Gonal-F Follitropin Alfa Injection 450 iU/ Vial Multiple-Dose Vial (RX)

Gonal-F (Follitropin Alfa) Injection 450 IU** is a synthetic form of the naturally occurring follicle-stimulating hormone (FSH). FSH is crucial in human fertility regulation, stimulating the growth and maturation of ovarian follicles in women and spermatogenesis in men. This product is specifically designed for use in assisted reproductive technologies (ART), such as in vitro fertilization (IVF), ovulation induction, and controlled ovarian hyperstimulation.

Key Components

• Follitropin Alfa 450 IU: The active ingredient, expressed in International Units (IU). This synthetic hormone is produced using recombinant DNA technology. 
  
• Multiple-Dose Vial: Contains the lyophilized (freeze-dried) form of Follitropin Alfa, making it suitable for multiple doses as per prescribed treatment.
  
• Bacteriostatic Water Pre-Filled Syringe: Sterile water containing an antimicrobial preservative (generally benzyl alcohol), used to reconstitute the powdered hormone into a solution ready for injection. 
  
• Administration Syringes: Six single-use syringes provided to facilitate the precise subcutaneous administration of the hormone. These syringes come with pre-attached 27-gauge needles, known for their thin and fine characteristics, designed to minimize discomfort during injection.

Indications
Gonal-F Follitropin Alfa is primarily used for:

• Ovulation Induction: In women with anovulation (lack of ovulation), including those with polycystic ovary syndrome (PCOS), to stimulate the follicles in the ovaries to mature and ovulate.
  
• Controlled Ovarian Hyperstimulation: As part of ART technologies to induce the growth of multiple ovarian follicles to retrieve oocytes for in vitro fertilization.
  
• Male Infertility: In combination with human chorionic gonadotropin (hCG) to stimulate spermatogenesis in men with certain types of hypogonadotropic hypogonadism.

How to Use

• Reconstitution:
• Use the pre-filled syringe containing bacteriostatic water to reconstitute the lyophilized powder in the vial.
  
• Ensure the mixture is fully dissolved and inspect for clarity. The reconstituted solution should appear clear and free of any particulate matter.
• Dosage:
• Follow the dosing schedule prescribed by the healthcare provider. Dosage varies based on individual response and the specific treatment protocol.
  
• Administration:
•  Using one of the provided 27-gauge syringes, draw the prescribed dose.
• Administer the injection subcutaneously, typically in the abdomen or upper thigh, rotating injection sites to avoid localized reactions.
• Dispose of used syringes and needles according to local regulations on medical waste.
• Storage
• Store the vial of lyophilized powder at room temperature, away from direct light.
• Once reconstituted, the solution can be refrigerated but should be used within a specified period (usually 28 days) as advised by the manufacturer.
• Do not freeze the reconstituted solution.

Precautions and Side Effects

• Monitoring: Frequent monitoring by a healthcare provider is essential to minimize the risk of complications like ovarian hyperstimulation syndrome (OHSS) or multiple pregnancies.
  
• Side Effects: Possible side effects include abdominal pain, bloating, nausea, headache, and injection site reactions. Severe side effects might include OHSS, pulmonary complications, and thromboembolic events. Any unusual or severe reactions should be reported immediately.

Gonal-F Follitropin Alfa Injection 450 IU in a multiple-dose vial with the accompanying bacteriostatic water syringe and administration syringes is a comprehensive and convenient treatment package for managing specific fertility issues. Proper usage, adherence to prescribed dosages, and regular monitoring are imperative for safe and effective outcomes.