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CARDIOVIS 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): TETRAKIS COPPER TETRAFLUOROBORATE / TETRAKIS COPPER TETRAFLUOROBORATE / TETRAKIS COPPER TETRAFLUOROBORATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Cardiovis 1 mg
Kit for radiopharmaceutical preparation
[Tetrakis (1-isocyanide-2-methoxy-2-methylpropyl)
copper(I)]tetrafluoroborate

if you have a kidney or liver disease.

You should inform your nuclear medicine doctor in case those
apply to you. You nuclear medicine doctor will inform you if you
need to take any special precautions after using this medicine.
Talk to your nuclear medicine doctor if you have any questions.
Before administration of Cardiovis you should

Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

-

be fasting for at least 4 hours if the product is going to be
used to perform images of your heart,

-

drink plenty of water before the start of the examination in
order to urinate as often as possible during the first hours
after the study.

If you have any further questions, ask your nuclear medicine
doctor who will supervise the procedure.

Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.

If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet. See
section 4.

Other medicines and Cardiovis

What is in this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Cardiovis is and what it is used for
What you need to know before Cardiovis is used.
How Cardiovis is used.
Possible side effects
How Cardiovis is stored.
Contents of the pack and other information
What Cardiovis is and what it is used for

This medicine is a radiopharmaceutical product for diagnostic use
only.
Cardiovis contains a substance called [tetrakis(1-isocyanide-2methoxy-2-methylpropyl) copper(I)] tetrafluoroborate which is used
to study the heart function and blood flow (myocardial perfusion)
by making an image of the heart (scintigraphy), for example in the
detection of heart attacks (myocardial infarctions) or when a
disease causes reduced blood supply to (a part of) the heart
muscle (ischaemia). Cardiovis is also used in the diagnosis of
breast abnormalities in addition to other diagnostic methods when
the results are unclear. Cardiovis can also be used to find the
position of overactive parathyroid glands (glands that secrete the
hormone that controls blood calcium levels).
After Cardiovis 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. You nuclear medicine doctor will
then take an image (scintigraphy) of the concerned organ which
can give your doctor valuable information about the structure and
the function of this organ or the location of e.g., a tumour.

A number of medicines, foods and beverages can adversely affect
the outcome of the planned investigation. It is therefore
recommended to discuss with the referring physician, which intake
should be discontinued before the investigation and when the
medicines should be taken again. Tell also your nuclear medicine
doctor if you are taking, have recently taken or might take any
other medicines, since they may interfere with the interpretation of
the images.
Especially tell your nuclear medicine doctor if you are taking
medicines which affect heart function and/or blood flow.
Please ask your nuclear medicine doctor before taking any
medicines
Pregnancy and breastfeeding
You must inform the nuclear medicine doctor before the
administration of Cardiovis if there is possibility you may be
pregnant, if you have missed your period or if you are breastfeeding. When in doubt, it is important to consult your nuclear
medicine doctor who will supervise the procedure.
If you are pregnant:
Your nuclear medicine doctor will only administer this medicine
during pregnancy if a benefit is expected which would outweigh
the risks.
If you are breastfeeding:
Please tell your nuclear medicine doctor, as he/she will advise you
to stop doing so until the radioactivity has left your body. This
takes about 24 hours. The expressed milk should be discarded.
Please ask your nuclear medicine doctor when you can resume
breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or
are planning to have a baby, ask your nuclear medicine doctor for
advice before taking this medicine.

The use of Cardiovis 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.

Driving and using machines

2.

Cardiovis contains sodium

What you need to know before Cardiovis is used

Cardiovis must not be used
-

if you are allergic to tetrakis (1 isocyanide-2-methoxy-2methylpropyl) copper(I)] tetrafluoroborate or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions
Take special care with Cardiovis
-

if you are pregnant or believe you may be pregnant

-

if you are breastfeeding

It is considered unlikely that Cardiovis will affect your ability to
drive or to use machines.

This medicinal product contains less than 1 mmol sodium (23 mg)
per vial, i.e. essentially ‘sodium-free’.
3.

How Cardiovis is used

There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Cardiovis will only be used in
special controlled areas. This product will only be handled and
given to you by people who are trained and qualified to use it
safely. These persons will take special care for the safe use of this
product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide
on the quantity of Cardiovis to be used in your case. It will be the
smallest quantity necessary to get the desired information.
The quantity usually recommended to be administered for an adult
ranges depending on the test to be performed, and ranges
between 200 and 2000 MBq (Megabecquerel, the unit used to
express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be
adapted to the child’s weight.
Administration of Cardiovis and conduct of the procedure
Cardiovis is administered in a vein of the arm or the foot
(intravenous administration).
One to two injections is sufficient to conduct the test that your
doctor needs.
After injection, you will be offered a drink and asked to urinate
immediately preceding the test.
The nuclear medicine doctor will inform you if you need to take
any special precautions after receiving this medicine. Contact your
nuclear medicine doctor if you have any questions.
The ready-to-use solution will be injected to you in a vein before
the scintigraphy is taken. The scanning may take place within 5 to
10 minutes or up to 6 hours after injection, depending on the test
.
In the case of a heart investigation, two injections may be
necessary, one at rest and one at stress (e.g., during a physical
exercise or pharmacological stress). The two injections will be
done at least two hours apart and not more than 2000 MBq in total
(1 day protocol) will be administered. A two day protocol is
feasible, also.
For the scintigraphy of breast abnormalities an injection of 750 to
1100 MBq is administered into a vein of your arm opposite to the
breast concerned, or into a vein of your foot.
To find the position of overactive parathyroid glands, the activity
administered is between 185 and 1100 MBq, depending on the
methods used.
If the medicine is going to be used to perform images of your
heart, then you will be asked not to eat anything for at least 4
hours before the test. After the injection, but before the image
(scintigraphy) is made, you will be asked to eat a light fatty meal, if
possible, or to drink one or two glasses of milk in order to
decrease the radioactivity in your liver and to improve the image.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual
duration of the procedure.
After administartion of Cardiovis has been performed, you
should:
avoid any close contact with young children and pregnant
women for the 24 hours following the injection,
urinate frequently in order to eliminate the product from
your body.
The nuclear medicine doctor will inform you if you need to take
any special precautions after receiving this medicine. Contact your
nuclear medicine doctor if you have any questions.

Should you have any further questions on the use of this medicine,
please, ask the nuclear medicine doctor who supervises the
procedure.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Allergic reactions possibly with shortness of breath, extreme
tiredness, being sick (usually within 2 hours after administration),
swelling beneath the skin that can occur in areas such as the face
and limbs (angioedema), and obstruct the airway, or leading to a
dangerous decrease of blood pressure (hypotension) and slow
heart beat (bradycardia) have been seen rarely. Doctors are
aware of this possibility and have emergency treatment available
for use in such cases. Local skin reactions have also been seen
rarely with itching, hives, rash, swelling and redness. If you
experience any of those, please refer immediately to your nuclear
medicine doctor.
Other possible side effects are listed in the order of their frequency
below:
Frequency

Possible side effects

common: may affect up to 1 in Metallic or bitter taste, smell alteration,
and dry mouth immediately after
10 people
injection

uncommon: may affect up to 1 Headache, chest pain, abnormal
in 100 people
ECG and feeling sick.
rare: may affect up to 1 in 1,000 abnormal heart rhythm, local
people
reactions at the injection site,
stomach ache, fever, fainting,
seizures, dizziness, flushing, skin
numbness or tingling, tiredness,
joint pains and stomach upset
(dyspepsia).
multiforme,
not known: frequency cannot be Erythema
widespread rash of
estimated from the available a
skin and mucosa.
data
This radiopharmaceutical will deliver low amounts of ionising
radiation associated with the least risk of cancer and hereditary
abnormalities.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5.

How Cardiovis is stored

You will not have to store this medicine. This medicine is stored
under the responsibility of the specialist in appropriate premises.
Storage of radiopharmaceuticals will be in accordance with
national regulation on radioactive materials.
The following information is intended for the specialist only.

If you have been given more Cardiovis than you should
An overdose is almost impossible, because you will only receive a
dose of Cardiovis precisely controlled by the nuclear medicine
doctor supervising the procedure. However in the case of an
overdose, you will receive the appropriate treatment. In particular,
the nuclear medicine doctor in charge of the procedure may
recommend that you drink abundantly in order to facilitate the
elimination of product from your body.

This medicine must not be used after the expiry date which is
stated on the label. The expiry date refers to the last day of that
month.
6.

Content of the pack and other information

What Cardiovis contains
The active substance is: [tetrakis (1-isocyanide-2-methoxy-2methylpropyl) copper(I)] tetrafluoroborate
One vial contains 1.0 mg [tetrakis (1-isocyanide2-methoxy-2methylpropyl) copper(I)] tetrafluoroborate.

The other ingredients are:
Stannous chloride dihydrate
L-cysteine hydrochloride monohydrate
Sodium citrate dihydrate
D-mannitol
What Cardiovis looks like and contents of the pack
The product is a kit for radiopharmaceutical preparation.
Cardiovis consist of white, lyophilised powder which has to be
dissolvedin a solution and combined with radioactive technetium
before use as an injection. Once the radioactive substance sodium
99m
99m
pertechnetate ( Tc) is added to the vial, technetium ( Tc)
sestamibi is formed. This solution is ready for injection.
Pack size
10 ml glass vials sealed with a chlorobutyl rubber stopper and
aluminium cap.
Vials are packed in cardboard boxes.
Pack size: 3 or 6 vials.
Marketing Authorisation Holder
National Centre for Nuclear Research
Andrzej Sołtan 7,
05-400 Otwock
Poland
Tel. +48 22 718 07 00
Fax: +48 22 718 03 50
e-mail: polatom@polatom.pl

Manufacturers
National Centre for Nuclear Research
Andrzej Sołtan 7,
05-400 Otwock
Poland
ROTOP Pharmaka GmbH
Bautzner Landstraße 400
01328 Dresden
Germany
This leaflet was last revised in:

The following information is intended for healthcare professionals
only:
The complete SmPC of Cardiovis is provided as a tear-off
sectionat the end of the printed leaflet in the product package, with
the objective to provide healthcare professionals with other
additional scientific and practical information about the
administration and use of this radiopharmaceutical.
Please refer to the SmPC
PL-Mibi-UK-eng-05

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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