TAUVID 800 MBq/mL Roztwór do wstrzykiwań

Treść ulotki

1. Tauvid 800 MBq/mL injectable solution, 1 900 MBq/mL injectable solution
   1. What is Tauvid and what is it used for
   2. What you need to know before Tauyvid is used
   3. How Tauvid is used
   4. Possible side effects
   5. How Tauvid is stored
   6. Package contents and other information

Tauvid 800 MBq/mL injectable solution, 1 900 MBq/mL injectable solution

flortaucipir (F)

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before this medicine is administered to you, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the specialist doctor in nuclear medicine responsible for performing the examination.
• If any side effects occur, including those not listed in this leaflet, tell the specialist doctor in nuclear medicine. See section 4.

Contents of this leaflet:

• 1. What Tauvid is and what it is used for
• 2. What you need to know before Tauvid is used
• 3. How Tauvid is used
• 4. Possible side effects
• 5. How to store Tauvid
• 6. Contents of the pack and other information

1. What is Tauvid and what is it used for

This medicine is a radiopharmaceutical (radioactive medicinal product) for diagnostic use only. Tauvid
contains the active substance flortaucipir ( F).
Tauvid is administered to adults with memory problems who are being evaluated for Alzheimer's disease so that doctors can perform a type of brain scan called PET
(positron emission tomography). A PET scan, together with other tests of brain function, can help the doctor find the cause of memory problems. Tauvid can help the
doctor determine whether or not you may have abnormal forms of tau protein in your brain. Abnormal forms of tau protein are present in the brains of people with Alzheimer's disease.
The use of Tauvid involves exposure to radioactivity. Your doctor and the specialist in nuclear medicine have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs
the risk due to radiation (see section 3).

2. What you need to know before Tauyvid is used

Tauvid must not be used

• if you are allergic to flortaucipir (F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor or nurse before you are given Tauvid

• if you have liver or kidney problems, as this may increase exposure to radiation
• if you are pregnant or think you might be
• if you are breastfeeding (see section 2, “Pregnancy, breastfeeding and fertility”).

Before Tauvid is administered, you must
Drink plenty of water before the start of the scan to urinate as often as possible during the first few hours
after the PET scan.

Children and adolescents
There is no indication for specific use of Tauvid in children and adolescents as
it is intended for use in adults with memory problems who are being evaluated for
Alzheimer's disease.

Other medicines and Tauvid
Tell the nuclear medicine specialist if you are taking, have recently taken or
might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a
pregnancy, ask your nuclear medicine specialist for advice before you are
given this medicine.
You must tell your nuclear medicine specialist before Tauvid is administered if
there is a possibility that you may be pregnant, if you have missed a menstrual period or if you are
breastfeeding. If in doubt, it is important to consult the nuclear medicine specialist in charge
of performing the scan.
If you are pregnant
Any radiopharmaceutical, including Tauvid, can have harmful effects on the unborn baby. The use of Tauvid is not
recommended in pregnant women. Your nuclear medicine specialist will only administer
this product during pregnancy if the expected benefit is greater than the risks.
If you are breastfeeding
The use of Tauvid is contraindicated during breastfeeding. You must stop breastfeeding for 24 hours
after the injection and discard any breast milk produced. Ask your nuclear medicine
specialist when you can resume breastfeeding (see section 3 “After
Tauvid is administered, you must”).

Driving and using machines
It is unlikely that Tauvid will affect your ability to drive or operate machinery.

Tauvid 800 MBq/mL and 1 900 MBq/mL contains ethanol
This medicine contains 790 mg of alcohol (ethanol) in each dose, which is equivalent to less than 20 mL
of beer or 8 mL of wine. The small amount of alcohol in this medicine will not have any significant effects.

Tauvid contains sodium
Tauvid 800 MBq/mL solution for injection contains up to 32 mg of sodium (the main component of
table salt) per dose. This corresponds to 1.6% of the maximum recommended daily intake
of sodium with the diet of an adult.
Tauvid 1 900 MBq/mL solution for injection contains up to 34 mg of sodium (the main component
of table salt) per dose. This corresponds to 1.7% of the maximum recommended daily
intake of sodium with the diet of an adult.

3. How Tauvid is used

There are strict rules on the use, handling and disposal of radiopharmaceuticals. Tauvid will be used
only in specially controlled areas. This medicine will be handled and administered only by qualified
and trained personnel to use it safely. Qualified personnel will pay particular attention to the safe use
of this radiopharmaceutical and will inform you about how they will perform the examination.
The specialist doctor in nuclear medicine supervising the examination will decide the amount of Tauvid to
use in your case. This will be the minimum amount necessary to obtain the desired information
from the PET scan. The recommended amount for an adult is normally 370 MBq. The
Megabecquerel (MBq) is the unit of measurement used to express radioactivity.

Administration of Tauvid and performance of the examination
Drink plenty of water before the start of the examination to urinate as often as possible during the first few
hours after the PET scan. Tauvid is administered via an intravenous injection followed by another intravenous
injection with a sodium chloride solution to ensure you receive the complete dose of Tauvid.
A single injection of flortaucipir (F) is sufficient to perform the brain scan.

Duration of the examination
The specialist doctor in nuclear medicine will inform you about how long the examination usually lasts. A
brain scan lasts 20 minutes and is normally performed approximately 80-100 minutes after the
injection of Tauvid.

After the administration of Tauvid, you must:

• Avoid close contact with infants, small children, children and pregnant women for 4 hours after the injection.

The specialist doctor in nuclear medicine will recommend that you urinate as often as possible during the
first few hours after the examination to reduce radiation exposure. Contact the specialist doctor in nuclear
medicine if you have any questions.

If you have been given too much Tauvid
An overdose is unlikely because you will only receive a single dose of Tauvid, carefully controlled by
the specialist doctor in nuclear medicine supervising the examination. However, in case of
overdose, you will receive appropriate treatment.
If you have any doubts about the use of Tauvid, contact the specialist doctor in nuclear medicine who
supervises the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not common (may affect up to 1 in 100 people):

• headache
• dysgeusia (altered sense of taste)
• pain at the injection site
• increased blood pressure

This radiopharmaceutical will release small amounts of ionising radiation associated with the minimal risk
of cancer and hereditary abnormalities (see paragraph 1 “What Tauvid is and what it is used for”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your nuclear medicine
specialist. You can also report side effects directly through the national reporting system detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How Tauvid is stored

You must not store this medicine. This medicine is stored under the responsibility
of the specialist in appropriate locations. The storage of radiopharmaceuticals will occur in accordance with
national regulations regarding radioactive products.
The following information is only for the specialist.
Tauvid must not be used after the expiry date which is reported on the label of the shielded container
and the vial after EXP.
Tauvid must not be administered if particles are present or if the color is altered.
This medicine does not require any particular storage temperature.

6. Package contents and other information

What Tauvid contains

• The active ingredient is flortaucipir ( F). Tauvid 800 MBq/mL solution for injection: 1 mL of solution for injection contains 800 MBq of flortaucipir ( F) at the date and time of calibration. Tauvid 1 900 MBq/mL solution for injection: 1 mL of solution for injection contains 1 900 MBq of flortaucipir ( F) at the date and time of calibration.
• The other ingredients are Tauvid 800 MBq/mL solution for injection: anhydrous ethanol, sodium chloride, water for injections (see section 2 “Tauvid contains ethanol and sodium”). Tauvid 1 900 MBq/mL solution for injection: anhydrous ethanol, disodium phosphate (to adjust the pH), dilute hydrochloric acid, sodium chloride, water for injections (see section 2 “Tauvid contains ethanol and sodium”).

Description of the appearance of Tauvid and contents of the pack
Tauvid is a clear, colorless solution for injection. It is supplied in a transparent glass vial of
15 mL.
Tauvid 800 MBq/mL solution for injection (injection): A multi-dose vial with a capacity of
15 mL containing from 1 to 15 mL of solution, corresponding to 800-12 000 MBq at the date and time of
calibration.
Tauvid 1 900 MBq/mL solution for injection (injection): A multi-dose vial with a capacity of
15 mL containing from 1 to 15 mL of solution, corresponding to 1 900-28 500 MBq at the date and time of
calibration.

Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands

Manufacturer
Curium Pet France
14 Rue De La Grange Aux Belles
75010 Paris,
France
Life Radiopharma Berlin GmbH
Max-Planck-Straße 4
12489 Berlin
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/
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The following information is intended exclusively for healthcare professionals:
The full Summary of Product Characteristics (SmPC) of Tauvid is provided as a separate
document within the medicinal product packaging in order to provide healthcare professionals
with further scientific and practical information on the administration and use of this radiopharmaceutical.
See the Summary of Product Characteristics [the SmPC must be included in the packaging].