Gonapure 75 Iu

Gonapure 75 Iu

Description:

Gonapure 75 iu (gonapure 75 i.u./ml i.m./s.c. vial) is a prescription fertility medicine containing follitropin alfa, a recombinant human follicle-stimulating hormone (fsh). It is used under specialist supervision to stimulate the ovaries in women and support spermatogenesis in men with certain types of infertility. Gonapure is administered by intramuscular (i.m.) or subcutaneous (s.c.) injection and is typically used as part of assisted reproductive technology (art) protocols such as in vitro fertilization (ivf), intracytoplasmic sperm injection (icsi), or controlled ovarian stimulation. This product is intended for use only by adults and must be prescribed and monitored by a fertility or endocrine specialist.

Indications:

• Controlled ovarian stimulation in women undergoing assisted reproductive techniques (e.g., ivf, icsi, intrauterine insemination) to induce the development of multiple follicles.
• Stimulation of follicular development in women with anovulation or oligo-ovulation (including polycystic ovary syndrome – pcos) who have not responded to first-line treatments such as clomiphene citrate, as directed by a specialist.
• Stimulation of spermatogenesis in adult men with hypogonadotropic hypogonadism (congenital or acquired) in combination with human chorionic gonadotropin (hcg), as prescribed by an endocrinologist or fertility specialist.
• Management of certain forms of infertility related to insufficient endogenous fsh production in both men and women, as part of a comprehensive fertility treatment plan.

Active Ingredients / Key Components:

• Follitropin alfa – 75 iu per ml (recombinant human follicle-stimulating hormone, fsh)
• Pharmaceutical form: solution for injection in vial for intramuscular (i.m.) or subcutaneous (s.c.) use.
• Excipients: Specific excipients, stabilizers, and preservatives are not listed in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.). Full excipient list and concentrations are provided in the official package insert, which should be consulted before use.

Dosage & Administration / How to Use:

• Gonapure 75 iu must only be used under the supervision of a physician experienced in fertility and hormonal treatments. Dosage is strictly individualized based on clinical response and hormone monitoring.
• Route of administration: Intramuscular (i.m.) or subcutaneous (s.c.) injection, as instructed by the treating physician. In some cases, patients may be trained to self-inject subcutaneously at home.
• Typical use in women (ovarian stimulation): Treatment usually starts within the first 7 days of the menstrual cycle. The starting dose and subsequent adjustments depend on ovarian response assessed by ultrasound and estradiol levels. The physician may increase or adjust the dose in small increments after several days if needed. When adequate follicular development is achieved, an hcg injection is administered to trigger ovulation.
• Typical use in men (hypogonadotropic hypogonadism): Used in combination with hcg. Fsh therapy is usually given several times per week over many months. Dosage and duration are determined by the specialist based on testicular volume, sperm analysis, and hormone levels.
• Do not change the dose, frequency, or duration of treatment without explicit medical advice. Never share vials or injection equipment with others.
• If a dose is missed, contact your doctor or fertility clinic for instructions. Do not double the next dose unless advised by your physician.
• Detailed reconstitution (if applicable), injection technique, and disposal of needles and syringes must follow the instructions provided by your healthcare professional and the product leaflet.

Clinical Benefits:

• Promotes controlled growth and maturation of ovarian follicles in women, improving the chances of successful ovulation and egg retrieval in assisted reproduction.
• Enhances follicular response in women with anovulation or poor ovarian response, especially when first-line oral ovulation induction has failed.
• Supports spermatogenesis in men with hypogonadotropic hypogonadism, helping to improve sperm production when used in combination with hcg.
• Allows individualized dose titration based on hormonal monitoring and ultrasound, helping to optimize treatment efficacy while reducing the risk of complications such as ovarian hyperstimulation syndrome (ohss).

Warnings & Contraindications:

• Use only under the supervision of a specialist experienced in fertility and hormonal treatments. Not for self-prescription or unsupervised use.
• Contraindicated in patients with hypersensitivity to follitropin alfa or any component of the formulation.
• Contraindicated in women with ovarian enlargement or ovarian cysts not due to polycystic ovary syndrome, unexplained vaginal bleeding, hormone-dependent tumors of the breast, ovary, uterus, testis, or pituitary/hypothalamus, or in those with primary ovarian failure where response is not expected.
• Contraindicated in pregnancy and during breastfeeding. Treatment must be discontinued if pregnancy occurs.
• Increased risk of ovarian hyperstimulation syndrome (ohss) in women; careful monitoring with ultrasound and hormone levels is essential. Inform your doctor immediately if you experience severe abdominal pain, rapid weight gain, nausea, vomiting, or difficulty breathing.
• Multiple pregnancy (twins or more) and ectopic pregnancy risks are increased with fertility treatments; careful monitoring is required.
• Use with caution in patients with known risk factors for thromboembolic events (e.g., personal or family history of thrombosis, severe obesity, thrombophilia). Inform your doctor about any such history.
• Consult your doctor before use if you have polycystic ovary syndrome, thyroid disease, adrenal disorders, pituitary or hypothalamic tumors, liver disease, kidney disease, or any serious chronic medical condition.
• Not intended to diagnose, treat, cure, or prevent any disease without appropriate medical supervision; it is a prescription fertility medicine that must follow approved indications.
• Keep out of reach of children. Use only the dose prescribed and follow all instructions for injection and disposal of sharps.

Side Effects:

• Common side effects in women: Abdominal discomfort or pain, bloating, pelvic pain, headache, breast tenderness, injection site reactions (redness, pain, swelling, bruising), mild nausea, and fatigue.
• Serious side effects: Ovarian hyperstimulation syndrome (ohss) with symptoms such as severe abdominal pain, rapid weight gain, shortness of breath, decreased urine output, and severe nausea or vomiting; blood clots (thromboembolic events); ovarian torsion; and allergic reactions. Seek urgent medical attention if these occur.
• In men: Injection site reactions, headache, gynecomastia (breast enlargement), acne, weight changes, and mood changes may occur. Report persistent or severe symptoms to your doctor.
• Allergic or hypersensitivity reactions (rash, itching, swelling of face or throat, difficulty breathing) require immediate medical attention and discontinuation of the drug.

Storage Instructions:

Store in a cool, dry place away from direct sunlight and heat sources. Follow any specific temperature requirements provided in the official package leaflet (e.g., refrigeration if stated). Keep the vial in its original packaging until use to protect from light. Do not freeze unless explicitly allowed in the product leaflet. Keep container tightly closed and out of reach of children. Do not use after the expiry date printed on the pack, and discard any remaining solution according to pharmacist or local regulations.

Specifications:

• Product type: Prescription fertility medicine – recombinant fsh (follitropin alfa).
• Strength: 75 iu/ml follitropin alfa.
• Form: Solution for injection in vial for intramuscular (i.m.) or subcutaneous (s.c.) use.
• Intended users: Adult men and women under specialist fertility or endocrine care.
• Pack size and total volume per vial are not specified in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.); refer to the product packaging for exact volume and number of doses per pack.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.