ETONOGESTREL subdermal implant

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    Prescription under medical supervision

     

    Therapeutic action

    • Hormonal contraceptive, progestogen

    Indications

    • Long-acting contraception

    Forms and strengths, route of administration

    • Flexible rod containing 68 mg of etonogestrel, in a sterile disposable applicator, to be inserted subdermally into the inner side of the non-dominant arm, 6 to 8 cm above the elbow crease, under local anaesthesia and aseptic conditions

    Dosage

    • The implant may be inserted at any moment of the cycle if it is reasonably certain the woman is not pregnant, including when switching from another form of contraception.  
    • Use condoms for 7 days after insertion of the implant if it is inserted:
      • more than 7 days after the start of menstruation;
      • more than 28 days postpartum if not breastfeeding; 
      • more than 7 days after an abortion.

    Duration

    • As long as this method of contraception is desired and it is well tolerated, for max. 3 years after which it no longer provides contraception and must be changed.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with breast cancer, severe or recent liver disease, unexplained vaginal bleeding, active thromboembolic disorders.
    • May cause: menstrual irregularities, amenorrhoea, menometrorrhagia, breast tenderness, headache, weight gain, itching, acne, mood changes, abdominal pain, gastrointestinal disturbances, allergic reactions.
    • Enzyme-inducing drugs (rifampicin, rifabutin, efavirenz, nevirapine, lopinavir, ritonavir, phenobarbital, phenytoin, carbamazepine, griseofulvin, etc.) reduce the effectiveness of the contraceptive.
    • Pregnancy: CONTRA-INDICATED
    • Breast-feeding: no contra-indication

    Remarks

    • Fertility returns rapidly after removal of the implant.
    • For the conditions for insertion or removal the implant, follow manufacturer’s instructions.

    Storage

     
    –  Below 25 °C