Presentation and Status in Health Basket
1 X 13.5 mg
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: 28 x 30 x 1.55 mm The device is inserted into the uterine cavity and is effective for up to three years. This device is to be inserted into the uterine cavity within seven days of the onset of menstruation. It can be replaced by a new system at any time in the cycle. 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, which may have occurred even if the threads are still visible.
Janess can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the brown colour of the removal threads. The T-frame of the device contains barium sulfate which makes it visible in X-ray examination. Removed by gently pulling on the threads with a forceps. If the threads are not visible and the system 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 the device, the system should be examined to ensure that it is intact.
Elderly patients: Janess has not been studied in women over the age of
65 years. There is no indication for the use of Janess in postmenopausal women.
Patients with hepatic impairment: Janess has not been studied in women with hepatic impairment. Janess is contraindicated in women with acute liver disease or liver tumour.
Patients with renal impairment: Janess has not been studied in women with renal impairment.
Paediatric population: Use of this product before menarche is not indicated.
For method of insertion: See prescribing information for full details.
Contraception for up to 3 years.
Pregnancy. Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections; Acute cervicitis or vaginitis; Postpartum endometritis or infected abortion during the past three months; Cervical intraepithelial neoplasia until resolved; Uterine or cervical malignancy; Progestogen-sensitive tumours, e.g. breast cancer; Abnormal vaginal bleeding of unknown etiology; Congenital or acquired uterine anomaly including fibroids which would interfere with insertion and / or retention of the intrauterine system (i.e. if they distort the uterine cavity); Acute liver disease or liver tumour; Hypersensitivity to the active substance or to any of the excipients.
This device should be used with caution after specialist consultation, or removal of the system should be considered if any of the following conditions exist or arise for the first time: Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, exceptionally severe headache, jaundice, marked increase of blood pressure, severe arterial disease such as stroke or myocardial infarction, Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of this device. However, there is generally no need to alter the therapeutic regimen in diabetics using LNG IUS.
Medical examination/ consultation: Before insertion, a woman must be informed of the benefits and risks of This device, including the signs and symptoms of perforation and the risk of ectopic pregnancy, see below. A physical examination including pelvic examination, examination of the breasts, and a cervical smear should be performed. Pregnancy and sexually transmitted diseases should be excluded. Genital infections should be successfully treated prior to insertion. The position of the uterus and the size of the uterine cavity should be determined. Fundal positioning of this device is important in order to maximize the efficacy and reduce the risk of expulsion. The instructions for the insertion should be followed carefully. Emphasis should be given to training in the correct insertion technique. Insertion and removal may be associated with some pain and bleeding. The procedure may precipitate a vasovagal reaction (e.g. syncope, or a seizure in an epileptic patient). A woman should be re-examined 4 to 6 weeks after insertion to check the threads and ensure that the system is in the correct position. Follow-up visits are recommended once a year thereafter, or more frequently if clinically indicated. This device is not for use as a post-coital contraceptive. The use of this device for the treatment of heavy menstrual bleeding or protection from endometrial hyperplasia during estrogen replacement therapy has not been established. Therefore it is not recommended for use in these conditions.
Ectopic pregnancy: In clinical trials, the overall incidence of ectopic pregnancy with this device was approximately 0.11 per 100 woman-years. Approximately half of the pregnancies that occur during this device use are likely to be ectopic. Women considering this device should be counselled on the signs, symptoms and risks of ectopic pregnancy. For women who become pregnant while using This device, the possibility of an ectopic pregnancy must be considered and evaluated. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially in connection with missed periods or if an amenorrheic woman starts bleeding. Because an ectopic pregnancy may impact future fertility the benefits and risks of using this device should be carefully evaluated, in particular for nulliparous women. Use in nulliparous women: This device is not first choice for contraception in nulliparous women as clinical experience is limited.
Effects on the menstrual bleeding pattern: Effects on the menstrual bleeding pattern are expected in most users of this device. Those alterations are a result of the direct action of levonorgestrel on the endometrium and may not correlate with the ovarian activity. Irregular bleeding and spotting are common in the first months of use. Thereafter, the strong suppression of the endometrium results in the reduction of the duration and volume of menstrual bleeding. Scanty flow frequently develops into oligomenorrhea or amenorrhea.
See prescribing information for full details.
The majority of women experience changes in menstrual bleeding pattern after insertion of Janess. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of prolonged, irregular and frequent bleeding decreases.
See prescribing information for full details.
Interactions can occur with drugs that induce hepatic microsomal enzymes, specifically cytochrome P450 enzymes, and may therefore increase the metabolism of levonorgestrel, resulting in increased clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, bosentan, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing the herbal remedy St. John’s Wort). On the other hand, substances known to inhibit drug-metabolizing enzymes (e.g. itraconazole, ketoconazole) may increase serum concentrations of levonorgestrel. The influence of these drugs on the efficacy of the device is not known, but it is not believed to be of major importance due to the local mechanism of action.
Magnetic resonance imaging (MRI): Non-clinical testing has demonstrated that a patient can be scanned safely after placement of the device under the following conditions: Static magnetic field of 3-Tesla or less, maximum spatial gradient magnetic field of 720-Gauss/cm or less. Under these conditions, with 15-min of scanning, the maximum temperature rise produced at the site of the device was 1.8°C. A small amount of imaging artifact may occur if the area of interest is in the exact same area or relatively close to the position of the device.
Pregnancy and Lactation
Pregnancy: The insertion of the device in pregnant women is contraindicated.
Lactation: In general, there appears to be no deleterious effect on infant growth or development when using any progestogen-only method after six weeks postpartum.
See prescribing information for full details.
Storage: This medicinal product does not require any special storage conditions. It is recommended to store at room temperature.