GNH USA

Europe — EMA

Kelzy

GNH USA supplies Kelzy (Dienogest/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy in women of reproductive age.

Dienogest, Ethinylestradiol | Lactose

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What is Dienogest, Ethinylestradiol | Lactose?

Dienogest/Ethinylestradiol, the active ingredient in Kelzy, is a combined oral contraceptive presented as an oral tablet for oral use. It works by suppressing ovulation and altering the endometrium to prevent implantation, providing reliable pregnancy prevention for women of reproductive age.

GNH USA supplies Kelzy as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑controlled distribution of this EU‑marketed hormonal contraceptive. The product meets European Union regulatory standards and is manufactured under GMP conditions, and is packaged with appropriate patient information.

What is Dienogest, Ethinylestradiol | Lactose used for?

Kelzy, a combined oral contraceptive, is indicated for hormonal contraception to prevent pregnancy.

Prevention of unintended pregnancy: provides reliable contraception for women seeking to avoid pregnancy. Family planning: enables controlled fertility management as part of reproductive health. Hormonal contraception: suppresses ovulation and stabilizes the endometrial lining to reduce breakthrough bleeding.

What are the side effects of Dienogest, Ethinylestradiol | Lactose?

Kelzy may be associated with a range of adverse reactions, which are generally classified by frequency and severity.

Common Side Effects: - Nausea: mild stomach upset that often resolves with continued use. - Headache: tension‑type or migraine‑like headaches. - Breast tenderness: temporary discomfort or swelling of the breasts. - Irregular bleeding: spotting or breakthrough bleeding, especially during the first cycles.

Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins or lungs, requiring immediate medical attention. - Severe hypertension: sudden increase in blood pressure that may lead to complications. - Liver dysfunction: jaundice, hepatitis, or abnormal liver enzyme levels. - Allergic reaction: rash, itching, swelling, or anaphylaxis.

What precautions apply to Dienogest, Ethinylestradiol | Lactose?

Before prescribing Kelzy, consider the following precautions and warnings.

- Contraindicated in women with a history of venous thromboembolism: avoid use due to clot risk. - Not for smokers over age 35 who smoke >15 cigarettes per day: increased cardiovascular risk. - Avoid during pregnancy: hormonal contraceptives are not indicated for pregnant women. - Caution in breastfeeding mothers: may affect milk production and infant exposure. - Use with caution in patients with liver disease: impaired metabolism may increase side effects. - Store at room temperature: keep below 25 °C, in the original packaging, protected from moisture and light.

What does Dienogest, Ethinylestradiol | Lactose interact with?

Kelzy can interact with other medicines, altering its effectiveness or safety profile.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): may markedly reduce contraceptive effectiveness. - Anticoagulants (e.g., warfarin): estrogen component can enhance clotting factor synthesis, potentially altering anticoagulant control. - High‑dose selective serotonin reuptake inhibitors (e.g., fluoxetine): may increase plasma levels of ethinylestradiol, raising risk of side effects.

Moderate Interactions (Monitor Closely): - Antifungal azoles (e.g., ketoconazole): can increase estrogen levels, requiring monitoring for adverse effects. - Antiretroviral drugs (e.g., protease inhibitors): may affect hormone metabolism, necessitating efficacy monitoring. - St. John’s wort herbal supplement: may reduce hormonal levels, decreasing contraceptive reliability.

Frequently asked questions

What is Kelzy used for?+
Kelzy is a combined oral contraceptive indicated for the prevention of pregnancy. It provides reliable hormonal birth control for women of reproductive age by suppressing ovulation and altering the uterine lining to prevent implantation.
How does Dienogest/Ethinylestradiol work in Kelzy?+
The formulation contains dienogest, a progestin, and ethinylestradiol, an estrogen. The estrogen suppresses the release of follicle‑stimulating hormone, while the progestin blocks the luteinizing hormone surge, together preventing ovulation and creating an endometrium that is unsuitable for embryo implantation.
What is the usual dose of Kelzy?+
The dosing regimen for Kelzy is determined by the prescribing healthcare professional. Typically, combined oral contraceptives are taken once daily for a specified cycle, but the exact schedule and any missed‑dose instructions must be provided by the prescriber.
Is Kelzy safe to use during pregnancy or breastfeeding?+
Kelzy is not intended for use during pregnancy and should be discontinued if pregnancy occurs. While limited data exist for breastfeeding, hormonal contraceptives may affect milk production and infant exposure, so a healthcare provider should be consulted before use.
How do I order Kelzy from GNH USA?+
To order Kelzy, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.
How does Kelzy compare with other combined oral contraceptives?+
Kelzy contains the same class of hormones—dienogest and ethinylestradiol—as many other combined oral contraceptives, offering comparable efficacy in preventing pregnancy. Differences may lie in the specific progestin used, which can influence side‑effect profiles, cycle control, and individual tolerability.
What are the storage requirements for Kelzy?+
Kelzy tablets should be stored at room temperature, below 25 °C, in the original packaging. Protect them from excess moisture and direct light to maintain potency throughout the shelf life.
How is Kelzy administered?+
Kelzy is taken orally, usually once daily at the same time each day, as directed by a healthcare professional. The tablets are swallowed with water and should not be chewed or broken unless otherwise instructed.
What are the most serious risks associated with Kelzy?+
Serious risks include venous thromboembolism, severe hypertension, liver dysfunction, and rare allergic reactions. Women with a history of clotting disorders, smoking over age 35, or certain medical conditions should discuss these risks with their prescriber.
Who should not use Kelzy?+
Kelzy is contraindicated in women with a known history of venous thromboembolism, active liver disease, certain hormone‑sensitive cancers, or those who are pregnant. It should also be avoided by smokers over 35 years of age and by individuals with uncontrolled hypertension.
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
Dienogest, Ethinylestradiol | Lactose
Route
Oral Use
Manufacturer
Uab Exeltis Baltics
Origin
EU

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