Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg, Luxembourg
Tenkasi 400 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 oritavancin diphosphate equivalent to 400 mg oritavancin.
After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Oritavancin |
Oritavancin is used for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). |
| List of Excipients |
|---|
|
Mannitol |
Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap.
3 individual vials are packaged in a carton.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg, Luxembourg
EU/1/15/989/001
Date of first authorisation: 19/03/2015
Date of latest renewal: 13/01/2020
| Drug | Countries | |
|---|---|---|
| TENKASI | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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