Metastron 37mbq/Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER METASTRON 37 MBq/ml solution for injection
(called Metastron in this leaflet)
Strontium-89 chloride
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. See section 4.
What is in this leaflet:
1. What Metastron is and what it is used for
2. What you need to know before Metastron is used
3. How Metastron is used
4. Possible side effects
5. How Metastron is stored
6. Contents of the pack and other information
1. What Metastron is and what it is used for
Metastron is a 'radiopharmaceutical' medicine for therapy only.
• It contains an active ingredient called 'strontium chloride'.
• It can be used to lower pain in your bones, which may happen if you have prostate cancer.
• Prostate cancer affects the 'prostate gland'.
The gland is found only in men.
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Your doctor will tell you anything else you need to know about how Metastron works.
The use of Metastron does involve exposure to 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 Metastron is used
Metastron must not be used:
• If you are allergic (hypersensitive) to Metastron or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your nuclear medicine doctor before you are given Metastron if you:
• have kidney problems
Children and adolescents
This medicines is not for use in children.
Before administration of Metastron 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.
Other medicines and Metastron
Tell your nuclear medicine doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because some medicines can affect the way Metastron works.
Before your treatment tell your doctor or nurse if you are taking any of the types of medicine below. This is because they may affect the results of your treatment.
• Medicines used for calcium therapy, such as calcium carbonate.
If you are not sure if the above applies to you, talk to your doctor or nurse before having Metastron.
Driving and using machines
Ask your doctor if you can drive or use machines after you have been given Metastron.
Tests you may have with Metastron
You may have blood samples taken and your blood monitored.
3. How Metastron is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Metastron 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 Metastron to be used in your case. It will be the smallest quantity necessary to get the desired effect.
The quantity to be administered usually recommended for an adult is 150 MBq (megabecquerel, the unit used to express radioactivity).
Administration of Metastron and conduct of the procedure
Metastron is given as a single injection into your vein (intravenous injection).
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of Metastron, you should:
• Urinate frequently in order to eliminate the product from your body.
• Take the following actions for the first week after you have been given Metastron because it will be in your urine:
• If a 'normal' toilet is available you should always use that instead of a urinal.
• You should flush the toilet twice after using it.
• You should wipe up any spilled urine with a tissue and flush it away.
• You should always wash your hands after using the toilet.
• Immediately wash your bedding or clothes if they become soiled with urine. Wash them separately from other clothes and rinse thoroughly.
• If you use any urine collection device ask your doctor or nurse about any changes on how to use it.
• Clean up blood if you cut yourself after being given Metastron. You should wash away any spilled blood for the first week after being given Metastron because it will be in your blood.
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 questions.
If you have been given more Metastron than you should
An overdose is unlikely because you will only receive a single dose of Metastron precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of overdose, you will receive the appropriate treatment.
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Should you have any further questions on the use of Metastron, please ask the nuclear medicine doctor who supervises the procedure.
Like all medicines, Metastron can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Very common (may affect more than 1 in 10 people).
• increase in pain within the first few days after the injection
• tests may show blood (haematological) toxicity.
This can include a decrease in platelets and white blood cells. Signs of this would be bleeding or bruising more easily than usual.
Common (may affect up to 1 in 10 people)
• feeling hot, usually in the face and neck
Reporting of side effects
If you get any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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 regulations on radioactive materials.
The following information is intended for the specialist only.
Metastron is kept out of the sight and reach of children. Metastron must not be used after the expiry date and time, which are stated on the label after 'EXP'.
Store below 25°C. Do not refrigerate or freeze.
What Metastron contains
• The active ingredient is strontium-89 chloride.
Each ml of Metastron contains 37 MBq/ml (Megabecquerel - the unit in which radioactivity is measured) of strontium-89 chloride at a fixed time.
• The other ingredients are strontium chloride and water for injections.
What Metastron looks like and contents of the pack
Metastron is supplied as a single colourless glass vial containing a clear, colourless solution for injection.
Marketing Authorisation Holder
GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA United Kingdom
Manufacturer
GE Healthcare Limited The Grove Centre White Lion Road Amersham
Buckinghamshire HP7 9LL United Kingdom
UK: PL 00221/0127
Metastron is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.
GE Healthcare
PATIENT
INFORMATION
Metastron
37 MBq/ml solution for injection Strontium-89 chloride SMS2P
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P/5913/03