Teslascan
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
02-08-2012
Produktets egenskaber
(SPC)
02-08-2012
Offentlige vurderingsrapport
(PAR)
02-08-2012
Aktiv bestanddel:
mangafodipir trisodium
Tilgængelig fra:
GE Healthcare AS
ATC-kode:
V08CA05
INN (International Name):
mangafodipir
Terapeutisk gruppe:
Contrast media
Terapeutisk område:
Magnetic Resonance Imaging
Terapeutiske indikationer:
This medicinal product is for diagnostic use only.Contrast medium for diagnostic magnetic resonance imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
Produkt oversigt:
Revision: 9
Autorisation status:
Withdrawn
Autorisation dato:
1997-05-22
Indlægsseddel
Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
TESLASCAN 0.01 MMOL/ML SOLUTION FOR INFUSION.
Mangafodipir trisodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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 or pharmacist.
IN THIS LEAFLET:
1.
What TESLASCAN is and what it is used for.
2.
Before you use TESLASCAN.
3.
How to use TESLASCAN.
4.
Possible side effects.
5.
How to store TESLASCAN.
6.
Further information.
1.
WHAT TESLASCAN IS AND WHAT IT IS USED FOR
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.
2.
BEFORE YOU USE TESLASCAN
DO NOT USE TESLASCAN IF ONE OF THE FOLLOWING CONDITIONS EXISTS:
-
Pregnancy
-
Allergy (hypersensitivity) to the active substance or any of the other
ingredients of TESLASCAN
-
Pheochromocytoma
-
Breast-feeding
_ _
-
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.
Medicinal product no longer authorised
18
PREGNANCY AND BREAST-FEEDING
TESLASCAN must not be used if you are pregnant.
The amount of TESLASCAN in breast milk is not k
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
TESLASCAN 0.01 mmol/ml solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01
mmol (10 μmol), equivalent to
6.91 mg of mangafodipir.
50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol
(500 μmol), equivalent to
345.5 mg of mangafodipir.
Excipient: Sodium 0.16 mmol (3.6 mg)/ml equivalent to 126 mg per
normal dose of 35 ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
A clear bright to dark yellow solution,
TESLASCAN has the following physicochemical properties:
pH: 7.0-8.0.
Osmolality (mosmol/kg H
2
O) at 37 °C
290
Viscosity (mPa.s) at 20 °C
1.0
Viscosity (mPa.s) at 37 °C
0.7
Density (g/ml) at 20 °C
1.01
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for
the detection of lesions of the
liver suspected to be due to metastatic disease or hepatocellular
carcinomas. As an adjunct to MRI to
aid in the investigation of focal pancreatic lesions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The medicinal product is for single intravenous use only as repeated
dosing has not been studied. It
should be administered as an intravenous infusion at the rate of 2-3
ml/min for liver imaging and at a
rate of 4-6 ml/min for imaging of the pancreas.
Near maximal enhancement of the normal liver and pancreas parenchyma
is generally observed 15-20
minutes from the start of administration and lasts for approximately
_ _
4 hours.
At the clinical dose the contrast agent has no T
2
-effect, and pre- and post- T
2
-weighted images are
equivalent. The clinical use of TESLASCAN has been investigated at
field strengths from 0.5 to 2.0
Tesla.
Medicinal product no longer authorised
3
DOSAGE FOR ADULTS
The recommended dose is 0.
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