Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Levosert 20 microgram/24 hours Intrauterine Delivery System.
| Pharmaceutical Form |
|---|
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Intrauterine delivery system (IUS). The product consists of an inserter and levonorgestrel IUS, which is loaded at the tip of the inserter. Inserter components are an insertion tube, plunger, flange, body and slider. The device consists of a white or almost white hormone-elastomer core, mounted on a T-body and covered in opaque tubing, which regulates the release of levonorgestrel. The T-body has a loop at the end of the vertical stem and two horizontal arms at the other end. Removal threads are attached to the loop. |
The active substance is levonorgestrel (LNG).
The intrauterine delivery system contains 52 mg levonorgestrel. The initial release of levonorgestrel is approximately 20 micrograms per day. This rate decreases progressively to approximately 8.6 micrograms/day after 6 years. The average in vivo release rate of LNG is approximately 14.3 micrograms/day over a period of 6 years.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levonorgestrel |
The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. |
| List of Excipients |
|---|
|
Polydimethylsiloxane (PDMS) reservoir |
Levosert IUS with the inserter device is individually packed into a thermoformed blister (polyester) package with a peelable lid (TYVEK-Polyethylene).
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
PL 04854/0158
28/12/2012
| Drug | Countries | |
|---|---|---|
| LEVOSERT | Austria, Ecuador, Estonia, Spain, Croatia, Ireland, Lithuania, Malta, New Zealand, Poland, United Kingdom |
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