Patient leaflet - Tetrofosmin Rotop 0.23 mg kit for Radiopharmaceutical Preparation
1. What Tetrofosmin ROTOP is and what it is used for
This medicine is for diagnostic use only. It is used to help to identify illness.
Tetrofosmin ROTOP is a ‘radio-pharmaceutical’ medicine. It is given before a scan and helps a special camera to see inside a part of your body.
- It contains an active ingredient called ‘tetrofosmin’. This is mixed with a r adioactive ingredient called ‘technetium-99m’ before it is used.
- Once injected it can be seen from outside your body by a special camera used in the scan.
- The scan can help your nuclear medicine doctor to see how well the heart is working, or to see damage to the heart after a heart attack.
- This medicine can also be given before a scan to look at lumps in the breast.
Your nuclear medicine doctor will explain which part of your body will be scanned.
The use of Tetrofosmin ROTOP does i nvolve exposure t o s mall 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 Tetrofosmin ROTOP is used
Tetrofosmin ROTOP must not be used:
- if you are allergic (hypersensitive) to the active ingredient or any other ingredient (listed in section 6).
- if you are pregnant or think you might be pregnant.
If any of the above applies to you or if you are not sure talk to your doctor.
Warnings and precautions
Talk t o y our nu clear m edicine do ctor be fore u sing Tetrofosmin ROTOP
- if the pe rson w ho w ill be gi ven t his m edicine i s a c hild or adolescent.
- if you are breastfeeding.
Before administration of Tetrofosmin ROTOP you should:
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.
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Tetrofosmin ROTOP
Please t ell y our nuclear m edicine doctor, w ho will s upervise t he procedure, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may interfere with the interpretation of the images. This includes herbal medicines.
If you are having a heart, scan tell your nuclear medicine doctor if you are taking any of the types of medicine below. This is because they may affect the results of your scan:
- Beta blockers such as atenolol, bisoprolol or propranolol, e.g. for high bl ood pr essure, c oronary ar tery d isease, heart r hythm disorder or heart failure
- Calcium c hannel bl ockers s uch as ni fedipine, di ltiazem or felodipine, e.g. for high blood pressure, coronary artery disease, heart rhythm disorder or heart failure
- Nitrates s uch as g lyceryl t rinitrate, i sosorbide mononitrate or isosorbide dinitrate, e.g. for high blood pressure, coronary artery disease, heart rhythm disorder or heart failure
- Any medicines for your blood pressure, your heart or heart failure
If you are not sure if any of the above applies to you, talk to your nuclear medicine doctor before using Tetrofosmin ROTOP.
Tetrofosmin ROTOP with food and drink
If you are having
- a heart scan: You may be asked not to eat the night before. Or you may be asked to have only a light breakfast on the morning of the scan.
- a breast scan: You can eat and drink liquids normally.
Pregnancy and breast-feeding
You should not be given Tetrofosmin ROTOP if you are pregnant or think you may be pregnant. This is because it may affect the baby.
Do not br east-feed i f y ou ar e gi ven Tetrofosmin ROTOP. Th is i s because small amounts of ‘radioactivity’ may pass into the mother’s milk. If you are breast-feeding, your nuclear medicine doctor may wait until you have finished breast-feeding before using Tetrofosmin ROTOP. If it is not possible to wait, your nuclear medicine doctor will ask you to:
- stop breast-feeding for 12 hours or longer, and
- use formula feed for your child, and
- express (remove) breast milk and throw away the milk.
Your nuclear medicine doctor will let you know when you can start breast-feeding again.
Driving and using machines
It is considered unlikely that Tetrofosmin ROTOP will affect your ability to drive or to use machines. Ask your nuclear medicine doctor if you can drive or use machines after you have been given Tetrofosmin ROTOP.
Tetrofosmin ROTOP contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
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3. How Tetrofosmin ROTOP is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Tetrofosmin ROTOP 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 Tetrofosmin ROTOP 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 f rom 250 to 800 MBq ( megabecquerel, t he u nit used t o express radioactivity).
Administration of Tetrofosmin ROTOP and conduct of the procedure
Tetrofosmin ROTOP is administered intravenously.
For a heart scan the usual dose is:
- one injection after you have rested.
- a second injection (after at least one hour), when your heart is working harder than normal. Such as during or just after exercise.
The order of the two injections may be the opposite way round for some patients. Other people only need one injection. In some cases your nuclear medicine doctor may decide that it is best to give the two injections on separate days.
For a breast scan the usual dose is:
- one single injection.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of Tetrofosmin ROTOP, 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 the nuclear medicine doctor if you have any questions.
If you have been given more Tetrofosmin ROTOP than you should
An overdose is unlikely, because you will only receive a single dose of Tetrofosmin ROTOP precisely controlled by the nuclear medicine doctor s upervising t he pr ocedure. H owever, i n t he c ase of a n overdose, you will receive the appropriate treatment.
4. Possible side effects
Like a ll m edicines, Tetrofosmin ROTOP can c ause s ide ef fects, although not everybody gets them. They are very rare (affecting less than 1 in 10,000 people).
Allergic reactions
If you have an al lergic reaction when you are in hospital or a c linic having the scan, tell the nuclear medicine doctor straight away. The signs may include:
- skin rash or itching or flushing
- swelling of the face
- difficulty in breathing
In more serious cases reactions may include:
- passing out (unconsciousness), feeling dizzy or lightheaded
If any of the side effects above happen after you leave the hospital or clinic, go straight to the casualty department of your nearest hospital.
Adverse Reactions
an uncomfortable feeling of warmth beginning where the injection was given
- headache
- feeling sick (nausea) or being sick (vomiting)
- changes in taste, such as a metallic taste
- changes in smell
- a warm feeling in the mouth
- increase in the number of white blood cells (seen when you have some types of blood tests)
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 the national reporting system
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How Tetrofosmin ROTOP 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 the national regulations for radioactive materials.
This f ollowing i nformation is i ntended f or he althcare or m edical professionals only.
Tetrofosmin ROTOP must not be used after the expiry date which is stated on the label.
6. Contents of the pack and other information
What Tetrofosmin ROTOP contains:
- The active ingredient is tetrofosmin. Vial 1 of Tetrofosmin ROTOP contains 0.23 mg of tetrofosmin as tetrofosmin (bis)tetrafluo-roborate.
- The other ingredients are stannous chloride dihydrate, disodium sulphosalicylate trihydrate, sodium gluconate, mannitol.
- Vial 2 contains sodium hydrogen carbonate and water for injection as solution.
What Tetrofosmin ROTOP looks like and contents of the pack
Tetrofosmin ROTOP kit consists of tw o d ifferent 1 0 ml g lass v ials which cannot be used separately. Vial 1 contains Tetrofosmin ROTOP powder and Vial 2 contains Tetrofosmin ROTOP solution.
Pack size: 2 Kits (Vial 1 and Vial 2)
5 Kits (Vial 1 and Vial 2)
Marketing Authorisation Holder and Manufacturer
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
This leaflet was last approved in June 2019.