Jaydess
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse reactions.
1. NAME OF THE MEDICINAL PRODUCT
Jaydess 13.5 mg intrauterine delivery system.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3. 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 T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. 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 x 30 x 1.55 mm
4. Clinical particulars
4.1 Therapeutic indications
Contraception for up to 3 years.
4.2 Posology and method of administration
Posology
Jaydess is inserted into the uterine cavity and is effective for up to three years.
Insertion and removal/ replacement
It is recommended that Jaydess should only be inserted by physicians/ healthcare providers who are experienced in IUS insertions and/ or have undergone training on the Jaydess insertion procedure.
Jaydess is to be inserted into the uterine cavity within seven days of the onset of menstruation. Jaydess can be replaced by a new system at any time in the cycle. Jaydess can also be inserted immediately after first trimester abortion.
Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than six weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum.
In case of a difficult insertion and/ or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound. Physical examination may not be sufficient to exclude partial perforation.
Jaydess can be distinguished from other IUSs by the visibility of the silver ring on ultrasound. The T-frame of Jaydess contains barium sulphate which makes it visible in X-ray examination.
Jaydess is removed by gently pulling on the threads with a forceps. If the threads are not visible and thesystem is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps. This may require dilatation of the cervical canal or surgical intervention.
The system should be removed no later than by the end of the third year. If the woman wishes to continue using the same method, a new system can be inserted immediately following removal of the original system.
If pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is still experiencing regular menses. If the system is removed at some other time during the cycle and the woman has had intercourse within a week, she is at risk of pregnancy unless a new system is inserted immediately following removal.
After removal of Jaydess, the system should be examined to ensure that it is intact.
Elderly patients
Jaydess has not been studied in women over the age of 65 years. There is no indication for the use of Jaydess in postmenopausal women.
Patients with hepatic impairment
Jaydess has not been studied in women with hepatic impairment. Jaydess is contraindicated in women with acute liver disease or liver tumor (see section 4.3).
Patients with renal impairment
Jaydess has not been studied in women with renal impairment.
Paediatric population
Use of this product before menarche is not indicated. For data on safety and efficacy in adolescents, see section 5.1.
Method of administration
To be inserted by a healthcare provider using aseptic technique.
Jaydess is supplied within an inserter in a sterile package, which should not be opened until needed for insertion. Do not resterilize. As supplied, Jaydess is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date which is stated on the carton and the blister after EXP.
Any unused product or waste material should be disposed of in accordance with local requirements.
Preparation for insertion
- Examine the patient to establish the size and position of the uterus, in order to detect any signs of acute genital infections or other contraindications for the insertion of Jaydess. If there is any doubt regarding pregnancy, a pregnancy test should be performed.
- Insert a speculum, visualize the cervix, and then thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
- Employ an assistant as necessary.
- Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, it may be more appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps can be applied to straighten the cervical canal. The forceps should remain in position and gentle counter traction on the cervix should be maintained throughout the insertion procedure.
- Advance a uterine sound through the cervical canal to the fundus to measure the depth and confirm the direction of the uterine cavity and to exclude any evidence of intrauterine abnormalities (e.g., septum, submucous fibroids) or a previously inserted intrauterine contraceptive which has not been removed. If difficulty is encountered, consider dilatation of the canal. If cervical dilatation is required, consider using analgesics and/or a paracervical block.
Insertion
|
1. First, open the sterile package completely (Figure 1). Then use aseptic technique and sterile gloves.
Figure 1 Jaydess Flange Mark Slider Handle with threads inside Insertion tube with plunger and scale 
 
 |
|
|
2. Push the slider forward in the direction of the arrow to the furthest position to load Jaydess into the insertion tube (Figure 2). |
Figure 2  |
|
IMPORTANT! Do not pull the slider downwards as this may prematurely release Jaydess. Once released, Jaydess cannot be re-loaded. |
|
|
3. Holding the slider in the furthest position, set the upper edge of the flange to correspond to the sound measurement of the uterine depth (Figure 3). |
Figure 3 |