Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Kyleena 19.5 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. The blue 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 inserter consists of a handle and slider that are integrated with flange, lock, pre-bent insertion tube and plunger. The removal threads are located within the insertion tube and handle. Dimensions of Kyleena: 28 × 30 × 1.55 mm |
The intrauterine delivery system contains 19.5 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 00010/0664
Date of first authorisation: 23 December 2016
| Drug | Countries | |
|---|---|---|
| KYLEENA | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States, South Africa |
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