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
Contraception.
For subcutaneous use.
JADELLE is a contraceptive method for long-term (up to five years) use (see Special warnings and precautions for use).
The patient must be informed that JADELLE implants may be removed at her request at any time.
Before insertion, the woman must be informed of the efficacy, risks, side effects and bleeding pattern changes to be expected with JADELLE. This discussion should include the information that a small proportion of women (17/1100 or 1.5%) experienced adverse effects from the removal of JADELLE including multiple or long incisions, pain, difficult removals and/or additional visits for the removal.
Training is required for the insertion and removal procedures, which should preferably be done by a healthcare professional and the given instructions must be followed closely. The implants are inserted with the disposable, sterile Trocar just beneath the skin.
Important: the disposable JADELLE Trocar is for single use only. After insertion, the Trocar must be disposed of in an appropriate sharps container. Strict asepsis must be observed here. The implants are inserted in the inner aspect of the upper left arm in right-handed women and in the right arm in left-handed women, approximately 8 cm above the fold in the elbow.
Before insertion, the skin is cleaned with an antiseptic and the insertion area anesthetized. An incision of 2 mm is made in the skin with a scalpel. The implants are inserted with the Trocar subdermally, in the shape of a V opening towards the armpit. Proper insertion will later facilitate removal and result in minimal scarring. After insertion of the second implant, the edges of the incision are pressed together, closed with a skin closure and dressed.
The patient should be advised to keep the insertion area dry for 3 days. The gauze and the bandage may be removed as soon as the incision has healed, normally after 3-5 days.
Following insertion, if it is suspected that the system is not in the correct position, it should be removed and a new one inserted.
JADELLE should be inserted within 7 days from the onset of menstrual bleeding. If the implants are inserted at any other time, pregnancy must be reliably excluded before insertion and an additional non-hormonal contraceptive method used for at least 7 days after the insertion.
JADELLE should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive (COC), but at the latest on the day after the tablet-free interval or placebo tablet phase.
In the latter case, the woman should be advised to additionally use a barrier contraceptive method during the tablet-free interval or placebo tablet phase.
In case a vaginal ring or transdermal patch has been used, JADELLE should preferably be inserted on the day of removal of the last ring or patch of a cycle pack, but at the latest when the next application would have been due.
The woman may switch any day from the minipill, another implant, or an IUS on the day of its removal, or from an injectable when the next injection would be due.
JADELLE may be inserted immediately. When doing so, no additional contraceptive measures are needed.
JADELLE may be inserted immediately after the second trimester abortion or childbirth. If inserted later than 21 days after childbirth, pregnancy should be reliably excluded and additional nonhormonal contraceptive precautions taken for a minimum of 7 days after the insertion.
JADELLE implants may be removed at any time for medical or personal reasons but they must be removed after five years from the insertion at the latest. The implants may be removed at any time of the menstrual cycle. Loss of contraceptive effect occurs immediately, and another contraceptive method should be used unless pregnancy is desired.
When starting the removal of implants, the skin is cleaned and a local anaesthetic is infiltrated under the implant ends. A skin incision of 4 mm is made with a scalpel below the bottom of the V. The implants are removed using a small (e.g. Mosquito) forceps. The implants should be removed very gently. This will take more time than the insertion. The implants may be nicked, cut or broken off during removal.
If removal proves difficult or both implants cannot be removed, the patient should be asked to return for a second visit after the removal area has healed. A non-hormonal method of contraception should be used until both implants have been completely removed. If the patient wishes to continue using this method, a new set of JADELLE implants may be inserted through the same incision, either in the same or in the opposite direction.
Following removal pregnancy may occur at any time.
There is no experience of overdose with JADELLE. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
60 Months.
Store below 30°C.
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.
No special requirements.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Information on insertion and removal is provided in the Dosage and Administration section and in the insertion instructions for JADELLE.
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