GNH USA

Europe — EMA

Levosert

GNH USA supplies Levosert (Levonorgestrel), a hormonal contraceptive for long‑acting reversible contraception and prevention of pregnancy up to five years.

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Levosert, is a progestin presented as a 52 mg intrauterine system for intrauterine use. It provides long‑acting reversible contraception and prevents pregnancy for up to five years.

GNH USA supplies Levosert as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Levonorgestrel used for?

Levosert, a hormonal contraceptive delivered via an intrauterine system, is indicated for:

- Long‑acting reversible contraception: provides up to five years of reliable pregnancy prevention. - Prevention of unintended pregnancy: suitable for women seeking a non‑daily, highly effective method. - Management of menstrual bleeding patterns: may reduce heavy or irregular bleeding in many users.

What are the side effects of Levonorgestrel?

Levosert may cause a range of adverse reactions. Most are mild and resolve with time.

Common Side Effects: - Irregular bleeding or spotting, especially during the first months. - Amenorrhea (absence of periods) after continued use. - Pelvic or uterine cramping. - Breast tenderness or mild hormonal symptoms. - Headache or mild nausea.

Serious or Rare Side Effects: - Uterine perforation during insertion. - Expulsion of the device. - Pelvic infection (e.g., PID) following placement. - Ectopic pregnancy if contraception fails. - Rare systemic hormonal effects such as thrombosis.

What precautions apply to Levonorgestrel?

Before insertion of Levosert, certain precautions should be observed to ensure safety and effectiveness.

- Screen for contraindications: ensure the patient has no active pelvic infection, unexplained vaginal bleeding, or known hypersensitivity to levonorgestrel. - Assess uterine anatomy: appropriate for a normal uterine cavity size and shape. - Confirm non‑pregnancy: a negative pregnancy test is required prior to placement. - Monitor device position: schedule follow‑up visits to check for displacement or expulsion. - Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levosert may interact with medications that affect levonorgestrel metabolism or hormone levels.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin): may significantly reduce contraceptive efficacy. - Certain antiretroviral protease inhibitors: can alter hormone concentrations and compromise effectiveness.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inducers (e.g., St. John’s wort, efavirenz): may modestly lower levonorgestrel levels. - Antifungal azoles and some antibiotics (e.g., griseofulvin): could affect hormone metabolism and require additional contraceptive measures. - Concurrent hormonal therapies (e.g., estrogen‑containing contraceptives): may increase overall hormonal exposure and warrant clinical review.

Frequently asked questions

What is Levosert used for?+
Levosert is an intrauterine system that delivers levonorgestrel directly to the uterus. It is used as a long‑acting reversible contraceptive to prevent pregnancy for up to five years and can also help regulate menstrual bleeding patterns.
How does levonorgestrel work in Levosert?+
Levonorgestrel released from the device thickens cervical mucus, reduces sperm motility, suppresses the growth of the uterine lining, and may inhibit ovulation. These combined actions prevent fertilisation and implantation, providing effective contraception.
What is the usual dose of Levosert?+
Levosert is supplied as a pre‑loaded 52 mg intrauterine system. The exact dosing regimen, including insertion timing and follow‑up schedule, is determined by the prescribing healthcare professional based on individual patient needs.
Is Levosert safe to use during pregnancy or breastfeeding?+
Levosert must not be used during pregnancy; a negative pregnancy test is required before insertion. Women who become pregnant while the device is in place should have it removed promptly. Limited data exist for breastfeeding, and clinicians should weigh benefits against potential risks.
How do I order Levosert from GNH USA?+
To order Levosert, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Levosert compare with other hormonal contraceptives?+
Compared with oral progestin pills, Levosert offers continuous, low‑dose hormone delivery without daily adherence, providing up to five years of protection. Unlike copper IUDs, it may reduce menstrual bleeding. Its efficacy is comparable to other levonorgestrel‑based IUS devices but with a distinct 52 mg dose and duration.
What are the storage and handling requirements for Levosert?+
Levosert should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect the device from moisture, direct sunlight and extreme temperatures to maintain its integrity until insertion.
How is Levosert administered?+
Levosert is inserted by a trained healthcare professional into the uterine cavity through the cervix. The procedure is performed in a clinical setting using a sterile inserter. Once placed, the device remains in situ for up to five years, after which it can be removed or replaced.
What are the most serious risks associated with Levosert?+
Serious risks include uterine perforation during insertion, device expulsion, pelvic infection, and, in rare cases, ectopic pregnancy if contraception fails. Prompt medical evaluation is essential if severe abdominal pain, unusual bleeding, or signs of infection occur.
Who should not use Levosert?+
Levosert is contraindicated in women with active pelvic infections, unexplained vaginal bleeding, known or suspected pregnancy, uterine anomalies that prevent proper placement, or hypersensitivity to levonorgestrel. Women with certain cancers or severe liver disease should also avoid its use.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Levonorgestrel
Route
Intrauterine Use
Manufacturer
Gedeon Richter Plc.
Origin
EU

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