GNH USA

Europe — EMA

Levosert One

GNH USA supplies Levosert One (Levonorgestrel), a progestin intrauterine system for long‑acting reversible contraception. Request a quote for global supply.

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Levosert One, is a progestin presented as a 20 µg/day release intrauterine system for intrauterine use. It provides long‑acting reversible contraception for women of reproductive age.

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

What is Levonorgestrel used for?

Levosert One, a levonorgestrel‑based intrauterine system, is indicated for hormonal contraception.

- Contraception: provides up to five years of reliable pregnancy prevention. - Heavy menstrual bleeding: may reduce menstrual blood loss and the need for additional therapy. - Dysmenorrhea: can lessen menstrual pain associated with prostaglandin‑mediated cramps.

What are the side effects of Levonorgestrel?

Levosert One may be associated with a range of adverse reactions.

Common Side Effects: - Irregular vaginal bleeding or spotting. - Amenorrhea (absence of periods). - Cramping or pelvic discomfort after insertion. - Insertion‑related pain. - Hormonal changes such as breast tenderness. - Headache or mild nausea.

Serious or Rare Side Effects: - Uterine perforation during insertion. - Expulsion or displacement of the device. - Pelvic inflammatory disease or severe infection. - Ectopic pregnancy if contraception fails. - Device migration to adjacent organs. - Severe allergic reaction to device components.

What precautions apply to Levonorgestrel?

Prior to insertion, clinicians should assess patient suitability and counsel on potential risks.

- Pregnancy screening: confirm the patient is not pregnant before placement. - Uterine anomalies: avoid use in women with known congenital uterine malformations. - Active infection: contraindicated in the presence of pelvic inflammatory disease or genital infections. - Malignancy: not recommended for patients with estrogen‑dependent cancers. - Follow‑up: schedule a post‑insertion check to verify correct positioning. - Storage: Store at below 25 °C: keep in the original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levonorgestrel released from an intrauterine system can be affected by certain concomitant medicines.

Major Interactions (Avoid): - Rifampicin, carbamazepine, phenytoin, or St. John’s wort: potent enzyme inducers that may lower levonorgestrel levels. - Antiretroviral efavirenz: may reduce contraceptive efficacy. - High‑dose enzyme‑inducing anticonvulsants: can compromise hormonal protection.

Moderate Interactions (Monitor Closely): - Ketoconazole or other azole antifungals: may increase levonorgestrel exposure. - Phenobarbital: moderate enzyme induction requiring monitoring. - Certain herbal supplements (e.g., ginseng): may alter hormone metabolism.

Frequently asked questions

What is Levosert One used for?+
Levosert One is an intrauterine system that delivers levonorgestrel locally to provide long‑acting reversible contraception. It is designed to prevent pregnancy for up to five years and may also help reduce heavy menstrual bleeding and menstrual pain.
How does levonorgestrel work in Levosert One?+
Levonorgestrel released from the device acts on the cervical mucus, endometrium, and sperm. It thickens cervical mucus to block sperm entry, suppresses endometrial growth, reduces sperm motility, and may inhibit ovulation, creating multiple barriers to fertilisation.
What is the usual dose of Levosert One?+
The dose of levonorgestrel released by Levosert One is fixed at approximately 20 µg per day for the duration of use. The prescribing clinician determines suitability and duration based on the patient’s medical profile.
Is Levosert One safe to use during pregnancy or breastfeeding?+
Levosert One is contraindicated in women who are pregnant. If pregnancy occurs, the device should be removed promptly. Limited data exist for breastfeeding; clinicians usually advise removal before initiating lactation, but individual assessment is required.
How do I order Levosert One from GNH USA?+
To order, 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 One compare with other hormonal contraceptives?+
Compared with oral progestins or combined pills, Levosert One offers continuous low‑dose levonorgestrel release without daily adherence, providing up to five years of protection. Unlike implants, it is placed in the uterus, which may result in fewer systemic side effects but requires a clinical insertion procedure.
What are the storage and handling requirements for Levosert One?+
Levosert One should be stored at temperatures below 25 °C, in its original sealed packaging, protected from moisture and direct sunlight. The device remains stable for its shelf‑life when these conditions are maintained.
How is Levosert One administered?+
Levosert One is inserted by a trained healthcare professional into the uterine cavity using a specialized inserter. The procedure is performed in a clinical setting under aseptic conditions, and the device remains in place for up to five years unless removal is indicated.
What are the most serious risks associated with Levosert One?+
Serious risks include uterine perforation during insertion, device expulsion or migration, pelvic inflammatory disease, and the rare possibility of ectopic pregnancy if contraceptive failure occurs. Prompt medical evaluation is essential if severe abdominal pain, abnormal bleeding, or signs of infection develop.
Who should not use Levosert One?+
Women with current pregnancy, active pelvic infection, untreated cervical or uterine cancer, unexplained vaginal bleeding, or known uterine anomalies should avoid Levosert One. Additionally, those with a history of severe allergic reaction to levonorgestrel or device components should not use it.
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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