Mirena

Mirena Manufacturers

• Bayer Healthcare Pharmaceuticals Inc.
  

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  Mirena | Bayer Healthcare Pharmaceuticals Inc.

  

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  Mirena contains 52 mg of levonorgestrel. Initially, levonorgestrel is released at a rate of approximately 20 mcg/day. This rate decreases progressively to half that value after 5 years.

  Mirena is packaged sterile within an inserter. Information regarding insertion instructions, patient counseling and record keeping, patient follow-up, removal of Mirena and continuation of contraception after removal is provided below.

  2.1. Insertion Instructions • NOTE: Mirena should be inserted by a trained healthcare provider. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion of Mirena. • Mirena is inserted with the provided inserter ( Figure 1a)  into the uterine cavity within seven days of the onset of menstruation or immediately after a first trimester abortion by carefully following the insertion instructions. It can be replaced by a new Mirena at any time during the menstrual cycle.

  Figure 1a. Mirena and inserter

  Preparation for insertion • Ensure that the patient understands the contents of the Patient Information Booklet and obtain consent. A consent form that includes the lot number is on the last page of the Patient Information Booklet. • Confirm that there are no contraindications to the use of Mirena. • Perform a urine pregnancy test, if indicated. • With the patient comfortably in lithotomy position, gently insert a speculum to visualize the cervix and rule out genital contraindications to the use of Mirena. • Do a bimanual exam to establish the size and position of the uterus, to detect other genital contraindications, and to exclude pregnancy. • Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution. Perform a paracervical block, if needed. • Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and apply gentle traction to align the cervical canal with the uterine cavity. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. Note that the tenaculum forceps should remain in position throughout the insertion procedure to maintain gentle traction on the cervix. • Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity, confirm its direction and exclude the presence of any uterine anomaly. If you encounter cervical stenosis, use dilatation, not force, to overcome resistance. • The uterus should sound to a depth of 6 to 10 cm. Insertion of Mirena into a uterine cavity less than 6 cm by sounding may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy. • After ascertaining that the patient is appropriate for Mirena, open the carton containing Mirena. Insertion Procedure

  Ensure use of sterile technique throughout the entire procedure.

  Step 1–Opening of the sterile package • Open the sterile package completely ( Figure 1b). • Place sterile gloves on your hands. • Pick up the handle of the inserter containing Mirena and carefully release the threads so that they hang freely.

  Place your thumb or forefinger on the slider. Make sure that the slider is in the furthest position away from you, for example, at the top of the handle towards the insertion tube (Figure 1b).
  NOTE: Keep your thumb or forefinger on the slider until insertion is complete.

  • With the centimeter scale of the insertion tube facing up, check that the arms of Mirena are in a horizontal position. If they are not, align them on a flat, sterile surface, for example, the sterile package (Figures 1b and 1c).

  Figure 1b. Aligning the arms with the slider in the furthest position

  Figure 1c. Checking that the arms are horizontal and aligned with respect to the scale

  Step 2–Load Mirena into the insertion tube • Holding the slider in the furthest position, pull on both threads to load Mirena into the insertion tube ( Figure 2a) . • Note that the knobs at the ends of the arms now meet to close the open end of the insertion tube ( Figure 2b).   If the knobs do not meet properly

  If the knobs do not meet properly, release the arms by pulling the slider back to the mark (raised horizontal line on the handle) (Figure 6a) . Re-load Mirena by aligning the open arms on a sterile surface (Figure 1b). Return the slider to its furthermost position and pull on both threads. Check for proper loading (Figure 2b).

  Figure 2a. Loading Mirena into the insertion tube

  Figure 2b. Properly loaded Mirena with knobs closing the end of the insertion tube

  Step 3–Secure the threads

  Secure the threads in the cleft at the bottom end of the handle to keep Mirena in the loaded position (Figure 3).

  Figure 3. Threads are secured in the cleft

  Step 4–Setting the flange

  Set the upper edge of the flange to the depth measured during the uterine sounding (Figure 4). 

   

  Figure 4. Setting the flange to the uterine depth

   Step 5–Mirena is now ready to be inserted

  • Continue to hold the slider with the thumb or forefinger firmly in the furthermost position. Grasp the tenaculum forceps with your other hand and apply gentle traction to align the cervical canal with the uterine cavity. • While maintaining traction on the cervix, gently advance the insertion tube through the cervical canal and into the uterine cavity until the flange is 1.5 to 2 cm from the external cervical os. • CAUTION: do not advance flange to the cervix at this step. Maintaining the flange 1.5 to 2 cm from the cervical os allows sufficient space for the arms to open (when released) within the uterine cavity (Figures 5 and 6b).   NOTE! Do not force the inserter. If necessary, dilate the cervical canal.

  Figure 5. Advancing insertion tube until flange is 1.5 to 2 cm from cervical os

  Step 6–Release the arms • While holding the inserter steady, release the arms of Mirena by pulling the slider back until the top of the slider reaches the mark (raised horizontal line on the handle) ( Figure 6a) . • Wait approximately 10 seconds to allow the horizontal arms of Mirena to open and regain its T-shape ( Figure 6b).

  Figure 6a. Pulling the slider back to reach the mark

  Figure 6b. Releasing the arms of Mirena

  Step 7–Advance to fundal position

  Gently advance the inserter into the uterine cavity until the flange meets the cervix and you feel fundal resistance. Mirena should now be in the desired fundal position (Figure 7).

  Figure 7. Mirena in the fundal position

  Step 8–Release Mirena and withdraw the inserter • While holding the inserter steady, pull the slider all the way down to release Mirena from the insertion tube ( Figure 8). The threads will release automatically from the cleft. • Check that the threads are hanging freely and gently withdraw the inserter from the uterus. Be careful not to pull on the threads as this will displace Mirena.

  Figure 8. Releasing Mirena from the insertion tube

  Step 9–Cut the threads • Cut the threads perpendicular to the thread length, for example, with sterile curved scissors, leaving about 3 cm visible outside the cervix ( Figure 9).
  NOTE: Cutting threads at an angle may leave sharp ends.

  Figure 9. Cutting the threads

  Mirena insertion is now complete.

  Important information to consider during or after insertion

  • If you suspect that Mirena is not in the correct position, check placement (for example, with transvaginal ultrasound). Remove Mirena if it is not positioned completely within the uterus. A removed Mirena must not be reinserted. • If there is clinical concern and/or exceptional pain or bleeding during or after insertion, appropriate and timely measures and assessments, for example ultrasound, should be performed to exclude perforation. 2.2 Patient Counseling and Record Keeping • Keep a copy of the consent form and lot number for your records. • Counsel the patient on what to expect following Mirena insertion. Give the patient the Follow-up Reminder Card that is provided with the product. Discuss expected bleeding patterns during the first months of Mirena use. [See Patient Counseling Information (17.1).] • Prescribe analgesics, if indicated. 2.3 Patient Follow-up • Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. 2.4 Removal of Mirena • Remove Mirena by applying gentle traction on the threads with forceps. The arms will fold upward as it is withdrawn from the uterus. Mirena should not remain in the uterus after 5 years. • Removal may be associated with some pain and/or bleeding or neurovascular episodes. • If the threads are not visible and Mirena is in the uterine cavity, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal [see Warnings and Precautions ( 5.13)]. • After removal of Mirena, verify that the system is intact. • During difficult removals, the hormone cylinder may slide over and cover the horizontal arms. This situation generally does not require further intervention once the system is verified to be intact. • If Mirena is removed mid-cycle and the woman has had intercourse within the preceding week, she is at a risk of pregnancy unless a new Mirena is inserted immediately following removal. 2.5 Continuation of Contraception after Removal • You may insert a new Mirena immediately following removal. • If a patient with regular cycles wants to start a different birth control method, remove Mirena during the first 7 days of the menstrual cycle and start the new method. • If a patient with irregular cycles or amenorrhea wants to start a different birth control method, or if you remove Mirena after the seventh day of the menstrual cycle, start the new method at least 7 days before removal.

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• Bayer Healthcare Pharmaceuticals Inc.
  

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  Mirena | Dermazoo, Llc

  

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