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PENTACIS 9.10MG KIT FOR THE PREPARATION OF TECHNETIUM (99MTC) PENTETATE INJECTION

Active substance(s): CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE / CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE / CALCIUM TRISODIUM DIETHYLENETRIAMINE PENTAACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PENTACIS 9.10 mg kit for the preparation of technetium
(99mTc) pentetate injection
Trisodium and calcium pentetate
Read all of this leaflet carefully before you will be
administered this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your referring doctor or
the specialist physician in Nuclear Medicine who will supervise
the procedure.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your referring doctor
or the specialist physician in Nuclear Medicine who has
supervisedthe procedure.
In this leaflet:
1. What Pentacis is and what it is used for
2. Before Pentacis is administered
3. How Pentacis will be used
4. Possible side effects
5. Further information

CIS bio international, member of IBA group
T0609pF
05/2012

1. WHAT PENTACIS IS AND WHAT IT IS USED FOR
Pentacis is a radiopharmaceutical product for diagnostic use
onlyi.e. a radioactive medicine used for diagnostic purposes.
Pentacis contains pentetate which is used in combination with a
radioactive solution of technetium (99mTc) in order to form a
solution of technetium (99mTc)-pentetate.
When injected into a vein of your arm, this product temporarily
collects in the kidneys or the brain. It collects in the lungs when
inhaled and in the stomach when ingested.
Because of its radioactivity, it can be detected outside the body
using a special camera, and pictures, known as scans, can be
taken. These scans will show exactly the distribution of the
radioactivity within the organ and the body. These scans give
valuable information about the structure and/or the functioning
of the concerned organ.
Pentacis is used for:
• the detection of abnormalities in your kidneys, your lungs or
your brain, and /or,
• the evaluation of the functioning of your kidneys, brain or
stomach.
Your doctor/Nuclear Medicine specialist will explain to you what
kind of examination will be performed.

2. BEFORE PENTACIS IS ADMINISTERED
Pentacis must never be used
• If you are allergic (hypersensitive) to trisodium and calcium
pentetate or any of the other ingredients of this medicine or to
any of the components of the labelled radiopharmaceutical.
These ingredients are listed in section 5.

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Take special care with Pentacis
Inform the specialist in Nuclear Medicine in the following
cases:
• If you have problems with your kidney function, you could
have difficulties in eliminating the product from you body. In this
case, the dose you should receive may need to be adjusted.
• If you are pregnant or believe you may be pregnant (see
section “Pregnancy and breast-feeding”).
• If you are breast–feeding (see section “Pregnancy and breastfeeding”).
• If you are under 18 years old
Taking other medicines
Please tell your doctor or the specialist physician in Nuclear
Medicine who will supervise the procedure if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.
Please tell your physician if you are taking, or have
administered, any of the following medicines/substances, since
they may interfere with your physician interpretation of the
images.:
• Captopril (medicine used to treat high blood pressure
conditions)
• Furosemide (diuretics or “water pills”)
• Mood altering medicines.
Pregnancy and breast-feeding
You must inform the specialist physician in nuclear medicine
before the administration of Pentacis if there is a possibility you
might be pregnant, if you have missed your period or if you
are breast-feeding.
When in doubt, it is important to consult your physician or the
specialist physician in Nuclear Medicine who will supervise the
procedure.

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If you are pregnant, your physician will only consider this
examination during your pregnancy in case of absolute necessity,
because it is recommended to avoid an examination using
technetium (99mTc) during pregnancy. This might involve a risk to
the foetus.
If you are breast-feeding
Resuming breast-feeding should be in agreement with the
specialist in Nuclear Medicine who will perform the
investigation. Usually, it can be resumed 12 hours after the
injection.
Please ask your doctor or the specialist physician in Nuclear
Medicine who will supervise the procedure before taking any
medicines.
Before Pentacis administration you should:
- drink plenty of water and to be well hydrated before the start of
the examination in order to urinate as often as possible during
the first hours after the study.
After administration of Pentacis has been performed, you
should:
- Urinate frequently in order to eliminate the product from your
body
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Pentacis will only be used in a
hospital. 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.
Driving and using machines
It is considered unlikely that Pentacis will affect your ability to drive
or to operate machinery.

4

Important information about some of the ingredients of
Pentacis
Pentacis contains 2.2 mg of sodium per vial.
Depending on the volume injected, the limit of 1 mmol (23 mg) of
sodium per dose administered may be exceeded. This must be
taken into account if you are on a low-salt diet. The Nuclear
Medicine specialist who is going to perform the examination will
be able to tell you the exact quantity of sodium injected.
3. HOW PENTACIS WILL BE USED?
The specialist physician in Nuclear Medicine supervising the
procedure will decide on the quantity of Pentacis to be used in
your case. It will be the minimal quantity necessary to get the
desired information.
The quantity to be administered usually recommended for an adult
ranges from 1.8 to 1800 MBq (MBq: Megabecquerel - the unit in
which radioactivity is measured), depending on the type of
examination and on the route of administration.
Use in children
In case of paediatric population, the quantity to be administered
will be adapted to the child’s body mass.
Administration of Pentacis and conduct of the procedure
Technetium (99mTc) pentetate is either administered by injection
into a vein of your arm, or by inhalation using a nebulizer. It can
also be swallowed as a liquid.
A single administration is sufficient to provide your physician with
the information needed.

5

Duration of the procedure
Your physician will inform you about the usual duration of the
procedure.The scans can be taken at any time from the beginning
of the administration, depending on the type of study which is to
be performed.
To study the functioning of your kidneys, a second set of scans
can be taken after you have been administered a medicine
(furosemide by injection or captopril orally) to help in diagnosis.
If you have been administered more Pentacis than you
should
An overdose is almost impossible because you will only receive a
single dose of Pentacis precisely controlled by the specialist
physician supervising the procedure. In particular, the specialist
physician supervising the procedure may recommend that you
drink abundantly in order to facilitate the elimination of Pentacis
from your body.
Should you have any further questionon the use of Pentacis,
please ask your doctor or the specialist in Nuclear Medicine
who supervises the procedure.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pentacis may cause side effects, although not
everybody gets them.
Very rare cases of allergic type reactions have been reported. The
following effects have been described :







redness of skin (flushing),
dizziness,
difficulty in breathing (dyspnoea),
itching,
hives (urticaria),
low blood pressure (hypotension).

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Any of the above could be sign of allergy (anaphylactic reaction).
Contact a doctor immediately.
Your doctor has considered that the clinical benefit that you will
obtain from the procedure with the radiopharmaceutical
overcomes the risk due to radiation.
If you notice any of the side effects, or if you notice any side
effects not listed in this leaflet, please tell your doctor or the
specialist physician in Nuclear Medicine who supervised the
procedure.

5.

FURTHER INFORMATION

What Pentacis contains
• The active substance is calcium trisodium pentetate.
Each vial contains 9.10 mg of pentetate.
• The other ingredients are stannous chloride dihydrate under
nitrogen atmosphere.

What Pentacis looks like and contents of the pack
You will not have to get this medicine or handle the packaging or
the vial. The following data is for your information only.
Pentacis is a soluble powder for injection which should be
dissolved and labeled with radioactive technetium (99mTc) before
use. When this powder is mixed with a solution of pertechnetate
(99mTc) of sodium, a solution of technetium (99mTc)-pentetate is
formed.
This solution is ready to be injected intravenously.
Packsize : kit of 5 multidose vials.
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Marketing Authorisation Holder and Manufacturer
CIS bio international
B.P. 32
91192 Gif-sur-Yvette Cedex
FRANCE
This leaflet was last approved in 02/2012.

The following information is intended for medical or healthcare
professionals only:
The complete Summary of Product Characteristics (SmPC) of
Pentacis is provided as a separate document 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 (SmPC should be included in the box).

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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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