MIRENA LEVONORGESTREL INTRAUTERINE SYSTEM 20 MCG/24 HR [SIN07915P]

Product Info

MIRENA LEVONORGESTREL INTRAUTERINE SYSTEM 20 MCG/24 HR

[SIN07915P]

4.1 Indications
Contraception.

Idiopathic menorrhagia. Mirena may be particularly useful in women with idiopathic menorrhagia requiring (reversible) contraception.

Protection from endometrial hyperplasia during oestrogen replacement therapy.

4.2 Dosage and method of administration

4.2.1 Method of administration

Mirena is inserted into the uterine cavity. It is effective for 8 years for contraception and for 5 years in the indication idiopathic menorrhagia.

In the indication for the protection from endometrial hyperplasia during oestrogen replacement therapy, clinical data beyond 4 years of use are limited. Mirena should therefore be removed after 4 years.

For timing regarding removal/replacement see section ‘Removal/Replacement’.

The in vivo levonorgestrel release rate 24 days after insertion is approximately 21 mcg/day, decreasing continuously to approximately 19 mcg/day after 1 year, to 11 mcg/day after 5 years and to 7 mcg/day after 8 years of use.

The average daily levonorgestrel release rates are approximately 20 mcg/day during the first year, 15 mcg/day during the first 5 years and 13 mcg/day over the complete 8 year period of use.
In women under hormonal replacement therapy, Mirena can be used in combination with oral or transdermal estrogen preparations without progestogens.

• Insertion and removal/replacement
  Insertion
  In women of fertile age, Mirena 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 of the cycle.

  Mirena can also be inserted immediately after the 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.

  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.

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

  Removal/Replacement

  Contraception
  The system should be removed or replaced after 8 years.

  If pregnancy is not desired, 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.

  Idiopathic menorrhagia
  The system should be removed or replaced in case symptoms of idiopathic menorrhagia return. If symptoms have not returned after 5 years of use, continued use of the system may be considered. Remove or replace after 8 years at the latest.

  Protection from endometrial hyperplasia during estrogen replacement therapy
  The system should be removed or replaced after 4 years.

  Mirena is removed by gently pulling on the threads with forceps. The use of excessive force during removal may cause damage to the device. After removal of Mirena, the system should be examined to ensure that it is intact.
  During difficult removals, single cases have been reported of the hormone cylinder sliding over the horizontal arms and hiding them together 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.

  If the threads are not visible, determine the location of the system via ultrasound or other method. If the system is in the uterine cavity, it may be removed using narrow forceps. This may require dilatation of the cervical canal or other surgical intervention.

  If the user wishes to continue using the same method, a new system can be inserted at the time of removal.

• Instructions for use and handling
  Mirena is supplied in a sterile pack which should not be opened until required for insertion. The exposed product should be handled with aseptic precautions. If the seam of the sterile package is broken, the product should be discarded.

  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.

4.2.2 Additional information on special populations

4.2.2.1 Pediatrics
Safety and efficacy of Mirena have been established in women of reproductive age. There is no relevant indication for the use of Mirena before menarche.

4.2.2.2 Geriatric patients
Mirena has not been studied in women over the age of 65 years.

4.2.2.3 Patients with hepatic impairment
Mirena is contraindicated in women with acute liver disease or liver tumour (see section 4.3, ‘Contraindications’).

4.2.2.4 Patients with renal impairment
Mirena has not been studied in women with renal impairment.

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;

• Progestogen-dependent tumours;

• Undiagnosed abnormal uterine bleeding;

• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity;

• Conditions associated with increased susceptibility to infections;

• Past attack of bacterial endocarditis or of severe pelvic infection in a woman with an anatomical lesion of the heart or after any prosthetic valve replacement;

• Active or previous severe arterial disease, such as stroke or myocardial infarction;

• 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;

• Hypersensitivity to the active substance or to any of the excipients.