GNH USA

Europe — EMA

Kelzy

GNH USA supplies Kelzy (Dienogest/Ethinylestradiol), a combined estrogen‑progestogen oral contraceptive for preventing pregnancy.

Dienogest, Ethinylestradiol | Lactose

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What is Dienogest, Ethinylestradiol | Lactose?

Dienogest, the active ingredient in Kelzy, is a combined estrogen‑progestogen oral contraceptive presented as an oral tablet for systemic use. It is indicated for preventing pregnancy in women of reproductive age and may also help regulate menstrual cycles.

GNH USA supplies Kelzy as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for global healthcare providers. Kelzy is manufactured under EU Good Manufacturing Practice guidelines and is distributed to meet the needs of diverse patient populations.

What is Dienogest, Ethinylestradiol | Lactose used for?

Kelzy, a combined estrogen‑progestogen oral contraceptive, is used in the hormonal regulation pathway to prevent unintended pregnancy.

- Contraception: prevents pregnancy by inhibiting ovulation and altering cervical mucus. - Menstrual cycle regulation: provides more predictable bleeding patterns and reduces menstrual‑related discomfort. - Moderate acne treatment: helps improve acne lesions associated with hormonal fluctuations.

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

Oral administration of Kelzy may be associated with a range of adverse reactions, varying in frequency and severity.

Common Side Effects: - Nausea: mild stomach upset, often transient. - Breast tenderness: discomfort or swelling of the breasts. - Headache: mild to moderate intensity. - Spotting or breakthrough bleeding: irregular light bleeding between periods. - Weight gain: modest increase in body weight. - Mood changes: irritability or emotional fluctuations.

Serious or Rare Side Effects: - Venous thromboembolism: deep vein thrombosis or pulmonary embolism. - Arterial thrombosis: stroke or myocardial infarction. - Severe hypertension: sudden increase in blood pressure. - Liver dysfunction: jaundice or abnormal liver enzymes. - Allergic reaction: rash, swelling, or anaphylaxis. - Visual disturbances: blurred vision or loss of sight.

What precautions apply to Dienogest, Ethinylestradiol | Lactose?

Before prescribing Kelzy, healthcare professionals should evaluate patient risk factors and provide appropriate counseling. - Cardiovascular assessment: review history of thrombosis, hypertension, or smoking. - Liver function: avoid use in patients with severe hepatic impairment. - Smoking restriction: advise women under 35 not to smoke more than 15 cigarettes per day. - Missed dose guidance: instruct on actions if a tablet is omitted to maintain efficacy. - Drug interaction review: assess concomitant use of enzyme‑inducing agents. - Store at ambient temperature: keep below 25 °C in the original packaging, protected from moisture.

What does Dienogest, Ethinylestradiol | Lactose interact with?

Kelzy can interact with other medicines that affect hormone metabolism or coagulation pathways.

Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): may reduce anticoagulant effect and increase clot risk. - Hepatic enzyme inducers (e.g., rifampin, carbamazepine): can lower contraceptive hormone levels, reducing efficacy. - Certain antiretrovirals (e.g., protease inhibitors): may alter hormone concentrations leading to failure.

Moderate Interactions (Monitor Closely): - Antibiotics (e.g., tetracycline, fluoroquinolones): may slightly decrease contraceptive effectiveness. - St. John’s wort: herbal inducer that can reduce hormone levels.

Frequently asked questions

What is Kelzy used for?+
Kelzy is a combined estrogen‑progestogen oral contraceptive indicated primarily for the prevention of unintended pregnancy in women of reproductive age. It may also be prescribed to help regulate menstrual cycles and to treat moderate hormonal acne.
How does Dienogest/Ethinylestradiol work?+
The two hormones work together to suppress the hypothalamic‑pituitary‑gonadal axis, preventing the luteinizing hormone surge that triggers ovulation. Ethinylestradiol stabilises the endometrium, while dienogest thickens cervical mucus and induces endometrial changes, creating an environment that is unfavorable for fertilisation and implantation.
What is the usual dose of Kelzy?+
The dosing regimen for Kelzy is determined by the prescribing clinician. Typically, the product is taken as one tablet daily at the same time each day, but the exact schedule and any special instructions are provided by the healthcare professional.
Is Kelzy safe during pregnancy or breastfeeding?+
Kelzy must not be used during an established pregnancy because it is intended to prevent conception, not to treat an existing pregnancy. While limited data exist for breastfeeding, most guidelines advise caution and suggest discussing alternative contraceptive options with a healthcare provider.
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 dienogest, a progestogen with a relatively low androgenic profile, combined with ethinylestradiol. Compared with older formulations that use levonorgestrel, Kelzy may offer a lower risk of acne worsening and a more favourable impact on lipid metabolism, while maintaining comparable contraceptive efficacy.
How should Kelzy be stored and handled?+
Kelzy tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister pack or container. Protect the product from excess moisture and direct sunlight. Do not store in the bathroom or near heat sources.
How is Kelzy administered?+
Kelzy is taken orally, usually as a single tablet taken each day at the same time. The tablet should be swallowed whole with water and not chewed or broken. Consistent daily intake helps maintain contraceptive effectiveness.
What are the most serious risks associated with Kelzy?+
The most serious risks include venous or arterial thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, stroke, or myocardial infarction. Severe hypertension, liver disorders and rare allergic reactions (including anaphylaxis) are also considered serious adverse events that require immediate medical attention.
Who should not use Kelzy?+
Kelzy is contraindicated in women with a history of thromboembolic disease, uncontrolled hypertension, severe liver disease, known or suspected breast cancer, or those who are pregnant. Smoking more than 15 cigarettes per day in women over 35 years of age also represents a contraindication.
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
Exeltis Slovakia
Origin
EU

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