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TEKTROTYD 16 MICROGRAM KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): ETHYLENEDIAMINE DIACETIC ACID / HYNIC-(D-PHE(1) TYR(3)-OCTREOTIDE).TFA

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The method of patient preparation may be different, dependent on the
examination protocol applied and the localization of imaged lesions.
Your doctor will determine the preparation.
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.

Package leaflet: Information for the patient
TEKTROTYD 16 μg
Kit for radiopharmaceutical preparation
Active substances: HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt
EDDA (Ethylenediamine-N-N’-diacetic acid)

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.
If you have any further questions, ask your nuclear medicine doctor
who will supervise the procedure.
If you get any side effects, talk to your nuclear medicine doctor. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What is TEKTROTYD and what it is used for
2. What you need to know before TEKTROTYD is used
3. How TEKTROTYD is used
4. Possible side effects
5. How TEKTROTYD is stored
6. Contents of the pack and other information
1. What TEKTROTYD is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
It is used to make images of specific cells in the stomach, bowel and pancreas such as:
• abnormal tissue or
• tumours
The use of TEKTROTYD 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.
2. What you need to know before TEKTROTYD is used
TEKTROTYD must not be used
if you are allergic to HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt, to EDDA
(Ethylenediamine-N,N’-diacetic acid) or to any of the excipients of this
medicine (listed in section 6) or to sodium pertechnetate (99mTc) solution
for injection.
Warnings and precautions
Take special care with TEKTROTYD
• if you are pregnant or believe you may be pregnant
• if you are breast-feeding
• if you are diagnosed with kidney failure
If any of the above information applies to you, please tell your nuclear
medicine doctor.
Before administration of TEKTROTYD
In order to obtain the best image quality adequate patient preparation
before administration of radiopharmaceutical is required.
Unless your doctor tells you otherwise, a light diet is recommended two
days before the examination.
Your doctor may recommend the administration of laxatives on the day
preceding the examination.
On the day of the examination fasting should continue until the recording
of the first pictures is completed.

Other medicines and TEKTROTYD
A number of drugs 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 medicinal products 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.
Pregnancy and breast-feeding
You must inform the nuclear medicine doctor before the administration
of TEKTROTYD 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 nuclear medicine doctor
who will supervise the procedure.
If you are pregnant
The nuclear medicine doctor will only administer this product during
pregnancy if a benefit is expected which would outweigh the risks.
If you are breast-feeding
Please ask your nuclear medicine doctor when you can resume breastfeeding.
Driving and using machines
There are no studies on the effects of TEKTROTYD on the ability to drive
and use machines.
It is considered unlikely that TEKTROTYD will affect your ability to drive
or to use machines.
TEKTROTYD contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially ‘sodium-free’.
3. How TEKTROTYD is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. TEKTROTYD 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 TEKTROTYD to be used in your case. It will be the smallest quantity necessary to get the desired information.
The quantity to be administered usually recommended for an adult
ranges from 370 MBq to 740 MBq (megabecquerel, the unit used to
express radioactivity).
Administration of TEKTROTYD and conduct of the procedure
After radiolabelling the drug is administered as a single intravenous injection. This product is not intended for regular or continuous administration.
After injection you will be offered a drink and asked to urinate immediately preceding the test.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration
of the procedure.
After administration of TEKTROTYD, you should
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 further questions.

If you have been given more TEKTROTYD than you should
An overdose is unlikely, because you will only receive a single dose of
TEKTROTYD precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will
receive the appropriate treatment increasing the elimination of the radionuclide from the body, e.g. by administration of liquids and frequent
bladder voiding.
Should you have any further question on the use of TEKTROTYD,
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.
During the evaluation of side effects the following frequency data are
taken as a basis:
very common:
common:
uncommon:
rare:
very rare:
not known:

more than 1 patient out of 10
1 to 10 patient out of 100
1 to 10 patient out of 1000
1 to 10 patient out of 10000
Less than 1 patient out of 10000
frequency cannot be estimated from available data

Very rarely, immediately after administration of TEKTROTYD there may
be transient headache or epigastric pain.

Each vial contains a white or nearly white lyophilisate for preparation of
a solution for injection.
Pack size: 2 vials for shared application
Marketing Authorisation Holder
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden, Germany
Phone: +49 351 26 31 02 10
Fax:
+49 351 26 31 03 13
e-mail: service@rotop-pharmaka.de
Manufacturer
National Centre for Nuclear Research
Swierk
Andrzej Sołtan 7, 05-400 Otwock-´
Poland
Phone: +48 22 718 07 00
Fax:
+48 22 718 03 50
e-mail: polatom@polatom.pl
This leaflet was last revised in February 2016.

The following information is intended for medical or healthcare professionals only:

This radiopharmaceutical will deliver low amounts of ionizing radiation.
It is very rare that this is associated with risk of cancer and hereditary
abnormalities.

The complete SmPC of TEKTROTYD 16 μg Kit for radiopharmaceutical
preparation 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

Reporting of side effects

Please refer to the SmPC.

If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How TEKTROTYD 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.
TEKTROTYD must not be used after the expiry date which is stated on
the labels.
6. Contents of the pack and other information
What TEKTROTYD contains
Vials I and II contain components for the radiopharmaceutical preparation of technetium (99mTc) tektrotyd.
Vial I:
The active substance is HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt
The excipients are
stannous chloride dihydrate,
tricine (N [tris(hydroxymethyl)methyl]glycine),
mannitol,
nitrogen

The excipients are
disodium hydrogen phosphate dodecahydrate, sodium hydroxide, nitrogen
What TEKTROTYD looks like and contents of the pack
The package contains two different glass vials of 10 ml in a cardboard
box.

PL-Tektrotyd-UK-eng-01

Vial II:
The active substance is EDDA (ethylenediamine-N,N’-diacetic acid).

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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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