GNH USA

Europe — EMA

Jadelle Sine Inserter

GNH USA supplies Jadelle Sine Inserter (Levonorgestrel), a progestogen hormonal contraceptive for long‑acting reversible pregnancy prevention.

Levonorgestrel

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What is Levonorgestrel?

Levonorgestrel, the active ingredient in Jadelle Sine Inserter, is a progestogen presented as a subcutaneous implant for subcutaneous use. It provides long‑acting reversible contraception for women of reproductive age.

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

What is Levonorgestrel used for?

Levonorgestrel is used as a hormonal contraceptive to prevent unintended pregnancy. - Contraception: Provides continuous prevention of pregnancy for up to five years after insertion. - Family planning: Enables women to plan pregnancies with a reliable, low‑maintenance method. - Post‑abortion contraception: Allows immediate initiation of long‑term birth control following an abortion procedure.

What are the side effects of Levonorgestrel?

Levonorgestrel implants may cause a range of adverse reactions.

Common Side Effects: - Irregular vaginal bleeding or spotting - Amenorrhea (absence of periods) - Headache - Acne or skin changes - Weight gain or mild fluid retention - Mood swings or depressive symptoms

Serious or Rare Side Effects: - Ectopic pregnancy if implantation occurs outside the uterus - Pelvic inflammatory disease - Insertion site infection or abscess - Device migration or expulsion - Severe allergic reaction (anaphylaxis) - Thromboembolic events (rare)

What precautions apply to Levonorgestrel?

Before using Jadelle Sine Inserter, certain precautions should be observed. - Pregnancy testing: Confirm the patient is not pregnant prior to insertion. - Breastfeeding: Discuss potential risks and benefits with a healthcare professional. - Medication review: Evaluate concurrent drugs that may affect hormonal activity. - Medical history: Assess for clotting disorders, liver disease, or hormone‑sensitive cancers. - Follow‑up care: Schedule regular visits to check implant position and monitor side effects. - Store at ambient temperature: Keep in original packaging, protect from moisture and direct sunlight.

What does Levonorgestrel interact with?

Levonorgestrel implants can interact with other medicines, requiring attention to avoid reduced efficacy or increased risk.

Major Interactions (Avoid): - Combined hormonal contraceptives: Concurrent use may increase hormonal load. - Enzyme‑inducing antiepileptics (e.g., carbamazepine, phenytoin): May lower contraceptive effectiveness. - Rifampin or other strong inducers: Can significantly reduce levonorgestrel levels.

Moderate Interactions (Monitor Closely): - Antifungal azoles (e.g., ketoconazole): May increase hormone concentrations. - Protease inhibitor antiretrovirals: May alter metabolism of levonorgestrel. - St. John’s wort (herbal supplement): Potentially decreases contraceptive efficacy.

Frequently asked questions

What is Jadelle Sine Inserter used for?+
Jadelle Sine Inserter is a subcutaneous implant that delivers levonorgestrel for long‑acting reversible contraception. It is intended to prevent pregnancy in women of reproductive age for up to five years after a single insertion by a qualified healthcare professional.
How does levonorgestrel work in this implant?+
Levonorgestrel released from the implant binds to progesterone receptors, suppressing ovulation, thickening cervical mucus to block sperm entry, and altering the uterine lining to make implantation unlikely. These combined actions provide continuous contraceptive protection without daily dosing.
What is the usual dose of Jadelle Sine Inserter?+
The dosage and number of implants are determined by the prescribing clinician based on the approved product specifications and the patient’s individual health profile. The prescriber decides the appropriate regimen at the time of insertion.
Is Jadelle Sine Inserter safe during pregnancy or breastfeeding?+
Jadelle Sine Inserter is contraindicated in pregnancy (Category X) and should not be inserted in a pregnant woman. Women who are breastfeeding should discuss potential risks with their healthcare provider, as hormonal exposure may affect milk production and infant exposure.
How do I order Jadelle Sine Inserter from GNH USA?+
To place an 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 (including any cold‑chain requirements) and necessary import documentation.
How does Jadelle Sine Inserter compare with other contraceptive methods?+
Compared with daily oral pills, Jadelle offers a once‑in‑a‑lifetime insertion that provides up to five years of protection, eliminating the need for daily adherence. Unlike intrauterine devices, it does not require uterine placement and can be removed easily if fertility is desired sooner.
What are the storage and handling requirements for Jadelle Sine Inserter?+
The implant should be stored at ambient temperature, below 25 °C, in its original sealed packaging. Protect it from moisture, direct sunlight, and extreme temperatures to maintain product integrity until the time of insertion.
How is Jadelle Sine Inserter administered?+
A qualified healthcare professional inserts the implant subcutaneously in the inner side of the upper arm using a pre‑filled inserter device. The procedure is minimally invasive, takes only a few minutes, and does not require anesthesia in most cases.
What are the most serious risks associated with Jadelle Sine Inserter?+
Serious risks include ectopic pregnancy, pelvic inflammatory disease, insertion‑site infection, device migration or expulsion, severe allergic reactions, and rare thromboembolic events. Patients should seek immediate medical attention if they experience severe abdominal pain, unusual bleeding, or signs of infection.
Who should not use Jadelle Sine Inserter?+
Women who are currently pregnant, have a known hypersensitivity to levonorgestrel, have active liver disease, a history of thromboembolic disorders, hormone‑sensitive cancers, or untreated abnormal uterine bleeding should avoid using this implant. A thorough medical evaluation is required before insertion.
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
Subcutaneous Use
Manufacturer
Bayer Oy
Origin
EU

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