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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
MIRENA 52 mg intrauterine contraceptive device (release rate: 20 microgram/24 hours)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MIRENA is an intrauterine system (IUS) containing 52 mg levonorgestrel. For details of release rates, see Section 5.2.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
MIRENA consists of a white or almost white drug core covered with an opaque membrane, which is mounted on the vertical stem of a T-body. The vertical stem of the levonorgestrel intrauterine system is loaded in the insertion tube at the tip of the inserter. Inserter components are an insertion tube, plunger, flange, body and slider. The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Brown coloured removal threads are attached to the loop. The T-body of MIRENA contains barium sulfate, which makes it visible in X-ray examination. The IUS and inserter are essentially free from visible impurities.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Contraception
Treatment of idiopathic menorrhagia provided there is no underlying pathology.
Prevention of endometrial hyperplasia during estrogen replacement therapy
4.2 Dose and method of administration
MIRENA is inserted into the uterine cavity. One administration is effective for five years.
The in vivo dissolution rate is approximately 20 microgram/24 hours initially and is reduced to approximately 18 microgram/24 hours after 1 year and to 10 microgram/24 hours after five years. The mean dissolution rate of levonorgestrel is about 15 microgram /24 hours over the time up to five years.
In women under hormone replacement therapy, MIRENA can be used in combination with oral or transdermal estrogen preparations without progestogens.
MIRENA, when inserted according to the insertion instructions, has a failure rate of approximately 0.2% at 1 year and a cumulative failure rate of approximately 0.7 % at 5 years.
4.2.1 Medical examination/consultation
Before insertion, the woman must be informed of the efficacy, risks and side effects of MIRENA and the differences between the IUS and the copper intrauterine devices (IUDs). In particular, the woman should be informed about the expected differences in bleeding pattern, amenorrhea and hormonal effects. Studies have suggested that good counselling is likely to reduce unnecessary removals of MIRENA.
A physical examination, including pelvic and breast examinations should be conducted. Cervical smear should be performed as needed, according to Healthcare Professional’s evaluation. Pregnancy, sexually transmitted diseases and endometrial pathology should be excluded, and genital infections have to be successfully treated. The position of the uterus and the size of the uterine cavity should be determined. Fundal positioning of MIRENA is particularly important in order to ensure uniform exposure of the endometrium to the progestogen, prevent expulsion and maximise efficacy. Therefore, the instructions for insertion should be followed carefully. Because the insertion technique is different from other intrauterine devices, special emphasis should be given to training in the correct insertion technique.
The woman should be re-examined 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Because irregular bleeding/spotting is common during the first months of therapy, it is recommended to exclude endometrial pathology before insertion of MIRENA.
If the woman continues the use of MIRENA inserted earlier for contraception, endometrial pathology has to be excluded in the case of bleeding disturbances that appear after commencing estrogen replacement therapy.
If bleeding irregularities develop during a prolonged treatment, appropriate diagnostic measures should also be taken.
4.2.2 Insertion and removal/replacement
In women of reproductive potential, MIRENA is to be inserted into the uterine cavity within seven days of the onset of menstruation. MIRENA can be replaced by a new intrauterine system at any time in the cycle. The intrauterine system 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, the possibility of perforation should be considered and appropriate steps should be taken, such as physical examination and ultrasound.
4.3 Contraindications
Known or suspected pregnancy
Current or recurrent pelvic inflammatory disease
Lower genital tract infection
Postpartum endometritis
Infected abortion during the past three months
Cervicitis
Cervical dysplasia
Uterine or cervical malignancy
Confirmed or suspected hormone dependent tumours including breast cancer
Undiagnosed abnormal uterine bleeding
Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity
Conditions associated with increased susceptibility to infections
Acute liver disease or liver tumour
Hypersensitivity to the active substance or to any of the excipients
4.4 Special warnings and precautions for use
MIRENA may be used with caution after specialist consultation, or removal of the intrauterine 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 in blood pressure
- severe arterial disease such as stroke or myocardial infarction
- acute venous thromboembolism.
MIRENA is not the method of first choice for nulligravid women.
Previous studies indicate that an increased number of sexual partners may increase susceptibility to sexually transmitted infections (see Section 4.4.5).
MIRENA is not the method of choice for postmenopausal women with advanced uterine atrophy as the cervical canal is likely to be narrow, making insertion more difficult.
MIRENA is not suitable for use as a post-coital contraceptive.
Current evidence indicates that estrogen replacement therapy should only be used short-term and that in most circumstances, the risk of long-term estrogen replacement therapy outweighs the benefits (see NZ HRT guidelines). This needs to be taken into consideration when co- prescribing MIRENA for endometrial protection. In addition, where MIRENA is used for endometrial protection during estrogen replacement therapy, please refer to the information contained in the Data Sheet for estrogen-containing preparations. In particular all prospective and current users of estrogen-replacement preparations should be advised of the risks and benefits of treatment and the need for treatment should be reviewed frequently.
4.4.1 Heart Disease
MIRENA may be used with caution in women who have congenital heart disease or valvular heart disease at risk of infective endocarditis. Antibiotic prophylaxis should be administered to these patients when inserting or removing MIRENA.
4.4.2 Diabetes
Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of MIRENA. However, there is generally no need to alter the therapeutic regimen in diabetics using MIRENA.
4.4.3 Tumours
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 estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of COC use. As 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. The risk of having breast cancer diagnosed in progestogen-only pill users is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs.
Due to the limited exposure in MIRENA trials in the indication “prevention of endometrial hyperplasia during estrogen replacement therapy”, the available data is not sufficient to confirm or refute a risk for breast cancer when MIRENA is used in this indication. The Data Sheet of the estrogen replacement therapy should also be consulted for additional information.
Irregular bleeding/spotting is common during the first few months of therapy, however this may mask some symptoms and signs of endometrial polyps or cancer. Endometrial pathology should therefore be excluded before using MIRENA. If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken.
Some studies suggest that combination oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV). Irregular bleeding patterns associated with the use of MIRENA could mask symptoms of cervical or endometrial cancer. Close clinical surveillance is essential in all women using MIRENA and in all cases of persistent or recurrent abnormal vaginal bleeding, appropriate diagnostic measures should be taken to eliminate the possibility of malignancy. Benign hepatic adenomas have been found to be associated with the use of oral contraceptives containing levonorgestrel. Although benign, hepatic adenomas may rupture and cause death through intra- abdominal hemorrhage. The contribution of the progestin component of oral contraceptives to the development of hepatic adenomas is not known.
4.4.4 Oligo/amenorrhoea
In a study with women of reproductive age using MIRENA, oligomenorrhea and amenorrhea developed gradually in 57% and 16% of women, respectively, at the end of the first year of use. The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation. A repeated pregnancy test is not necessary in amenorrheic women unless indicated by other signs of pregnancy.
When MIRENA is used in combination with continuous estrogen replacement therapy, a non- bleeding pattern gradually develops in most women during the first year. The rate of total amenorrhea for at least 90 days is about 30% when MIRENA is used in perimenopausal
In a large, prospective, comparative, non-interventional cohort study in IUD users (n=61, women) with a 1 year observational period, the incidence of perforation was 1.3 (95% CI: 1.1- 1.6) per 1000 insertions in the entire study cohort; 1.4 (95% CI: 1.1-1.8) per 1000 insertions in the MIRENA cohort and 1.1 (95% CI: 0.7-1.6) per 1000 insertions in the copper IUD cohort. Extending the observational period to 5 years in a subgroup of this study (N = 39,009 women using MIRENA or copper IUD), the incidence of perforation detected at any time during the entire 5-year period was 2.0 (95% CI: 1.6–2.5) per 1000 insertions.
The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 1). These risk factors were confirmed in the subgroup followed up for 5 years. Both risk factors were independent of the type of IUD inserted.
Table 1: Incidence of perforation per 1000 insertions for the entire study cohort observed over 1 year, stratified by breastfeeding and time since delivery at insertion (parous women) Breastfeeding at time of insertion Not breastfeeding at time of insertion
Insertion ≤ 36 weeks after delivery
5.6 (95% CI: 3.9-7.9; n=6,047 insertions)
1.7 (95% CI: 0.8-3.1; n=5,927 insertions)
Insertion ≥ 36 weeks after delivery
1.6 (95% CI: 0.0-9.1; n=608 insertions)
0.7 (95% CI: 0.5-1.1; n=41, insertions)
The risk of perforations may be increased in women with fixed retroverted uterus.
Re-examination after insertion should follow the guidance given under the heading “Medical Examination” (see Section 4.2.1), which may be adapted as clinically indicated in women with risk factors for perforation.
4.4.8 Ectopic pregnancy
Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher 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. In clinical trials, the ectopic pregnancy rate with MIRENA was approximately 0.1% per year. In a large, prospective, comparative, non-interventional cohort study with an observation period of one year, the ectopic pregnancy rate with MIRENA was 0.02%. This rate is lower than in women not using any contraception (0.3–0.5 % per year). The absolute risk of ectopic pregnancy in MIRENA users is low. However, when a woman becomes pregnant with MIRENA in situ , the relative likelihood of this pregnancy being ectopic is increased and urgent assessment is required.
4.4.9 Sexually transmitted infections
MIRENA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). The woman should be advised that additional measures, e.g. condoms, are needed to prevent the transmission of STIs.
4.4.10 Lost threads
If the retrieval threads are not visible at the cervix on follow-up examinations, pregnancy must be excluded. The threads may have been drawn up into the uterus or cervical canal and may reappear during the next menstrual period. If pregnancy has been excluded, the threads may usually be located by gently probing with a suitable instrument. If they cannot be found, the
possibility of expulsion or perforation should be considered. Ultrasound diagnosis may be used to ascertain the correct position of the intrauterine system. If ultrasound is not available or successful, X-ray may be used to locate MIRENA.
4.4.11 Ovarian Cysts
Since the contraceptive effect of MIRENA is mainly due to its local effect, ovulatory cycles with follicular rupture usually occur in women of fertile age. Sometimes atresia of the follicle is delayed and folliculogenesis may continue. These enlarged follicles cannot be distinguished clinically from ovarian cysts. Ovarian cysts have been reported as adverse reactions in approximately 7% of women using MIRENA. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia.
In most cases the ovarian cysts disappear spontaneously within 2 - 3 months, but if they persist continued ultrasound monitoring and other diagnostic/therapeutic measures are recommended. Rarely, surgical intervention may be required.
4.5 Interaction with other medicines and other form of interaction
Interactions can occur with drugs that induce or inhibit microsomal enzymes, which can result in increased or decreased clearance of sex hormones.
Substances increasing the clearance of levonorgestrel, e.g.:
Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and products containing St. John’s wort.
The influence of these medicines on the contraceptive efficacy of MIRENA is not known, but it is not believed to be of major importance due to the local mechanism of action.
Substances with variable effects on the clearance of levonorgestrel:
When co-administered with sex hormones, many HIV/HCV protease inhibitors and non- nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of the progestogen.
Substances decreasing the clearance of levonorgestrel (enzyme inhibitors), e.g.:
Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the progestin.
4.6 Fertility, pregnancy and lactation
4.6.1 Fertility
Studies have suggested that in women who discontinue MIRENA for planned pregnancy, the pregnancy rate at one year is similar to those who do not use contraception.
4.6.2 Pregnancy
Pregnancy Category B3.
The use of MIRENA during an existing or suspected pregnancy is contraindicated (see Section 4.3). If the woman becomes pregnant when using MIRENA, removal of the intrauterine system is recommended, since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour. Removal of MIRENA or probing of the uterus may result in spontaneous abortion. Ectopic pregnancy should be excluded. If the intrauterine contraceptive cannot be gently removed, termination of the pregnancy may be considered. If the woman wishes to continue the pregnancy and the intrauterine system cannot be withdrawn, she should
Table 2: Adverse reactions reported in clinical trials with MIRENA
System Organ Class Very Common Common Uncommon Rare
Psychiatric Disorders Depressed mood/Depression Nervousness Decreased libido
Altered mood
Nervous System Disorders
Headache Migraine
Gastrointestinal Disorders
Abdominal /pelvic pain
Nausea Abdominal distension
Skin and Subcutaneous Tissue Disorders
Acne Hirsutism
Alopecia Pruritis Eczema
Rash Urticaria
Musculoskeletal, Connective Tissue and Bone Disorders
Back pain**
Reproductive System and Breast Disorders
Bleeding changes including increased and decreased menstrual bleeding, spotting, oligomenorrhoea and amenorrhoea Vulvovaginitis* Genital discharge*
Upper genital tract infection Ovarian cyst Dysmenorrhoea Breast tenderness Breast pain** Intra-uterine contraceptive device expulsion (complete and partial)
Cervicitis/ Papanicolaou smear normal, class II Uterine perforation***
General Disorders and Administration Site Conditions
Oedema
Investigations Weight increased
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
- Endometrial prevention trials: “common” ** Endometrial prevention trials: “very common” *** This frequency is based on a large, prospective, comparative, non-interventional cohort study in IUD users which showed that breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth are independent risk factors for perforation (see Section 4.4.7 Perforation). In clinical trials with MIRENA that excluded breastfeeding women, the frequency of perforation was "rare".
4.8.3 Description of post market adverse reactions
Pregnancy, puerperium and perinatal conditions
When a woman becomes pregnant with MIRENA in situ, the relative risk of ectopic pregnancy is increased.
Breast Disorders
The risk of breast cancer is unknown when MIRENA is used in the indication “prevention of endometrial hyperplasia during estrogen replacement therapy”. Cases of breast cancer have been reported in MIRENA users (frequency unknown, see Section 4.4).
Immune System Disorders Hypersensitivity including rash, urticaria and angioedema
Reproductive system disorders
The removal threads may be felt by the partner during intercourse.
Injury, poisoning and procedural complications
The following ADRs have been reported in connection with the insertion or removal procedure of MIRENA: Procedural pain, procedural bleeding, insertion-related vasovagal reaction with dizziness or syncope. The procedure may precipitate a seizure in an epileptic patient.
Infections and infestations
Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see Section 4.4).
Investigations Blood pressure increased
4.8.4 Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to https://nzphvc.otago.ac.nz/reporting/
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Plastic IUD with progestogen ATC Code: G02BA
Levonorgestrel is a white or almost white, odourless or almost odourless, crystalline powder. It is insoluble in water or hexane, slightly soluble in ethanol or acetone, and sparingly soluble in methylene chloride. The chemical name for levonorgestrel is 13β-ethyl-17β-hydroxy-18,19- dinor-17α-pregn-4-en-20-yn-3-one. The CAS registry number for levonorgestrel is 797-63-7.
Chemical Formula: C 21 H 28 O 2 Molecular Weight: 312. Melting Point: 232-239 °C
5.1.1 Mechanism of action
Levonorgestrel is a progestogen with anti-estrogenic activity used in gynaecology in a number of ways: as the progestogen component in oral contraceptives and in hormone replacement therapy, or alone for contraception in progestogen-only pills and subdermal implants. Levonorgestrel can also be administered into the uterine cavity as an intrauterine delivery system. This allows a very low daily dosage, as the hormone is released directly into the uterine cavity.
5.1.3.2 Menorrhagia
MIRENA can be successfully used in the treatment of idiopathic menorrhagia where no underlying pathology causing excessive bleeding can be found (see Section 4.3). In menorrhagic women, the 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. Compared to endometrial ablation or resection, MIRENA demonstrated equal efficacy in reducing the menstrual blood loss up to two years. Another clinical trial (Study number 102-90528) compared the use of MIRENA with various standard oral treatments prior to a planned hysterectomy. More patients in the MIRENA group (67% compared to 15% in the reference group) decided to continue with MIRENA rather than proceed with hysterectomy).
Menorrhagia caused by submucosal fibroids may respond less favourably to treatment with MIRENA. 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. MIRENA appears to have similar effects to endometrial ablation/resection in reducing the menstrual blood loss up to two years. Reduced bleeding increases the concentration of blood ferritin and haemoglobin. MIRENA also alleviates dysmenorrhea.
5.1.3.3 Hormone Replacement Therapy (HRT)
MIRENA provides the progestogenic component of continuous hormone replacement therapy (HRT). Due to the local administration, the systemic levonorgestrel concentration is very low.
To date, clinical data presented on the use of MIRENA for the prevention of endometrial hyperplasia has been from study trials of 24 months duration or less. Studies have demonstrated the efficacy of MIRENA in preventing endometrial hyperplasia during continuous estrogen treatment when administering estrogen either orally or transdermally. The observed hyperplasia rate under estrogen therapy alone is as high as 20% after one year of continuous treatment. In clinical studies with a total of 634 perimenopausal and postmenopausal users of MIRENA, no endometrial hyperplasias were reported during the observation period varying from one up to five years.
The concomitant estrogens used in the HRT studies were oral continuous estradiol valerate 2 mg/24 hours, continuous transdermal estradiol 50 microgram/24 hours, oral conjugated equine estrogen 0.625, 1.25 mg/day estradiol implants 36 microgram/24 hours and estradiol gel 1. mg/24 hours. MIRENA was effective in preventing endometrial hyperplasia in association with these regimens.
In clinical studies with MIRENA and copper IUDs used in contraception, no significant differences were found between the groups in serum levels of triglycerides, HDL cholesterol and total cholesterol after two and five years of treatment. The effect of MIRENA on lipid levels has been shown to be neutral.
5.2 Pharmacokinetic properties
The active ingredient of MIRENA is levonorgestrel. Levonorgestrel is directly released into the uterine cavity. Estimated in vivo release rates for different time points in time are provided in Table 3.
Table 3: Estimated in vivo release rates for MIRENA Time Estimated in vivo release rate (μg/24 hrs) Initial 20 1 year after insertion 18 5 years after insertion 10 Average over 5 years 15
5.2.1 Absorption
Following insertion, levonorgestrel is released from the IUS into the uterine cavity without delay based on serum concentration measurements. More than 90% of the released levonorgestrel is systemically available.
After insertion of MIRENA, levonorgestrel is detectable in serum after 1 hour. The maximum concentration is reached within 2 weeks after insertion. In correspondence with the declining release rate, the median serum concentration of levonorgestrel declines from 206 picogram/mL (25th to 75th percentiles: 151 picogram/mL to 264 picogram/mL) at 6 months to 194 picogram/mL (146 picogram/mL to 266 picogram/mL) at 12 months, and to 131 picogram/mL (113 picogram/mL to 161 picogram/mL) at 60 months in women of reproductive age weighing above 55 kg.
The high local drug exposure in the uterine cavity leads to a strong concentration gradient via the endometrium to the myometrium (gradient endometrium to myometrium >100-fold), and to low concentrations of levonorgestrel in serum (gradient endometrium to serum>1000-fold).In postmenopausal women using MIRENA together with non-oral estrogen treatment, the median serum concentration of levonorgestrel declines from 257 picogram/mL (25th to 75th percentiles: 186 picogram/mL to 326 picogram/mL) at 12 months to 149 picogram/mL (122 picogram/mL to 180 picogram/mL) at 60 months. When MIRENA is used together with oral estrogen treatment, the serum levonorgestrel concentration at 12 months is increased to approx. 478 picogram/mL (25th to 75th percentiles: 341 picogram/mL to 655 picogram/mL) due to the induction of sex hormone binding globulin (SHBG) by oral estrogen treatment.
5.2.2 Distribution
Levonorgestrel is bound non-specifically to serum albumin and specifically to SHBG. Less than 2% of the circulating levonorgestrel is present as free steroid. Levonorgestrel binds with high affinity to SHBG. Accordingly, changes in the concentration of SHBG in serum result in an increase (at higher SHBG concentrations) or in a decrease (at lower SHBG concentrations) of the total levonorgestrel concentration in serum. The concentration of SHBG declined on average by about 20-30% during the first month after insertion of MIRENA, remained stable during the first year and increased slightly thereafter.
The mean apparent volume of distribution of levonorgestrel is about 106 L. Body weight and serum SHBG concentration have been shown to affect systemic levonorgestrel concentration i.e. low body weight and/or a high SHBG level increase levonorgestrel concentration. In women of reproductive age with a low body weight (37 to 55 kg) the median serum concentration of levonorgestrel is about 1.5 fold higher.
5.2.3 Biotransformation
Levonorgestrel is extensively metabolised. The most important metabolic pathways are the reduction of the Δ4-3-oxo group and hydroxylations at positions 2α, 1β and 16β, followed by conjugation. CYP3A4 is the main enzyme involved in the oxidative metabolism of levonorgestrel. The available in vitro data suggest that CYP mediated biotransformation reactions may be of minor relevance for levonorgestrel compared to reduction and conjugation.
5.2.4 Elimination
The total clearance of levonorgestrel from plasma is approximately 1.0 mL/min/kg. Only trace amounts of levonorgestrel are excreted in unchanged form. The metabolites are excreted with the faeces and urine at an excretion ratio of about 1. The excretion half-life which is mainly represented by metabolites is about 1 day.
6.6 Special precautions for disposal and other handling
If the seam of the sterile package is broken, the IUS should be discarded as medicinal waste. A removed IUS and inserter should be handled as medicinal waste, since it may contain hormone remnants and blood contaminants.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
6.6.1 Instructions for use/handling
MIRENA is supplied in a sterile pack which should not be opened until required for insertion by a professional experienced in the insertion of MIRENA. Because the insertion technique is different from other intrauterine devices, special emphasis should be given to training in the correct insertion technique. The exposed product should be handled with aseptic precautions. For further information, see Section 4.2.2_._ Special instructions for insertion are in the package.
MIRENA is supplied with a patient reminder card in the outer package. Complete the patient reminder card and give it to the patient, after insertion.
7. MEDICINE SCHEDULE
Prescription Medicine
8. SPONSOR
Bayer New Zealand Limited P O Box 2825 Shortland Street Auckland 1140 New Zealand Free phone 0800 233 988
9. DATE OF FIRST APPROVAL
2 April 1998
10. DATE OF REVISION OF THE TEXT
19 October 2021
® Registered Trademark of the Bayer Group, Germany
Summary table of changes
Section changed Summary of new information 6.4 Special precautions for storage
Update to the storage conditions.
