TELESCAN Solution for infusion (2012)
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Περιεχόμενα
Name of the medicinal product
TESLASCAN 0.01 mmol/ml solution for infusion.
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), ...
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<sub>2</sub>O) at 37°C: 290 Viscosity (mPa.s) ...
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 ...
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Pregnancy and lactation. Phaeochromocytoma. Severely reduced liver function (Child Pugh class C), especially severe obstructive hepatobiliary ...
Special warnings and precautions for use
Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur. Familiarity with the practice and technique of resuscitation and treatment of ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Pregnancy The safety of TESLASCAN in human pregnancy has not been established. TESLASCAN must not be used during pregnancy (see section 4.3). Prior to administration of TESLASCAN to women of child bearing ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Most of the adverse reactions reported were transient and of mild intensity. Those most commonly reported were: feeling of warmth/flushing, headache and nausea. In clinical trials with Teslascan, adverse ...
Overdose
Serious adverse events have not been reported in healthy subjects with dosages up to 5 times the normal clinical dose (maximum dose investigated). High doses of manganese can have negative inotropic and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Paramagnetic MRI contrast medium ATC Code: V08CA05 Mangafodipir is a chelate containing the metal manganese which has paramagnetic properties and is responsible for the contrast ...
Pharmacokinetic properties
Mangafodipir trisodium is metabolised (dephosphorylated) and manganese ions are released from the mangafodipir by exchange with plasma zinc (mainly) after intravenous administration. Manganese and the ...
Preclinical safety data
Non-clinical studies reveal no special hazard for humans based on conventional studies of genotoxicity, safety pharmacology and validating kinetics and metabolism. Relevant adverse effects from repeated ...
List of excipients
Ascorbic acid Sodium chloride Sodium hydroxide and/or hydrochloric acid (pH adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products. A separate cannula should be used.
Shelf life
Unopened: 2 years. Once opened the product should be used immediately.
Special precautions for storage
Keep the vial in the outer carton in order to protect from light. The product should be used immediately after first opening (see section 6.3).
Nature and contents of container
50 ml clear, colourless vials (type 1 glass). The containers are closed with rubber stoppers and sealed with aluminium caps with polypropylene lids. TESLASCAN is supplied in packs of 1 50 ml and 10 50 ...
Special precautions for disposal and other handling
TESLASCAN vials should be visually inspected for particulate matter and for the integrity of the container prior to use. Vials are intended for single use only; any unused portions must be discarded. ...
Marketing authorization holder
GE Healthcare AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, NO-0401, OSLO, Norway
Marketing authorization number(s)
EU/1/97/040/001 EU/1/97/040/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22.05.1997 Date of latest renewal: 22.05.2007
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