Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay North Dock, Dublin, D01 V4A3, Ireland
Implanon NXT, 68 mg implant for subdermal use.
| Pharmaceutical Form |
|---|
|
Implant for subdermal use. Radiopaque, non-biodegradable, white to off-white, soft flexible rod with a length of 4 cm and 2 mm in diameter. |
Implanon NXT is a radiopaque, non-biodegradable, progestagen-only, flexible implant preloaded in a sterile, disposable applicator.
Each radiopaque implant contains 68 mg of etonogestrel; the release rate is approximately 60-70 µg/day in week 5-6 and has decreased to approximately 35-45 µg/day at the end of the first year, to approximately 30-40 µg/day at the end of the second year and to approximately 25-30 µg/day at the end of the third year. The applicator is designed to be operated with one hand and to help facilitate correct subdermal insertion of the implant.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etonogestrel |
Etonogestrel is the biologically active metabolite of desogestrel, a progestagen widely used in OCs. It is structurally derived from 19-nortestosterone and binds with high affinity to progesterone receptors in the target organs. The contraceptive effect of etonogestrel is primarily achieved by inhibition of ovulation. |
| List of Excipients |
|---|
ImplantCore: Ethylene vinylacetate copolymer (28% vinyl acetate, 43 mg) Skin: Ethylene vinyl acetate copolymer (15% vinyl acetate, 15 mg) |
The blister pack contains one implant (4 cm in length and 2 mm in diameter) which is preloaded in the stainless steel needle of a ready-for-use, disposable sterile applicator. The applicator containing the implant is packed in a blister pack made of transparent polyethyleneterephthalate glycol (PETG) sealed with a lidding made of high density poly ethylene (HDPE). The content of the blister pack is sterile unless the package is damaged or opened.
Pack sizes: Carton box with 1 blister pack, carton box with 5 blister packs.
Not all pack sizes may be marketed.
Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay – North Dock, Dublin, D01 V4A3, Ireland
PA23198/017/001
Date of first authorisation: 19 March 1999
Date of last renewal: 28 August 2013
| Drug | Countries | |
|---|---|---|
| IMPLANON | Austria, Australia, Brazil, Ecuador, Spain, Ireland, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, South Africa |
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