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CARDIOLITE KIT FOR THE PREPARATION OF TECHNETIUM TC-99M SESTAMIBI

Active substance(s): CYSTEINE HYDROCHLORIDE MONOHYDRATE / STANNOUS CHLORIDE DIHYDRATE / TETRAKIS COPPER TETRAFLUOROBORATE

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515224-1008
Package leaflet: Information for the patient
Cardiolite® Kit for radiopharmaceutical
preparation of Technetium Tc-99m Sestamibi
Injection
Tetrafluoroborate tetrakis (2-methoxy isobutyl
isonitrile ) copper (1), Stannous chloride
dihydrate, L-cysteine hydrochloride
Please all of read this leaflet carefully before you
are given your injection because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
nurse.
- If you get any side effects, talk to your doctor or
nurse>. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet
1. What Cardiolite is and what it is used for
2. What you need to know before you are given
Cardiolite
3. How Cardiolite is given
4. Possible side effects
5. How to store Cardiolite
6. Contents of the pack and further information
1. What Cardiolite is and what it is used for
The name of this medicine is Cardiolite. Cardiolite
contains the active ingredients Tetrakis (2- methoxy
isobutyl isonitrile) Copper (I) Tetrafluoroborate,
Stannous chloride dihydrate and, LCysteine
hydrochloride-monohydrate.
When mixed with a solution of the radioactive
substance Sodium Pertechnetate (Tc-99m), these
form a substance called Technetium (Tc-99m)
Sestamibi .
This medicine is for diagnostic use only.
When injected, Technetium (Tc-99m) sestamibi
temporarily collects in a particular organ of the body
(for example, the heart, the gall-bladder, the colon,
the kidneys). Because the substance contains a small
amount of radioactivity, it can be detected from
outside the body using special cameras and a picture,
known as a scan, can be taken. This scan will show
exactly where the radioactivity is within the organ and
the body. This can give the doctor valuable
information about the structure and function of that
organ.
Cardiolite is used:

to study blood flow, particularly in the heart•

to help to identify possible breast abnormalities
when used with a mammogram

to investigate over activity of the parathyroid
glands in the neck (these glands help control
the level of calcium in your body)

2. What you need to know before you are given
Cardiolite
You should not be given Cardiolite:

if you are allergic (hypersensitive) to Tetrakis (2methoxy isobutyl isonitrile) Copper (I)
Tetrafluoroborate, Stannous chloride dihydrate
and, L-Cysteine hydrochloride monohydrate or
any of the other ingredients. (see section 6)

If you are, or think you may be pregnant.
This product is not recommended for patients under
18 years of age.
Take Special Care with Cardiolite
Warnings and Precautions
If technetium (Tc-99m) sestamibi is being used to
study blood flow in your heart,

you should not eat for at least four hours prior to
the study.
Your doctor may ask you to have a light fatty meal or
drink a glass or two of milk after each injection, prior
to imaging.
After you have been given Cardiolite,

you may be asked to drink plenty of water and to
empty your bladder regularly to minimise
radiation exposure.
Important information about this product
The use of technetium (Tc-99m) sestamibi does
involve giving small amounts of radioactivity.
The risk this involves is very small and your doctor
will not consider carrying out the investigation unless
he believes that the risk is outweighed by the
potential benefit of the study.
If you have any doubt, do not hesitate to ask your
doctor.
Other medicines and Cardiolite
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
those obtained without a prescription
Pregnancy and Breast-Feeding
Please tell your doctor if you are, or think you may be
pregnant.
If you are pregnant, your doctor will only use this
product if he considers that the potential benefit
outweighs the risk to your baby.
Please tell your doctor if you are breast-feeding as he
may delay the investigation until breastfeeding
is completed or ask you to stop breast-feeding for at
least 24 hours until the radioactivity is no longer in
your body. Any milk expressed during that time
should be thrown away.

Driving and using machinery
Cardiolite does not affect your ability to drive or to
operate machinery.

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 radiologist.

3. How Cardiolite is used
Your doctor will prepare the radioactive Technetium
(Tc-99m) Sestamibi from the Cardiolite,following strict
laws covering the use, handling and disposal of
radioactivity.

5. How to Store Cardiolite
The product label includes the appropriate storage
conditions and the expiry date for the batch of
product. Hospital personnel will ensure that the
product is stored correctly and not administered to
you after the stated expiry date.

Your doctor will decide on the amount of radioactive
technetium (Tc-99m) sestamibi to be used. This will
be the minimum amount necessary to give a scan
clear enough to supply the requiredinformation.
Technetium (Tc-99m) sestamibi is given by injection
into a vein. Usually one to two injections is enough to
provide your doctor with the information needed. If
two injections are needed, they will be given at least
six hours apart and you will be asked to do an
exercise test before you are given one of the
injections.
Scans can be taken after 5 to 10 minutes and up to 6
hours after the injection. It is likely that several scans
in different positions may be needed.
If you are given more Cardiolite than you should
be
If you are accidentally given too much Cardiolite you
will be asked to drink plenty of water and go to the
toilet regularly to minimise radiation exposure.
4. Possible side effects
Like all medicines Cardiolite can cause side effects,
although not everybody gets them.
If you have any of the following symptoms you should
tell a doctor immediately:

Seizures (fits)

difficulty in catching your breath or

a fall in blood pressure after the injection.
More commonly you may experience:

a metallic or bitter taste,

transient headache,

flushing or a non-itching rash immediately after
injection of Technetium Tc-99m sestamibi.
A few other patients have reported:

irritation around the site of injection;

swelling in the limbs;

indigestion;

a feeling of sickness or vomiting;

an itching or related rash;

a dry mouth;

fever;

dizziness;

tiredness;
These side effects usually go away quickly without
any treatment.

6. Contents of the pack and other information
What Cardiolite contains
Each 5ml vial contains the following active
ingredients:
1 mg tetrakis (2-methoxy isobutyl isonitrile) copper (I)
tetrafluoroborate,
0.075 mg stannous chloride dihydrate and 1 mg Lcysteine hydrochloride-monohydrate.
The other ingredients are:
Sodium citrate dihydrate
Mannitol
What Cardiolite looks like and the contents of the
pack
Cardiolite Kit for Radiopharmaceutical Preparation is
a powder contained in a 5ml glass vial.When mixed
with a solution of the radioactive substance sodium
pertechnetate (Tc-99m),technetium (Tc-99m)
sestamibi injection is formed.
Cardiolite is available in cartons containing 2 or 5
vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Lantheus MI UK Limited
Festival House,
39 Oxford Street
Newbury, Berkshire, RG14 1JG
United Kingdom
Manufacturer responsible for batch release in the
EU
Penn Pharmaceutical Services Limited
Units 23/24 Tafarnaubach Industrial Estate
Tredegar Gwent, Wales UK NP22 3AA
7. Date of last revision of Package Leaflet
September 2011

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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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