Source: European Medicines Agency (EU) Revision Year: 2011 Publisher: TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, UK
Ablavar 0.25 mmol/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to pale yellow liquid. |
1 ml Ablavar solution for injection contains 244 mg (0.25 mmol) gadofosveset trisodium equivalent to 227 mg gadofosveset.
Each vial of 10 ml solution contains a total of 2.44 g (2.50 mmol) of gadofosveset trisodium equivalent to 2.27 g of gadofosveset
Each vial of 15 ml solution contains a total of 3.66 g (3.75 mmol) of gadofosveset trisodium equivalent to 3.41g of gadofosveset.
Each vial of 20 ml solution contains a total of 4.88 g (5.00 mmol) of gadofosveset trisodium equivalent to 4.54g of gadofosveset.
Excipient: This medicinal product contains 6.3 mmol sodium (or 145 mg) per dose.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gadofosveset |
Gadofosveset is a formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate substituted with a diphenylcyclohexylphosphate group (gadofosveset trisodium), for use in magnetic resonance imaging (MRI). Gadofosveset binds reversibly to human serum albumin. |
| List of Excipients |
|---|
|
Fosveset |
10 and 20 ml colourless type I glass vials with chloro- or bromobutyl elastomer stopper and aluminium bordered cap (plastic disk).
Pack sizes:
1, 5, or 10 vials x 10 ml (in 10-ml glass vial)
1, 5, or 10 vials x 15 ml (in 20-ml glass vial)
1, 5, or 10 vials x 20 ml (in 20-ml glass vial)
Not all pack sizes may be marketed.
TMC Pharma Services Ltd., Finchampstead, Berkshire RG40 4LJ, UK
EU/1/05/313/001-009
Date of first authorisation: 3 October 2005
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