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MIBG (I123) INJECTION

Active substance(s): 3-IODOBENZYLGUANIDINE SULPHATE / IOBENGUANE(123-I) / 3-IODOBENZYLGUANIDINE SULPHATE / IOBENGUANE(123-I) / 3-IODOBENZYLGUANIDINE SULPHATE / IOBENGUANE(123-I)

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DRN 5379

MIBG (1123) Injection United Kingdom & Northern Ireland
Package leanet: Information for the user

MIBG 11 23
solution for injection
Active substances:

123 1as

iobenguane and 3-iodobenzylguanidine

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 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 or pharmaCIst.
In this leaflet:
1, What MIBG 1123 is and what it is used for
2, Before you use MIBG 1123
3, How to use MIBG 1123
4, Possible side effects
5, How to store MIBG 1123
6, Further information

1.

What MIBG 1123 is and what it is used
for

This medicine is for diagnostic use only,
MIBG 1123 is used through a scan to examine the:

location of certain tumours

adrenal medulla, part of the glands which are located on the top of
each kidney

heart function
This medicine contains a radioactive substance which when injected, collects
in certain organs such as the heart,
The radioactive substance can be photographed from outside the body,
using special cameras which take a scan, This scan shows the distribution of
radioactivity within the organ and body, This also gives the doctor valuable
information about the structure and function of that organ ,

2.

Before you use MIBG 1123

Do not use MIBG 1123
if you are

allergic (hypersensitive) to 1131as iobenguane and 3-iodobenzyl-guanidine
or any of the other ingredients,

Take special care with MIBG 1123
This medicine does involve treatment with radioactivity, Your doctor
will only give you this medicine if the benefit outweighs the risk ,
MIBG 1123 is given in one single dose by specialists, who will take
responsibility for any necessary precautions.
Your doctor will inform you if you need to take any special precautions
after using this medicine, Contact your doctor if you have any
questions,

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription,
Your doctor may recommend that you stop the following medicines
before treatment:
• diltiazem, nifedipine, verapamil or similar substances used to
treat high blood pressure and heart disorders
• amitriptyline, imipramine or similar substances used to treat
depressions
• phenylephrine, ephedrine, phenylpropanolamine or similar
substances often contained in nasal drops or sprays to treat
blocked nose
• reserpine : a medicine to treat high blood pressure via the central
nervous system
• labetalol : a medicine to reduce high blood pressure
• medicines to treat mental disorders with active substance names
mostly ending in "azine" such as, promethazine, fluphenazine,
chlorprothixine
• cocaine

Pregnancy and breast·feeding


Pregnancy
Tell your doctor if you are pregnant or think you could be, Your
doctor will only administer MIBG 1123 during pregnancy if it is
absolutely necessary, as it could harm the unborn child ,

Breast·feeding
Tell your doctor if you are breast-feeding as he may delay
treatment until breast-feeding is finished, He may also ask you to
stop breast·feeding for 3 days and discard this milk, until the
radioactivity is no longer in your body,
Ask your doctor or pharmacist for advice before taking any medicine,

Driving and using machines
MIBG 1123 is unlikely to impair the ability to drive and operate
machinery,

95379006 BYS0 5d 16 CON 5379 United Kingdom SPC 1710201 2/ 16 CON 5379 Uniled Kingdom PIL 1710201 2

DRN 5379

3.

MIBG (11 23) Injection United Kingdom & Northern Ireland

How to use MIBG 1123

5.

How to store MIBG 1123

MIBG 1123 will always be used in a hospital or similar setting. It will only
be administered to you by qualified people trained to safe handle
radioactive material.

Do not use MIBG 11 23 after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature , between 1525°C as stated on the label.

Your doctor will decide the MIBG 11 23 amount to be used. The dose
administered will depend on the procedure.
The lowest dose possible will be used to produce adequate X-ray
images.

6.

The usual dose is:

What MIBG 1123 contains

Approximate dose for adults is :

80 - 200 MBq injected into the vein over several minutes.
MBq is the unit used to measure radioactivity, and defines the activity
of a quantity of radioactive material.

The active substances are 123 1as iobenguane and 3-iodobenzylguanidine.
One millilitre of MIBG 11 23 contains 74 MBq iodine-123 and 0.5 mg 3iodobenzylguanidine.

Ch ildren under 18 years
Lower doses are used for chi ldren according to their body weight.

Method of use
One injection is usually sufficient.
You will receive a medicine to reduce the thyroid uptake, one to two
days before injection until three days after injection .
Scans are usually taken on the day after injection and may be
repeated one day later.



MIBG 1123 is packaged in type 1 Ph.Eur glass vials closed with a butyl
rubber stopper and sealed with an aluminium crimp cap. It is supplied in one
vial containing 1, 2, 3, 4 or 5 ml.

Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder
Mallinckrodt UK Commercial Ltd.
4500 Parkway
Whiteley
Fareham
Hampshire P015 ?NY
United Kingdom
Tel : +44(0)1329224477, Fax: +44(0)1329224442
PL 41744/0006



Manufacturer
Mallinckrodt Medical BY, Westerduinweg 3
1755 LE Petten, The Netherlands

If you use more MIBG 11 23 than you should

If you have any further questions on the use of this product, ask your
doctor.

The other ingredients are: citric acid, sodium citrate, gentisic acid,
copper sulphate, tin(II)sulphate and water for injections.

What MIBG 11 23 looks like and contents of the pack

Drink and urinate as much as possible before and after treat·
ment. This will prevent active substance gathering in the bladder.

It is unlikely that overdose will occur as this medicine is given under control
by a doctor. However, if this happens you will receive appropriate treatment
from your doctor.
Drinking as much as possible will help remove the radioactive substance
more quickly.

Further information

This leaflet was last approved in 10/2012.

4.

Possible side effects

Like all medicines, MIBG 11 23 can cause side effects, although not
everybody gets them .
Side effects can occur with the following frequencies:
rare, occurs in 1 to 10 per 10,000 users

allergic reactions with symptoms such as:
- flushes
- itching, hives,
- nausea
- cold chills
Hospital staff will treat these reactions, if they occur.

The following side effects may also occur during or immediately after
injection, if MIBG 123 is administered too fast:
- palpitations
- difficulty breathing
- heat sensations
- temporary high blood pressure
- abdominal cramps
These symptoms should disappear within one hour.
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 pharmacist.

95379006BYSOSd 16 CON 5379 United Kingdom SPC 17102012 / 16 CON 5379 United Kingdom PIL 1710201 2

Expand Transcript

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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