Pregnyl 5000 IU/vial (IM/SC Injection)

Indications

• Ovulation induction in infertility due to anovulation or impaired follicle-ripening (female)
• Preparation of follicles for puncture in controlled ovarian hyperstimulation programs (female)
• Luteal phase support (female)
• Threatened and habitual abortion (female)
• Hypogonadotropic hypogonadism (male)
• Delayed puberty associated with insufficient gonadotropic pituitary function (male)
• Cryptorchidism (male)
• Treatment to oligospermia (male)

Pharmacology

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

Dosage & Administration

• Reconstituted Human Menopausal Gonadotrophin solution should be slowly administered intramuscularly
• Dosage for ovulation induction and preparation of follicles for puncture (female)
• Dosage for luteal phase support (female)
• Dosage for threatened & habitual abortion (female)
• Dosage for hypogonadotropic hypogonadism (male)

Interaction

• No interactions of clinical relevance are known

Contraindications

• Known or suspected androgen-dependent tumors

Side Effects

• Allergic reactions
• Unwanted ovarian hyperstimulation syndrome (female)
• Water and sodium retention (male)

Pregnancy & Lactation

• Pregnancy Category X
• Contraindicated in women who are or may become pregnant
• Not to be used during lactation

Precautions & Warnings

• Increased risk of multiple births
• Unwanted ovarian hyperstimulation
• Close monitoring of estrogen levels
• Potential symptoms of ovarian hyperstimulation syndrome

Use in Special Populations

• Induction of androgen secretion may induce precocious puberty in pediatric patients
• Discontinue therapy if signs of precocious puberty occur in pediatric patients
• Clinical studies did not include subjects aged 65 and over

Overdose Effects

• Acute toxicity is very low
• No symptoms of acute parenteral overdose known in humans

Therapeutic Class

• Female Sex hormones

Storage Conditions

• 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

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