Posology : מינונים

4.2 Posology and method of administration
Starting treatment

• Contraception and idiopathic menorrhagia

In women of fertile age, Mirena is inserted into the uterine cavity within seven days of the onset of menstruation. It can be replaced by a new system at any time of the cycle.

Post-partum insertion: To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six 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. Mirena can also be inserted immediately after the first trimester abortion.

Mirena is ef fective for 5 years in the indications for contraception and idiopathic menorrhagia so should be removed after 5 years 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.
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.

• Protection from endometrial hyperplasia during oestrogen replacement therapy.

When used f or 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.

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 provides the progestogen component of hormone therapy (HRT). Theref ore 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.

Instructions for use and handling

Only to be inserted by a trained healthcare professional using aseptic technique.
Mirena is supplied within an inserter in a sterile package which should not be opened until needed f or 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.

How to Insert Mirena

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.

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 (f igure 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.

Af ter 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 4.3  Contraindications).

Patients with renal impairment

Mirena has not been studied in women with renal impairment.