Prolific IM/SC Injection

Pharmacodynamic Properties: Highly Purified Human Chorionic Gonadotrophin has LH activity. LH is indispensable in normal female and male gamete growth and maturation, and gonadal steroid production.

• In the female: Human Chorionic Gonadotrophin is given as a substitute for the endogenous mid-cycle LH surge to induce the final phase of follicular maturation, leading to ovulation. Human Chorionic Gonadotrophin  is also given as a substitute for endogenous LH during the luteal phase.
• In the male: Human Chorionic Gonadotrophin is given to stimulate Leydig cells to promote the production of testosterone.

Pharmacokinetic Properties: Maximal Human Chorionic Gonadotrophin  plasma levels will be reached approximately six hours after a single injection of Human Chorionic Gonadotrophin . Human Chorionic Gonadotrophin  is for approximately 80 percent metabolized, predominantly in the kidneys. Following intramuscular injection (IM) the apparent elimination half-life of Human Chorionic Gonadotrophin  is about 2 days. On basis of the recommended dose regimens and elimination half-life, accumulation does not occur.

After addition of the solvent to the freeze-dried substance, the reconstituted Human Menopausal Gonadotrophin solution should be slowly administered intramuscularly.

In the female: Ovulation induction and preparation of follicles for puncture: Usually, one injection of 5000- 10000IU Human Menopausal Gonadotrophin to complete treatment with an FSH-containing preparation.

Luteal phase support: Two repeat injections of 2500 to 5000IU. Each may be given within nine days following ovulation or embryo transfer (for example on day 3, 6 and 9 after ovulation induction).

Threatened & habitual abortion:  5000IU Human Menopausal Gonadotrophin will be given as  deep intramuscular injection twice weekly from the time of diagnosis (all before the 7th week of gestation)

In the male: Hypogonadotropic hypogonadism: 2500 to 5000 IU Human Menopausal Gonadotrophin, two times per week. If the main complaint is sterility, additional doses of an FSH-containing (50IU FSH) are to be administered daily or two to three times a week. 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 in some cases be maintained by Human Menopausal Gonadotrophin alone.

No interactions of clinical relevance are known.

Known or suspected androgen-dependent tumours, such as prostatic carcinoma or breast carcinoma in the male.

Allergic reactions have occasionally been reported with the use of urinary gonadotrophin preparations. These mostly involve local reactions such as pain and rash at the injection site, and generalized reactions such as rash and fever.

In the female: Unwanted ovarian hyperstimulation syndrome. Which is Characteristic symptoms of unwanted ovarian hyperstimulation and the ovarian hyperstimulation syndrome are  included under 'Special warnings and special precautions for use'.

In the Male: Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production. Treatment with Prolific  leads to increased androgen production.

Therefore: Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production. Prolific should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.

Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Use in lactation: It must not be used during lactation

In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiplets birth. Unwanted ovarianhyperstimulation: In patients treated for infertility due to anovulation or impaired follicular ripening, the prior administration of an FSH containing preparation may lead to unwanted ovarian hyperstimulation. Therefore ultrasonic assessment of follicular development and determinations nations of estrogen levels should be performed prior to FSH-treatment and at regular intervals during FSH-treatment. Estrogen levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reach excessively high values. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of a treatment preparing for IVF/ET or GIFT/ZIFT), the administration of the FSH-containing preparation should be discontinued immediately. In that case Prolific must not be given, because the administration of an LH-active gonadotrophin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome. This warning is particularly important with respect to patients with polycystic ovarian disease. Clinical symptoms of mild ovarian hyperstimulation syndrome are gastro-intestinal problems (pain, nausea, diarrhoea), painful breasts, and mild to moderate enlargement of ovaries and ovarian cysts. In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening. This is characterized by large ovarian cysts (prone to rupture), ascites, often hydrothorax and occasionally

Pediatric Use: Induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.

Geriatric Use: Clinical studies of Chorionic gonadotropin for injection did not include subjects aged 65 and over.

The acute toxicity of urinary gonadotropin preparations has been shown to be very low. There are no symptoms of an acute parenteral overdose known in humans.

Female Sex hormones

There are two options:

• Store at 2°C-8°C (in refrigerator). Do not freeze.
• Store below 25°C for a single period of not more than 3 months.

Protect from light & keep in dry place.