Posology : מינונים

4.2 Posology and method of administration
Posology

Mirena is inserted into the uterine cavity and is effective for 5 years in the indications contraception and idiopathic menorrhagia.

In the indication for protection from endometrial hyperplasia during oestrogen replacement therapy, clinical data (from clinical trials conducted in women of 18 years and over) beyond 4 years of use are limited. Mirena should therefore be removed after 4 years.

Mirena is supplied within an inserter in a sterile package which should not be opened until required for insertion. The exposed product should be handled with aseptic precautions. If the seal of the sterile package is broken, the product should be discarded (see Section 6.6 for disposal instructions).

Mirena is supplied with a patient reminder card in the outer package. Complete the patient reminder card and give it to the patient, after IUS insertion.

Insertion
It is strongly recommended that Mirena should only be inserted by physicians who are experienced in Mirena insertions and/or have undergone sufficient training for Mirena insertion.



Table 1: When to insert Mirena in women of fertile age

Starting Mirena              - Exclude pregnancy before insertion (see section 4.3 Contraindications).
Consider the possibility of ovulation and conception before using this product. Mirena is not suitable for use as a post-coital contraceptive.
- Mirena should be inserted into the uterine cavity within 7 days of the onset of menstruation. In this case Mirena provides contraceptive protection upon insertion and no back-up contraception is needed.
- If insertion within 7 days of the onset of menstruation is not possible or the woman does not experience regular menses, Mirena may be inserted at any time during the menstrual cycle provided that the healthcare professional can reliably exclude the possibility of prior conception. Following insertion, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Postpartum insertion         In addition to the instructions above (Starting Mirena): 
Postpartum insertions should be postponed until the uterus is fully involuted, however should not be performed earlier than 6 weeks after delivery. If the patient is experiencing significant post-partum bleeding and/or pain then infection or other causes should be excluded before insertion. If involution is substantially delayed, consider waiting until 12 weeks postpartum.

Insertion after first-       Insert Mirena immediately after a first-trimester abortion or trimester abortion or        miscarriage unless it is a septic abortion (See contraindications). In this miscarriage                  case no back-up contraception is needed.

Switching to Mirena          If inserted during active use of oral contraceptive, insert Mirena at any from an oral or vaginal      time, including during the hormone-free interval. Continue taking the hormonal contraceptive       oral contraceptive until the end of the current treatment cycle.

Replacing Mirena             Mirena can be replaced by a new system at any time in the menstrual cycle. In this case no back up contraception is needed.


•        Protection from endometrial hyperplasia during oestrogen replacement therapy 
When used for endometrial protection during oestrogen replacement therapy, Mirena can be inserted at any time in an amenorrhoeic woman, or during the last days of menstruation or withdrawal bleeding.


Mirena provides the progestogen component of hormone therapy (HRT). Therefore in women receiving HRT, Mirena can be used in combination with oral or transdermal oestrogen preparations without additional exogenous progestogens. 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.

In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, please refer to section 4.4.

• Mirena is supplied sterile having been sterilised with ethylene oxide. Do not resterilise. For single use only.
Do not use if the inner package is damaged or open. Insert before the month and year shown on the label.

• Mirena is inserted with the provided inserter (figure 1 in the 'Insertion Instructions') into the uterine cavity by carefully following the insertion instructions.

Please see the 'Insertion instructions' section of this leaflet.

Removal/ replacement
Please see the 'Insertion instructions' section of this leaflet.

Mirena is removed by gently pulling on the threads with forceps. If the threads are not visible and the system is in the uterine cavity, it may be removed using a narrow tenaculum. This may require dilatation of the cervical canal or other surgical intervention.

For contraception and idiopathic menorrhagia: the system should be removed after 5 years of use. If the user wishes to continue using the same method, a new system can be inserted at the same time, in which case no additional protection is required.

For protection from endometrial hyperplasia during oestrogen replacement therapy: clinical data (from clinical trials conducted in women of 18 years and over) beyond 4 years of use are limited. Mirena should therefore be removed after 4 years.

If pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation in women of fertile age, provided the woman is experiencing regular menses. If the system is removed at some other time during the cycle or the woman does not experience regular menses and the woman has had intercourse within a week, she is at risk of pregnancy. To ensure continuous contraception a new system should be immediately inserted or an alternative contraceptive method should have been initiated (e.g.
condoms) starting at least 7 days before the removal.

After removal of Mirena, the system should be checked to ensure it is intact. During difficult removals, single cases have been reported of the hormone cylinder sliding over the horizontal arms and hiding them inside the cylinder. This situation does not require further intervention once completeness of the IUS has been ascertained. The knobs of the horizontal arms usually prevent complete detachment of the cylinder from the T- body.

Information on special populations

Paediatric population
There are no relevant indications for use of Mirena before menarche.

Geriatric patients

Mirena has not been studied in women over the age of 65 years.
Patients with hepatic impairment
Mirena is contraindicated in women with acute liver disease or liver tumour (see section 4.3).

Patients with renal impairment

Mirena has not been studied in women with renal impairment.