Ovunal-sc

Uses

the female:

• Ovulation induction in infertility due to anovulation or impaired follicle-ripening.
• Preparation of follicles for puncture in controlled ovarian hyperstimulation programs (ART).
• Luteal phase support.
• Threatened and habitual abortion

In the male:

• Hypogonadotropic hypogonadism (also cases of idiopathic dysspermias have shown a positive response to gonadotropins).
• Delayed puberty associated with insufficient gonadotropic pituitary function.
• Cryptorchidism, (not due to anatomical obstruction)
• Used to treat oligospermia

Dosage

Ovunal-sc dosage

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

In the female: Ovulation induction and preparation of follicles for puncture: Usually, one injection of 5000- 10000IU Human Menopausal Gonadotrophinto 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 Gonadotrophinwill 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 Gonadotrophinalone.

Side Effects

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 Ovunal-sc 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. Ovunal-sc should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.

Precaution

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 Ovunal-sc 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

Interaction

No interactions of clinical relevance are known.

Pregnancy & Breastfeeding use

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

Contraindication

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

Special Warning

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.

Acute Overdose

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.

Storage Condition

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.

Innovators Monograph

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