Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2020 Publisher: Bayer New Zealand Limited, P O Box 2825, Shortland Street, Auckland 1140, New Zealand Free phone 0800 233 988 www.bayer.co.nz
JADELLE levonorgestrel 2 × 75 mg subcutaneous implants.
| Pharmaceutical Form |
|---|
|
Subcutaneous implant. The implants are flexible, sealed, white to off-white rods, about 43 mm in length and 2.5 mm in diameter. |
JADELLE consists of two implants to be inserted subdermally. Each implant contains 75 mg levonorgestrel.
The release rate of levonorgestrel is about 100 microgram/day at one month after insertion, declining to about 40 microgram/day within one year, to about 30 microgram/day within three years and to about 25 microgram/day within five years.
For full list of excipients, see List of excipients.
| 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 |
|---|
|
Silicone elastomers |
The sterile implants are packed in a moulded polyethylene terephtalate blister package sealed with a coated, spunbonded polyethylene film. If the seam of the sterile package is broken, the product should be discarded.
Each pack contains two 75 mg implants for insertion.
Bayer New Zealand Limited, P O Box 2825, Shortland Street, Auckland 1140, New Zealand
Free phone 0800 233 988
www.bayer.co.nz
Date of first approval: 9 September 2015
| Drug | Countries | |
|---|---|---|
| JADELLE | Ecuador, Finland, Mexico, Nigeria, New Zealand, South Africa |
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