What is it and how is it used?
TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.
This medicine is for diagnostic use only.
TESLASCAN is used in magnetic resonance imaging (MRI) to detect certain lesions in the liver and pancreas.
What do you have to consider before using it?
Do not use TESLASCAN if one of the following conditions exists:
- Allergy (hypersensitivity) to the active substance or any of the other ingredients of TESLASCAN
- Severe kidney disease
- Severe liver disease
Take special care with TESLASCAN if one of the following conditions exists:
- Severe heart disease - in particular heart failure or when there is a risk of disorders of heart rhythm
- in patients with injuries of the blood brain barrier and severe cerebral disease
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) may occur.
Using other medicines:
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
TESLASCAN must not be used if you are pregnant.
The amount of TESLASCAN in breast milk is not known. As a precaution, to prevent exposing infants to the medicine, breast-feeding should be stopped from the time of dosing and all milk should be discarded for the first 14 days afterwards.
Driving and using machines:
No effects are known. There is no reason why you cannot drive after the investigation, unless you feel dizzy or are unsure of yourself.
Important information about some of the ingredients of Teslascan
This medicine contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml. To be taken into consideration by patients on a controlled sodium diet.
How is it used?
TESLASCAN is for use in patients over the age of 18 years.
The amount given will depend on the weight of the patient: 0.5 ml/kg body weight is the recommended dosage for adults and elderly.
TESLASCAN is for intravenous use and will be infused before the MRI examination. TESLASCAN may be infused into a vein, normally an arm vein, via a thin plastic tube. The administration may last for up to 15-20 minutes.
TESLASCAN should be visually inspected for particulate matter and for the integrity of the container prior to use. Vials are intended for single use only. The medicinal product should not be mixed with other medicinal products. Any unused portions must be discarded.
There is no known antidote to this contrast medium. Treatment of any overdose will be performed at the hospital. Treatment will be supportive to relieve the symptoms.
High doses of manganese can make the heart pump less efficiently, dilate the blood vessels, as well as induce disturbances of heart rhythm.
What are possible side effects?
Like all medicines, TESLASCAN can cause side effects, although not everybody gets them.
The reported side effects are usually mild and of short duration:
Common (1 in 100 to 1 in 10 patients experiences the side effect):
- Feeling of warmth/flushing
Uncommon (1 in 1,000 to 1 in 100 patients experiences the side effect):
- Hypersensitivity reactions (e.g., skin reactions, rhinitis (nasal catarrh) pharyngitis (throat inflammation))
- Paraesthesia (sensation of tingling)
- Abdominal pain
- Injection site pain
- Taste sensations
Rare (1 in 10,000 to 1 in 1,000 patients experiences the side effect):
Very rare (less than 1 in 10,000 patients experiences the side effect):
- Visual disturbances
- Chest pain
Anaphylactoid reactions (wheeziness, difficulty in breathing or tightness or pain in the chest) may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the radiologist/radiographer or your doctor orpharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use TESLASCAN after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Once opened the product should be used immediately. For single use only. Any unused portion should be discarded.
Do not use Teslascan if the colour changes from dark yellow to brown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What TESLASCAN contains
- The active substance is mangafodipir trisodium.1 ml of solution contains 7.57 mg mangafodipir trisodium anhydrous (corresponding to 0.01 mmol per ml)
- The other ingredients are ascorbic acid, sodium chloride, sodium hydroxide and/or hydrochloric acid (for pH adjustment) and water for injections.
What TESLASCAN looks like and contents of the pack
Solution for infusion.The solution is clear and bright to dark yellow in colour.
The medicine is supplied in pack of:
1 vial of 50 ml
10 vials of 50 ml
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer:
GE Healthcare AS
P.O. Box 4220 Nydalen
NO-0401 OSLO, Norway
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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