Pregnyl 5000 IU

Pregnyl 5000 iu hcg consists of a freeze-dried powder for injection. The active ingredient [human chorionic gonadotrophin (hCG)] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity.

An ampoule contains 5000 I.U. hCG.

Powder for solution for injection. The powder is a white, dry powder or cake.

4. Clinical particulars
4.1 Therapeutic indications

In the female

Sterility due to the absence of follicle-ripening or ovulation.

In combination with FSH or HMG, promotion of controlled superovulation in medically assisted reproduction programmes.

In the male

Hypogonadotrophic hypogonadism.

Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis.
4.2 Posology and method of administration

Posology

In the female

Sterility due to the absence of follicle-ripening or ovulation.

5,000–10,000 IU hCG to induce ovulation, following treatment with an FSH (Follicle Stimulating Hormone) or HMG (Human Menopausal Gonadotrophins) preparation.

In combination with FSH or HMG, promotion of controlled superovulation in medically assisted reproduction programmes.

5,000–10,000 IU hCG 30 - 40 hours after the last FSH or HMG injection. Pregnyl should not be administered if the following criteria have not been met: at least 3 follicles greater than 17mm in diameter are present with 17ß estradiol levels of at least 3500 pmol/L (920 picogram/ml). Oocyte collection is carried out 32 - 36 hours after the hCG injection.

As luteal phase support, two to three injections of 1,000 to 3,000 IU hCG each may be given within nine days of ovulation or embryo transfer, for example on day 3, 6 and 9 after ovulation induction or embryo transfer.

In the male

Hypogonadotrophic hypogonadism.

500–1,000 IU hCG 2-3 times weekly.

Delayed puberty associated with insufficient gonadotrophic pituitary function.

1,500 IU hCG twice weekly for at least 6 months.

Sterility in selected cases of deficient spermatogenesis.

Usually, 3,000 IU hCG per week in combination with an FSH or HMG preparation.

This treatment should be continued for at least three months before any improvement in spermatogenesis can be expected. During this treatment testosterone replacement therapy should be suspended. Once achieved, the improvement may sometimes be maintained by hCG alone.

Method of Administration

After addition of the solvent to the freeze-dried substance, the solution should be given immediately by intramuscular or subcutaneous injection. Any unused solution should be discarded. Subcutaneous injection may be carried out by patient or partner, provided that proper instruction is given by the physician. Self administration of Pregnyl should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.