Intrauterine contraceptive with copper TCu380Plus models: Mini, Normal, Maxi SMB®
IUDs do not protect against sexually transmitted diseases/AIDS
TCu 380Plus SMB® should only be inserted and removed by/under the supervision of/a practicing gynecologist/physician.
For doctors
The TCu 380Plus SMB® IUD is sterile, ready to use, and consists of two flexible arms in a modified T-shape and a vertical shaft made of low-density polyethylene with barium sulfate, which is radiopaque. It is wrapped with a copper wire with a diameter of 0.40 mm (mm), providing a surface area of 380 mm₂± 23 mm₂(mm₂). For easy removal, the shaft is tied with a polyamide monofilament thread and packaged with the insertion tube in a peel-open pouch. The insertion tube is equipped with a movable flange that helps determine the depth to which the insertion tube should be inserted through the cervical canal into the uterine cavity. (FIGURE I)
The sterile disposable package containing the TCu 380Plus SMB® IUD with insertion components is “for single use only.”
Indications for use
- The TCu 380Plus SMB® IUD is indicated for intrauterine contraception in women of childbearing age.
- TCu 380Plus SMB® can be administered after childbirth or abortion.
- TCu 380Plus SMB® can also be used as emergency contraception, however, in this case the risk of developing pelvic inflammatory disease is higher.
TCu 380Plus SMB® is recommended for women who:
- Women of childbearing age
- Are in a mutually monogamous relationship
- Have no history of pelvic inflammatory disease (PID)
- Decided not to use hormonal contraceptives
TCu 380Plus should not be administered to a woman who:
- Pregnant
- Still retains previously entered VMZ
- Has a suspected genital tract malignancy, including undiagnosed vaginal bleeding and an unresolved abnormal Pap smear or a serious uterine abnormality
- Has postpartum endometritis or post-abortion infection within the past three months
- Has Wilson's Disease or a known allergy to copper
- Has genital actinomycosis
TCu 380Plus SMB® should not be the method of first choice for a woman who has:
- Painful or prolonged menstruation
- Severe anemia
- Cervical stenosis or narrowing of the cervical canal
- Lack of access to a medical center for further treatment
- History of ectopic pregnancy
Expiration date
CONTRACEPTIVE EXPIRY DATE
TCu 380Plus SMB® can remain inserted in the uterus for a maximum period of 5 years. If the patient requires continued contraception, a new TCu 380Plus SMB® should be inserted immediately.
Contraindication
A. ABSOLUTE
- Pregnancy
- Acute pelvic inflammatory disease or history of pelvic inflammatory disease (PID)
- Postpartum endometritis or abortion
- Sexually transmitted diseases (STDs), including lower genital tract infections such as gonorrhea or chlamydia
- At high risk of STDs because she or her partner has multiple sexual partners
- Known or suspected genital tract malignancy, including undiagnosed dysfunctional uterine bleeding
- Congenital anomaly of the uterus
- Copper allergy
- Untreated acute cervicitis or vaginitis, including bacterial vaginosis, until the infection is controlled
- Conditions associated with increased susceptibility to infections by microorganisms. Such conditions include, but are not limited to, leukemia, acquired immunodeficiency syndrome (AIDS), and intravenous drug use
- Wilson's disease
- Small uterine cavity
- To avoid burns/perforations, radiotherapy and diathermy should be contraindicated, especially when applied to the lower pelvis.
- Patients with uterine fibrosis
B. RELATIONSHIPS
- Severe dysmenorrhea
- Blood clotting disorders
- Cardiovascular diseases
C. SECONDARY EFFECTS
- Spotting between periods
- Menstrual bleeding may be heavier and/or longer.
- Possible abdominal pain
- Partial or complete expulsion
- Inflammatory disease of the vagina
- Hysterectomy
Storage conditions
Store at a temperature of 15°C to 30°C in a dry place, away from direct sunlight, heat sources, water and mechanical damage.
Producer
Manufacturer: SMB Corporation of India 13, 33 – 36, Prem Industrial Estate, Yogeshwari (E), Mumbai – 400 060, India
Authorized representative: LLC "SYNTHESIS"
24321, Ukraine, Vinnytsia region, Ladyzhyn city, Energetikov st., building 32
