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  • Kyleena
    / Bayer


    Active Ingredient
    Levonorgestrel 19.5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    IUS

    1 X 19.5 mg

    not in the basket chart 37277 11286

    Dosage

    Placement of Kyleena: Placement of Kyleena will be done by a physician who has undergone training on the insertion procedure and after a gynaecological examination.
    Kyleena can either be placed:
    • within 7 days from the start of your menstrual bleed (your monthly period).
    • immediately after a first trimester abortion provided that there are no genital infections.
    • after giving birth only after the womb has returned to its normal size, and not earlier than 6 weeks after delivery.
    Examination by the doctor before placement may include:
    • a cervical smear test (Pap smear).
    • examination of the breasts.
    • other tests, e.g. for infections, including sexually transmitted diseases, as necessary. The doctor will also do a gynaecological examination to determine the position and size of the womb.
    After a gynaecological examination:
    • an instrument called a speculum is placed into the vagina, and the cervix may be cleansed with an antiseptic solution.
    Kyleena is then placed into the womb using a thin, flexible plastic tube (the placement tube). Local anaesthesia may be applied to the cervix prior to placement.
    • some women feel dizzy or faint during placement or after Kyleena is placed or removed.
    • patient may experience some pain and bleeding during or just after placement.

    Follow-up examination: You should have your Kyleena checked 4-6 weeks after placement, and thereafter regularly, at least once a year.
    Your doctor may determine how often and what kinds of check-ups are required in your particular case. If you received a patient reminder card from your doctor bring this with you to every scheduled appointment.
    Removal of Kyleena: Kyleena should be removed no later than the end of the
    fifth year of use.
    Kyleena can be easily removed at any time by your doctor, after which pregnancy is possible. Some women feel dizzy or faint during or after Kyleena is removed. You may experience some pain and bleeding during removal of Kyleena.
    If pregnancy is not desired, Kyleena should not be removed after the seventh day of the menstrual cycle (monthly period) unless you use other methods of contraception (e.g. condoms) for at least 7 days before the IUS removal.
    If you have irregular periods (menses) or no periods, you should use a barrier method of contraception for 7 days before removal.
    A new Kyleena can also be placed immediately after removal, in which case no additional protection is needed.
    If you have further questions regarding use of the medicine, consult the doctor or pharmacist.


    Indications

    Kyleena is used for the prevention of pregnancy (contraception) for up to five years.
    Kyleena is a T-shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel.
    Kyleena works by reducing the monthly growth of the lining of the womb and thickening the cervical mucus. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm.


    Contra-Indications

    sensitivity (allergic) to lovonorgestrel or to any of the other ingredients contained in the medicine.
    pregnancy.
    current pelvic inflammatory disease (PID; infection of the female reproduction organs) or have had this condition multiple times in the past.
    conditions associated with increased susceptibility to pelvic infections.
    infection in the lower genital tract (an infection in the vagina or the cervix [neck of the womb]).
    infection of the womb after delivery of a child, after an abortion or after miscarriage during the past 3 months.
    currentl cell abnormalities in the cervix.
    cancer or suspected cancer of the cervix or womb.
    tumours which are sensitive to progestogen hormones to grow, e.g. breast cancer.
    unexplained uterine bleeding.
    abnormality of the cervix or womb including fibroids that distort the cavity of the womb.
    active liver disease or liver tumour.
    Also, Kyleena is not indicated for use before the first menstrual bleeding (menarche).


    Side Effects

    Very common side effects: may affect more than 1 in 10 people
    • headache
    • abdominal/pelvic pain
    • acne/greasy skin
    • bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods and absence of bleeding
    • ovarian cyst
    • inflammation of the external genital organs and vagina (vulvovaginitis)
    Common side effects: may affect up to 1 in 10 people
    • depressed mood/depression
    • migraine
    • feeling sick (nausea)
    • upper genital tract infection
    • painful menstruation
    • breast pain/discomfort
    • device expulsion (complete and partial)
    • hair loss
    • genital discharge
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Kyleena must not be used during pregnancy.
    Lactation: You can use Kyleena during breast-feeding. Levonorgestrel has been identified in small quantities in the breast milk of breast-feeding women.
    However, no negative effects have been seen on infant growth and development or the amount or the quality of the breast milk.
    See prescribing information for full details.


    Manufacturer
    Bayer Oy, Finland
    Licence holder
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