Epifasi 5000 Iu 1 Amp

Epifasi 5000 Iu 1 Amp

Description:

Epifasi 5000 iu 1 amp is a prescription hormonal medicine containing human chorionic gonadotrophin (hCG), produced by EIPICO. It is supplied as an injectable ampoule with a potency of 5000 international units (iu) and is used under medical supervision in the management of specific fertility and hormonal disorders in both women and men. In women, hCG is used mainly to trigger ovulation after controlled ovarian stimulation. In men and boys, it is used in selected cases of cryptorchidism (undescended testes) not due to anatomical obstruction, and as a diagnostic and pre‑operative aid. This medicine must only be used as directed by a specialist physician experienced in fertility and hormonal therapies.

Indications:

• Female infertility – ovulation induction: used to induce final follicular maturation and ovulation after carefully monitored stimulation of follicular growth with human menopausal gonadotrophins (HMG) or clomiphene citrate.
• Assisted reproductive protocols where an ovulation trigger with hCG is required, as prescribed by a fertility specialist.
• Male cryptorchidism (undescended testes) not due to anatomical obstruction, particularly in prepubertal boys, as part of hormonal management.
• Diagnostic aid in cryptorchidism to help determine the need for surgical intervention.
• Pre‑operative use in cryptorchidism to facilitate surgery by increasing testicular size and cord length, as directed by a pediatric urologist or surgeon.

Active Ingredients / Key Components:

• Human chorionic gonadotrophin (hCG) – 5000 iu per ampoule (exact excipient composition and concentrations , please check the product leaflet or the manufacturer’s official website).

Dosage & Administration / How to Use:

• Epifasi 5000 iu 1 amp is for parenteral use only and must be administered by a healthcare professional or exactly as instructed by a physician.
• Route of administration: usually intramuscular (im) or subcutaneous (sc) injection, depending on physician preference and local guidelines.
• Female ovulation induction: the dose, timing, and number of injections are individualized based on ovarian response after stimulation with HMG or clomiphene citrate. Typically given as a single ovulation trigger injection when follicles reach the appropriate size, strictly according to the fertility specialist’s protocol.
• Male cryptorchidism: dosage, frequency, and duration vary with age, body weight, and clinical status. Treatment schedules are determined by the pediatric endocrinologist or urologist; do not adjust dose without medical advice.
• Do not self‑inject unless you have been fully trained by a healthcare professional in proper injection technique, dose preparation, and disposal of sharps.
• Do not use if the solution is discolored, contains particles, or the ampoule is cracked or damaged.
• Never share needles, syringes, or ampoules with others.

Clinical Benefits:

• Supports ovulation induction in women with anovulation or oligo‑ovulation when used after appropriate follicular stimulation, helping to improve chances of conception.
• Mimics the natural luteinizing hormone (LH) surge, promoting final maturation and release of the egg and supporting luteal function in early cycles.
• Assists in the hormonal management of cryptorchidism in boys not due to anatomical obstruction, potentially aiding testicular descent in selected cases.
• Facilitates surgical planning and technique in cryptorchidism by increasing testicular size and cord length when used pre‑operatively, as advised by the surgeon.

Warnings & Contraindications:

• Use only under the supervision of a specialist physician experienced in fertility and hormonal therapy.
• Contraindicated in known hypersensitivity to human chorionic gonadotrophin or any component of the formulation.
• Contraindicated in hormone‑dependent tumors such as androgen‑dependent or estrogen‑dependent cancers, and in patients with hormone‑sensitive malignancies unless specifically advised by an oncologist.
• Not to be used in women with ovarian enlargement not due to polycystic ovary syndrome, uncontrolled thyroid or adrenal dysfunction, or unexplained vaginal bleeding.
• Risk of ovarian hyperstimulation syndrome (OHSS) in women undergoing fertility treatment; careful monitoring of ovarian response (ultrasound and hormone levels) is essential before administering hCG.
• May increase the risk of multiple pregnancy (twins or more) when used in ovulation induction protocols.
• Use with caution in patients with a history of thromboembolic disorders, severe cardiac disease, or migraine; discuss risks with your doctor.
• Consult your doctor before use if pregnant, nursing, taking other medications, or if you have medical conditions such as hormone‑dependent tumors, liver disease, kidney disease, or clotting disorders.
• Not intended for general use as a weight‑loss aid or performance‑enhancing drug; misuse can cause serious adverse effects.
• Keep out of reach of children.

Side Effects:

• Common side effects may include injection site pain, redness, or swelling; headache; fatigue; mood changes; nausea; or mild abdominal discomfort.
• In women undergoing fertility treatment, serious side effects can include ovarian hyperstimulation syndrome (OHSS) with symptoms such as severe abdominal pain, rapid weight gain, nausea, vomiting, diarrhea, shortness of breath, or decreased urine output. Seek urgent medical attention if these occur.
• Allergic reactions, including rash, itching, dizziness, or difficulty breathing, may occur in rare cases. Stop treatment and seek immediate medical help if signs of allergy appear.
• In males, possible side effects may include gynecomastia (breast enlargement), acne, fluid retention, or mood changes, depending on dose and duration.
• Contact your doctor promptly if you experience severe or persistent side effects, or any symptom that concerns you.

Storage Instructions:

Store in a cool, dry place away from direct sunlight, according to the storage conditions specified on the package insert (refrigeration may be required depending on the formulation; follow pack instructions). Keep the ampoule in its original packaging until use. Do not freeze. Keep container tightly closed if applicable and keep out of reach of children. Do not use after the expiry date printed on the pack.

Specifications:

• Form: Injectable ampoule.
• Strength: 5000 iu human chorionic gonadotrophin (hCG) per ampoule.
• Pack size: 1 ampoule per pack.
• Intended use: Prescription hormonal medicine for fertility management and cryptorchidism, to be used under medical supervision.

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.