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drug-medicine : cardiolite

 

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Medicine: cardiolite

PATIENT INFORMATION LEAFLET

CARDIOLITE®

1.IDENTIFICATION OF THE MEDICINAL PRODUCT

NAME OF THE MEDICINAL PRODUCT

CARDIOLITE®

QUALITATIVE COMPOSITION

Active ingredient:

Tetrakis (2-methoxy isobutyl isonitrile) copper (I) tetrafluoroborate
Stannous chloride dihydrate
L-Cysteine hydrochloride-monohydrate USP

Other ingredients:

Sodium citrate dihydrate
Mannitol

QUANTITATIVE COMPOSITION

Each vial contains 1 mg tetrakis (2-methoxy isobutyl isonitrile) copper (I) tetrafluoroborate, 0.075 mg stannous chloride dihydrate and 1 mg L-cysteine hydrochloride-monohydrate. Cardiolite is available in cartons containing 2 or 5 vials.

PHARMACEUTICAL FORM

The product is a powder which, when mixed with a solution of the radioactive substance sodium pertechnetate (Tc-99m), forms technetium (Tc-99m) sestamibi injection.

PHARMACO-THERAPEUTIC GROUP

Technetium (Tc-99m) sestamibi is a diagnostic radio pharmaceutical which, when injected, temporarily collects in a particular organ of the body (for example, the heart, the gall-bladder, the colon, the kidneys).

 

2.WHEN IS THE PRODUCT USED?

When injected, technetium (Tc-99m) sestamibi can be used:

  • to study blood flow, particularly in the heart
  • to help to identify possible breast abnormalities when used with other diagnostic techniques
  • to investigate overactivity of the parathyroid (a gland in the neck which controls calcium balance).

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 organ and the body. This can give the physician valuable information about structure and function of that organ.

 

3.WARNINGS

WHEN SHOULD THIS PRODUCT NOT BE USED?

Pregnancy.

IN CASE OF DOUBT, IT IS ESSENTIAL TO CONSULT YOUR DOCTOR BEFORE YOU RECEIVE THIS PRODUCT.

Under 18 years of age.

It is not usual for this product to be used in patients under 18 years because it has not been fully investigated in this age group.

SPECIAL WARNINGS

The use of technetium (Tc-99m) sestamibi does involve administration of small amounts of radioactivity. The risk this involves is very small and your doctor will not consider carrying out the investigation unless he believes that the risk is outweighed by the potential benefit of the study.

PRECAUTIONS FOR USE

Because technetium (Tc-99m) sestamibi is administered as a single dose by trained personnel, there are no precautions which are your responsibility. Because there are strict laws covering the use, handling and disposal of radioactivity, technetium (Tc-99m) sestamibi will always be used in a hospital or a similar setting. It will only be handled by people who are trained and qualified in the safe handling of radioactive material. Following administration you may be asked to drink plenty of water and to empty your bladder regularly to minimise radiation exposure.

IN CASE OF DOUBT, DO NOT HESITATE TO CONSULT YOUR DOCTOR.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

There are no known interactions.

IN ORDER TO AVOID POSSIBLE INTERACTIONS WITH OTHER MEDICINAL PRODUCTS, YOU SHOULD TELL YOUR DOCTOR IF YOU ARE TAKING ANY OTHER MEDICINE, EITHER PRESCRIBED OR BOUGHT WITHOUT A PRESCRIPTION.

PREGNANCY-LACTATION

It is important to tell your doctor if there is any possibility that you are pregnant. Special consideration is given to the use of radiopharmaceuticals during pregnancy. Your doctor will only use this product if he considers that the potential benefit outweighs the risk. Tell your doctor if you are breast-feeding as he may delay the investigation 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.

 

EFFECTS ON ABILITY TO DRIVE OR TO OPERATE MACHINERY

Technetium (Tc-99m) sestamibi has no effect on your fitness to drive or to operate machinery.

SPORTSMEN AND SPORTSWOMEN

There are no particular precautions for the use of technetium (Tc-99m) sestamibi by people engaged in active sport.

LIST OF THOSE EXCIPIENTS, KNOWLEDGE OF WHICH IS IMPORTANT FOR THE SAFE USE OF MEDICINAL PRODUCT IN CERTAIN PATIENTS

This product contains no ingredients which might necessitate special consideration being given to its use for particular types of patients.

 

4.HOW IS THIS PRODUCT USED?

DOSAGE

Your doctor will decide on the amount of radioactive technetium (Tc-99m) sestamibi to be used. This will be the minimum amount necessary to give a scan clear enough to supply the required information. Single doses may be from 185 MBq up to a maximum of 925 MBq (Megabecquerel - the unit in which radioactivity is measured). When two injections are necessary, not more than a total of 925 MBq should be administered.

If technetium (Tc-99m) sestamibi is being used to study blood flow in your heart, you should not eat for at least four hours prior to the study. Your doctor may ask you to have a light fatty meal or drink a glass or two of milk after each injection, prior to imaging.

METHOD AND ROUTE OF ADMINISTRATION

Technetium (Tc-99m) sestamibi is administered by injection into a vein.

FREQUENCY OF ADMINISTRATION AND APPROPRIATE TIME OF ADMINISTRATION

Usually one to two injections is sufficient to provide your doctor with the information needed. If two injections are needed, they will be given at least six hours apart and you will be asked to carry out an exercise test before you are given one of the injections.

DURATION OF THE TREATMENT

Scans may be taken up to 6 hours after the injection.

ACTION TO BE TAKEN IN THE CASE OF AN OVERDOSE

In the case of overdose you will be asked to drink plenty of water and go to the toilet regularly.

 

5.UNDESIRABLE EFFECTS

You may experience a metallic or bitter taste, transient headache, flushing or a non-itching rash immediately after injection of Technetium Tc-99m sestamibi. A few people have reported other symptoms, including: irritation around the site of injection; swelling in the limbs; indigestion; a feeling of sickness or vomiting; an itching or related rash; a dry mouth; fever; dizziness; tiredness; difficulty in catching your breath or a fall in blood pressure after the injection.

Seizures (fits) have been reported rarely.

IT IS IMPORTANT THAT YOU TELL YOUR DOCTOR IF YOU FEEL ANY ILL-EFFECTS, WHETHER OR NOT THEY ARE OF A TYPE MENTIONED IN THIS LEAFLET.

6.STORAGE

The product label includes the appropriate storage conditions and the expiry date for the batch of product. Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.

 

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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