NOVAPLUS T 380 Cu NORMAL (Cu 380a) INTRAUTERINE DEVICE

NOVAPLUS T 380 Cu NORMAL (Cu 380) INTRAUTERINE DEVICE
NOVAPLUS T 380 Cu NORMAL (Cu 380a) INTRAUTERINE DEVICE
Description/Details
Each modified T shaped frame of SMB Copper T 380 Plus (Cu T 380 Plus) is made from compound of Low Density Polyethylene and Barium Sulphate
Sterilet (Cupru) Novaplus Copper T 380 Eurogine Normal - 
(15% - 24%) wounded with 0.39mm diameter copper wire providing a surface area of 380mm2 ± 23 mm2.
NOVA T 380 Intrauterine device (IUD) COMPOSITION: NOVA T 380 is an intrauterine device made of polyethylene and wound with copper wire with a silver core. The surface area of the copper is 380 mm2. The polyethylene body, shaped as a modified T is impregnated with barium sulphate. Removal threads, pigmented with iron oxide are attached to the base of the vertical arm of the T. PHARMACOLOGICAL CLASSIFICATION: A. 34 Other – intrauterine device PHARMACOLOGICAL ACTION: Copper IUDs prevent pregnancy by preventing fertilisation. This is based on the inhibition of sperm and egg transport and/ or the capacity of the sperm to fertilise eggs. This happens through cytotoxic and phagocytic effects before the egg reaches the uterine cavity. After the removal of NOVA T 380 fertility is promptly restored. The pregnancy rate with NOVA T 380 has been 0.6 per 100 woman-years. INDICATIONS: Contraception. CONTRA-INDICATIONS: • Known or suspected pregnancy; • current or recurrent pelvic inflammatory disease; • lower genital tract infection; • postpartum endometritis; • Infected abortion during the past three months; • Untreated cervicitis; • Untreated cervical dysplasia; • Untreated uterine or cervical malignancy; • Undiagnosed abnormal uterine bleeding; • Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; • Copper allergy; • Wilson’s disease; • Coagulation disturbances; • Conditions associated with increased susceptibility to infections

The T is equipped with polyamide monofilament thread (suture) for easy removal. It is packed together with an insertion tube and rod in a peelable pouch.

The insertion tube is equipped with a movable flange to aid in gauging the depth to which the insertion tube should be inserted through the cervical canal and into the uterine cavity.
Centimeter Scale printed in blue is provided on the Insertion Tube for exact positioning of the flange on the Insertion Tube before Insertion.
NOVA PLUS T-380 AG
The intrauterine device Novaplus T 380 Ag (Cu380 + Ag) is an intrauterine device for preventing unforeseen pregnancy.
The plastic core is wrapped in copper wire with a silver core.
The IUD affects the speed of the sperm, slows down the movement of the egg into the uterus and prevents the introduction of an already fertilized egg into the uterine cavity.
The core, made of silver, prevents damage to the copper winding, which extends the duration of the contraceptive functions of the spiral. Silver ions provide protection against inflammatory effects and other problematic processes.
The T-shape provides the most reliable fastening of the spiral, allows the device not to harm the uterus as a whole.
The probability of a displacement or loss of a spiral with this shape is equal to zero.
In recent years, the reliability of T-shaped spirals has increased, and it has become much easier to use them.
The maximum recommended duration of stay of the IUD in the uterine cavity is 5 years.
NOVA PLUS T-380 AG
PROPRIETARY NAME AND DOSAGE FORM: NOVA T 380 Intrauterine device (IUD) COMPOSITION: NOVA T 380 is an intrauterine device made of polyethylene and wound with copper wire with a silver core. The surface area of the copper is 380 mm2. The polyethylene body, shaped as a modified T is impregnated with barium sulphate. Removal threads, pigmented with iron oxide are attached to the base of the vertical arm of the T. PHARMACOLOGICAL CLASSIFICATION: A. 34 Other – intrauterine device PHARMACOLOGICAL ACTION: Copper IUDs prevent pregnancy by preventing fertilisation. This is based on the inhibition of sperm and egg transport and/ or the capacity of the sperm to fertilise eggs. This happens through cytotoxic and phagocytic effects before the egg reaches the uterine cavity. After the removal of NOVA T 380 fertility is promptly restored. The pregnancy rate with NOVA T 380 has been 0.6 per 100 woman-years. INDICATIONS: Contraception. CONTRA-INDICATIONS: • Known or suspected pregnancy; • current or recurrent pelvic inflammatory disease; • lower genital tract infection; • postpartum endometritis; • Infected abortion during the past three months; • Untreated cervicitis; • Untreated cervical dysplasia; • Untreated uterine or cervical malignancy; • Undiagnosed abnormal uterine bleeding; • Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity; • Copper allergy; • Wilson’s disease; • Coagulation disturbances; • Conditions associated with increased susceptibility to infections
INTERACTIONS: The limited available experience with NOVA T 380 indicates that medicine effects interfering with NOVA T 380's contraceptive efficacy are unlikely. PREGNANCY AND LACTATION: Pregnancy: NOVA T 380 is not to be used during an existing or suspected pregnancy (see “Contra-indications”). If the woman becomes pregnant when using NOVA T 380 removal of the device is recommended, since the IUD left in situ may increase the risk of abortion and preterm labour. Removal of the IUD or probing of the uterus may result in spontaneous abortion. If the device cannot be gently removed, termination of the pregnancy may be considered. If the woman wishes to continue the pregnancy and the device cannot be withdrawn, she should be informed about these risks and the possible consequence of premature birth to the infant. In addition, ectopic pregnancy should be excluded and the course of such a pregnancy should be closely monitored. The woman should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever. She should be informed that, to date, there is no evidence of birth defects in cases where a pregnancy continues to term with NOVA T 380 in place. Lactation: NOVA T 380 does not interfere with lactation. DOSAGE AND DIRECTIONS FOR USE: NOVA T 380 is supplied sterile, sterilised by irradiation. It is for single use only. Do not use if the pouch is damaged or open. Do not resterilise. Use before the date shown on the pouch label. To be inserted by a qualified healthcare professional. NOVA T 380 is inserted into the uterine cavity. It is effective for five years.
Product Description
 
Technical features:
 
99,99% pure copper contraceptive wire 
380 mm2 of copper surface depending on the model. 
2 sizes available (normal and mini) to improve its fitting into the uterus.
Y-shaped IUD.
Contraceptive safety up to 5 years.
Pre-loading insertion system.
For contraceptive purpose.
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