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Berlex Canada
Intrauterine Copper
Intrauterine Contraceptive
Description: Nova-T is an intrauterine device made of plastic (polyethylene) approximately in the shape of a T. Polyethylene threads are attached to the lower portion. The horizontal and vertical arms of the T are 32 mm in length and 1.2 mm in diameter; a loop 2.6 mm wide is found at the tip of the vertical arm; and a thin copper wire (107-141 mg Cu, surface area of 200 mm stablized with a silver core (11-29 mg Ag) is coiled onto the vertical portion of the T. The silver core prevents fragmentation of the wire and prolongs the lifespan of the device.
Indications And Clinical Uses: For intrauterine contraception in gynecologically normal women of childbearing age. The reported annual pregnancy rate for intrauterine devices is less than 1 to 6 per 100 women.
Duration of Use: Nova-T can be left inserted for a maximum of 30 months. If continued contraception is desired by the patient, a new Nova-T should be inserted at once.
Contra-Indications: Nova-T should not be used in the presence or suspicion of: pregnancy, malignant tumor in the genital area; acute, subacute and chronic pelvic inflammatory disease (including a history of such infections), profuse menstrual bleeding; congenital or acquired anatomical changes of the uterus or cervix; endometriosis; hypoplasia or extreme positional anomalies of the uterus; genital bleeding of unknown origin; clotting disorders; conditions which can lead to or promote bacteremia (e.g., valvular defects, congenital heart disease); severe anemia; conditions associated with a weakened immune defense; Wilson's disease; copper allergy; a history of ectopic pregnancy. tag_WarningWarnings

Manufacturers' Warnings In Clinical States: The risk/benefit ratio of inserting an intrauterine device must be carefully weighed following surgery on the uterine body or in the pelvic and abdominal cavity, and particularly on the fallopian tubes, since there have been isolated reports of an increased risk of ectopic pregnancy and uterine perforation.

The rate of expulsion may be increased when insertions are made before normal uterine involution occurs following delivery or abortion. It is recommended that Nova-T be inserted 1 month postpartum or postabortion. Current data indicate that slightly higher expulsion and pregnancy rates may be anticipated with earlier insertion.

In young and nulliparous women, the risk/benefit ratio must be carefully appraised because of reports of higher failure rates and complications. Some epidemiological surveys suggest that nulliparous patients using an intrauterine device may be at a greater risk of pelvic inflammatory disease and subsequent infertility. Women with multiple sexual partners also seem to be more affected in this respect.

Patients should be examined for the presence of pelvic inflammatory disease before inserting Nova-T. In cases of infection (e.g., subsequent to a septic abortion or a sexually transmitted disease) appropriate treatment should be given before inserting the IUD.

Nova-T, as other intrauterine devices, is not effective in preventing ectopic pregnancies. There is therefore a risk of an ectopic pregnancy occurring with an intrauterine device in situ.

Nova-T should be removed for the following reasons: Perforation of the uterus which places the device outside the uterine cavity (usually occurs during insertion).

Excessive and persistent bleeding and cramping, and inflammation in the region of the uterus or pelvis minor, to prevent worsening of these symptoms or possible infertility. Note: In patients with inflammation or mild symptoms indicative of inflammatory changes (e.g., discharge), bacteriological examinations and antibiotic therapy, where applicable, are indicated. If actinomycetes are found in cytological smears, consideration must be given to removing the intrauterine device as a precaution - particularly after it has been in situ for a long time - even in asymptomatic patients and to giving appropriate treatment.

Partial or total downward displacement of Nova-T within the cervical canal (in some cases the tip of the "T" device can be palpated). Note: Nova-T should be removed by gentle traction on the threads or on the tip of the "T". When Nova-T is in the cervical canal, protection against pregnancy may be reduced or absent.

Pregnancy occurring with Nova-T in situ. Note: Nova-T should be removed by pulling on the threads to reduce the increased risk of secondary symptoms (e.g. abortion, general bacterial infection); however, if Nova-T cannot be withdrawn, termination of pregnancy should be considered.

Important: If there is any suspicion that Nova-T is incorrectly positioned, it must be removed and replaced by another sterile Nova-T.

Precautions: Prior to inserting Nova-T, the physical examination should include a complete pelvic examination and a Papanicolaou smear. Pregnancy must be ruled out.

It is advisable to insert Nova-T at the end of the menstrual period since at this time the patient is unlikely to be pregnant and the cervical canal is still dilated.

Nova-T must be placed as high as possible within the uterine cavity, to help avoid downward displacement, expulsion or accidental pregnancy.

As a general principle, Nova-T should be inserted under aseptic conditions.

The patient should be informed that she may have some spotting, light bleeding or cramps during the first few days after insertion. If these events continue or are severe, they should be reported to the physician.

If there is complaint of discomfort during intercourse, the possibility of displacement or cervical perforation should be ruled out.

Should the patient become aware that Nova-T has been expelled, she should contact her physician because she is no longer protected from pregnancy.

The patient should contact her physician immediately if she misses a menstrual period or thinks she may be pregnant.

After insertion the threads remain outside the cervical canal in the vagina. At weekly intervals or at least after each menstrual period, the patient should be instructed to verify with a finger whether the threads of Nova-T can be felt in the vagina. If the patient cannot feel the threads or sense the device, she should see her physician. If the threads are not visible, they may have been drawn up into the cervical canal or Nova-T may have been expelled unnoticed. In exceptional cases Nova-T may be lying outside the uterus as a result of perforation. An x-ray examination should be performed to assess the situation. The plastic component of Nova-T contains barium sulfate and therefore gives good contrast. The position of Nova-T can also be ascertained by ultrasound. Normally, Nova-T can be removed by simply pulling on the threads. If Nova-T is inside the uterus, the device or the threads can be gripped through the cervical canal by a slender, slightly convex forcep. If the position of the device is extrauterine, surgical removal is essential, using laparoscopy if possible.

Patients should be followed up at 1, 3, 6 and 12 months after insertion, and thereafter at approximately yearly intervals. A Papanicolaou smear should be done at least once a year.

Ectopic pregnancy must be considered in the presence of vague lower abdominal complaints associated with irregular cycles (especially amenorrhea after persistent bleeding).

Women who are taking anticoagulants should inform their physician because of the increased tendency to hemorrhage.

Reports have been published indicating that the contraceptive effect of intrauterine devices appears to be diminished in patients receiving chronic treatment with NSAIDs (particularly ASA) and with corticoids; however, experience has shown that contraceptive protection is not reduced during short-term treatment of dysmenorrhea with NSAIDs.

Caution should be exercised when performing diathermy (short-wave or microwave), of the sacral or abdominal region since heating of the copper can subsequently damage Nova-T.

Adverse Reactions: In extremely rare cases, a brief loss of consciousness or decelerated pulse rate may occur during insertion or removal of intrauterine devices. Perforation of the uterus or the cervix may occur. Initially, Nova-T can cause persistent pain in the lower abdomen or sacral area, but this usually subsides.

Menstrual bleeding is sometimes stronger and of longer duration than normal, or is more painful. Iron-deficiency anemia may then occur in individual cases. Slight intermenstrual bleeding, often in the form of spotting, may occur but it usually subsides spontaneously (the physician should be informed if intermenstrual bleeding persists).

Lower abdominal infections, with the risk of subsequent infertility, occur more frequently in patients using an IUD device than in other women.

Isolated cases of skin reactions have been described in the literature which may be attributable to copper allergy, since they disappeared when the copper device was removed.

Dosage And Administration: Insertion Technique: Prior to Insertion: Prior to the insertion of Nova-T the patient should be given a thorough gynecological examination. The size and position of the uterus should be established and pregnancy or other contraindications should be ruled out (see Contraindications).

Insertion: Nova-T can be inserted on any day of the cycle; however, the last days of menses are recommended since at this time the patient is unlikely to be pregnant and the cervical canal is still dilated, thus facilitating insertion. Given its small diameter, the insertion tube is easy to introduce and usually does not call for further dilation.

As a general principle, Nova-T should be inserted under aseptic conditions using sterile gloves. The following steps should be followed when inserting Nova-T: 1. Insert a speculum to visualize the external os uteri and disinfect the vagina and cervix. 2. Use a tenaculum forcep to stretch the neck of the uterus. The forceps should be left in position until Nova-T has been inserted. 3. Utilize a sound to determine the position and length of the uterine lumen. 4. Prepare Nova-T: Open the plastic covering far enough to expose the lower end of the insertion tube; however, Nova-T and the insertion tube are not to be withdrawn. While holding the tube firmly with one hand, expose the threads and draw the device into the insertion tube.

Steadying the yellow ring with one hand, move the insertion tube until the yellow ring's lower rim indicates the previously sounded length on the scale. Holding the threads slightly stretched with one hand, place the plunger into the tube with the free hand. This will ensure that the threads are lying straight in the tube and are not disarranged by the plunger. If necessary, the insertion tube can be bent so that it is better adapted to the position of the uterus.

Remove Nova-T from the plastic covering. Gently insert Nova-T into the cervical canal and advance it until the yellow ring touches the cervix. The broad sides of the yellow ring must be horizontal to ensure subsequent correct unfolding of the arms.

Hold the plunger firmly with one hand and draw the tube back until it reaches the ribbed part of the plunger, thereby, removing the yellow ring from the cervix (distance approximately 1.5 cm). The arms of Nova-T are now unfolded.

Advance the insertion tube until the yellow ring touches the cervix again. Nova-T is then in contact with the fundus uteri.

To release Nova-T entirely from the insertion tube, hold the plunger firmly and draw the tube back as far as the backstop. To avoid entangling the threads between the tube and the plunger, carefully remove the plunger first and then the insertion tube. Cut the threads about 3 cm from the cervix. See manufacturer's package insert for illustration of the above steps.

Availability And Storage: Individual sterile package units, with an insertion tube imprinted with a centimetre scale, and a plunger. (Shown in Product Recognition Section)