Mona Lisa

Mona Lisa

Manufacturer:

Mona Lisa N.V.

Distributor:

CNW
Full Prescribing Info
Contents
Mona Lisa Cu375 IUD carrying 375 mm2 of copper surface area. Mona Lisa CuT 380A/Mona Lisa NT Cu380/Mona Lisa NT Cu380 Mini IUD carrying 380 mm2 of copper surface area.
Description
The Mona Lisa CuT 380A Intrauterine Device (IUD) is made of polyethylene and barium sulphate. Copper wire is wound around the vertical arm. There are two additional copper sleeves integrated into the hori­zontal arms and moved to the maximum position on the tip of the arms. The copper surface is 380 mm2.
Dimension: The Mona Lisa CuT 380A is 31.95 mm ± 0.35 mm wide and 35.95 mm ± 0.25 mm long.
The polyethylene frame and the wire are radio-opaque.
Characteristics: Mona Lisa CuT 380A offers almost complete protection against pregnancy. It remains effective longer than any other non-copper IUD-based reversible family planning method. Correctly inserted, the IUD is safe for women at low risk of sexually transmitted disease.
The Mona Lisa CuT 380A is an intrauterine contraceptive device made of polyethylene and barium sulphate. The bended side arms are flexible and shaped in such a way as to keep the IUD adjacent to the fundus, even in case of uterine contractions, without stretching the uterine cavity or touching the entrance of the fallopian tubes.
Mona Lisa CuT 380A IUD prevents pregnancy by blocking fertilization.
The contraceptive effect is likely due to a pronounced sterile inflammatory reaction, which takes place as a result of a foreign body response in the uterus. The concentration of various types of white blood cells, prostaglandins and enzymes in uterine and tubal fluids increases markedly. These changes interfere with the movement of sperm in the genital tract, reducing their potential fertilizing capacity, so that fertilization is not possible.
In the fallopian tubes, where fertilization is thought to take place, there are found fewer sperm in copper IUD users than in non-users. Thus, the primary action is most likely altering the function or survival of sperm and ova before they can meet.
Content: Copper, Polyethylene, Barium sulphate, Polyamide 6.
Indications/Uses
Female contraception (long lasting).
Contraindications
Absolute: Malignant diseases of the genital tract; Vaginal bleeding; Pregnancy; Past history of ectopic pregnancy or predisposing factors; Infections of the genital tract; Sexually transmitted diseases during the last 12 months (except bacte­rial vaginitis, repeated herpes infection hepatitis B); Abortion with infection during the last 3 months, pelvic inflammatory disease (PID); Uterine malformations (congenital or acquired); Allergy to copper.
Relative: Valvular heart disease; Anaemia; Coagulation disorders; Anti-inflammatory treatment; Wilson's disease; Multiple sexual partners; Nulliparity.
Special Precautions
Before inserting the IUD, a thorough medical history and an examina­tion of the pelvic and abdominal cavity as well as a cervical smear are mandatory. Pregnancy, genital infections or sexually transmitted diseases should be excluded. The position of the uterus and the size of the ute­rine cavity must be determined to ensure correct insertion of the IUD. Mona Lisa CuT 380A is designed for women with a uterine cavity depth of 6 - 9 cm.
One month after the insertion of an IUD the woman must be re-examined to determine whether the IUD is properly placed and if there are signs of infection. Subsequent follow-up examinations are to be performed annually or more frequently if clinically indicated.
Pelvic inflammatory disease during IUD use should be treated without delay. For this reason the user must be instructed to report to her physician if there are suspicious signs such as vaginal discharge, pelvic pain and fever. This can be ascertained by gynaecological examination and/or ultra­sound (if available). If treatment with antibiotics is not effective after 48 hours and signs of PID persist, the IUD must be removed immediately.
Excessive bleeding or dysmenorrhoea during the first cycle after insertion should also be carefully assessed to ascertain if this is caused by the IUD, in which case it might have to be removed.
The possibility of perforation of the uterus during the insertion should always be considered, especially if the nylon threads are invisible or cannot be drawn out of the cervical canal. If there are any doubts about the position of the IUD (e.g. if the IUD is extremely difficult or painful to insert) the appropriate diagnostic techniques should be used (flat x-ray of the pelvis, ultrasonogarphy, hysteroscopy, laparoscopy).
If the nylon threads appear to be longer than at insertion, an ultrasound should be carried out to determine if the IUD has been displaced, what might decrease its contraceptive efficacy.
If the threads are not visible at follow-up examination, at first pregnancy must be excluded. The threads may have possibly been drawn up into the cervical canal or the uterus and usually reappear during the next menstruation. In case of doubt the IUD can be identified by feeling carefully with a suitable instrument, by ultrasound or by x-ray after excluding pregnancy.
In case of accidental pregnancy with the IUD in situ, it is mandatory to determine (by ultrasound) whether the pregnancy is intrauterine or ectopic. Up to the end of the first trimester, if the threads are visible, the IUD should be carefully removed. After that the patient should be offered the option of elective abortion as soon as possible, since there is an increased risk of PID and other obstetric problems, e.g. premature labour, placenta praevia and abruptio placentae.
However, if the woman wishes to continue her pregnancy, close monitoring is mandatory. She should be informed about the risks of keeping the IUD in situ.
There are no contraindications to breastfeeding with an IUD in situ.
Perforation: Perforation or penetration of the uterine corpus or cervix by the IUD may occur, usually during insertion. The risk is increased during the postpartum period and slightly increased if the woman is fully breastfeeding. The device must be removed as soon as possible if this occurs.
Side Effects
During use of IUDs heavier menstrual bleeding, slight intermenstrual bleeding, anaemia, dysmenorrhoea, pain in the lower abdomen or sacral area as well as pelvic infection may occur. The risk of an ectopic pregnancy is increased. In rare cases, the IUD may penetrate into the wall of the uterus or perforate it. Allergic skin reactions may occur.
Drug Interactions
The available experience indicates that, in general, drug interference with the contraceptive efficacy of Mona Lisa CuT 380A is highly unlikely. However, published reports appear to show diminished efficacy with long term use of non-steroidal anti-inflammatory drugs (especially acetyl salicylic acid) and of corticosteroids. Short term use in the treatment of dysmenorrhoea with non-steroidal anti-inflammatory drugs does not appear to reduce contraceptive efficacy.
Do not perform diathermy (short wave and microwave) of the sacral or abdominal region since heating may cause heat injury to the surrounding tissue.
Caution For Usage
Physician instructions to IUD users: Users should be informed in detail as to the advantages and disadvantages of IUD contraception, not only so that they understand how it works, but above all so that any complications can be detected early. The user must learn how to feel the threads emerging from the cervical canal.
Insertion: First eliminate the possibility of pregnancy: The best time for insertion is during menstruation to prevent insertion during non-diagnosed pregnancy. At this time the external and internal cervical os are physiologically dilated. This facilitates the insertion of the IUD without the need to dilate the canal in most instances.
Alternatively, the IUD may be introduced within 5 days of unprotected coitus or within 15 minutes of delivery of the placenta or abortion in the first trimester. In these last two cases a higher expulsion rate is expected. Insertion immediately after unprotected coitus can increase the risk of PID.
If the IUD cannot be inserted immediately after delivery of the placenta or abortion, insertion should be delayed for at least six weeks. In case of caesarean section insertion should be delayed for 12 weeks after delivery, although this is controversial.
Prior to insertion the vagina, cervix and cervical canal should be cleansed with an antiseptic solution. It is essential to determine the exact position of the uterus by bimanual pelvic palpation so that the Mona Lisa CuT 380A can be inserted along its longitudinal axis. This can be accomplished by grasping the anterior or posterior lip of the cervix, depending on whether the uterus is anteverted or retroverted.
A local anaesthetic may be applied as a gel or can be injected in and around the cervix prior to insertion.
Hysterometry should be carried out and the ascertained depth of the uterus be marked on the Mona Lisa CuT 380A inserter tube with the aid of the movable flange.
Step-by-Step loading instructions: The IUD may be used by trained medical staff only. In order to minimize the risk of contamination we recommend using sterile gloves.
1. Open the sterile packaging of the Mona Lisa CuT 380A. Take the loading capsule and push it over the side arms.
2. Push the side arms as far as they will go into the loading capsule until they fit completely in it and pull the insertion tube back carefully until the Mona Lisa CuT 380A lies freely in the loading capsule.
3. Now squeeze the loading capsule gently on the side and push the insertion tube over the side arms up to the end of the copper sleeves. The side arms may not be further slid into the insertion tube, since otherwise the tube can be stretched too strongly and unpleasant edges can arise.
4. Remove the loading capsule. Mona Lisa CuT 380A fits safely in the insertion tube.
5. Holding the threads straight in the tube, place the plunger into the insertion tube. This prevents that the threads will be disarranged by inserting the plunger.
Adjust the sliding flange so that the length of the tube above it corresponds to the depth of the uterus as previously measured by hystero­metry. Ensure that the wider part of the flange indicates the direction in which the side arms of the IUD will open in the uterus.
Note: The ends of the side arms of the Mona Lisa CuT 380A must not be slid further into the insertion tube than described under 3 and must not remain bended for over five minutes within the insertion tube; otherwise they may not bend back completely and may not return to their original 90° angle.
6. Carefully introduce the insertion tube containing the Mona Lisa CuT 380A into the uterine cavity until it touches the fundus of the uterus. The sliding flange must be in contact with the cervix.
7. Holding the plunger steady, pull the insertion tube downwards to the base of the plunger. The sidearms of the IUD are now entirely released in the uterus.
To prevent pulling the device from its fundal position, first remove the plunger while keeping the insertion tube steady and only then remove the insertion tube.
Cut the threads leaving 2-3 cm visible outside the cervix.
Removal: Mona Lisa CuT 380A should be replaced after 10 years.
Again, the most appropriate time to remove the IUD is during menstruation since both the internal and external cervical os are fully dilated. Grasp threads of IUD with a tenaculum and pull it along the longitudinal axis of the uterus. Try to insert the forceps at the entrance to the cervical canal in order to grasp the vertical arm of the IUD as soon as it has passed the internal cervical os. This avoids excessive tension on the threads, which could cause them to break. While doing this, distract the patient's attention by asking her to cough, and then remove the Mona Lisa 380A with one firm tug.
Insertion and removal of the IUD could cause slight pain and bleeding or may precipitate a vasovagal attack or an epileptic seizure.
After removal, inspect the Mona Lisa CuT 380A to see that none of the arms have been left in the uterine cavity.
In case of a lost IUD or lost parts of an IUD in the uterine cavity either hysteroscopy or ultrasonography or x-rays should be used to determine its location: curettage may be advisable. In very rare cases of uterine perforation laparoscopy may be needed.
Incompatibilities: No known incompatibilities.
Storage
Store in a dry place, below 35°C.
Protect from direct sunlight and moisture.
Shelf-life: Four years.
ATC Classification
G02BA02 - plastic IUD with copper ; Belongs to the class of intrauterine contraceptives used in contraception.
Presentation/Packing
Mona Lisa Cu375 IUD 1 piece/box. Mona Lisa CuT 380A IUD 1 piece/box. Mona Lisa NT Cu380 IUD 1 piece/box. Mona Lisa NT Cu 380 Mini IUD 1 piece/box.
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