She-Plus injection (IM/SC)

Human chorionic Gonadotropin 2000/5000/1000

Pharmacodynamic properties: She-Plus is a preparation of human chorionic gonadotrophin obtained from

the urine of pregnant women. It stimulates the steroidogenesis in the gonads by virtue of a biological effect similar to that
of LH (Luteinizing hormone, which is the same as interstitial cell stimulating hormone). In the male it promotes the
production of testosterone and in the female the production of estrogens and particularly of progesterone after ovulation.
In certain cases, this preparation is used in combination with human menopausal gonadotrophin (HMG). Because HCG is
of human origin, no antibody formation is to be expected.
Pharmacokinetic properties: Maximal hCG plasma levels will be reached in males after a single IM or SC injection of
hCG at approximately six and sixteen hours respectively, and in females after approximately 20 hours. hCG is
approximately 80 per cent metabolized, predominantly in the kidneys. IM and SC administration of hCG were found to be
bioequivalent regarding the extent of absorption and the apparent elimination half-lives of approximately 33 hours. On
basis of the recommended dose regimens and elimination half-life, cumulation is not expected to occur.
INDICATIONS & DOSAGE :
In the male: Hypogonadotrophic hypogonadism: 500 - 1,000 Units 2-3 times weekly. Delayed
puberty associated with insufficient gonadotrophic pituitary function: 1,500 Units twice weekly
for at least 6 months. Sterility in selected cases of deficient spermatogenesis: Usually, 3,000
Units per week in combination with an HMG preparation.
In the female: Sterility due to the absence of follicle-ripening or ovulation: 5000 - 10 000 Units
hCG to induce ovulation, following treatment with an HMG (human menopausal gonadotrophins)
preparation. Up to 3 repeat injections of up to 5000 Units hCG each, may be given within the
following 9 days to prevent insufficiency of the corpus luteum. In conjunction with HMG, in the
promotion of controlled superovulation in medically assisted reproduction programmes: 5000 -
10 000 Units hCG 30 - 40 hours after the last HMG injection. She-Plus should not be
administered if the following criteria have not been met: It is recommended that at least 3
follicles greater than 17mm in diameter are present with 17 oestradiol levels of at least 3500
pmol/L (920 picogram/ml). Oocyte collection is carried out 32 - 36 hours after the hCG injection.
DRUG INTERACTIONS: This medication may interfere with certain laboratory tests (including
luteinizing hormone-LH/follicle stimulating hormone-FSH levels), possibly causing false test
results
Special warnings and precautions for use:
In the female: • since infertile women undergoing assisted reproduction, and particularly
IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. • In
the pregnancies occurring after induction of ovulation with gonadotrophic preparations, there is
an increased risk of abortion and multiplets. Unwanted Hyperstimulation: During treatment of
female patients, determinations of oestrogen levels and assessment of ovarian size and if
possible, ultrasonography should be performed prior to treatment and at regular intervals during
treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g. more than
doubling on 2 or 3 consecutive days, and possibly reaching excessively high pre-ovulatory
values. The diagnosis of unwanted ovarian hyperstimulation may be confirmed by ultrasound
examination. The severe form of ovarian hyperstimulation syndrome may be life-threatening and
is characterised by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very
often hydrothrax and occasionally thrombo-embolic phenomena.
In the male: • 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. • hCG should be used cautiously in prepubertal
boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored
regularly.
Overdose: The toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead to
hyperstimulation of the ovaries.
CONTRAINDICATIONS:• Hypersensitivity to human gonadotropins or any of the substances of She-Plus.
• Presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary
disorders)
• Breast, uterine, ovarian, testicular tumours , • Vaginal bleeding of unknown cause, • Known or
suspected androgen-dependent tumours, carcinoma of the prostate or mammary carcinoma in
males.