indication 1) Women who do not ovulate (including polycystic ovary syndrome [PCOD]) and do not respond to clomiphene citrate treatment. 2) For patients undergoing superovulation or assisted fertility techniques, such as in vitro fertilization-embryo transfer (IVF), gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT), gonafin can stimulate the development of multiple follicles.

ingredient

Main ingredients: Recombinant human follicle stimulating hormone α. Follicle stimulating hormone produced by genetic engineering using Chinese hamster ovary cells.

Excipients: sucrose, sodium dihydrogen phosphate, disodium hydrogen phosphate, methionine, Tween 20, phosphoric acid and sodium hydroxide.

Character

Sterile, pyrogen-free white lyophilized powder.

Indications

1) Women who do not ovulate (including polycystic ovary syndrome [PCOD]) and who do not respond to clomiphene citrate treatment.

2) For patients undergoing superovulation or assisted fertility techniques, such as in vitro fertilization-embryo transfer (IVF), gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT), gonafin can stimulate the development of multiple follicles.

specification

5.5 μg (75 IU).

Dosage

The use of this product should be conducted under the guidance of a doctor with experience in treating reproductive problems.

This product is used for subcutaneous injection. The lyophilized powder should be diluted with the provided solvent before use. Gonafin 5.5 μg (75 IU) should not be mixed and dissolved with Gonafin other specifications. To avoid large volume injections, 1 ml of solvent can dissolve up to 3 bottles of lyophilized powder.

The dosage of Guonafen is based on the dosage of urinary FSH. Clinical use has confirmed that the dosage of Guonafen is consistent with the currently used urinary FSH preparation in daily dose, medication regimen and monitoring procedures. However, in clinical studies conducted with the same medication regimen, gonafin compared with urinary FSH. The total dose of gonafin to achieve ovulation was less than urea-derived FSH, and the total course of treatment was shorter than urea-derived FSH. And showed better efficacy. It has been demonstrated that single-dose and multiple-dose gonafin are bioequivalent at the same dose.

It is recommended to start treatment based on the following starting doses:

Women who do not ovulate (including polycystic ovary syndrome [PCOD]):

The goal of Gonafin treatment is to mature a single follicle, which can release eggs after hCG injection.

Gonafin is injected once a day. Patients with menstruation should begin treatment within the first 7 days of the menstrual cycle.

Treatment should be individualized based on the patient's response. The efficacy can be evaluated by (i) ultrasound examination of follicle size and / or (ii) estrogen levels. The usual dosage starts from 5.5 ~ 11 μg (75 ~ 150 IU) follicle stimulating hormone every day, if necessary, increase by 2.75 μg (37.5 IU) or 5.5 μg (75 IU) every 7 or 14 days to achieve full rather than excessive Reaction. The maximum daily dose usually does not exceed 16.5 μg (225 IU). If the patient does not respond adequately after 4 weeks of treatment, this cycle should be abandoned and a higher starting dose than the previous cycle should be used for the next treatment.

When a satisfactory response is achieved, a single dose of chorionic gonadotropin 5000-10000 IU should be injected 24 to 48 hours after the last injection of gonafin. It is recommended that patients have sex or intrauterine insemination on the day and day of injection of chorionic gonadotropin.

If the reaction is excessive, the treatment should be stopped and the human chorionic gonadotropin should be stopped (see notes).

Restart treatment at a lower dose in the next cycle.

Women who undergo ovarian stimulation to promote the development of multiple follicles before in vitro fertilization and other assisted pregnancy techniques:

Usually the superovulatory regimen starts on the second or third day of the treatment cycle, and daily injections of gonafin 11 ~ 16.5 μg (150 ~ 225IU). Monitor with serum estrogen concentration and / or ultrasound until the follicles are fully developed. Adjust the dose according to the patient's response, the daily dose is usually not higher than 33 μg (450 IU). Patients generally get full follicle development on the 10th day of treatment (range 5-20 days).

24 to 48 hours after the last injection of Gonafin, a single dose of 10,000 IU of human chorionic gonadotropin was injected to induce the final maturation of the follicles.

Gonadotropin-releasing hormone (GnRH) agonists are commonly used to down-regulate in order to suppress the endogenous LH peak and achieve the purpose of controlling the basic level of LH. Commonly used regimen is: after 2 weeks of GnRH agonist treatment, gonafin treatment is started, and then the two drugs are used at the same time until the follicles are fully developed. For example, after using the agonist for 2 weeks, 11 to 16.5 μg (150 to 225 IU) of gonafin is given daily for the first 7 days, and then the dose is adjusted according to ovarian response.

IVF experience shows that usually the success rate of the first four treatments remains stable and then begins to decrease.

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