MERIONAL 150 IU (MENOTROPINS – HUMAN MENOPAUSAL GONADOTROPINS)

Powder and solvent for solution for injection | 1 vial + 1 diluent

Medical Description

Merional 150 IU contains menotropins, also known as human menopausal gonadotropins (hMG), a hormonal preparation with both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. These hormones play essential roles in reproductive function and fertility.

FSH stimulates the growth and development of ovarian follicles in women, while LH supports follicular maturation, estrogen production, and ovulation. In men, gonadotropins support testicular function and spermatogenesis.

Merional is used in medically supervised fertility treatment protocols to stimulate ovarian follicular development in women and support sperm production in selected men with hypogonadotropic hypogonadism.

Active Ingredients

Each Merional 150 IU vial contains:

• FSH (Follicle-Stimulating Hormone): Promotes the development and growth of ovarian follicles.
• LH (Luteinizing Hormone): Supports ovarian steroid hormone production and follicular maturation.

The supplied diluent is used to dissolve the powder before administration. The preparation is intended for injection, with the route determined by the product information and prescribing physician.

Indications and Uses

Merional may be prescribed for:

1. Female Infertility: Stimulation of ovarian follicular development in women with ovulatory disorders who require gonadotropin treatment.
2. Assisted Reproductive Technology (ART): Controlled ovarian stimulation to promote the development of multiple follicles during IVF and other assisted reproduction procedures.
3. Male Infertility: In selected men with hypogonadotropic hypogonadism, as part of hormonal treatment to stimulate spermatogenesis, usually in combination with hCG.

Mechanism of Action

Merional provides exogenous FSH and LH activity, replacing or supplementing the natural gonadotropins involved in reproductive function.

• In women: FSH stimulates ovarian follicular growth, while LH supports estrogen synthesis and follicular development. Together, these activities help prepare follicles for ovulation or assisted reproductive procedures.
• In men: Gonadotropin activity supports testicular function. LH stimulates testosterone production by Leydig cells, while FSH acts on Sertoli cells to support sperm development.

Dosage and Administration

• The dosage and duration of treatment are individualized according to the patient's diagnosis, age, ovarian or testicular response, and treatment protocol.
• In women, treatment is generally adjusted according to ultrasound findings and, when appropriate, serum estradiol levels.
• In men, treatment is determined according to hormonal evaluation and semen analysis.
• The powder must be reconstituted using the supplied diluent before injection.
• Administration should be performed according to the prescribed route and instructions of a fertility specialist.

Important: Merional must not be self-administered without appropriate medical instruction and monitoring.

Contraindications

Merional should not be used in patients with:

• Hypersensitivity to menotropins or any of the product ingredients.
• Tumours of the hypothalamus or pituitary gland.
• Ovarian, uterine, or breast cancer in women.
• Testicular tumours or prostate cancer in men.
• Primary ovarian failure or premature menopause.
• Ovarian cysts or enlarged ovaries unrelated to polycystic ovarian disease.
• Unexplained vaginal bleeding.
• Pregnancy or breastfeeding.
• Reproductive tract abnormalities that make pregnancy unlikely or unsafe.

Possible Side Effects

Potential adverse effects include:

• Headache.
• Abdominal pain, bloating, or discomfort.
• Nausea, vomiting, or diarrhoea.
• Injection-site pain, redness, or inflammation.
• Ovarian cyst formation or enlargement.
• Breast enlargement or tenderness.
• Acne and weight gain.
• Ovarian Hyperstimulation Syndrome (OHSS).
• Rarely, ovarian torsion, allergic reactions, or thromboembolic events (blood clots).

Severe abdominal pain, rapid weight gain, persistent vomiting, reduced urine output, or difficulty breathing may indicate serious ovarian hyperstimulation syndrome and require immediate medical assessment.

Precautions and Warnings

• Treatment must be supervised by a fertility specialist experienced in gonadotropin therapy.
• Regular ultrasound monitoring and hormonal assessments may be required to evaluate ovarian response.
• Excessive ovarian stimulation can lead to serious complications, including OHSS.
• There is an increased risk of multiple pregnancy during ovarian stimulation.
• Patients with a personal or family history of thromboembolic disorders should be carefully evaluated.
• Merional should not be used during pregnancy or breastfeeding.
• The first injection should be administered under appropriate medical supervision.

Storage Conditions

• Store at a temperature not exceeding 25°C.
• Keep in the original packaging to protect from light.
• Keep out of reach of children.
• Use the reconstituted solution immediately after preparation.
• Do not use if the solution contains particles or is not clear.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Merional is a prescription-only hormonal medication that must be used strictly under the supervision of a qualified fertility specialist. Dosage and treatment duration should be individualized according to the patient's medical condition and response to therapy. Never initiate, adjust, or discontinue treatment without consulting your healthcare provider.

References

The following sources were used to prepare this description:

1. Merional Patient Information Leaflet – IBSA: Product-specific indications, contraindications, administration, adverse effects, and storage. Merional official patient leaflet (PDF).
2. Electronic Medicines Compendium (eMC): Menopur 150 IU Summary of Product Characteristics – menotropin composition, pharmacological activity, indications, and clinical precautions. eMC – Menopur 150 IU.
3. U.S. Food and Drug Administration (FDA): Menotropins prescribing information and safety warnings. FDA prescribing information.
4. DailyMed – National Library of Medicine (NIH): Menotropins clinical information and safety profile. DailyMed – Menotropins.
5. European Association of Urology (EAU): Guidelines on male infertility and gonadotropin treatment. EAU Male Infertility Guidelines.
6. Medicines and Healthcare products Regulatory Agency (MHRA): Product information and regulatory documentation for gonadotropin preparations. MHRA-derived product information.