Nova T 380 Intrauterine Device

Nova T 380 Intrauterine Device

1. PRODUCT NAMENOVA T 3802. COMPOSITIONIntrauterine device made of polyethylene, wrapped around a copper spiral stabilized by a silver core. The copper surface area is 380 mm2. 3. PHARMACEUTICAL FORMIntrauterine device (IUD)4. CLINICAL INFORMATION 4.1. Therapeutic indicationsPrevention of conception4.2. Dosage and method of administrationNOVA T 380 is inserted into the uterine cavity. Its contraceptive effectiveness is maintained for five years. Insertion and removal Before inserting NOVA T 380, the patient must be informed of the effectiveness, risks and side effects of this device. A physical examination including a pelvic examination should be performed. A cytology smear should be performed depending on the medical assessment. Possible pregnancy, genital infections and sexually transmitted diseases must be excluded. The position of the uterus and the size of the uterine cavity must be determined. &It's serious; You must carefully follow the insertion instructions. The patient should be re-examined 4-12 weeks after insertion and annually thereafter or more frequently if clinically indicated. We recommend insertion during or immediately after menstruation. If a possible pregnancy has been ruled out, NOVA T 380 can be inserted at any time of the cycle. Thanks to the small diameter of the applicator and the consequent ease of introduction, dilation is usually not necessary. NOVA T 380 can be replaced with a new device at any time of the cycle and can also be inserted immediately after an abortion performed in the first trimester. Insertion after childbirth must be postponed until the uterus has completely involuted, but not earlier than 6 weeks after childbirth. If the involution of the uterus is significantly delayed, you will have to wait until the twelfth week after giving birth. In case of difficulty in insertion and/or excessive pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate measures such as physical examination and ultrasound should be undertaken. It is recommended that Nova T 380 be inserted only by doctors/healthcare personnel who have experience with the insertion of Nova T 380 and/or have undergone sufficient training for the insertion of Nova T 380. NOVA T 380 can be removed by exercising light traction on the wires with pliers. Using excessive force when removing may cause damage to the device or parts of the device. After Nova T removal, the device should be examined to ensure that it is intact. If the wires are not visible and the device is in the uterine cavity, removal should be postponed until the end of the next menstruation, as the wires usually become visible soon after menstruation. If the wires are also not found in this case, the device can be removed with fine pliers. This may require dilation of the cervical canal. NOVA T 380 must be removed after five years. If the patient wishes to continue using the same method, it can be immediately replaced with a new device. If the patient does not wish to become pregnant, removal should be performed within seven days of the onset of her period provided her cycle is regular. If the device is removed at any other time of the cycle or in the absence of regular cycles, there is a risk of pregnancy if you have sexual intercourse in the previous week. To ensure continued contraceptive effectiveness a new device should be inserted immediately or an alternative contraceptive method considered. Insertion and removal may be associated with pain and bleeding. Insertion can cause a brief loss of consciousness as a vasovagal reaction, and a seizure in epileptic patients. 4.3. ContraindicationsAscertained or presumed pregnancy; current or recurrent pelvic inflammatory disease; lower genital tract infection; postpartum endometritis, septic abortion in the last three months; untreated cervicitis; untreated cervical dysplasia; untreated cervical and endometrial carcinomas; abnormal uterine hemorrhage of unknown etiology; congenital or acquired uterine anomalies, including fibroids if they deform the uterine cavity; copper allergy; Wilson's disease; coagulation disorders; conditions associated with increased susceptibility to infections. 4.4. Special Warnings and PrecautionsCopper IUDs may cause heavier menstrual flow and dysmenorrhea. NOVA T 380 is not the first choice method for women who have excessive menstrual flow, anemia, dysmenorrhea or who take anticoagulants. If such conditions occur during the use of NOVA T 380, the need to remove the device should be considered. NOVA T 380 should be used with caution in women suffering from congenital heart disease or valve defects at risk of infective endocarditis. NOVA T 380 is not the first choice method for young nulliparous women. Higher rates of pregnancies and removals due to expulsion, bleeding and/or pain and infections were reported in this group compared to other women using the same device. Pelvic infection The applicator protects NOVA T 380 from contamination with microorganisms during insertion. In patients using a copper IUD, the highest rate of pelvic infections is seen during the first month after insertion and declines thereafter. Risks of pelvic inflammatory disease are recognized in women who have sexual intercourse with multiple partners, frequent sexual intercourse and in young women. Pelvic infections can decrease fertility and increase the risk of ectopic pregnancies. As with other gynecological or surgical procedures, serious infections or sepsis (including group A streptococcal sepsis) may occur following IUD insertion, although they are extremely rare. If the woman suffers from endometritis or recurrent pelvic infections, or if an acute infection does not respond to treatment within a few days, NOVA T 380 must be removed. Bacteriological tests and a check-up are recommended, even in the presence of mild symptoms that indicate infections, such as pathological vaginal discharge. Expulsion Symptoms of partial or complete expulsion of any type of IUD may include bleeding or pain. However, it may happen that the device is expelled from the uterine cavity without the woman realizing it. Partial expulsion may decrease the effectiveness of the NOVA T 380. When the device is not in the correct position it must be removed and replaced with a new one. The patient should be shown how to check the IUD threads. Perforation Cases of perforation or penetration of the body of the uterus or cervix by an intrauterine device may occur, mainly during insertion, although this may not be noticed until later. In these cases the device must be removed as soon as possible. In a large prospective non-interventional-comparative cohort study in IUD users (n. 61,448 women) with one year of observation, the incidence of perforation occurred with a frequency of 1.3 (95% CI: 1.1 -1.6) per 1,000 insertions within the entire study cohort: 1.4 (95% CI: 1.1-1.8) per 1,000 insertions in the cohort using a levonogestrel-releasing intrauterine device and 1. 1 (95% CI: 0.7-1.6) per 1,000 insertions in those using a copper IUD. By extending the observation period to 5 years in a subgroup of this study (39,009 women using a levonogestrel-based device or copper IUD), the incidence of perforation detected at any time during the entire five-year period was 2.0 (95% CI: 1.6-2.5) per 1,000 insertions. The study demonstrated that an increased risk of perforation was associated both with insertion during the breastfeeding phase and when this was carried out within 36 weeks following birth (see table 1). These risk factors were confirmed in the subgroup followed for 5 years. Both risk factors were independent of the type of IUD inserted. Table 1: Frequency of perforation event per 1,000 insertions for the entire study cohort observed for one year, divided according to the breastfeeding phase and the time interval between insertion and delivery (multiparous women)

	Lactating at time of insertion	Not breastfeeding at time of insertion
Insertion ? 36 weeks postpartum	5.6 (95% CI 3.9-7.9; n. 6,047 insertions)	1, 7 (95% CI 0.8-3.1; n. 5,927 insertions)
Insertion >36 weeks postpartum	1.6 (95% CI 0.0-9.1; n. 608 insertions)	0.7 (95% CI 0.5-1.1; n. 41,910 insertions)

The risk of perforations may be increased in women with a fixed, retroverted uterus. Ectopic pregnancy Although ectopic pregnancies can occur during IUD use, current data indicate that women using copper IUDs are not at a significantly higher overall risk of ectopic pregnancy than women who do not use any contraceptive method. However, there is a greater chance of an ectopic pregnancy with the presence than without an IUD in situ. Women with a history of ectopic pregnancy, pelvic surgery, or major pelvic infection are at higher risk of an ectopic pregnancy. The possibility of an ectopic pregnancy should be considered in the case of lower abdominal pain, especially if accompanied by absence of menstruation or if an amenorrheic woman begins menstruating again. Threads not found If during the check-up exams the threads are not seen protruding from the cervical canal, the absence of a possible pregnancy must be ascertained. It is possible that the threads have become tangled in the uterine cavity or cervical canal and may reappear during the next menstrual flow. If pregnancy has been ruled out, it is usually possible to locate the threads by gently exploring with a suitable instrument. If they cannot be recovered, the possibility of expulsion or perforation must be considered. One method to locate the location of the IUD is to use ultrasound. If this technique is not available or has not given satisfactory results, NOVA T 380 can be localized by radiological examination. 4.5. Interactions with other drugs and other forms of interactionThe available data on the use of NOVA T 380 indicate that drug effects that interfere with the contraceptive efficacy of NOVA T 380 are very unlikely. The evidence described in the literature does not justify the inclusion of interactions with non-steroidal anti-inflammatory drugs and corticosteroids in the precautions/warnings. Magnetic Resonance Imaging (MRI) Published data from nonclinical testing of T-shaped copper IUDs indicate that a woman can be safely examined after Nova T placement (MRI Conditional*). One study examined the effect of MRI on three copper models containing IUDs, including the Nova T, and found no deflection or significant changes in the temperature of the devices in the 1.5 Tesla magnetic field. A study with another T-shaped copper IUD using a 3.0 Tesla system found no magnetic field interactions during sequences routinely used for clinical imaging: no deflections, twisting forces/ rotation, or significant heating of the device. Nor were any significant artifacts observed to interfere with clinical imaging. *according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment". 4.6. Use during pregnancy and breastfeeding PregnancyNova T 380 must not be used during confirmed or presumed pregnancy. If a woman becomes pregnant while using the NOVA T 380, it is recommended to remove the device, as the IUD in situ may increase the risk of miscarriage and premature birth. Removing the IUD or examining the uterus can cause a miscarriage. An ectopic pregnancy must be excluded. If the device cannot be removed gently, termination of the pregnancy may be considered. If the woman wishes to continue the pregnancy and it is not possible to remove the device, she should be informed of the above risks and the possible consequences of premature birth for the newborn. The course of such pregnancy must be carefully monitored. The patient should be asked to report any symptoms that suggest pregnancy complications, such as crampy abdominal pain with fever. You should also be informed that there is currently no evidence of fetal malformations in cases where the pregnancy reaches term with the IUD in situ. Breastfeeding NOVA T 380 does not interfere with breastfeeding. 4.7. Adverse reactionsIncreased intensity of menstrual flow; small intermenstrual blood losses; dysmenorrhea; pain in the lower abdomen or back; anemia. If the method fails, there is a risk that the pregnancy could be ectopic. Pelvic inflammatory disease may occur during IUD use. The IUD or its parts may pierce or penetrate the uterine wall. The risk of perforation is increased during breastfeeding and in women who have had the device inserted within 36 weeks postpartum (see section 4.4 special warnings and precautions). Allergic skin reactions may occur. Infections and infestations. Cases of sepsis (including group A streptococcal sepsis) have been reported following insertion of IUDs (see section 4.4 special warnings and precautions). 4.8. OverdoseNot applicable. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic propertiesCopper IUDs avoid pregnancy by preventing fertilization. This effect is based on inhibition of sperm and egg transport and/or the ability of the sperm to fertilize the egg. This process occurs through cytotoxicity and phagocytosis effects before the egg reaches the uterine cavity. After removal of the IUD, fertility is immediately restored. The incidence of pregnancies with NOVA T 380 is 0.6 per 100 woman-years. 5.2. Pharmacokinetic propertiesNot applicable. 5.3. Preclinical safety dataThe preclinical safety of copper-containing intrauterine devices has been widely confirmed. No teratogenesis was found in animal studies. These studies do not suggest any particular risk for use in humans. 6. PHARMACEUTICAL INFORMATION 6.1 List of excipientsCopper, Silver, Polyethylene, Barium sulphate, Iron oxide. 6.2. IncompatibilitiesNone known. 6.3. Validity periodThree years. 6.4. Special precautions for storageStore away from light and moisture. 6.5. Nature and contents of the packageThe device and its accessories were packaged in a heat-sealed sterilizable casing made of polyester/polyethylene/polyamide. 6.6. Instructions for useThe NOVA T 380 is distributed sterile, sterilized by irradiation. Single use. Do not sterilize again. Do not rework, reuse, rework or resterilization may compromise the structural integrity of the device and/or lead to device failure. Do not use if package is damaged or opened. Do not use the device after the expiry date indicated on the packaging. Ensure that each device is used under aseptic conditions. The device must be inserted by qualified healthcare personnel. Detailed instructions for insertion are included in the package. After removal, NOVA T 380 must be disposed of following local regulations for the elimination of non-biodegradable waste. The device must be removed no later than five years after its insertion.