Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Jaydess 13.5 mg intrauterine delivery system.
| Pharmaceutical Form |
|---|
|
Intrauterine delivery system (IUS). The product consists of a whitish or pale yellow drug core covered with a semi-opaque membrane, which is mounted on the vertical stem of a T-body. In addition, the vertical stem contains a silver ring located close to the horizontal arms. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown coloured removal threads are attached to the loop. The vertical stem of the IUS is loaded in the insertion tube at the tip of the inserter. The IUS and inserter are essentially free of visible impurities. Dimensions of Jaydess: 28 × 30 × 1.55 mm. |
The intrauterine delivery system contains 13.5 mg levonorgestrel.
For the full list of excipients, see section 6.1.
For details of release rates, see section 5.2.
| 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 elastomer |
The product is individually packed into a thermoformed blister package (PETG) with a peelable lid (PE).
Pack sizes: 1x1 and 5x1.
Not all pack sizes may be marketed.
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
PL 00010/0587
Date of first authorisation: 25 January 2013
| Drug | Countries | |
|---|---|---|
| JAYDESS | Austria, Ecuador, Spain, Finland, France, Hong Kong, Ireland, Malta, New Zealand, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
