast-feeding again.

5

Driving and using machines
Ask your doctor if you can drive or
use machines after you have been
given MIBG Diagnostic.
Important information about
some of the ingredients of MIBG
Diagnostic
• MIBG Diagnostic contains benzyl
alcohol. Benzyl alcohol may
cause toxic reactions and allergic
reactions in infants and children
up to 3 years old.

Important information about MIBG
Diagnostic
When MIBG Diagnostic is used you
are exposed to radioactivity.
• Your doctor will always consider
the possible risks and benefits
before you are given the
medicine.
Ask your doctor if you have any
questions.

6

3. how MIBG Diagnostic is given
MIBG Diagnostic will be given to you
by a specially trained and qualified
person.
• MIBG Diagnostic will always be
used in a hospital or clinic.
• Your doctor will tell you to take
another medicine 24 to 48 hours
before you are given MIBG
Diagnostic. You will continue to
take this medicine for at least 5
days. This medicine is to stop
radioactivity building up in your
thyroid gland.
• They will tell you anything you
need to know for its safe use.
Your doctor will decide on the dose
that is best for you.

The usual dose is:
• A single slow injection (given
over 30 to 300 seconds).
4. Possible side effects
Like all medicines, MIBG Diagnostic
can cause side effects, although not
everybody gets them.
No significant side effects are to be
expected when you are given
MIBG Diagnostic.
If you notice any side effects please
tell your doctor or nurse.

7

5. how to store MIBG Diagnostic

6. Further information

MIBG Diagnostic is kept out of the
reach and sight of children.

What MIBG Diagnostic contains
• The active ingredient is
[131I]iobenguane. Each vial of
MIBG Diagnostic contains
between 9.25-18.5 MBq/ml
(Megabecquerel – the unit in
which radioactivity is measured)
of iodine-131) at a fixed time.
• The other ingredients are
sodium chloride, benzyl alcohol
and water for injections.

The product label includes the
correct storage conditions and the
expiry date for the batch. Hospital
staff will ensure that the product is
stored and disposed of correctly
and not used after the expiry date
stated on the label.

What MIBG Diagnostic looks like
and contents of the pack
MIBG Diagnostic is supplied as a
single colourless glass vial
containing a solution for injection.

EVS 220113 / 0112 / Oe 1200

Marketing authorisation holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunschweig
Germany
This leaflet was last approved in
07/2009.
Marketing authorisation
UK: PL 00221/0124

GE and the GE Monogram are trademarks of General Electric Company.

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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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