DIU Nova T 380

What is NOVA T 380 and when is it used?

NOVA T 380 is a T-shaped pessary that is placed in the uterus to prevent pregnancy. The vertical part of the T-shaped plastic body has a winding of copper wire, which corresponds to a total copper surface of approx. 380 mm². This wire contains a silver core which, as studies have shown, prevents the copper wire from breaking. Two removal cords are attached to the loop-shaped lower end of the vertical part.

How does NOVA T 380 work?

The latest studies have shown that copper-containing intrauterine devices (IUDs) have a contraceptive effect at an early stage by preventing the fertilization of the female egg. The IUD restricts the mobility of sperm and egg cells and inhibits the ability of sperm to fertilize egg cells.During its period of use, NOVA T 380 constantly releases small amounts of copper into the uterus, but these are so minimal that they are completely harmless for the wearer of the pessary. The average daily amount of copper ingested with normal nutrition is far greater than that which is supplied to the body through the pessary.

How effective is NOVA T 380?

The pregnancy rate of NOVA T 380 is 0.6 per 100 woman-years.

When should NOVA T 380 not be used?

The intrauterine device should not be used in the case of:

• existing or suspected pregnancy;existing or recurrent (recurring) abdominal infections and inflammatory genital diseases;inflammation of the uterus after childbirth or abortion within the last three months;untreated cervicitis (inflammation of the cervix);cancer of the cervix or uterus;un treated cervical dysplasia (tissue changes in the cervix);uterine bleeding of unknown cause;anatomical changes in the uterus or cervix (including fibroids) with a change in position of the uterus;copper allergy;Wilson's syndrome (disorder of the body's copper balance);blood clotting disorders;increased susceptibility to infection.

NOVA T 380 is not the first-choice contraceptive method for young women who have not yet given birth.

When is caution required when using NOVA T 380?

A vaginal swab and other tests, e.g. to detect infections or sexually transmitted diseases, may be required before the IUD is inserted. A gynecological examination must be carried out to determine the size and position of the uterus.During the use of intrauterine devices containing copper, heavy menstrual bleeding or painful menstrual cramps (dysmenorrhoea) may occur. NOVA T 380 is not the method of first choice for women with very heavy menstrual bleeding, anemia or dysmenorrhea, as well as patients who take anticoagulant preparations. If such conditions occur during the use of the NOVA T 380, removal of the IUD should be considered.NOVA T 380 should be used with particular caution in women with congenital heart disease or heart valve defects with an increased risk of infectious heart inflammation.

Infections

NOVA T 380 is inserted with the help of an insertion tube to reduce the risk of infection. Nevertheless, the risk of abdominal infection is increased immediately after insertion. Abdominal infections in IUD users usually occurrelated to sexually transmitted diseases. There is an increased risk of infection if the woman or her partner frequently changes sex partners. Abdominal infections require immediate medical attention. A pelvic infection can affect fertility and increase the risk of an extra-uterine pregnancy (ectopic pregnancy). In very rare cases, serious infections or sepsis (very serious generalized infection that can be fatal) can occur immediately after the insertion.If pelvic inflammatory disease occurs repeatedly or an acute infection does not respond to treatment within a few days, the IUD must be removed.Contact your doctor immediately if you experience persistent abdominal pain, fever, painful sexual intercourse, or unusual discharge. If you develop severe pain or fever immediately after inserting Nova-T, it may indicate a serious infection that needs prompt treatment.

Perforation

Puncture or perforation of the uterine wall may be most likely to occur at insertion, although it may not be noticed until some time later. A NOVA T 380 that is outside the uterus no longer protects against pregnancy. Surgery may be necessary to remove NOVA T 380. The risk of perforation is increased in women who are breastfeeding and who have had an insertion up to 36 weeks after delivery, and may be increased in women with a fixed backward-leaning uterus.

Ejection

The muscular contractions of the uterus during menstruation can occasionally displace or expel the IUD. This can manifest itself in pain and unusual bleeding. If the IUD is not in the correct position, the protection against pregnancy is reduced.

Magnetic Resonance Imaging (MRI) and NOVA T 380

Magnetic Resonance Imaging scans under most standard conditions can be safely performed while using the Nova T.

Octopic pregnancy (pregnancy outside the uterus)

Although ectopic pregnancy can occur with use of IUDs are possible, according to current knowledge, IUD users have no higher risk of an ectopic pregnancy than women who do not use contraception. However, if pregnancy occurs while using an IUD, a thorough investigation is indicated. There is an increased risk of peritoneal pregnancy after a previous peritoneal pregnancy, surgery in the pelvic cavity or pelvic infections. If the menstrual period starts too late, the bleeding is weak and there is abdominal pain, an ectopic pregnancy must be considered.

Anemia

Copper-containing intrauterine devices can lead to heavier menstrual bleeding. As a result, there may be an increased risk of anemia.

Can NOVA T 380 be used during pregnancy or while breastfeeding?

Pregnancy is unlikely while using NOVA T 380. However, if you become pregnant and wish to continue the pregnancy, the IUD should be removed, otherwise there is a risk of miscarriage or premature birth. The course of pregnancy should be closely monitored. There are no indications that congenital defects in the child are to be expected if a pregnancy is carried to term despite the insertion of an IUD. If the IUD cannot be easily removed, an abortion should be considered. If you want to continue the pregnancy but do not want to remove the IUD m&opossible, talk to your doctor, who will explain how to proceed. You should consult a doctor immediately, especially if you experience cramping abdominal pain with fever.

There are no concerns about breastfeeding while using NOVA T 380.

How do you use NOVA T 380?

When should NOVA T 380 be inserted?

NOVA T 380 can be inserted on any day of the cycle. However, it is best to insert it within the first seven days after the onset of menstrual bleeding, as the risk of an undetected pregnancy is lowest during this period. The IUD insert is also possible immediately after an abortion, as long as there are no genital infections. After childbirth, an IUD should not be inserted before 6 weeks (see section «When is caution required when using NOVA T 380? - Perforation»).

Can tampons be used?

It is recommended to use sanitary towels or pads. If you use tampons, please change them very carefully.

What should you watch out for during sexual intercourse?

The IUD has a contraceptive effect immediately after it is inserted. Normally, neither you nor your partner will feel the pessary during intercourse. If you do, you should have your doctor check that the IUD is still in the correct position before having sexual intercourse again.

How is NOVA T 380 inserted?

First, an instrument - called a "speculum" - is inserted into the vagina and the cervix is ??disinfected with an antiseptic solution. Then the IUD is inserted into the uterus through a thin, flexible plastic tube. You can feel this process, but it is usually not associated with any particular pain.

How long can NOVA T 380 be used?

NOVA T 380 protects you against pregnancy for five years. After that it should be removed. A new IUD can be inserted again immediately. However, a vaginal swab should have been taken beforehand.

How can I determine whether the NOVA T 380 is sitting correctly?

After each menstrual period, you can check for yourself whether the NOVA T 380 threads can be felt in the vagina. If you carefully insert your index finger into the vagina, you can feel it in front of the cervix.Please do not pull on the threads, otherwise the NOVA T 380 may be accidentally pulled out. If you cannot feel the threads, this could be a sign of penetration of the uterine wall (perforation) or expulsion. If this happens, you should avoid intercourse or use a barrier method (such as condoms). Please tell your doctor.

What if I want to become pregnant or the NOVA T 380 needs to be removed for some other reason?

NOVA T 380 can be removed by your doctor at any time. After that, pregnancy is possible again. Removal is usually painless. After the IUD has been removed, normal fertility returns.If there is no desire to become pregnant, NOVA T 380 should not be removed after the seventh day of menstrual bleeding (monthly bleeding) unless contraception is guaranteed by other methods (e.g. condoms) at least seven days before removal. If you have irregular periods, you should use barrier methods of contraception for seven days prior to removal and continue to use them until your period returns. A new NOVA T 380 can be inserted immediately after removal, in which case no additional contraception is necessary.

When should a doctor be consulted?

Your IUD should be checked 4?12 weeks after insertion. After that should gynecologyTechnical check-ups are carried out at regular intervals ? but at least once a year. You should also inform your doctor if

• Your cycle becomes irregular and menstrual problems occur;Your menstrual period does not occur (if you suspect pregnancy);Persistent abdominal pain (possibly with fever) or unusual vaginal discharge occurs;You or your partner have pain or discomfort during sexual intercourse;You no longer have the threads of the IUD in your vagina en;The IUD has shifted and you can feel its lower end in the vagina.

What side effects can NOVA T 380 have?

It is completely normal if you notice certain changes in your normal menstrual bleeding in the first few months. The number of days you have bleeding or light bleeding between periods may increase. Menstrual bleeding can also become heavier. After inserting the NOVA T 380, abdominal pain may initially occur, but this usually subsides again after a short time. Persistent pain and very heavy bleeding may indicate that the IUD has been partially expelled. In this case, it must be removed and a new one correctly inserted. Failure of this contraceptive method can result in an ectopic pregnancy.Pelitis can occur while using the IUD. Cases of sepsis (a very serious generalized infection that can be fatal) have been reported after IUD insertion. See also the section «When is caution required when using NOVA T 380? - Infections».The risk of uterine perforation is increased in breastfeeding women and women with an insertion up to 36 weeks after delivery. See also the section «When is caution required when using NOVA T 380? - Perforation».In rare cases, pain or drowsiness may occur immediately after insertion. If these symptoms do not go away within half an hour when lying still, the IUD may not be inserted correctly. The correct position should be checked by means of an examination and the IUD should be removed if necessary.The IUD can cause allergic skin reactions.

What does NOVA T 380 contain?

Copper wire with a silver core.

Manufacturer

Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany.

Status of information

January ar 2019.

Form

NOVA T

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The length of stay of this intrauterine devices is 5 years. It should be removed or replaced by (month/year): ____/____ at the latest.Please keep this brochure safe.