Package leaflet: Information for the patient

TEKTROTYD 16 Mg

Kit for radiopharmaceutical preparation Active substances: HYNIC-[D-Phe¹, Tyr’-octreotide] TFA salt EDDA (Ethylenediamine-N-N'-diacetic acid)

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.

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. 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: 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.

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

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 Andrzej Sottan 7, 05-400 Otwock-Swierk 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:

The complete SmPC of TEKTROTYD 16 pg 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

^Rep°rtm^{g 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 f^9mTc) 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

Vial II:

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