Manufacturer: Mona Lisa N.V.
Active Substance(s): COPPER
Strength: 380mm2
Pack Size: 1 x 380mg T-Shaped IUD
T-Safe CU 380A QL is a contraceptive device for women. It doesn’t contain hormones and its effective action is provided due to the simple structure of the contraceptive. It is T-shaped and consists of a plastic stem with copper wire on the vertical part and copper tips fixed on the horizontal part. T-Safe CU 380A QL has a copper surface of 380 mm² and guarantees safe contraception up to 10 years (recommendation of the WHO).
INFORMATION
T-SAFE® CU 380A QL IUD Product Description
The T-SAFE® CU 380A QL IUD is a long-acting intrauterine contraceptive device designed for high efficacy in preventing pregnancies. Its T-shaped structure comprises polyethylene and barium sulfate, with a copper surface area of 380 mm² to ensure optimal contraceptive effectiveness. The IUD benefits from advanced technology, similar to the principles of a safe software defined perimeter and temperature-controlled supply chain and logistic management, ensuring reliability and safety in its design.
Key Features and Benefits
This T-SAFE IUD offers 10 years of reliable contraception and is a suitable option for women seeking hormone-free methods. The recommended uterine length is at 6 to 9 cm, with key benefits including:
- High efficacy with annual pregnancy rates of 0.4% or less.
- Immediate fertility restoration after removal.
- Suitable for breastfeeding women.
A thin copper wire is wound around the plastic IUD body, continuously releasing small amounts of copper ions into the uterus. This process alters the mucous membrane and cervical mucus, significantly reducing sperm mobility. As a result, sperm either fail to reach the egg or are present in insufficient numbers to achieve fertilization.
T-SAFE® CU 380A QL IUD Ingredients
Contraceptive devices contain different ingredients, which deliver effectiveness and safety to individuals. Notably, this IUD device features the following materials:
- Polyethylene frame for durability.
- Copper wire and sleeves for contraceptive action.
- Radiopaque materials for visibility during imaging.
- Part of the T-SAFE® brand of copper IUD products.
Intrauterine Contraceptive Indications and Treatment Applications
Extensive international studies confirm that copper IUDs are safe and highly effective for long-term use. Intrauterine contraception involves placing an IUD in the uterus, where it prevents pregnancy. This T-SAFE copper IUD has indications, including:
- Women seeking long-term contraception.
- Those with contraindications to hormonal contraceptives.
- Emergency contraception use within 5 days of unprotected intercourse.
However, like any contraceptive method, this IUD does not guarantee absolute protection. If your patient’s period is delayed, it is essential to consult with their doctor or visit a clinic promptly for further evaluation and guidance.
T-SAFE® CU 380A QL IUD Dosage and Administration
A trained healthcare provider should insert this hormonal birth control in a medical clinic with sterile conditions. It’s essential to follow these key steps when inserting this copper IUD:
- Determining uterine depth using a hysterometer.
- Insertion during menstruation to avoid undiagnosed pregnancy.
- Proper positioning to minimize complications like perforation.
T-SAFE IUDs Side Effects and Warnings
These intrauterine devices may cause potential risks that patients may find unusual or may cause discomfort. The possible side effects that patients may experience during their IUD use include:
- Intermittent bleeding initially, with increased menstrual bleeding
- In some cases, more severe and painful menstrual pain
- Abdominal discomfort
In an infrequent instance, the IUD may be expelled. Moreover, although failures are rare, they carry a slightly higher risk of ectopic pregnancy. Rare but serious risks may also occur, which require immediate medical attention for appropriate management.
- Pelvic Infections: Increased risk within the first month of use.
- Uterine Perforation: Risk higher for postpartum women.
T-SAFE® CU 380A QL IUD Precautions and Contraindications
Medical professionals must understand all necessary information about the intrauterine device (IUD), including its health risks, benefits, contraindications, and precautions. Their expertise and comprehensive knowledge can help them educate patients and allow them to make informed treatment decisions. The copper intrauterine product has contraindications, such as:
- Pregnancy
- Recent sexually transmitted infection
- Uterine or vaginal bleeding
- Distorted or small uterine cavity
- Genital malignancy
- Pelvic inflammatory disease
- Severe immunosuppression
- Wilson’s disease
- Medical diathermy
- Hypersensitivity to copper
Patients should seek their medical provider when pain or discomfort occurs during sexual intercourse, or a sudden change in their periods. Additionally, practitioners must perform regular follow-ups 3 to 6 weeks after IUD insertion to check placement and rule out infections. Afterward, annual check-ups must be necessary to ensure safety and continuous efficacy.
T-SAFE® CU 380A QL IUD Long-Term Considerations
Long-term usage of IUDs may alter bleeding patterns, but they generally decrease over time. Patients should understand that regular monitoring and follow-up appointments ensure effectiveness for several years, health safety, and minimal adverse effects.
Furthermore, patients may find using this copper IUD cost-efficient. It can last for multiple years, which can help them save, instead of using other contraceptive or birth control options.
T-SAFE® CU 380A QL Intrauterine Device Manufacturer and Regulatory Information
Mona Lisa N.V. manufactures the copper IUD, which is sterilized with ethylene oxide and packed for single use. Proper storage between 0°C and 35°C ensures the integrity of this copper IUD product.
T-SAFE® CU 380A QL Intrauterine Device FAQs
How long can it last?
This copper IUD can last up to 10 years compared to other IUDs. It’s worth noting that patients must consistently undergo check-up appointments after insertion to ensure safety and efficacy. Furthermore, only licensed and trained medical professionals must insert these IUDs to prevent complications.
Can it be used during breastfeeding?
Yes, it’s safe for lactating women. Individuals can ensure their suitability with this copper IUD through a thorough consultation with healthcare providers. These professionals can assess the patient’s overall health, concerns, and current conditions, to ensure the product’s maximum efficacy.
When should it be removed?
Medical professionals may recommend IUD replacement after 10 years, or earlier if complications arise. Patients must regularly monitor for any unusual symptoms or reactions that may occur throughout their copper IUD experience.
T-SAFE® CU 380A QL IUD Product Description
The T-SAFE® CU 380A QL IUD is a long-acting intrauterine contraceptive device designed for high efficacy in preventing pregnancies. Its T-shaped structure comprises polyethylene and barium sulfate, with a copper surface area of 380 mm² to ensure optimal contraceptive effectiveness. The IUD benefits from advanced technology, similar to the principles of a safe software defined perimeter and temperature-controlled supply chain and logistic management, ensuring reliability and safety in its design.
Key Features and Benefits
This T-SAFE IUD offers 10 years of reliable contraception and is a suitable option for women seeking hormone-free methods. The recommended uterine length is at 6 to 9 cm, with key benefits including:
- High efficacy with annual pregnancy rates of 0.4% or less.
- Immediate fertility restoration after removal.
- Suitable for breastfeeding women.
A thin copper wire is wound around the plastic IUD body, continuously releasing small amounts of copper ions into the uterus. This process alters the mucous membrane and cervical mucus, significantly reducing sperm mobility. As a result, sperm either fail to reach the egg or are present in insufficient numbers to achieve fertilization.
T-SAFE® CU 380A QL IUD Ingredients
Contraceptive devices contain different ingredients, which deliver effectiveness and safety to individuals. Notably, this IUD device features the following materials:
- Polyethylene frame for durability.
- Copper wire and sleeves for contraceptive action.
- Radiopaque materials for visibility during imaging.
- Part of the T-SAFE® brand of copper IUD products.
Intrauterine Contraceptive Indications and Treatment Applications
Extensive international studies confirm that copper IUDs are safe and highly effective for long-term use. Intrauterine contraception involves placing an IUD in the uterus, where it prevents pregnancy. This T-SAFE copper IUD has indications, including:
- Women seeking long-term contraception.
- Those with contraindications to hormonal contraceptives.
- Emergency contraception use within 5 days of unprotected intercourse.
However, like any contraceptive method, this IUD does not guarantee absolute protection. If your patient’s period is delayed, it is essential to consult with their doctor or visit a clinic promptly for further evaluation and guidance.
T-SAFE® CU 380A QL IUD Dosage and Administration
A trained healthcare provider should insert this hormonal birth control in a medical clinic with sterile conditions. It’s essential to follow these key steps when inserting this copper IUD:
- Determining uterine depth using a hysterometer.
- Insertion during menstruation to avoid undiagnosed pregnancy.
- Proper positioning to minimize complications like perforation.
T-SAFE IUDs Side Effects and Warnings
These intrauterine devices may cause potential risks that patients may find unusual or may cause discomfort. The possible side effects that patients may experience during their IUD use include:
- Intermittent bleeding initially, with increased menstrual bleeding
- In some cases, more severe and painful menstrual pain
- Abdominal discomfort
In an infrequent instance, the IUD may be expelled. Moreover, although failures are rare, they carry a slightly higher risk of ectopic pregnancy. Rare but serious risks may also occur, which require immediate medical attention for appropriate management.
- Pelvic Infections: Increased risk within the first month of use.
- Uterine Perforation: Risk higher for postpartum women.
T-SAFE® CU 380A QL IUD Precautions and Contraindications
Medical professionals must understand all necessary information about the intrauterine device (IUD), including its health risks, benefits, contraindications, and precautions. Their expertise and comprehensive knowledge can help them educate patients and allow them to make informed treatment decisions. The copper intrauterine product has contraindications, such as:
- Pregnancy
- Recent sexually transmitted infection
- Uterine or vaginal bleeding
- Distorted or small uterine cavity
- Genital malignancy
- Pelvic inflammatory disease
- Severe immunosuppression
- Wilson’s disease
- Medical diathermy
- Hypersensitivity to copper
Patients should seek their medical provider when pain or discomfort occurs during sexual intercourse, or a sudden change in their periods. Additionally, practitioners must perform regular follow-ups 3 to 6 weeks after IUD insertion to check placement and rule out infections. Afterward, annual check-ups must be necessary to ensure safety and continuous efficacy.
T-SAFE® CU 380A QL IUD Long-Term Considerations
Long-term usage of IUDs may alter bleeding patterns, but they generally decrease over time. Patients should understand that regular monitoring and follow-up appointments ensure effectiveness for several years, health safety, and minimal adverse effects.
Furthermore, patients may find using this copper IUD cost-efficient. It can last for multiple years, which can help them save, instead of using other contraceptive or birth control options.
T-SAFE® CU 380A QL Intrauterine Device Manufacturer and Regulatory Information
Mona Lisa N.V. manufactures the copper IUD, which is sterilized with ethylene oxide and packed for single use. Proper storage between 0°C and 35°C ensures the integrity of this copper IUD product.
T-SAFE® CU 380A QL Intrauterine Device FAQs
How long can it last?
This copper IUD can last up to 10 years compared to other IUDs. It’s worth noting that patients must consistently undergo check-up appointments after insertion to ensure safety and efficacy. Furthermore, only licensed and trained medical professionals must insert these IUDs to prevent complications.
Can it be used during breastfeeding?
Yes, it’s safe for lactating women. Individuals can ensure their suitability with this copper IUD through a thorough consultation with healthcare providers. These professionals can assess the patient’s overall health, concerns, and current conditions, to ensure the product’s maximum efficacy.
When should it be removed?
Medical professionals may recommend IUD replacement after 10 years, or earlier if complications arise. Patients must regularly monitor for any unusual symptoms or reactions that may occur throughout their copper IUD experience.
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