Pentacis 9.10mg Kit For The Preparation Of Technetium (99mtc) Pentetate Injection
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Package leaflet: information for the patient
PENTACIS 9.10 mg kit for radiopharmaceutical preparation Trisodium and calcium pentetate
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 Pentacis is and what it is used for
2. What you need to know before Pentacis is used
3. How Pentacis is used
4. Possible side effects
5. How Pentacis is stored
6. Contents of the pack and other information
1. What Pentacis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Pentacis contains pentetate which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium ("mTc)-pentetate.
When injected into a vein of your arm, this product temporarily collects in the kidneys or the brain. It collects in the lungs when inhaled and in the stomach when ingested.
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 will show exactly the distribution of the radioactivity within the organ and the body. These scans give valuable information about the structure and/or the functioning of the concerned organ.
Pentacis is used for:
• the detection of abnormalities in your kidneys, your lungs or your brain, and /or,
• the evaluation of the functioning of your kidneys, brain or stomach.
Your doctor/Nuclear Medicine specialist will explain to you what kind of examination will be performed.
The use of Pentacis does involve exposure to low 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 Pentacis is used Pentacis must not be used
• If you are allergic to trisodium and calcium pentetate or any of the other ingredients of this medicine (listed in section 6).
CIS bio international. Member or IBA Molecular group or companies
T0609pG
11/2013 2
Warnings and precautions
Take special care with Pentacis
• Talk to your nuclear medicine doctonlf you have problems with your kidney function, you could have difficulties in eliminating the product from you body. In this case, the dose you should receive may need to be adjusted.
• 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 breast-feeding”).
• If you are under 18 years old.
Before administration of Pentacis 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.
After administration of Pentacis you should:
- Urinate frequently in order to eliminate the product from your body
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Pentacis
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:
• Captopril (medicine used to treat high blood pressure conditions)
• Furosemide (diuretics or “water pills”)
• Mood altering medicines.
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 Pentacis 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
Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually, breast-feeding can be resumed 12 hours after the injection.
Driving and using machines
It is considered unlikely that Pentacis will affect your ability to drive or to use machines.
Pentacis contains 2.2 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 must be taken into account if you are on a low-salt diet. The nuclear medicine doctor who supervises the procedure will be able to tell you the exact quantity of sodium injected.
3. How Pentacis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Pentacis 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 Pentacis 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 2 to 740 MBq (megabecquerel, the unit used to express radioactivity), depending on the type of examination and on the route of administration.
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to the child’s weight.
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' Molecular
Package leaflet: information for the patient
PENTACIS 9.10 mg kit for radiopharmaceutical preparation Trisodium and calcium pentetate
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 Pentads is and what it is used for
2. What you need to know before Pentacis is used
3. How Pentacis is used
4. Possible side effects
5. How Pentacis is stored
6. Contents of the pack and other information
1. What Pentacis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Pentacis contains pentetate which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium (99mTc)-pentetate.
When injected into a vein of your arm, this product temporarily collects in the kidneys or the brain. It collects in the lungs when inhaled and in the stomach when ingested.
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 will show exactly the distribution of the radioactivity within the organ and the body. These scans give valuable information about the structure and/or the functioning of the concerned organ.
Pentacis is used for:
• the detection of abnormalities in your kidneys, your lungs or your brain, and /or,
• the evaluation of the functioning of your kidneys, brain or stomach.
Your doctor/Nuclear Medicine specialist will explain to you what kind of examination will be performed.
The use of Pentacis does involve exposure to low 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 Pentacis is used Pentacis must not be used
• If you are allergic to trisodium and calcium pentetate or any of the other ingredients of this medicine (listed in section 6).
CIS bio international. Member ot IBA Motecutar croup of companies
T0609pG
11/2013
Warnings and precautions
Take special care with Pentacis
• Talk to your nuclear medicine doctor:lf you have problems with your kidney function, you could have difficulties in eliminating the product from you body. In this case, the dose you should receive may need to be adjusted.
• 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 breast-feeding”).
• If you are under 18 years old.
Before administration of Pentacis 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.
After administration of Pentacis you should:
- Urinate frequently in order to eliminate the product from your body
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Pentacis
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:
• Captopril (medicine used to treat high blood pressure conditions)
• Furosemide (diuretics or “water pills")
• Mood altering medicines.
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 Pentacis 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
Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually, breast-feeding can be resumed 12 hours after the injection.
Driving and using machines
It is considered unlikely that Pentacis will affect your ability to drive or to use machines.
Pentacis contains 2.2 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 must be taken into account if you are on a low-salt diet. The nuclear medicine doctor who supervises the procedure will be able to tell you the exact quantity of sodium injected.
3. How Pentacis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Pentacis 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 Pentacis 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 2 to 740 MBq (megabecquerel, the unit used to express radioactivity), depending on the type of examination and on the route of administration.
Use in children and adolescents
In children and adolescents, the quantity to be administered will be adapted to the child's weight.
Administration of Pentacis and conduct of the procedure
Technetium (MmTc) pentetate is either administered by injection into a vein of your arm, or by inhalation using a nebulizer, it can also be swallowed as a liquid.
One injection is sufficient to provideyour nuclear medicine doctor with the information needed
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure. The scans can be taken at any time from the beginning of the administration, depending on the type of study which is to be performed.
To study the functioning of your kidneys, a second set of scans can be taken after you have been administered a medicine (furosemide by injection or captopril orally) to help in diagnosis.
After administration of Pentacis
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 Pentacis than you should
An overdose is unlikely because you will only receive a single dose of Pentacis precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.
In particular, the nuclear medicine doctor supervising the procedure may recommend that you drink abundantly in order to facilitate the elimination of Pentacis from your body.
Should you have any further question on the use of Pentacis, please ask the nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare cases of allergic type reactions have been reported. The following effects have been described:
• redness of skin (flushing),
• dizziness,
• difficulty in breathing (dyspnoea),
• itching,
• hives (urticaria),
• low blood pressure (hypotension).
Any of the above could be sign of 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.
Your doctor has considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the risk due to radiation.
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.QQv.uk/vellowcard.
By reporting side effects you can help provide information on the safety of this medicine.
5. How Pentacis 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.
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5
6. Contents of the pack and other information What Pentacis contains
• The active substance is calcium trisodium pentetate. Each vial contains 9.10 mg of pentetate.
• The other ingredients are stannous chloride dihydrate.
What Pentacis 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.
Pentacis is a soluble powder for injection which should be dissolved and labeled with radioactive technetium (99fnTc) before use. When this powder is mixed with a solution of pertechnetate (99mTc) of sodium, a solution of technetium (99mTc)-pentetate is formed.
This solution is ready to be injected intravenously.
Packsize: kit of 5 multidose vials.
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency http://www.mhra.aov.uk
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Pentacis 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.
Administration of Pentacis and conduct of the procedure
Technetium (MmTc) pentetate is either administered by injection into a vein of your arm, or by inhalation using a nebulizer. It can also be swallowed as a liquid.
One injection is sufficient to provideyour nuclear medicine doctor with the information needed
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure. The scans can be taken at any time from the beginning of the administration, depending on the type of study which is to be performed.
To study the functioning of your kidneys, a second set of scans can be taken after you have been administered a medicine (furosemide by injection or captopril orally) to help in diagnosis.
After administration of Pentacis
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 Pentacis than you should
An overdose is unlikely because you will only receive a single dose of Pentacis precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.
In particular, the nuclear medicine doctor supervising the procedure may recommend that you drink abundantly in order to facilitate the elimination of Pentacis from your body.
Should you have any further question on the use of Pentacis, please ask the nuclear medicine doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare cases of allergic type reactions have been reported. The following effects have been described:
• redness of skin (flushing),
• dizziness,
• difficulty in breathing (dyspnoea),
• itching,
• hives (urticaria),
• low blood pressure (hypotension).
Any of the above could be sign of 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.
Your doctor has considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the risk due to radiation.
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 Pentacis 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 Pentacis contains
• The active substance is calcium trisodium pentetate. Each vial contains 9.10 mg of pentetate.
• The other ingredients are stannous chloride dihydrate.
What Pentacis 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.
Pentacis 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 ("mTc)-pentetate is formed.
This solution is ready to be injected intravenously.
Packsize: kit of 5 multidose vials.
Marketing Authorisation Holder and Manufacturer
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency http://www.mhra.aov.uk
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Pentacis 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.
This leaflet was last revised in 11/2013.
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