Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Sivextro 200 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder. |
Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate.
After reconstitution each mL contains 50 mg tedizolid phosphate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tedizolid |
Tedizolid is an oxazolidinone prodrug. The antibacterial activity of tedizolid is mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis. Tedizolid is primarily active against Gram-positive bacteria. |
| List of Excipients |
|---|
|
Mannitol |
Type I (10 ml) clear borosilicate tubing glass vial with a siliconised grey chlorobutyl rubber stopper.
Available in packs of 1 vial and 6 vials.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
EU/1/15/991/002
EU/1/15/991/003
Date of first authorisation: 23 March 2015
Date of latest renewal: 09 January 2020
| Drug | Countries | |
|---|---|---|
| SIVEXTRO | Austria, Brazil, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Mexico, Poland, Singapore, United Kingdom, United States |
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