Juno Bio-T Intrauterine Spiral

Indications for use of IUD
A woman's desire to prevent pregnancy.
Treatment and prevention of Asherman's syndrome.
As a postcoital method, the IUD can be inserted within 5 days (120 hours) after unprotected sexual intercourse.

Recommended timing for IUD insertion:

• any day of the menstrual cycle (preferably from day 4 to day 19);

• immediately after an uncomplicated medical abortion performed by vacuum aspiration or curettage;

• after the involution of the uterus (5 - 6 weeks after uncomplicated childbirth), including during lactational amenorrhea;

• immediately after the removal of an IUD whose term of use has expired, if the woman wishes to continue intrauterine contraception and there are no contraindications to the use of an IUD;

• for postcoital contraception, the IUD should be inserted within 5 days (120 hours) after unprotected sexual intercourse.

Adaptation to the IUD

During the adaptation period of the patient's body to the IUD (3-4 months), changes in the menstrual cycle may occur. Menstrual discharge may be accompanied by pulling pain in the lower abdomen or sacral area, which usually subsides quickly.

To increase the acceptability of the IUD and shorten the adaptation period, it is recommended to:

• conduct a thorough examination of women to identify contraindications to the use of the IUD;

• take a differentiated approach to selecting the IUD model based on the individual characteristics of the woman's body, plans for childbearing, and timing of IUD insertion;

• use the recommended technique for inserting the intrauterine device and optimal timing for its installation;

• prophylactically prescribe antibiotics;

• prescribe NSAIDs in the first days after IUD insertion and during the first three menstrual discharges.

anchor made of polymer material.
bimetallic copper wire, monofilament thread.

Contraindications for IUD Use
Intrauterine contraception is absolutely contraindicated (categories 3 and 4 according to WHO criteria for the acceptability of contraceptive methods):

• in case of pregnancy (suspected or confirmed);

• in malignant diseases of the female reproductive organs;

• in current background/premalignant conditions of the cervix;

• in severe thrombocytopenia;

• in vaginal bleeding of unknown etiology (suspected serious disease);

• in gestational trophoblastic disease;

• in uterine fibroids with deformation of the uterine cavity;

• in any congenital or acquired anomalies of the uterine cavity that lead to deformation incompatible with IUD insertion;

• in current pelvic inflammatory disease;

• in STIs (purulent cervicitis, chlamydial infection, or gonorrhea currently), increased risk of STIs;

• in AIDS (on antiretroviral therapy);

• in pelvic tuberculosis;

• in allergy to copper, silver, and copper (for silver-containing IUD models), to bee products (for the "Yunona Bio-T Super" IUD); - in Wilson's disease.

The product is supplied sterile and ready for use.
Gas sterilization - ethylene oxide.
The shelf life of the IUD in packaging is 5 years. The use of the IUD after the expiration date indicated on the label is not permitted. The shelf life is determined by the preservation of the sterility of the IUD in its final packaging. Reuse of the products is not permitted.
The use of the IUD is not permitted if the integrity of the sterilization (final) packaging is compromised. If the integrity of the sterilization (final) packaging is compromised, the product must not be used and should be disposed of.
The product should be stored at a temperature between +5 °C and +40 °C, in a place protected from direct sunlight and moisture.
The IUD must be used immediately after removal from the final packaging.
Used products must be disposed of in accordance with current sanitary and epidemiological requirements for the handling of used medical devices.
The IUD is not subject to technical, service maintenance, or repair.
The IUD should only be used by qualified medical personnel.
Intrauterine contraceptive devices do not protect against sexually transmitted infections and the human immunodeficiency virus (STIs/HIV).

• Increased menstrual blood loss. With the use of an IUD, an increase in the duration of menstrual bleeding by 1-2 days and an increase in the volume of menstrual blood loss by 50-55% may be observed. Patients with a tendency to iron deficiency anemia should monitor laboratory indicators for timely diagnosis and correction of this condition.
• Pre- and intermenstrual spotting. In cases of persistent menstrual cycle disturbances, partial expulsion of the IUD or other conditions requiring removal of the contraceptive should be excluded. In the absence of indications for removal of the contraceptive, medication therapy (NSAID group drugs) may be possible.

Complications

• Pain syndrome during IUD insertion/removal. This condition is rarely observed. In patients with a low pain threshold, the use of local anesthetics is advisable.

• Uterine perforation during IUD insertion. Cases of uterine perforation during IUD placement are rare (less than 1 in 3000 insertions). Extreme caution should be exercised if there is a retroverted uterus. If perforation is suspected, the location of the IUD should be clarified. The contraceptive must be removed. Surgical intervention may be required.

• Development of PID. It is currently believed that the development of PID in the first few months after IUD insertion may be related to contamination of the uterine cavity during the placement of the contraceptive with endogenous vaginal and cervical microflora. The cause of PID development 3-4 months after the placement of the contraceptive is STIs, not the procedure itself. To reduce risks, it is necessary to exclude infectious contraindications to the use of intrauterine contraceptive methods and to strictly adhere to aseptic and antiseptic techniques during the IUD insertion procedure. Antibiotic prophylaxis may be used during the insertion of the contraceptive. Information about the identification of adverse events that have signs of an adverse event (incident), as well as information about side effects and complications not specified in the instructions for use, should be reported to the manufacturer.

Intrauterine contraceptive device "Yunona Bio-T,"
The anchor IUD has a T-shape and is made from polymer material with specified mechanical characteristics.

A copper wire is placed on the shaft of the anchor. At the end of the anchor shaft, there is a loop for attaching a monofilament transcervical thread, at least 100 mm long. The nominal length of the anchor is 36 mm, and the nominal width is 32 mm. The purity level of the copper in the copper wire is at least 99.9%. The nominal area of the active copper-containing surface is 380 mm².
The IUD is supplied in a paper-film package along with a polymer insertion tube (with a diameter of no more than 5 mm) and a piston. A movable polymer limiter is installed on the insertion tube to indicate the depth of insertion and the plane of opening of the anchor arms.

Maximum usage period: IUD "Yunona Bio-T Super" - no more than 5 years.

Indication for use - gynecology, intrauterine contraception. The installation and removal of the intrauterine contraceptive device (IUD) must be performed by a trained medical professional (obstetrician-gynecologist) in a medical facility.
Class of potential risk associated with the use of the medical device according to the nomenclature classification of medical devices:
Principle of action:
The mechanism of action of the IUD consists of initiating chemical changes that inactivate sperm and the egg before their fusion, as well as initiating changes that prevent implantation.
The contraceptive effect develops immediately after the IUD is placed in the uterine cavity.
Fertility restoration occurs immediately after the IUD is removed from the uterine cavity.

Indications for IUD removal

Fertility restoration after IUD removal occurs immediately.
The IUD should be removed:

• at the woman's request on any day of the menstrual cycle;

• mandatory removal of the IUD after the expiration of its usage period;

• if there is uncertainty about the correct placement of the IUD immediately after insertion, the contraceptive must be removed and a new contraceptive device inserted;

• the contraceptive must be removed in the event of developing inflammatory diseases of the pelvic organs (PID);

• in the case of persistent menstrual cycle disorders against the background of the IUD, or the appearance of vaginal bleeding of unknown etiology (suspected serious illness);

• in the event of developing anemia;

• in the case of partial expulsion of the IUD;

• in the presence of pain syndrome associated with the presence of the IUD in the uterine cavity;

• in the event of pregnancy occurring with the IUD in place. In this situation, in most cases, a uterine pregnancy is diagnosed; however, ectopic pregnancy must be ruled out. Women who become pregnant while using the IUD should be informed of the increased risk of septic spontaneous abortion, increased risk of preterm labor, and infection if the IUD remains in the uterus. Women wishing to maintain the pregnancy should be informed that removal of the IUD (if conditions for this procedure are met) will reduce the potential risks of adverse pregnancy outcomes.
However, the procedure of IUD removal itself increases the risk of miscarriage. The frequency of unplanned pregnancy with IUD use is less than 1 case per 100 women using this method during the first year (6 - 8 cases per 1000 women). A slight risk of unplanned pregnancy persists throughout the entire period of IUD use (about 2 cases per 100 women over 10 years of use).

Juno Bio-T intrauterine device is a medical product used for contraception in women. The device is made from medical-grade material and has a coiled shape that is inserted into the uterine cavity. It is a long-term method of contraception and can be used for up to 5 years. The device is an effective and convenient form of contraception, and its insertion is performed by medical professionals in a healthcare setting. If you plan to use a contraceptive device, be sure to consult with your doctor.