Osteocis
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* Molecular
Package leaflet: Information for the patient
OSTEOCIS 3 mg kit for radiopharmaceutical preparation sodium oxidronate
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.
1. What Osteocis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Osteocis contains sodium oxidronate which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium (99mTc)-oxidronate.
When injected into a vein of your arm, this product temporarily collects in your bones. Because of its radioactivity it can be detected outside the body using a special camera, and pictures, known as scans, can be taken. These scans give valuable information about the structure of your bones.
Osteocis is used to determine if there is any bone abnormality.
The use of Osteocis 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.
What is in this leaflet:
1. What Osteocis is and what it is used for
2. What you need to know before Osteocis is used
3. How Osteocis is used
4. Possible side effects
5. How Osteocis is stored
6. Contents of the pack and other information
2. What you need to know before Osteocis is used
Osteocis must not be used
• If you are allergic to sodium oxidronate (diphophonates) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with Osteocis
• If you are pregnant or believe you may be pregnant (see section “Pregnancy and breast-feeding”).
• If you are breast-feeding (see section “Pregnancy and breastfeeding”).
• If you are under 18 years of age, because damage in growing bones may be observed after radiation exposure.
Please talk to your nuclear medicine doctor if any of the above apply
to you. Osteocis may not be suitable for you. Your nuclear medicine
doctor will advise you.
CIS bio international. Member of IBA Molecular group ol companies
T2009pF 2
11/2013
Before administration of Osteocis 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 Osteocis
Tell your nuclear medicine doctor 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. Particular examples are:
• Chelates (used to treat metal poisoning),
• Diphosphonates (used to treat bones disease ),
• Tetracycline antibiotics (used to treat cancer),
• Medicines containing iron (used to treat anaemia ),
• Medicines containing aluminium salts (used to treat gastric problems).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
You must inform the nuclear medicine doctor before the administration of Osteocis 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
It is recommended to avoid an examination using technetium (99mTc) during pregnancy because it may involve a risk to the foetus.
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
Tell your nuclear medicine doctor if you are breast-feeding as he/she may delay the examination until breast-feeding is completed or ask you to stop breast-feeding for a short while until the radioactivity is no longer in your body. Milk should be banked prior to injection and the subsequent breastfeeding discarded after injection.
Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually breast feeding can be resumed 4 hours after injection.
Driving and using machines
It is considered unlikely that Osteocis will affect your ability to drive or to use machines.
Osteocis contains 6.3 mg of sodium per vial. Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per dose administered may be exceeded. This should be taken into account if you are on low a low-salt diet.
3. How Osteocis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Osteocis 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 Osteocis 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 300 MBq to 700 MBq (megabecquerel, the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to the child’s weight.
Administration of Osteocis and conduct of the procedure Osteocis is injected into a vein of your arm.
One injection is sufficient to provide your doctor with the information needed. Before the scan you will be told to urinate. This will increase the quality of the scan.
(t>CL
' Moleculai
Package leaflet: Information for the patient
OSTEOCIS 3 mg kit for radiopharmaceutical preparation sodium oxidronate
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 Osteocis is and what it is used for
2. What you need to know before Osteocis is used
3. How Osteocis is used
4. Possible side effects
5. How Osteocis is stored
6. Contents of the pack and other information
1. What Osteocis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Osteocis contains sodium oxidronate which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium ("mTc)-oxidronate.
When injected into a vein of your arm, this product temporarily collects in your bones. Because of its radioactivity it can be detected outside the body using a special camera, and pictures, known as scans, can be taken. These scans give valuable information about the structure of your bones.
Osteocis is used to determine if there is any bone abnormality.
The use of Osteocis 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 Osteocis is used
Osteocis must not be used
• If you are allergic to sodium oxidronate (diphophonates) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Take special care with Osteocis
• If you are pregnant or believe you may be pregnant (see section "Pregnancy and breast-feeding”).
• If you are breast-feeding (see section “Pregnancy and breastfeeding”).
• If you are under 18 years of age, because damage in growing bones may be observed after radiation exposure.
Please talk to your nuclear medicine doctor if any of the above apply to you. Osteocis may not be suitable for you. Your nuclear medicine doctor will advise you.
CIS bio international, Member of IBA Molecular group of companies
T2009pF 2
11/2013
Before administration of Osteocis 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 Osteocis
Tell your nuclear medicine doctor 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. Particular examples are:
• Chelates (used to treat metal poisoning),
• Diphosphonates (used to treat bones disease ),
• Tetracycline antibiotics (used to treat cancer),
• Medicines containing iron (used to treat anaemia ),
• Medicines containing aluminium salts (used to treat gastric problems).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
You must inform the nuclear medicine doctor before the administration of Osteocis 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
It is recommended to avoid an examination using technetium (99mTc) during pregnancy because it may involve a risk to the foetus.
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
Tell your nuclear medicine doctor if you are breast-feeding as he/she may delay the examination until breast-feeding is completed or ask you to stop breast-feeding for a short while until the radioactivity is no longer in your body. Milk should be banked prior to injection and the subsequent breastfeeding discarded after injection.
Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually breast feeding can be resumed 4 hours after injection.
Driving and using machines
It is considered unlikely that Osteocis will affect your ability to drive or to use machines.
Osteocis contains 6.3 mg of sodium per vial. Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per dose administered may be exceeded. This should be taken into account if you are on low a low-salt diet.
3. How Osteocis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Osteocis 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 Osteocis 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 300 MBq to 700 MBq (megabecquerel, the unit used to express radioactivity).
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to the child's weight.
Administration of Osteocis and conduct of the procedure Osteocis is injected into a vein of your arm.
One injection is sufficient to provide your doctor with the information needed. Before the scan you will be told to urinate. This will increase the quality of the scan.
During the administration of Osteocis you should avoid movement to prevent inflammation around the injection site due to an administration under the skin.
After administration of Osteocis
In order to ensure the most efficient use of the product, you are recommended to avoid strenuous exercise after injection until satisfactory scans have been taken. This avoid accumulation of the product in muscles.
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 questions.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
The scans can be taken during a few minutes after the injection in some cases or at 2 or 3 hours after the injection.
If you have been given more Osteocis than you should
An overdose is unlikely, since Osteocis is administered by a doctor under strictly controlled conditions. However, in the case of an overdose, you will receive the appropriate treatment.
Should you have any further question on the use of Osteocis, please ask the nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Technetium (MmTc) oxidronate does not usually produce any side effects. Very rare cases of allergic type reactions have been reported.
The following effects have been described :
• rash,
• feeling sick (nausea),
• low blood pressure (hypotension),
• pain in joints (arthralgia).
Onset of these reactions can be delayed 4 to 24 hours after injection.
Any of the above could be sign of an allergy (anaphylactic reaction). Contact a doctor immediately.
This radiopharmaceutical will deliver 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 Yellow Card Scheme, Website: www.mhra.aov.uk/vellowcard.
By reporting side effects you can help provide information on the safety of this medicine.
5. How Osteocis 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.
6. Contents of the pack and other information What Osteocis contains
• The active substance is sodium oxidronate.
• The other ingredients are stannous chloride dihydrate, ascorbic acid, sodium chloride
What Osteocis looks like and contents of the pack
You will not have to get this medicine or handle the packaging or the vial. The following data is for your information only.
Osteocis is a soluble powder for injection which should be dissolved and labeled with radioactive technetium (99mTc) before use. When this powder is mixed with a solution of pertechnetate (99f"Tc) of sodium, a solution of technetium (99mTc)-oxidronate is formed.
This solution is ready to be injected intravenously.
Packsize : kit of 5 multidose vials.
Each vial contains 3 mg of sodium oxidronate.
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Osteocis 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.
Please refer to the SmPC.
Marketing Authorisation Holder and Manufacturer
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
This leaflet was last revised in 11/2013.
During the administration of Osteocis you should avoid movement to prevent inflammation around the injection site due to an administration under the skin.
After administration of Osteocis
In order to ensure the most efficient use of the product, you are recommended to avoid strenuous exercise after injection until satisfactory scans have been taken. This avoid accumulation of the product in muscles.
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 questions.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
The scans can be taken during a few minutes after the injection in some cases or at 2 or 3 hours after the injection.
If you have been given more Osteocis than you should
An overdose is unlikely, since Osteocis is administered by a doctor under strictly controlled conditions. However, in the case of an overdose, you will receive the appropriate treatment.
Should you have any further question on the use of Osteocis, please ask the nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Technetium (99mTc) oxidronate does not usually produce any side effects. Very rare cases of allergic type reactions have been reported.
The following effects have been described :
• rash,
• feeling sick (nausea),
• low blood pressure (hypotension),
• pain in joints (arthralgia).
Onset of these reactions can be delayed 4 to 24 hours after injection.
Any of the above could be sign of an allergy (anaphylactic reaction). Contact a doctor immediately.
This radiopharmaceutical will deliver 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 Yellow Card Scheme, Website:
By reporting side effects you can help provide information on the safety of this medicine.
5. How Osteocis 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.
5
6. Contents of the pack and other information What Osteocis contains
• The active substance is sodium oxidronate.
• The other ingredients are stannous chloride dihydrate, ascorbic acid, sodium chloride
What Osteocis looks like and contents of the pack
You will not have to get this medicine or handle the packaging or the vial. The following data is for your information only.
Osteocis is a soluble powder for injection which should be dissolved and labeled with radioactive technetium (99mTc) before use. When this powder is mixed with a solution of pertechnetate (99mTc) of sodium, a solution of technetium (99mTc)-oxidronate is formed.
This solution is ready to be injected intravenously.
Packsize : kit of 5 multidose vials.
Each vial contains 3 mg of sodium oxidronate.
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency
httD://www.mhra.aov.uk
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Osteocis 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.
Please refer to the SmPC.
Marketing Authorisation Holder and Manufacturer
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
This leaflet was last revised in 11/2013.
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