Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Praha 7, Czech Republic
Macugen 0.3 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear and colourless. |
One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegaptanib |
Pegaptanib is a pegylated modified oligonucleotide that binds with high specificity and affinity to extracellular Vascular Endothelial Growth Factor (VEGF165) inhibiting its activity. VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD. |
| List of Excipients |
|---|
|
Sodium chloride |
Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric (brombutyl rubber) plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric (bromobutyl/synthetic isoprene) tip cap.
Each pre-filled syringe contains approximately 0.25-0.27 ml of solution.
Each carton contains one pre-filled syringe in a pouch (single dose pack).
The pack is supplied without a needle.
PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Praha 7, Czech Republic
EU/1/05/325/002
Date of first authorisation: 31/01/2006
Date of latest renewal: 19/11/2015
| Drug | Countries | |
|---|---|---|
| MACUGEN | Lithuania, Romania, United States |
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