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Inofolic ®

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Brand Name
IVF-C Inj. 1000 IU, 5000 IU
Generic Name
Human Chorionic Gonadotrophin
Therapeutic Segment
Obstetrics & Gynecology, Infertility
Form
Injection

IVF-C is a preparation of human chorionic gonadotropin (hCG) extracted and purified from the urine of pregnant women. hCG is a water-soluble polypeptide hormone produced by the human placenta.

The action of hCG is virtually identical to that of pituitary although hCG also seems to have a small degree of FSH activity. In male, IVF-C is given in an attempt to stimulate the interstitial cells of the testes (cells of Leydig) to produce androgen and in female, in the second phase of the cycle, to maintain the functional integrity of the corpus luteum and to stimulate its secretion of progesterone.

In ART, IVF-C should be administered for the final development and maturation of the ovarian follicles and to trigger ovulation. Therefore, IVF-C must be given following the administration of Follimon (Urofollitropin) or IVF-M (Menotropin), once follicular maturation has occurred.

Composition

Each vial of IVF-C inj. is accompanied by a solvent vial or ampoule containing 1 ml of isotonic, sterile and pyrogen-free sodium chloride for injection.

1 vial of IVF-C contains

Human chorionic gonadotropin (USP) …………………………………… 1000 IU, 5000 IU
Excipient: D-Mannitol ………………………………………………………………20.0, 20.0 mg

Description

White or almost White lyophilized powder for injection in a clear vial.

Indications and usage

Hypogonadotropic Disorders

Cryptorchidism, Hypogonadism, Hypogonadotropic eunuchoidism, Sperm asthenia Azoospermia, Hypomenorrhea (Extended follicular phase), Hypermenorrhea or Metropathia hemorrhagica, Threatened abortion, Habitual abortion, Primary and secondary amenorrhea or Anovulatory cycle.

Dosage and Administration

1) Cryptorchidism, Hypogonadism, Hypogonadotropic eunuchoidism

If a special indication is not given, 5000 IU or l000 IU of IVF-C should be administered intramuscularly every other day for an enough time period.
Cautious monitoring should be performed to avoid excessive gonadal development and sexual pre-maturation during IVF-C administration and especially careful monitoring is required in case of young patients.

2) Sperm asthenia, Azoospermia

5000 IU of IVF-C should be administered in combination with 500 IU of menotropin everyday for 90~l20 days.

3) Hypomenorrhea( Extended follicular phase)

1000 IU IVF-C should be administered everyday through the last week of expected menstruation day.

4) Hypermenorrhea or Metropathia hemorrhagica

1000 IU of IVF-C per day should be administered during the second week of menstrual cycle. Administration of more dose than this should be made only by physician’s indication.

5) Threatened abortion

5000 IU of IVF-C should be administered immediately and can be repeated twice a day until the risk of abortion disappears. Afterwards, the dose should be diminished to 1000 IU and continued to be administered twice a week.

6) Habitual abortion

5000 IU of IVF-C should be administered every other day during the 2nd ~ 3rd months of pregnancy and 1000 IU should be continued to be administered for the following 2 months.

7) Primary and secondary amenorrhea or Anovulatory cycle

The ovary should be stimulated by the administration of proper amount of menotropin under physician’s indication during the period caused by hypopituitarism or decreased ovarian sensitivity to pituitary gonadotropin. This administration should be continued until estrogen reaches appropriate level. The ovulation should be induced by administering 2000 IU of IVF-C per day continuously for following 1-2 days.

Warnings and Precautions

1. IVF-C should not be administered to following patients

Patients with prostatic carcinoma or other androgen-dependent neoplasm and who are suspicious to have such diseases. Patients with a prior allergic reaction to gonadotropins.

Patients with precocious puberty.

2. IVF-C should be cautiously administered to following patients

Patients with prostatomegaly.

Patients with-epilepsy, migraine, asthma, and cardiac or renal disease. (Fluid retention, edema, and so on may occur since androgen production is promoted.)

3. Adverse Effects

Shock: Because shock may occur in rare cases, sufficient monitoring should be made. In case facial blush, heartburn, dyspnea, etc. occur, the administration should be discontinued and proper treatments made.

Hypersensitivity: Since rash and so on may occur, the administration should be discontinued in case of this.

Psychoneural System: Dizziness, excitation, insomnia, depression, fatigue, etc. may occur.

Circulatory System: Thrombosis and cerebral thrombosis can rarely occur.

Continuous administration for a long time: Hypersexuality, sustained penis erection, acne, and gynecomastia can occur in male and signs of masculinization such as trachyphonia, polytrichia, clitorism, acne, etc. in female.

Others: In case signs of precocious puberty occur during the administration to prepubertal patients, administration should be discontinued.

4. General Precautions

In case hCG is used after or in conjunction with a follicle stimulating hormone preparation to treat female infertility, ovarian hyperstimulation symptom such as Meigs syndrome accompanied by ovarian swelling, rupture of tumid ovary, ascites and pleural effusion may occur and caution should be made with followings.

  1. Since there is a risk of multiple birth, patients should be informed of this previously.
  2. Whether patients have subjective symptoms such as abdominal pain, abdominal discomfort, vomiting, lumbago, etc. should be cautiously monitored.
  3. Whether patients have ovarian swelling should be confirmed by an internal examination.

5. Drug Interactions

In case hCG is administered after or in combination with follicle stimulating hormone to induce ovulation, ovarian hyperstimulation syndrome such as Meigs syndrome accompanied by ovarian swelling, rupture of tumid ovary, ascites and pleural effusion may occur and furthermore thrombosis and cerebral infarction can be caused by hemeconcentration and an accentuation of blood coagulation capability.

6. Precautions on application

  1. Pain at site of injection can be caused by intramuscular injection.
  2. Because a precipitation can be made by ethanol, etc., a syringe should be used after disinfecting and Washing with a small amount of solvent accompanied.
  3. The reconstituted solution should be used immediately.

How Supplied

  1. 1000 IU: 1, 3, 10, 20 vials with solvent vials or ampoules/pack
  2. 5000 IU: 1, 3, 5, 10, 20 vials with solvent vials or ampoules/pack

Storage Condition

Shelf Life

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