PREGNYL 5000IU Powder for solution for injection Ref.[6665] Active ingredients: Chorionic gonadotrophin (human)

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.

The toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead to hyperstimulation of the ovaries (see OHSS, see section 4.4).

Shelf life: 36 months.

Store in refrigerator (2°C to 8°C). Do not freeze. Keep the ampoules in the outer carton to protect from light.

2ml ampoule containing freeze-dried powder with 1ml ampoule of solvent (sodium chloride 9mg/ml). Pregnyl is available in packs of 1, 3 or 10 ampoules of powder and solvent.

Not all pack sizes may be marketed.

In correspondence please quote batch number.

Pregnyl should be reconstituted with the solvent provided. Do not use if the solution contains particles or if the solution is not clear. Since an opened ampoule cannot be resealed in such a way to further guarantee the sterility of the contents, the solution should be used immediately after reconstitution. Discard any remaining solution after single use.

Any unused product or waste material should be disposed of in accordance with local requirements.