Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
IVEMEND 150 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to off-white amorphous powder. |
Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fosaprepitant |
Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant. The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out. |
| List of Excipients |
|---|
|
Disodium edetate (E386) |
10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.
Pack sizes: 1 or 10 vials.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/07/437/003
EU/1/07/437/004
Date of first authorisation: 11 January 2008
Date of latest renewal: 11 January 2013
| Drug | Countries | |
|---|---|---|
| IVEMEND | Austria, Canada, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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