NeoSpect
depreotide
Depreotide
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What NeoSpect is and what it is used for.
Before you use NeoSpect.
How to use NeoSpect.
Possible side effects.
How to store NeoSpect.
Further information.
Medicinal product no longer authorised
NeoSpect is a radiopharmaceutical product used for diagnostic purposes. A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour). Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken. This scan will show exactly the distribution of the radioactivity within the body. This can give the doctor valuable information such as the location of a tumour.
NeoSpect is for diagnostic use only. NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung. When injected, the radiolabelled compound binds to malignant cancer tissue. Your doctor will then take a picture (scan) of your lungs using a special camera. The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour. The evaluation also includes examinations by CT-scan or chest X-ray.
if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or to the radioactive technetium.
if there is any possibility that you are pregnant.
if you are breast-feeding.
if you are suffering from diabetes or other related conditions
if you have a renal disease
if you have a liver disease
NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group.
The use of NeoSpect does involve exposure to small amounts of radioactivity, however your doctor will always consider the possible risks and benefits when considering the use of this product.
To minimise the dose of radiation absorbed by the bladder, the intake of fluids should be increased during the first few hours after injection to permit frequent voiding.
There is only limited data available regarding interactions with other products.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
You should tell your doctor if there is any possibility that you are pregnant, or if you are breast- feeding.
No studies on the effects on the ability to drive and use machines have been performed. However, it is not considered likely that NeoSpect will affect your ability to drive or to operate machinery.
Medicinal product no longer authorised
NeoSpect is for use in patients over the age of 18 years.
The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with 555-740 MBq of technetium-99m.
Radiolabelled NeoSpect is administered as a single injection into a vein. After labelling with the radioactive sodium pertechnetate (99mTc) solution for injection, radiolabelled NeoSpect will be injected before the scan is taken.
The scanning may take place 2-4 hours after injection of NeoSpect.
Any 99mTc-depreotide which remains in your body, will naturally lose its radioactivity within 2-3 days. Because there are strict laws covering the use, handling and disposal of radioactivity, NeoSpect will
always be used in a hospital or a similar setting. It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
If overdose is suspected, symptomatic treatment will be administered. Your doctor may recommend that you drink plenty of fluids to speed removal of traces of the radiopharmaceutical from your body.
Like all medicines, NeoSpect can cause side effects, although not everybody gets them.
Most of the side effects reported were transient and of mild intensity. Most frequently reported were:
* | headache | * | nausea |
* | vomiting | * | diarrhoea |
* | abdominal pain | * | dizziness |
* | flushing | * | fatigue |
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Keep out of the reach and sight of children.
The product label includes the appropriate storage conditions and the expiry date for the product. Do not use NeoSpect after the expiry date which is stated on the label.
Trained hospital staff will ensure the correct storage of NeoSpect.
Medicinal product no longer authorised
The active substance is 47 micrograms depreotide as depreotide trifluoroacetate.
The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate and hydrochloric acid and/or sodium hydroxide to adjust pH.
The product is a kit for radiopharmaceutical preparation.
NeoSpect is a powder for solution for injection that has to be dissolved and labelled with radioactive technetium before use. When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed. This solution is ready for injection into a vein.
Pack sizes
1 vial containing 47 micrograms of depreotide.
5 vials, each vial containing 47 micrograms of depreotide. Not all pack sizes may be marketed.
CIS bio international
B.P. 32
91192 GIF sur YVETTE cedex FRANCE
CIS bio international
B.P. 32
91192 GIF sur YVETTE cedex FRANCE
Medicinal product no longer authorised