iMedi.co.uk

Angiocis

Informations for option: Angiocis, show other option

1. What Angiocis is and what it is used for

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*    Molecular

Package leaflet: Information for the patient

ANGIOCIS 20 mg kit for radiopharmaceutical preparation Sodium pyrophosphate decahydrate

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 Angiocis is and what it is used for

2.    What you need to know before Angiocis is used

3.    How Angiocis is used

4.    Possible side effects

5.    How Angiocis is stored

6.    Contents of the pack and other information

This medicine is a radiopharmaceutical product for diagnostic use only.

Angiocis is a diagnostic radiopharmaceutical i.e. a medicine used for diagnostic purposes only, in combination with a radioactive solution of technetium (99rnTc).

Angiocis contains stannous pyrophosphate which is injected first into a vein of your arm, so that the red blood cells can fix the radioactive element, technetium ("mTc). Then when injected also into a vein of your arm, technetium (99mTc) can temporarily collect on the red blood cells. 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 circulation of red blood cells within the heart cavity, aorta, large artery and vein pathways.

Angiocis can be used:

•    to determine your heart function, or

•    to detect vascular abnormalities, or

•    to localise gastro-intestinal bleeding.

Your nuclear medicine doctor will explain to you what kind of examination will be performed.

The use of Angiocis in combination with technetium (99mTc) 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.

CIS bto international. Member or IBA Molecular oroup of companies

T0709pF

11/2013

2. What you need to know before Angiocis is used Angiocis must not be used:

•    If you are allergic to sodium pyrophosphate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with Angiocis

•    If you have an allergic disease, since indeed some cases of allergic type reactions have been reported with this kind of examination.

•    If you are pregnant or believe you may be pregnant.

•    If you are breast-feeding.

Before administration of Angiocis 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 Angiocis

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:

•    Heparin (substance that prevents blood clotting),

•    Aluminium salts (used to treat gastric problems),

•    Medicines used to treat high blood pressure or heart conditions such as prazosin, methyldopa, hydralazin, digitalic related compounds, beta- blockers (e.g. propranolol), calcium channel blockers (e.g. verapamil, nifedipine), quinidine,..,

   Nitrates (e.g. nitroglycerin) used to treat chest pain called angina,

•    Anthracycline antibiotic (used to treat cancer),

•    lodinated contrast medicines used to perform radiography.

If you suffer from an intoxication of excess tin, the quality of images may also be affected. Please tell your nuclear medicine doctor.

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 Angiocis 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 pregnantlt is recommended to avoid examination with 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 she/he 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.

Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually breast feeding can be resumed 12 hours after injection.

Driving and using machines

It is considered unlikely that Angiocis will affect your ability to drive or to use machines.

Angiocis contains 4,15 mg of sodium per vial that is less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free’.

3


Package leaflet: Information for the patient

ANGIOCIS 20 mg kit for radiopharmaceutical preparation Sodium pyrophosphate decahydrate

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 Angiocis is and what it is used for

2.    What you need to know before Angiocis is used

3.    How Angiocis is used

4.    Possible side effects

5.    How Angiocis is stored

6.    Contents of the pack and other information

This medicine is a radiopharmaceutical product for diagnostic use only.

Angiocis is a diagnostic radiopharmaceutical i.e. a medicine used for diagnostic purposes only, in combination with a radioactive solution of technetium ("mTc).

Angiocis contains stannous pyrophosphate which is injected first into a vein of your arm, so that the red blood cells can fix the radioactive element, technetium ("mTc). Then when injected also into a vein of your arm, technetium (99mTc) can temporarily collect on the red blood cells. 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 circulation of red blood cells within the heart cavity, aorta, large artery and vein pathways.

Angiocis can be used:

•    to determine your heart function, or

•    to detect vascular abnormalities, or

•    to localise gastro-intestinal bleeding.

Your nuclear medicine doctor will explain to you what kind of examination will be performed.

The use of Angiocis in combination with technetium (99mTc) 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.

CIS bio international. Member of I BA Molecular group of companies

T0709pF

11/2013    2

2. What you need to know before Angiocis is used    Pregnancy and breast-feeding

Angiocis must not be used:

•    If you are allergic to sodium pyrophosphate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with Angiocis

•    If you have an allergic disease, since indeed some cases of allergic type reactions have been reported with this kind of examination.

•    If you are pregnant or believe you may be pregnant.

•    If you are breast-feeding.

Before administration of Angiocis 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 Angiocis

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:

•    Heparin (substance that prevents blood clotting),

•    Aluminium salts (used to treat gastric problems),

•    Medicines used to treat high blood pressure or heart conditions such as prazosin, methyidopa, hydralazin, digitalic related compounds, beta- blockers (e.g. propranolol), calcium channel blockers (e.g. verapamil, nifedipine), quinidine,..,

   Nitrates (e.g. nitroglycerin) used to treat chest pain called angina,

•    Anthracycline antibiotic (used to treat cancer),

•    lodinated contrast medicines used to perform radiography.

If you suffer from an intoxication of excess tin, the quality of images may also be affected. Please tell your nuclear medicine doctor.

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 Angiocis 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 pregnantlt is recommended to avoid examination with technetium (9*"Tc) 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 she/he 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.

Please ask your nuclear medicine doctor when you can resume breastfeeding. Usually breast feeding can be resumed 12 hours after injection.

Driving and using machines

It is considered unlikely that Angiocis will affect your ability to drive or to use machines.

Angiocis contains 4,15 mg of sodium per vial that is less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.

3


There are strict laws on the use, handling and disposal of radiopharmaceutical products. Angiocis in combination with technetium (99mTc) 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 Angiocis and technetium (99mTc) 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 0.25 mg to 5.75 mg, and the recommended activity of fechnetium ("mTc) to be administered ranges from 740 MBq to 925 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 Angiocis and conduct of the procedure

The study needs two injections into a vein of your arm:

Firstly: injection of a solution of Angiocis.

Secondly: thirty minutes after the first injection, another injection of a solution containing technetium (99mTc).

Duration of the procedure

The scans can be taken immediately after the second injection.

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Angiocis and technetium (99mTc), 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.

If you have been given more Angiocis than you should

An overdose is unlikely, s ince Angiocis 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 Angiocis, 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.

Very rare cases of allergic type reactions have been reported.

The following effects have been described:

•    redness of the face (flush),

•    headache,

•    low blood pressure,

•    feeling sick (nausea) and/or dizzy,

•    swelling of the arm,

•    rash (erythema) and itching at the injection site,

•    profuse sweating (diaphoresis) and buzzing (tinnitus),

•    hives (urticaria),

•    generalised rash,

•    irregular heart beat (cardiac arrhythmia),

•    swelling of the face (facial oedema) and coma.

This could be signs 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.

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 information on the safety of this medicine.

5. How Angiocis 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 Angiocis contains

•    The active substance is sodium pyrophosphate decahydrate.

•    The other ingredients are stannous chloride dihydrate and concentrated hydrochloric acid.

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.

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 Angiocis 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.

What Angiocis 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.

Angiocis is a soluble powder for injection which must be dissolved before use. This solution is ready to be injected intravenously.

Packsize: kit of 5 multidose vials.

Each vial contains 20.12 mg of sodium pyrophosphate decahydrate.

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Angiocis in combination with technetium (99mTc) 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 Angiocis and technetium (99mTc) 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 0.25 mg to 5.75 mg, and the recommended activity of fechnetium ("mTc) to be administered ranges from 740 MBq to 925 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 Angiocis and conduct of the procedure

The study needs two injections into a vein of your arm:

Firstly: injection of a solution of Angiocis.

Secondly: thirty minutes after the first injection, another injection of a solution containing technetium (99mTc).

Duration of the procedure

The scans can be taken immediately after the second injection.

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Angiocis and technetium (99mTc), 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.

If you have been given more Angiocis than you should

An overdose is unlikely, s ince Angiocis 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 Angiocis, 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.

Very rare cases of allergic type reactions have been reported.

The following effects have been described:

•    redness of the face (flush),

•    headache,

•    low blood pressure,

•    feeling sick (nausea) and/or dizzy,

•    swelling of the arm,

•    rash (erythema) and itching at the injection site,

•    profuse sweating (diaphoresis) and buzzing (tinnitus),

•    hives (urticaria),

•    generalised rash,

•    irregular heart beat (cardiac arrhythmia),

•    swelling of the face (facial oedema) and coma.

This could be signs 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.

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 information on the safety of this medicine.

5. How Angiocis 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 Angiocis contains

•    The active substance is sodium pyrophosphate decahydrate.

•    The other ingredients are stannous chloride dihydrate and concentrated hydrochloric acid.

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.

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 Angiocis 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.

What Angiocis 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.

Angiocis is a soluble powder for injection which must be dissolved before use. This solution is ready to be injected intravenously.

Packsize: kit of 5 multidose vials.

Each vial contains 20.12 mg of sodium pyrophosphate decahydrate.

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