"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.
DOSAGE AND ADMINISTRATION
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 T2-effect, and pre- and post- T2-weighted images are equivalent. The clinical use of TESLASCAN (mangafodipir) has been investigated at field strengths from 0.5 to 2.0 Tesla.
Dosage for adults
The recommended dose is 0.5 ml/kg bodyweight (5 μmol/kg bodyweight). This corresponds to a dose of 35 ml for a 70 kg person. Above 100 kg body weight, 50 ml is usually sufficient to provide a diagnostically adequate contrast effect.
Dosage for elderly 4
Pharmacokinetics in the elderly has not been investigated. However, clinical studies to date do not suggest that a dose adjustment is required.
Children and adolescents
Safety and efficacy in patients below the age of 18 have not been documented i.e. children (2-11 years) and adolescents (12-18 years).
List of excipients
Sodium hydroxide and/or hydrochloric acid (pH adjustment)
Water for injections.
This medicinal product must not be mixed with other medicinal products.
A separate cannula should be used.
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 above).
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 (mangafodipir) is supplied in packs of 1 x 50 ml and 10 x 50 ml vials.
Not all pack sizes may be marketed
Special precautions for disposal and other handling
TESLASCAN (mangafodipir) 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.
The required volume to be given to the patient should be determined and any excess volume should be withdrawn from the vial before infusion.
Connective tubing may be flushed with physiological saline (sodium chloride 9 mg/ml (0.9%)), to ensure complete administration of the contrast medium.
Marketing Authorisation Holder:
GE Healthcare AS
P.O. Box 4220 Nydalen
NO-0401 OSLO, Norway
Marketing Authorisation Numbers:
Date Of First Authorisation/Renewal Of The Authorisation:
Date of first authorisation: 22.05.1997
Date of latest renewal: 22.05.2007
Date Of Revision Of The Text: 22.05.2007
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Teslascan Information
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