MIRENA … Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. A study in monkeys with intrauterine delivery of levonorgestrel for 12 months confirmed local pharmacological activity with good local tolerance and no signs of systemic toxicity. Clinical experience of the outcomes of pregnancies with Mirena in situ is limited. To prevent pregnancy, Mirena: 1. An ultrasound should be arranged to locate the device and alternative contraception should be advised in the mean time. • Protection from endometrial hyperplasia during oestrogen replacement therapy. To bookmark a medicine you must sign up and log in. Reporting suspected adverse reactions after authorisation of the medicinal product is important. However, for progestogen-only contraceptive preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs. During difficult removals, single cases have been reported of the hormone cylinder sliding over the horizontal arms and hiding them inside the cylinder. To know more, see our. Women should be encouraged to attend cervical and breast screening as appropriate for their age. In the event of early signs of a vasovagal attack, insertion may need to be abandoned or the system removed. Pearl Index är ett statistiskt mått för att uppskatta olika preventivmedels effektivitet [1].Metoden har fått sitt namn efter Raymond Pearl som introducerade indexet 1933 och det har varit populärt i över 70 år, till stor del på grund av att det är lätt att räkna ut.. Pearl Index … The Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA). The product information of the oestrogen component of the HRT should be consulted prior to the use of Mirena as the important risk factors associated with HRT use should be considered, such as the risk of endometrial cancer, breast cancer and venous thromboembolisms. 2.1 Overview . MIRENA 52 mg intrauterine contraceptive device (release rate: 20 microgram/24 hours) 2. Similar contraceptive efficacy has been observed in a large post-marketing study with more than 17000 women using Mirena. Mirena must be removed if the woman experiences recurrent endometritis or pelvic infection, or if an acute infection is severe. Because of the low plasma concentrations, there are only minor effects on the metabolism. The influence of these drugs on the contraceptive efficacy of Mirena has not been studied but is not believed to be of major importance due to the local mechanism of action. There are no known effects on the ability to drive or use machines. There appear to be no deleterious effects on infant growth or development when using any progestogen-only method after six weeks postpartum. Protection from endometrial hyperplasia during oestrogen replacement therapy. Two of the 5 studies were 5year studies and 3 were 1- year studies. … Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. However, a system can be expelled from the uterine cavity without the woman noticing it. It allows continued monitoring of the benefit/risk balance of the medicinal product. You may insert a new Mirena immediately following removal. Her strong passion of sharing knowledge with the medical fraternity has motivated her to be a part of Medical Dialogues. The estimated Pearl Index, calculated based on data from the 7-cycle study, was 27.5 (95% CI: 22.4%, 33.5%). Use of Mirena (levonorgestrel-releasing intrauterine system; Bayer), has been extended up to 6 years for pregnancy prevention as compared to the previous indication of only 5 years by the US food and drug administration. When a woman becomes pregnant with Mirena in situ, the relative risk of ectopic pregnancy is increased (see sections 4.4 and 4.6). Mirena is supplied within an inserter in a sterile package which should not be opened until needed for insertion. 2. LNG is a progestin commonly used in combination hormonal contraceptives (CHCs), and is a 19-nor-testosterone derivative. As the system decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion. Mirena should be used with caution in postmenopausal women with advanced uterine atrophy. A repeated pregnancy test is not necessary in amenorrhoeic subjects unless indicated by other symptoms. There is no need to remove Mirena unless the symptoms fail to resolve within the following 72 hours or unless the woman wishes Mirena to be removed. By continuing to browse the site you are agreeing to our policy on the use of cookies. The product information of the oestrogen component of the treatment should also be consulted for additional information. About 0.1% of the levonorgestrel dose is transferred during breast-feeding, but it is not likely that there will be a risk for the child with the dose released from Mirena, when it is inserted in the uterine cavity. Pelvic infection: The insertion tube helps to prevent Mirena from contamination with micro-organisms during the insertion and the Mirena inserter has been designed to minimise the risk of infections. The active ingredient of Mirena is levonorgestrel. In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, please refer to section 4.4. She has published scientific papers in national and international journals. Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see section 4.4). The excess risk gradually disappears during the course of the 10 years after cessation of COC use. Most of the hormone stays inside the uterus, and only a small amount is absorbed into the rest of the body. However, when a woman becomes pregnant with Mirena in situ, the relative likelihood of ectopic pregnancy is increased. 400 South Oak Way, Reading, Berkshire, RG2 6AD. Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the progestin. 3. Mirena Intrauterine System. Idiopathic menorrhagia. To ensure continuous contraception a new system should be immediately inserted or an alternative contraceptive method should have been initiated (e.g. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Substances increasing the clearance of levonorgestrel, e.g. This information is intended for use by health professionals, Mirena® 20 micrograms/24 hours intrauterine delivery system. MIRENA Data Sheet Vx2.0, CCDS 23 1 . General Information: As the insertion technique is different from other intrauterine devices, special emphasis should be given to training in the correct insertion technique. The forceps should remain in position and gentle counter traction on the cervix should be maintained throughout the insertion procedure. Active or previous severe arterial disease, such as stroke or myocardial infarction is a contraindication when Mirena is used in conjunction with an oestrogen for HRT use. IMPORTANT! This may require dilatation of the cervical canal or other surgical intervention. The failure rate also includes pregnancies due to undetected expulsions and perforation. In women of fertile age, Mirena is inserted into the uterine cavity within seven days of the onset of menstruation. Results from three comparative studies indicate that in menorrhagic women, menstrual blood loss decreased by 62-94% at the end of three months and by 71-95% at the end of six months of use. - Suppression of ovulation in some women. Hormonspiralen sind sehr sichere Methoden zur Empfängnisverhütung der Frau (Pearl Index Mirena® 0,16 und Jaydess® 0,33). This rate is lower than the rate of 0.3-0.5 % per year estimated for women not using any contraception. If an ultrasound cannot locate the device and there is no evidence of expulsion, a plain abdominal X-ray should be performed to exclude an extrauterine device. The risk of breast cancer is increased in post-menopausal women using systemic (i.e. 1. Post-partum insertion: To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. An endometrial biopsy should also be considered. : Phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort. The risk of breast cancer when Mirena is prescribed to provide the progestogen component of HRT is not yet known. The study was not powered to demonstrate noninferiority (to show noninferiority against Mirena with a Pearl index [number of pregnancies per 100 woman-years] as a target variable of 0.2 per … First, open the sterile package completely (Figure 1). An assessment of the uterine cavity should be performed using ultrasound scan. • Confirmed or suspected hormone dependent tumours including breast cancer, • Current or recurrent pelvic inflammatory disease, • Postpartum endometritis, infected abortion during the past three months, • Conditions associated with increased susceptibility to infections, • Congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity, • Liver tumour or other acute or severe liver disease, • Acute malignancies affecting the blood or leukaemias except when in remission, • Recent trophoblastic disease while hCG levels remain elevated. Levonorgestrel is delivered directly into the uterine cavity. - Active or previous severe arterial disease, such as stroke or myocardial infarction (See section 4.3 when Mirena is used in conjunction with an oestrogen for HRT use). There are no relevant indications for use of Mirena before menarche. Physical examination should be guided by this and by the contraindications and warnings for use. The hormone is contained within a … If the patient is experiencing significant post-partum bleeding and/or pain then infection or other causes should be excluded before insertion. The T-frame of Mirena contains barium sulphate, which makes it visible in X-ray examination. Very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding including spotting, oligomenorrhoea, amenorrhoea (see section 5.1). Should this not happen, continued ultrasound monitoring and other diagnostic/therapeutic measures are recommended. The following adverse reactions have been reported in connection with the insertion or removal procedure of Mirena: pain, bleeding and insertion-related vasovagal reaction with dizziness or syncope (see section 4.4). Mirena is a hormonal intrauterine device classified as a long-acting reversible contraceptive method. Complete the patient reminder card and give it to the patient, after IUS insertion. The Extension Trial study was performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Do not use if the inner package is damaged or open. If difficulty is encountered, consider dilatation of the canal. Estimated in vivo release rates for different points in time are provided in table 3. 5. • Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilise the uterus. Undesirable effects are more common during the first months after the insertion, and subside during prolonged use. Mirena ® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 6 years. The frequency of benign ovarian cysts depends on the diagnostic method used (see section 4.4) but has been estimated from clinical trial data to occur in 7% of users. Women with a previous history of ectopic pregnancy carry a higher risk of a further ectopic pregnancy. If bleeding irregularities develop during a prolonged treatment, appropriate diagnostic measures should also be taken as irregular bleeding may mask symptoms and signs of endometrial polyps or cancer. No embryotoxicity was seen in the rabbit following intrauterine administration of levonorgestrel. In users of copper intrauterine devices (IUDs), the highest rate of pelvic infections occurs during the first month after insertion and decreases later. The product is individually packed into a thermoformed blister package with a peelable lid. Because irregular bleeding/spotting may occur during the first months of therapy in pre-menopausal women, it is recommended to exclude endometrial pathology before insertion of Mirena. As with other gynaecological or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) can occur following IUS insertion, although this is extremely rare. When to check for pregnancy in women of child bearing potential: The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation and expulsion should be excluded. Do not resterilise. Mirena is removed by gently pulling on the threads with forceps. Levonorgestrel-releasing intrauterine system (IUS). Accordingly, such pregnancies should be closely monitored. Mirena is effective for 5 years in the indications for contraception and idiopathic menorrhagia so should be removed after 5 years use. septum, submucous fibroids) or a previously inserted intrauterine contraceptive which has not been removed. Before insertion, a complete personal and family medical history should be taken. If they cannot be found, they may have broken off, the system may have been expelled, or rarely the device may be extrauterine after having perforated the uterus. The efficacy of Mirena in preventing endometrial hyperplasia during continuous oestrogen treatment is the same when oestrogen is administered orally or transdermally. This situation does not require further intervention once completeness of the IUS has been ascertained. Pelvic infection may have serious consequences as it may impair fertility and increase the risk of ectopic pregnancy. Mirena consists of a small T-shaped frame made from a plastic called polyethylene. Ectopic pregnancy: The absolute risk of ectopic pregnancy in Mirena users is low. Glucose tolerance: Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Mirena. • Hypersensitivity to the active substance or to any of the excipients. It can be expected that the systemic hormone exposure of the foetus through the maternal circulation is lower than with any other hormonal contraceptive method. Date of first authorisation/renewal of the authorisation. Brown removal threads are attached to the loop. This rate decreases progressively to half that value after 5 years.Mirena must be removed by the end of the fifth year and can be replaced at the time of removal with a new Mirena if continued contraceptive protection is desired.Mirena is supplied within an inserter in a sterile package (see Figure 1) that must not be opened until required for insertion [see Description (11.2)]. Increased menstrual flow or unexpected bleeding may be indicative of expulsion. If the uterus is retroverted, it may be more appropriate to grasp the posterior lip of the cervix. If the seal of the sterile package is broken, the product should be discarded (see Section 6.6 for disposal instructions). Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. Prior to insertion pregnancy should be excluded and genital infection should be successfully treated. This may be associated with severe pain and continued bleeding. In case of an accidental pregnancy with Mirena in situ, ectopic pregnancy should be excluded (see section 4.4) and the system must be removed and termination of the pregnancy should be considered. This allows a very low daily dosage, as the hormone is released directly into the target organ. the women were willing to continue with its use and have a continuing need for contraception. Mirena may be particularly useful for contraception in patients with excessive menstrual bleeding, and can be successfully used in the treatment of idiopathic menorrhagia. IMPORTANT! While holding the inserter steady, pull the slider to the mark to open the horizontal arms of Mirena (Figure 5). The Pearl Index is defined as the number of contraceptive failures per 100 women-years of exposure, and uses as the denominator the total months or cycles of exposure from the initiation of the product to … The system consists of a white or almost white hormone-elastomer core, mounted on a T-body and covered in opaque tubing, which regulates the release of levonorgestrel. The Pearl Index was developed by Raymond Pearl in 1934 and has been used for over eighty years. • Insert a speculum, visualise the cervix and then thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. If menorrhagia persists then the woman should be re-examined. The risk of perforation may be increased in women with a fixed retroverted uterus. † The Pearl Index is a measure of contraceptive efficacy essentially equivalent to the annual pregnancy risk if 100 women were to use a … Inserter components are an insertion tube, plunger, flange, body and slider. Remove the system if it is not positioned properly within the uterine cavity. In a large prospective comparative non-interventional cohort study with an observation period of 1 year, the ectopic pregnancy rate with Mirena was 0.02%. For details click on the link: Mirena [package insert]. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. In fertile women the average number of spotting days/month decreases gradually from nine to four days during the first six months of use. • 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. Thickens mucus in the cervix to stop sperm from reaching or fertilizing an egg 2. The contraceptive efficacy of has been studied in 5 major clinical studies with 3330 MIRENA women using MIRENA. Although early intrauterine devices were associated with heavy painful periods, recent intrauterine devices have revolutionised both contraception and … A half life of 20 hours is considered the best estimate although some studies have reported values as short as 9 hours and others as long as 80 hours. The white T-body has a loop at one end and two arms at the other end. When used in combination with oestrogen replacement therapy, perimenopausal users of Mirena may experience spotting and irregular bleeding during the first months of the treatment. The risk of having breast cancer diagnosed in users of progestogen-only methods (POPs, implants and injectables), including Mirena, is possibly of similar magnitude to that associated with COC. Pharmacotherapeutic group: Plastic IUD with progestogen. oral or transdermal) hormone replacement therapy (HRT). In another clinical study to evaluate the contraceptive efficacy of Mirena during extended use beyond 5 years, the failure rate during Year 6 was 0.29% (Year 6 Pearl Index 0.35). The levonorgestrel-releasing intrauterine device (IUD) (Mirena) is a frequently used and effective method of contraception, with a Pearl index of 0.1. Year 1: Pearl Index of 0.16; 95% upper CL of 0.58; cumulative 5-year pregnancy rate, based on 13 pregnancies, estimated by the Kaplan-Meier method was 1.45%; 95% upper CL of 2.53%. Another important finding, although one in agreement with experience with other synthetic steroids, has been marked differences in metabolic clearance rates among individuals, even when administration was by the intravenous route. Polydimethylsiloxane tubing (containing silica, colloidal anhydrous). Dilate the cervical canal, if necessary. The woman should be kept supine, the head lowered and the legs elevated to the vertical position if necessary in order to restore cerebral blood flow. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2020. It can be replaced by a new system at any time of the cycle. The failure rate (Pearl Index) was approximately 0.2% at 1 year and the cumulative failure rate was approximately 0.7% at 5 years. with ultrasound). It calculates the number of contraceptive failures for a birth control method per 100 woman years (HWY) … 2 INTRODUCTION . The procedure may precipitate fainting as a vasovagal reaction, or a seizure in an epileptic patient. Women should be advised that Mirena does not protect against HIV (AIDs) and other sexually transmitted disease (please refer to the section below on pelvic infections). 1. Because of the intrauterine administration and the local exposure to the hormone, teratogenicity (especially virilisation) cannot be completely excluded. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COCs), mainly using oestrogen-progestogen preparations. Re-examination after insertion should follow the guidance given above under the heading "Medical examination" above, which may be adapted as clinically indicated in women with risk factors for perforation. This site uses cookies. The ectopic pregnancy rate is 0.02 per 100 woman-years. While holding the slider all the way down, gently remove the inserter by pulling it out. One, 5, and 0 pregnancies occurred in the LNG-IUS12, LNG-IUS16, and Mirena groups, respectively (3-year unadjusted Pearl indices: 0.17, 0.82, and 0). Mirena is supplied with a patient reminder card in the outer package.
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