Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Oxurion NV, Gaston Geenslaan 1, B-3001, Leuven, Belgium
JETREA 0.5 mg/0.2 mL concentrate for solution for injection.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for injection (sterile concentrate). Clear and colourless solution. |
Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution.
After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.
* Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ocriplasmin |
Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA). |
| List of Excipients |
|---|
|
Mannitol |
0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap. Pack containing 1 vial.
Oxurion NV, Gaston Geenslaan 1, B-3001, Leuven, Belgium
EU/1/13/819/001
Date of first authorisation: 13 March 2013
Date of latest renewal: 8 December 2017
| Drug | Countries | |
|---|---|---|
| JETREA | Austria, Australia, Cyprus, Estonia, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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