Pulmocis Kit For Preparation Of Technetium Human Albumin Macroaggregates Injection
Package leaflet: information for the patient
Pulmocis 2 mg kit for radiopharmaceutical preparation Human albumin as macroaggregates
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 doctorwho 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 Pulmocis is and what it is used for
2. What you need to know before Pulmocis is used
3. How Pulmocis is used
4. Possible side effects
5. How Pulmocis is stored
6. Contents of the pack and other information
1. What Pulmocis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Pulmocis is a diagnostic radiopharmaceutical i.e. a radioactive medicine used for diagnostic purposes only. Pulmocis contains human albumin which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium (99mTc) human albumin.
When injected into a vein of your arm, this product temporarily collects in the lungs and the veins.
Because of the 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 blood flow in the lungs or in the veins.
Pulmocis is mainly used for the examination of the lung, and secondarily for the examination of the veins.Your nuclear medicine doctor will explain to you what kind of examination will be performed.
The use of Pulmocis does involve exposure to small 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 Pulmocis is used Pulmocis must not be used:
- If you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).
CIS bio international. Member of IBA Molecular group of companies
T1309pG
11/2013
Warnings and precautions Pulmocis contains human albumin.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of Pulmocis the name and batch number of the product are recorded in order to maintain a record of the batches used.
Take special care with Pulmocis
• If you are pregnant or believe you may be pregnant
• If you are breastfeeding
• If you are aware of a heart condition or a respiratory failure, you
should draw this to the attention of your nuclear medicine doctor since it may affect this test.
Please talk to your doctor/nuclear medicine doctor if any of the
above apply to you. Pulmocis may not be suitable for you. Your doctor/nuclear medicine doctor will advise you.
Before administration of Pulmocis 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 Pulmocis
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. For example:
• Medicines used to treat cancer (chemotherapeutic agents) such as bleomycin, methotrexate, busulfan, cyclophosphamide,
• Heparin (substance that prevents blood clotting),
• Bronchodilators (medicines used to help breathing),
• Nitrofurantoin (antibiotic to treat urinary-tract infections),
• Methysergide (medicine used to migraine prevention),
• Magnesium sulphate (medicine used to treat magnesium deficiency),
• Heroin (opium-like drug).
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 Pulmocis 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:
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 investigation until breast-feeding is completed or ask you to stop breast-feeding for a short while until the radioactivity has left your body. This takes about 12 hours. In this case, the expressed milk should be discarded. Please ask your nuclear medicine doctor when you can resume breast-feeding.
Driving and using machines
It is considered unlikely that Pulmocis will affect your ability to drive or to use machines.
3
Package leaflet: information for the patient
Pulmocis 2 mg kit for radiopharmaceutical preparation Human albumin as macroaggregates
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 doctorwho 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 Pulmocis is and what it is used for
2. What you need to know before Pulmocis is used
3. How Pulmocis is used
4. Possible side effects
5. How Pulmocis is stored
6. Contents of the pack and other information
1. What Pulmocis is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
Pulmocis is a diagnostic radiopharmaceutical i.e. a radioactive medicine used for diagnostic purposes only. Pulmocis contains human albumin which is used in combination with a radioactive solution of technetium (99mTc) in order to form a solution of technetium (99mTc) human albumin.
When injected into a vein of your arm, this product temporarily collects in the lungs and the veins.
Because of the 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 blood flow in the lungs or in the veins.
Pulmocis is mainly used for the examination of the lung, and secondarily for the examination of the veins.Your nuclear medicine doctor will explain to you what kind of examination will be performed.
The use of Pulmocis does involve exposure to small 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 Pulmocis is used Pulmocis must not be used:
- If you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).
CIS bio international. Member of IBA Molecular group of companies
T1309pG
11/2013 •• 2
Warnings and precautions Pulmocis contains human albumin.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes, it is strongly recommended that every time you receive a dose of Pulmocis the name and batch number of the product are recorded in order to maintain a record of the batches used.
Take special care with Pulmocis
• If you are pregnant or believe you may be pregnant
• If you are breastfeeding
• If you are aware of a heart condition or a respiratory failure, you
should draw this to the attention of your nuclear medicine doctor since it may affect this test.
Please talk to your doctor/nuclear medicine doctor if any of the
above apply to you. Pulmocis may not be suitable for you. Your doctor/nuclear medicine doctor will advise you.
Before administration of Pulmocis 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 Pulmocis
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. For example:
• Medicines used to treat cancer (chemotherapeutic agents) such as bleomycin, methotrexate, busulfan, cyclophosphamide,
• Heparin (substance that prevents blood clotting),
• Bronchodilators (medicines used to help breathing),
• Nitrofurantoin (antibiotic to treat urinary-tract infections),
• Methysergide (medicine used to migraine prevention),
• Magnesium sulphate (medicine used to treat magnesium deficiency),
• Heroin (opium-like drug).
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 Pulmocis 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:
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 investigation until breast-feeding is completed or ask you to stop breast-feeding for a short while until the radioactivity has left your body. This takes about 12 hours. In this case, the expressed milk should be discarded. Please ask your nuclear medicine doctor when you can resume breast-feeding.
Driving and using machines
It is considered unlikely that Pulmocis will affect your ability to drive or to use machines.
3
3. How Pulmocis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Pulmocis 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 Pulmocis 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 37 to 185 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 Pulmocis and conduct of the procedure Pulmocis is administered by injection into a vein of your arm.
One injection is sufficient to conduct the test that your nuclear medicine doctor needs.
If you have been given more Pulmocis than you should:
An overdose is unlikely because you will only receive a single dose of technetium (99mTc) human albumin macroaggregates injection 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 technetium (99mTc) human albumin macroaggregates injection from your body.
Should you have any further question on the use of Pulmocis, please ask the nuclear medicine doctor who supervises the procedure..
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of allergic type including very rare life-threatening reactions have been reported.
The following effects have been described however their frequency cannot be estimated from the available data (frequency not known):
• chest pain,
• chills (rigor),
• circulatory collapse (fainting, sweats, paleness, low blood pressure)
• local allergic reactions such as rash at the injection site.
Any of the above could be signs of allergy (anaphylactic reaction). Duration of the procedure Contact a doctor immediately.
Your Nuclear medicine doctor will inform you about the usual duration of
the procedure. This radiopharmaceutical will deliver low amounts of ionising radiation
associated with the least risk of cancer and hereditary abnormalities.
After administration of Pulmocis, 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.
5
6
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 more information on the safety of this medicine.
5. How Pulmocis 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.
Detailed information on this medicine is available on the web site of the MHRA
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Pulmocis 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.
6. Contents of the pack and other information What Pulmocis contains
• The active substance is human albumin as macroaggregates.
• The other ingredients are human albumin, stannous chloride dihydrate, sodium chloride.
What Pulmocis 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 are for your information only.
Packsize: kit of 5 multidose vials.
Each vial contains 2 mg of human albumin as macroaggregates.
Marketing Authorisation Holder and Manufacturer
CIS bio international RN306- Saclay B.P. 32
F-91192 Gif-sur-Yvette Cedex
This leaflet was last revised in 11/2013
3. How Pulmocis is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Pulmocis 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 Pulmocis 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 37 to 185 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 Pulmocis and conduct of the procedure Pulmocis is administered by injection into a vein of your arm.
One injection is sufficient to conduct the test that your nuclear medicine doctor needs.
If you have been given more Pulmocis than you should:
An overdose is unlikely because you will only receive a single dose of technetium (99mTc) human albumin macroaggregates injection 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 technetium (99mTc) human albumin macroaggregates injection from your body.
Should you have any further question on the use of Pulmocis, please ask the nuclear medicine doctor who supervises the procedure..
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of allergic type including very rare life-threatening reactions have been reported.
The following effects have been described however their frequency cannot be estimated from the available data (frequency not known):
• chest pain,
• chills (rigor),
• circulatory collapse (fainting, sweats, paleness, low blood pressure)
• local allergic reactions such as rash at the injection site.
Any of the above could be signs of allergy (anaphylactic reaction). Duration of the procedure Contact a doctor immediately.
Your Nuclear medicine doctor will inform you about the usual duration of
the procedure. This radiopharmaceutical will deliver low amounts of ionising radiation
associated with the least risk of cancer and hereditary abnormalities.
After administration of Pulmocis, 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.
5
6
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 more information on the safety of this medicine.
5. How Pulmocis 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 radiopharmaceuticais will be in accordance with national regulation on radioactive materials.
Detailed information on this medicine is available on the web site of the MHRA
The following information is intended for medical or healthcare professionals only:
The complete SmPC of Pulmocis 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.
6. Contents of the pack and other information What Pulmocis contains
• The active substance is human albumin as macroaggregates.
• The other ingredients are human albumin, stannous chloride dihydrate, sodium chloride.
What Pulmocis 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 are for your information only.
Packsize: kit of 5 multidose vials.
Each vial contains 2 mg of human albumin as macroaggregates.
Marketing Authorisation Holder and Manufacturer
CIS bio international RN306- Saclay B.P. 32
F-91192 Gif-sur-Yvette Cedex
This leaflet was last revised in 11/2013
8